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 .
Election/Restrictions
Applicant’s response to the restriction/ election requirement from 7/22/2025 is acknowledged. Applicant has made the following election with traverse.
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Applicant has argued, after claim amendments, that the inventions “contain repetitive technical features which are the core of the present application and belong to the same category and should not be grouped separately.” In response, they do not. To compare, for instance, Group I, it contains ingredients 1), 2), 3 and 4), where as Group III contains ingredients 1) and 2).
On further consideration of the art the election of species requirement is hereby withdrawn. The restriction/ election requirement is hereby MADE FINAL. Claims 12-20 are pending, and have been examined herewith across their breadth.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 19 and 20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12, from which claim 20 depends, recites in relevant part: “A method for modulating vaginal flora, wherein the method includes the steps of using a vaginal bacteriostatic composition, wherein the vaginal bacteriostatic composition comprises the following ingredients: [. . .] wherein the method for modulating vaginal flora refers to at least one of the following: inhibiting abnormal vaginal flora, restoring and/or maintaining vaginal lactobacilli.”
Claim 19, which depends from claim 12, is considerably broader than claim 12 and fails to further limit its subject matter. Claim 19 recites: “The method according to claim 12, wherein the vaginal bacteriostatic composition is used to restore and/or maintain normal vaginal flora, and/or to restore and/or maintain normal vaginal microecology, and/or to restore and/or maintain normal vaginal acidity, and/or to clean and take care of the vagina and/or vulva, and/or to reduce and/or eliminate vaginal pruritus, soreness, dryness, irritation, and dyspareunia, and/or to reduce and/or eliminate abnormal vaginal discharge and unpleasant odor of vaginal discharge.”
Claim 20, which depends from claim 12, is considerably broader than claim 12 and fails to further limit its subject matter. Claim 20 recites: “The method according to claim 12, wherein the vaginal bacteriostatic composition is used to prevent and/or treat the imbalance of vaginal flora, bacterial vaginosis, aerobic vaginitis, cytolytic vaginosis, vulvovaginal Candidiasis, and/or atrophic vaginitis.”
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112
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.
Claims 12-20 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.
The Examiner incorporates by reference her rejection under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, of Applicant’s claims 19 and 20.
In view of this rejection noted above, it is unclear what the overall scope of Applicant’s claims is, thus rendering the claims vague and indefinite. Further confusion comes from other claim terms in claim 12 as well. For instance, it recites the claim term “using a vaginal bacteriostatic composition”, which seems to suggest that the claim should more appropriately be limited to “A method for modulating bacterial vaginal flora”, but it is not, i.e. it is directed to “A method for modulating vaginal flora”. Further confusion in this regard comes from claim 12, which in fact expressly recites that the “bacteriostatic composition is used to prevent and/ or treat . . . vulvovaginal Candidiasis”, wherein Candida is an yeast pathogen, not a bacterial pathogen.
Claim 19 is further vague and indefinite because it is unclear what the limitation to “take care of the vagina and/or vulva” means. This limitation further renders the claims vague and indefinite because it is unclear what area is being treated. Namely, while claim 12 is directed to a method of modulating vaginal flora, wherein the vagina is understood to mean the muscular canal that extends from the vulva to the neck of the uterus (cervix), dependent claim 19 recites treatment outside of the vagina- i.e. the vulva, wherein the vulva is understood to mean the outer part of the female genitalia, including the labia majora, labia minora and clitoris.
Claim 20 is further vague and indefinite for the reasons in the preceding paragraph, because it also recites “vulvovaginal Candidiasis”.
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.
Claims 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018064978 A1 to Zeng et al. (corresponding to the English language equivalent US 20190231748 A1 to Zeng et al., which was used in the rejection (collectively, “Zeng”)), and further in view of US 20070292355 A1 to Tamarkin et al. (“Tamarkin”).
Zeng relates to “an antimicrobial agent combination for use in preparing a composition for vagina. The combination of antimicrobial agents is strong in inhibiting against Escherichia coli, and/or Staphylococcus aureus, and/or Candida. The present disclosure also relates to a composition for vagina, which has a strong inhibition effect on Escherichia coli, and/or Staphylococcus aureus, and/or Candida. Being used in the vagina, the composition can promote the restoration of beneficial lactobacillus, increase the acidity of the vagina. It is suitable for modulating microecology and balancing microorganism in the vagina, and selectively decontaminating vagina.” (Abstract). Zeng further discloses a method for preventing and/or treating vaginal infectious diseases, such as bacterial vaginosis, etc. (per Applicant’s claim 20). ([0044]). The dosage form of the composition is a solution, a water-soluble gel, or an emulsive ointment. ([0026]).
