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/EP2022/078440, filed 12 Oct 2022; and claims benefit of foreign priority document EP 21202228.9, filed 12 Oct 2021. This foreign priority document is in English.
Claims 44-61 are pending in the current application and are examined on the merits herein.
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 (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 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 44-51 are rejected under 35 U.S.C. 103 as being unpatentable over Sachetto et al. (US 4,357,467, issued 02 Nov 1982, provided by Applicant in IDS filed 24 July 2024) in view of Titcomb et al. (US 4,590,076, issued 20 May 1986, cited in PTO-892).
Sachetto et al. teaches a depolymerized cellulose powder having substantially an amorphous structure (abstract). Sachetto et al. teaches working examples of the cellulose having an average polymerization degree (DP) of 68 (example 1 at column 7, lines 5-35), or samples of cellulose such as sample 1 having a DP of 57 and a degree of crystallinity of 45% or sample 4 having a DP of 27 and a degree of crystallinity of 17% (example 2 at column 7, line 50 to column 9, line 15), addressing limitations of claims 44, and 49-51. This powder has increased compatibility, as compared with a native or regenerated cellulose, with other basic products such as starches, proteins and lipids; improved dispersivity in water which favors gel formation; and significant usefulness of the above two properties in respect to the foodstuff industry, namely in connection with the preparation of new formulations susceptible to contain as much as 25% of depolymerized cellulose, solving problems of texturization and improvement of organoleptic properties in the presence of proteins and sugars (column 11, line 60 to column 12, line 15), addressing limitations of claim 47. Sachetto et al. teaches the working example of a dietetic candy bar (column 12, line 25-55). Sachetto et al. teaches the depolymerized cellulose powder having substantially an amorphous structure as an improvement over microcrystalline cellulose, particularly in the field of food chemistry (column 1, lines 35-50).
Sachetto et al. does not specifically disclose a bakery product comprising the cellulose (claim 44), such as a bread (claim 45).
Titcomb et al. teaches reduced calorie bread compositions that incorporate an alpha-cellulose substituent and have a higher fiber content than comparable standard bread. The compositions include standard ingredients as well as various effective amounts of non-standard ingredients which enhance the taste and improve the texture so that the reduced calorie, high fiber bread compositions have comparable eating quality and textures as standard bread products (abstract). Titcomb et al. teaches the working examples of a standard white enriched bread comprising 20.0 weight units of powdered alpha-cellulose in a total of 249.3855 weight units of the final bread (example 1 at column 60 to column 6, line 20), or the bakery product of a bread comprising approximately 8% by weight of cellulose, addressing limitations of claims 44-45 and 47. Titcomb et al. teaches the invention encompasses modification of whole wheat bread similar to standard white enriched bread (column 2, line 65; column 4, lines 1-20), or a wholemeal bread addressing limitations of claim 46.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Sachetto et al. in view of Titcomb et al. in order to formulate the depolymerized cellulose powder having substantially an amorphous structure of Sachetto et al. into a bread as taught by Titcomb et al. One of ordinary skill in the art would have been motivated to combine Sachetto et al. in view of Titcomb et al. with a reasonable expectation of success because Sachetto et al. teaches the amorphous depolymerized cellulose powder having advantageous properties in the foodstuff industry and an improvement over microcrystalline cellulose in the field of food chemistry, and Titcomb et al. reduced calorie bread compositions having a higher fiber by incorporation of alpha-cellulose, suggesting it would have been obvious to formulate the depolymerized cellulose powder having substantially an amorphous structure of Sachetto et al. into a bread as taught by Titcomb et al. in order to improve the bread with the advantageous taught by Sachetto et al.
Regarding claim 48, Sachetto et al. in view of Titcomb et al. does not specifically teach the cellulose has a fermentation degree of 7.6% to 45.8%. The application at page 13 of the specification describes the fermentation degree as a result of the accessibility of the cellulose as a combination of the DP and crystallinity. 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 Sachetto et al. teaches working examples of the cellulose having the same degree of polymerization and degree of crystallinity as claimed, and there is reason to believe these products would have the same properties such as fermentation degree of the product as claimed. Further, MPEP 2112 provides “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) In this case, the properties of the depolymerized cellulose powder having substantially an amorphous structure of Sachetto et al. are inherent to the cellulose powder taught therein, and these same properties of the cellulose powder would be necessarily present in the bread made obvious by Sachetto et al. in view of Titcomb et al.
Claims 52-61 are rejected under 35 U.S.C. 103 as being unpatentable over Sachetto et al. (US 4,357,467, issued 02 Nov 1982, provided by Applicant in IDS filed 24 July 2024) in view of Titcomb et al. (US 4,590,076, issued 20 May 1986, cited in PTO-892) as applied to claims 44-51 above, and further in view of Pituch-Zdanowska et al. (Prz. Gastroenterol., 2015, 10(3), p135–141, cited in PTO-892).
Sachetto et al. in view of Titcomb et al. teaches as above applied to claims 44-51.
Sachetto et al. in view of Titcomb et al. does not specifically teach a method of treating an inflammation from a colon disorder in a subject comprising administering the cellulose to the subject (claim 52).
Pituch-Zdanowska et al. teaches review available data about the potential anti-inflammatory role of dietary fiber in the course of inflammatory bowel diseases (IBD), which are primarily Crohn’s disease and ulcerative colitis. A potentially protective effect of high-fiber diet on intestinal disorders was described as early as in 1973 (page 135, abstract). Pituch-Zdanowska et al. teaches the dietary fibers considered include non-starch polysaccharides and resistant oligosaccharides such as cellulose (page 136, left column). In animal models of inflammatory bowel diseases, fiber-supplemented diets resulted in decrease in some of the pro-inflammatory mediators, or alterations to the gut microbiota such as significant increases in caecal Lactobacillus and Bifidobacterium which are positively correlated with a reduction of chronic intestinal inflammation (page 138). Pituch-Zdanowska et al. teaches a study in humans in which the experimental diet increased dietary fiber intake by including whole-wheat bread, vegetables, and 25 g of wheat bran per day (page 138, bottom of right column).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Sachetto et al. in view of Titcomb et al. further in view of Pituch-Zdanowska et al. in order to treat inflammation from a colon disorder such as the IBD ulcerative colitis. One of ordinary skill in the art would have been motivated to combine Sachetto et al. in view of Titcomb et al. further in view of Pituch-Zdanowska et al. with a reasonable expectation of success because Pituch-Zdanowska et al. teaches the potential anti-inflammatory role of dietary fiber such as cellulose in the course of inflammatory bowel diseases, and teaches the example in which the experimental diet increased dietary fiber intake by including foods such as whole-wheat bread, and Sachetto et al. in view of Titcomb et al. teach an improved bread composition having a higher fiber content by incorporating cellulose, suggesting it would have been obvious to treat inflammation from a colon disorder such as the IBD ulcerative colitis by supplementing the diet with a higher fiber bread as taught by Sachetto et al. in view of Titcomb et al.
Conclusion
No claim is found to be allowable.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693