DETAILED
ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Amendments
2. The amendments filed Feb. 24, 2026 have been entered. Claims 13-14 and 16-18 have been amended. Claims 1-12 and 15 were cancelled. Claims 19-28 and 31 have been cancelled. Claims 32-35 have been newly added. Claims 13-14, 16-18, 29-30 and 32-35 are under consideration in this Office Action.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on Oct. 22, 2025 and Dec. 22, 2025 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Grounds of Rejection
4. The following rejections have been withdrawn in view of Applicants amendments and arguments:
a) The rejection of claims 15, 19-28 and 31 under 35 U.S.C. 101 has been withdrawn in view of applicants amendments and arguments.
b) The deposit rejection of claims 13-20, 22-26 and 28-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of applicants amendments and arguments.
c) The written description rejection of claims 13-14 and 17-18 under 35 U.S.C. 112, first paragraph, is withdrawn in view of applicants amendments and arguments.
d) The rejection of claims 13-15, 17-18 and 26 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of applicants amendments and arguments.
e) The rejection of claims 19-20, 23-26, 28 and 31 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn in view of applicants amendments and arguments.
f) The objection of claims 14 and 29 is withdrawn in view of applicants amendments and arguments.
g) The rejection of claims 19-20, 28 and 31 under 35 U.S.C. 102(a)(1) as being anticipated by Mandar et al; is withdrawn in view of applicants amendments and arguments.
Maintained Grounds of Rejection
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
5. Claims 13-14, 16-18, 29-30 and 32-35 are rejected under 35 U.S.C. 101 because claims 13-14, 16-18, 29-30 and 32-35 are not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 13-14, 16-18, 29-30 and 32-35 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims are drawn to a composition comprising an isolated bacterial strain capable of prevention, inhibition, or treatment of biofilm formation of pathogens, wherein the bacterial strain is selected from Lactobacillus crispatus LB714R, deposited under the accession number DSM 33732, Lactobacillus crispatus LB919R deposited under accession number DSM 34097, Lactobacillus jensenii LB918R deposited under accession number DSM 34096, Lactobacillus crispatus LB912R deposited under accession number DSM 34095, or Lactobacillus gasseri LB905R deposited under accession number DSM 34094, wherein the isolated bacterial strain is viable or non-viable is stabilized in freeze dried, lyophilized or microencapsulated forms or wherein the non-viable cells is provided as a lysate, as a fraction, as a ferment, as metabolites, as an extract, as a derivative, as analogues, as postbiotics, as paraprobiotics or as a mutant of one of the bacterial strains.
The LB918R, LB919R, LB912R, and LB905R strains were isolated from the vagina of a healthy woman; see the instant specification at paragraph 238. LB714R isolated from vagina of woman in late pregnancy; see the instant specification at paragraph 239. Therefore the deposited strains were naturally occurring strains.
The deposited Lactobacillus crispatus, Lactobacillus jensenii and/or Lactobacillus gasseri strains are not “markedly different” in structure than naturally occurring Lactobacillus crispatus, Lactobacillus jensenii and/or Lactobacillus gasseri strains
commonly found in the vaginal tract of healthy women. Additionally, Pediococcus pentosaceus naturally occurs in the vaginal tract as part of the diverse microbiota. Pediococcus species and has been identified as natural inhabitants. L. plantarum is a type of probiotic bacterium that is commonly isolated from the vaginal tract. It is a component of a healthy vaginal microbiota and is recognized for its beneficial properties in protecting against vaginal infections.
These claims fail to satisfy the non-naturally occurring requirement. Furthermore, there is no structural difference because of the mere aggregation of natural occurring strains of commonly found in the vaginal tract. A composition comprising bacterial strains together as a composition does not change the structure of the naturally occurring bacterial strains. When the isolated bacterial strain are viable the strains are stabilized in freeze dried, lyophilized or microencapsulated form. Freeze drying and lyophilization is a process which removes water and allows for retaining structure, color and nutritional benefits. Therefore, the viable cells, even when dried or lyophilized have not obtained a different genetic form. When the isolated bacterial strains are nonviable strains are paraprobiotic. L. crispatus is considered a paraprobiotic because it is a non-living naturally occurring form of the probiotic. Naturally occurring Lactobacillus crispatus is a dominant, protective bacterium in the healthy vaginal microbiome that produces several key postbiotics (functional metabolites and components) to maintain health. These postbiotics, including lactic acid, hydrogen peroxide, and various bactericidal components, act as natural antibiotics and immune modulators. Therefore, the instant claims clearly recite naturally occurring products.
