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 claims filed Jan 20, 2026 has been entered. Claims 1-6, 8-9, and 12-17 have been amended. Claims 7, 10 and 18 have been cancelled.
Claims 1-6, 8-9, 11-17, and 19-21 are under consideration in this Office Action.
Priority
3. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in India on 2022-08-20. It is noted, however, that applicant has not filed a certified copy of the 202241047456 application as required by 37 CFR 1.55.
Therefore, because foreign priority is not perfected, the effectively filed date of application 18/235,910 is the filed date of Aug 21, 2023.
Withdrawal of Rejections
4. The following rejections have been withdrawn in view of applicants amendments:
a) The rejection of claims 1-21 under 35 U.S.C. 102(a)(2) as being anticipated by Simmons et al;
b) The rejections of claims 1-2, 4-5, 7-8 and 10-11 under 35 U.S.C. 102(a)(2) as being anticipated by Dannenberg et al;
c) The rejections of claims 1-21 under 35 U.S.C. 103 as being unpatentable over Cheng et al., in view of Simmons et al.
d) The deposit rejection of claims 7, 10, and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph; and
e) The scope of enablement rejection of claim 18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph; and
f) The deposit rejection of claims 1-6, 8-9, 11-17, and 19-21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Maintained Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 13-17 and 19-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating vaginitis caused by Gardnerella vaginalis, in human female subjects, the method comprising the steps of: (a) providing a composition comprising the following ingredients per single dosage: i) a prebiotic; and ii) dried live bacteria of the strains Lactobacillus crispatus UBLCp01, Lactobacillus gasseri UBLG36, and Lactobacillus johnsonii UBLJ0; and (b) administering 0.1-5 billion cfu of each strain within the composition intravaginally to female human in need of treatment;
does not reasonably provide enablement for a method of preventing bacterial and yeast-associated vaginitis in a human female subjects, the method comprising the steps of: (a) providing a composition comprising the following ingredients per single dosage: one or more dried live bacteria of the strains comprising 0.1-5 billion cfu of Lactobacillus crispatus UBLCp01, 0.1-5 billion cfu of Lactobacillus gasseri UBLG36, and 0.1-5 billion cfu of Lactobacillus johnsonii UBLJ0; and (b) administering the composition intravaginally to human female subject, wherein the composition forms a protective biofilm by the one or more dried live bacteria on the vaginal epithelium, thereby inhibiting adherence of pathogenic microorganisms associated with vaginitis.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CAFC 1988),page 1404.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)). These include: nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. In re Fisher, 427 F.2d 833,839, 166 USPQ 18, 24 (CCPA 1970) states, "The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art." "The "amount of guidance or direction" refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictablethe art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling" (MPEP 2164.03). The MPEP further states that physiological activity can be considered inherently unpredictable. Thus, Applicant assumes a certain burden in establishing that inventions involving physiological activity are enabled. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: The nature of the invention is a method of treating or preventing bacterial and yeast associated vaginitis in human female subjects, the method comprising the steps of: (a) providing a composition comprising the following ingredients per single dosage: one or more dried live bacteria of the strains comprising 0.1- 5 billion cfu of Lactobacillus crispatus UBLCp01, 0.1- 5 billion cfu of Lactobacillus gasseri UBLG36, and 0.1- 5 billion cfu of Lactobacillus johnsonii UBLJ0; and (b) administering the composition intravaginally to the human female subject wherein the composition forms a protective biofilm by the one or more dried live bacteria on the vaginal epithelium thereby inhibiting adherence of pathogenic microorganisms associated with vaginitis; wherein the relative level of skill of those in the art is deemed to be high.
Breadth of the claims: The claims are broadly drawn to a method of treating or preventing bacterial and yeast associated vaginitis in human female subjects, the method comprising the steps of: (a) providing a composition comprising the following ingredients per single dosage: one or more dried live bacteria of the strains comprising 0.1- 5 billion cfu of Lactobacillus crispatus UBLCp01, 0.1- 5 billion cfu of Lactobacillus gasseri UBLG36, and 0.1- 5 billion cfu of Lactobacillus johnsonii UBLJ0; and (b) administering the composition intravaginally to the human female subject wherein the composition forms a protective biofilm by the one or more dried live bacteria on the vaginal epithelium thereby inhibiting adherence of pathogenic microorganisms associated with vaginitis. Thus, the claim encompasses preventing bacterial and yeast associated vaginitis.
