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 .
DETAILED ACTION
Claims 1-13, 15, 17-19, 21, 23-31 and 35 are cancelled.
Claims 14, 16, 20, 22 and 32-34 are pending and under examination herein.
Priority
This application is a 371 of PCT/EP2019/085473 filed 12/17/2019, which claims priority to FRANCE 18 73109 filed 12/17/2018.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
In view of the certified English translation received on June 27, 2024, the effective filing date of the claims is perfected to December 17, 2018.
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.
Maintained rejection: Claims 14, 16, 20, 22 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Premanathan et al. (“Treatment of oral candidiasis (thrush) by Saccharomyces cerevisiae”, International Journal of Medicine and Medical Sciences, 2011, Vol. 3, Issue 3, pp.83-86; previously cited) in view of Pericolini et al. (“Therapeutic activity of a Saccharomyces cerevisiae-based probiotic and inactivated whole yeast on vaginal candidiasis”, Virulence, 2017, Vol. 8, No. 1, pp.74-90; previously cited), Moyes et al. (“Mucosal Immunity and Candida albicans Infection”, Journal of Immunology Research, 2011, Volume 2011, Article ID 346307, 9 pages; previously cited), and Simon et al. (WO 2009/103884 A2, published on August 27, 2009; previously cited). As the original Simon document is in French, an English translation is relied upon for support. The rejection of claim 20 is further evidenced by The European Medicines Agency (“Guideline on the quality of water for pharmaceutical use”, published on July 20, 2020, Document EMA/CHMP/CVMP/QWP/496873/2018, 10 pages; https://www.ema.europa.eu/en/quality-water-pharmaceutical-use-scientific-guideline; previously cited).
Regarding claim 14, Premanathan teaches treatment of oral candidiasis (thrush) by Saccharomyces cerevisiae (title). Premanathan teaches applying an S. cerevisiae paste to cover the infected area for 3 min, thrice a day until recovery (p.2, 2nd column – Treatment). Premanathan teaches activating one gram of S. cerevisiae in lukewarm sterile water for 5 minutes (p.2, 2nd column – Treatment).
Premanathan does not teach a Saccharomyces cerevisiae strain deposited with CNCM on October 17, 2007 under accession number I-3856, or wherein said Saccharomyces cerevisiae yeast strain is in an inactive form.
However, Pericolini teaches that vaginal administration of Saccharomyces cerevisiae live yeast (GI) and in part, inactivated whole yeast Saccharomyces cerevisiae (IY) were able to positively influence the course of vaginal candidiasis by accelerating the clearance of fungus (abstract). Pericolini teaches that IY is able to self-aggregate with the maximum score, and the same score was observed when IY was added with C. albicans (p.75, 2nd column, last paragraph). Pericolini further teaches that IY administration significantly prevented the adherence of BLI Candida to the vaginal epithelium (p.76, 1st column; Fig. 6C). Pericolini teaches that both IY and GI show competition and interference in the adhesion of Candida to vaginal epithelium, that is the most reliable indicator for interaction with human vaginal epithelium (p.82, 2nd column last paragraph).
Simon teaches a new strain Saccharomyces cerevisiae deposited under the number CNCM I-3856 (English translation p.2, mid-page). Simon teaches Saccharomyces cerevisiae obtained from the strain CNCM No. I-3856 and/or at least one yeast derivative selected from yeast extracts, wall derivatives, parietal glucans, parietal mannoproteins, and mixtures thereof (English translation p.2, 2nd paragraph from bottom; p.3, paragraph 6). Simon further teaches that certain fractions of yeasts and/or yeast derivatives have been described for their beneficial effects on the digestive tract (English translation p.2, Description paragraph 6). Simon teaches the yeast or derivative according to the invention or the composition comprising it are preferably administered orally (English translation p.4, Description paragraph 10). Simon further teaches that administration of ScProI reduces DSS-induced colonization of C. albicans (English translation p.9, last 2 paragraphs).