Additionally, the product claims as a whole do not recite something significantly different from the judicial exceptions because the additional formulations do not impose meaningful limits on the claim scope therefore substantially all practical applications of the judicial exception are covered. Furthermore, the dependent claims are all recited at a high level of generality, and/or are well-understood, purely conventional and routine in the field, and/or are merely appended to the judicial exception without a significant change in the structure of the judicial exception itself as evidenced by the prior art recited within the rejections.
The Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980), held a claim to a genetically engineered bacterium eligible, because the claimed bacterium was not a “product of nature” exception. (Emphasis added). As the Court explained, the modified bacterium was patentable because the patent claim was not to a “hitherto unknown natural phenomenon,” but instead had “markedly different characteristics from any found in nature,” due to the additional plasmids and resultant capacity for degrading oil. 447 U.S. at 309-10, 206 USPQ at 197.
Subsequent judicial decisions have made clear that the Supreme Court’s decision in Chakrabarty is “central” to the eligibility inquiry with respect to nature-based products. See, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972, 1979 (2013). For example, the Federal Circuit has indicated that “discoveries that possess ‘markedly different characteristics from any found in nature,’ … are eligible for patent protection.” In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1336, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014) (quoting Chakrabarty, 447 U.S. at 310, 206 USPQ2d at 197). In Roslin, the claimed invention was a live-born clone of a pre-existing, non-embryonic, donor mammal selected from cattle, sheep, pigs, and goats. An embodiment of the claimed invention was the famous Dolly the Sheep, which the court stated was “the first mammal ever cloned from an adult somatic cell.” Despite acknowledging that the method used to create the claimed clones “constituted a breakthrough in scientific discovery”, the court relied on Chakrabarty in holding the claims ineligible because “Dolly herself is an exact genetic replica of another sheep and does not possess ‘markedly different characteristics from any [farm animals] found in nature.’” Roslin, 750 F.3d at 1337, 110 USPQ2d at 1671.
If the applicant chooses to amend the instant claims, the examiner recommends that applicant consider the U.S. Supreme Court ruling that the additional steps should consist of more than well-understood, routine, conventional activity already engaged in by the scientific community. Such putative additional components, when viewed as a whole, might add nothing significant beyond the sum of their parts taken separately. The Court has made clear that to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words "apply it." Essentially, appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible.
The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June 13, 2013). Also see the December 4, 2014 and May 4, 2016 Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products (the Guidance).
Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are held to claim a law of nature and natural products, and are therefore rejected as ineligible subject matter under 35 U.S.C. 101.
Response to Arguments
6. Applicant's arguments filed Feb. 24, 2026 have been fully considered but they are not persuasive. Claims 13-14, 16-18, 29-30 and 32-35 are rejected under 35 U.S.C. 101. Applicants argue that the instant claims are drawn to isolated bacterial strain that is viable or non-viable cells wherein the viable isolated bacterial strain is stabilized in freeze dried, lyophilized or microencapsulated forms or wherein the non-viable cells is provided as a lysate, as a fraction, as a ferment, as metabolites, as an extract, as a derivative, as analogues, as postbiotics, as paraprobiotics or as a mutant of one of the bacterial strains.
Neither isolation, nor the bacteria being viable and/or nonviable provide a structural different or describe unique and different characteristics. However, these claims still fail to satisfy the non-naturally occurring requirement. Furthermore, there is no structural difference because of the mere aggregation of natural occurring strains of commonly found in the vaginal tract. The instantly claimed composition comprising bacterial strains together as a composition does not change the structure of the naturally occurring bacterial strains. When the isolated bacterial strain are viable the strains are stabilized in freeze dried, lyophilized or microencapsulated form. Freeze drying and lyophilization is a process which removes water and allows for retaining structure, color and nutritional benefits. Therefore, the viable cells, even when dried or lyophilized have not obtained a different genetic form. Applicants have not pointed to any bacterial characteristics which are different and unique which thereby provide differences between the instant claims strains and the naturally occurring strains.
When the isolated bacterial strains are nonviable strains are paraprobiotic. L. crispatus is considered a paraprobiotic because it is a non-living naturally occurring form of the probiotic. Naturally occurring Lactobacillus crispatus is a dominant, protective bacterium in the healthy vaginal microbiome that produces several key postbiotics (functional metabolites and components) to maintain health. Therefore, the L. crispatus is a naturally occurring paraprobiotic and/or postbiotics which do not add any structural differences. Again, Applicants did not argue that the naturally occurring L. crisptaus paraprobiotic and/or postbiotics provide structural differences. Thus, Applicants arguments are not found persuasive because the instant claims clearly recite naturally occurring products.
