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, filed 07/13/2023 is a National Stage entry of PCT/US2022/070198, International Filing Date: 01/14/2022. PCT/US2022/070198 Claims Priority from Provisional Application 63138131, filed 01/15/2021.
Status of Claims
Claims 31-43 are pending as of the response filed on 11/6/25. Claims 1-30 have been canceled.
Applicant's election with traverse of the compound 2-(((R)-pyrrolidin-3-yl)amino)-1-((R)-2-((3aS,4S,6S,7aR)-3a,5,5-trimethylhexahydro-4,6-methanobenzo[d][1,3,2]dioxaborol-2-yl)pyrrolidine-1-yl)ethan-1-one, and the use recited by claim 37 in the reply filed on 11/6/25 is acknowledged. The traversal is on the ground(s) that unity of invention is not lacking in view of the newly submitted claims as Song doesn’t mention increasing the proliferation of cuboidal alveolar type 2 (AEC2) cells or restoring the diminished proliferation of AEC2 cells. In view of the new claims, the species election requirement is withdrawn. Claims 31-43 have been examined in their entirety.
Claims 31-43 were examined. Claims 32-34 and 36-37 are rejected. Claims 34-35, 37-40, and 42 are objected to. Claims 31, 41, and 43 are allowed.
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.
Claims 32-34 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 32 recites the DPP4 inhibitor as “(2S,4S)-4-(4-(pyrimidin-2-yl)piperazin-1-yl)pyrrolidine-2-yl)(pyrrolidine-1-yl)methanone (gosogliptin)”. However, “gosogliptin” as known in the art (Pubchem) corresponds to a compound having a different IUPAC name:
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. The claim is indefinite as the metes and bounds aren’t clear. Claims 33 and 36 are similarly rejected as they refer to “gosogliptin” without further clarifying the IUPAC name and chemical structure.
Claim 32 also recites the DPP4 inhibitor as “(2S,4S)-4-fluoro-1-((1-hydroxy-2-methylpropan-2-yl)glycyl)pyrrolidine-2-carbonitrile (TS-021)”. However, “TS-021” as known in the art (Pubchem) corresponds to a compound having a different IUPAC name, in particularly the benzenesulfonate salt:
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. The claim is indefinite as the metes and bounds aren’t clear. Claims 34, and 37 are similarly rejected as they refer to “TS-021” without further clarifying the IUPAC name or chemical structure.
Claim 32 also recites the DPP4 inhibitor as “3-(but-2-yn-1-yl)-5-methyl-2-(piperazin-1-yl)-3,5-dihydro-4H-imidazo[4,5-d]pyridazine-4-one (E-3024)”. However, “E-3024” as known in the art (CAS) corresponds to a compound having a different IUPAC name, in particularly the 4-benzenesulfonate salt:
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. The claim is indefinite as the metes and bounds aren’t clear. Claims 34, and 37 are similarly rejected as they refer to “E-3024” without further clarifying the IUPAC name or chemical structure.
The claims also recite the following DPP4 inhibitors: “PSN-9301” and “TQ-F3083”. However, the art doesn’t recognize a chemical structure for either of these inhibitors, and in particular, Applicants’ specification also doesn’t provide a chemical structure for these inhibitors. The metes and bounds of the claims aren’t clear, as it is uncertain what these names actually refer to, since the chemical formula or chemical structures of these agents aren’t known.
Claim Objections
Claims 34 and 37 are objected to because of the following informalities: the claims repeat the same compounds multiple times. For instance, claim 34 recites “(2R,3S,5R)-2-(2,5-difluorophenyl)-5-(5-(methylsulfonyl)-3,4,5,6-tetrahydropyrrolo[3,4-c]pyrrol-2(1H)-yl)tetrahydro-2H-pyran-3-amine;” and “ZYDPLA-1;”, however, these names refer to the same compound.
Claims 34 and 37 recite “2-(4-((2-((2S,5R)-2-cyano-5-ethynylpyrrolidin-1-yl)-2-oxoethyl)amino)-4-methylpiperidin-1-yl)isonicotinic acid;” and “ABT-279;”, however, these names refer to the same compound.
Claims 34 and 37 recite “((R)-1-(L-valyl)pyrrolidine-2-yl)boronic acid;” and “BXCL-701 (talabostat);”, however these names refer to the same compound.
Appropriate correction is required.
Claims 35, 38-40, and 42 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.
Information Disclosure Statement
The IDS filed on 11/6/25 has been considered.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627