Detailed Action
The present office action is in response to the application filed on 06 Dec 2024.
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 .
Status
Claims 1-11, 13-14, 16, and 19-26 of the pending application have been examined on the merits. Acknowledgement is made of the cancellation of claims 12, 15, and 17-18.
Priority
Applicants identify the instant application, Serial #: 18/872,457, filed 06 Dec 2024, as a National Stage Entry of International Patent Application #: PCT/IB2023/056041, filed 12 Jun 2023, which claims foreign priority from Foreign Application #s: IN202311035100, filed 19 May 2023, IN202311030125, filed 26 Apr 2023, and IN202211033194, filed 10 Jun 2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 06 Dec 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: “A crystalline Form PL1 of Paltusotine” should be “Crystalline Form PL1 of Paltusotine”. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: “A crystalline Form PL11 of Paltusotine” should be “Crystalline Form PL1 of Paltusotine”. Appropriate correction is required.
Claim 24 is objected to because of the following informalities: “pharmaceutical formulation , the process” should be “pharmaceutical formulation, the process”. Appropriate correction is required.
Claims 11, 13-14, 19, 22-23, and 26 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.
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, 5, 9-10, 16, 20-21, and 25 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.
Regarding claims 1 and 5, claim 1 is directed to Form PL1 of Paltusotine which is characterized by
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272
629
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Claim 5 is directed to Form PL11 of Paltusotine which is characterized by
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273
639
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Greyscale
However, it is unclear how the named crystalline Forms PL1 and PL11 of Paltusotine can be characterized by one of the data sets and not the other data sets. Named crystalline forms of compounds necessarily have both XRPD patterns and 13C NMR spectrums of the specified crystalline form. Applicant may overcome this rejection by amending the claims to be clear and consistent internally.
Regarding claim 9, claim 9 recites the limitation, "The crystalline Form PL1 of Paltusotine according to Claim 5," in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 5 is directed to crystalline Form PL11 and not PL1. Applicant may overcome this rejection by amending the claim to recite crystalline Form PL11.
Regarding claims 9-10 and 20-21, the phrase "about" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicant may overcome this rejection by removing the word “about” from the claims.
Regarding claims 16 and 25, claim 16 is directed towards a “method of treating a condition comprising administering a therapeutically effective amount of the crystalline Form PL1 of Paltusotine…” and claim 25 is directed towards a “method of treating a condition comprising administering a therapeutically effective amount of the crystalline Form PL11 of Paltusotine…” However, it is unclear where the compounds are being administered. Applicant may overcome this rejection by amending the claims to recite a subject that the compounds are administered to.
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 2-4 and 6-8 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. Claims 2-4 fail to further limit claim 1 which is directed to Form PL1 of Paltusotine. The named crystalline form necessarily comprises each characteristic found in the dependent claims. Claims 6-8 fail to further limit claim 5 which is directed to Form PL11 of Paltusotine. The named crystalline form necessarily comprises each characteristic found in the dependent claims. 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.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zhao et al. ( ACS Med Chem Lett, 2023, 14:66-74) is considered pertinent for teaching discovery of paltusotine. US 2019/0218202 is considered pertinent for teaching crystalline forms of paltusotine. WO 2021/011641 (provided in IDS 12/04/24) is considered pertinent for teaching crystalline forms of paltusotine.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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