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 .
Claim Status
Applicant’s claim declaration, amendments and arguments in the response filed 29 July 2025 are acknowledged.
Claims 24, 25, & 27-39 are pending.
Claims 1-23 & 26 are cancelled.
Claims 24 , 34, 36, 38 & 39 are amended.
Claims 27, 28, 30, 32 & 39 are withdrawn.
Claims 24, 25, 29, 31 & 33-38 are under consideration.
Declaration Filed Under § 1.132
The declaration filed on 29 July 2025 by Applicant is acknowledged. The declaration is addressed in the response to Applicant’s traverse below.
Withdrawn Objections/Rejections
The objection to claim 34 is withdrawn due to an amendment which removes the unnecessary word “of”.
The objection to claim 36 is withdrawn due to an amendment which adds the word “and” to signal the end of the list.
The rejection of claim 38 under 35 USC 112(b) is withdrawn due to amendments which remove the indefinite term "including”.
The rejection of claim 26 under 35 U.S.C. 103 over Flourish Vaginal Care System [as evidenced by Feminine Care], Food and Drug Administration [as evidenced by Mayo Clinic Store], Zhou, and Menard is withdrawn due to cancellation of the claim.
The rejection of claims 24, 25, 33-35 & 38 under 35 U.S.C. 103 over Flourish Vaginal Care System [as evidenced by Feminine Care], Food and Drug Administration [as evidenced by Mayo Clinic Store] and Zhou; claim 36 under 35 U.S.C. 103 over Flourish Vaginal Care System [as evidenced by Feminine Care], Food and Drug Administration [as evidenced by Mayo Clinic Store], Zhou, Strgar, Cojocarin, Waugh, Daboush, Huang [as evidenced by John Henry Clarke] and Yun; and claims 29, 31 and 37 under 35 U.S.C. 103 over Flourish Vaginal Care System [as evidenced by Feminine Care], Food and Drug Administration [as evidenced by Mayo Clinic Store], Zhou, Strgar, Cojocarin, Waugh, Daboush, Huang [as evidenced by John Henry Clarke], Yun and Vysokov [as evidenced by Camus-Bablon] is withdrawn due to claim 24 limitations to recite the applying the topical gel, applying the suppository, and cleaning the vagina of the subject are performed until the dysbiotic vaginal condition of the subject is remediated.
New & Maintained Objections/Rejections
Claim Objections
Claim 38 is objected to because of the following informalities: Claim 38 is grammatically incorrect having a comma followed by a semicolon (i.e. “,;”) in line 10.
Claim 38 also needs the conjunction, “and” or “or” at the end of the list in the second to the last line. For example “ or female-to-male gender transition….”
Appropriate correction is required.
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.
Claim 38 is 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 38 depends from claim 24. Claim 24 recites “a dysbiotic vaginal condition”. Claim 38 expands the conditions to dysbiotic conditions beyond that of vaginal conditions by reciting “the dysbiotic condition”. This is important because the claim 38 Markush group recites a “hormone-sensitive cancer” which could reasonably encompass dysbiotic conditions of the breast in relation to breast cancer.
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.
Applicant may wish to consider whether an amendment to recite “wherein the dysbiotic vaginal condition is caused by…” would obviate the rejection.
Response to Arguments
Applicant argues that claim 38 has been amended as suggested by the Examiner (reply, pg. 6).
This is not persuasive. Claim 38, line 2, still recites “the dysbiotic condition”.
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.
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.
Claims 24, 25, 33-35 & 38 are rejected under 35 U.S.C. 103 as being unpatentable over Flourish Vaginal Care System [Published: 08/24/2020, IDS filed-13 December 2023, previously cited; as evidenced by Feminine Care (Published: 12/31/2019; IDS filed-13 December 2023, previously cited)], Food and Drug Administration [Published: 03/12/2020; filed IDS filed-13 December 2023, previously cited; as evidenced by Mayo Clinic Store (Published: 09/26/2021); IDS filed-13 December 2023, previously cited], Zhou (CN 1557288; Published: 12/29/2004; IDS filed-13 December 2023, previously cited) and Menard (Published: 08/22/2011, previously cited).
