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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 13 Jan 2026 has been entered.
Claim Status
The amended claim set filed 13 Jan 2026 is acknowledged. Claims 23, 27-31, and 33-36 are currently pending. Of those, claims 23 and 31 are currently amended, and claim 36 is new. No claims are withdrawn. Claims 1-22, 24-26, and 32 are cancelled. Claims 23, 27-31, and 33-36 will be examined on the merits herein.
Response to Arguments
The Applicants’ arguments filed 13 Jan 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Final Office Action mailed 16 Oct 2025 will be referred to as “FOA.”
Objection(s) and Rejection(s) Withdrawn
The following rejections are withdrawn in view of the claim amendments to limit the subject population and the corresponding arguments:
The rejection of claims 23 and 27-30 under 35 U.S.C. 102(a)(2) as being anticipated by Chiozza et al. (FOA par. 6-20).
The rejection of claims 23 and 27-30 under 35 U.S.C. 102(a)(1) as being anticipated by Simon et al. (FOA par. 21-25).
The rejection of claims 31 and 33-35 under 35 U.S.C. 103 as being unpatentable over Simo n et al. in view of Biedermann et al. (FOA par. 26-32).
The double patenting rejections related to Application Nos. 17/413,716; 17/414,084; 17/425,588; and 18/550,349 and U.S. Patent Nos. US 7459159 B2; US 9533017 B2; and US 9750762 B2.
New Rejection(s)
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The 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.
Claims 23, 27-31, and 33-36 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Katz et al. (US-20070244069-A1; hereafter Katz; PTO-892) as evidenced by or in view of Roussel et al. (2018, Appl Microbiol Biotechnol 102, 6175–6189; hereafter Roussel; made of record in PTO-892 mailed 26 Sep 2024).
Regarding claim 23, Katz teaches “methods of using the outer cell walls of yeast, and degradative and digestive products of the outer cell walls of yeast—also known as mannan oligosaccharides, and synthetic mannan oligosaccharides, to treat, palliate, relieve prevent and/or eliminate urinary tract infections of humans” [0017 emphasis added], including uncomplicated cystitis caused by E. coli [0007] (i.e. preventing the disease of simple cystitis in those infected by uropathogenic E. coli bacteria). Katz teaches that women are more prone to urinary tract infections (UTIs) than men [0006] and teaches a specific example of treating a woman [0041]. Katz teaches a method step of administering D-Mannose with CranActin™ (500 mg Mannose, 200 mg cranberry extract, Solaray) [0042], and teaches that the D-mannose is created by purifying it from yeast cell walls [0038-0039] (i.e. administering a composition comprising an active ingredient, wherein the active ingredient consists of a yeast selected from the group of … purified yeast cell walls) and can be made from S. cerevisiae [0014]. The mannose oligosaccharide preparation was also used to prevent UTI symptoms when administered to a woman who was expected to experience UTIs [0044] (i.e. she was infected with uropathogenic E. coli bacteria during the study period). Katz teaches that in livestock, mannose is known to act by binding to the proliferation-promoting protein type 1 fimbriae on E. coli and also alter immune function [0015]. For the limitation “prevents… by reducing a presence and/or multiplication of uropathogenic Escherichia coli bacteria in said subject's urinary tract”, MPEP 2112.01 states: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
Regarding claim 31, the claim is anticipated for the same reasons as claim 21. Katz teaches a method step of administering D-Mannose with CranActin™ (500 mg Mannose, 200 mg cranberry extract, Solaray) [0042], and teaches that the D-mannose is created by purifying it from yeast cell walls [0038-0039] (i.e. administering a composition comprising an active ingredient, wherein the active ingredient consists of a yeast selected from the group of … purified yeast cell walls, and an extract selected from the group consisting of an extract of cranberry…).
Regarding claim 36, the claim is anticipated for the same reasons as claim 21. Katz teaches prevention of urinary tract infections by E. coli, and teaches administering the same composition as claimed (“comprising an active ingredient, wherein the active ingredient consists of a yeast selected from the group of … purified yeast cell walls”). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
Regarding claims 27 and 33, Katz teaches the purification process of mannose (“a yeast selected from the group of … purified yeast cell walls”) involves drying the product [0038].
Regarding claim 28, “This formulation may be ingested with food or drink by the patient.” [0031] (i.e. oral administration). Katz also teaches a specific example of the composition being administered orally with water [0042].
Regarding claims 29 and 34, the mannose can be formulated as a capsule, tablet, or powder [0031].
Regarding claims 30 and 35, “This formulation may be ingested with food or drink by the patient.” [0031].
Regarding all claims, the claim limitation of a purified cell wall obtained by culture of either S. cerevisiae strain CNCM I-3856 or S. cerevisiae var. boulardii strain CNCM I-3799 is interpreted as a product defined by its process of making. See MPEP 2113: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Roussel provides evidence that Saccharomyces cerevisiae CNCM I-3856 contains mannan in the cell wall that binds to type 1 fimbriae, and can effectively agglutinate E. coli (pg. 6185 col. 1 par. 1, Figure 1D, Figure 6). Mannose is a chemical with a defined chemical structure, so there is no evidence that the source of the mannose (i.e. what strain it was purified from) would have any effect on the claimed structure. So the MOS product of Katz appears to be the same as the claimed purified cell wall product, even if it were to be produced from a different S. cerevisiae strain. Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983).
Alternately, assuming for the sake of argument that the MOS purified from the cell wall of S. cerevisiae strain CNCM I-3856 were structurally different from other S. cerevisiae MOS, one of ordinary skill would consider it obvious to choose the specific strain of S. cerevisiae taught by Roussel instead of the generic yeast or S. cerevisiae strain taught in Katz because a specific strain must be chosen in order to reduce the method to practice, and because “S. cerevisiae CNCM I-3856 has already recognized probiotic properties. The strain displayed beneficial effects against enteric E. coli pathogens” (Roussel pg. 6176 col. 1 par. 2), and Roussel demonstrated that the S. cerevisiae CNCM I-3856 cell wall has the same anti-E. coli fimbriae-binding property (Roussel pg. 6185 col. 1 par. 1, Figure 1D, Figure 6) that Katz teaches as the invention’s known mechanism of action when treating livestock [0015]. Therefore, choosing this strain would have the benefit of choosing a well-characterized, human-safe strain whose cell wall is known to have the desired function, increasing the expectation of success.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645