[Federal Register: August 10, 2007 (Volume 72, Number 154)]
[Proposed Rules]
[Page 44992-45001]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10au07-19]
[[Page 44992]]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
37 CFR Part 1
[Docket No.: PTO-P-2006-0004]
RIN 0651-AC00
Examination of Patent Applications That Include Claims Containing
Alternative Language
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Notice of proposed rule making.
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SUMMARY: The United States Patent and Trademark Office (Office) is
proposing to revise the rules of practice pertaining to any claim using
alternative language to claim one or more species. The search and
examination of such claims often consume a disproportionate amount of
Office resources as compared to other types of claims, because
determining the patentability of these claims often requires a separate
examination of each of the alternatives within the claims. The Office
expects that requiring applicants who choose to draft claims that read
on multiple species using alternative language to maintain a certain
degree of relatedness among the alternatives will enable the Office to
do a more thorough and more reliable examination of such claims.
Comment Deadline Date: To be ensured of consideration, written comments
must be received on or before October 9, 2007. No public hearing will
be held.
ADDRESSES: Comments should be sent by electronic mail message over the
Internet addressed to markush.comments@uspto.gov. Comments may also be
submitted by mail addressed to: Mail Stop Comments--Patents,
Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313-1450, or
by facsimile to (571) 273-7754, marked to the attention of Kathleen
Kahler Fonda, Legal Advisor, Office of the Deputy Commissioner for
Patent Examination Policy. Although comments may be submitted by mail
or facsimile, the Office prefers to receive comments via the Internet.
If comments are submitted by mail, the Office prefers that the comments
be submitted on a DOS formatted 3\1/2\-inch disk accompanied by a paper
copy.
Comments may also be sent by electronic mail message over the
Internet via the Federal eRulemaking Portal. See the Federal
eRulemaking Portal Web site (http://www.regulations.gov) for additional
instructions on providing comments via the Federal eRulemaking Portal.
The comments will be available for public inspection at the Office
of the Commissioner for Patents, located in Madison East, Tenth Floor,
600 Dulany Street, Alexandria, Virginia, and will be available through
anonymous file transfer protocol (ftp) via the Internet (http://www.uspto.gov
). Because comments will be made available for public
inspection, information that the submitter does not desire to make
public, such as an address or phone number, should not be included in
the comments.
FOR FURTHER INFORMATION CONTACT: Kathleen Kahler Fonda, Legal Advisor,
Office of the Deputy Commissioner for Patent Examination Policy, by
telephone at (571) 272-7754; by mail addressed to: Box Comments
Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-
1450; or by facsimile to (571) 273-7754, marked to the attention of
Kathleen Kahler Fonda.
SUPPLEMENTARY INFORMATION:
I. Background Information. As part of its ongoing efforts to
enhance patent quality and reduce pendency in accordance with the 21st
Century Strategic Plan, the Office is proposing to revise its treatment
of claims that recite alternatives, whether the claims use Markush or
other forms of alternative language. While the origins of the Markush
claim drafting technique lie in the chemical arts, claims that recite
alternatives are now commonplace in all areas of technology. Applicants
sometimes use Markush or other alternative formats to claim multiple
inventions and/or to recite hundreds, if not thousands, of alternative
embodiments of a single invention in one claim. Proper search of such
complex claims, particularly those using Markush language, often
consume a disproportionate amount of Office resources as compared to
other types of claims. The prosecution of these complex claims likewise
often requires separate examination and patentability determinations
for each of the alternatives within the claim, e.g., if the
alternatives raise separate prior art, enablement, or utility issues.
Furthermore, the variety and frequency of alternatives recited in
claims filed in applications pending before the Office, driven in part
by trends in emerging technologies, have exacerbated problems with
pendency.
In addition to comments on the proposed rules, the Office welcomes
further suggestions for changes that would improve the examination of
claims that recite Markush or other alternative language while
appropriately balancing the interests of the Office with those of
applicants and the public. The Office expects that improving practices
pertaining to claims that recite alternatives will enhance its ability
to grant quality patents that effectively promote innovation in a
timely manner.
A. Brief History of Office Treatment of Claims that Recite
Alternatives. Claims that define species within the scope thereof by
enumeration are now commonplace in all areas of technology. However,
the Office had formerly deemed them unacceptable, apparently for
failure to comply with the definiteness requirement of 35 U.S.C. 112.
See Manuel C. Rosa, Outline of Practice Relative to ``Markush'' Claims,
34 J. Pat. Off. Soc'y 324, 324 (1952); Manual of Patent Examining
Procedure (MPEP) section 706.03(d) (2nd Ed. 1953). In Ex parte Markush,
1925 Dec. Comm'r Pat. 126, 128 (1924), the Office officially sanctioned
a claim drafting technique, already in use for some time, wherein the
phrase ``selected from the group consisting of'' is followed by a
closed listing of specific members of the group. Claims including such
language became known as ``Markush claims.'' For example, if a claim to
a chemical composition requires a particular alcohol, that alcohol
could be defined via Markush language such as ``an alcohol selected
from the group consisting of methanol, ethanol, and isopropanol;'' or
``an alcohol of the formula R-OH, wherein R is selected from the group
consisting of CH3-, CH3CH2-, and
(CH3)2CH-.''
In addition to the indefiniteness issue, another factor giving rise
to claims using Markush language was
the change from claims based on the central type of definition to
those based on the peripheral definition. With the peripheral-type
claims came the necessity of avoiding invalidity by reason of
inoperative species which might be included within the metes and
bounds of the claim. In mechanical cases, this problem is overcome
by the use of elements defined as ``means'' but chemical claims do
not lend themselves well to such a solution due to the fact that
equivalence in chemical cases is difficult to establish. The Markush
claim may be regarded as a partial solution to this problem, since
it permits an applicant to claim a subgeneric group containing those
materials which have been actually tested and known by applicant to
be operable.
Richard L. Kelly, et al., Markush Claims, 37 J. Pat. Off. Soc'y 164,
171 (1955). Thus, Markush practice arose from a need to address
problems presented in claiming chemical compounds when an applicant
could only define his or her invention by setting forth at least one
set of alternatives from which a selection must be made. Most of the
court decisions concerning claims that recite
[[Page 44993]]
alternatives involve Markush practice and reflect problems associated
with claiming compounds by their chemical structure.
The Office has long wrestled with problems associated with Markush
claiming. As noted in a 1935 review article:
[T]he extent to which the patent professional * * * made use of
the Markush formula indicated that its application had gone far
afield of the original intent. It was like a fire which had spread
beyond control. It became the medium through which totally unrelated
substances could be assembled under the guise of a genus. * * * If
one member were found to be old or inoperative, that one was
stricken from the group, and the diminished group reasserted with
renewed vigor. In such a case the search required was for as many
individual species as there were members recited in the group.
V.I. Richard, Claims Under the Markush Formula, 17 J. Pat. Off. Soc'y
179, 190 (1935).
By the 1950s, the Office generally viewed members of a proper
Markush group as patentably indistinct from each other. See Manuel C.