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.
7. Claims 13-15 and 17-18 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 pre-AIA the applicant regards as the invention.
The claim is vague and indefinite in the use of the phrase/terms fraction, ferment, metabolites, extracts, derivatives, analogues, postbiotics or mutants. Since it is unclear what amount of modification is permitted as implied by the recitation of fractions, ferment, metabolites, extracts, derivatives, analogues, postbiotics or mutants and what amount of fraction, ferment, metabolites, extracts, derivatives, analogues, postbiotics or mutants is comprised within the composition. For instances, the composition must comprise the bacterial strains and not the metabolites, which are produced by the bacteria. Therefore the claims recite an unclear. The claims do not define the criteria for another bacterial strain to
The claims fail to recite an effective amount of L. crispatus, L. jensenii or L. gasseri fraction, ferment, metabolites, extracts, derivatives, analogues, postbiotics or mutants. Since it is unclear how the composition is to be varied as referred to in the claims, there is no way for the person of skill in the art to ascribe a discrete and identifiable definition to the amounts of L. crispatus, L. jensenii or L. gasseri fraction, ferment, metabolites, extracts, derivatives, analogues, postbiotics or mutants. Therefore the rejection is maintained.
Response to Arguments
8. Applicant's arguments filed Feb. 24, 2026 have been fully considered but they are not persuasive. The rejection of claims 13-15 and 17-18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is maintained. Applicants assert that one of ordinary skill would know that:
Fractions are products obtained by separating components via known biochemical methods.
Metabolites are compounds naturally produced by microbial metabolism.
Ferment is produced when the bacterial strain grows and ferments
Extracts are obtained by extraction processes well-known in the field.
Derivative are chemically modified versions of bacterial components or metabolites.
Analogue are compounds similar in structure or function to natural bacterial components
Mutants are strains modified by natural or induced mutation.
However, Applicant is reminded that the rejection was not based upon the definition of the words. Instead, the rejection is based upon the fact that the claims do not define whether the composition comprises bacterial cell envelope, bacterial cytoplasm or a bacterial appendages, like a flagella or pili; nor does the claim recite what amount of bacterial fraction needs to be present within the composition.
Applicants point to metabolites and points to be definition of metabolites being compounds naturally produced by microbial metabolism. However metabolites are components produced by the bacteria and are not a nonviable form of the claimed bacteria. Therefore, this term is unclear within the metes and bounds of the claims.
Applicants point to ferments and points to be definition of ferment being the byproduct of bacterial strain growth, i.e, culture medium. However ferment is the byproduct of bacteria growth and are not a nonviable form of the instantly claimed bacteria. Therefore, this term is unclear within the metes and bounds of the claims.
Applicants point to derivatives, analogues and mutants. However, Applicants have failed to define the metes and bounds for another strain to be deemed a derivative, analogue or mutant. Neither the claims nor the specification provide a definition to decide which strains can be classified as a derivative. The is no definition which includes or excludes any vaginal tract isolate of L. crispatus, L. jensenii or L. gasseri to a derivative or analogue. Additionally, there is no definition limiting the type of number of mutations necessary or prohibited for a vaginal tract isolate of L. crispatus, L. jensenii or L. gasseri to a be classified as a mutant.
Therefore, none of Applicants arguments are persuasive and the rejection is maintained.
Duplicate Claims
9. Applicant is advised that should claim 13 be found allowable, claim 17 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 13 is directed to a composition of LB918R, LB919R, LB912R, and LB905R strains. Claims 17 and 29 also recite the same composition comprising the same deposited strains of Lactobacillus. The intended use of the strain, capability of prevention, inhibition or treatment of biofilm formation, carries no patentable weight. As the composition of strains remains identical, each of claim 17 is drawn to the identical composition as the composition recited in claim 13.