Note: Homeopathic products are recognized in the art as coming from plants, minerals, or animals (see Homeopathy; Published: 04/2021; IDS filed-13 December 2023).
With regard to claims 24 & 38, and the elected species, Flourish Vaginal Care System teaches a system for treating bacterial vaginosis (BV; i.e. a dysbiotic condition of the vagina) comprising Restore® Vaginal Gel (i.e. topical gel), BiopHresh® Vaginal Homeopathic Suppository (i.e. a suppository comprising homeopathic drugs), and Balance Moisturizing Personal Wash (pg. 1-3). With regard to claim 24, Flourish Vaginal Care System teaches the Restore® Vaginal Gel is a vaginal gel so it is applied to the vagina (pg. 2). With regard to claim 24, Flourish Vaginal Care System teaches the Restore® Vaginal Gel is applied as needed for comfort and moisture, as such the amount is effective (pg. 2). With regard to claim 24, Flourish Vaginal Care System teaches the vaginal homeopathic suppository is a capsule which is applied after the vaginal area is clean and dry (i.e. applying a dosage of a suppository to the vagina of the subject; pg. 2). With regard to claim 24, Flourish Vaginal Care System teaches the personal wash is applied to intimate areas of the body which is reasonably the vagina since the Flourish Vaginal Care System teaches their system is directed to and concerned with BV (pg. 1-3). The vagina of the subject is reasonably cleaned because the personal wash is a wash, washes clean things, and Flourish Vaginal Care System teaches the wash doesn’t have “toxic saponifiers” which are “found in most bar soaps and OTC cleansers” (pg. 2). With regard to claim 24, the topical gel, Flourish Vaginal Care System teaches the Restore® Vaginal Gel comprises lactic acid and is iso-osmolar, making it much less likely to alter the acid-base balance of the vagina and therefore less likely to predispose to BV (pg. 2). With regard to claim 24, Flourish Vaginal Care System teaches the BiopHresh® Vaginal Homeopathic Suppository comprises: A) kreosotum 6C HPUS (i.e. homeopathic drug) and Nitricum Acidum 6C HPUS (i.e. homeopathic drug), and B) a probiotic blend Lactobacillus acidophilus LA02, Lactobacillus crispatus LCR01, Lactobacillus gasseri LGS06, Lactobacillus fermentum LF08 (i.e. Limosilactobacillus fermentum LF08) , Lactobacillus plantarum LP01 (i.e. Lactiplantibacillus plantarum LP0l), Lactobacillus rhamnosis LR06 (i.e. Lacticaseibacillus rhamnosus LR06), and Lactobacillus salivarius CRL1328 (i.e. Ligilactobacillus salivarius CRL 1328; pg. 2). With regard to claims 24 & 25, as evidenced by Feminine Care, Balance Moisturizing Personal Wash comprises water, cocamidopropyl hydroxysultaine, lactic acid, and aloe barbadensis leaf juice (Feminine Care-pg. 6). With regard to claims 24 & 33, Flourish Vaginal Care System teaches the vaginal gel is applied every other day or as needed for comfort or moisture (i.e. regularly); the suppository is applied every third day (i.e. regularly and less frequently than once a day); and recommends the personal wash for daily use (i.e. regularly; pg. 2). With regard to claim 34, the subject treated with the method taught by Flourish Vaginal Care System necessarily has a lower vaginal pH as soon as 12 weeks after starting the method compared with the vaginal pH before starting the method because the method taught by Flourish Vaginal Care System comprises a vaginal gel with a pH of 3.7 (vaginal pH ranges from about 3.8 to 4.5) which comprises lactic acid and a suppository that comprises ascorbic acid (pg. 2). With regard to claim 35, the subject practicing the method taught by Flourish Vaginal Care System necessarily has a lower chance of having recurrence of the dysbiotic vaginal condition compared to a subject not treated with the method because the method taught by Flourish Vaginal Care System comprises “homeopathic remedies for BV relief” in the suppository. With regard to claim 24, Flourish Vaginal Care System teaches many sexual lubricants and vaginal moisturizers available on the market are hyperosmolar and hyperosmolar lubricants can be damaging to the epithelium and may alter the pH of the vagina (pg. 2). With regard to claim 24, Flourish Vaginal Care System teaches the vaginal gel is applied for “moisture” and “comfort” and is reasonably a lubricant (pg. 2). With regard to claim 24, Flourish Vaginal Care System teaches in the field of their invention it is postulated that lubricants and moisturizers may predispose to BV by altering the pH of the vagina” (pg. 2).