Rosa, U.S. Dep't of Commerce, Training Manual for Patent Examiners:
Outline of Practice Relative to ``Markush'' Claims 11 (1958) (``These
decisions uniformly hold that a reference for one of the members of the
group is a reference for the entire group.'') (citing In re Ayres, 83
F.2d 297, 29 USPQ 424 (CCPA 1936); Ex parte Ellis, 18 J. Pat. Off.
Soc'y 731 (1936) (abstract only); Ex parte Rutherford, 63 USPQ 102 (Bd.
Pat. App. 1943); Ex parte Watt, 63 USPQ 163 (Bd. Pat. App. 1942); Ex
parte Schroy, 26 J. Pat. Off. Soc'y 498 (1944) (abstract only)). In
1958, the Court of Customs and Patent Appeals (CCPA), predecessor of
the current Court of Appeals for the Federal Circuit (Federal Circuit),
explained that Markush claims ``were originally regarded as an
exception to the previously acceptable claim terminology and were
rigidly restricted to groups of substances belonging to some recognized
class.'' In re Ruff, 256 F.2d 590, 598, 118 USPQ 340, 348 (CCPA 1958).
However, Markush practice had been substantially liberalized in that
``the original rigid, emergency-engendered restrictions have been
progressively relaxed through the years to the point where it is no
longer possible to indulge in a presumption that the members of a
Markush group are recognized by anyone to be equivalents except as they
`possess at least one property in common which is mainly responsible
for their function in the claimed relationship.' '' Ruff, 256 F.2d at
599, 118 USPQ at 348 (quoting MPEP section 706.03(y) (2nd ed. 1953)).
The Ruff court concluded that in view of such liberalization, the mere
fact that components were claimed as members of a Markush group could
not be relied upon to establish the equivalency of these components.
However, the Ruff court acknowledged that an applicant's expressed
recognition of an art-recognized or obvious equivalent could be used as
evidence that such equivalency does exist. See Ruff, 256 F.2d at 595,
118 USPQ at 345.
After the Ruff decision, the Office tried several approaches to
rein in administrative problems arising from Markush claims. These
included rejecting claims on the following bases: 35 U.S.C. 112, ] 2;
35 U.S.C. 121 (accompanied by a restriction requirement and withdrawal
of the claim); and a ``judicially created doctrine'' of improper
Markush grouping. See Edward C.Walterscheid, Markush Practice
Revisited, 61 J. Pat. Off. Soc'y 270, 271 (1979). However, the CCPA
clearly enunciated its view that these statute-based rejections were
improper. In In re Wolfrum, the court held that it is improper to
reject a Markush claim under 35 U.S.C. 112, ] 2, merely because more
than one independent and distinct invention is encompassed by the
claim. 486 F.2d 588, 591, 179 USPQ 620, 622 (CCPA 1973). In a later
case, the court explained that 35 U.S.C. 121 ``provides the
Commissioner with the authority to promulgate rules designed to
restrict an application to one of several claimed inventions when those
inventions are found to be `independent and distinct.' It does not,
however, provide a basis for an examiner acting under the authority of
the Commissioner to reject a particular claim on that same basis.'' In
re Weber, 580 F.2d 455, 458, 198 USPQ 328, 331-32 (CCPA 1978) (emphases
in original). Notably, although it determined that there was no
statutory basis for rejecting a claim under 35 U.S.C. 121, the Weber
court remanded the case to the Office for consideration of a
doctrinally based ``improper Markush claim'' rejection. See also In re
Haas, 486 F.2d 1053, 1054, 179 USPQ 623, 626 (CCPA 1973) (holding that
following a restriction requirement, the withdrawal of a Markush claim
from consideration not only in the application at issue but
prospectively in any subsequent application on the basis of its content
was effectively a rejection of that claim).
Shortly after Weber and Haas, the CCPA provided a detailed analysis
of Markush practice in In re Harnisch, 631 F.2d 716, 206 USPQ 300 (CCPA
1980). In that case, the Office rejected a claim drawn to coumarin
compounds useful as dyes based on a judicially created doctrine,
gleaned by the Office Board of Appeals (Board) from a number of cited
CCPA decisions, as reciting an improper Markush group. According to the
Board, both final product dyes and intermediate compounds from which
they could be synthesized were within the scope of the claim, and the
claim failed for misjoinder because some species within its scope were
not ``functionally equivalent'' to others. The court reversed the
Board's decision, explaining that it is improper for the Office to
refuse to examine that which applicants regard as their invention,
unless the subject matter of the claim lacks ``unity of invention.'' In
tracing the history of ``improper Markush'' rejections, the court
observed:
In the early years of the development of Markush practice, many
of the cases involved the problem of clarity--avoiding the
uncertainties of alternatives and the like. More recently, the cases
have centered on problems of scope, which are related to enablement.
Assuming enablement, however, there remains a body of Markush-
practice law regarding Markush-type claims, particularly in the
chemical field, concerned more with the concept of what might be
better described as the concept of unity of invention. At least the
term would be more descriptive and more intelligible internationally
than is the more esoteric and provincial expression 'Markush
practice.' It is with this unity of invention concept in mind that
we approach the propriety of the appealed claims.
631 F.2d at 721, 206 USPQ at 305.
The Harnisch court then explained that the Office had a ``perfect
right'' to rely on rules derived from case law ``to determine whether
the claims before it were or were not in proper form to be examined for
patentability.'' 631 F.2d at 720, 206 USPQ at 304. The Harnisch court
further suggested that the Office consider exercising its rule making
powers to forestall procedural problems arising from Markush claims.
631 F.2d at 722 n.6, 206 USPQ at n.6. While it is clear from Harnisch
that the CCPA was not hostile to the concept of ``improper'' Markush
claims, the Office has not received further guidance from its reviewing
courts as to the propriety of a Markush rejection since Harnisch.
The struggle to balance the needs of inventors for coverage of the
full scope of their inventions with those of the Office for search and
examination responsibilities commensurate in scope with resources is a
long-standing one. The Office ``must have some means for controlling
such administrative matters as examiners' caseloads and the amount of
searching done per filing fee.'' Weber, 580 F.2d at 458, 198 USPQ at
332. Controlling examiners' caseloads is a
[[Page 44994]]
much more significant concern in 2007 than it was in 1978. The volume
and complexity of patent applications continue to outpace the examining
corps' current capacity to examine them. The result is a pending--and
growing--application backlog of historic proportions. Thus the Office
does not believe that controlling the amount of searching per filing
fee will, by itself, resolve the administrative issues raised by the
use of Markush or alternative language.
For a more comprehensive review of the history of Markush claiming,
see V.I. Richard, Claims Under the Markush Formula, 17 J. Pat. Off.
Soc'y 179 (1935); Richard L. Kelly, et al., Markush Claims, 37 J. Pat.
Off. Soc'y 164 (1955); Edward C. Walterscheid, Markush Practice
Revisited, 61 J. Pat. Off. Soc'y 270 (1979); and In re Harnisch, 631
F.2d 716, 206 USPQ 300 (CCPA 1980).
