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
Priority
This application is a CON of 18/364,690 filed 08/03/2023 (abandoned); 17/328,590 filed 05/24/2021 (abandoned); 17/184,870 filed 02/25/2021 (US PAT 11760749); 16/682,821 filed 11/13/2019 (US PAT 10934277); and 16/518,516 filed 07/22/2019 (abandoned).
This application claims benefit to PRO 62/701,726 filed 07/21/2018.
Information Disclosure Statement
The information disclosure statement(s) (IDS) dated 06/24/2024 have been considered.
Claim Rejections - 35 USC § 112(a)
The following is a quotation 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.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the compound of claim 1, does not reasonably provide enablement for co-crystal. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with the claim.
The claim invites a person having ordinary skill in the art to determine the other applicable compounds in the co-crystal, their number of mole and make the co-crystal using any means/procedure known to the artisan. Acid addition salts are disclosed as co-crystals in the specification but the procedures are not disclosed. There are no disclosures how to modify the process of making the exemplified salts to make the co-crystals. By deleting co-crystal, the rejection will be overcome.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burai et al., Org. & Biomolecular Chem. (2010), 8(9) 2252-59, as cited in the IDS dated 06/24/2024.
Burai et al teaches
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, process of making the compound and co-crystal thereof during recrystallization. See pages 2252, 2256 (col. 2, last procedure) and 2258 (col. 2, first procedure). The chiral purity is about 90% or greater, (table 1). See also the entire document.
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.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Burai et al., Org. & Biomolecular Chem. (2010), 8(9) 2252-59.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Burai et al teaches
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, as set forth in the rejection under 35 USC 102 above.
Ascertaining the differences between the prior art and the claims at issue. (See MPEP § 2141.02)
Burai does not teach a salt of the prior art compound.
Considering objective evidence present in the application indicating obviousness or nonobviousness. (See MPEP § 2142-2144)
It is well-known in the art that a compound and its salts are obvious variants. One is not patentable over the other. A PHOSITA with reasonable expectation of success would have known and be motivated to claim salts of the compound at the time the invention was made. The motivation is because such is a routine practice in the art, and to avoid the prior art.
The claim is not allowable over the prior art and knowledge well-known in the art.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, US patent 10,934,277. Although the claims at issue are not identical, they are not patentably distinct from each other because, the chiral purity of the claims in the patent is non-limiting. Therefore, embraces 90% or more. The property of the instant compound is non-limiting, and embraces the properties cited in claims 1-11 of the patent. The compound in the patent is claimed in the instant, the difference being that co-crystal is also claimed herewith.
Contact Information
Claim 1 is rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.F./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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