Guidance of the specification/The existence of working examples: The specification teaches 24 well plate cells were plated at a concentration of 1x105 and allowed to reach near confluence. Then the cells were replenished with fresh (KSF) medium followed by treatment with Lactobacillus crispatus UBLcP-01, Lactobacillus gasseri UBLG-36 and Lactobacillus johnsonii UBLJ-01 and various blends described in Table 3, in the presence and absence of GV for 24 h at paragraph [0179]. At best in vitro assays preformed in presence of Gardnerella vaginalis, show cell cultures were effective in down regulating the production of specific cytokines.
There are no protocols provided which demonstrate that the combination of Lactobacillus strains will prevent or treat bacterial and yeast associated vaginitis in human female subjects. There are no challenge experiments were any type of female subject was administered one or more Lactobacillus mixture and prevented from getting vaginitis. There is no teaching as to what the most effective route of administration for the Lactobacillus strains. There is no teaching of treating or preventing bacterial and yeast-associated vaginitis with the administration of one or more Lactobacillus strains. There are different types of vaginitis, such as bacterial vaginosis, yeast vaginitis (vulvovaginal candidiasis), atrophic vaginitis, allergic vaginitis, and irritant vaginitis in humans. In this case, there is merely a general suggestion that the combination of strains that do not apply directly to the instant invention. There are no working examples of the claimed method of prevention. Thus, the scope of the scope of the claims is extremely broad compared to the guidance and exemplification provided in the specification. The scope of the claims must bear a reasonable correlation with the scope of enablement. See In re Fisher, 166 USPQ 19 24 (CCPA 1970).
State of the art: The state of the prior art is such that it is well established in the art that there are no approved vaccines for bacterial and yeast associated vaginitis, at best some vaccines have been developed or are in early stages of development for recurrent vulvovaginal candidiasis (RVVC) and other specific types of vaginitis, such as bacterial vaginosis. Applicant did not prevent either. Thus there are no administrable Lactobacillus strains which will prevent bacterial or yeast associated vaginitis. There is no teaching of treating or preventing vaginitis in any of these subjects.
Currently, there are no licensed vaccines or immunotherapeutics against fungal infections. Healthcare-associated and community-acquired Candida infections have substantially increased in prevalence in recent years, as has antifungal resistance. Globally, a substantial number of women are afflicted with vulvovaginal infections due to Candida spp. Most notable is recurrent vulvovaginal candidiasis (RVVC), which is estimated by self-reported diagnosis to impact 6%–9% of women in the United States, with an estimated 138 million women worldwide affected by RVVC annually and 492 million affected with RVVC at some point during their lifetime. Although RVVC has been historically defined by some as ≥4 episodes per year, in practice women with ≥3 episodes per year are treated similarly in clinical settings. Recurrent vulvovaginal candidiasis has a substantially negative impact on quality of life related to symptoms, frequency, and unpredictability. Currently, RVVC is treated with repeated or prolonged antifungal therapy, which has variable efficacy, poses specific safety concerns, and adds selective pressure for antifungal resistance. Thus, a safe and effective vaccine would represent a substantial improvement in management of RVVC. Importantly, a vaccine effective against RVVC could lead to a vaccine against life-threatening Candida infections, including those caused by drug-resistant isolates. See Edwards et al., (A Fungal Immunotherapeutic Vaccine (NDV-3A) for Treatment of Recurrent Vulvovaginal Candidiasis—A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial, Clinical Infectious Diseases, Volume 66, Issue 12, 15 June 2018, Pages 1928–1936).