Claim 17 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 13. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Response to Arguments
10. Applicant's arguments filed Feb. 24, 2026 have been fully considered but they are not persuasive. The objection of claim 17 is maintained. Claims 13 and claim 17 both recite an isolated bacterial strain comprising a composition comprising an isolated bacterial strain, wherein the bacterial strain is selected from Lactobacillus crispatus LB714R, deposited under the accession number DSM 33732, Lactobacillus crispatus LB919R deposited under accession number DSM 34097, Lactobacillus jensenii LB918R deposited under accession number DSM 34096, Lactobacillus crispatus LB912R deposited under accession number DSM 34095, or Lactobacillus gasseri LB905R deposited under accession number DSM 34094, wherein the isolated bacterial strain is viable or non-viable cells, wherein the viable isolated bacterial strain is stabilized in freeze dried, lyophilized or microencapsulated forms or wherein the non-viable cells is provided as a lysate, as a fraction, as a ferment, as metabolites, as an extract, as a derivative, as analogues, as postbiotics, as paraprobiotics or as a mutant of one of the bacterial strains. Thus both compositions contain the exact same bacterial strains with no other additional components. Therefore, Applicant that claim 17 is drawn to an independent composition is not found persuasive because the instantly claimed strains are identical. Accordingly, the rejection is maintained.
Claim Rejections - 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
11. Claims 18 and 30 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Mandar et al. (WO 2020074547 published 2020-01-16; priority to 2018-10-09).
The claims are directed to a medical composition comprising one or more bacterial strains, wherein the bacterial strain is selected from the species Lactobacillus crispatus, Lactobacillus gasseri or, Lactobacillus jensenii, wherein the isolated bacterial strain is viable or non-viable cells wherein the viable isolated bacterial strain is stabilized in freeze dried, lyophilized or microencapsulated forms or wherein the non-viable cells is provided as a lysate, as a fraction, as a ferment, as metabolites, as an extract, as a derivative, as analogues, as postbiotics, as paraprobiotics or as a mutant of one of the bacterial strains and wherein the composition further comprises a lactic acid bacteria selected from one or more Pediococcus strains and/or one or more Lactobacillus plantarum.
Mandar et al., describe a Lactobacillus crispatus strain or a mutant or variant of any thereof, a composition comprising, consisting essentially, or consisting of exactly or at least 1, 2, 3, 4, 5 or 6 different Lactobacillus crispatus strains selected from these strains, hygiene products comprising said strains, and the use of such strains and compositions in therapy [abstract]. The composition may further comprise one or more further (different) strains of probiotic bacteria, which may, e.g. be selected from: (i) Lactobacillus crispatus mutants and/or variants as defined above; (ii) different Lactobacillus crispatus strains; and/or (iii) any other probiotic bacteria [para 38]. Such "other probiotic bacteria" may, e.g., be lactic acid bacteria. They may, e.g., be from the genera Lactobacillus. Such "other probiotic bacteria" may, e.g., be lactic acid bacteria. They may, e.g., be from the genera Lactobacillus, L. plantarum, and/or L. gasseri [para 40]. Many probiotic strains are available from public culture collections such as the American Type Culture Collection (ATCC), e.g., L. plantarum (ATCC 14917), L. gasseri (ATCC 9857), and/or L. jensenii (ATCC 25258) [para 41]. Mandar et al., instant claim 6 recites in pertinent part a composition wherein the composition comprises L. crispatus and further comprises one or more further probiotic bacteria, e.g. selected from Lactobacillus gasseri, L. jensenii, and/or L. plantarum.
The strains provided herein may be considered to be "isolated", i.e. removed from their natural environment [para 21]. The Lactobacillus crispatus strain provided herein may be a culture in liquid form, frozen form, dried form (e.g. spray-dried) or freeze-dried (lyophilised) form. The Examples show that the freeze-dried form has an excellent shelf life, with viability remaining substantially unchanged during storage at -20° C for one year. Thus, the freeze-dried form, e.g. a lyophilised powder, is of particular interest [para 22]. Example 9 teach analysis of shelf life to check the viability [para 116 and para 117]. The term "probiotic bacteria" as used herein refers to live microorganisms which, when administered in appropriate amounts to a subject, affect the microbiota of the subject, thereby preferably conferring a health benefit on the subject [para 39]. Thus, Mandar et al., teach viable cells and cells tested for their viability.
Such mixtures or combinations of probiotic bacteria may be administered for maintaining or restoring a beneficial microbiota, e.g. a vaginal microbiota. They may be in a combined preparation for separate, simultaneous, or sequential use in therapy, e.g. the treatment or prevention of dysbiosis, vaginosis, vulval and/or vaginal yeast infection, villitis, and/or urinary tract infection [para 43 and 85-86]. The composition may be formulated as liquids, as semi-solids or as solids, e.g. liquid solutions, dispersions, suspensions, tablets, capsules, pills, suppositories, powders, sachets, cachets, elixirs, emulsions, syrups, creams, gels, and the like. It may be a form suitable for oral, topical, rectal, intravaginal, genital, and/or intranasal administration. The preferred form depends on the intended mode of administration and therapeutic application [para 61].
