United States Patent and Trademark Office OG Notices: 04 Sep 2007
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.
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 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 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 10(23) 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 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 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 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 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 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 1.140. Where the
examiner disagrees with an applicant's statement under proposed
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 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 1.75(j)
or (k) or 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 1.75(j)
and (k) and 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 (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
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 1.140, which provides for the restriction
of a claim to a single invention, and the proposed amendment to 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 1.141 to 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 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 1.75(a) or a restriction
requirement under proposed 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).
The content of current paragraph (b) of 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 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 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 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
1.143, 1.144 and 1.181. The current rule indicates applicant "will" be
required to restrict, and does not reference 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 .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 1.475. The language is analogous to that in proposed
1.142(d). Paragraph (d) is 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 ( 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 1.143, 1.144 and 1.181.
The language is analogous to that it proposed 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:
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 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 1.140.
3. Section 1.140 is added after the undesignated center heading
"Joinder of Inventions in One Application; Restriction" to read as
follows:
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 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 ( 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:
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:
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
1.75(a). Any non-elected invention must be canceled before the claim
will be allowed, subject to reconsideration and review as provided in
1.143, 1.144 and 1.181.
6. Section 1.143 is revised to read as follows:
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:
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 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 1.181).
8. Section 1.145 is revised to read as follows:
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 1.143, 1.144 and 1.181.
9. Section 1.146 is revised to read as follows:
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:
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 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
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 ( 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 1.143, 1.144 and 1.181.
August 2, 2007 JON W. DUDAS
Under Secretary of Commerce for
Intellectual Property and Director of the
United States Patent and Trademark Office