DETAILED ACTION
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 .
Response to Amendment
The RCE filed 2026 May 11 is acknowledged. Claims 1-6, 41, 48-50, 55, 56, 79, 82, 83, 88, 89, 102, and 103 are pending in the examined application. The 35 U.S.C. 112 and 102 rejections are overcome for the following reasons: variables na and nb are no longer part of the structure; and amended variable X1 is not is taught by PEPIN (US 5342835), YANG (WO 2004106296), and MARTINBOROUGH (WO 2006050476).
Claims 1-6, 41, 48-50, 55, 56, 79, 82, 102, and 103 are allowable. Claims 82, 83, and 89, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among inventions I-IV, as set forth in the Office action mailed on 2024 November 18, is hereby withdrawn and claims 82, 93, and 89 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
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.
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 83, 88, and 89 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for amelioration of hypertension, heart failure, colon epithelial function, and diarrhea and non-enabling for the amelioration of the scope of disorders recited in claim 89 and prevention of the disorders recited in claims 82, 83, and 89. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Consideration of the relevant factors sufficient to establish a prima facie case for lack of enablement is set forth herein below:
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to treating a disease with a compound of claim 1. Thus, the claims taken together with the specification imply that a compound of claim 1 can treat a disease or disorder recited in claim 82, 83, and 89. The definition of treatment includes prevention (page 39, second paragraph to page 40, second paragraph).
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The state of the prior art and (4) the predictability or unpredictability of the art:
DIAZ (Current Hypertension Reports, 2013, 15, 659-668) describes that more research is needed to understand prevention of hypertension (page 665, column 1, last paragraph to column 2, second paragraph).
PONIKOWSKI (ESC Heart Failure, 2014, 1, 4-25) describes that more research is needed to understand prevention of heart failure (page 11, column 1, first paragraph to page 13, column 1, paragraph 2).
HERSHFINKEL (International Journal of Molecular Sciences, 2018, 19, 439, 1-19) describes the following ideas: GPR39 is linked to enhancing colon epithelial function (page 6/19, last paragraph to page 7/19, first paragraph); and more research is needed to understand prevention of heart failure (page 10/19, second paragraph).
POPOVICS (Cellular and Molecular Life Sciences, 2011, 68, 85-95) describes the following ideas: GPR39 is linked to diarrhea treatment (page 92, column 2, paragraph 2); and more research is needed to understand prevention of heart failure (page 93, column 2, paragraph 2).
The relative skill of those in the art:
While the artisan generally would have an advanced degree in a disorder related to GPR39, their high level of skill and knowledge is insufficient to overcome the lack of understanding as to how GPR39 functions in the body or to overcome the art recognition that this disease is poorly understood and treatments have generally failed.
The amount of direction or guidance presented and the presence or absence of working examples:
The specification has provided guidance for amelioration of hypertension, heart failure, colon epithelial function, and diarrhea.
The specification does not provide guidance for the amelioration of the scope of disorders recited in claim 89 and prevention of the disorders recited in claims 82, 83, and 89.
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to treatment of a disorder related to GPR39 and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 41, 48, 49, 55, and 79 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 13 , 75, 103, 122, and 123 of copending Application No. 18/645159 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because example 5 of 18/645159 is encompassed by the specified claims of the examined for the following reasons: X1 is NH-C(O)-cyclopropyl; Z1-Z3 are each H; X2 is a 2,6-dimethyltetrahydro-2H-thiopyran-4-carbonyl-1,1-dioxide group, in which each instance of R3 is Me, Y1 is N, and Y2 is SO2; and R2 is pyrrolidine.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. This rejection is maintained due to other rejections still pending in the present office action.
Conclusion
Claims 1, 2, 41, 48, 49, 55, 79, 83, 88, and 89 are not allowed.
Claims 3-6, 50, 56, 82, 102, and 103 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: YANG (WO 2004106296, published 2004 December 9) does not describe a compound in which variable X1 is C(O)NH-cyclopropyl.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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