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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/US2020/064200 filed 12/10/2020, which claims the benefit of the priority of US Provisional application 62/946,320 filed 12/10/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements submitted on 10/15/2025 have been considered by the examiner.
Election/Restrictions
Claims 50, 63, and 65 are withdrawn from further consideration pursuant to 37 CFR
1.142(b) as being drawn to a nonelected Group II-IV. Election was made without traverse in the reply filed on 04/04/2025. Applicant’s election without traverse of Group I drawn to a compound, in the reply filed on 04/04/2025 is acknowledged.
Applicant further elects the species of
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Claim Status
Claims 1, 8-9, 19, 21-23, 28, 33, 37-38, 43, 45, 47, 50, 63, 65 and 91-95 are pending. Claims 2-7, 10-18, 20, 24-27, 29-32, 34-36, 39-42, 44, 46, 48-49, 51-62, 64 are canceled. Claims 1, 8, 21-22, 33, 37, 45, 47 are amended. Claims 50, 63 and 65 are withdrawn. Claims 91-95 are new. Claims 1, 8-9, 19, 21-23, 28, 33, 37-38, 43, 45, 47, 91-95 are being examined on the merits in this office action.
Claim Objections and Rejections- Withdrawn
The objection to claim 47 is withdrawn in view of the claim amendment.
The rejection of claims 1, 3, 8-9, 18-19, 21-23, 28, 30, 33-34, 37-38, 43-45, and 47 under 35 U.S.C. 103 as being obvious over Liu et al. (WO2019168654A2 – hereinafter “Liu”) is withdrawn in view of the claim amendments and arguments.
The rejection of claims 1, 37-38, 43-44, 93-95 on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. US11674136B2 withdrawn in view of the claim amendments
Claim Rejections - 35 USC § 112 – Maintained and Updated
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, 8-9, 19, 21-23, 28, 33, 37-38, 43, 45, 47, 91-95 are 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.
MPEP § 2137 states that "the written description requirement for a genus must be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
For written description, the analysis (a) considers actual reduction to practice, (b) disclosure of drawings or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties, functional characteristics when coupled with known or disclosed and (d) representative number of examples.
Actual reduction to practice and (b) disclosure of drawings or structural chemical formulas:
The instant claims recite a compound of Formula
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Applicant has reduced to practice the species
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Examiner notes that the instant claims currently recite the compound of Formula I with a laundry list of possible groups or variables and the claims are not a representation of any particular species. Thus, the claim scope encompass trillions of species and appears to be vast and highly varied. Written description issues may also arise if the knowledge and level of skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed product arising from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not necessarily constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) (See MPEP 2162.1 (A).
sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties
A correlation between structure and function, for the instantly claimed genus of compounds, is not disclosed in the specification. Examiner notes that the species disclosed in the instant application comprise the structure of Formula I. The instant claims however, list numerous variables or functional groups that could be attached to the compound leading to the numerous compounds.
Representative number of examples
A “representative number of species” means the species which are adequately described are a representative of the entire genus. Therefore, when there is a substantial variation within a genus, the applicant must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). See MPEP 2163.3 (ii).
The elected species and the compounds recited in the application specification are not a representation of the entire genus recited in the claims. The instant Examples are focused on synthesis of the compounds and the biological assays of the compounds and that two macrocycles showed inhibition profiles, JOMBtrans and JOBBtrans, both of which have 10-40 uM IC50 values and contain a conserved 3-carboxy-piperidine structure. It does not appear that the Examples disclose a representative number of species that are a representative of the entire genus given the several variables recited in the claims. Thus, the specification fails to provide adequate written description for the genus of compounds claimed 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.
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive.
Applicant argues that the claims have been amended and that the species are sufficiently represented (Arguments Page 2).
The arguments presented above have been fully considered but are not persuasive. Examiner notes that the claims presently recite a laundry list of possible groups or variables and the claims are not a representation of any particular species. Thus, the claim scope encompass trillions of species and appears to be vast and highly varied. Written description issues may also arise if the knowledge and level of skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed product arising from the disclosed process.
Double Patenting – Maintained and updated
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, 8-9, 19, 21-23, 28, 33, 37-38, 43, 45, 47, and 91-95 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-7, 10, 16-17, 21, 28, 31, 37-38, 41, 47, 50, and 56 of copending Application No. 18/974,042. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application recite a compound of Formula I-A with the structure
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(claims 1-3).
The instant claims recite a compound of Formula
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The claims of the patent anticipate the instant claims.
Regarding claims 8-9, 19, 33, 37-38, and 91-95, the claims of the copending application recite a compound with the structure
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Regarding claims 21-23, 28, 43, the claims of the copending application recite that
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(claim 2).
Regarding claim 45, the claims of the copending application recite the compound
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(claim 7, 10,16-17, 21, 28, 31).
Regarding claim 47, the claims of the copending application recite a pharmaceutical composition comprising the compound (claim 56).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive.
Applicant argues that the claims have been amended to recite the subject matter of claim 3 and that the copending application is earlier filed.
Examiner notes that the claims of the copending application still anticipate the amended claims. Further, with regards to the copending application, the double patenting rejection is not the only remaining rejection. Thus the rejection is maintained.
Closest prior art
The closest prior art is Liu et al. (WO2019168654A2 – hereinafter “Liu”).
Liu teaches that the compounds include
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(claim 23, [00142]). The compounds of Liu do not read on the instant compounds.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 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, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654