Moyes teaches Candida species are the most common fungal pathogens of humans and the causative agents of oral, gastrointestinal, and vaginal candidiasis, giving rise to severe morbidity in millions of individuals worldwide (p.1, 1st column last paragraph). Moyes teaches that Candida species cause mucosal disease in a significant proportion of immunosuppressed patients and women of fertile age with the majority of these individuals experiencing superficial mucosal candidiasis such as thrush (relevant to treating oropharyngeal candidiasis in a subject) (p.2, 1st column last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the Saccharomyces cerevisiae strain taught by Premanathan with the Saccharomyces cerevisiae CNCM I-3856 strain taught by Simon in the method of Premanathan to arrive at the claimed invention. Each of Premanathan and Simon teach the treatment of Candida infections using Saccharomyces cerevisiae. One of ordinary skill in the art would have been motivated to select the Saccharomyces cerevisiae CNCM I-3856 strain taught by Simon in the composition taught by Premanathan because Moyes teaches that Candida species cause oral, gastrointestinal, and vaginal candidiasis, and Simon teaches that the Saccharomyces cerevisiae CNCM I-3856 reduces colonization of C. albicans in the intestinal mucosa. One of ordinary skill in the art would have found it beneficial to select the Saccharomyces cerevisiae strain CNCM I-3856 in a composition to treat oropharyngeal candidiasis because it was known that the strain reduces colonization of C. albicans.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Saccharomyces cerevisiae paste formulation taught by Premanathan to comprise an inactive form taught by Pericolini. One of ordinary skill in the art would have reasonably expected that replacing the whole yeast taught Premanathan with Saccharomyces cerevisiae strain CNCM I-3856 taught by Simon in an inactive form taught by Pericolini would predictably result in a decrease of C. albicans because Pericolini teaches that inactive yeast accelerated the clearance of fungus, and Simon teaches certain fractions of yeast have been described for their beneficial effects on the digestive tract. One of ordinary skill in the art would have been motivated to use the inactive yeast form taught by Pericolini, because Pericolini demonstrated that both active and inactive forms were shown to be effective in decreasing C. albicans.
Regarding claim 16, Premanathan teaches activating one gram of S. cerevisiae in lukewarm sterile water for 5 minutes (p.2, 2nd column – Treatment). Premanathan is silent as to whether the yeast are inactive.
Pericolini teaches inactivated yeast of S. cerevisiae as a primary grown inactivated dried whole yeast obtained by drum-drying of S. cerevisiae (p.86, 1st column – Study products).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the dry yeast taught by Premanathan with inactivated dried yeast taught by Pericolini. One of ordinary skill in the art would reasonably expect that replacing the dry yeast of Premanathan with inactive yeast of Pericolini would predictably result in an inactive yeast strain that could be administered to a subject, because Pericolini teaches administering inactivated yeast to a mouse, and it was known in the art at the time of invention that live yeast, dry yeast and inactive yeast could be administered to a subject.
Regarding claim 20, Premanathan teaches that the Saccharomyces cerevisiae was activated by soaking in lukewarm sterile water for 5 min, and the paste was applied to cover the infected area (p.2, 2nd column – Treatment). Premanathan is silent as to whether sterile water is a pharmaceutically acceptable excipient. However, as evidenced by the European Medicines Agency, water may be present as an excipient or used for reconstitution of products (p.3, Introduction – 1st paragraph). The European Medicines Agency further states that water is the most commonly used excipient in medicinal products, with the minimum quality of water selected depending on the intended use of the product (p.5, Section 5.1. Water present as an excipient in the final formulation). Thus, Premanathan teaches wherein the effective amount of the Saccharomyces cerevisiae is comprised in a pharmaceutical composition which further comprises at least one physiologically acceptable excipient.
Premanathan does not teach a Saccharomyces cerevisiae strain deposited with CNCM on October 17, 2007 under accession number I-3856.
