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 1-8, 11, 26, 29-31, 34, 39-41, 43 and 97-98 are currently amended. Claims 9-10, 12-25, 27-28, 32-33, 35-38, 42, 44-96, 99-114 are cancelled by the applicant. Claims 1-8, 11, 26, 29-31, 34, 39-41, 43 and 97-98 are pending and under examination.
Priority
This application is a 371 of PCT/US2022/078741, filed on 10/26/2022. It claims the benefit of U.S. Provisional Patent Application No. 63/273,013, filed on 10/28/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/29/2024 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 1, 4 and 7 objected to because of the following informalities:
Claim 1 is objected to for missing a “,” after “about 70,000” in the claim.
Claims 4 and 7 recites “The thin film of claim 1, further comprising… and any combination thereof”. Proper syntax for such listings is “The thin film of claim 1, further comprising… or any combination thereof”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b)
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 1-8, 11, 26, 29-31, 34, 39-41, 43 and 97-98 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 1 recites the term “PVA” in multiple subsections. This term is an acronym and is unclear whether it refers to polyvinyl acetate, polyvinyl alcohol, or another material, and is thus indefinite. For the purpose of this examination, it will be assumed that “PVA” refers to polyvinyl alcohol.
Claim 1 refers to the molecular weight (MW) of PVA in multiple subsections. However, it fails to specify the units of molecular weight (e.g., Da, kDa, g/mol, kg/mol, etc.,) and is thus rendered indefinite. For the purpose of examination, the unit for MW of PVA is assumed to be Da (also termed g/mol).
Claim 1 recites “about 0% (w/w)”. it is unclear what effects the term “about”, a term that allows for some degree of error in measurement around measurable amounts, gives to the value of zero, thus rendering it indefinite. A suggested amendment is to remove the term “about” that is currently in front of the “0% (w/w)”.
Claims 2-8, 11, 26, 29-31, 34, 39-41, 43 and 97-98 are also rejected for being dependents of indefinite claim 1.
Claim 7 contains the trademark/trade name “carpobol”. 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 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.
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 1-8, 11, 26, 29-31, 34, and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Popov et al. (US20150125539A1) in view of Sun et al. (US20150152187A1) in further view of Oliveira et al. (US20170224749A1).
Popov et al. discloses particles, compositions, and methods that aid particle transport in mucus [abstract]. Popov et al. teaches that the composition may be administered via the vaginal route [¶250]. Popov et al. teaches that dosage forms for topical and vaginal administration of the composition may include sprays, creams, ointments, pastes, gels, or solutions and other forms [¶266, 250-251], all of which may be film-forming. Popov et al. teaches that D and L-lactic acid may be used to aid in precipitation of the composition [¶166]. Popov et al. teaches that the composition comprises a plurality of particles having a core and surface-altering coatings [¶¶8-11], with one or more synthetic polymers such as polyvinyl alcohols (“PVA”) comprising the core and coating [¶¶115, 128, 161, 190], and such synthetic polymers having molecular weights ranging from 25 kDa to 200 kDa [¶189]. Popov et al. teaches that liquid forms of the composition may include diluents and humectants such as glycerol [¶¶252, 262]. Popov et al. renders the addition of alginic acid to be optional [¶¶166, 249, 262], which obviates its exclusion. Popov et al. teaches that the composition may comprise a buffer [¶147]. Popov et al. teaches that citric acid, tartaric acid, and benzoic acid can be used to aid in the precipitation process of the composition [¶166]. Popov et al. teaches that the composition may include preservatives [¶133]. Popov et al. teaches that benzoic acid may be used to aid in precipitation [¶ 166]. Popov et al. teaches that hydroxypropyl methylcellulose (“HPMC”) [referred to as Methocel] may be used as a surface-altering agent [¶415]. Popov et al. further teaches multiple embodiments where Methocel E50 (HPMC E50) was used in such compositions [e.g., ¶417, table 3]. Popov et al. teaches that a variety of bases may be also added to the composition to facilitate precipitation, including sodium hydroxide (NaOH) [¶167]. The limitations of claims 40 and 41 are considered post-use characteristics, and thus bear no patentable weight.
However, Popov et al. fails to teach the concentration of the above components. Popov et al. also fails to teach the limitation of claim 11 (i.e., xanthan gum at 0.05% (w/w) to about 1.5% (w/w)). In addition, Popov et al. fails to teach such compositions being used as thin films.