Claim 18 recites the intended use of the strain to be capable of prevention, inhibition, or treatment of biofilm formation of pathogen, however a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
A composition and its properties are inseparable. Therefore, if the prior art teaches the identical composition (Lactobacillus strains), the properties applicant discloses and/or claims (treating and/or preventing vaginal infection; improving fertility; and/or reducing the risk of premature birth) are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Accordingly, Mandar et al., disclose of each and every limitation of the instantly filed claims.
Response to Arguments
12. Applicant's arguments filed Feb. 24, 2026 have been fully considered but they are not persuasive. The rejection of claims 18 and 30 under 35 U.S.C. 102(a)(1) as being anticipated by Mandar et al., is maintained despite Applicants arguments and amendments.
Mandar clearly and specifically teach a medical composition comprising one or more bacterial strains, wherein the bacterial strain is selected from the species Lactobacillus crispatus, Lactobacillus gasseri or, Lactobacillus jensenii, wherein the isolated bacterial strain is viable or non-viable cells wherein the viable isolated bacterial strain is stabilized in freeze dried or lyophilized and wherein the composition further comprises a lactic acid bacterium of one or more Lactobacillus plantarum. Each and every instantly rejected claim limitation is described. Therefore Applicants amendment does not overcome the rejection contrary to their arguments otherwise.
New Grounds of Rejection Necessitated By Applicants Amendment
Claim Rejections - 35 USC § 102
13. Claims 18, 30 and 35 are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by Vedel et al. (WO 2020074547 published 2020-01-16; priority to 2018-10-09).
Vedel et al., describe a composition comprising at least one lactic acid bacterium [abstract]. The present invention provides a composition for the prevention of an infection, comprising an effective concentration (a therapeutically effective amount) of one or more species or strains of probiotic bacteria, such as Lactobacillus spp., within a pharmaceutically-acceptable carrier [para 105]. The at least one lactic acid bacteria may be selected from the group comprising Lactobacillus plantarum, Lactobacillus jensenii, Lactobacillus crispatus, Lactobacillus gasseri, or analogs, derivatives, or fragments thereof [para 39]. The composition according to the present invention may preferably comprise a pharmaceutically or cosmetically acceptable vehicle or excipient. The at least one lactic acid bacterium according to the present invention may preferably be selected from the genera Lactobacillus, ,and Pediococcus [para 38]. Lactobacillus plantarum LB356R, which is deposited as DSM 33094 [para 40].
It is preferable for the composition to be present in solid, liquid, viscous form or as a dried form. In an embodiment the at least one lactic acid bacterium and/or the composition according to the present invention may be freeze-dried. The composition according to the present invention may comprise a cryoprotectant. The composition may preferably be formulated into an emulsion; an oil; a gum; a paste; a powder; a talc; a lotion; a custard; a foam; a crème; a gel; an ointment; a suspension; a mist; a spray; or a liquid [para 10-110].
Therefore, Vedel et al., teach the instantly rejected claims.
Pertinent Art
14. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Lynch et al., (WO2017152137) teach microbial compositions and methods of using the same. The microbial compositions provided include, therapeutically effective amounts of Lactobacillus and Pediococcus pentosaceus and are particularly useful for methods of treating and preventing inflammatory diseases. The Lactobacillus species are Lactobacillus crispatus, Lactobacillus jensenii, and L. plantarum.
Gueniche et al., (WO 2011070509) teach compositions comprising Pediococcus sp., especially
P. acidilactici, and Lactobacillus species: especially L. crispatus, L. gasseri, L. plantarum.
Castiel et al., (EP2306970) describe a composition comprising This second microorganism may be Pediococcus, L. crispatus, L. gasseri.
Cheng et al., (US Patent 12,397,024) describe a multi-lactobacillus composition is a dominant strain separated and selected from the vagina of a healthy woman in China. The multi-lactobacillus composition comprises at least three of the following activecomponents: Lactobacillus johnsonii, Lactobacillus gasseri, Lactobacillus rhamnosus, Lactobacillus crispatus, and Lactobacillus jensenii.
Conclusion
15. No claims allowed.
16. 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.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Peter Paras, can be reached on 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANA A HINES/Primary Examiner, Art Unit 1645
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