However, Simon teaches a new strain Saccharomyces cerevisiae deposited under the number CNCM I-3856 (English translation p.2, mid-page). Simon further teaches that administration of ScProI reduces DSS-induced colonization of C. albicans (English translation p.9, last 2 paragraphs).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the Saccharomyces cerevisiae strain taught by Premanathan with the Saccharomyces cerevisiae CNCM I-3856 strain taught by Pericolini in the paste formulation with sterile water in the method of Premanathan, because it would have amounted to a simple substitution of one known Saccharomyces cerevisiae strain with another, and it was known in the art at the time of invention that Saccharomyces cerevisiae could be used to treat oropharyngeal candidiasis.
Regarding claim 22, Premanathan teaches patients were treated for oral thrush immediately after the diagnosis (p.2, 2nd column – 1st paragraph). Premanathan teaches that the paste formulation was applied to cover the infected area (relevant to wherein the pharmaceutical composition is for administration by the oral route) (p.2, 2nd column – Treatment).
Premanathan, Pericolini and Moyes do not teach the pharmaceutical composition further comprising at least one additional active pharmaceutical ingredient having an antibiotic or analgesic effect (claim 22, claim 24).
However, Simon teaches the yeast ScProI and/or derivative may also be administered with other active ingredients such as antibiotics, analgesics, and mixtures thereof (English translation p.4, 2nd paragraph from bottom).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Premanathan in view of Pericolini and Moyes to further include an additional active ingredient having an antibiotic or analgesic effect as taught by Simon to arrive at the claimed invention. One of ordinary skill in the art would have reasonably expected that combining an antibiotic or analgesic with the composition of Premanathan, Pericolini and Moyes would predictably result in a composition for preventing and/or treating oropharyngeal candidiasis, because it would have amounted to a combination of known elements in a predictable way to treat oropharyngeal candidiasis, and it was known in the art at the time of invention that one could combine Saccharomyces cerevisiae with additional active ingredients in a single pharmaceutical composition.
Regarding claim 33, Premanathan teaches that children treated with Augmentin for various ailments developed candidiasis after 3 to 5 days of Augmentin treatment (relevant to wherein the oropharyngeal candidiasis is a side effect of a medical treatment) (p.2, 2nd column – 1st paragraph). Premanathan further teaches that oral candidiasis is prevalent in 75% of the HIV/AIDS patients (relevant to the oropharyngeal candidiasis is present or likely to develop in a patient in an immunocompromised state) (p.4, 1st column 4th paragraph).
Regarding claim 34, Premanathan teaches the treatment of children patients, but is silent on the age of the patient population (p.2, 1st column – last paragraph). Premanathan further teaches that oral candidiasis is prevalent in 75% of the HIV/AIDS patients but is silent on the age of the patient population (p.4, 1st column 4th paragraph).
Moyes teaches that Candida species cause mucosal disease in the elderly and edentulous individuals, such as Candida-associated denture stomatitis (p.1, 2nd column).
Maintained rejection: Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Premanathan et al. (“Treatment of oral candidiasis (thrush) by Saccharomyces cerevisiae”, International Journal of Medicine and Medical Sciences, 2011, Vol. 3, Issue 3, pp.83-86; previously cited) in view of Pericolini et al. (“Therapeutic activity of a Saccharomyces cerevisiae-based probiotic and inactivated whole yeast on vaginal candidiasis”, Virulence, 2017, Vol. 8, No. 1, pp.74-90; previously cited), Moyes et al. (“Mucosal Immunity and Candida albicans Infection”, Journal of Immunology Research, 2011, Volume 2011, Article ID 346307, 9 pages; previously cited), and Simon et al. (WO 2009/103884 A2, published on August 27, 2009; previously cited) as applied to claims 14, 16, 20 and 22 above, and further in view of Nguyen et al. (“Advanced drug delivery systems for local treatment of the oral cavity”, Therapeutic Delivery, 2015, Vol. 6, No. 5, pp.595-608; previously cited). As the original Simon document is in French, an English translation is relied upon for support.
