Examination of Patent Applications That Include Claims Containing Alternative Language, 44992-45001 [E7-15591]

Agencies

• DEPARTMENT OF COMMERCE
• Patent and Trademark Office

[Federal Register Volume 72, Number 154 (Friday, August 10, 2007)]
[Proposed Rules]
[Pages 44992-45001]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15591]



[[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 (https://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 (https://
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

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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

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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 https://
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

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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.