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 .
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
Claims 1-16 are pending in this application. This application claims priority to provisional application 63/456,387, filed on 03/31/2023.
Claim Rejections - 35 USC 112(b)
The following is a quotation of the second paragraph 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.
Claim 5 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim 5 recites the broad recitation “zinc sulfate”, and claim 5 also recites “zinc sulfate heptahydrate” which is the narrower statement of the range/limitation.
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 12-16 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 (within the claimed about 2-200 mM in the instant claims 1 and 4) 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).
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.
Claims 1 and 3-13 are rejected under 35 U.S.C. 103(a) as being unpatentable 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).
Takacs et al. 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).
According to Goolsbee et al. post-menopausal women having decreased estrogen which results in increased the susceptibility to microbial infection (paragraph 150) while microbial infection includes vaginal candidiasis infection (paragraph 70, 73, and 148). Thus, the patient population being treated with zinc containing vaginal gel taught by Takacs et al. would include patients susceptible to vaginal candidiasis infection (the instant claim 1) and susceptible to recurrent vaginal candidiasis infection (the instant claims 3 and 4) and thus the method taught by Takacs et al. prevents vaginal candidiasis infection in patients susceptible to vaginal candidiasis infection and susceptible to recurrent vaginal candidiasis infection. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, Takacs et al. teach, either expressly or inherently implied, each and every limitation of the instant claims. Please refer to MPEP 2112.02.II:
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use. The court went on to reverse the obviousness rejection of claims 2-5 and 7-10 which recited a process of using a new compound. The court relied on evidence showing that the nonaddictive property of the new compound was unexpected.). See also In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966) (The claim was directed to a process of inhibiting light degradation of polypropylene by mixing it with one of a genus of compounds, including nickel dithiocarbamate. A reference taught mixing polypropylene with nickel dithiocarbamate to lower heat degradation. The court held that the claims read on the obvious process of mixing polypropylene with the nickel dithiocarbamate and that the preamble of the claim was merely directed to the result of mixing the two materials. “While the references do not show a specific recognition of that result, its discovery by appellants is tantamount only to finding a property in the old composition.” 363 F.2d at 934, 150 USPQ at 628
Claims 1-16 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. whose teachings are discussed above and applied in the same manner.
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.
Correspondence
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.
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/HONG YU/
Primary Examiner, Art Unit 1614