The teachings of Premanathan et al., Pericolini et al., Moyes et al. and Simon et al. are discussed above.
Regarding claim 32, Premanathan in view of Pericolini and Moyes teach the application of a pharmaceutical paste formulation comprising Saccharomyces cerevisiae yeast strain CNCM I-3856 administered in the oral cavity. Simon teaches the use of a composition of Saccharomyces yeast for the preparation of a medicinal product and/or a pharmaceutical active ingredient intended for humans and/or animals (English translation p.3, 1st paragraph).
Premanathan, Pericolini, Moyes and Simon do not teach wherein the pharmaceutical composition is in the form of a toothpaste, a mouthwash or an oral gel.
However, Nguyen teaches that several drug delivery systems have been developed for the local treatment and prevention of various diseases in the oral cavity (abstract). Nguyen teaches semisolid dosage forms (gels/creams/pastes) including oral gels, toothpastes, mouthwashes and further teaches Daktarin® oral gel for treating oropharyngeal candidiasis (Table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the paste formulation of Premanathan in view of Pericolini, Moyes and Simon into an oral gel formulation taught by Nguyen, because Nguyen teaches the use of an oral gel formulation for the treatment of oropharyngeal candidiasis. One of ordinary skill in the art would reasonably expect that formulating the pharmaceutical composition in the form of an oral gel would predictably result in a composition that could prevent and/or treat oropharyngeal candidiasis, because it would amount to substituting one known pharmaceutical form for another, and it was known in the art at the time of invention that oral gel formulations could be used to treat oropharyngeal candidiasis.
Response to Arguments
Applicant argues that the claims have been limited to consisting of administering Saccharomyces cerevisiae yeast strain I-3856 in the inactive form (See Remarks dated 11/25/25, p.5 last paragraph to p.6 top line). Applicant argues that the inactive form of Saccharomyces cerevisiae yeast strain I-3856 is capable of considerably reducing the fungal burden in the oral cavity of Candida albicans infected mice (See Remarks dated 11/25/25, p.6, top paragraph). Applicant argues that irrespective of the day on which measurements were carried out, similar benefits were induced by the inactive form of Saccharomyces cerevisiae I-3856, live form of the yeast strain and fluconazole (See Remarks dated 11/25/25, p.6 top paragraph).
Applicant argues that Premanathan discloses the use of an undefined Saccharomyces cerevisiae yeast induced by Augmentin use in children, which is activated by soaking in lukewarm sterile water for 5 minutes and then the Saccharomyces cerevisiae paste is used to cover the infected area of the oral cavity for 3 minutes thrice a day until recovery (See Remarks dated 11/25/25, p.6, 2nd paragraph). Applicant argues that Premanathan does not teach the Saccharomyces cerevisiae strain I-3856 for the treatment of oropharyngeal candidiasis, nor such a method of treatment wherein Saccharomyces cerevisiae is in an inactive form (See Remarks dated 11/25/25, p.6 paragraph 3).
Applicant argues that Pericolini reports a study to determine the potential therapeutic activity of the Saccharomyces cerevisiae strain I-3856 in live form or in inactivated form against vaginal candidiasis caused by C. albicans in a mouse model (See Remarks dated 11/25/25, p.6 paragraph 3).
Applicant argues that even if Moyes teaches that Candida species causes oral, gastrointestinal and vaginal candidiasis, one skilled in the art knew that the behavior of pathogenic fungi such as Candida albicans and of Saccharomyces cerevisiae yeast strains with respect to vaginal mucosa is not transposable to the oropharyngeal mucosa, the environments of these mucosae are being different (See Remarks dated 11/25/25, p.6 last paragraph).
