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
Claims 1-10 are pending in the application. Claims 1-10 are rejected.
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/CN2023/091140, filed April 27th, 2023, which claims priority under 35 U.S.C. 119(a-d) to CN202210456939.3, filed April 27th, 2022.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because it is recited as a “use” of a compound.
Applicant is directed to MPEP 2173.05(q): ‘"Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 ").’
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 8 and 10 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 8 is rejected as indefinite since the preamble recites “The compound or the pharmaceutically acceptable salt thereof according to claim 1, wherein the compound is selected from:” and where the list includes the following salt:
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The introduction to the list refers to the compound being particular structures but where the structure above is already in salt form. It is unclear if the claim is (1) limited to only the salt form of compound 31 as depicted, (2) would include the non-salt form of compound 31 or (3) would include the salt form as depicted and potentially further salt additions, such as 2:1 acid:compound salts. It is suggested that Applicant amend claim 8 to recite: “The compound or the pharmaceutically acceptable salt thereof according to claim 1, wherein the compound or the pharmaceutically acceptable salt is selected from:”.
Claim 10 is rejected as indefinite since it recites a “use” without setting forth any actual active steps. MPEP 2173.05(q) states: “It is appropriate to reject a claim that recites a use but fails to recite steps under 35 U.S.C. 101 and 35 U.S.C. 112(b) if the facts support both rejections.”
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5 and 7-11 of copending Application No. 18/557,919 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending case recite carboxylic acids and corresponding esters thereof. For instance, claim 8 of the copending case recites the following compound:
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The compound is embraced by instant formula (I) where R is C3 alkyl, Ar is the third option depicted in instant claim 1, Y is O, R1 is C2 alkylene and R2 is hydrogen. The structure above is embraced by instant claims 1, 2 (formula (IV)), 3, 4, 5, 6 and 7. Regarding instant claim 9, claim 9 of the copending case recites analogous compositions. Regarding instant claim 10, this claim is rejected as indefinite; however, claim 10 of the copending case recites a method of administering the compound for treating gout or hyperuricemia. Regarding instant claim 8, this claim recites the following compound:
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The compound of the instant claims differs from the compound of the copending claims based on replacement of a ring -CH= group with -N=. The claims of the copending case, however, recite this type of replacement. Claim 1 of the copending case recites the following options for the corresponding ring:
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Furthermore, the claims of the copending case teach the corresponding free acid:
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Accordingly, a person having ordinary skill in the art in seeking to making additional useful compounds of the copending genus would have reasonably expected the instantly claimed compound to possess structural features necessary for utility.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Closest Prior Art
The closest prior art appears to be U.S. Patent PGPub No. 2005/0090529 by McAlpine et al., which discloses the following compound on page 82:
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The prior art compound differs from the instant claims based on the identity of the instant variable Ar. The compound above, however, is only disclosed as an intermediate and the prior art fails to provide any motivation to modify it. The genus of the prior art does not even generically encompass compounds instantly claimed since the cyano group of the intermediate above corresponds to a heterocycle in the prior art generic formula:
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For these reasons, the prior art fails to teach or reasonably suggest any compounds instantly claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
Prosecution Insights