DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claim 1 is pending and under current examination.
Specification
The abstract of the disclosure is objected to because it contains greater than 150 words and is greater than one paragraph. Correction is required. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities: The independent claim lacks the article “A” at the beginning of each claim. See MPEP 608.01(n)(IV).
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.
Claim 1 is 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 1, lines 24 and 26 recites "hydrocarbon-based group". As there is no standard for what is embraced by the term "hydrocarbon-based group" (i.e. it is unknown what additional atoms are permitted in a hydrocarbon-based group), a person of ordinary skill in the art cannot readily ascertain the metes and bounds of the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim 1 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shroot et al. (US Patent No. 4,548,942; issue date: 10/22/1985; cited in the IDS filed 06/24/2025) in view of Pagani et al. (J. Med. Chem Vol 43, pages 199-204; publication year: 2000; cited in the IDS filed 06/24/2025), and further in view of eMedicine (Propionibacterium Infections; available online from: 12/22/2008; cited in the IDS filed 06/24/2025).
Shroot discloses applying a composition to the skin (i.e. a keratin material) containing antibacterial actives against gram-positive bacteria for treatment of acne (col 1, lines 40-41 and 19-23 and eMedicine, first paragraph under introduction. The compounds disclosed by Shroot are structurally similar to those embraced by the instant claims (col 1):
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The core structure in the compounds disclosed by Shroot differs from the compounds required by the instant claims in that the sulfur and nitrogen are linked by a covalent bond in Shroot; however, Pagani discloses that compounds meeting the structural requirements of instant claim 1 were also known at the time of the instant invention to be effective against gram-positive bacteria (page 199, right column):
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where X = O or S. The skilled Artisan would have been motivated to replace the compounds disclosed by Shroot with, for example, compound 2a or 2b of Pagani, where R = C6H13 or CH3, respectively, because these compounds are demonstrated to have greater efficacy than compounds possessing the core structure disclosed by Shroot (Pagani: table 1 comparing compound 2a to compound 6, which corresponds to the compounds disclosed by Shroot where R1 = C6H13).
The compounds disclosed by Pagani meet the structural limitations set forth in claims 1-6, for example, as follows: compound 2b, where R = CH3, is N-methyl-2-thioxo-1,2-dihydropyridine-3-carboxamide, wherein R1 = H and R2 = CH3 in formula (I) according to instant claims 1.
It is noted that the instant invention is directed towards a method of depigmenting, lightening, and/or whitening keratin materials whereas the method of Shroot is directed towards treating acne; however the method rendered obvious over the combined teachings of Shroot and Pagani possesses the same active step as the instant method, thus a skin depigmenting, lightening, and/or whitening effect must also necessarily be present. The examiner considers this limitation to be met by the combined disclosures of Shroot and Pagani, particularly since there is no quantitative requirement recited in the instant claims regarding the extent of depigmenting, lightening, and/or whitening. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. See In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. In re Best, Bolton, and Shaw, 195 USPQ 430, 433 (CCPA 1977) citing In re Brown, 59 CCPA 1036, 459 F.2d 531, 173 USPQ 685 (1972).
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-13 of copending Application No. 18875814 (reference application);
claims 1-15 of copending Application No. 18877253 (reference application);
claims 1-13 of copending Application No. 18877255 (reference application);
claims 1-15 of copending Application No. 18874784 (reference application);
claim 1-19 and 22 of copending Application No. 18392567 (reference application);
claims 1-15 of copending Application No. 18267333 (reference application);
claims 1-15 of copending Application No. 18257731 (reference application);
claims 1-21 of copending Application No. 17844934 (reference application);
claims 1-12 of copending Application No. 17844939 (reference application);
claims 11-22 of copending Application No. 18031267 (reference application); and
claims 34-53 of copending Application No. 16061908 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the cited applications embrace a method of applying a composition comprising a compound falling within the scope of formula (I) or (I’), as recited in instant claim 1, to keratin material (i.e. skin).
With regard to the ‘814 application, these claims are directed to a composition; however the method of application to skin is disclosed in the specification at page 31.
The examiner has relied upon the specification to delineate the scope of the invention embraced by the copending application, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-9 of U.S. Patent No. 9138392; cited in the IDS filed 06/24/2025;
claims 1-20 of U.S. Patent No. 11052028; cited in the IDS filed 06/24/2025;
claims 1-20 of U.S. Patent No. 12491146;
claims 1-15 of U.S. Patent No. 12521333; and
claims 1-20 of U.S. Patent No. 12226506.
Although the claims at issue are not identical, they are not patentably distinct from each other because render obvious the instant claims.
Inter alia, the claims of the cited patents embrace a method of applying a composition comprising a compound falling within the scope of formula (I) or (I’), as recited in instant claim 1, to keratin material (i.e. skin).
With regard to the ‘028, these claims are directed to a composition; however the method of application to skin is disclosed in the specification in e.g. the abstract.
The examiner has relied upon the specification to delineate the scope of the invention embraced by the copending application, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617