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 .
Applicant’s amendment and remarks filed on 1/14/2026 are acknowledged. Claims 1 and 11 are amended. Claims 1-11 are pending.
Election/Restrictions
Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-10 are currently under examination.
Information Disclosure Statement
The information disclosure statement filed on 10/22/2025 has been considered. A signed copy is enclosed.
New Claim Objections
Claims 4 and 6-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections Withdrawn
The rejection of claims 1-10 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of applicant’s amendment thereto.
Claim Rejections Maintained
35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The rejection of claim(s) 1-3, and 5 under 35 U.S.C. 102(a)(1) as being anticipated by Pei et al (US Patent 7468270) is maintained for the reasons set forth in the previous office action.
The instant claims are drawn to methods of treating and/or preventing infertility or recurrent pregnancy loss in a female by administering Lactobacillus salivarius CECT 5713 or a mutant thereof.
Pei et al disclose methods of treating female subjects by administering Lactobacillus salivarius CECT5713 (see abstract and column 9, lines 14-20). The subjects can be pregnant and administration can be oral (see column 11, lines 15-20). Though the reference is silent with respect to preventing infertility and recurrent pregnancy loss, if the method works as applicant claims, then the administration to female and pregnant individuals would necessarily work to prevent infertility and recurrent pregnancy loss.
Applicant argues:
1. That Pei is directed to a process for selecting bacterial strains based on specific criteria and does not address infertility or recurrent pregnancy loss. Applicant argues that the language of Pei focusses on selection criteria and does not require clinical administration to pregnant women.
2. That the mice used in the studies of Pei were not indicated to be infertile or experiencing recurrent pregnancy loss; for the study’s purpose, the mice would need viable pregnancies and selecting infertile mice would defeat the purpose. Applicant asserts that the patent therefore neither discloses nor contemplates administering strains to individuals suffering from infertility or recurrent pregnancy loss.
3. That the instant inventors have discovered that oral administration of a Lactobacillus salivarius CECT 5713 to women with unexplained infertility or recurrent pregnancy loss achieved pregnancy with unexpected effectiveness and reproductive success, providing reduction in vaginal pH and increases in various cytokines in women who achieved pregnancy and that Pei does not disclose any teaching related to vaginal pH or increasing vaginal cytokine levels.
4. That Pei does not disclose administering the claimed probiotic to subjects needing treatment or prevention of infertility or recurrent pregnancy loss and does not disclose any therapeutic effect related to these conditions.
5. That, even if one were to assume that administration of strains to female and pregnant individuals in Pei would inherently prevent infertility or recurrent pregnancy loss if the claimed method works, such an assumption is unsupported by the disclosure of Pei. Applicant argues that Pei is entirely silent on infertility or recurrent pregnancy loss and that its purpose is limited to selecting probiotic strains based on transfer capability to breast milk or amniotic fluid and other general probiotic properties. Applicant further argues that the fact that a strain can reach breast milk or amniotic fluid does not establish that administration of the strain would treat or prevent infertility or recurrent pregnancy loss. Applicant points out that the instant specification provides experimental evidence demonstrating unexpected therapeutic outcomes in women.
6. That the examiner’s reasoning relies on speculation rather than disclosure and that anticipation requires that every element of the claimed invention be expressly or inherently disclosed. Applicant argues that the Pei reference does not disclose or suggest administration of probiotics for the treatment or prevention of infertility or recurrent pregnancy loss and dos not disclose any mechanism or result that would inherently achieve such outcomes.
7. That the Pei reference fails to anticipate the claimed invention because it does not disclose:
a. administration of probiotics for the treatment or prevention of infertility or recurrent pregnancy loss.
b. any therapeutic outcomes related to reproductive health, or
c. the specific physiological changes demonstrated in the instant application.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
Regarding argument 1, either applicant’s claimed method works the way applicant suggests or it does not. The outcome of administration does not change based on a practitioner or subjects desires or wishes. According to what applicant claims, administration of L. salivarius 5713 to female subjects treats and/or prevents infertility or recurrent pregnancy loss. If applicant is correct (and applicant is welcome to show evidence or reasoning that this is not the case), then the subject does not need to be pregnant or even trying to be pregnant. The claims include prevention of infertility or recurrent pregnancy. Therefore, the subject could be infertile without realizing it or could face infertility or recurrent pregnancy loss in the future. According to what applicant claims, administration of the strain will solve this regardless of whether the subject knows or wants it. Therefore, when Pei administered the strain to female subjects, they were necessarily treating and/or preventing infertility or recurring pregnancy loss. Whether Pei includes selecting of bacterial strains is not relevant to whether they teach administration of the claimed bacterial strain to female subjects. Further, there is nothing in the instant claims requiring clinical administration of anything to pregnant women.
Regarding argument 2, prevention of infertility and recurrent pregnancy loss includes stopping future infertility and recurrent pregnancy loss. Therefore, there is nothing in the claims requiring the mice to be suffering from infertility or recurrent pregnancy loss.
Regarding argument 3, whether the results applicant found in their studies were unexpected is not relevant to a determination of anticipation. There is nothing in the claims requiring anything to do with a change in vaginal pH or cytokine levels.
Regarding argument 4, Pei specifically discloses administering the claimed probiotic to female subjects. This would necessarily prevent infertility and recurrent pregnancy loss whether or not Pei recognized it.
Regarding argument 5, there is no need for Pei to disclose changes in infertility or recurrent pregnancy for the method to be anticipated. The assumption that the method works is based on applicant’s own claims. If applicant wishes to contend that the method does not work, they are welcome to. However, for the moment, the examiner is assuming that, based on what applicant asserts, that administration of the claimed probiotic will do what applicant says. Therefore, it did what applicant says when Pei administered it. Whether or not they recognized it, Pei practiced the method and disclosed the only active step required.
Regarding argument 6, the only method step set forth in the instant claims is administration of L salivarius 5713 to a female subject. The rest of the claims is a description of an outcome or a desire. Pei disclosed this method step. The outcome happened whether it was recognized or not. The only speculation made by the examiner is that applicant’s claims work the way they say.
Regarding argument 7:
a. Pei administered the same probiotic to female subjects which necessarily resulted in prevention of infertility or recurrent pregnancy loss,
b. there is no need for Pei to disclose any therapeutic outcomes because the required outcome would necessarily have happened, and
c. there are no specific physiological changes mentioned in the claims.
Conclusion
No claim is 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 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 Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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