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
Status of 18/729,403
Claims 1, 3, 4, 9, 13, 15, 19-22, 25-26, 28-30, 34-35, and 39-43 are currently pending.
Priority
Instant application 18/729,403, filed 7/16/2024, claims priority as follows:
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Receipt of the foreign priority application is acknowledged.
Information Disclosure Statement
All references from the IDS submitted on 7/17/2024 have been considered unless marked with a strikethrough.
Election/Restriction
Applicant’s election of Group I, claims 1, 3, 4, 9, 13, 15, 19-22, 25-26, 28-30, 34-35, and 42-43, drawn to compounds and compositions of formula (Ia), without traverse in the reply filed 8/4/2026 is acknowledged. Applicant’s election of 6-chloro-3-((4-hydroxy-1-((1R,2R)-1-methyl-2-(trifluoromethyl)cyclopropane-1-carbonyl)piperidin-4-yl)methyl)-7-(4-((3R,6S)-6-methylmorpholin-3-yl)phenyl)-3,7-dihydro-4H-pyrrolo[2,3-d]pyrimidin-4-one as the species in the same reply, is also acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and no prior art was identified. Therefore, the Examiner expanded the search to a compound of instant formula (Ia):
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Where n is 0, R’ is H, m is 0, R4 is Cl, and R3 is C3 cycloalkyl substituted with a C1 alkyl. Compound (S)-6-Chloro-3-((4-hydroxy-1-(1-methylcyclopropane-1-carbonyl)piperidin-4-yl)methyl)-7-(4-(morpholin-3-yl)phenyl)-3,7-dihydro-4/-/-pyrrolo[2,3-c/]pynmidin-4-one recited in claim 34 on page 252:
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Is a compound of this expanded species. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 1, 22, 25, 26, 28, 34-35, and 42-43 read on the elected and expanded species. Claims 3-4, 9, 13, 15, 19-21, 29, 30, and 39-41, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
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.
Claim 28 is 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 28 recites the term, “preferably”, in reference to preferred substituents or variables. The term is indefinite because the phrase is exemplary language and it is not clear if the contents after the term are required, or just examples of what is required. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 22, 25, 26, 28, 34-35, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Almac Discovery Limited (WO 2018/073602 A1, cited in the IDS of 7/17/2024, herein after “Almac”). This rejection applies to the expanded species, and though the reference shares an applicant and inventors, Almac qualifies as prior art under 35 U.S.C. 102(a)(1) because it was published more than a year before the effective filing date of the instant claims.
Determining the scope and contents of the prior art
The reference Almac teaches piperidine derivatives as ubiquitin specific protease 7 inhibitors (title, abstract), and specifically teaches compound 226 (page 237):
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Which partially maps to instant formula (Ia):
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When n is 0, m is 0, R4 is Cl, and R3 is C3 cycloalkyl that is optionally substituted with a C1 alkyl. The difference between compound 226 and the expanded species of instant formula (Ia) is the position of the substitution of the morpholine ring on the aryl ring, and the connection of the morpholine ring to the aryl ring by a C-N bond versus a C-C bond. Example 226 was placed in DMSO (page 237), which constitutes a pharmaceutical composition, and was determined to have an IC50 of <250 nm in USP7 inhibition assays (page 49).
Ascertaining the differences between the prior art and the claims at issue
The reference Almac fails to teach an anticipatory expanded species of instant Formula (Ia) where n is 0, R’ is H, m is 0, R4 is Cl, and R3 is C3 cycloalkyl substituted with a C1 alkyl.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of ubiquitin specific protease 7 inhibitors. An artisan possess the technical knowledge necessary to make adjustments to the inhibitors to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said ubiquitin specific protease 7 inhibitors and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
It would have been prima facie obvious to one of ordinary skill to arrive at the morpholine substituted at the para-position with the C-C bond of the instant expanded species from the morpholine substituted at the meta-position with the C-N bond of Almac because according to MPEP § 2144.09, second paragraph, “Compounds with are position isomers or homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.” In re Wilder, 563 F 2d 457, 195 USPQ426 (CCPA 1997). The expanded species of instant formula (Ia), the isomer, is expected to be preparable by the same methods as the compounds of Almac, and generally to have the same properties. The expectation is then deemed the motivation for preparing the morpholine substituted at the para-position with the C-C bond. A skilled artisan would have reasonably predicted that the isomer would be successful in light of the teachings of Almac.
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, 22, 25, 26, 28, 34-35, and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 17, and 21-22 of U.S. Patent No. 10,766,903 (herein after the “’903 Patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘903 Patent teaches compounds of formula (I):
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Which when R1 is H, R2 is a C3 cycloalkyl substituted with a C1 alkyl, Q is
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, where R9a is Cl and R9b is a substituted C6 aryl, generate a compound of the expanded species. The compound of this species is recited in claim 21 of the ‘903 Patent in col 266 as the second compound. Similar to above, it would have been prima facie obvious to one of ordinary skill to arrive at the morpholine substituted at the para-position with the C-C bond of the instant expanded species from the morpholine substituted at the meta-position with the C-N bond of the ‘903 Patent because according to MPEP § 2144.09, second paragraph, “Compounds with are position isomers or homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.” In re Wilder, 563 F 2d 457, 195 USPQ426 (CCPA 1997). The expanded species of instant formula (Ia), the isomer, is expected to be preparable by the same methods as the compounds of the ‘903 Patent, and generally to have the same properties. The expectation is then deemed the motivation for preparing the morpholine substituted at the para-position with the C-C bond. A skilled artisan would have reasonably predicted that the isomer would be successful in light of the teachings of ‘903 Patent.
Claim Objections
Claims 22, 25, 26, 28, 34, 42, and 43 are objected to for a minor informality. The claims recite “A compound”, but should recite, “The compound”. Appropriate correction is required.
Claim 34 is objected to for a minor informality. The compound names are not separated by commas, semicolons, or another separation technique. Appropriate correction is required.
Claim 43 is 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.
Conclusion
Claims 1, 22, 25, 26, 28, 34-35, and 42 are rejected. Claims 22, 25, 26, 28, 34, 42, and 43 are objected to. Claims 3-4, 9, 13, 15, 19-21, 29, 30, and 39-41 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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