DETAILED ACTION
The present application is a domestic application filed 29 April 2024, which is a continuation of US Application No. 16/756,978 (now US Patent No. 11,998,559), filed 17 April 2020, which is a national stage entry of PCT/JP2018/037018, filed 03 October 2018, which claims foreign priority to JP2017-201880, filed 18 October 2017.
Claims 1-14 are pending in the current application and are examined on the merits herein.
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 .
Claim Interpretation
The recitation “for ameliorating judgement”…”to a person in need of amelioration of judgement” in claim 1, is not expressly defined in the present application.
According to para [0115] of the published application, “Specifically, the agent for maintaining or ameliorating judgment according to the present invention is applied to a person in need of suppression of decrease in judgment or those in need of amelioration of judgment for the purpose of suppressing decrease in judgment or ameliorating judgment. Those in need of suppression of decrease in judgment include young people, healthy middle-aged and elderly people, elderly people, people who have a tendency to decrease judgment, people who have decreased judgment, and people suffering from dementia. In addition, as one embodiment of the agent for maintaining or ameliorating judgment according to the present invention, there is indicated a method involving identifying a person in need of suppression of decrease in judgment or in need of amelioration of judgment, and administering the agent for maintaining judgment according to the present invention to the person.
Thus, the patient population of claim 1, is broadly and reasonably interpreted to include young people, healthy middle-aged and elderly people, elderly people, people who have a tendency to decrease judgment, people who have decreased judgment, and people suffering from dementia.
The recitation “for ameliorating a cognitive function”…”to a person in need of amelioration of cognitive function” in claim 8, is not expressly defined in the present application.
According to para [0116] of the published application, “Specifically, the agent for maintaining or ameliorating a cognitive function according to the present invention is applied to a person in need of suppression of decrease in cognitive function or those in need of amelioration of a cognitive function for the purpose of suppressing decrease in cognitive function or ameliorating a cognitive function. Those in need of suppression of decrease in cognitive function or in need of amelioration of a cognitive function include people suffering from dementia as well as young people, healthy middle-aged and elderly people, elderly people, and people who have a tendency to decrease a cognitive function. In addition, as one embodiment of the agent for maintaining or ameliorating a cognitive function according to the present invention, there is indicated a method involving identifying a person in need of suppression of decrease in cognitive function or in need of amelioration of a cognitive function, and administering the agent for maintaining a cognitive function according to the present invention to the person.”
Thus, the patient population of claim 8, is broadly and reasonably interpreted to include young people, healthy middle-aged and elderly people, elderly people, people who have a tendency to decrease judgment, people who have decreased judgment, and people suffering from dementia.
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, 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.
Claim 1-3, 5, 8-10, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Evidence-Based Complementary and Alternative Medicine, 2013, cited in IDS submitted 29 April 2024).
Lee et al. teach administration of glucosylceramide ameliorated the memory impairment in aged mice (title). Lee et al. teach the glucosylceramide formula contains 61.3% glucosylceramide (p.2, right col., first para). Lee et al. teach the glucosylceramide was comprised primarily of ceramide with 4,8-sphinganine (dl8:2) and alpha-hydroxypalmitic acid. Lee et al. teach the double bond at C-4 is trans (p.8).
Lee et al. teach using mice to determine the effect of glucosylceramide on memory function (p.4, left col., last para). Lee et al. teach orally administering glucosylceramide as a food to aged mice (p.2, 2.1). Lee et al. teach using mice as a model of aging (p.6-7). Lee et al. teach glucosylceramide is more bioavailable and more soluble than ceramide; and is hydrolyzed in vivo to generate ceramide (p.8, penultimate para). Lee et al. teach “glucosylceramide plays an important role in anti-inflammatory and memory enhancement, and it could be a potential new therapeutic agent for the treatment of dementia” (p.8, last para). Lee et al. also teach glucosylceramide could be a potential new therapeutic agent for the treatment of Alzheimer’s disease (AD; abstract).
