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 the Claims
Applicant’s cancelation of all claims and addition of new claims 16-33 in the response filed on March 4th 2026 is acknowledged. Claims 16-33 are pending and are examined on their merits.
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.
Claim 21 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 21 recites the limitation "Y3" in reference to claim 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "Y1" in reference to claim 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "ring D" in reference to claim 16. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112(a)
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 16-33 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.
Claim 21 recites:
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While the genus is described in the specification (specification, pg. 9), zero embodied structures are provided in support of the genus (i.e. applicant has not provided a single example of a structure wherein the middle ring system contains 3 spiro-condensed rings). Applicant’s written description is thereby inadequate to support claim 21 as written and applicant will be considered not to be in possession of the subformula of claim 21.
Claim 16, 32-33, and their dependent claims 17-31 recite “an isomer thereof.” The written description is inadequate to support this limitation as written. The scope described by applicant’s description is supportive of stereoisomers of the compounds (specification, pg. 15), but not the general term, “isomers,” as the term implies the inclusion of structural isomers, wherein the molecular formula is identical but the bonding patterns differ. Applicant will be considered to only be in possession of “stereoisomers” of the compounds and not “isomers” in general.
Claims 16, 32-33, and their dependent claims 17-24 and 27-31 recite the proviso:
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Of these structures, only one carries support in applicant’s original disclosure:
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Thus, all other structures in the above proviso are considered new matter. The proviso is considered valid for the above structure only.
35 U.S.C. § 102 Rejections Overcome by Amendment
Applicant’s cancelation of all previous claims and addition of new claims 16-33 in the response filed on March 4th 2026 is acknowledged. Applicant’s new claims carry a proviso that the compound cannot be:
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As this is the compound upon which the previous 102 rejections were based, all 102 rejections are thereby withdrawn.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16-20, 22-24 and 27-33, and their dependent claims 17-24 and 27-31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Brizgys (U.S. Patent No. 12,091,404 issued on September 17th 2024, effectively filed on March 11th 2021).
Brizgys recites the compounds,
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[Brizgys, Examples 1, 2, 7, 9, 10, 16, support found in provisional application 63/159,853]
These compounds anticipate claims 16-20, 22-24, and 30-33
Claim 27 is directed towards a pharmaceutical composition comprising the compound above and a carrier. Brizgys teaches pharmaceutical compositions of the compound (Brizgys, col. 73-74, claim 2), anticipating claim 27.
Claims 28-29 are directed towards the treatment of GLP-1 mediated diseases, including diabetes with the compound above. Brizgys teaches the treatment of diabetes (Brizgys, col. 39), anticipating claims 28-29.
Claim Rejections - 35 USC § 103
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.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Brizgys (U.S. Patent No. 12,091,404 issued on September 17th 2024, effectively filed on March 11th 2021).
Claim 26 is directed to compounds, including:
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Each of these compounds differs from Brizgys’ Example 6:
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in just a single location:
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In each of these cases, the compounds are merely positional isomers of Brizgys’ Example 6, varying in the connectivity of one group, but in no other manner. One of ordinary skill in the art would thereby reasonably make these modifications, and claim 26 is prima facie obvious.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Brizgys (U.S. Patent No. 12,091,404 issued on September 17th 2024, effectively filed on March 11th 2021) in view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012).
Claim 25 is directed to compounds, including:
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which differs from Brizgys’ Example 6:
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in just the replacement of a hydrogen with a single methyl group:
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One of ordinary skill in the art would have a reasonable expectation of success in performing this replacement, because the replacement of hydrogens with methyls is one of the most common bioisosteric replacements in the field of drug discovery (Brown, pg. 17). Claim 25 is therefore prima facie obvious.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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