Flourish Vaginal Care System does not teach the topical gel used in the method comprises “ water…and potassium chloride”, nor does Flourish Vaginal Care System teach applying the topical gel, applying the suppository, and cleaning the vagina of the subject are performed until the dysbiotic vaginal condition of the subject is remediated.
With regard to claim 24, Food and Drug Administration teaches Bionourish Lubricant which comprises water, hydroxyethylcellulose, hyaluronic acid, sodium chloride, lactic acid, and calcium chloride (Table 2, pg. 3 of 5). As evidenced by Mayo Clinic Store, Bionourish is a vaginal gel (Figure; pg. 1). Food and Drug Administration teaches Bionourish is intended to moisturize and lubricate upon vaginal application to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication (pg. 3 or 5).
With regard to claim 24, Zhou teaches a formulation comprising lactic acid to improve the wetness and acidity a woman’s vagina, benefit the survival of lactobacillus in a woman’s vagina, and inhibit invading harmful bacteria (title; abstract). With regard to claim 24, Zhou teaches vaginal secretions comprise potassium, sodium and chlorine (pg. 2). Zhou teaches the formulation of their invention also comprises potassium and sodium chloride (Zhou’s-claims 4 & 5). Zhou exemplifies a vaginal liquor comprising lactic acid, sodium chloride and potassium chloride (pg. 3).
With regard to claim 24, in the same field of invention of BV, Menard teaches taking lactobacillus rhamnosus and L. crispatus intravaginally improve the vaginal flora (pg. 299). In another study, Menard teaches the after two intravaginal capsules of probiotics containing 109 L. rhamnosus GR-1 and 109 L. reuteri RC-14 daily at bedtime for 5 days (i.e. performing the method regularly) resulted in significantly reduced symptomatic BV in 85% of the women in the probiotic group (i.e. condition is remediated) in a 15 day follow-up (pg. 299). Menard teaches this protocol had a cure rate (pg. 299).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
With regard to the topical gel formulation, at least rationale (G) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the method taught by Flourish Vaginal Care System by substituting the generically taught lactic acid containing vaginal gel with a vaginal gel comprising water, hydroxyethyl cellulose, calcium chloride, sodium chloride, hyaluronic acid, lactic acid and potassium chloride as suggested by the combined teachings of Food and Drug Administration and Zhou because Flourish Vaginal Care System, Food and Drug Administration and Zhou are drawn to compositions which moisturize and lubricate the vagina. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to moisturize and lubricate the vagina with a gel that supports the vaginal flora and is less likely to predispose to BV through maintenance of the acid-base balance and osmolarity through use of salts, including potassium chloride, which are naturally present in vaginal fluid.
With regard to the method steps, it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the method suggested by Flourish Vaginal Care System, by performing the method regularly until BV symptoms are alleviated/cured as suggested by Menard because the method suggested by the combined teachings of Flourish Vaginal Care System, Food and Drug Administration and Zhou teach a probiotic intravaginal suppository comprising lactobacillus species to treat BV and intravaginally applied lactobacillus is regularly applied until symptoms are resolved/remediated/cured as taught by Menard in BV treatment methods. The ordinary skilled artisan would have been motivated to do so, with an expectation of success in order to cure the infection as taught by Menard.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Flourish Vaginal Care System [as evidenced by Feminine Care], Food and Drug Administration [as evidenced by Mayo Clinic Store], Zhou and Menard, as applied to claims 24, 25, 33-35 & 38 above, and further in view of Strgar (US 2019/0083429; Published: 03/21/2019), Cojocarin (US 2016/0017254; Published: 01/21/2016), Waugh (US 2019/0105261; Published: 04/11/2019), Daboush (US 2020/0338137; Published: 10/29/2020), Huang [US 2006/0223765, Published: 10/05/2006; as evidenced by John Henry Clarke (Published: 07/22/2015)] and Yun (US 2019/0274937; Published: 09/12/2019).
