DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election with traverse of Group I in the reply filed on 9/25/2025 is acknowledged. Applicant traverses on the grounds that the various inventions “share special technical features” (Applicant Arguments, Page 24). Namely, as argued by Applicant, the various inventions (differing in comprising core rings comprising a nitrogen, oxygen or sulfur) all share an inventive concept since “every other portion of the molecule is consistent” (Applicant Arguments, Page 24).
The argument cannot possibly be found persuasive. Despite the fact that some features are shared between the Groups of Invention, the Groups of Invention do not share a single structural similarity and, indeed, are separately classified.
Nevertheless, if it is Applicant’s contention that compounds having a specified structure and made up of distinct and defined atoms do, in fact, share an inventive concept with structurally unrelated compounds comprising different atoms, Applicant is required to state this affirmatively on the record, in which case prior art will be applied accordingly. Until then, Applicant’s arguments are not found persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claim 64 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election without further specifying traverse of a single species in the reply filed on 9/25/2025 is also acknowledged.
The elected species read upon claims 1-2, 4, 6, 8, 11, 13, 40, 50, 53, 58-59 and 63. Claims 3, 26, 21 and 60-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Rejections – 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. See In re Harnisch, 631 F.2d 716 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations: FIRST, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. And SECOND, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
Claims 1-2, 4, 6, 8, 11, 13, 40, 50, 53, 58 and 63 are rejected on the grounds of containing an “improper Markush grouping”, which contains species that fail to share a single structural similarity.
The claims are drawn to compounds of formula I as follows:
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The Markush grouping of formula I is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
FIRST, the alternatives are not members of the same recognized physical or chemical class or the same art-recognized class. For example, claim 1 embraces the following unrelated compounds from among a virtually unlimited potential list of alternatives:
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(classified in C07D 337/00) wherein A is a 6 membered arylene; L1 is absent (i.e., n is 0); X is N; each of X1-X4 are C; Y and Y2 are S; Z is S; and Z1 is S;
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(classified in C07D 273/00) wherein A is a 5 membered heteroarylene; L1 is (CH2)8 and O and C(O) (i.e., n is 9); X is CH; X1 and X2 are N, X3 is C, and X4 is N; Y and Y2 are O; Z is C(O); and Z1 is SO2; and
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(classified in C07D 209/00) wherein A is a 9 membered heteroarylene; L1 is CH2, NH, CH2, S, CH2 and O (i.e., n is 5); X is CH; each of X1-X4 is CH; Y is S; Y2 is NH; Z is a 4 membered cycloalkylene; and Z1 is O.
Additionally, the alternatives are not disclosed in the Specification or known in the art to be functionally equivalent and have a common use. For example, claim 1 embraces the following compounds, both of which are classified in C07D 209/00, and identified in the Specification at Paragraph 0587:
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(Compound 91, which binds ABL1(H396P) with approximately 100% affinity (see Page 230, Table 1)); and
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(Compound 141, having no ABL1(H396P) binding affinity (see Page 230, Table 1)).
And SECOND, the alternative chemical compounds – which do not belong to a recognized class as set forth above – do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1).
Claim Rejections - 35 USC § 112
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.
Claims 1-2, 4, 6, 8, 11, 13, 40, 50, 53, 58 and 63 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
The claims contain 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, at the time the application was filed, had possession of the claimed invention. In particular, support cannot be found for the compounds of formula I as instantly claimed.
The MPEP §2163 states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. In the case of chemical entities, Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), which notes that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, “not a mere wish or plan for obtaining the claimed chemical invention.” While the court recognizes that, “[i]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass” (Id.), it is also recognized that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim and/or the genus must be sufficiently detailed to show that applicant was in possession of the claimed invention as a whole (see Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)). If a genus has substantial variance, the disclosure must present a sufficient number of representative species that encompass the genus in order to adequately describe the genus (i.e., the disclosure must describe a sufficient variety of species to reflect the variation within that genus). See MPEP § 2163. Otherwise, as stated by the court in Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company (Fed. Cir. 2010), “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus”.
In the instant case, it is evident that the genus of compounds embraced formula I has substantial variance. Indeed, the genus is virtually without limit, embracing hundreds of millions of potential compounds bearing no structural resemblance to one another what-so-ever, including for example:
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(classified in C07D 337/00) wherein A is a 6 membered arylene; L1 is absent (i.e., n is 0); X is N; each of X1-X4 are C; Y and Y2 are S; Z is S; and Z1 is S;
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(classified in C07D 273/00) wherein A is a 5 membered heteroarylene; L1 is (CH2)8 and O and C(O) (i.e., n is 9); X is CH; X1 and X2 are N, X3 is C, and X4 is N; Y and Y2 are O; Z is C(O); and Z1 is SO2; and
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(classified in C07D 209/00) wherein A is a 9 membered heteroarylene; L1 is CH2, NH, CH2, S, CH2 and O (i.e., n is 5); X is CH; each of X1-X4 is CH; Y is S; Y2 is NH; Z is a 4 membered cycloalkylene; and Z1 is O.
Yet, while the instant Specification discloses approximately 175 compound species within formula I, each of the compounds has the following significantly limited structure:
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While the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad generic. For example, in In re Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d 1008 (Fed. Cir. 1989). In the instant case, it is similarly determined that the disclosure of 175 compound compounds all having a single related core does not adequately describe a subgenus embracing hundreds of millions of additional compound species bearing no structural relationship with those disclosed compounds. That is, the Specification does not disclose a sufficient variety of species to reflect the extreme variance in the genus.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
As such, claims 1-2, 4, 6, 8, 11, 13, 40, 50, 53, 58 and 63 are rejected.
Claim Objections
Claim 59 is objected to as depending from a rejected base claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 4, 6, 8, 11, 13, 40, 50, 53, 58-59 and 63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of copending Application No. 18/725,951.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘951 claims are similarly drawn to compounds of formula I which read on the instantly claimed compounds of formula I.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET. 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.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611