B. Claims Reciting Alternatives. Claims that use alternative
language to define multiple species are often confusing and complex,
and frequently border on being unmanageable. A single claim may
continue for pages; even relatively short claims may encompass millions
of species in the alternative. Claims that recite alternatives,
especially in the chemical and biotechnological arts, often describe
alternatives which themselves have multiple, nested points of variation
or other complex variations, or set forth alternatives that lack either
a shared utility or a common structure.
Markush formats and other forms of alternative language are
generally used in two different contexts. First, a chemical compound or
a portion thereof (either claimed as such, or as a component of a
process or composition), may be defined using Markush language. In
Harnisch, the court found that the claimed compounds, which were
defined as members of a Markush group, had ``unity of invention''
because they shared a common function as dyes, and shared a substantial
structural feature as coumarin compounds. 631 F.2d at 722, 206 USPQ at
305. Current Office practice, stemming from Harnisch, is that compounds
that are defined by Markush language are directed to a single invention
(i.e., have ``unity of invention'') when they ``(1) share a common
utility, and (2) share a substantial structural feature essential to
that utility.'' See MPEP 803.02 (8th Ed., Rev. 5, Aug. 2006). Second,
entire process steps or components of a claimed invention, rather than
a single compound or portion(s) thereof, may be defined using
alternative language. According to current Office policy, Markush
format is acceptable when defining such process steps or components if
all the members of the group possess at least one property in common
which is mainly responsible for their function in the claimed
relationship, and it is clear from their very nature or from the prior
art that all of them possess this property. See MPEP 2173.05(h) (8th
Ed., Rev. 5, Aug. 2006).
1. Example of Markush Format Alternative Language. Typical examples
of apparently straightforward claims using the Markush format can be
found in the PCT International Search and Preliminary Examination
Guidelines (PCT Guidelines), Chapter 10 (available at http://www.wipo.int/pct/en/texts/pdf/ispe.pdf
). Examples of such claims are
set forth in paragraphs 10.38--10.45; paragraphs 10.52--10.59 therein
address unity of invention issues specifically pertaining to
biotechnological inventions.
Example 24 from the PCT Guidelines, reproduced below, is
illustrative of an apparently straightforward claim which would
actually be quite complex to search and examine.
10.44 Example 24
Claim 1: A pharmaceutical compound of the formula: A--B--C--D--E
Wherein:
A is selected from C1-C10 alkyl or alkenyl or
cycloalkyl, substituted or unsubstituted aryl or C5-
C7 heterocycle having 1-3 heteroatoms selected from O and
N;
B is selected from C1-C6 alkyl or alkenyl or
alkynyl, amino, sulfoxy, C3-C8 ether or
thioether;
C is selected from C5-C8 saturated or
unsaturated heterocycle having 1-4 heteroatoms selected from O, S or
N or is a substituted or unsubstituted phenyl;
D is selected from B or a C4-C8 carboxylic
acid ester or amide; and
E is selected from substituted or unsubstituted phenyl, naphthyl,
indolyl, pyridyl, or oxazolyl.
This claim reads on approximately 2.564 x 1023 possible
species, there is no substantial feature shared by all species, and
there is no indication that the species share a specific common
utility. Claims in patent applications, especially those in the
chemical and biotechnological arts, are often significantly more
complex to search and examine than the apparently straightforward
example above.
2. Examples of Other (Non-Markush) Alternative Language. Claims
that recite alternatives usually define species that fall within the
scope of a claim; however, such claims occasionally recite a list of
species that are excluded from the scope of a claim. The most common
forms of claims that set forth alternatives employ the phrase
``selected from the group consisting'' or the term ``or.'' Other claim
limitations written in an alternative form that do not use these
phrases include, for example, the following:
(1) ``A composition comprising any 10 molecules from Table 1''
(wherein Table 1 includes 1000 chemical formulas);
(2) ``A protein having SEQ ID NO: 1, wherein any polar residue
may be substituted by a proline residue;'' or ``a protein having SEQ
ID NO: 2'' (where a review of SEQ ID NO: 2 of the sequence listing
shows that at certain positions, specific alternative variations are
permitted); and
(3) ``A polypeptide consisting of a contiguous 10-mer fragment
of SEQ ID NO: 3'' (where a review of the sequence listing shows that
fully defined SEQ ID NO: 3 is 200 residues long, and thus the claim
reads upon plural fragments in the alternative: residues 1-10,
residues 2-11, residues 3-12, etc.).
3. Example of Alternative Language in Process Claims. Although the
above examples are directed to product claims, process claims also may
be drafted in alternative language format. A process claim could, for
example, recite a list of alternative active steps or achieve a list of
alternative effects. Thus, a process claim employing alternative
language could require the same product to achieve different effects,
or require different products to achieve the same effect. Furthermore,
such a process claim could recite two features which vary. A simple
example of such a claim is:
``A process of administering product A, B, or C to treat disease
D, E, or F.'' Such a claim would read upon a matrix of nine species
wherein the species do not all require either administering the same
product or treating the same disease.
C. Current Practice With Respect to Claims Reciting a Markush
Group. Current Office policy requires examination of all species of a
claim that recites a Markush group when the alternatives are
sufficiently few in number or so closely related that search and
examination can be made without serious burden. See MPEP 803.02 (8th
Ed., Rev. 5, Aug. 2006). Consistent with the Harnisch decision, the
Office cannot refuse to examine what applicants regard as their
invention unless the subject matter in a claim lacks unity of
invention. As a result, even where the search and examination of a
claim that has ``unity of invention'' would require serious burden, the
examiner must determine the patentability of the claim. In such case,
however, the examiner may require applicant to elect a single species
under 37 CFR 1.146 for initial search and examination to facilitate
examination on the merits. If the elected species is not allowable,
examination of the Markush claim will be limited to the
[[Page 44995]]
elected species and any species not patentably distinct therefrom, and
any separate claims to the elected species and any species not
patentably distinct therefrom. See MPEP 803.02 (8th Ed., Rev. 5, Aug.
2006). Claims drawn to species patentably distinct from the elected
species are held withdrawn from further consideration. If the elected
species is allowable, then the search and examination of the Markush
claim will be extended to non-elected species to the extent necessary
to determine patentability of the claim. This may require a separate
search and examination of each alternative claimed, i.e., a separate
patentability determination of each non-elected species.
The Harnisch court did not set forth a generally applicable test
for the Office to follow in determining whether, in an application
filed under 35 U.S.C. 111(a), alternatives within a claim have ``unity
of invention,'' nor did it suggest a specific mechanism by which the
Office could refuse to examine a claim that lacks ``unity of
invention.'' The procedure described in the paragraph above applies
when the alternatives within a claim have ``unity of invention.''
However, to date, the Office has not established official procedures
for examiners to follow when examining a claim that recites
alternatives wherein the alternatives lack ``unity of invention'' or
for restricting an application to one invention where multiple
independent and distinct inventions are recited as alternatives in a
single claim. The Office is proposing to revise the rules of practice
to provide such procedures.
