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 .
Status of claims
Claims 1-17 are cancelled. Claims 18-31 and 33 are new. Claims 18-31 and 33 are pending and under examination.
Priority
This application is a 371 of 371 of PCT/EP2022/063442, filed on 05/18/2022. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCTEP2022063442, filed on 05/18/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/09/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 19, 21-31, and 33 are objected to because of the following informalities:
Claim 19 states “bacterial vaginosis, trichomoniasis and candidiasis or a combination thereof”. Proper syntax is “bacterial vaginosis, trichomoniasis, candidiasis, or a combination thereof”.
Claims 21-31 and 33 recite “A controlled release, antimicrobial gel of…”. Proper syntax is “The controlled release, antimicrobial gel of…”.
Claims 21 and 22 recite “release of anti-infective agent from the gel”. Proper syntax is “release of the anti-infective agent from the gel”.
Claim 23 recite that “the muco-adhesive agent and the gel-forming agent also acts…”. Proper syntax is “the muco-adhesive agent and the gel-forming agent also act…”
Claim 29 is objected to for “the anti-infective monoterpenoid phenol agent”. A suggested amendment is to alter the claim language to “the monoterpenoid phenol anti-infective agent” to be consistent with claim 18.
Claim 29 recites “phenol agent is thymol or carvacrol or a combination thereof”. Proper syntax is “phenol agent is thymol, carvacrol, or a combination thereof”.
Claim 30 recites “which contains a humectant”. Proper syntax is “which further contains a humectant”.
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not). In this case, claim 32 is skipped and goes directly to claim 33 from claim 31.
Appropriate correction is required.
Claim Rejections – 35 USC § 112 (b)
Claims 18-31 and 33 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 18 recites the limitation "the anti-infective agents" (plural form) in the claim where only one anti-infective agent is introduced earlier in the claim (a monoterpenoid phenol anti-infective agent). There is insufficient antecedent basis for this limitation in the claim. Applicant may refer to “the anti-infective agent”.
Claims 19-31 and 33 are rejected for being dependent to indefinite claim 18.
Claim 21 recites that the “release of anti-infective agent from the gel is higher within 3 hours of application of the gel at a pH greater than 4.5”. However, It is unclear what the release “is higher” than, thus rendering the claim indefinite.
Claim 22 is also rejected for being dependent to indefinite claim 21.
Claim 22 recites that “up to 30% or more of anti-infective agent is released”. However, the units of “%” is not stated (e.g., mass, molar, volume), rendering the claim indefinite.
Claim 28 contains the trademark/trade name “Carbopol”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe carbomer and, accordingly, the identification/description is indefinite.
Claim 31 states that “at the end of 72 hours, the gel matrix is shed from the vaginal cavity”. However, it is unclear when the time-clock starts for the 72 hours (e.g., at application of the gel to the vaginal cavity, at the moment the drug begins to release into the vaginal cavity, or some other time prior to or after the administration, etc.,), thus rendering the claim indefinite.
Claim Rejections – 35 USC § 103
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 18-23, 25-31, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Pauletti (WO2007035515A2) as evidenced by Fuisz (US20090098192A1) and further evidenced by Arnold et al. (US20150010654A1) and further evidenced by Mumper et al. (US20020132008A1)
Pauletti discloses a vaginal delivery of therapeutic agents having a substrate affinity for metabolic cytochrome P-450 enzymes and membrane efflux transporter systems [¶abstract].
Regarding Claim 18, Pauletti teaches that the composition can be formulated as a sustained and controlled release drug system [page 51, lines 18-19]. Pauletti teaches that the vaginal mucosal composition may be delivered as a gel [page 20, lines 16-17], with the drug encapsulated within the matrix [page 51, lines 23-27].
Pauletti teaches that the composition may have mucoadhesive agents [page 37, line 1]. Pauletti further teaches that polycarbophil polymers (i.e., stated to be the mucoadhesive polymer per present claim 26) can be used in the composition [page 47, line 29], which are known bio-adhesive polymers as evidenced by Fuisz [¶31].
Pauletti teaches that the composition may also contain hydrogel-forming polymers [page 52, lines 7-12].
Pauletti teaches that the composition may contain thymol [page 48, line 1] (i.e., stated to be the monoterpenoid phenol anti-infective agent per present claim 29), which is a mucus absorption enhancer as evidenced by Fuisz [¶65].
The recited “said gel is formulated for a single application to the vaginal cavity” is an intended use characteristic thereby bearing no patentable weight.
Pauletti teaches that the bio-adhesive systems of the composition composed of polyacrylic acid (i.e., the gel-forming agent recited in present claim 27) may release the pharmacological agent for up to five days once appropriately formulated [page 53, lines 7-10].