Sun et al. discloses a pharmaceutical composition comprising compounds and pharmaceutically acceptable carriers, excipients, or binders [¶52]. Sun et al. teaches that the formulation may be suitable for vaginal administration in the form of pessaries, tampons [indicating intravaginal administration], creams, gels, pastes, foams, or spray formulas and carriers in the art known to be appropriate [¶1076]. Sun et al. teaches that the composition may include film-forming agents [¶1064]. Sun et al. teaches that viscosity-increasing agents (e.g., xanthan gum), humectants (e.g., glycerol), preservatives, and buffers can be included in the composition [¶1064]. Sun et al. teaches that the composition may contain water as a carrier or be non-aqueous for parenteral administration [¶1071]. Sun et al. specifically teaches that the pharmaceutical composition may comprise one or more of the following in any combination: lactic acid, polyvinyl alcohol, citric acid, tartaric acid, benzoic acid, sodium citrate, sodium benzoate, xanthan gum, and hydroxypropyl methylcellulose [¶1065]. Sun et al. teaches that the above components may be present in the pharmaceutical composition at any concentration, such as, for example, at least A, wherein A is 0.0001% w/v, 0.001% w/v, 0.01% w/v, 0.1% w/v, 1% w/v, 2% w/v, 5% w/v, 10% w/v, 20% w/v, 30% w/v, 40% w/v, 50% w/v, 60% w/v, 70% w/v, 80% w/v, or 90% w/v [¶1066]. Sun et al. further teaches that the above components may be present at any concentration, such as, for example, at most B, wherein B is 90% w/v, 80% w/v, 70% w/v, 60% w/v, 50% w/v, 40% w/v, 30% w/v, 20% w/v, 10% w/v, 5% w/v, 2% w/v, 1% w/v, 0.1% w/v, 0.001% w/v, or 0.0001% w/v [¶1066]. This squarely overlaps with the claimed concentrations of all components assuming that the density of the composition is approximately 1 g/mL (e.g., water is the carrier), or even if the composition density ranges from 0.5 g/mL to 5 g/mL.
Oliveira et al. discloses compositions for films, and method of preparation thereof, for prevention and treatment of urogenital infections, particularly vaginal infections [abstract]. Oliveira et al. teaches that such films are thin structures [¶13], with the vaginal films of variable thicknesses depending on composition and preparation method, and those ranging from 0.1 mm to 3 mm or 0.09-3mm in thickness [¶60, 65 and 73]. Oliveira et al. teaches that advantages of vaginal films include portability, low cost, and improved comfort and efficacy [¶11]. Oliveira et al. teaches that the thin vaginal film compositions can include lactic acids as prebiotics and buffers [¶33, 51, 128], polyvinyl alcohols as mucoadhesive polymers [¶53], and glycerol as a cryoprotectant [¶53]. Oliveira et al. also teaches the inclusion of hydroxypropyl methylcellulose in such compositions as an additional mucoadhesive polymer [claim 30 of Oliveira et al.; ¶¶ 53-54].
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 composition of Popov et al. to include the component concentrations taught by Sun et al. for formation of the vaginal thin film compositions taught by Oliveira et al. This is because all references are directed to a pharmaceutical composition suitable for vaginal/topical administration and disclose overlapping excipient systems, including lactic acid, PVA, glycerol, HPMC, and buffers. A person of ordinary skill in the art would have thus been motivated to use the concentrations taught by Sun et al. to provide workable pharmaceutical formulations containing the same known excipients for the same route of administrations, while optimizing routine formulation properties such as viscosity, film formation, buffering/pH control, precipitation, preservation function, and muco-adhesion to arrive at the vaginal thin film compositions taught by Oliveira et al. Because Sun et al. expressly teaches that these components may be used in any combination at broad concentrations encompassing the claimed ranges, and because adjusting commonly known excipient concentrations to achieve predictable formulation properties is routine optimization of result-effective variables in pharmaceutical applications, a person of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Popov et al. (US20150125539A1) in view of Sun et al. (US20150152187A1) in further view of Oliveira et al. (US20170224749A1) in further view of Singh et al. (WO2020086705A2).
Popov et al., Sun et al., and Oliveira et al. collectively teach all required limitations of present claims 1-8, 11, 26, 29-31, and 34.
However, Popov et al., Sun et al., and Oliveira et al. fail to collectively teach the required limitations of present claims 39.
Singh et al. discloses a pharmaceutical composition and methods for using the pharmaceutical composition [abstract]. Singh et al. teaches that the composition may be topically delivered to the vaginal mucosa [¶6]. Singh et al. teaches that dosage forms for the composition include gels, foams, films, intravaginal rings, douches, suspensions, and emulsions [¶65]. Singh et al. teaches that the composition may exhibit a mucoadhesive detachment force of at least 0.1 N, more particularly at least 0.2 N [¶48].