Lee et al. teach ceramide is necessary in sphingolipid metabolism, and is a critical second messenger (p.2, second para). Lee et al. teach glucosylceramide is a major sphingolipid in plants such as soybean, corn, rice and wheat. Lee et al. teach glucosylceramide has been shown to improve the skin barrier function through dietary and topical administration. In addition, Lee et a. teach oral administration of glucosylceramide strongly suppressed mRNA expression of the proinflammatory cytokines IL-1β and IL-6 in mice. Lee et al. teach ceramides regulate neuronal survival and differentiation.
Lee et al. do not expressly disclose administering the glucosylceramide to a person (present claims 1 and 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer glucosylceramide to a person because Lee et al. found it was effective at enhancing memory in aged mice. The skilled artisan would have recognized the mice served as an in vivo animal model to test the therapeutic effect of the glucosylceramide. In view of the therapeutic efficacy demonstrated, one having ordinary skill in the art would have been motivated to administer the glucosylceramide of Lee et al. to a person to maintain or ameliorate memory. The use of “aged mice” suggests administering the glucosylceramide to elderly people including those with dementia.
Based on the definition for a person in need provided in the Specification, the person in need is broadly and reasonably interpreted to include elderly people and those with dementia. Thus, administering glucosylceramide to elderly people or those with dementia will necessarily ameliorate judgement and cognitive function.
The recitation “ceramide is derived from tuber of Amorphophallus konjac and wherein the ceramide comprises a sphingoid moiety of 4,8-sphingadienine or a glucosyl ceramide thereof” in claims 1 and 8 is a product-by-process limitation. The chemical structure “wherein the ceramide comprises a glucosyl ceramide of 4,8-sphingadienine” in claims 1 and 8 are taught by Lee et al. Patentability is based on the chemical compound itself, and not on where (or what plant) it was obtained from. 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."”.
The recitation “wherein a dosage of the ceramide is 0.6 to 10 mg per day” in claims 5, 12 and 14 is not clearly an active step, or defined as the amount administered.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claims 1-3, 5, 8-10, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. as applied to claims 1-3, 5, 8-10, 12 and 13 above, and further in view of Uchiyama et al. (J. Health Sci, 2008, vol. 54, no. 5, pp. 559-566, cited in IDS submitted 29 April 2024).
Lee et al. teach as discussed above. Lee et al. teach ceramide is necessary in sphingolipid metabolism, and is a critical second messenger (p.2, second para). Lee et al. teach glucosylceramide is a major sphingolipid in plants such as soybean, corn, rice and wheat. Lee et al. teach glucosylceramide has been shown to improve the skin barrier function through dietary and topical administration. In addition, Lee et a. teach oral administration of glucosylceramide strongly suppressed mRNA expression of the proinflammatory cytokines IL-1β and IL-6 in mice. Lee et al. teach ceramides regulate neuronal survival and differentiation.
Lee et al. do not expressly disclose wherein the ceramide is derived from tuber of Amorphophallus konjac (present claims 1 and 8).
Uchiyama et al. teach preparing a beverage containing 0.3% glucosylceramide, prepared from Amorphophallus konjac (A. konjac), (p.559-560, bridging paragraphs; and p.561, Test Beverage). Uchiyama et al. teach orally administering the test beverage to humans for a period of 12 weeks (p.561, Human Study Design). Uchiyama et al. found “test beverage…may alleviate sleeplessness caused by itching, which should help people to lead more active daily lives and improve their quality of life”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to orally administer glucosylceramide derived from A. konjac to elderly and those with dementia because Lee et al. recognize ceramides and glucosylceramides can be obtained from many different plants, and have a variety of activity including ameliorating memory impairment. The ordinary artisan would have had a reasonable expectation of success because the prior art as a whole do not differentiate function based on the source of ceramide/glucosylceramide. In addition, the prior art as a whole do not differentiate function based on any structural differences that may exist amongst glucosylceramides.
