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 .
Priority
The present application, filed September 29, 2023, is a national stage application of PCT/JP2022/009524, filed March 4, 2022, and claims priority to foreign priority application JP2021-057101, filed March 30, 2021.
Status of the Application
Applicant’s communication, received May 26, 2026, wherein claims 11 and 15 are amended, claims 12-14 and 19 are canceled, and new claim 20 is added, is acknowledged.
Claims 11, 15-18, and 20 are pending in this application and examined on the merits herein.
Withdrawn Rejections
Applicant’s amendment, received May 26, 2026, with respect to the rejection of claims 11-19 under 35 USC § 112(a) as lacking enablement for a method for prevention of a disease associated with cytokine overproduction in a subject, has been fully considered and found to be persuasive to remove the rejection because claims 12-14 and 19 are canceled and claim 11 is amended to recite a method for treatment of an autoimmune disease, which is enabled by the specification. Therefore the rejection is withdrawn.
Applicant’s amendment, received May 26, 2026, with respect to the rejection of claims 11-19 under 35 USC § 112(a) as lacking enablement for a method for treatment of all diseases associated with cytokine overproduction, has been fully considered and found to be persuasive to remove the rejection because claims 12-14 and 19 are canceled, and claims 11 and 20 now claim a method for treatment of an autoimmune disease and a method for treatment of collagen disease, joint, or muscular inflammation or pain, skin inflammation, systemic lupus erythematosus, Sjogren's syndrome, and/or psoriasis in a subject, all of which are enabled by the specification. Therefore the rejection is withdrawn.
Applicant’s amendment, received May 26, 2026, with respect to the rejection of claims 13 and 19 under 35 USC § 112(b) as indefinite, has been fully considered and found to be persuasive to remove the rejection because claims 13 and 19 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received May 26, 2026, with respect to the rejection of claim 14 under 35 USC § 112(d) for failing to further limit the subject matter of the claim upon which it depends, has been fully considered and found to be persuasive to remove the rejection because claim 14 is canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received May 26, 2026, with respect to the rejection of claims 11 and 14-16 under 35 USC § 102 as anticipated by Huang, has been fully considered and found to be persuasive to remove the rejection because claim 11 is amended to require treating an autoimmune disease, which Huang does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received May 26, 2026, with respect to the rejection of claims 11-16 under 35 USC § 102 as anticipated by Ueki 2007 as evidenced by Deng, has been fully considered and found to be persuasive to remove the rejection because claim 11 is amended to require treating an autoimmune disease, which Ueki 2007 does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received May 26, 2026, with respect to the rejection of claims 11 and 14-16 under 35 USC § 102 as anticipated by Ueki 2008, has been fully considered and found to be persuasive to remove the rejection because claim 11 is amended to require treating an autoimmune disease, which Ueki 2008 does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received May 26, 2026, with respect to the rejection of claims 11-15 and 17-19 under 35 USC § 102 as anticipated by Yamamoto, as evidenced by Møhlenberg and Méndez-Sánchez, has been fully considered and found to be persuasive to remove the rejection because claim 11 is amended to require treating an autoimmune disease, which Yamamoto does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received May 26, 2026, with respect to the rejection of claims 11 and 17-19 under 35 USC § 103 as unpatentable over Yamamoto in view of Izumori, has been fully considered and found to be persuasive to remove the rejection because claim 11 is amended to require treating an autoimmune disease, which the combination of Yamamoto and Izumori does not teach. Therefore the rejection is withdrawn.
The following is a new objection to the amended claims received May 26, 2026.
Claim Objections
Claim 20 is objected to because of the following informalities: Claim 20 recites: “A method for treatment of collagen disease, joint, or muscular inflammation or pain, skin inflammation, systemic lupus erythematosus, Sjogren's syndrome, and/or psoriasis in a subject, comprising…”. The Office is interpreting this phrase as directed to treating joint or muscular inflammation or pain.
Please amend this phrase to recite: “A method for treatment of collagen disease, joint[[,]] or muscular inflammation or pain, skin inflammation, systemic lupus erythematosus, Sjogren's syndrome, and/or psoriasis in a subject, comprising…”.
Appropriate correction is required.
The following are new grounds of rejection, necessitated by Applicant’s amendment received May 26, 2026. Applicant’s arguments are moot in view of the new grounds of rejection below.