Applicant argues that while vaginal candidiasis is equally common in immunocompetent and immunocompromised women, oropharyngeal candidiasis is infrequent except in immunocompromised states, and thus it would not have been obvious to one skilled in the art to modify Premanathan with the Saccharomyces cerevisiae CNCM I-3856 strain taught by Pericolini because Moyes teaches that Candida species cause oral, gastrointestinal and vaginal candidiasis (See Remarks dated 11/25/25, p.6 last paragraph to p.7 top paragraph). Applicant refers to findings of Pericolini and argues that in view of the results presented in Pericolini demonstrating superiority of the live form of the Saccharomyces cerevisiae yeast strain I-3856 over the inactive form, Pericolini teaches away from selecting the inactivated form over the live form to fight Candida infection (See Remarks dated 11/25/25, p.7). Applicant argues that Pericolini experimentally shows that administration of Saccharomyces cerevisiae CNCM I-3856 strain in live form (GI) and in inactivated form (IY) results in a significant reduction of fungal load, with effect of GI evidenced until 12 days post infection while effect of IY was observed only until day 4, and based on the results presented in Pericolini, it was not foreseeable that in the context of oropharyngeal candidiasis that irrespective of the day on which the measurements were carried out, similar benefits were induced by the inactive form of the Saccharomyces cerevisiae yeast strain number I-3856, the live form of the yeast strain and fluconazole (See Remarks dated 11/25/25, p.7 last paragraph to top of p.8).
Applicant argues Simon describes Saccharomyces cerevisiae yeast strain CNCM I-3856m which is used in the live form or the fractionated form (See Remarks dated 11/25/2025, p.8 middle paragraph). Applicant argues that Simon does not teach or even suggest using the inactivated form, and the European Medicines Agency merely teaches water is an excipient (See Remarks dated 11/25/2025, p.8 middle paragraph).
Applicant argues that regarding claim 32, Nguyen is unable to remedy the deficiencies of Premanathan in view of Pericolini, Moyes and Simon (See Remarks dated 11/25/25, p.8 paragraphs 2-3).
Applicant's arguments filed June 25, 2025 have been fully considered but they are not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The instant claims are directed to a method with the single active method step of administering to a subject a Saccharomyces cerevisiae yeast strain CNCM I-3856 in an inactive form. As discussed in the rejection above, Premanathan teaches a method of treating oropharyngeal candidiasis with an active method step of administering Saccharomyces cerevisiae to said subject (p.2, 2nd column – Treatment). Pericolini teaches that live and inactive S. cerevisiae decreased fungal burden of C. albicans and the results were comparable to fluconazole at specific timepoints (p.75, 2nd column top paragraph and Fig. 2 panel B). Simon teaches the Saccharomyces cerevisiae strain CNCM No. I-3856, and that the administration of the strain reduces DSS-induced colonization of C. albicans (English translation p.9, last two paragraphs). Moyes teaches that Candida species cause oral, gastrointestinal, and vaginal candidiasis (p.1, 1st column last paragraph). One of ordinary skill in the art would reasonably expect that based on the teachings of Pericolini that inactivated yeast are effective in decreasing fungal burden, and the teaching of Simon that the specific S. cerevisiae strain I-3856 reduced colonization of C. albicans, the selection of Saccharomyces cerevisiae strain I-3856 in inactive form would be effective in treating oropharyngeal candidiasis in a subject.
Regarding applicant’s argument that Pericolini teaches away from using inactivated form, Pericolini teaches that both active and inactive forms are able to decrease fungal burden, demonstrating that the inactive form is effective in treating Candida albicans infection.
Regarding applicant’s argument regarding the environment of the vaginal mucosa and oral mucosa, the primary reference, Premanathan, teaches applying Saccharomyces cerevisiae yeast to the oral mucosa to treat oropharyngeal candidiasis. One of ordinary skill in the art would recognize that Premanathan’s teachings apply to the treatment and use of S. cerevisiae as applicable to the oral mucosal environment.
