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 .
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 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.
DETAILED ACTION
Status of claims
The amendment filed on 06/22/2026 is acknowledged. New claim 17 has been added. Claims 1-17 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 06/22/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. Applicant’s amendments have overcome the 35 U.S.C. 112(b) rejection of claim 5 from the previous Office Action. 35 U.S.C. 103(a) rejection of claims 1 and 3-13 over Takacs et al. (Zinc-containing Vaginal Moisturizer Gel Improves Postmenopausal Vulvovaginal Symptoms: A Pilot Study, Journal of Menopausal Medicine, April 25, 2019, page 63-68) as evidenced by Goolsbee et al. (US 2012/0245080 A1) from the previous Office Action by the examiner. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Rejections maintained
The following rejections of the claims are remained for reasons of record and the following. In addition, the new claim is hereby included in the rejections and the rejections are modified (newly underlined).
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-6, 10, and 12-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Goolsbee et al. (US 2012/0245080 A1).
Goolsbee et al. teach a method of treating vaginal candidiasis infection (the claimed vulvovaginal candidiasis, VVC, in the instant claim 1, while treating meaning the subject to be treated has VVC, the instant claim 2) (paragraph 70, 73, and 148)
comprising local applying a composition in gel form (paragraph 84 and 98) daily for ≥35 days and being continued until conditions improved (the instant claims 1, 4, 12, and 13) (paragraph 18, 134, 135, and 166) comprising
0.01% by weight of zinc salt including zinc sulfate (the instant claim 5) (paragraph 74).
The concentration of about 0.01% by weight of zinc sulfate in a gel is calculated to be 618 µM (the instant claims 1 and 4, corrected from “within the claimed about 2-200 mM in the instant claims 1 and 4” in the previous office action based on rationale of curing the deficiency in zinc concentration in the instant claims 1, 4, and 6 presented in the previous office action) based on 161.47 g/mol zinc sulfate molecular weight and about 1 g/mL gel density (0.01 g/100 g → 0.1 g/1000 g → 0.1 g/L → (0.1 g/161.47 g/mol)/L → 0.000619 M → 619 µM).
Goolsbee et al. meet all of the limitations of claims 3 and 4. Goolsbee et al. disclose the method preventing or decreasing the likelihood of recurrence and frequency of vaginal yeast infections (the claimed recurrent VVC) (paragraph 152).
Goolsbee et al. meet all of the limitations of claim 10. Goolsbee et al. disclose the composition further comprising lactic acid (paragraph 89 and 92).
Zinc sulfate being zinc sulfate heptahydrate in the instant claim 17 means zinc sulfate heptahydrate being added to form the gel. Zinc sulfate heptahydrate in a gel containing water (the claimed hydrogel and water in gel base taught by Goolsbee et al.) exists as Zn2+, SO42, and seven H2O molecules, i.e., zinc sulfate heptahydrate no longer exists as zinc sulfate heptahydrate, thus zinc sulfate being zinc sulfate heptahydrate is a product-by-process limitation. The determination of patentability of a product-by-process claim is based on the product itself, not its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process. See MPEP 2113.I.
Goolsbee et al. do not teach the same zinc concentration in the instant claims 1, 4, and 6.
This deficiency is cured by the rationale that optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ
The concentration of zinc as an active in a vaginal composition for treating vaginal candidiasis infection is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize to reach another workable product or process. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal zinc concentration in order to best achieve the desired results. See MPEP 2144.05:
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Goolsbee et al. do not teach the same treatment regimen in the instant claims 14-16.
This deficiency is cured by Goolsbee et al.’s teaching of treatment being continued until conditions improved and the rationale that determining optimum treatment regimen is routine in the pharmaceutical arts.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to come up with the treatment regimen. The person of ordinary skill in the art is a health care provider, pharmacist, or medicinal chemist. The claimed drug is already known in the art. The art also recognizes what conditions are treatable by the claimed drug. The claimed treatment regimen represents no more than a determination of the workable frequency and length of treatment for achieving the known effect.
Response to Applicants’ arguments:
Applicant’s argument of the instant claim 1 recites 2-200 µM zinc, not 2-200 mM zinc, is addressed in the corrected rejection above.
Applicants argue that the rejection did not provide guidance for selecting the claimed zinc concentration.
However, this argument is not deemed persuasive. As stated in the rejection above and in the previous office action, it would have been customary for an artisan of ordinary skill to determine the optimal zinc concentration in order to best achieve the desired results. Furthermore, Goolsbee et al. also teach zinc gluconate being a suitable zinc salt. 0.01% by weight of zinc gluconate results in 219 µM of Zn2+ (MW of zinc gluconate 455.7 g/mol) while the instant specification defines “about” as ±10% deviation, thus the claimed 2-200 µM → 1.9-220 µM. Thus, the 219 µM Zn2+ taught by Goolsbee et al. is within the claimed about 2-200 µM. Please refer to MPEP 2144.05.II.A and MPEP 2144.05.III.A:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
“Where the issue of criticality is involved, the applicant has the burden of establishing his position by a proper showing of the facts upon which he relies.”
Applicants argue that VCC is among a wide variety of unrelated mucosal and dermal disorders taught by Goolsbee et al.
However, this argument is not deemed persuasive. Although VCC is taught among a wide variety of mucosal disorders (alternative disorders other than VCC) by Goolsbee et al.; Goolsbee et al. do teach VCC as one of the disorders to be treated. Please refer to MPEP 2145 X/D.1.:
“The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed”
Claims 1-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Goolsbee et al. (US 2012/0245080 A1) in view of Takacs et al. (Zinc-containing Vaginal Moisturizer Gel Improves Postmenopausal Vulvovaginal Symptoms: A Pilot Study, Journal of Menopausal Medicine, April 25, 2019, page 63-68).
The teachings of Goolsbee et al. are discussed above and applied in the same manner.
Goolsbee et al. do not specify the gel form being a hydroxy ethyl cellulose hydrogel (the instant claims 7-9) and the composition is self-administrated (the instant claim 11).
This deficiency is cured by Takacs et al. who teach a method of treating genitourinary symptoms of menopause in post-menopausal women (1st paragraph under “Introduction) comprising
self-applying (the instant claim 11) nightly for 2 consecutive weeks (the instant claims 1, 4, 12, and 13) a zinc containing vaginal gel (JUVIA vaginal gel; Fempharma Europe, LLC., Budapest, Hungary) comprising
zinc sulfate (the instant claims 1, 4, and 5); lactic acid (the instant claim 10); water and hydroxyethyl cellulose (forming hydroxyethyl cellulose hydrogel in the instant claims 7-9) (the full paragraph in the right column on page 64);
wherein 20 µM zinc sulfate (the instant claims 1, 4, 5, and 6) significantly stimulates the vaginal smooth muscle cell elastin production within 48 hours (the 1st full paragraph in the left column on page 67).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Goolsbee et al. and Takacs et al. to specify a vaginal gel comprising zinc taught by Goolsbee et al. being a hydroxy ethyl cellulose hydrogel and a vaginal gel being self-administrated. A vaginal gel comprising zinc being a hydroxy ethyl cellulose hydrogel and a vaginal gel being self-administrated was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Argument regarding the 103 rejection is basically the same as the above rejection, thus the response discussed above applies here as well and is not persuasive for reason discussed above.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HONG YU/
Primary Examiner, Art Unit 1614