The teachings of Flourish Vaginal Care System, Food and Drug Administration, Zhou and Menard are described above. In brief, the combined teachings suggest a method of treating BV with a vaginal gel, a suppository, and wash. The combined teachings suggest the vaginal gel used in the method comprises water, hydroxyethylcellulose, calcium chloride, hyaluronic acid, lactic acid, and potassium chloride. Combined teachings suggests the suppository used in the method comprises homeopathic drugs, and “a probiotic blend comprising…”. The combined teachings suggest the wash used in the comprises water, cocoamidopropyl hydroxysultaine and lactic acid.
Neither Flourish Vaginal Care System, Food and Drug Administration, Zhou, nor Menard teach the amount of the reagents in their respective compositions.
In the same field of invention, with regard to the topical gel, Strgar teaches an embodiment which is a vaginal lubricant with a pH from 3.0-5.0 which has a biomatched osmolality of a healthy vagina with hyperosmolal lubricants linked with associated risk of BV ([0010] [0012] [0063] & [0070]). With regard to claim 36, Strgar in Example 4 teaches the vaginal gel comprises water in an amount of 90-99%, hydroxyethylcellulose in an amount of 0.5-5.0%, calcium chloride in an amount of 0.001-1.5%, sodium chloride in an amount of 0.1-1.5% and potassium chloride in an amount of 0.001-1.5% [0104]. More broadly, Strgar teaches the racemic lactic acid “may comprise about 0.5% to about 1.5% of formulation” with the formulation lubricating the vagina [0072].
In the same field of invention of personal “lubricants that match closely the vaginal fluid”, with regard to the vaginal gel, Cojocarin teaches an aqueous lubricant comprising hyaluronic acid in an amount of about 0.4 to about 1.0% by weight (Cojocarin’s claim 3; [0016]). Hyaluronic acid is taught by Cojocarin to be “a lubricating component to relieve vaginal dryness” and “moisturizing component” ([0011] & [0017]) .
In the same field of invention, with regard to the vaginal suppository, Waugh teaches compositions which may be suppositories used to treat BV ([0195] & [0233]). Waugh teaches kreosotum to be an active agent with active agents present in an amount from about 0.1 % to about 25 wt.% ([0092] & [0114]).
In the same field of invention, with regard to the vaginal suppository, Huang teaches a method for inhibiting and/or treating a vaginal infection which may be BV (title; [0051]). Huang teaches the “ treatment composition …[is] to aid in topical application. The treatment composition may be in the form of a… suppository” [0039]. Huang teaches inclusion of nitric acid as a mineral acid to function as a pH modifier used to control the pH in a range that is biocompatible. [0048]. The amount of nitric acid/pH modifier is taught to be “about 0.001% to about 5% by weight, in some embodiments between about 0.001 to about 1% by weight, and in some embodiments, between about 0.1% to about 0.25% by weight of the treatment composition” [0048]. As evidenced by John Henry Clarke, nitric acid was called Nitricum Acidum in 1902 (pg. 1).
In the same field of invention, with regard to the vaginal suppository, Daboush teaches probiotic suppositories that can be used in an embodiment to treat BV (title; [0109]). Daboush in their claim 18 teaches the dose of at least one viable probiotic bacteria in the dried biofilm suppository of their invention is 1:1 (i.e. 50%) to 1:10 (i.e. 9.0%; Daboush’s claim 18). Daboush teaches the probiotic bacteria for use in their invention belong to Lactobacillus including Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus plantarum, Lactobacillus rhamnous and Lactobacillus salivarius (Daboush’s claim 11; [0077] [0078] &[0121]).
