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 20 January 2023 and is the national stage entry of PCT/US21/44076 filed 30 July 2021. The Applicant claims priority to provisional application 63/059,817 filed 31 July 2020. The provisional application does not teach a method of treating bacterial vaginosis comprising administering zinc, therefore, the effective filing date for the claims is 30 July 2021.
Election/Restrictions
Applicant’s election of Group II (method for treating bacterial vaginosis) and zinc, bovine lactoferrin, lactose, and Lactobacillus gasseri in the reply filed on 28 August 2025 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)).
Claim Objections
Claim 1 is objected to because of the following informalities: “for treatment of bacterial vaginosis of zinc.” It is not clear if zinc is part of bacterial vaginosis or intravaginal administration. Applicant may want to delete “for treatment of bacterial vaginosis” for clarity purposes. Appropriate correction is required.
Claim 68 is objected to because of the following informalities: “occurrences” as a plural term, but claim 69 refers to “said occurrence.” Applicant may want to amend claim 69 to “a first occurrence of said plurality of occurrences.” Appropriate correction is required.
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) 64, 65, 68, 71-74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goolsbee et al. (US 2012/0245080 A1), as evidenced by stanfordchildrens.org.
Goolsbee teaches a method of treating bacterial vaginosis comprising mineral salts. The mineral portion may be zinc and manganese (paras. 16, 40, 74; entire teaching). The mineral salt may be in an amount of 0.01-30% (para. 74), partially addressing claim 64. The composition may be administered intravaginally (para. 130) and may further comprise lactoferrin, such as bovine lactoferrin (para. 110), with any degree of saturation (para. 119). The amount of lactoferrin may be 50-400 mg (para. 129) and may be administered with the mineral salt at the same time (para. 127), addressing claim 65. The mineral salt may be administered multiple times a day in numerous doses, once every other day, once weekly, etc. (para. 134), addressing claim 68. The formulation for vaginal administration (para. 95) addresses claim 71. The composition is administered over a period of days or weeks, such as 35 days or more (para. 135), addressing claims 72-74.
Goolsbee does not specifically teach a dose of zinc in the range from 25-5000 micrograms in claim 64.
In regards to the dose of zinc in claim 64, the mineral salt may be in an amount of 0.01-30% (para. 74.) or 0.25-5.5% zinc gluconate (para. 16). For example, a 10 g solution of zinc gluconate may give around 78 mg of zinc when 5.5% zinc gluconate is present (14.3 mg of zinc per 100 mg of zinc gluconate, stanfordchildrens.org, pg. 2). That being said and in lieu of objective evidence of unexpected results, the dose can be viewed as a variable that achieves the recognized result of successfully making the zinc composition and performing the method of treating bacterial vaginosis. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of zinc as nonobvious.
Claim(s) 64, 65, 68, 71-80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goolsbee et al. (US 2012/0245080 A1), Detrano (EP 0094232 A2), Allen (Compounding Suppositories, Part II, Secundum Artem, 2013), and USP 711 Dissolution Guide (2011).
In regards to claim(s) 64, 65, 68, 71-74, Goolsbee, as applied supra, is herein applied in its entirety for its teachings of a method for treating bacterial vaginosis comprising zinc.
Goolsbee teaches that their composition may be in the form of a solid, liquid, gel, suppository, etc. (paras. 17, 91, 130), which is interpreted as addressing the suppository limitation in claim 75. The composition may comprise various excipients (para. 96), such as a mucoadhesive agent and viscosity modulating agent. Goolsbee teaches PVP in an amount of 0.04-15% and glycerin in an amount of 0.05-5% (para. 16), which is interpreted as addressing excipients that are commonly used as binders and gelling agents in claim 77. The mineral salt may be in an amount of 0.01-30% (para. 74) where the minerals may include zinc and manganese, partially addressing claim 78. The composition may be administered intravaginally (para. 130) and may further comprise lactoferrin, such as bovine lactoferrin (para. 110), with any degree of saturation (para. 119). The amount of lactoferrin may be 50-400 mg (para. 129) and may be administered with the mineral salt at the same time (para. 127), addressing claims 79 and 80. Other exemplary materials include gelatin and cocoa butter (para. 91).
Goolsbee does not specifically teach the parameters of claims 75 and 76, or the amount of manganese in claim 78.
Detrano teaches that the dissolution time of suppositories depends on the base material of the suppository (pg. 16, lns. 6-15).
Allen teaches that liquefaction of suppository materials varies. For example, cocoa butter takes approximately 3-7 mins, gelatin takes about 30-40 mins, and PEG takes around 30-50 mins (pg. 3).