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.
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 11 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (Publication no. WO 2006006757 A1; cited in PTO-892) in view of Doyle (Doyle, F.; et al. Journal of Process Control 2007, vol. 17, pp. 572-576; cited in PTO-892) and Kahaly (Kahaly, G.; J.; et al. Autoimmunity Reviews 2016, vol. 15, pp. 644-648; cited in PTO-892).
Lee teaches a composition comprising a hexose monophosphate for lowering blood glucose by the action of orally administered hexose monophosphate (cover page, abstract, lines 1-2).
Lee teaches diabetes mellitus (DM) is a complex chronic disorder of carbohydrate, fat and protein metabolism, which occurs due to relative or absolute deficiency of insulin secretion by pancreatic beta cells or deficient insulin receptors on cells (p. 1, lines 8-12). Lee teaches diabetes mellitus commonly occurs in two forms: insulin-dependent diabetes (type 1 diabetes) and insulin independent diabetes (type 2 diabetes). Lee teaches type 1 develops due to damage to the beta cells in the pancreas that reduces or completely stops the production of insulin, and that individuals with type 2 diabetes have insulin resistance and glucose availability different from normal people, although insulin secretion is sufficient in the pancreas (p. 2, line 14 to p. 3, line 1).
Lee teaches that approaches for controlling diabetes mellitus are limited to several methods and negatively affect the body because they control glucose metabolism in a fashion different from the control system of the body, and thus, there is a need for the development of drugs capable of replacing insulin or oral hypoglycemic agents (p. 5, line 23 to p. 6, lines 3).
Lee teaches a composition for lowering blood glucose level comprising a hexose monophosphate (p. 39, claim 1), and further claims the hexose monophosphate is selected from a group that includes D-allose-1-phosphate and D-allose-6-phosphate (p. 40, claim 7). D-allose-1-phosphate and D-allose-6-phosphate are each interpreted herein as D-allose derivatives, as recited in claim 11.
Finally, Lee claims the composition may be formulated into an oral preparation, an aerosol spray, an ointment or an injectable preparation (p. 42, claim 13) or formulated into a solid or liquid food (p. 42, claim 14).
Lee does not expressly teach treating as autoimmune disease by administering a D-allose derivative, as recited in claim 11.
Doyle teaches type 1 diabetes mellitus is a disease characterized by complete pancreatic β-cell insufficiency, and the only treatment is with subcutaneous or intravenous insulin injections (p. 572, right column, introduction section, lines 1-3) (emphasis added). Doyle teaches that one must individualize the treatment for type 1 diabetes to mimic normal physiology in order to prevent the complications of hyper- and hypoglycemia (elevated glucose levels, and low glucose levels, respectively) (p. 572, right column, introduction section, lines 7-11).
Kahaly teaches that Type 1 diabetes (T1D) is a chronic autoimmune disease characterized by the loss of insulin-producing pancreatic β-cells (p. 644, Abstract, lines 2-3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to administer a composition comprising D-allose-1-phosphate or D-allose-6-phosphate to a subject for the purposes of treating the autoimmune disease type 1 diabetes. One of ordinary skill in the art would have been motivated to administer a composition comprising D-allose-1-phosphate and D-allose-6-phosphate to a subject for the purposes of treating the autoimmune disease type 1 diabetes because Lee teaches a need for drugs capable of replacing insulin or oral hypoglycemic agents in treatment of type 1 and type 2 diabetes, and because Lee teaches compositions comprising D-allose-1-phosphate or D-allose-6-phosphate for lowering blood glucose levels. Accordingly, one of ordinary skill in the art would have considered administering a composition comprising D-allose-1-phosphate or D-allose-6-phosphate to a subject for lowering blood glucose levels, and would have recognized such an approach may be effective for controlling blood glucose levels in subjects affected with type 1 diabetes.
Regarding a method of treating type 1 diabetes, because Doyle teaches insulin as a treatment for type 1 diabetes and that one must individualize the treatment for type 1 diabetes to mimic normal physiology to prevent complications from, for example, hyperglycemia, the administration of a composition comprising D-allose-1-phosphate or D-allose-6-phosphate for the purposes of controlling blood glucose levels and reducing the likelihood of hyperglycemia is reasonably considered as a method of treating type 1 diabetes.