Given the above teachings, the pH dependency of the release of the anti-infective agent recited in this claim and the boundedness of the muco-adhesive agent to the vagina would be both inherent to the aforementioned formulation teachings of Pauletti (via a matter of routine optimization of result-effective formulation variables) and may also be considered post-use-characteristics (which would thus bear no patentable weight).
Regarding Claim 19, this is merely a further-limiting element of the intended use already stated in claim 18.
Regarding Claim 20, this would be an inherent effect of the above formulation taught by Pauletti.
Regarding claims 21 and 22, once the above formulation is optimized as a sustained or controlled release agent taught by Pauletti, such characteristic would be inherent to the composition. Additionally, these two claims define such characteristics of the formulation to be post-use (i.e., after application of the gel per these present claims), which indicates that they do not bear patentable weight.
Regarding claim 23, given that Pauletti teaches that the bio-adhesive polyacrylic acid (i.e., the gel-forming agent recited in present claim 27) and the acidic Polycarbophil (i.e., the mucoadhesive polymer per present claim 26) may be present in such gels [page 47, line 29; page 53, lines 7-10], their acidic effects would be inherent.
Regarding claim 25 and 27, Pauletti teaches that the bio-adhesive systems of the composition composed of polyacrylic acid may release the pharmacological agent for up to five days once appropriately formulated [page 53, lines 7-10].
Regarding claim 26, Pauletti further teaches that polycarbophil polymers can be used in the composition [page 47, line 29], which are known bio-adhesive polymers as evidenced by Fuisz [¶31].
Regarding claim 28, Pauletti teaches that stabilizing agents such as carbomer 934P or 940 (which are forms of Carbopol) may be used in such compositions [page 47, line 26].
Regarding claim 29, Pauletti teaches that the composition may contain thymol [page 48, line 1], which is a mucus absorption enhancer as evidenced by Fuisz [¶65].
Regarding claim 30, Pauletti teaches that the composition may contain lubricants such as glycerin [page 47, line 27], which is a prevalent mucosal humectant as evidenced by Arnold et al. [¶407].
Regarding claim 31, this is a post-use characteristic (thus bearing no patentable weight) which would also be inherent to the aforementioned formulation teachings of Pauletti via routine optimization of result-effective variables. This is evidenced by Mumper et al. which teaches that vaginal gel formulations containing polyacrylic acid polymers, such Carbomer, have been shown to stay attached to the mucosal lining in the vagina for up to three to five days [¶86].
Regarding claim 33, its claimed delivery to the vaginal cavity is an intended use characteristic bearing no patentable weight. In addition, the single-use, pre-filled syringe tube as claimed is separate from the composition of claim 18, thus bearing no patentable weight.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate the vaginal gel composition of Pauletti to include the known mucoadhesive/bio-adhesive polymers, polycarbophil, thymol, Carbopol, and glycerin as taught by Pauletti and evidenced by Fuisz and D, and to optimize the formulation for sustained vaginal residence and controlled release for at least three days as evidenced by Mumper et al. The motivation would have been to improve mucosal adhesion, optimize residence time, provide moisture and comfort, the release of active agents, and achieve enhanced therapeutic efficacy against bacterial infections. A person of ordinary skill in the art would have done so with a reasonable expectation of success because Pauletti expressly teaches controlled release systems, encapsulation within the matrix, muco-adhesion and hydrogel-forming polymers, thymol, glycerin, and polycarbophil/carbomer-type polymers for vaginal delivery, While Fuisz, Arnold et al. and Mumper et al. merely evidence the known properties and predictable functions of those same components in mucosal/vaginal formulations.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Pauletti (WO2007035515A2) in view of Griffiss (WO2020076805A1).
Pauletti teaches all required limitations of present claims 18-23, 25-31, and 33.
However, Pauletti fails to teach the requirements of present claim 24.
Griffiss discloses compositions (e.g., gels, suppositories, and the like) and methods for modulating the acidity and/or alkalinity of the fluidic environment of human reproductive organs and systems [¶abstract]. Griffiss teaches that the pH range of the composition is from about 3.5 to about 4.5 to be suitable for administration to a reproductive aged female [page 17, lines 25-27].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the vaginal gel composition of Pauletti to have a pH within the claimed range of 2.5 to 4. This is because Griffiss teaches reproductive/vaginal compositions, including gels, having a pH of 3.5 to 4.5 suitable for administration to reproductive-age females, which overlaps with the present claimed range. A person of ordinary skill in the art would have been motivated to select and optimize the pH of Pauletti’s vaginal gel within the overlapping acidic range taught by Griffiss to provide a composition compatible with the vaginal environment and suitable for vaginal administration. A reasonable expectation of success would have existed because adjusting pH is a routine, predictable formulation parameter, and Griffiss expressly teaches that the overlapping pH range is suitable for the same type of reproductive/vaginal compositions.
Conclusions
No claim is found allowable.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/Primary Examiner, Art Unit 1613
Prosecution Insights