USP 711 Dissolution Guide teaches Apparatus 1 test, which describes 2 hours of testing (pg. 6), as well as general method steps of testing. The testing parameters include using a buffered solution, measuring the pH within 0.05 units of a specific pH, using a speed regulating device, and taking samples at timed intervals (pgs. 1, 5).
In regards to claims 75 and 76, Detrano teaches that the dissolution time of suppositories depends on the base material of the suppository (pg. 16, lns. 6-15), Allen teaches that liquefaction of suppository materials varies, and USP 711 Dissolution Guide teaches Apparatus 1 test, which describes 2 hours of testing (pg. 6), as well as general method steps of testing. A person of ordinary skill in the art would have been led to combine the teachings because Detrano and Allen teach dissolution times for suppositories and Goolsbee’s teaching is directed towards drug delivery in the form of a suppository. Since Goolsbee’s teaching is silent on dissolution properties of their suppository, a person of ordinary skill in the art would have been motivated to combine the teachings with a reasonable expectation of success. A skilled artisan would also have been easily led and motivated to optimize and alter the parameters of the dissolution test based on the active ingredients and materials. Detrano and Allen teach dissolution times for different base materials and USP 711 Dissolution Guide teaches that the dissolution takes place over a testing period of at least 2 hours, the teachings are interpreted as addressing the limitations of the vaginal suppository tablet, which “is formulated to dissolve” over specific time periods.
In regards to the dose of manganese in claim 78, the mineral salt may be in an amount of 0.01-30% (para. 74.) That being said and in lieu of objective evidence of unexpected results, the dose can be viewed as a variable that achieves the recognized result of successfully making the composition and performing the method of treating bacterial vaginosis. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of manganese as nonobvious.
Claim(s) 64-66, 68, 70-84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goolsbee et al. (US 2012/0245080 A1), Detrano (EP 0094232 A2), Allen (Compounding Suppositories, Part II, Secundum Artem, 2013), USP 711 Dissolution Guide (2011), and Kort et al. (US 2020/0138881 A1).
In regards to claim(s) 64, 65, 68, 71-80, Goolsbee, Detrano, Allen, and USP 711 Dissolution Guide, as applied supra, is herein applied in its entirety for its teachings of a method for treating bacterial vaginosis comprising zinc.
Goolsbee does not specifically teach administering a probiotic or antibiotic in claims 66, 70, 81-84.
Kort teaches administering a vaginal capsule or tablet (para. 18) to administer zinc and manganese in a probiotic composition (para. 20). In some examples, Lactobacillus gasseri is used (para. 32), addressing claim 66. Kort teaches that it is common to administer antibiotics to decrease the recurrence of bacterial vaginosis (para. 15). Method of treatment includes administering the composition after the course of antibiotics is finished (para. 16), addressing claims 70 and 81-84.
Since Goolsbee does not specifically teach administering a probiotic or antibiotic in claims 66, 70, 81-84, one of ordinary skill in the art would have been motivated to use Kort’s teaching of using a probiotic and administering the treatment following antibiotics. A skilled artisan would have been led to use Kort’s teaching since both Goolsbee and Kort provide teachings of treating bacterial vaginosis.
Claim(s) 64-66, 68-84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goolsbee et al. (US 2012/0245080 A1), Detrano (EP 0094232 A2), Allen (Compounding Suppositories, Part II, Secundum Artem, 2013), USP 711 Dissolution Guide (2011), Kort et al. (US 2020/0138881 A1), and Kostakis (The role of calprotectin in obstetrics and gynecology, European Journal of Obstetrics & Gynecology and Reproductive Biology, 2010).
In regards to claim(s) 64-66, 68, 70-84, Goolsbee, Detrano, Allen, USP 711 Dissolution Guide, and Kort, as applied supra, is herein applied in its entirety for its teachings of a method for treating bacterial vaginosis comprising zinc.
Goolsbee does not specifically teach that the patient has an elevated level of vaginal calprotectin at the first occurrence of zinc in claim 69.
Kostakis teaches that calprotectin is associated with pathological processes in vaginal physiology (abs), as well as infectious and inflammatory responses and diseases (pg. 4, left column).
Since Goolsbee does not specifically teach that the patient has an elevated level of vaginal calprotectin at the first occurrence of zinc in claim 69, one of ordinary skill in the art would have been motivated to use Kostakis’ teaching that calprotectin is an immune response to bacterial and viral infections and inflammation (pg. 1) with a reasonable expectation of success. Goolsbee teaches compositions and methods of treating mucosal and dermal disorders, such as inflammation of mucosa in the vagina (para. 15). Therefore, bacterial vaginosis is expected to elicit an immune response in the form of calprotectin presence, addressing claim 69.
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
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613