D. Proposed Treatment of Claims that Recite Alternatives. In a
separate rule making, the Office proposed to revise the rules of
practice relating to the examination of claims in patent applications
to focus its initial examination on a limited number of claims. See
Changes to Practice for the Examination of Claims in Patent
Applications, 71 FR 61 (Jan. 3, 2006), 1302 Off. Gaz. Patent Office
1329 (Jan. 24, 2006) (proposed rule). Applicants should not be
permitted to circumvent the proposed claims rules by presenting a
single claim that sets forth multiple independent and distinct
inventions in the alternative. Although comments were requested
regarding how claims that read on multiple species using alternative
language should be counted for purposes of proposed 37 CFR 1.75(b)(1),
the Office did not propose a specific rule change to address the issue.
Furthermore, the comments received from the public did not address the
issue of how to treat a single claim that encompasses more than one
independent and distinct invention.
Regardless of whether the proposed rules pertaining to the number
of claims are promulgated, the Office needs to address the challenges
created by claims that employ alternative language, particularly
Markush language, for the reasons discussed above. As noted above,
applicants in all areas of technology have been filing increasing
numbers of claims that employ alternative language; the complexity and
variety of the format of those claims are also on the rise. To enable
the Office to do a better, more thorough and reliable examination of
such claims, the Office is proposing rules to limit each claim to a
single invention and to define acceptable formats for claims that set
forth alternatives. These proposed rules are not intended to change
current restriction practice with regard to multiple independent and
distinct inventions claimed in separate claims of an application.
Rather, they are intended to provide a mechanism by which the Office
can require a single claim to be limited to a single invention.
1. Each claim must be limited to a single invention. A claim that
is directed to multiple independent and distinct inventions would meet
the statutory eligibility requirement for restriction set forth in 35
U.S.C. 121:
If two or more independent and distinct inventions are claimed
in one application, the Director may require the application to be
restricted to one of the inventions. * * *
35 U.S.C. 121.
Through the use of the word ``may,'' the statute is permissive, not
mandatory, and gives the Director discretion to require restriction.
Thus, the Office proposes that if a single claim defines multiple
independent and distinct inventions, the examiner may apply a
restriction requirement before examination. In determining whether a
claim is limited to a single invention, the claim as a whole must be
considered; the discrete components of the claim are not to be analyzed
in isolation. See, e.g., Diamond v. Diehr, 450 U.S. 175, 188-89, 209
USPQ 1, 9 (1981); W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d
1540, 1548, 220 USPQ 303, 309 (Fed. Cir. 1983).
As a general principle, a claim that encompasses more than one
species, but does not list alternatives, defines one generic invention.
If such a claim were restricted, the generic invention might never be
examined as a whole if the claim were divided into parts. Weber, 580
F.2d at 458, 198 USPQ at 330 (``The totality of the resulting
fragmentary claims would not necessarily be the equivalent of the
original claim.''). Although dividing one generic claim by restriction
may not be appropriate under Weber, making a requirement for an
election of species for initial search and examination purposes would
be permissible under Sec. 1.146. This procedure provides a practical
way to examine a large genus:
Restriction of the members which applicants are permitted to
combine in the Markush group evolved from the administrative
principle promulgated by the Patent Office that only a single
invention can be claimed in a single application. The reason for
such a rule is based upon the very real necessity of avoiding
multiple searches for a single fee. Consequently, the problem of
proper grouping is simply one of administration, and restriction of
members which properly may be combined in a Markush group is solely
based on the premise that only one invention may be claimed in any
one application.
Kelly, 37 J. Pat. Off. Soc'y at 171-172. See also the Office commentary
quoted by the court in In re Feight, 181 F.2d 206, 209, 85 USPQ 274,
277 (CCPA 1950):
The appellant's position, therefore, amounts to this: that an
applicant may include claims to a number of independent inventions
in a single application and, by also including one or more claims,
however improper, which recite all of these inventions, may compel
the Patent Office to act upon the merits of all his claims. The mere
statement of this proposition seems sufficient to show its
unsoundness since, if accepted, it would be possible for an
applicant to obtain an examination of an unlimited number of
independent inventions for a single fee, by including in his
application a claim which catalogued all of them.
If any portion of a claim requires selection from a list of
alternatives, then the claim as a whole should be treated as a claim
that reads on multiple species using alternative language, and would be
subject to the provisions of proposed Sec. Sec. 1.75(j) and 1.140. For
example, the following claims define the same subject matter:
1. A composition comprising component 1 selected from the group
consisting of A, B, and C and component 2 selected from the group
consisting of D, E, and F.
2. A composition comprising AD, AE, AF, BD, BE, BF, CD, CE, or CF.
In the above example, AD, AE, AF, etc., each represent individual
alternative species. Determining whether the claimed subject matter is
limited to a single invention does not depend on there being a
community of properties among the variable members of the Markush
expressions themselves (A, B, C, etc.), but rather depends on
[[Page 44996]]
whether the individual species (AD, AE, AF, etc.) within the scope of
the claim define a single invention. This is not always a
straightforward task, especially when claims employ complex alternative
language.
In the 1950s, as a general rule, members of a proper Markush group
were not considered to be patentably distinct from each other. Training
Manual for Patent Examiners: Outline of Practice Relative to
``Markush'' Claims at 11. That practice ended when the court in Ruff,
quoting MPEP 706.03(y) (2nd ed. 1953), indicated that Markush practice
had been liberalized to such an extent that the mere fact that
components were claimed as members of a Markush group could not be
relied upon to establish the equivalency of these components. 256 F.2d
at 599, 118 USPQ at 348. However, the court also observed that an
applicant's expressed recognition of an art-recognized or obvious
equivalent may be used as evidence that such equivalency does exist.
256 F.2d at 595, 118 USPQ at 345. Similarly, in a later case, the
Commissioner of Patents determined that if there is an express
admission that claimed species would have been obvious over each other
within the meaning of 35 U.S.C. 103, an examiner should not require
restriction. See In re Lee, 199 USPQ 108, 109 (Comm'r Pat. 1978).
In addition to proposing a requirement limiting a claim to a single
invention, the Office is proposing to specify that when subject matter
that reads on multiple species is defined in a single claim using
alternative language, the claim is limited to a single invention when
at least one of the following two conditions is met: (1) All of the
species encompassed by the claim share a substantial feature essential
for a common utility, or (2) all of the species are prima facie obvious
over each other. The first definition is based on the guidance provided
by the CCPA in In re Harnisch. The second definition codifies the long-
standing principle that it is improper to restrict between species that
are prima facie obvious over each other.
The Office proposes to encourage applicants, when filing a claim
that employs alternative language, to provide an explanation as to why
the claim is directed to a single invention. Applicant may explain, for
example, that the species share a substantial feature essential for a
common utility. The feature could be a common structure, material, or
act necessary for at least one shared specific, substantial, and
credible utility (i.e., 35 U.S.C. 101 utility). Alternatively,
applicant may explain that the species are prima facie obvious over
each other.
