otDETAILED ACTIONNotice 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 .
Election/Restrictions
Applicant’s election without traverse of species: compound 6, 4-((2R,3S,4S,5R)-3-(3,4-difluoro-2-(oxazol-5-ylmethoxy)phenyl)-4,5-dimethyl-5-(trifluoromethyl)tetrahydrofuran-2-carboxamido)picolinamide (shown below), and acute pain, in the reply filed on 05/06/2026 is acknowledged.
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Applicant has not pointed to any errors in Examiner’s analysis of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Applicant asserts that claims 1, 4, 6-10, 12, 14, 19, 22, 25-26, 32, 34 and 36-38 encompass the elected species. However, only claim 32 reads on the elected species. Claim 1, and all of its dependent claims, do not read on the elected species because: the third provision of claim 1 (page 4) requires that R is NRXaRYa, where RXa can be hydrogen, but RYa is not hydrogen. Therefore, elected species compound 6 does not read on claims 1, 4, 6-10, 12, 14, 19, 22, 25-26, 34 and 36-38.
In the Response to Restriction Requirements as filed on 05/06/2026, applicants have amended claims 32 and 38; cancelled no claims; and added no new claims. Therefore, claim 32 is currently pending and under consideration.
Priority
The instant application is a 35 U.S.C. § 371 International Application No. PCT/US2022/032196,
filed June 3, 2022, which claims the benefit of U.S. Provisional Application No. 63/197,199, filed June 4,
2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 04/01/2025 is in compliance with the provisions of 37 CFR 1.97. All references have been considered except where marked with a strikethrough. A signed copy of Form 1449 is included with this Office Action.
The applicant has an obligation to call the most pertinent prior art to the attention of the U.S. Patent and Trademark Office in a proper fashion. Burying one reference in one hundred other IDS references is like citing nothing. PENN YAN BOATS, INC. v. SEA LARK BOATS, INC. 175 USPQ 260 (S.D. Fla. 1972). Golden Valley Microwave Foods, Inc. v. Weaver Popcorn Co. Inc., 24 USPQ2d 1801 (U.S. Dist. N. Dist. IN 1992).
Specification
Acknowledgement is made of the drawings received 12/01/2023. These drawings are acceptable.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Claim Objections
In claim 1, it is suggested that Applicant amend the definition of R2c to replace “wherein said cycloalkyl is” with “wherein said cycloalkyl of R2c is”. While the Examiner finds that a person of ordinary skill reading the instant claims would readily appreciate that phrases within a paragraph defining R2c would not reasonably extend to previous definitions such as R4b1, R4b2, R5b1 and R5b2, the change above would avoid any possible challenge that claim 1 is somehow indefinite because there are multiple previous instances of “cycloalkyl”. Similarly, it is suggested that Applicant amends the definition of RXc to replace “wherein said cycloalkyl is” with “wherein said cycloalkyl of RXc is” and to replace “wherein said heterocyclyl and heteroaryl are” with “wherein said heterocyclyl and heteroaryl of RXc are”. This style of amendment is suggested for the limitations R4c (“wherein said cycloalkyl of R4c”), R5c (“wherein said cycloalkyl of R5c”), and the instances it occurs in the third provision of claim 1 (e.g., R2c, R4c, R5c), as well.
Claim 10 is objected to because of the following informality: there is an additional space between the “C1-C6 alkoxy,” and “NH2” of the claim. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: there should be a space inserted between “…C1-C6 alkyl,-and/or…” of the claim. Furthermore, the dash in front of the “and/or” should be removed. Additionally, “and/or” should just read “and”. Altogether, the claim objections would be overcome if amended to recite “…wherein R4b1 is H or C1-C6 alkyl, and R4b2 is H or C1-C6 alkyl.” Appropriate correction is required.
Claim 17 is objected to because of the following informality: there should be a space inserted between “…C1-C6 haloalkyl,–(C1-C6 alkylene)-OH…”of the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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, 10, 26, and 36-37 are 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.
Claim 1 is rejected as vague and indefinite with regards to the three provisions (claim 1, page 4). The current language makes it unclear if all three provisions are required to be operating concurrently or if each is independent of the others. To remove ambiguity, Examiner recommends amending the claim to recite phraseology such as, “…provided that when no more than two of X2a, X4a, X5a, and X6a are N or N+-O- and when no more than one of X3c, X4c, X5c, and X6c are N or N+-O-, then R is ORa…” (emphasis added).
Regarding claim 10, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 26, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 36, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 37 is rejected to as vague and indefinite. It is unclear as to what kind of subject is receiving the method of treating or lessening the severity of. Examiner recommends amending the claim to recite “…in a subject in need thereof…” (emphasis added).
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10 and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10, which depends on claim 1, recites the limitation “…wherein…RYa is H, OH, C1-C6 alkyl, -(C1-C6 alkylene)-RZa1, or 4-6 membered heterocyclyl…” (emphasis added). However, claim 1 has a specific provision that excludes hydrogen as a variable for RYa, in the recitation “…provide that…R is NRXaRYa, wherein RYa is OH, -(C1-C6 alkylene)-RZa1…”. Therefore, claim 10 broadens the scope of claim 1.
Claim 17, when depends on claim 1, recites a limitation that does not further narrow the scope of X3c as originally defined in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 4, 6-10, 12, 14, 17, 19, 22, 25-26, and 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/566,297 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
For example, claim 1 of instant application specifies the limitation where R is ORa, and Ra is H to ultimately afford a CO2H at this position. Claim 1 of reference ‘297 recites R3a is COOH, and indeed, there are species claims (shown below) exemplifying this.
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In these instances, independent claim 1 of instance and reference applications cover overlapping scope, and therefore, the reference patent and instant application are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 11,834,441 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 32 discloses (page 42) the following species:
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Each and every required element of the above instant species is taught by reference claim 1. A PHOSITA can immediately envisage the above species from the genus claimed in the reference patent. The claimed species is obvious over the reference genus in view of the ‘441 patent, specifically in view of reference claim 5 (col 463, lines 35-45), which discloses the des-bromo version of the exact same compound, shown below, and also teaches other species with halogens (col 472, lines 55-5; col 489, lines 35-45) at this position, shown, below:
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Furthermore, the reference teaches that this position is alternatively usable as H or halo.
Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,919,887 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The basis of the rejection is the same as the previously stated nonstatutory double patenting rejection used for U.S. Patent No. 11,834,441 B2. Instant claim 32 teaches the previously cited compound (page 42) where each and every required element is taught by reference claim 1.
Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,247,021 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The basis of the rejection is the same as the previously stated nonstatutory double patenting rejection used for U.S. Patent No. 11,834,441 B2. Instant claim 32 teaches the previously cited compound (page 42) where each and every required element is taught by reference claim 1.
Conclusion
Claims 1, 4, 6-10, 12, 14, 17, 19, 22, 25-26, 32, 34 and 36-37 are rejected.
Claims 30 and 38 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUKE ALAN BORALSKY whose telephone number is (571)272-9746. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 am.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.B./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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