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 thin film compositions collectively taught by Popov et al., Sun et al., and Oliveira et al. in view of Singh et al. to provide a thin film having the claimed bio-adhesive strength. This is because all four references are directed towards films for vaginal applications, and Singh et al. expressly teaches such vaginally administered pharmaceutical films exhibiting a mucoadhesive detachment force of at least 0.1 N, particularly at least 0.2 N. A person of ordinary skill in the art would have been motivated to incorporate the mucoadhesive properties taught by Singh et al. into the compositions jointly taught by Popov et al., Sun et al., and Oliveira et al. in order to improve retention of the formulation at the vaginal mucosa, thereby enhancing residence time and effectiveness of the administered composition. Because Popov et al., Sun et al., Oliveira et al., and Singh et al. are all directed to similar vaginal pharmaceutical delivery systems employing conventional film-forming excipients, one of ordinary skill in the art would have had a reasonable expectation of success in achieving the claimed bio adhesive strength through routine optimization of known formulation parameters.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Popov et al. (US20150125539A1) in view of Sun et al. (US20150152187A1) in further view of Oliveira et al. (US20170224749A1) in further view of Sprott et al. (US20090118503A1).
Popov et al., Sun et al., and Oliveira et al. collectively teach all required limitations of present claims 1-8, 11, 26, 29-31, and 34.
However, Popov et al., Sun et al., and Oliveira et al. fail to collectively teach the required limitations of present claims 43.
Sprott et al. discloses pharmaceutical compositions comprising compounds and methods for treating a patient by administering such pharmaceutical compositions [¶17]. Sprott et al. teaches that the agents can be administered via trans-mucosal route across the vagina or vaginally [¶¶1207, 1210]. Sprott et al. teaches that the composition can be formulated as gels, pastes, solutions, or suspensions [¶¶1143, 1207]. Sprott et al. teaches that the composition may contain film-forming materials [¶1194]. Sprott et al. teaches that the composition may have a tensile strength from about 0.8 to about 2.0 Mpa [¶1181].
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 pharmaceutical compositions of Popov et al., Sun et al., and Oliveira et al. in view of Sprott et al. to provide a thin film having the claimed tensile strength. This is because Sprott et al. expressly teaches transmucosal vaginal pharmaceutical compositions containing film-forming materials and exhibiting tensile strengths overlapping with those in the present claims. A person of ordinary skill in the art would have thus been motivated to incorporate the tensile strength properties of Sprott et al. into the composition of Popov et al., Sun et al., and Oliveira et al. in order to optimize the film integrity, flexibility, and retention during vaginal administration. Because Popov et al., Sun et al., Oliveira et al., and Sprott et al. are all directed to similar vaginal pharmaceutical delivery systems using conventional film-forming excipients, a person of ordinary skill in the art would have had a reasonable expectation of success in achieving the claimed tensile strength through routine optimization of known formulation components and concentrations.
Claims 97-98 are rejected under 35 U.S.C. 103 as being unpatentable over Popov et al. (US20150125539A1) in view of Sun et al. (US20150152187A1) in further view of Oliveira et al. (US20170224749A1) in further view of Garg et al. (US20040009223A1),
Popov et al., Sun et al., and Oliveira et al. collectively teach all required limitations of present claims 1-8, 11, 26, 29-31, and 34.
However, Popov et al., Sun et al., and Oliveira et al. fail to collectively teach the required limitations of present claims 97-98.
Garg et al. discloses antimicrobial and contraceptive compositions and methods which prevent and/or reduce the risk of transmission of sexually transmitted diseases through sexual activity as well as prevent and/or reduce the risk of pregnancy [abstract]. Garg et al. teaches that the composition is suitable for application within the vagina [¶18]. Garg et al. teaches that the composition can be formulated in dosage forms such as gels, creams, lotions, viscous liquids, powders, films, suppositories, foams, and the like [¶17].
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 thin film compositions collectively taught by Popov et al., Sun et al., and Oliveira et al. in view of Garg et al. to use the claimed thin films for contraception and prevention of sexually transmitted infections. This is because Garg et al. expressly teaches antimicrobial and contraceptive vaginal compositions for preventing pregnancy and reducing transmission of sexually transmitted diseases, including formulations in film dosage forms. A person of ordinary skill in the art would have thus been motivated to apply the film-forming vaginal compositions of Popov et al., Sun et al., and Oliveira et al. for the known contraceptive and antimicrobial purposes taught by Garg et al. in order to provide localized vaginal delivery for preventing pregnancy and sexually transmitted infections. Furthermore, because Popov et al., Sun et al., Oliveira et al., and Garg et al. are all directed to similar vaginal pharmaceutical delivery systems utilizing conventional dosage forms, a person of ordinary skill in the art would have had a reasonable expectation of success in using the modified compositions for the claimed methods of contraception and preventing sexually transmitted infections.
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