DETAILED ACTION
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 .
This application is the national stage entry of PCT/JP2022/018278, filed 20 April 2022; and claims benefit of foreign priority document JAPAN 2021-086394, filed 21 May 2021. This foreign priority document is not in English.
Claims 1-15 are pending in the current application. Claims 1-8, drawn to non-elected inventions, are withdrawn. Claims 9-15 are examined on the merits herein.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 9-15, in the reply filed on 10 March 2026 is acknowledged.
Claims 1-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 March 2026.
Claim Rejections - 35 USC § 102
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.
Claims 9-11 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shirai et al. (WO 2020/075424 A1, published 16 April 2020, English language equivalent US 2022/0211786, provided by Applicant in IDS filed 12 Dec 2023).
Shirai et al. discloses an immunostimulator containing glucan and having an immunostimulatory effect, derived from yeast cell wall and is water-insoluble (abstract). The content percentage of β-glucan in the immunostimulator is, for example, 30 mass % or more and 50 mass % or less (page 2, paragraph 17). Shirai et al. discloses methods for manufacturing immunostimulator 1 and 2 from yeast cell walls derived from beer yeast in which sodium hydroxide was added to a slurry containing the yeast cell walls to a final concentration of about 1.5 mass % or about 2.0 mass %, and the slurry was heated to 90 °C for the hydrolysis treatment. The treated yeast cell wall slurry was neutralized and subjected to centrifugation (page 4, paragraph 53 to page 5, paragraph 54), where the addition of sodium hydroxide to the slurry is interpreted as the step of washing yeast cell walls under alkaline conditions, and addressing limitations of claim 9-11 and 13-14. Shirai et al. discloses the working embodiments of #5 containing 41.2% β-glucan, #10 containing 41.1% β-glucan, and #12 containing 43.0% β-glucan (page 6, table 1), addressing limitations of claim 9. Assuming an aqueous solution density of approximately 1 g/mL, the NaOH concentration of 1.5 mass % or about 2.0 mass % will give a pH of approximately 13.5 or 13.7, addressing limitations of claim 10.
Therefore the disclosure of Shirai et al. taken as a whole, and specifically the working embodiments of #5, #10, and #12, meet limitations of claims 9-11 and 13-14.
Claims 9-11 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Minami et al. (WO 2020/003905 A1, published 09 Jan 2020, English language equivalent US 2021/0254118, provided by Applicant in IDS filed 12 Dec 2023).
Citations to Minami et al. are found in English language equivalent US 2021/0254118.
Minami et al. discloses an interleukin-6 production promoter that comprises a crude yeast cell wall hydrolysate, and an interleukin-10 production promoter that comprises a crude yeast cell wall hydrolysate (abstract). Minami et al. discloses the preparation of the comparative example of yeast glucan (YG) in which the yeast cell walls derived from a brewer's yeast were adjusted to pH 11 with sodium hydroxide, then heated to 90 ° C, and treated for 18 hours. The hydrolysates were adjusted to pH 5.5 with hydrochloric acid and then centrifuged to obtain heavy solutions. The heavy solutions were dried with a drum dryer to obtain yeast glucan (YG) (page 3, paragraphs 34-36), where the adjustment to pH 11 with sodium hydroxide is interpreted as the step of washing yeast cell walls under alkaline conditions, meeting limitations of claims 9-11 and 13. The YG has a β-glucan purity of approximately 33% (page 3, paragraph 39; figure 1), interpreted as a β-glucan content of approximately 33% by mass and meeting limitations of claim 9. The YG stimulates production of IL-6 and IL-10 compared to a negative control (page 3, paragraphs 40-44; figures 2-3), meeting limitations of claim 14.
Therefore the method of preparing the comparative example of yeast glucan (YG) disclosed in Minami et al. in interpreted to meet all limitations of claims 9-11 and 13-14.
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.
Claims 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Minami et al. (WO 2020/003905 A1, published 09 Jan 2020, English language equivalent US 2021/0254118, provided by Applicant in IDS filed 12 Dec 2023).
Minami et al. discloses as above regarding claims 9-11 and 13-14. Minami et al. further teaches the yeast cell walls to be hydrolyzed may be subjected to a washing treatment under alkaline conditions before the hydrolysis treatment, as needed (page 2, paragraph 23). Steps such as centrifugation may be used for the purpose of removing contaminated substances to secure quality as a food or drink (page 2, paragraph 24). Minami et al. further teaches the immunopotentiating effect of β-glucan, obtained by centrifugal purification after hydrolysis or an enzymatic treatment of yeast cell walls, has been reported (page 1, paragraph 5).