Regarding applicant’s argument that even if Moyes teaches Candida species causes oral, vaginal and GI candidiasis, one of ordinary skill in the art would expect the behavior of Candida and S. cerevisiae to be different in the vaginal mucosa and oral mucosa: Premanathan teaches the treatment of oropharyngeal candidiasis in the oral cavity. One of ordinary skill in the art would recognize that Premanathan’s teachings account for the behavior of Candida and S. cerevisiae in the oral cavity mucosal environment.
Regarding applicant’s arguments that Simon does not teach using the inactivated form: Pericolini teaches the use and effectiveness of both live and inactivated forms of S. cerevisiae. Simon is relied upon to teach using the specific Saccharomyces cerevisiae strain I-3856, and that the administration of this strain reduced colonization of C. albicans.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the time frame of treatment; the degree of Candida albicans clearance relative to live form; immunocompromised status of the patient) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Maintained rejection: Claims 14, 16, 20, 22 and 33-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 9 and 13 of U.S. Patent No. 9,533,017 in view of Premanathan et al. (“Treatment of oral candidiasis (thrush) by Saccharomyces cerevisiae”, International Journal of Medicine and Medical Sciences, 2011, Vol. 3, Issue 3, pp.83-86; previously cited) in view of Pericolini et al. (“Therapeutic activity of a Saccharomyces cerevisiae-based probiotic and inactivated whole yeast on vaginal candidiasis”, Virulence, 2017, Vol. 8, No. 1, pp.74-90; previously cited) and Moyes et al. (“Mucosal Immunity and Candida albicans Infection”, Journal of Immunology Research, 2011, Volume 2011, Article ID 346307, 9 pages; previously cited).
The instant claims 14, 16, 20, 22 and 33-34 are directed towards a method for preventing and/or treating oropharyngeal candidiasis in a subject, said method comprising administering to said subject a Saccharomyces cerevisiae yeast strain deposited with the CNCM on October 17, 2007 under Accession Number I-3856, wherein said Saccharomyces cerevisiae yeast strain is in an inactive form. Claim 35 is directed towards a method for preventing or inhibiting the spread of Candida infection to the esophagus, the stomach or small intestine in a patient with oropharyngeal candidiasis, the method comprising a step of administering to said patient a Saccharomyces cerevisiae yeast strain deposited with the CNCM on October 17, 2007 under Accession Number I-3856, wherein said Saccharomyces cerevisiae yeast strain is in an inactive form or in a fractionated form.
Patented claim 1 is directed towards a method for the prevention and/or the treatment of vaginal mycoses, comprising administering an effective dose of the Saccharomyces cerevisiae strain deposited on Oct. 17, 2007 at the CNCM under registration number CNCM I-3856 to a subject in need thereof (relevant to instant claim 14 and 35 - the active step of administering to said subject a Saccharomyces cerevisiae yeast strain deposited with the CNCM on October 17, 2007 under Accession Number I-3856; “a subject in need thereof” is relevant to instant claim 33 – wherein the oropharyngeal candidiasis is a side effect of a medical treatment, or the oropharyngeal candidiasis is present or likely to develop in a patient in an immunocompromised state; instant claim 34 – wherein the oropharyngeal candidiasis is present in an infant or an elderly person; instant claim 35 – in a patient with oropharyngeal candidiasis).
Patented claim 1 does not recite a method for the treatment of oropharyngeal candidiasis in a subject, or wherein said Saccharomyces cerevisiae yeast strain is in an inactive form.
However, Premanathan teaches treatment of oral candidiasis (thrush) by Saccharomyces cerevisiae (title). Premanathan teaches applying a S. cerevisiae paste to cover the infected area for 3 min, thrice a day until recovery (relevant to a method for treating oropharyngeal candidiasis in a subject, said method comprising administering to said subject a Saccharomyces cerevisiae strain) (p.2, 2nd column – Treatment).