When applicant submits an explanation in a timely manner, the
examiner will fully consider it. If convincing, the examiner will not
object to the claim as being directed to more than one invention, nor
will restriction be required under proposed Sec. 1.140. Where the
examiner disagrees with an applicant's statement under proposed Sec.
1.140(b), the examiner must provide an explanation why applicant's
statement is not convincing and why the claim is not limited to a
single invention. The Office is of the opinion that providing
applicants with the opportunity to explain upon filing why a claim that
reads on multiple species using alternative language complies with the
proposed rule ultimately will reduce the number of restriction
requirements and shorten the overall time to a first Office action on
the merits of the claims.
As noted above, the Office proposal defines two ways in which a
claim that employs alternative language would meet the requirement of
being limited to a single invention. However, a claim that encompasses
more than one embodiment by using generic terminology (i.e., without
requiring selection from of a list of alternatives) would not be
subject to the provisions of Sec. 1.140. For example, a claim reciting
the generic limitation ``a means for attaching,'' in the context of a
specification that discloses staples, tape, and glue as suitable means
would encompass several species. However, the ``means for attaching''
limitation would not subject the claim to the provisions of Sec.
1.75(j) or (k) or Sec. 1.140 because the claimed invention does not
require, and is not limited to, the means specifically disclosed in the
specification. By contrast, a claim reciting the limitation ``an
attachment means selected from the group consisting of staples, glue,
or tape'' would be subject to the provisions of proposed Sec. 1.75(j)
and (k) and Sec. 1.140.
The Office also proposes that if an application seeks the benefit
under title 35, United States Code, of a prior-filed application and
discloses subject matter that was not disclosed in the prior-filed
application, the applicant must identify which claim or claims in the
application are disclosed in the manner provided by the first paragraph
of 35 U.S.C. 112 in the prior-filed application. This proposal would
reduce examination complexities and identify situations wherein a prior
art reference that anticipates or renders prima facie obvious at least
one species within the scope of a claim would not be available as prior
art against another species if that species was set forth in a separate
claim.
2. Format Requirements for a Claim With Species Presented as a Set
of Alternatives. Under current practice, a claim that sets forth
multiple independent and distinct inventions in the alternative via
Markush format is examined in accordance with MPEP 803.02. Applicants
frequently present claims that define alternative species in a complex
manner, e.g., defining alternatives by reference to a set of additional
alternatives, setting forth alternatives that encompass the same
species, and listing components that are not interchangeable as
alternatives. Given the administrative difficulties that arise during
the search and examination of claims that present species using
alternative language and the proposal to require each claim to be
limited to a single invention, the Office proposes to require a
simplified format for the presentation of such claims and to set forth
conditions that must be met by any claim that uses alternative
language. It is generally understood that ``members of [a] Markush
group are * * * alternatively usable for the purposes of the
invention.'' In re Driscoll, 562 F.2d 1245, 1249, 195 USPQ 434, 436
(CCPA 1977). Similarly, with regard to international applications, the
PCT Guidelines (paragraph 5.18) specifies that a claim can contain
alternatives ``provided those alternatives are of a similar nature and
can fairly be substituted one for another, and provided also that the
number and presentation of alternatives is a single claim does not make
the claim obscure or difficult to construe.'' The Office proposes to
adopt language similar to that in the PCT Guidelines, specifically
requiring that the number and presentation of alternatives in the claim
not make the claim difficult to construe, and requiring that each
alternative within a list of alternatives must be substitutable one for
another. In addition, to reduce the complexity of determining whether a
claim is directed to a single invention, the Office proposes to specify
that no alternative may itself be defined as a set of further
alternatives. Finally, the Office proposes to specify that no
alternative may be encompassed by any other alternative within a list
of alternatives, unless there is no other practical way to define the
invention. When alternatives partially overlap in scope, it is more
difficult to determine whether a single claim encompasses more than one
invention. Thus, a single claim that includes alternatives that either
fully overlap
[[Page 44997]]
(e.g., ``selected from the group consisting of an adhesive agent, tape,
and glue'') or partially overlap (e.g., ``selected from the group
consisting of citrus fruits and tropical fruits'') in scope may be
subject to an objection. Applicants should file a series of individual
claims from the broadest scope that they feel they are entitled to the
narrowest scope they are willing to accept. Put differently, applicant
should narrow the scope of protection sought via separate claims and
not via nested sets of overlapping alternatives.
Discussion of Specific Rules
Title 37 of the Code of Federal Regulations, Part 1, is proposed to
be amended as follows:
Section 1.75: Section 1.75(a) is proposed to be amended by adding
the proviso that a claim must be limited to a single invention. While
it has long been Office policy to exercise the discretionary authority
granted in 35 U.S.C. 121 to restrict an application to a single
invention, the Office has not yet established mechanisms for objecting
to the format of a single claim that is directed to multiple
independent and distinct inventions, or restricting a single claim to a
single invention. Proposed Sec. 1.75(a) would provide the basis for
objecting to the format of a claim that is directed to two or more
independent and distinct inventions. See also the proposed addition of
Sec. 1.140, which provides for the restriction of a claim to a single
invention, and the proposed amendment to Sec. 1.142(b), which provides
that the propriety of a requirement for restriction will be determined
without regard to whether the plural inventions are recited in separate
claims or as alternatives within a single claim.
Section 1.75(d)(2) is proposed to be amended by deleting the
reference to Sec. 1.141 to Sec. 1.146 as unnecessary in view of
proposed changes to those rules. Paragraph (d)(2) is also proposed to
be amended by adding the proviso that if an application seeks the
benefit under title 35, United States Code, of a prior-filed
application and discloses subject matter that was not disclosed in the
prior-filed application, the applicant must identify which claim or
claims in the application are disclosed in the manner provided by the
first paragraph of 35 U.S.C. 112 in the prior-filed application.
Section 1.75(e) is proposed to be amended to replace ``the nature
of the case admits, as in the case of'' with ``the application
describes a claimed invention as'' to use more current terminology.
Paragraphs (e)(1) and (e)(3) are proposed to be amended to replace the
word ``combination'' with ``invention'' to clarify that this provision
is applicable to any claimed invention, not just one considered to be a
combination.
Section 1.75(j) is proposed to be added to set forth the required
format for a claim that reads on multiple species using alternative
language. A claim that does not comply with the provisions of this
section would be subject to an objection. The Office proposes to add
paragraph (j)(1) to specify that the number and presentation of
alternatives in a claim must not make the claim difficult to construe.
The proposed rule language is consistent with that of the PCT
Guidelines (paragraph 5.18). Paragraphs (j)(2) and (j)(3) are proposed
to be added to specify that no alternative can itself be defined as a
set of further alternatives within a claim and that no alternative can
be encompassed by any other alternative within a list of alternatives,
unless there is no other practical way to define the invention.
Section 1.75(j)(4) is proposed to be added to require each
alternative within a list of alternatives to be substitutable one for
another. The proposed rule is consistent with paragraph 5.18 of the PCT
Guidelines and current Office practice (see MPEP 2173.05(h)). Thus a
claim that employs alternative language would not be in a proper format
unless all of the alternatives are interchangeable, and substitution of
one for another would result in the same invention.
