Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This office action is in response to applicant’s reply filed on July 1, 2026.
Status of Claims
Amendment of claims 1, 15, 17, cancellation of claims 2-14, 16 and 18-33, and addition of claims 35-36 is acknowledged.
Claims 1, 15, 17 and 34-36 are currently pending and are the subject of this office action.
Claims 34-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on December 23, 2025.
Claims 1, 15 and 17 are under examination.
Priority
The present application claims priority to provisional application No. 63/328,795 filed on 04/08/2022.
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections – Improper Markush Group (Modified Rejection Necessitated by Amendment).
Claims 1, 15 and 17 stand rejected under Improper Markush Group.
The improper Markush Group Rejection is based on a judicially approved doctrine when the claim contains an improper grouping of alternatively useable species. A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
In the instant case, claim 1 discloses the compounds of Formula V:
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Within Formula V, each B2 and B3 can be any of the 29 groups disclosed in pages 7-9 of the amended claims (provided that at least one of B2 or B3 contains a carboxyl group, ester group or an amide group). Even when A6 is a bond, that combination of groups can afford hundreds of different compounds, structurally completely unrelated.
Further A6 can be:
“a single bond, -NH-, unsubstituted carbonyl, substituted carbonyl, unsubstituted
amide, substituted amide, substituted alkyl, unsubstituted alkylthio, substituted alkylthio, substituted aryl, unsubstituted aryl, substituted heteroaryl, unsubstituted heteroaryl, substituted C₃-C₂₀ cycloalkyl, unsubstituted C₃-C₂₀ cycloalkyl, substituted C₁-C₂₀ heterocyclyl, or unsubstituted C₁-C₂₀ heterocyclyl”, which will make the possible combinations into the millions.
These formulas have completely different core structures and are classified in completely different groups. As such the above Formula V encompasses millions of compounds, the majority of which are structurally unrelated and definitively classified in different groups/subgroups.
This makes almost impossible to run a comprehensive search of what is claimed.
Even claim 17 discloses 20 completely unrelated structures.
These compounds lack unity of invention since they do not share a common utility and/or they do not share a substantial structural feature essential to that utility: In re Harnisch, 631 F.2d 716, 206 USPQ 300(CCPA 1980); and Ex parte Hozumi, 3 USPQ2d 1059 (Bd. Pat. App. & Int. 1984).
Claim Rejections - 35 USC § 112 (Modified Rejection Necessitated by Amendment).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 15 stand rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 15-17 encompass compounds by Formula V:
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Within Formula V, each B2 and B3 can be any of the 29 groups disclosed in pages 7-9 of the amended claims (provided that at least one of B2 or B3 contains a carboxyl group, ester group or an amide group). Even when A6 is a bond, that combination of groups can afford hundreds of different compounds, structurally completely unrelated.
Further A6 can be:
“a single bond, -NH-, unsubstituted carbonyl, substituted carbonyl, unsubstituted
amide, substituted amide, substituted alkyl, unsubstituted alkylthio, substituted alkylthio, substituted aryl, unsubstituted aryl, substituted heteroaryl, unsubstituted heteroaryl, substituted C₃-C₂₀ cycloalkyl, unsubstituted C₃-C₂₀ cycloalkyl, substituted C₁-C₂₀ heterocyclyl, or unsubstituted C₁-C₂₀ heterocyclyl”, which will make the possible combinations into the millions.
MPEP 2173.04 states:
Breadth of a claim is not to be equated with indefiniteness. In re Miller, 441 F.2d 689, 169 USPQ 597 (CCPA 1971). If the scope of the subject matter embraced by the claims is clear, and if applicants have not otherwise indicated that they intend the invention to be of a scope different from that defined in the claims, then the claims comply with 35 U.S.C. 112, second paragraph. > See Ultimax Cement Mfg. v. CTS Cement Mfg., 587 F.3d 1339, 1352 (Fed. Cir. 2010) (finding that “a claim to a formula containing over 5000 possible combinations is not necessarily ambiguous if it sufficiently notifies the public of the scope of the claims."). <
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Undue breadth of the claim may be addressed under different statutory provisions, depending on the reasons for concluding that the claim is too broad. If the claim is too broad because it does not set forth that which applicants regard as their invention as evidenced by statements outside of the application as filed, a rejection under 35 U.S.C. 112, second paragraph, would be appropriate. If the claim is too broad because it is not supported by the original description or by an enabling disclosure, a rejection under 35 U.S.C. 112, first paragraph, would be appropriate. If the claim is too broad because it reads on the prior art, a rejection under either 35 U.S.C. 102 or 103 would be appropriate.