At best, Gynatren contains at least 7×109 inactivated microorganisms of eight Lactobacillus strains in approximately equal amounts (8.75×108 microorganisms per strain). Three strains belong to the species L. vaginalis, three strains to L. rhamnosus, one strain to L. fermentum and one to L. salivarius. The eight specific aberrant polymorphous Lactobacillus strains have been deposited at the Westerdijk Institute (Centraalbureau voor Schimmelcultures) in 1977 under the strain numbers CBS 465.77 to CBS 472.77. Inactivated material from the eight strains is mixed and diluted with physiological sodium chloride solution. Phenol is added as a preservative. The further ingredients are formaldehyde and sodium ethylmercuric thiosalicylate as preservatives and sodium chloride solution as a diluent. Another brand name of Gynevac is FemiVac. It is designed to combat Trichomonas vaginalis and Gardnerella vaginalis. Therefore, this composition comprises significantly more ingredients then just the Lactobacillus strains. See Gynatren package insert. Hamburg, Germany: Strathmann GmbH & Co. KG; August 2017. NDV-3A and PEV7 for yeast (Candida), which showed promise in early trials, and Gynevac or similar Lactobacillus-based vaccines for bacterial vaginosis. There is no single Lactobacillus species containing composition which prevents and treats bacterial and yeast associated vaginitis.Thus, the state of the art recognized that it would be highly unpredictable with regard to the treatment and prevention of bacterial or yeast associated vaginitis with a single Lactobacillus strain.
Relative Skill of Those in the Art: One of ordinary skill in the art could not predictably extrapolate the teachings in the specification, limited to the method of prevention and/or treatment of bacterial and yeast associated vaginitis, as broadly as claimed. In view of the lack of support in the art and specification for an effective and protective method, it would require undue experimentation on the part of the skilled artisan to make and use the claimed method; therefore the full scope of the claims is not enabled.
The specification does not enable the genus because where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one particular species, what other species will work. See MPEP 2164.03. One of skill in the art would neither expect nor predict the appropriate functioning of the vaccine as broadly as is claimed. Without such guidance, the changes which can be made in polypeptides structure and still function as a vaccine is unpredictable and the experimentation left to those skilled in the art is unnecessarily and improperly extensive and undue. See Amgen, Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F, 2d 1200, 18 USPQ 1016 (Fed. Cir. 1991) at 18 USPQ 1026 1027 and Ex parte Forman, 230 USPQ 546 (BPAI 1986).
In view of the lack of the predictability, the lack of guidance and direction provided by applicant, and the absence of working examples, undue experimentation would be required to practice the claimed method with a reasonable expectation of success, absent a specific and detailed description in applicant’s specification of how to prevent or/and treat vaginitis, commensurate in scope with the claimed invention.
Response to Arguments
6. Applicant's arguments filed Jan. 20, 2026 have been fully considered but they are not persuasive. The scope of enablement rejection of claims 13-17 and 19-21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is maintained for reasons described above.
Applicants point to the claim reciting “…administering the composition intravaginally to human female subject, wherein the composition forms a protective biofilm by the one or more dried live bacteria on the vaginal epithelium, thereby inhibiting adherence of pathogenic microorganisms associated with vaginitis.” However, the claim language is drawn to events that occur within the body of the host. The amended claim language does not include any additional method steps. Rather the amended claim language recites the intended result of the administered composition. Therefore the amendment does not overcome the scope of enablement rejection.
Applicants argue that the isolation of the Lactobacillus strains does not require undue experimentation. The Office agrees and points Applicants attention to the claimed method of prevention and/or treatment of bacterial and yeast associated vaginitis, comprising administering single Lactobacillus strain to treat and prevent all types of bacterial and yeast associated vaginitis in human females. There is no single strain of Lactobacillus which prevents and treats both bacterial and yeast associated vaginitis. There is no combination of Lactobacillus strains which treat and/or prevent bacterial and yeast associated vaginitis in a human female. Applicants did not point to any challenge experiments.
Applicants point to Example 6 of the instant specification which is drawn to the compositions with all three strains at between 0.25 and 0.5 bn, and individual strains at 1bn. No where within Example 6 was E. coli, C. albicans, G. vaginalis and P. mirabilis prevented in any in vitro assay. Table 6 shows antimicrobial potential , however none of E. coli, C. albicans, G. vaginalis and/or P. mirabilis was prevented. There are no animal model experiments; no challenge experiments, no examples showing prevention, no reduction of symptoms; no molecular test showing the absence of pathogens, no Nugent Score results; no Amsel criteria testing; and/or no BVBlue test regarding detection of BV; yet Applicants urge that undue experimentation is not required. This argument is not persuasive especially since there is no single Lactobacillus strain composition which would prevent both bacterial and yeast associated vaginitis infections.