Section 1.75(k) is proposed to be added to specify that a claim
must be self-contained, without incorporating another part of the
specification or drawings by reference, unless there is no other
practical way to define the invention. If a claim incorporates another
part of the specification or drawings by reference, and that portion of
the specification or drawings defines a set of alternatives, the claim
must comply with, and is subject to the provisions of, paragraph (j) of
this section and Sec. 1.140. This section is proposed to be added to
ensure that a claim would receive the same treatment whether defined by
alternative language explicitly set forth in the claim or defined by
alternative language that is incorporated by reference to another
portion of the specification.
Section 1.140: Section 1.140 is proposed to be added to require a
claim to be limited to a single invention in applications filed under
35 U.S.C. 111(a). Paragraph (a) is proposed to be added to specify that
a claim presenting alternatives must be limited to a single invention,
and to specify that a claim would be considered as limited to a single
invention where all the species encompassed by the claim meet at least
one of the following two conditions: (i) Share a substantial feature
essential for a common utility, or (ii) are prima facie obvious over
each other.
Alternatives share a substantial feature necessary for a common
utility when they share a utility that complies with the requirements
of 35 U.S.C. 101. A substantial feature in this context is a feature,
such as a particular structure, material, or act, without which the
claimed alternatives would not retain the shared utility.
Paragraph (b) is proposed to be added to indicate that the
presentation of a claim that reads on multiple species using
alternative language may be accompanied by a statement explaining why
the claim is limited to a single invention. This would provide the
applicant with the opportunity to present an explanation as to why a
claim is limited to a single invention before the Office determines
whether an objection under proposed Sec. 1.75(a) or a restriction
requirement under proposed Sec. 1.142 would be proper.
Section 1.141: Section 1.141(a) is proposed to be revised by
replacing ``may not'' with the more permissive term ``should not'' in
the context of claiming two or more independent and distinct inventions
in one application. The proposed revision is consistent with current
practice as the Director has not made restriction mandatory.
Furthermore, the ``exception'' language in paragraph (a), i.e., that
different species may be specifically claimed in different claims
provided the application also includes an allowable claim generic
thereto, is proposed to be deleted. If the application includes an
allowable generic claim, restriction would be improper and the generic
claim would define a single invention.
Section 1.141(b) is proposed to be revised to clarify when
restriction would be appropriate where an application claims a product,
a process of making that product, and a process of using that product.
The proposed revision clarifies that a three-way restriction
requirement can be made only where the process of making the product is
distinct from the product, the process of using the product is distinct
from the product, and the processes of making and using the product are
distinct from each other.
Section 1.142: Section 1.142(a) is proposed to be revised to
specify that the provisions therein authorize restriction requirements
in applications filed under 35 U.S.C. 111(a).
[[Page 44998]]
The content of current paragraph (b) of Sec. 1.142 is proposed to
be moved to paragraph (d) and further modified. Section 1.142(b) as
proposed recites that the propriety of a restriction requirement will
be determined without regard to whether plural inventions are recited
in separate claims or as alternatives within a single claim. This
proposal, which substantively corresponds to Sec. 1.475(e) (pertaining
to unity of invention determinations in National Stage applications
filed under 35 U.S.C. 371), provides support for an intra-claim
restriction requirement, i.e., a requirement to limit a single claim to
a single invention.
Section 1.142(c) is proposed to be added to incorporate subject
matter from current paragraph (b) and indicate that any claim limited
solely to a non-elected invention, if not cancelled, is withdrawn from
further consideration, although it is subject to reinstatement in the
event the restriction requirement is withdrawn.
Section 1.142(d) is proposed to be added to provide that any claim
that recites both an elected invention and a non-elected invention will
be objected to as failing to comply with Sec. 1.75(a), which requires
each claim to be limited to a single invention. Section 1.142(d) as
proposed would also provide that any non-elected invention must be
canceled before a claim that recites both an elected invention and a
non-elected invention would be allowed (subject to reconsideration and
review as provided in Sec. Sec. 1.143, 1.144, and 1.181).
Section 1.143: Section 1.143 is proposed to be revised to add a new
paragraph (a), and to move the current paragraph, with clarifying
revisions, to new paragraph (b). Paragraph (a) is proposed to be added
to specify that the election of an invention or species may be made
with or without traverse, although traversal is necessary to preserve
the right to petition. Paragraph (b) is proposed to be revised to
indicate that the applicant must indicate an election of one invention
or species for prosecution, and that any request for reconsideration of
the requirement must distinctly and specifically point out supposed
errors in the requirement.
Section 1.144: Section 1.144 is proposed to be revised to clarify
when an applicant may petition the Director to review the requirement
for restriction. Paragraph (a) as proposed requires a timely request
for reconsideration of the requirement. Paragraph (b) as proposed
provides that a petition may be filed after a restriction requirement
is made final or a second requirement for restriction is made, even if
the second requirement is not made final, whereas the present rule
requires a final restriction requirement before petitioning. Proposed
paragraph (b) also sets forth when a petition must be filed, i.e.,
within the earlier of two months of the mailing date of the final
requirement for restriction from which relief is requested or the
filing of a Notice of Appeal. Paragraph (c) is proposed to be added to
specify that a petition before the second requirement will be dismissed
as premature, and that filing a petition does not obviate applicant's
obligation to timely reply to the remainder of the action. Paragraph
(d) is proposed to be added to specify that the two-month period for
filing the petition is not extendable and that late filed petitions may
be dismissed as untimely.
Section 1.145: Section 1.145 is proposed to be revised by
specifying that after an Office action on an application, if the
applicant presents by amendment one or more claims directed to an
invention distinct from and independent of the invention previously
claimed, the applicant may be required to restrict the claims to the
invention previously claimed if the amendment is entered, subject to
reconsideration and review as provided in Sec. Sec. 1.143, 1.144 and
1.181. The current rule indicates applicant ``will'' be required to
restrict, and does not reference Sec. 1.181.
Section 1.146: Section 1.146 is proposed to be revised to permit an
examiner, in the course of examining a claim directed to a single
invention that encompasses multiple patentably distinct species, to
require an election of one disclosed species of the claim for initial
search and examination purposes.
Section 1.146(b) is proposed to be added to specify that the
examiner may require the applicant to restrict a claim that was subject
to an election requirement under paragraph (a) of this section to the
one or more species that were searched and examined if any species
encompassed by the claim is not patentable.
Under current practice, before searching the prior art for the
claimed invention, an examiner makes an initial determination as to
whether the claims presented are directed to a single invention or
multiple independent and distinct inventions. If a single claim
encompasses multiple species, the examiner may require a provisional
election of a single species. See MPEP 803.02 and 809.
Under the proposed rule, when a claim encompasses multiple species,
an examiner may continue to require a provisional election of a single
disclosed species, even if a claim is limited to a single invention.