Further MPEP 2173.05(h) recites:
A Markush claim may encompass a large number of alternative species, but is not necessarily indefinite under 35 U.S.C. 112, second paragraph for such breadth. In re Gardner, 427 F.2d 786, 788 (CCPA 1970) (“Breadth is not indefiniteness.”). In certain circumstances, however, a Markush group may be so expansive that persons skilled in the art cannot determine the metes and bounds of the claimed invention. For example, a Markush group that encompasses a massive number of distinct alternative species may be indefinite under 35 U.S.C. 112, second paragraph if one skilled in the art cannot determine the metes and bounds of the claim due to an inability to envision all of the members of the Markush group. In such a circumstance, an examiner may reject the claim for indefiniteness under 35 U.S.C. 112, second paragraph.
In the instant case, the claims are incredibly broad, the universe of compounds encompassed by Formula V are in the millions.
Definitively, the claims are not supported by the original description or by an enabling disclosure, and no person skilled in the art will be able to determine the metes and bounds of the claimed invention.
Claim Rejections - 35 USC § 112 (Modified Rejection Necessitated by Amendment).
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 15 stand rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claims 1 and 15 encompass compounds of Formula V:
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M.P.E.P. #2163 states: “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention….one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process”.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the Federal Circuit stated that “the hallmark of written description is disclosure.” A specification adequately describes an invention when it “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. at 1351. “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbott Labs, 636 F.3d 1341, 1348 (Fed. Cir. 2011).
The description requirement of the patent statute requires a description of an actual invention, not merely an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984) (holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate’). This matter is of particular importance in the evaluation of claims drawn to a chemical genus which identifies a core compound bearing variable substituents. It has been held that “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification...demonstrates that the applicant has invented species sufficient to support a claim to a genus” with such breadth. Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2D 1161, 1171 (Fed. Cir. 2010). An adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties of species falling within the genus sufficient to distinguish the genus from other materials. Id., quoting Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997).
However, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. Ariad, 94 USPQ2D at 1171. 35 U.S. C. 112, first paragraph, requires a description of the invention that “clearly allow[s] persons of ordinary skill in the art to recognize that the inventor invented what is claimed.” Ariad at 1172, quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (1562-63) (Fed. Cir. 1991) (emphasis added). A sufficient disclosure is one which reasonably conveys to one having ordinary skill in the art that the inventor had possession of the claimed subject matter as of the filing date of the application in question. Vas-Cath, 935 F.2d at 1563. The description must reasonably describe the invention, not simply indicate a result which one might achieve if one actually made the invention. Eli Lilly, 119 F.3d at 1568. To properly evaluate whether an applicant has complied with the written description requirement therefore requires an analysis of whether the skilled artisan would recognize, from the description provided, the applicants were in possession of sufficient compounds representing the full breadth of diversity of the genus claimed.
A description of a chemical genus will usually comprise a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the members of the genus, which features constitute substantial portion of the genus. See Univ. of California vs. Eli Lilly, 43 USPQ 2d 1398, 1406 (Fed. Cir. 1997). This is analogous to enablement of a genus under section 112 first, by showing enablement of a representative number of species within the genus. A chemical genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus.
Within Formula V, each B2 and B3 can be any of the 29 groups disclosed in pages 7-9 of the amended claims (provided that at least one of B2 or B3 contains a carboxyl group, ester group or an amide group). Even when A6 is a bond, that combination of groups can afford hundreds of different compounds, structurally completely unrelated.
Further A6 can be:
“a single bond, -NH-, unsubstituted carbonyl, substituted carbonyl, unsubstituted
amide, substituted amide, substituted alkyl, unsubstituted alkylthio, substituted alkylthio, substituted aryl, unsubstituted aryl, substituted heteroaryl, unsubstituted heteroaryl, substituted C₃-C₂₀ cycloalkyl, unsubstituted C₃-C₂₀ cycloalkyl, substituted C₁-C₂₀ heterocyclyl, or unsubstituted C₁-C₂₀ heterocyclyl”, which will make the possible combinations into the millions, despite that the specification discloses a list of only 20 compounds that are encompassed by the general formula V (see for example claim 17).
The size of the genus thus described is phenomenal, against which applicant have offered evidence of being in possession of about 20 compounds. This small set of compounds cannot be viewed as being reasonably representative of the genus of compounds of Formula V in its claimed scope because no readily apparent combination of identifying characteristics is provided, other than the disclosure of those specific species as examples of the claimed genus, and in no way either represent the breadth of variable moieties which applicants have claimed, nor permit the skilled artisan to recognize that such claim breadth was actually in the applicants possession as of the time of filing the instant application.
Given the broad scope of the claimed subject matter, Applicant has not provided sufficient written description that would allow the skilled in the art to recognize that Applicant was in possession of most the compounds of Formula V as claimed.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
July 20, 2026.
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