However, Pericolini teaches that vaginal administration of Saccharomyces cerevisiae live yeast (GI) and in part, inactivated whole yeast Saccharomyces cerevisiae (IY) were able to positively influence the course of vaginal candidiasis by accelerating the clearance of fungus (abstract). Pericolini teaches inactivated yeast of S. cerevisiae as a primary grown inactivated dried whole yeast obtained by drum-drying of S. cerevisiae (relevant to wherein said Saccharomyces cerevisiae yeast is in an inactive form) (p.86, 1st column – Study products).
Moyes teaches Candida species are the most common fungal pathogens of humans and the causative agents of oral, gastrointestinal, and vaginal candidiasis, giving rise to severe morbidity in millions of individuals worldwide (p.1, 1st column last paragraph). Moyes teaches that Candida species cause mucosal disease in a significant proportion of immunosuppressed patients and women of fertile age with the majority of these individuals experiencing superficial mucosal candidiasis such as thrush (relevant to treating oropharyngeal candidiasis in a subject) (p.2, 1st column last paragraph).
Each of Patent ‘017, Premanathan and Pericolini teach administering Saccharomyces cerevisiae yeast strain to treat a Candida infection. The active method step of administration in the instant claims is identical to the active method step of administration in patented claim 1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the prevention and/or treatment of vaginal mycoses taught by Patent ‘017 with the treatment of oropharyngeal candidiasis taught by Premanathan, because Moyes teaches that Candida infections can cause oral, gastrointestinal and vaginal candidiasis, and it would have amounted to a simple substitution of one infected mucosal surface for another.
Patented claim 2 recites administering an effective dose of yeast obtained by culturing the Saccharomyces cerevisiae strain deposited on October 17, 2007 at the CNCM under registration number CNCM I-3856 to a subject (reads on instant claim 14 similar to patented claim 1 above).
Patented claim 5 recites the method as claimed in claim 2, wherein the yeast is in the form of dead yeast (reads on instant claim 14, instant claim 35: wherein the yeast strain is in the inactive form).
Patented claim 9 recites a method for the prevention and/or the treatment of vaginal mycoses comprising administering an effective dose of a composition comprising a yeast obtained by culturing the Saccharomyces cerevisiae strain deposited on Oct. 17, 2007 at the CNCM under registration number CNCM 1-3856 and/or a derivative of said yeast to a subject in need thereof, wherein the composition optionally comprises at least one pharmaceutically acceptable excipient (reads on instant claim 20 – wherein the effective amount of the Saccharomyces cerevisiae yeast strain number I-3856 is comprised in a pharmaceutical composition which further comprises at least one physiologically acceptable excipient).
Patented claim 13 recites the method as claimed in claim 9, wherein said yeast and/or said derivative is in combination with another active principle (reads on instant claim 22 – wherein the pharmaceutical composition further comprises at least one additional active pharmaceutical ingredient having a soothing, anti-irritant, analgesic, anti-inflammatory, wound-healing, or antifungal activity).
Therefore the instant claims are obvious over the patented claims of ‘017 in view of Premanathan, Pericolini and Moyes.
Response to Arguments
Applicant argued that for the reasons discussed above, Premanathan, Pericolini, Moyes and Simon do not teach or suggest the features of the claimed invention, and requested that if the rejection is maintained, that the rejection be held in abeyance until there are allowed claims in the present patent application (See Remarks dated 11/25/2025, p.9 – Double Patenting).
Applicant's arguments filed November 25, 2025 have been fully considered but they are not persuasive. Applicant’s response to hold the rejection in abeyance is improper. The rejection cannot be held in abeyance as per MPEP §804 I. B.1.: As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated.
Conclusion
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 DEEPA MISHRA whose telephone number is (571) 272-6464. The examiner can normally be reached Monday - Friday 9:30am - 3:30pm EST.
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, Louise W. Humphrey can be reached on (571) 272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEEPA MISHRA/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657