Therefore the invention taken as a whole is prima facie obvious.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Lee (Publication no. WO 2006006757 A1; cited in PTO-892) in view of Doyle (Doyle, F.; et al. Journal of Process Control 2007, vol. 17, pp. 572-576; cited in PTO-892) and Kahaly (Kahaly, G.; J.; et al. Autoimmunity Reviews 2016, vol. 15, pp. 644-648; cited in PTO-892).
as applied to claim 11 above, and further in view of Izumori (U.S. pre-grant publication no. 20050245459 A1; cited in IDS received December 8, 2023).
Lee, Doyle, and Kahaly teach as described in the above rejection under 35 U.S.C. § 103.
Lee, Doyle, and Kahaly do not teach their food product comprising D-allose as a health functional food, as recited in claim 18.
Izumori teaches their invention relates to a method of utilizing the physiological activity of rare saccharides, specifically D-allose and D-psicose, and to produce a functional food or drug utilizing the physiological activity of the rare saccharide (p. 1, [0012], lines 1-5) (emphasis added). Izumori further teaches the functional food of their invention is suitable for use in the fields of health foods for preventing particular diseases and of preventive medicines.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to formulate D-allose as a health functional food for use in the method of treating type 1 diabetes obvious over Lee in view of Doyle and Kahaly. One of ordinary skill in the art would have been motivated to formulate D-allose as a health functional food for use in the method of treating type 1 diabetes because Lee, Doyle and Kahaly render obvious the method of treating the autoimmune disease type 1 diabetes, as described in the above rejection, including teaching administration of D-allose in the form of a food, and because Izumori teaches functional foods for use as health foods that comprise D-allose. Therefore, one of ordinary skill in the art would have recognized that D-allose, administered as a food by Lee, may also be specifically formulated and administered as a health functional food when administered to subjects, as taught by Izumori.
Therefore the invention taken as a whole is prima facie obvious.
Claims 11, 15-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kagawa (Publication no. JP 2005263744 A; cited in PTO-892) in view of Mellado (Mellado, M.; et al. Frontiers in Immunology 2015, vol. 6, article 384; cited in PTO-892).
Kagawa was published in a language other than English. Both the original document and an English language machine translation are cited in the PTO-892 and attached to this office action. Citations below refer to the English language machine translation document. Kagawa teaches a T lymphocyte proliferation inhibitor that utilizes the effect of rare sugars, preferably D-psicose and D-allose, on suppressing T lymphocyte proliferation (English translation, p. 3, lines 2-4).
Kagawa teaches a study that examines the usefulness of rare sugars (D-allose, D-psicose) in the treatment of autoimmune disease models (arthritis model, systemic lupus erythematosus model) (English translation, document p. 33, lines 5-8). Kagawa teaches that both D-allose and D-psicose showed inhibitory effects on cell proliferation, that the inhibitory effect on T and CD4+ T cells was stronger than the inhibitory effect on PBMCs, and that the growth inhibitory effect of D-allose was concentration-dependent and superior to that of D-psicose (English translation, document p. 37, [0021], lines 1-5).
Moreover, Kagawa teaches and claims a method for inhibiting T lymphocyte proliferation, characterized by utilizing the effect of rare sugars on suppressing lymphocyte proliferation in order to prevent and/or treat the progression of symptoms of immune-related diseases caused by abnormalities in T lymphocytes (English translation, document pp. 51-52, claim 8), and further claims the rare sugar is D-psicose and/or D-allose (English translation, document p. 52, claim 9). Furthermore, Kagawa teaches and claims a method for inhibiting T lymphocyte proliferation according to claim 8, which utilizes the above-mentioned effects of rare sugars in the form of a composition containing D-psicose, D-allose and/or its derivatives and/or mixtures thereof (English translation, document p. 52, claim 10) (emphasis added), and wherein the composition is in a form selected from the group that includes sweeteners, seasonings, food additives, food ingredients, food and beverages, health foods and beverages, pharmaceuticals and animal feeds (English translation, document p. 53, claim 11).
Kagawa does not teach a method of treating an autoimmune disease, as recited in claim 11. In addition, Kagawa does not teach a method of treating, for example, joint inflammation or pain, as recited in claim 20.