For example, if a specification discloses staples, tape, and glue as
exemplary ``means for attaching,'' an applicant may present one claim
reciting the limitation ``a means for attaching'' (which clearly
includes within its scope multiple species) and in addition present one
or more claims that specify the particular means. If each species that
employs a specific means is patentably distinct from the other species,
the ``means for attaching'' claim would be a claim that links together
otherwise restrictable inventions. If an applicant elects a particular
means in reply to a requirement for a provisional election of a single
disclosed species and the examiner determines that species is
allowable, the examiner would be required, consistent with current
practice, to continue to examine the ``means for attaching'' claim
until a determination on the patentability of the claim is reached. If
the ``means for attaching'' claim is allowable, then any claim that
depends from or otherwise requires all the limitations of the allowable
claim would be examined for patentability and the provisional election
would no longer be effective.
In addition to being applicable to a claim that defines multiple
species using generic terminology, i.e., without requiring selection of
an alternative, the proposed provision would also apply to a claim that
uses alternative language. Evidence that supports a finding that one
species does not comply with the requirements of 35 U.S.C. 101 or 112
would not necessarily support a finding of lack of utility, enablement,
or adequate written description with regard to any other species. Thus,
where the elected species is patentable but the claims are not enabled
or adequately described over their entire scope, the proposed rule
would permit an examiner to require restriction of the claims to the
elected species (and allowable obvious variants thereof).
Section 1.499: This section is proposed to be revised by
designating the currently undesignated paragraph as paragraph (a) and
adding new paragraphs (b), (c), and (d).
Paragraph (b) is proposed to be added to address treatment of a
claim limited solely to a non-elected invention in a national stage
application. The language corresponds to that in proposed Sec.
1.142(c). Paragraph (c) is proposed to be added to indicate that any
claim in a national stage application that recites in the alternative
both an elected and a non-elected invention will be objected to as
failing to comply with Sec. 1.475. The language is analogous to that
in proposed Sec. 1.142(d). Paragraph (d) is
[[Page 44999]]
proposed to be added to set forth that if, after an Office action in a
national stage application, the applicant presents by amendment one or
more claims directed to an invention that lacks unity of invention
(Sec. 1.475) with the invention previously claimed, the applicant may
be required to restrict the claims to the invention previously claimed
if the amendment is entered, subject to reconsideration and review as
provided in Sec. Sec. 1.143, 1.144 and 1.181. The language is
analogous to that it proposed Sec. 1.145.
Rule Making Considerations
Administrative Procedure Act: As discussed previously, the court in
Harnisch invited the Office to exercise its rule making authority under
former 35 U.S.C. 6(a) to anticipate and forestall the ``procedural
problems'' surrounding Markush claims. 631 F.2d at 722 n.7, 206 USPQ at
306 n.7. Therefore, these rule changes involve interpretive rules, or
rules of agency practice and procedure. See Bachow Communs., Inc. v.
FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (rules governing an application
process are ``rules of agency organization, procedure, or practice''
and exempt from the Administrative Procedure Act's notice and comment
requirement); see also Fressola v. Manbeck, 36 USPQ2d 1211, 1215
(D.D.C. 1995) (``it is extremely doubtful whether any of the rules
formulated to govern patent or trade-mark practice are other than
`interpretive rules, general statements of policy, * * * procedure, or
practice.' '') (quoting C.W. Ooms, The United States Patent Office and
the Administrative Procedure Act, 38 Trademark Rep. 149, 153 (1948)).
Therefore, the changes being proposed in this notice involve
interpretive rules, or rules of agency practice and procedure.
Accordingly, prior notice and an opportunity for public comment were
not required pursuant to 5 U.S.C. 553(b)(A) (or any other law).
Nevertheless, the Office is seeking public comment on proposed changes
to obtain the benefit of such input prior to adopting changes to the
rules of practice on these issues.
Regulatory Flexibility Act: As prior notice and an opportunity for
public comment are not required pursuant to 5 U.S.C. 553 (or any other
law), neither a regulatory flexibility analysis nor a certification
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are
required. See 5 U.S.C. 603.
Executive Order 13132: This rule making does not contain policies
with federalism implications sufficient to warrant preparation of a
Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).
Executive Order 12866: This rule making has been determined to be
not significant for purposes of Executive Order 12866 (Sept. 30, 1993),
as amended by Executive Order 13258 (Feb. 26, 2002) and Executive Order
13422 (Jan. 18, 2007).
Paperwork Reduction Act: This notice involves information
collection requirements which are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.). The collections of information involved in
this notice have been reviewed and previously approved by OMB under OMB
control numbers: 0651-0031, and 0651-0032. The United States Patent and
Trademark Office is not resubmitting the other information collections
listed above to OMB for its review and approval because the changes in
this notice do not affect the information collection requirements
associated with the information collections under these OMB control
numbers. The principal impacts of the changes in this proposed rule are
to: (1) Expressly require that a claim be limited to a single
invention; and (2) specify the conditions under which a claim that
reads on multiple species by using alternative language to list
species) will be treated as limited to a single invention.
Interested persons are requested to send comments to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
New Executive Office Building, Room 10202, 725 17th Street, NW.,
Washington, DC 20503, Attention: Desk Officer for the Patent and
Trademark Office; and (2) Robert A. Clarke, Deputy Director, Office of
Patent Legal Administration, Commissioner for Patents, P.O. Box 1450,
Alexandria, VA 22313-1450.
Notwithstanding any other provision of law, no person is required
to respond to nor shall a person be subject to a penalty for failure to
comply with a collection of information subject to the requirements of
the Paperwork Reduction Act unless that collection of information
displays a currently valid OMB control number.
List of Subjects in 37 CFR Part 1
Administrative practice and procedure, Inventions and patents,
Lawyers.
For the reasons set forth in the preamble, 37 CFR part 1 is
proposed to be amended as follows:
PART 1--RULES OF PRACTICE IN PATENT CASES
1. The authority citation for 37 CFR part 1 continues to read as
follows:
Authority: 35 U.S.C. 2(b)(2).
2. Section 1.75 is amended by revising paragraphs (a), (d)(2), and
(e), and adding paragraphs (j) and (k) to read as follows:
Sec. 1.75 Claims.
(a) The specification must conclude with a claim particularly
pointing out and distinctly claiming the subject matter which the
applicant regards as his or her invention or discovery. A claim must be
limited to a single invention.
* * * * *
(d) * * *
(2) If an application seeks the benefit under title 35, United
States Code, of a prior-filed application and discloses subject matter
that was not disclosed in the prior-filed application, the applicant
must identify which claim or claims in the application are disclosed in
the manner provided by the first paragraph of 35 U.S.C. 112 in the
prior-filed application.
(e) Where the application describes a claimed invention as an
improvement, any independent claim should contain in the following
order:
(1) A preamble comprising a general description of all the elements
or steps of the claimed invention which are conventional or known;
(2) A phrase such as ``wherein the improvement comprises''; and
(3) Those elements, steps, and/or relationships which constitute
that portion of the claimed invention which the applicant considers as
the new or improved portion.