Claim 1 of Zeng recites in relevant part: An antimicrobial agent combination for use in preparing a composition for vagina, wherein the antimicrobial agent combination comprises the following antimicrobial agents: (1) 2-phenylethanol and/or phenoxyethanol, total content of which is calculated as 0.05 to 0.60 percent (weight/volume) of 2-phenylethanol; (2) propionic acid and/or sodium, and/or benzoic acid and/or sodium benzoate and/or para-methoxybenzoic acid and/or sodium para-methoxybenzoate and/or esters of p-hydroxybenzoate, total content of which is calculated as 0.25 to 0.70 percent (weight/volume) of sodium propionate (per Applicant’s claims 12 in part, and claim 15).
Claim 4 of Zeng recites in relevant part the antimicrobial agent combination according to claim 1, wherein the composition for vagina further comprises one or more antimicrobial agents selected from a group consisting of, inter alia, diacetic acid, sodium diacetate (which one of skill in the art would know to be a dicarboxylic acid or a salt thereof), and benzyl alcohol (an aromatic alcohol according to Applicant’s claim 14).
Claim 5 of Zeng recites in relevant part the antimicrobial agent combination according to claim 1, wherein the composition for vagina further comprises one or more saccharides selected from a group consisting of glucose, fructose, mannose, sucrose, isomaltulose, 1-kestose, nistose trihydrate, 1F-fructofuranosylnystose, maltose, isomaltose, isomaltotriose, isomaltotetraose, isomaltopentaose, trehalose, cellobiose, melibiose, gentiobiose, gentiooligosaccharide, raffinose, panose, maltooligosaccharide, isomaltulooligosaccharide, fructooligosaccharide, glucomannan, dextrin, starch, and glycogen, with a total content of saccharides ranging from 1.0 percent to 9.0 percent (weight/volume) (according to Applicant’s claim 16).
Claim 6 of Zeng recites in relevant part the antimicrobial agent combination according to claim 1, wherein the composition for vagina further comprises one or more amino acids selected from a group consisting of glutamic acid, glutamine, aspartic acid, asparagine, isoleucine, phenylalanine, valine, leucine, proline, and threonine, with total content of the amino acids ranging from 0.1 percent to 10.0 percent (weight/volume) (according to Applicant’s claim 17).
Claim 7 of Zeng recites in relevant part the antimicrobial agent combination according to claim 1, wherein for the use of claim 1, the composition further comprises one or more estrogen and/or phytoestrogen agents selected from a group consisting of diethylstilbestrol, estradiol, estriol, daidzein, aglycone of daidzein, genistin, genistein, glycitein, aglycone of glycitein, biochanin, coumestrol, and formononetin, with total content of estrogen and/or phytoestrogen agents ranging from 0.001 percent to 1.0 percent (weight/volume) (according to Applicant’s claim 18).
Zeng discloses a composition with dicarboxylic acids and/or salts thereof, but does not explicitly disclose one or more of the dicarboxylic acids and/or salts thereof selected from the group consisting of glutaric acid, adipic acid, pimelic acid, and salts thereof; the total content of which, calculated as dicarboxylic acid, is in the range of 0.50%—2.50% (w/w), per Applicant’s claim 12.
Tamarkin relates to an augmented anti-infective foamable composition comprising: a foamable carrier; a therapeutically safe and effective concentration of an anti-infective agent; an augmenting agent selected from the group consisting of a keratolytic agent and a skin penetration enhancer; and a propellant; wherein the composition is housed in a container and upon release is expandable to form a breakable foam, and wherein the foamable carrier is selected to generate a foam of good or excellent quality in the presence of the augmenting agent and anti-infective agent (claim 1), wherein the augmenting agent is selected from the group consisting of glutaric acid (pentanedioic acid), adipic acid, pimelic acid (claim 12), and wherein the penetration enhancer is selected from the group consisting of lauric acid and caprylic acid (claim 16). Tamarkin also relates to a method a method of treating, alleviating or preventing a disorder of a body cavity comprising administering the foamable composition (claim 37), wherein the disorder is selected from a vaginal disorder, such as bacterial vaginosis (claim 51).
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to combine the teachings of Zeng and Tamarkin in order to practice Applicant’s claimed invention with a reasonable expectation of success. The skilled artisan would have been motivated to do so because Zeng teaches Applicant’s claimed method with a nearly identical composition, short of the specific dicarboxylic acids claimed herein and their amounts, while teaching dicarboxylic acids broadly. The skilled artisan would have been further motivated to do so because vaginal compositions for the same use with overlapping ingredients as in Zeng and Applicant’s claims are known in the art for the same use, to include with the specific dicarboxylic acids claimed by Applicant and with other overlapping ingredients further claimed by Applicant. With respect to the specific amount of dicarboxylic acids claimed by Applicant, the skilled artisan would have been motivated to do so in order to improve efficacy, as the dicarboxylic acids are disclosed in the art as result-effective variables. "When 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627