Mellado teaches rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic inflammation in joints, associated with synovial hyperplasia and with bone and cartilage destruction. Mellado teaches that although the primacy of T cell-related events early in the disease continues to be debated, there is strong evidence that autoantigen recognition by specific T cells is crucial to the pathophysiology of rheumatoid synovitis, and that T cells are key components of the immune cell infiltrate detected in the joints of RA patients (p. 1, Abstract, lines 1-6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to administer a composition comprising D-allose to a subject for the purposes of treating the autoimmune disease rheumatoid arthritis. One of ordinary skill in the art would have been motivated to administer a composition comprising D-allose to a subject for the purposes of treating the autoimmune disease rheumatoid arthritis because Kagawa teaches D-allose as inhibiting the proliferation of T lymphocytes, suggesting its use for treating immune-related diseases and specifically suggesting its use in models of arthritis, and because Mellado teaches T cells are key components of the immune cell infiltrate detected in the joints of RA patients. Accordingly, one of ordinary skill in the art would have considered administering a composition containing D-allose for the purposes of treating rheumatoid arthritis, because administration of such a composition would have been expected to inhibit T lymphocyte proliferation and to treat the progression of symptoms of immune-related diseases caused by abnormalities in T lymphocytes, such as T cell infiltration in rheumatoid arthritis.
Regarding the form of the composition recited in claims 16-17, because Kagawa teaches the composition comprising D-allose may be in the form of for example, food additives, food ingredients, food and beverages, health foods and beverages, and pharmaceuticals, administration of D-allose in a form taught by Kagawa satisfies claims 16-17.
Regarding the method of treating joint inflammation as recited in claim 20, because Mellado teaches rheumatoid arthritis is a disease characterized by chronic inflammation in joints, the method of treating rheumatoid arthritis in a subject by administering a composition containing D-allose as the active ingredient also satisfies the method of treating joint inflammation, as recited in claim 20.
Therefore the invention taken as a whole is prima facie obvious.
Claim 15 depends from claim 11 and requires the D-allose derivative is a D-allose derivative listed in the claim. Claim 11 may be practiced with D-allose or a D-allose derivative, and thus claim 15 further limits an alternative treatment not required by the method of claim 11. Because Kagawa teaches D-allose as a treatment, and claim 15 further limits an alternative to D-allose, claim 15 is also obvious over Kagawa in view of Mellado.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kagawa (Publication no. JP2005263744A; cited in PTO-892) in view of Mellado (Mellado, M.; et al. Frontiers in Immunology 2015, vol. 6, article 384; cited in PTO-892) as applied to claim 11 above, and further in view of Izumori (U.S. pre-grant publication no. 20050245459 A1; cited in IDS received December 8, 2023).
Kagawa and Mellado teach as described in the above rejection under 35 U.S.C. § 103.
Kagawa and Mellado do not teach their food product comprising D-allose as a health functional food, as recited in claim 18.
Izumori teaches their invention relates to a method of utilizing the physiological activity of rare saccharides, specifically D-allose and D-psicose, and to produce a functional food or drug utilizing the physiological activity of the rare saccharide (p. 1, [0012], lines 1-5) (emphasis added). Izumori further teaches the functional food of their invention is suitable for use in the fields of health foods for preventing particular diseases and of preventive medicines.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to formulate D-allose as a health functional food for use in the method of treating rheumatoid arthritis obvious over Kagawa in view of Mellado. One of ordinary skill in the art would have been motivated to formulate D-allose as a health functional food for use in the method of treating rheumatoid arthritis because Kagawa and Mellado render obvious the method of treating the autoimmune disease rheumatoid arthritis, as described in the above rejection, including teaching administration of D-allose in the form of a food, and because Izumori teaches functional foods for use as health foods that comprise D-allose. Therefore, one of ordinary skill in the art would have recognized that D-allose, administered as a food by Kagawa, may also be specifically formulated and administered as a health functional food when administered to subjects, as taught by Izumori.
Therefore the invention taken as a whole is prima facie obvious.
Response to Applicant’s arguments: With respect to previous rejection that relied on Izumori, Applicant argues that Izumori does not cure the deficiencies of the primary reference (Yamamoto) as they relate to the instant claims. Because the above rejections are a new grounds of rejection, this argument is considered moot.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/B.M.B./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
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