Neither Examples 6.1 nor 6.2 depict providing a composition comprising the following ingredients per single dosage: one or more dried live bacteria of the strains comprising 0.1-5 billion cfu of Lactobacillus crispatus UBLCp01, 0.1-5 billion cfu of Lactobacillus gasseri UBLG36, and 0.1-5 billion cfu of Lactobacillus johnsonii UBLJ0; and (b) administering the composition intravaginally to human female subject, wherein the composition forms a protective biofilm by the one or more dried live bacteria on the vaginal epithelium, thereby inhibiting adherence of pathogenic microorganisms associated with vaginitis. Examples 6.1 and 6.2 do not even use vaginal epithelial cells (VECs) which are essential components in diagnosing vaginitis, particularly in identifying clue cells to diagnose bacterial vaginosis (BV) via saline wet mount microscopy. They are also used to detect inflammatory changes and to evaluate the vaginal microbiome. Thus Applicants arguments did not provide enabling support.
Next Applicants point to Tables 4 showing auto-aggregation and co-aggregation and Table 5 showing Biofilm formation potential of the instant specification. Neither Table 4 nor 5 shows the administration of Lactobacillus preventing bacterial or yeast associated vaginitis in any human female. There is scientific evidence of testing vaginal discharge. There was no traditional vaginitis testing, and there are no molecular test, therefore Applicants cannot determine the treatment or prevention of vaginitis. Thus showing the potential to form biofilm on planktonic cells provides information regarding the protective mechanism allowing bacteria to adhere to the vaginal epithelium, resist antibiotic treatment, and survive environmental stressors like low pH and hydrogen peroxide. These sessile communities create a robust extracellular matrix that contributes to recurrent infections by shielding bacteria and enabling a dormant state that can survive therapy. This does not show prevention of bacterial and yeast associated vaginitis in a human female after administration of a single Lactobacillus species. Therefore, none of Applicants arguments have been found persuasive and the rejection is maintained.
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.
7. Claims 1-6, 8-9 and 11-12 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 1-6, 8-9 and 11-12 are determined to be directed to natural products and do not recite something “significantly different” than the natural product. Natural products are “judicial exemptions”. The rationale for this determination is explained below:
Claims 1-6, 8-9 and 11-12 are drawn to a composition for treating vaginitis comprising dried live bacteria of the strains Lactobacillus crispatus UBLCp01, Lactobacillus gasseri UBLG36, Lactobacillus johnsonii UBLJ01 and a prebiotic.
The strains Lactobacillus crispatus UBLCp01, Lactobacillus gasseri UBLG36, Lactobacillus johnsonii UBLJ01 are not “markedly different” in structure than naturally occurring Lactobacillus crispatus UBLCp01, Lactobacillus gasseri UBLG36, Lactobacillus johnsonii UBLJ01. All three strains were isolated from the vagina of healthy reproductive age Indian women.
Prebiotics such as frutooligosaccharides (FOS) are naturally occurring which include fibers found in plants like chicory, onions, garlic, asparagus, and bananas. These indigestible compounds act as prebiotics by feeding beneficial bacteria, which can lead to health benefits such as improved bowel function and increased mineral absorption. Ascorbic acid, also known as vitamin C, is a naturally occurring nutrient found in various fruits and vegetables. Natural antifungals include essential oils like tea tree oil, oregano oil, and eucalyptus oil; certain foods and extracts such as garlic, apple cider vinegar, coconut oil, and ginger; and some oral supplements like caprylic acid. Thus, all of the ingredients of the composition are therefore not markedly different from their counterparts found in nature.
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 Lactobacillus, prebiotics and the other components together as a composition; the composition combination does not change the structure of the naturally occurring ingredients.
Additionally, the product claims as a whole do not recite something significantly different from the judicial exceptions because the additional components do not impose meaningful limits on the claim scope therefore substantially all practical applications of the judicial exception are covered. Furthermore, the additional elements in dependent claims such as antioxidants and antifungals 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.