In the same field of invention, with regard to the personal wash, Yun teaches cleaning compositions which preserve the natural microflora of the vagina in humans (abstract). Yun teaches their cleaning compositions may be beneficially used in combination with topical probiotic therapies which may be comprised when using classical soaps (abstract). Yun in Example Q3 teaches a formulation comprising water, 10% cocamidopropyl hydroxysultaine, and q.s. lactic acid (pg. 5). More broadly, Yun teaches lactic acid to be an organic acid used as an acidity regulator for the composition and that the organic acids are used “at a concentration of less than..2.5 wt % more specific less than 1 wt %” (pg. 5, [0025] & [0027]). More broadly, Yun teaches a specific embodiment such that “ the present invention provides a cosmetic cleaning composition; comprising at least 50 wt % water, 1-25 wt % glycerol ester surfactant, 1-20 wt % co-surfactants, 0.01-1 wt % organic acids and 1-4 wt % emollients” [0035].
With regard to the topical/vaginal gel used in the method, at least rationale (G) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the topical/vaginal gel used in the method suggested by Flourish Vaginal Care System, Food and Drug Administration, Zhou and Menard by adjusting the amount of water to be 90-99%, hydroxyethylcellulose to be 0.5-5.0%, calcium chloride to be 0.001-1.5%, sodium chloride to be of 0.1-1.5%, hyaluronic acid to be 0.4 to about 1.0%, lactic acid to be 0.5-1.5% and potassium chloride to be 0.001-1.5% as suggested by the combined teachings of Strgar and Cojocarin because Flourish Vaginal Care System teaches a vaginal gel for moisture and comfort (i.e. lubrication) and Strgar and Cojocarin are directed to vaginal compositions which moisturize and lubricate the vagina and it is obvious to modify similar compositions in the same way for the same purpose. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order use art recognized reagents in amounts suitable for vaginal gel formation and vaginal moisturization/lubrication.
With regard to the suppository used in the method, at least rationale (G) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the suppository used in the method suggested by Flourish Vaginal Care System, Food and Drug Administration, Zhou and Menard by adjusting the amount of homeopathic drugs, kreosotum and Nitricum Acidum/nitric acid, to be present in a combined amount of about from 0.101 % to about 30 wt.% and the amount of probiotic blend to be 9.0%-50 % as suggested by the combined teachings of Waugh, Huang and Daboush because the combined teachings Flourish Vaginal Care System, Waugh, Huang and Daboush are directed to methods and suppositories to treat BV and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to use the homeopathic drugs, kreosotum and Nitricum Acidum/nitric acid, and probiotic blend in the suppository for treating BV in amounts that are art recognized as suitable for doing so.
With regard to the personal wash used in the method, at least rationale (G) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the method suggested by the combined teachings of Flourish Vaginal Care System, Food and Drug Administration, Zhou and Menard by adjusting the amount of water in the wash to be at least 50 wt %, the amount of cocamidopropyl hydroxysultaine 1-20 wt % and the amount of lactic acid to be 0.01-1 wt % as suggested by the Yun because the method suggested by the combined teachings of Flourish Vaginal Care System, Food and Drug Administration, Zhou and Menard use a probiotic blend in a suppository and a personal wash comprising water, lactic acid, and cocamidopropyl hydroxysultaine to treat BV and Yun teaches vaginal soaps/cleansers used in conjunction with probiotic vaginal therapies comprise at least 50 wt % water, 1-20 wt% cocamidopropyl hydroxysultaine/co-surfactant, and 0.01-1 wt % lactic acid/organic acid. It is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to use water, lactic acid, and cocamidopropyl hydroxysultaine in a vaginal wash in amounts that are art accepted as suitable for vaginal washes.
With regard to recited amount of water, hydroxyethyl cellulose, calcium chloride, sodium chloride, hyaluronic acid, lactic acid, and potassium chloride in the topical gel; homeopathic drugs and probiotic blend in the suppository; and water cocamidopropyl hydroxysultaine and lactic acid in the wash, the combined teachings of Flourish Vaginal Care System, Food and Drug Administration, Zhou, Menard, Strgar, Cojocarin, Waugh, Daboush, Huang and Yun teach these reagents in amount which overlap or fall within the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 29, 31 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Flourish Vaginal Care System [as evidenced by Feminine Care], Food and Drug Administration [as evidenced by Mayo Clinic Store], Zhou, Menard, Strgar, Cojocarin, Waugh, Daboush, Huang [as evidenced by John Henry Clarke] and Yun as applied to claims 24, 25, 33-36 & 38 above, and further in view of Vysokov [RU 2308951 (Published: 10/27/2007); as evidenced by Camus-Bablon (US 2005/0037033; Published: 02/17/2005)] .
