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 .
Priority
The instant application was filed 14 October 2024 and is the national stage entry of PCT/US2023/065786 filed 14 April 2023. The Applicant claims priority to provisional application 63/363,038 filed 14 April 2022. The effective filing date of the instant application is 14 April 2022.
Election/Restrictions
Applicant’s election of Group II (claims 37-41, 43, 44, 46, and 47) in the reply filed on 20 August 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 4, 6, 10-12, 16, 18, 20, 21, 24, 26, and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20 August 2026.
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 44 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 44 recites the limitation "the active agent effective against Candida albicans" in lines 1-2 of claim 44. There is insufficient antecedent basis for this limitation in 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 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.
Claim(s) 37-41, 43, 44, 46, and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Embil et al. (WO 2005/087270 A1), as evidenced by Matilda (matilda.org).
Regarding claim 37, Embil teaches a gel or cream (pg. 7, lns. 12-15) topical composition (abs, entire teaching) to treat vaginal infections. The composition may comprise tinidazole (pg. 5, ln. 28) in an amount of 0.5-10% (pg. 5, lns. 25-27) and boric acid as a further active ingredient or to adjust the pH (pg. 10, ln. 5). Citric acid, which is interpreted as a buffering agent, may be in an amount of 1.2% (Example 4). Embil also teaches a first active agent in an amount of 0.1-5% (pg. 5, lns. 17-20) and a second active agent in an amount of 0.5-10% (pg. 5, lns. 25-27). Therefore, it is interpreted that an additional active agent, such as boric acid, may be in an amount of the remaining 85-99.4%. The composition may comprise carriers and excipients (pg. 16, lns. 19-23) and does not require EDTA.
Regarding claims 38-40, the composition may comprise metronidazole (pg. 5, ln. 1) or tinidazole (pg. 5, ln. 28).
Regarding claims 41 and 43, the composition may comprise miconazole (claim 6).
Regarding claim 44, the composition may comprise miconazole (claim 6), where a first active agent may be in an amount of 0.1-5% (pg. 5, lns. 17-20) and a second active agent may be in an amount of 0.5-10% (pg. 5, lns. 25-27). Miconazole is an example of an active agent effective against Candida albicans (instant specification, para. 17).
Regarding claim 46, the composition may be in the form of a pessary, gel, cream, tampon, or foam and when provided as pessaries, the base may be made of hard fats (pg. 7, lns. 22-29). A vaginal pessary is interpreted similarly to a vagina ovule since both are designed to melt or dissolved when administrated (evidenced by Matilda, pgs. 1, 4).
Regarding claim 47, the composition may be in the form of a pessary (pg. 7, lns. 22-29), metronidazole (pg. 4, ln. 17), boric acid (pg. 10, ln. 5), and an excipient (pg. 16, lns. 19-23). The “consists essentially of” language only “limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s) of the claimed invention.” And absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising."(See MPEP 2111.03 (III)).
Embil does not teach an exact combination of at least one nitroimidazole compound, boric acid, and an excipient in claim 37.
In regards to selecting the combination of at least one nitroimidazole compound, boric acid, and an excipient in claim 37, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Embil teaches a gel or cream (pg. 7, lns. 12-15) topical composition (abs, entire teaching) to treat vaginal infections comprising tinidazole (pg. 5, ln. 28) in an amount of 0.5-10% (pg. 5, lns. 25-27), boric acid as a further active ingredient or to adjust the pH (pg. 10, ln. 5), and an excipient (pg. 16, lns. 19-23), whereas the claimed invention is directed to a gel, cream, or vaginal suppository composition comprising at least on nitroimidazole compound, boric acid, and an excipient. Since Embil teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
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.
Claims 37-41, 43, 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 51-53 of copending Application No. 19/579,880 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 51 of the reference application recites a composition comprising a nitroimidazole active agent or imidazole active agent and boric acid for treating vaginitis, which corresponds to instant claims 37-41, 43, and 44 regarding a composition for vaginal administration comprising a nitroimidazole compound, imidazole compound, and boric acid.
Claim 52 of the reference application recites the use of a composition comprising a nitroimidazole active agent or imidazole active agent and boric acid, which corresponds to instant claims 37-41, 43, and 44 regarding a composition for vaginal administration comprising a nitroimidazole compound, imidazole compound, and boric acid.
Claim 53 of the reference application recites a kit comprising an imidazole active agent and boric acid to deliver the composition to treat the vagina, which corresponds to instant claims 37-41, 43, and 44 regarding a composition for vaginal administration comprising a nitroimidazole compound, imidazole compound, and boric acid.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613
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