DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant's election with traverse of Group II, and species of
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in the reply filed on March 27, 2025 and January 24, 2026 is acknowledged. The traversal is on the ground(s) that a broader range of R3 substituents would not make the search more complex. This is not found persuasive because the various substituents require separate structure searches. Therefore, there is a burden in examining the full scope of the claims.
The requirement is still deemed proper and is therefore made FINAL.
Priority
3. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
4. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation C2-25 alkenyl, and the claim also recites “preferably a C2-6 alkenyl...” which is the narrower statement of the range/limitation. In the present instance, claim 14 recites the broad recitation C1-4 alkyl, and the claim also recites “preferably methyl, ethyl...” which is the narrower statement of the range/limitation; and the broad recitation C11-21 alkyl, and the claim also recites “preferable C13-19 alkyl”; which is the narrower statement of the range/limitation; and the broad recitation C11-23 alkenyl, and the claim also recites “preferable a polyunsaturated C13-23 alkenyl” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
5. Claim 10 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.
The claim recites “
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” which is a functional limitation. The skilled artisan is not apprised of the structures which are within this limitation. Furthermore, the absence of the definition of variable R3 does not allow for the skilled artisan to determine the structural metes and bounds of the compounds of formula (I.1). For this reason, the claim is indefinite. Applicants may overcome this ground of rejection by amending the claim to include the structural limitation for variable R3, for example, as set forth in claim 11.
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.
6. Claims 10-12 and 14-17 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,029,715. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons provided below.
Determination of Scope and Contents of the Claims of the Patent
The claims are drawn to the method for the treatment or reducing the risk of a retinoid X receptor mediated signaling dysfunction (eg. ameliorating or reducing the risk of vitamin A5 deficiency) comprising administration of a compound
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. The claims are directed to the specific embodiments of, for example, Applicant’s elected species (eg. column 56). For compositions, see for example claim 7.
Ascertaining the differences between claims of patent and claims at issue
The preferred embodiment anticipates the present claims to the elected species of
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Resolving the level of ordinary skill in the pertinent art - Prima Facie Case of
Obviousness
MPEP 2144.08.11.A.4(c) states "...consider teachings of a preferred species within the
genus. If such a species is structurally similar to that claimed, its disclosure may
motivate on of ordinary skill in the art to choose the claimed species or subgenus from
the genus, based on the reasonable expectation that structurally similar species usually
have similar properties." This is a "Genus-Species Guidelines” for the examination
based on 35 USC 103. An analogous guideline was followed here for the analysis of
obviousness type double patenting. As such the claims suggest to the skilled artisan to practice the invention.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621