*All references refer to the English language translation.
The combined teachings of Flourish Vaginal Care System, Food and Drug Administration, Zhou, Menard, Strgar, Cojocarin, Waugh, Daboush, Huang and Yun are described above. Briefly, the teachings of combined prior art suggest a method for treating BV with a topical/vaginal gel, suppository and wash. Flourish Vaginal Care System teaches the wash used in the method comprises more than 60% premium aloe. As evidenced by Feminine Care, Balance Moisturizing Personal Wash comprises water, cocamidopropyl hydroxysultaine, lactic acid, and aloe barbadensis leaf juice (Feminine Care-pg. 6).
Neither Flourish Vaginal Care System, Food and Drug Administration, Zhou, Menard, Strgar, Cojocarin, Waugh, Daboush, Huang nor Yun teach the applying the topical gel is performed more than once every day; the cleaning of the vagina is performed more than once every day; or the amount of aloe leaf juice in the wash is from 0.1-5.0 weight %.
In the same field of prevention of BV and prophylaxis of vaginal dysbacteriosis due to normalizing the microflora, with regard to claim 31, Vysokov teaches the composition used in their method is used twice a day (after hygiene procedures) for 10 days; thereby teaching the hygiene procedures/washing occurs twice a day (i.e. more than once a day; abstract; pg. 7 & 8). With regard to claim 29, Vysokov teaches the composition of their invention comprises a gel and gelling agent and as such is reasonably a gel (Vysokov’s claims 2 & 4). With regard to claim 29, Vysokov teaches the composition used in their method is used twice a day (after hygiene procedures) for 10 days (i.e. the applying of the topical gel is performed more than once every day; pg. 7). With regard to claim 37, Vysokov teaches inclusion of aloe in the compositions of their invention as a biologically active additive used in an amount of 0.01 wt% to 2.00 wt% (Vysokov’s claim 7; pg. 6). As evidenced by Camus-Bablon, “[a]loe is the dried juice of leaves of A. barbadensis..” (i.e. aloe juice; [0030]). Vysokov teaches aloe “has an anti-inflammatory and bactericidal effect, increases the elasticity of the mucous membranes” (pg. 6).
With regard to claim 29, least rationale (G) may apply in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the method suggested by the combined teachings of “Flourish Vaginal Care System… and Yun” by adjusting the frequency of applying the topical/vaginal gel to twice a day as suggested by Vysokov because the topical/vaginal gel taught by Vysokov is used in a method treat BV and restore the vaginal microflora twice a day. It is obvious to modify similar methods in the same way for the same purpose of treating BV and restoring the vaginal microflora. The ordinary skilled artisan would be motivated to do so, with an expectation of success, in order to treat BV, and restore the vaginal microflora.
With regard to claim 31, at least rationale (G) may apply in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the method suggested by the combined teachings of “Flourish Vaginal Care System… and Yun” by adjusting the frequency of washing to twice a day as suggested by Vysokov because the personal wash is used cleanse in a method to treat BV and Vysokov teaches in methods to prevent BV daily hygiene is performed twice a day. It is obvious to modify similar methods in the same way for the same purpose of cleaning and treating BV. The ordinary skilled artisan would be motivated to do so, with an expectation of success, in order to cleanse the vagina, treat BV, and restore the vaginal microflora.
With regard to claim 37, at least rationale (G) may be applied in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the method suggested by the combined teachings of “Flourish Vaginal Care System… and Yun” by adjusting the amount of aloe barbadensis leaf juice to be 0.01 wt% to 2.00 wt% of the personal wash as taught by Vysokov because aloe barbadensis leaf juice is used in this amount in methods to prevent BV and restore vaginal microflora due to its anti-inflammatory and bactericidal effects and ability to increase the elasticity of the mucous membranes. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to use the aloe barbadensis leaf juice in an amount art recognized as effective in preventing BV and restoring the vaginal microflora.
