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
Filing Receipt
The filing receipt mailed 09/19/2023 states the instant application is a CON of both non-provisional applications 17/572,037, filed 01/10/2022, and non-provisional application 17/381,005, filed 07/20/2021, which claim benefit of provisional application 63/118,431, filed 11/25/2020. The instant application finds support in the provisional application. Therefore, the effective filing date is 11/25/2020.
Information Disclosure Statement
The IDS submitted 09/19/2023 and 09/05/2024 have been considered.
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 57-67 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.
Independent claims 57 and 62 use the term “substantially”. “Substantially” is not defined in the instant specification. The instant specification and claims also do not provide a way for one of ordinary skill in the art to determine what is and is not “substantially similar”.
Therefore, one of ordinary skill in the art would not immediately know the metes and bounds of the instant claims.
As claims 58-61 and 63-67 are dependent on the independent claims, they are also rejected.
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.
Co-pending application 18/253,023
Claim 68-71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of copending Application No. 18/253,023 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 68 is drawn to a process of preparation of crystalline compound II comprising adding sodium hydroxide in water to an acetone solution of Compound I or an alkyl ester of compound 1 (scheme shown below).
Claim 68 scheme
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688
518
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Reference claim 1 is drawn to a multistep process of preparation of the same compound II. The reference claim in step (2) (shown below) states “reacting compound 5 with sodium hydroxide, potassium hydroxide, or lithium hydroxide in a suitable solvent to provide compound 6.
Reference claim
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474
542
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The claim does not specify a “suitable solvent” but the reference specification in para. [0066] states “in some embodiments, the suitable solvent is water, methanol, ethanol…acetone…”.
The instant claim further requires filtering of the crystalline compound II and filtering drying the solids to provide the crystalline compound II. However, filtering solids from solution and filter drying are both techniques that are well known within the art and one of ordinary skill would find it obvious to practice additional filtering and drying steps as they are routine steps in crystallization.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624