Minami et al. does not specifically disclose the production method wherein the wherein the washing under alkaline conditions comprises: adjusting the pH of a wash mixture containing yeast cell walls to a pH of 8 to 14, and separating the solid and liquid using a centrifuge with addition of water (claim 12).
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 teachings of Minami et al. in order to include a washing treatment under alkaline conditions before the hydrolysis treatment. One of ordinary skill in the art would have been motivated to modify the teachings of Minami et al. with a reasonable expectation of success because Minami et al. further teaches the yeast cell walls to be hydrolyzed may be subjected to a washing treatment under alkaline conditions before the hydrolysis treatment as needed, and teaches the step of centrifugation as a method of purifying the composition both in the prior art and in the preparation of the comparative example. Further, with regard to claim 9, if the step of adjustment to pH 11 with sodium hydroxide cannot reasonably be interpreted as the step of washing yeast cell walls under alkaline conditions, then the broader teaching of Minami et al. suggests a separate washing treatment under alkaline conditions before the hydrolysis treatment and teaches the step of centrifugation as a method of purifying the composition. While the invention of Minami et al. is described as a crude yeast cell wall hydrolysate in which the product has not been subjected to a step for increasing purity, MPEP 2123 at I. provides ““The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983)” In this case Minami et al. teaches the production of the comparative example of purified YG and teaches the background art recognizes the desirability of the making the purified β-glucan. Therefore the use of Minami et al. as a reference is not limited what Minami et al. describes as their own invention, and in this case the broader disclosure of the reference suggests the purified comparative example YG is also desired.
Claim Rejections - 35 USC § 102/103
Claim 15 is 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 Minami et al. (WO 2020/003905 A1, published 09 Jan 2020, English language equivalent US 2021/0254118, provided by Applicant in IDS filed 12 Dec 2023) in view of Engstad et al. (International Immunopharmacology, 2002, 2(11), p1585-1597, cited in PTO-892).
Minami et al. discloses and teaches as above regarding claims 9-14. Minami et al. further teaches the yeast which the yeast cell walls are derived is not particularly limited and are preferably yeasts belonging to the genus Saccharomyces including brewer's yeasts and baker's yeasts (page 2, paragraphs 18-19).
Minami et al. does not specifically disclose the production method wherein the glucan composition is an IL-8 production promoter (claim 15).
Engstad et al. discloses soluble β-1,3-glucan has been demonstrated to protect against infection and shock in rats and mice, and clinical studies suggest that administration of soluble glucans to trauma/surgical patients decreases septic complications and improves survival. An underivatized, soluble yeast β-1,3-glucan induced minor amounts of TNFα, IL-6, and IL-10, and induced the production of significant amounts of IL-8 and TF (page 1585, abstract; page 1588, figure 1). β-1,3-Glucan is the component responsible for the majority of biological activities of zymosan, a commonly used leukocyte stimulant derived from the cell wall of Baker’s yeast (Saccharomyces cerevisiae) (page 1585, right column).
Regarding claim 15, Minami et al. is silent as to the properties of the glucan composition YG to be an IL-8 production promoter. MPEP 2112.01 especially at I. citing In re Best, 562 F.2d 1252, 195 USPQ 430 (C.C.P.A. 1977) and In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly recited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to show the products of the applicant and the prior art are not the same or that the prior art products do not necessarily possess the characteristics of the claimed product. In this case Minami et al. discloses the YG produced by the same method as claimed and having functional properties to induce IL-6 and IL-10. Further, Engstad et al. provides evidence that soluble yeast β-1,3-glucan possesses functional properties to induce IL-6, IL-10, and IL-8. Therefore there is reason to believe the method disclosed in Minami et al. inherently produces the YG that necessarily possesses the same characteristics of the product made by the claimed method.
In the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Minami et al. in view of Engstad et al. in order to modify the method of Minami et al. in order to produce a glucan composition that is an IL-8 production promoter. One of ordinary skill in the art would have been motivated to combine Minami et al. in view of Engstad et al. with a reasonable expectation of success because Engstad et al. teaches β-1,3-glucan is the component responsible for the majority of biological activities of zymosan, a commonly used leukocyte stimulant derived from the cell wall of Baker’s yeast, and teaches soluble yeast β-1,3-glucan possesses functional properties to induce IL-6, IL-10, and IL-8, and the method of Minami et al. extracts β-glucan preferably from yeasts such as brewer's yeasts and baker's yeasts, suggesting it would have been obvious to modify the method of Minami et al. in order to produce a glucan composition that both induces IL-6 and IL-10 and is an IL-8 production promoter.
Conclusion
No claim is found to be allowable.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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