DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 15, 2025 has been entered.
Response to Amendment
3. The amendments to the claims filed on August 15, 2025 have been fully considered. The amendments are sufficient to overcome the outstanding ground of rejection which is withdrawn.
Claim Objections
4. Claims 17 (duplicate of 13), 19 (duplicate of 15), 20 (duplicate of 16), 21 (duplicate of 16), 34 (duplicate of 30), 37 (duplicate of 16), 38 (duplicate of 24), 39 (duplicate of 25) and 41 (duplicate of 13) objected to for being a substantial duplicate of the corresponding -claims denoted inside the parentheses.
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.
5. Claim 12 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 refers to a method of claim 6, however, claim 6 is cancelled. It is not possible to interpret the metes and bounds of a method claim that does not recite a method. Claim 12 recites only the clause that “the compound is of the general formula (8), or a pharmaceutically acceptable salt or solvate thereof.” This claim was not further examined on the merits because the metes and bounds could not be ascertained. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
6. Claim 36 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim does not further narrow the scope of the claim it depends on. Claim 36 is directed to a method of claim 34. Claim 34 requires a pharmaceutical composition comprising a compound of
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or a pharmaceutically acceptable salt or solvate thereof. Claim 36 requires a pharmaceutical composition comprising
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or a pharmaceutically acceptable salt or solvate. The scope of the dependent claim is the same as the scope of the claim it depends from. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
7. Claims 1-5, 13-21, 24-34 and 36-48 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13, 14, 23 and 24 of copending Application No. 18,904,228 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons provided below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Determination of Scope and Contents of the Claims of the Copending Application
The claims are directed to methods of modulating GABAA receptor activity by administration of a compound of structure
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. The method is for the disorders which include pain, for example, fibromyalgia, neuropathic pain, osteoarthritis, etc.
Ascertaining the differences between claims of copending application and claims at issue
The claims of the copending application contain embodiments that anticipate the present claims.
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.
8. Claims 1-5, 13-21, 24-34 and 36-48 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-21 of U.S. Patent No. 12,134,619. 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 directed to methods of modulating GABAA receptor activity by administration of a compound of structure
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. The method is for the disorders which include pain, for example, fibromyalgia, neuropathic pain, osteoarthritis, etc.
Ascertaining the differences between claims of the patent and claims at issue
The claims of the patent contain embodiments that anticipate the present claims.
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