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
This application claims benefit of priority to Provisional Application 63/033,008 filed on 06/01/2020 and is a 371 of PCT/US2021/035245 filed on 06/01/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Amendment and Claim Status
In the reply filed on 08/19/2025, Applicant amended claims 1 and 15-17 and canceled claims 2 and 12.
Claims 1, 3-11 and 13-22 are currently pending and under examination.
Withdrawn Rejections
The 35 USC § 101 rejection over previously examined claims 1-14 and 16-21 is withdrawn due to Applicant’s amendment and persuasive arguments. The claims, when taken as a whole, drawn to the four bacterial strains and an effective amount of a cryoprotectant, provide markedly different effects than the closest natural counterpart.
The 35 USC § 102 rejection over previously examined claims 1 and 15-22 is withdrawn due to Applicant’s amendment to instant claim 1.
Maintained Rejections (with modifications as necessitated by amendment)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-11 and 13-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kiss (WO 2012035028 A1, 03/22/2012) (IDS Reference) and De Seta et al. (US 20170071990 A1, 03/16/2017) (IDS Reference).
Regarding claims 1, 3-4, 13-14 and 21, Kiss discloses a composition for the restoration of vaginal flora (Abstract). Kiss further discloses a composition based on microbial cultures, preferably lyophilized cultures or liquid cultures, comprising four Lactobacillus strains (Claim 1 of Kiss). The combination of Lactobacillus strains consists of Lactobacillus crispatus, Lactobacillus rhamnosus, Lactobacillus jensenii and Lactobacillus gasseri (Claim 2 of Kiss). Kiss further discloses the composition contained potato maltodextrin (Table 3 and Table 4), reading on a cryoprotectant. As ‘an effective amount’ is not defined, any amount that would be capable of some level of cryopreserving reads on an effective amount. Thus, the amounts disclosed by Kiss, 161 mg/dose in composition 1 (Table 3) and 23 mg/dose in composition 2 (Table 4) read on an effective amount.
Kiss does not disclose wherein the composition includes between 25-75% L. crispatus or wherein the composition includes between 0.1-5% L. rhamnosus.
However, De Seta et al. disclose a composition containing multiple Lactobacillus strains for the treatment of vaginitis. De Seta et al. further disclose when the composition consists of L. crispatus, L. jensenii, L. gasseri and L. rhamnosus, the L. crispatus is present in an amount between 1 and 11% and the L. rhamnosus is present in an amount between 1 and 11% (Paragraph [0063]).
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 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.” See MPEP 2144.05(II)(A). See also, In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine all operable and optimal concentrations of the claimed component (i.e., L. crispatus) because the claimed component is an art-recognized result-effective variable having pharmacological ability as disclosed by the prior art above. Therefore, the claimed component would have been routinely and predictably optimized in the pharmaceutical art. The differences between the instant claim and that suggested by the prior art, appear minor in nature. Although the prior art does not teach the amount or percentage claimed, since the claimed component is known to have a pharmacological effect as discussed by the prior art above, it would have been conventional and within the skill level of an ordinary artisan to identify and modify the percentages and amounts of the claimed component motivated by the desire to create a composition for effectively treating vaginitis as taught by De Seta et al.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Additionally, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I). As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected an amount of L. rhamnosus between 1 and 11%, which encompasses a majority of the ranges of the instant claims, in the composition of Kiss with a reasonable expectation of success as that is a range disclosed by the prior art used in a composition for promoting vaginal health as taught by De Seta et al.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have created a composition for treating vaginitis, with a reasonable amount of success, comprising L. crispatus, L. gasseri, L. jensenii and L. rhamnosus with the claimed amounts due to routine experimentation and as the amounts are disclosed in the prior art
Regarding claims 5-7, Kiss does not disclose wherein the composition includes between 1-10% L. gasseri.
However, De Seta et al. disclose when the composition consists of L. crispatus, L. jensenii, L. gasseri and L. rhamnosus, the L. gasseri is present in an amount between 1 and 11% (Paragraph [0063]).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Additionally, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I). As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected an amount of L. gasseri between 1 and 11%, which encompasses the ranges of the instant claims, in the composition of Kiss with a reasonable expectation of success as that is a range disclosed by the prior art used in a composition for promoting vaginal health as taught by De Seta et al.
Regarding claims 8-10, Kiss does not disclose wherein the composition includes between 1-10% L. jensenii.
However, De Seta et al. disclose when the composition consists of L. crispatus, L. jensenii, L. gasseri and L. rhamnosus, the L. jensenii is present in an amount between 1 and 11% (Paragraph [0063]).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Additionally, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I). As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected an amount of L. jensenii between 1 and 11%, which encompasses the ranges of the instant claims, in the composition of Kiss with a reasonable expectation of success as that is a range disclosed by the prior art used in a composition for promoting vaginal health as taught by De Seta et al.
Regarding claim 11, Kiss does not disclose wherein the composition includes 0.1-5% L. acidophilus.
However, De Seta et al. disclose L. acidophilus is one Lactobacillus species present in vaginal microflora (Paragraph [0006]). De Seta et al. further disclose multiple studies have shown L. acidophilus are able to inhibit adhesion and/or growth of Candida albicans through production of biosurfactants or similar bactericide substances (Paragraph [0032]). Candida and bacterial vaginosis are the most common diseases affecting women of fertile age (Paragraph [0035]).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include L. acidophilus in the composition of Kiss as it is known to help prevent the growth of Candida as taught by De Seta et al. Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include L. acidophilus in the composition of Kiss in an amount between 1 and 11%, which encompasses the majority of the range disclosed in the instant claim, as all other Lactobacillus strains in the composition of De Seta et al. were included in an amount between 1 and 11% and it would be expected a similar Lactobacillus strain would be included in a similar amount.