* * * * *
(j) A claim that reads on multiple species by using alternative
language must meet the following conditions:
(1) The number and presentation of alternatives in the claim does
not make the claim difficult to construe;
(2) No alternative is defined as a set of further alternatives
within the claim; and
(3) No alternative is encompassed by any other alternative within a
list of alternatives, unless there is no other practical way to define
the invention.
(4) Each alternative within a list of alternatives must be
substitutable one for another.
(k) A claim may not incorporate another part of the specification
or drawings by reference, unless there is no other practical way to
define the invention. If a claim incorporates
[[Page 45000]]
another part of the specification or drawings by reference, and that
portion of the specification or drawings sets forth alternatives, the
claim must comply with, and is subject to the provisions of, paragraph
(j) of this section and Sec. 1.140.
3. Section 1.140 is added after the undesignated center heading
``Joinder of Inventions in One Application; Restriction'' to read as
follows:
Sec. 1.140 Requirement for a claim to be limited to a single
invention in an application filed under 35 U.S.C. 111(a).
(a) Two or more independent and distinct inventions may not be
claimed in a single claim. See Sec. 1.75(a). A claim that reads on
multiple species using alternative language is limited to a single
invention when all the species encompassed by the claim meet at least
one of the following two conditions:
(1) The species share a substantial feature essential for a common
utility, or
(2) The species are prima facie obvious over each other.
(b) The presentation of a claim that reads on multiple species
using alternative language (Sec. 1.75(j)) may be accompanied by a
statement explaining why the claim is limited to a single invention.
Such a statement shall be considered by the Office if filed by the
applicant at the same time as the presentation of such a claim and may
be considered by the Office if filed by the applicant after the
presentation of such a claim but before the mailing date of any
restriction requirement or action on the merits.
4. Section 1.141 is revised to read as follows:
Sec. 1.141 Different inventions in one application filed under 35
U.S.C. 111(a).
(a) Two or more independent and distinct inventions should not be
claimed in one application.
(b) Where claims to a product, process of making the product, and
process of using the product are included in an application, a three-
way requirement for restriction can be made only where the process of
making the product is distinct from the product, the process of using
the product is distinct from the product, and the processes of making
and using the product are distinct from each other.
5. Section 1.142 is revised to read as follows:
Sec. 1.142 Requirement for restriction to a single invention in an
application filed under 35 U.S.C. 111(a).
(a) If two or more independent and distinct inventions are claimed
in a single application filed under 35 U.S.C. 111(a), the examiner in
an Office action may require the applicant in the reply to that action
to elect an invention to which the claims will be restricted, this
official action being called a requirement for restriction. Such
requirement will normally be made before any action on the merits;
however, it may be made at any time before final action.
(b) The propriety of a requirement for restriction shall be
determined without regard to whether the plural inventions are recited
in separate claims or as alternatives within a single claim.
(c) Any claim limited solely to a non-elected invention, if not
canceled, is withdrawn from further consideration. Any claim withdrawn
from further consideration as a result of a restriction requirement and
election is subject to reinstatement in the event the restriction
requirement is withdrawn or overruled.
(d) Any claim that recites both an elected and a non-elected
invention in the alternative will be objected to as failing to comply
with Sec. 1.75(a). Any non-elected invention must be canceled before
the claim will be allowed, subject to reconsideration and review as
provided in Sec. Sec. 1.143, 1.144 and 1.181.
6. Section 1.143 is revised to read as follows:
Sec. 1.143 Reconsideration of requirement for restriction.
(a) The election of an invention or species may be made with or
without traverse. To preserve a right to seek reconsideration or
petition for review of a requirement for restriction, the election must
be with traverse.
(b) If the applicant traverses a requirement for restriction, he or
she may request reconsideration of the requirement, including
withdrawal or modification, distinctly and specifically pointing out
supposed errors in the requirement. In requesting reconsideration, the
applicant must indicate an election of one invention or species for
prosecution, which invention or species shall be the one elected in the
event the requirement becomes final. The requirement for restriction
will be reconsidered on such a request.
7. Section 1.144 is revised to read as follows:
Sec. 1.144 Petition from requirement for restriction.
(a) Applicant may petition the Director to review the requirement
for restriction. A petition will not be considered unless
reconsideration of the requirement was timely requested (see Sec.
1.143).
(b) A petition may be filed after the requirement for restriction
is made final or a second requirement for restriction is made, even if
the second requirement is not final. The petition must be filed within
the earlier of:
(1) Two months of the mailing date of the final requirement for
restriction from which relief is requested; or
(2) The filing of a Notice of Appeal.
(c) A petition filed before the earlier of a final restriction
requirement or a second requirement for restriction will be dismissed
as premature. Filing a petition does not obviate applicant's obligation
to timely reply to the remainder of the action.
(d) The two-month period for filing a petition is not extendable.
Late filed petitions may be dismissed as untimely (see Sec. 1.181).
8. Section 1.145 is revised to read as follows:
Sec. 1.145 Subsequent presentation of claims for a different
invention in an application filed under 35 U.S.C. 111(a).
If, after an Office action on an application, the applicant
presents by amendment one or more claims directed to an invention
distinct from and independent of the invention previously claimed, the
applicant may be required to restrict the claims to the invention
previously claimed if the amendment is entered, subject to
reconsideration and review as provided in Sec. Sec. 1.143, 1.144 and
1.181.
9. Section 1.146 is revised to read as follows:
Sec. 1.146 Requirement for an election of a single species in an
application filed under 35 U.S.C. 111(a).
(a) If one or more claims are directed to a single invention but
encompass multiple disclosed and patentably distinct species,
regardless of whether the claim uses alternative language, the examiner
may require the applicant to elect one species that is disclosed in the
application as filed for initial search and examination.
(b) The examiner may require the applicant to restrict any claim
that was subject to an election requirement under paragraph (a) of this
section to the one or more species that were searched and examined if
any species encompassed by the claim is not patentable.
10. Section 1.499 is revised to designate the current paragraph as
paragraph (a) and to add paragraphs (b), (c), and (d) to read as
follows:
Sec. 1.499 Unity of invention during the national stage.
* * * * *
(b) Any claim limited solely to a non-elected invention, if not
canceled, will be withdrawn from further consideration. Any claim
withdrawn
[[Page 45001]]
from further consideration is subject to reinstatement in the event the
restriction requirement is withdrawn or overruled.
(c) Any claim that recites in the alternative both an elected and a
non-elected invention will be objected to as failing to comply with
Sec. 1.475. Any non-elected invention must be canceled before the
claim will be allowed, unless the restriction requirement is withdrawn
or overruled.
(d) If, after an Office action on an application, the applicant
presents by amendment one or more claims directed to an invention that
lacks unity of invention (Sec. 1.475) with the invention previously
claimed, the applicant may be required to restrict the claims to the
invention previously claimed if the amendment is entered, subject to
reconsideration and review as provided in Sec. Sec. 1.143, 1.144 and
1.181.
Dated: August 2, 2007.
Jon W. Dudas,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. E7-15591 Filed 8-9-07; 8:45 am]
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