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
Pursuant to the preliminary amendment dated 9/13/2023, claim 1-10 are cancelled and claims 11-25 are newly added.
Claims 11-25 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/FR2022/050459, filed on 3/15/2022. The instant application claims foreign priority to FR 2102618 filed on 3/16/2021. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 9/13/2023.
Information Disclosure Statement
The information disclosure statement (IDS) dated 9/13/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS has been placed in the application file and the information therein has been considered as to the merits.
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.
Claims 11-14 and 16-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) that does not integrate the judicial exception into a practical application, without significantly more. The rejected claims are directed to yeast extracts comprising beta glucans. The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Specifically, the claim recites an extract comprising beta-glucans, which as explained in the specification was isolated from naturally occurring yeast S. cerevisiae. The yeast derived beta-glucans, are a nature-based product, so it is compared to its closest naturally occurring counterpart (i.e. beta-glucan in its natural state) to determine if it has markedly different characteristics. Because there is no indication in the record that isolation of a composition comprising beta-glucan has resulted in a marked difference in structure, function, or other properties as compared to its counterpart, the instant claims recite a product of nature exception. Moreover, the fact pattern in the instant case is similar to the fact pattern in Myraid: In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different... The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977. The isolated genes of Myriad are comparable to the extracted compounds in the instant claims, in that they are obtained by the hand of man in a form that does not exactly exist in nature, but the human intervention in both scenarios does not rise to the level of resulting in the obtained product having markedly different characteristics, compared to the closest naturally occurring counterpart.
Claim Rejections - 35 USC § 112(b)
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.
Claims 13-15 are rejected 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.
With respect to claims 13 and 14, the term "in particular" is interpreted to be equivalent to “preferably”, which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Preferences, options and examples are properly set forth in the specification, but when included in the claims lead to confusion over the intended scope of the claim. See MPEP § 2173.05(d). For examination purposes, the broadest claim limitation(s) will be considered without taking into account preferences or examples.
With respect to claim 15, the phrase “weak acid solution” renders the claim indefinite for two reasons: 1) it is unclear if “weak” is intended to describe the chemical identity of the acid (i.e. weak acid such as acetic acid versus strong acid such as HCl) or if “weak” is describing the concentration of the acid in solution; 2) if “weak” is meant to describe the concentration, the phrase is further indefinite because “weak” is a relative term. The term "weak" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claims 11-13, 16, 17, 20, 21, 24 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Conway et al. (WO 1998/26787 A1, PTO-892).
Conway et al. discloses an animal feed or pharmaceutical composition comprising beta(1,6)glucans derived from extraction of S. cerevisiae cell walls, where the composition is used in a method for enhancing lactic acid producing bacteria in the GI tract and suppressing growth of an undesired bacteria, specifically E. coli, in the GI tract. (Abstract; p. 2, Ln. 4-12; p. 4, Ln. 3-35; Examples 2, 3; Claims 1, 2, 7) Conway further discloses that conditions associated with microbiome imbalance that are treated by administering yeast derived beta-glucans include diarrhea, IBS, IBD, Chron’s, constipation, colon cancer, sleep disorders, rheumatoid arthritis, chronic fatigue syndrome, hyperactivity, and ulcerative colitis. (pp. 14-15 bridge¶)
Accordingly, the instant claims are anticipated by the prior art.
Claims 11-13, 16, 17, 20, 21, 24 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Sullivan et al. (US 2012/0258930 A1, PTO-892).
O’Sullivan et al. discloses an animal feed composition comprising beta(1,6)glucans derived from extraction of S. cerevisiae cell walls, where the composition is used in a method for improvement of gastrointestinal health, immunity and performance by direct dietary intervention with the glucan composition, where the improvement or maintenance of gastrointestinal health or function is intended to prevent or prophylactically treat disorders associated with poor gastrointestinal health or function, such as Crohn's disease, irritable bowel syndrome, and other such chronic conditions. Other disorders associated with poor gastrointestinal health are less serious and can include food-borne pathogens and certain bacteria, specifically E. coli, and viruses that often result in diarrhea, poor stool quality, low birth weight or weight gain, or other symptoms of poor gastrointestinal health. (Abstract; ¶0008, 0026, 0036; Claims 30-35)
Accordingly, the instant claims are anticipated by the prior art.
Claims 11-13 and 15-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ostroff et al. (US 2004/0014715 A1, PTO-892).
Ostroff et al. discloses a pharmaceutical composition comprising PGG glucan derived from extraction of S. cerevisiae cell walls, where PGG glucan is poly-(1,6)-beta-D-glucopyranosyl (1,3)-beta-D-glucopyranose, further where the composition is used in a method for treating or preventing pathogenesis of infection in humans or animals by one or more infectious agents, specifically E. coli, where symptoms of the infection include gastrointestinal effects including nausea, vomiting, and gastrointestinal bleeding. (Abstract; ¶0008, 0012-0015, 0066; Example 2; Claim 2) Ostroff discloses that the pharmaceutical composition may be administered to animals via oral, enteral, topical, parenteral, intravenous, subcutaneous, intraperitoneal, intramuscular, or intranasal routes, which meets the limitation of being a veterinary composition.
Ostroff further discloses that PGG glycan is prepared as known in the art incorporated by reference, such as James et al. (US 5663324, 1997, PTO-892). James discloses isolation of PGG glycan by a process comprising: i) isolating an insoluble fraction by treating S. cerevisiae with alkali followed by centrifugation; ii) treating the fraction from i) with acetic acid and iii) isolating a solubilized PGG glycan by final hot, alkali treatment. (Example 2)
Accordingly, the instant claims are anticipated by the prior art.
Claim Rejections - 35 USC § 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 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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Conway et al. (WO 1998/26787 A1, PTO-892), or in the alternative over O’Sullivan et al. (US 2012/0258930 A1, PTO-892), in view of Simon et al. (WO 2009/103884A2, IDS).
The disclosure of Conway or O’Sullivan are referenced as discussed above. The cited prior art does not teach the S. cerevisiae strains as claimed.
Simon et al. discloses that S. cerevisiae strains deposited under the Collection Nationale de Culture de Microorganismes include CNCM I-3799 and CNCM I-3856. (p. 2, Claims 1-2)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the known S. cerevisiae strains CNCM I-3799 and/or CNCM I-3856 could be employed in the composition of Conway or O’Sullivan, thereby arriving at the instant invention. The use of these strains is reasonable based on the teaching of Simon. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Conway et al. (WO 1998/26787 A1, PTO-892), or in the alternative over O’Sullivan et al. (US 2012/0258930 A1, PTO-892), in view of Bröker (US 5,663,061; 1997, PTO-892).
The disclosure of Conway or O’Sullivan are referenced as discussed above. The cited prior art does not teach the claimed components of alpha-glucan and mannan, or the percentages thereof.
Bröker discloses that the carbohydrates in Baker’s yeast (a.k.a. S. cerevisiae) comprises mainly mannan and chitin, as well as beta-glucan (46-54%), alpha-glucan (28%). (Col. 1, Ln. 35-45)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that in view of the teaching of Bröker, the carbohydrate extracts of Conway or O’Sullivan would comprise mannan, beta-glucan and alpha-glucan, in percentages that overlap the instant claims. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1693