Regarding claims 15-17, Kiss discloses the composition can be in the form of suppositories, vaginal capsules, coated capsules, tablets and pills (Claim 9 of Kiss). Kiss does not expressly disclose a soluble shell. However, the suppositories and vaginal capsules disclosed by Kiss would inherently dissolve in the body to release the bacterial mixture therein.
Regarding claims 18-20, Kiss discloses Composition 1 containing L. crispatus at 1 x 109 CFU, L. rhamnosus at 1 x 109 CFU, L. jensenii at 0.2 x 109 and L. gasseri at 0.3 x 109 (Table 1). The combination of all four bacteria creating the composition equates to the mixture of bacteria being 2.5 x 109. As such, the mixture of bacteria at 2.5 x 109 falls within the ranges listed by instant claims 18-20.
Regarding claim 22, Kiss discloses the composition being for use in the treatment of bacterial vaginosis (Claim 10 of Kiss).
35 USC § 103 – Response to Arguments
In the reply filed on 08/19/2025, Applicant noted, in Footnote 2 on Page 7, the compositions of De Seta et al. also include boric acid.
It is noted instant claim 1 recites the “ … composition, comprising: a mixture of bacteria …”. Comprising is open language and allows for additional elements as long as the instantly claimed elements are also present.
Applicant further noted, in Footnote 3 on Page 8, that is it not clear whether the disclosed % values refer to a % of the composition as a whole or a % of the bacterial mixture.
Respectfully, the Examiner does not share this opinion. De Seta et al. specifically disclose “ … mixture of Lactobacillus consists of L. crispatus, L. jensenii, L. gasseri and L. rhamnosus is present in said mixture in an amount by weight …”. It is clear to the Examiner that ‘said mixture’ is referring back to the mixture of just Lactobacillus.
In the reply filed on 08/19/2025, Applicant made multiple arguments which will be addressed below.
Applicant argued the prior art of record, Kiss and De Seta et al., do not disclose a teaching, suggestion motivation or reason to formulate a composition as claimed, wherein the mixture includes 25-75% L. crispatus and 0.1-5% L. rhamnosus (Page 7, Paragraph 3).
Applicant’s arguments have been fully considered, and while the Examiner agrees that neither Kiss nor De Seta et al. disclose a specific composition wherein the mixture includes 25-75% L. crispatus and 0.1-5% L. rhamnosus, the rejection set forth in the Office Action mailed on 05/19/2025 does not state such. The rejection stated it would have been conventional and within the skill level of an ordinary artisan to identify and modify the percentages and amounts of the claimed component motivated by the desire to create a composition for effectively treating vaginitis. This rejection is based on routine optimization. See MPEP 2144.05(II)(A).
Applicant argued De Seta et al. suggest using equivalent amounts of each Lactobacillus species (Page 7, Last Paragraph – Page 8, Paragraph 2).
Applicant’s arguments have been fully considered but are not persuasive. De Seta et al. specifically disclose each strain is present in the mixture in an amount between 11% and 1% (Paragraph [0063]). De Seta et al. do not state the four strains are present in equivalent amounts. As each strain is present in the mixture in an amount between 11% and 1%, the L. crispatus could be present at 11%, the L. rhamnosus at 1%, the L. jensenii at 5% and the L. gasseri at 11%, still reading on each strain being present in the mixture in an amount between 11% and 1%.
Applicant further argued the present record does not contain the basis required to support a rejection based on routine optimization. Applicant further asserted an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have a reasonable expectation of success is required (Page 8, Paragraph 3 – Page 9, Paragraph 2).
Applicant’s arguments have been fully considered, but are not persuasive. It is the Examiner’s position that record does contain the basis required to support a rejection based on routine optimization. As stated in the Office Action of 05/19/2025, L. crispatus is a result effective variable, a point Applicant did not refute, which has pharmacological ability. “After KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.” See MPEP 2144.05(II)(B). Therefore, the explanation of why it would be routine optimization and why there is a reasonable expectation of success is because L. crispatus is a known result-effective variable with pharmacological ability.
Applicant argued the cited references do not teach or suggest that L. rhamnosus predominantly produces a different isomer of lactic acid than the other three species. Applicant further argued the composition of the instant application would be expected to result in relatively more D-lactic acid and less L-lactic acid than the compositions of the prior art and pointed to Tables 1 and 2 of the instant Specification (Page 9, Last Paragraph – Page 10, Paragraph 2).
Applicant’s arguments have been fully considered, and are persuasive in that the references do not teach such. However, this argument overall is not persuasive because the fact that Applicant has recognized another reason for modifying the concentrations of bacteria as instantly-claimed, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Additionally, the Examiner reviewed Tables 1 and 2. Regarding the tables, the strains presented in the tables are not claimed. The claims are drawn to the broad genus of L. crispatus, L. gasseri, L. jensenii and L. rhamnosus, there are no specific strains claimed. Therefore, the claims are not commensurate with the showing because the Tables are drawn to specific strains of each Lactobacilli. Moreover, if Applicant was arguing there are unexpected results, there are no unexpected results seen. It is well known that Lactobacilli produce lactic acid and reduce the pH of the environment which they are in. Therefore, it would be expected that the pH of the MRS broth would be lower as that is what lactic acid bacteria do. Absent a showing of unexpected results, the claimed ranges are obvious when looking at the prior art.
Conclusion
Claims 1, 3-11 and 13-22 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY T WHITE whose telephone number is (571)272-0683. The examiner can normally be reached Monday - Friday 8:30 - 5:00 EST.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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