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 steps, 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
8. Applicant's arguments filed Jan. 20, 2026 have been fully considered but they are not persuasive. Applicants alleges that the bacterial species are not naturally occurring. However, Lactobacillus crispatus UBLCp01, Lactobacillus gasseri UBLG36, and Lactobacillus johnsonii UBLJ01 were all isolated from the vagina of healthy reproductive age Indian women. See Ahire et al., (Probiotics Antimicrob Proteins. 2023 Apr;15(2):275-286). Therefore, each strain is naturally occurring and isolated from a naturally occurring female humans. Applicants have made no arguments or presented any evidence that the bacterial strains have been genetic modified.
Applicants urge that the composition comprises combined components at optimized concentrations. Applicants attention is directed to the specific claim language. The composition comprises one dried bacterial strain. Therefore the claim does not require a combination of components. These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. Because both claims are directed to a statutory category, e.g., a composition of matter (Step 1: YES), and are nature-based products (a mixture of bacteria), the markedly different characteristics analysis is used to determine if the nature-based products are exceptions.
Additionally, Applicants attention is directed to Example 6, entitled Bacterial Mixtures. Applicants arguments are not found persuasive because there is no indication in the specification that the claimed mixture of bacteria has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring bacteria. Thus, the mixture does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. Accordingly, the claims are directed to an exception (Step 2A: YES). Because the claims do not include any additional features that could add significantly more to the exception (Step 2B: NO), the claims do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101. See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948):
Discovery of the fact that certain strains of each species of these bacteria can be mixed without harmful effect to the properties of either is a discovery of their qualities of noninhibition. It is no more than the discovery of some of the handiwork of nature and hence is not patentable. The aggregation of select strains of the several species into one product is an application of that newly-discovered natural principle. But however ingenious the discovery of that natural principle may have been, the application of it is hardly more than an advance in the packaging of the inoculants. Each of the species of root-nodule bacteria contained in the package infects the same group of leguminous plants which it always infected. No species acquires a different use. The combination of species produces no new bacteria, no change in the three species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee. Recently, the Supreme Court looked back to this claim as an example of ineligible subject matter, stating that “the composition was not patent eligible because the patent holder did not alter the bacteria in any way.” Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 2117 (2013).
Applicants urge that naturally occurring Lactobacillus species do not exist in dried form. However, the state of the art does not support Applicants assertion. Naturally occurring dried bacteria are microorganisms that have entered a dormant state, often forming spores or protective layers to survive adverse environmental conditions like extreme dryness, high salt, or lack of nutrients. Certain bacteria in the gastrointestinal tract, including Lactobacillus species, can be found in dried states within fecal samples. See Yang et al., J of Diary Science. Vol. 93, Issue 7, July 2010, pages 3136-3145. All the instantly recited bacterial species are naturally found together and can naturally found together in dried form. Therefore, naturally occurring Lactobacillus species do exist in dried form; especially since the Lactobacillus crispatus UBLCp01, Lactobacillus gasseri UBLG36, and/or Lactobacillus johnsonii UBLJ01 were all isolated from the vaginas of healthy reproductive age Indian women.
For all the reasons described above, the rejection is maintained.
New Grounds of Rejections
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.
9. Claims 1-6, 8-9, 11-17, and 19-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With respect to dependent claim 1 and claim 13 recite the limitation "bacterial and yeast-associated vaginitis". The metes and bounds of the phrase are not clear. It is unclear how to define bacterial and yeast associated vaginitis. What is the difference between bacterial vaginitis and yeast vaginitis and the instantly recited bacterial and yeast associated vaginitis. It is unclear if applicants are including nonspecific bacterial vaginosis, vaginal dysbiosis, vaginitis caused by allergies, chemical irritants, and/or low estrogen levels. The metes and bounds for determining the associated factors, are unclear. Therefore, clarification is required to overcome the rejection.
Claim 13 recites the limitation “the strains” and "the vaginal epithelium" in the claim. There is insufficient antecedent basis for this limitation in the claim.
Conclusion
10. No claims allowed.
11. 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.
12. 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 Dan Kolker, can be reached on 571-272-3181. 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