With regard to recited amount of aloe barbadensis leaf juice in the wash, frequency of applying the topical/vaginal gel, and frequency of applying the personal wash, the combined teachings of Flourish Vaginal Care System, Food and Drug Administration, Zhou, Menard Strgar, Cojocarin, Waugh, Daboush, Huang, Yun and Vysokov teach these parameters with values which overlap or fall within the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
Applicant argues amended claim 24 includes the features of cancelled claim 26 (reply, pg. 7). Applicant argues the references individually stating Fluorish does not teach the topical gel has hydroxyethyl cellulose, calcium chloride, sodium chloride, hyaluronic acid, and potassium chloride. Applicant argues Fluorish does not teach applying the topical gel, applying the suppository, and regularly cleaning the vagina regularly until the dysbiotic condition is remedied. Applicant argues if you modify Flourish’s gel through Zhou’s teachings you do not get the topical gel used in the method of claim 24 (reply, pg. 8).
This is not persuasive. Flourish Vaginal Care System teaches a system for treating bacterial vaginosis (BV; i.e. a dysbiotic condition of the vagina) comprising Restore® Vaginal Gel (i.e. topical gel), BiopHresh® Vaginal Homeopathic Suppository (i.e. a suppository comprising homeopathic drugs), and Balance Moisturizing Personal Wash (pg. 1-3). Food and Drug Administration teaches Bionourish Lubricant which comprises water, hydroxyethylcellulose, hyaluronic acid, sodium chloride, lactic acid, and calcium chloride (Table 2, pg. 3 of 5). Zhou teaches a formulating with lactic acid to improve the wetness and acidity a woman’s vagina, benefit the survival of lactobacillus in a woman’s vagina, and inhibit invading harmful bacteria (title; abstract). Zhou exemplifies a vaginal liquor comprising lactic acid, sodium chloride and potassium chloride (pg. 3). It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. AG. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is... a person of ordinary creativity, not an automaton.” Id. at 1742.
Applicant argues Menard does not teach the composition of the gel or the method of treatment (reply, pg. 7).
This is not persuasive. Menard is used to teach practicing the method until there is a remediating of the condition in a patient population with BV that is treated with probiotic vaginal capsules/suppositories.
Applicant argues the beneficial effects obtained by the method as shown by a Declaration (pg. 8). Declarant argues that the pH of the vagina dropped over with treatment by midstudy (Declaration, pg. 12). Declarant argues the improvement in physical symptom burden of the patients was statistically significant (Declaration- pg. 13). Declarant argues that those with BV show a disrupted flower with lower Lactobacillus and that some participants with BV experienced an increase in Lactobacillus as their infections resolved (Declaration, pg. 15). Applicant argues the study periods of 12 or 24 weeks (reply, pg. 8).
This is not persuasive. First the declaration used trademarked products and there was no disclosure the reagents in these products or amount. The showing was not commensurate with the scope of the claims. "[O]bjective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
Next, the declaration described the invention but did not address the rejection. It refers only to the system and not to the individual claims of the application. As such the declaration does not show that the objective evidence of nonobviousness is commensurate in scope with the claims.
The prior art already had a treatment system in place to treat BV. Applicant’s declaration showed that a system with similar products using similar method steps worked as it was intended to function. This is not relevant to the issue of nonobviousness of the claimed subject matter and provides no objective evidence thereof. The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Applicant did not show that their treatment system performed unexpectedly better.
With specific regard to the study period, the claims recite applying the gel, the suppository and cleaning the vagina until the dysbiotic conditions are remediated. Applicant is arguing unrecited features as pertaining to the 12 or 24 weeks.
Applicant argues claim 36 depends from claim 24 which now includes features of cancelled claim 26 (reply, pg. 9). Applicant reiterates this argument as it applies to claims 29, 31, and 37 (reply, pg. 9).
This is not persuasive. Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Menard is used to treat applying treatment to patients with BV until their condition is remediated.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/LORI K MATTISON/ Examiner, Art Unit 1619
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619