The recitation “ceramide is derived from tuber of Amorphophallus konjac and wherein the ceramide comprises a sphingoid moiety of 4,8-sphingadienine or a glucosyl ceramide thereof” in claims 1 and 8 is a product-by-process limitation. The chemical structure “wherein the ceramide comprises a glucosyl ceramide of 4,8-sphingadienine” in claims 1 and 8 are taught by Lee et al. Patentability is based on the chemical compound itself, and not on where (or what plant) it was obtained from. 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."”.
Thus the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claims 4, 5, 7, 11, 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. and Uchiyama et al. as applied to claims 1-3, 5, 8-10, 12 and 13 above, and further in view of Arkadir et al. (US 2019/0254992, cited in IDS submitted 29 April 2024), as evidenced by Capucho et al. (Dement Neuropsychol, 2011, vol. 5, no. 4, pp. 297-302, cited in IDS submitted 29 April 2024).
Lee et al. teach as discussed above.
Lee et al. do not expressly disclose a composition containing a ceramide content of 1-20% by mass, or a dosage of 0.6 to 10 mg per day (present claims 4, 5, 7, 11, 12, 14). While Lee et al. teach treating dementia and improving memory and suggests it may be useful for the treatment of AD, Lee et al. do not expressly disclose ameliorating judgement and cognitive function (present claims 1 and 8).
Uchiyama et al. teach as discussed above.
Arkadir et al. teach a therapeutic combination of beta-glycolipids and 4-[(2-amino-3,5-dibromophenyl)methylamino]cyclohexan-1-ol for the treatment of disorders associated with protein misfolding (abstract). Arkadir et al. expressly disclose beta-glycolipids include glucosylceramide (claim 2). Arkadir et al. teach a method of treating AD, dementia, cognitive decline, and early signs or symptoms associated therewith (claims 15, 28, 34). Arkadir et al. teach administering a combination of glucosylcerebroside (GC) and ambroxol at a dose of 1 mg/kg to mice in a Parkinson’s disease model to evaluate its neuroprotective effect (example 2). Arkadir et al. teach administering glucosyl ceramide at a dose of 1-10 mg/kg (para [0298]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer glucosylceramide to a person to ameliorate judgement and cognitive function.
One having ordinary skill in the art would have been motivated to administer glucosylceramide of 4,8-sphingadienine to a person to ameliorate judgement and cognitive function because Lee et al. found it was effective at enhancing memory in aged mice, teach glucosylceramide could be a potential new therapeutic agent for the treatment of AD, and Arkadir et al. teach administering compositions comprising glucosylceramides to treat AD, dementia, cognitive impairment, and early signs or symptoms associated therewith.
The ordinary artisan would have been motivated to administer the ceramide in the form of a food or beverage because Lee et al. teach administering ceramides in the form of a food; and Uchiyama et al. teach administering them in the form of a beverage.
With respect to dosage, one having ordinary skill in the art would have been motivated to administer the glucosylceramide of Lee et al. at a dose of about 1-10 mg/kg, wherein Arkadir et al. exemplify administering compositions comprising glucosylceramides at a dose of 1 mg/kg to treat AD, dementia, cognitive impairment, and early signs or symptoms associated therewith.
With respect to concentration by mass, the skilled artisan would have been motivated to vary the concentration of the glucosylceramide by weight while ensuring the necessary amount is delivered to ameliorate cognitive impairment and dementia. See MPEP 2144.05, “Generally, 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.”.
Treating judgement is not defined in the present Specification. It is only described in the context of ameliorating memory, AD and cognition (see para [0117 of the present published application). Treating AD, dementia, cognitive impairment and memory impairment is expected to result in ameliorating judgement since it is dependent on memory and cognition (as evidenced by Capucho et al., p.297, first full para).
With respect to the geometry of the double bonds, Lee et al. teach the C4 double bond of 4,8-sphinganine (dl8:2) is trans. The other double bond being cis or trans (per claims 26-28) are the only two geometric isomers that can exist. It is expected cis-8 or trans-8 will have similar properties. See MPEP 2144.09, “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
Thus the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,998,559. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference Patent are drawn towards administering the same composition, in the same amount and dosage to ameliorate cognitive function in Alzheimer’s disease.
The claims of the reference Patent anticipate claims 1-14 of the present application.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
