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 .
Claims 1-12 are pending and under examination.
Information Disclosure Statement
The information disclosure statements filed 7/24/23, 9/18/23, 3/24/25, 10/8/25 and 11/27/25 have been considered and initialed copies are enclosed.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it repeat information given in the title and it comprises implied phrases such as “the present invention” and “the inventors solved the problem”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 6 and 10 are objected to because of the following informalities:
A health food, a food with a health claim, a food specialized for health uses, a food for patients, a functional food, a functional nutritional food, a nutritional supplement food and wherein the food composition is a supplement is essentially the same thing thus, rendering the list redundant. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a composition for increasing muscle mass and suppressing a decrease in muscle mass, comprising as an effective component at least one selected from the group consisting of spirulina, phycocyanin, a spirulina enzymatically degraded product, and a phycocyanin enzymatically degraded product.
The claims are drawn to a composition for increasing muscle mass and suppressing muscle atrophy, comprising as an effective component at least one selected from the group consisting of spirulina, phycocyanin, a spirulina enzymatically degraded product, and a phycocyanin enzymatically degraded product of phycocyanin.
Claims 8 and 12 also require that the composition is used for curing, preventing or improving sarcopenia or locomotive syndrome.
The specification states that spirulina enzymatically degraded product is an enzymatically degraded product obtained by enzyme action to decompose the protein, saccharide etc. of spirulina.
Thus, “spirulina enzymatically degraded product” encompass degradation products of spirulina protein or spirulina saccharide and obtained using a wide variety of enzyme.
The specification states that phycocyanin is an enzymatically degraded product obtained by enzyme action to decompose the phycocyanin. This encompasses products obtained by a wide variety of enzymes.
In the examples, a spirulina enzymatically degraded product was obtained by enzymatic degradation of spirulina with enzyme SD-NY10. After the reaction, the solution was centrifuged, supernatant collected and freeze-dried to obtain the spirulina enzymatically degraded product.
The supernatant obtained by enzymatic degradation of spirulina with enzyme SD-NY10 is not representative of the genus of “spirulina enzymatically degraded product” which broadly encompasses degradation products of spirulina protein or spirulina saccharide with any enzyme. In the instance, where the enzyme is a protease, different proteases will yield different degradation products. No particular spirulina protein or particular spirulina saccharide was enzymatically degraded. Moreover, the contents of the supernatant obtained by enzymatic degradation of spirulina with enzyme SD-NY10 was not taught in the specification.
In the examples, a phycocyanin enzymatically degraded product was obtained enzymatic degradation of phycocyanin with enzyme SD-NY10. After the reaction, the solution was centrifuged, supernatant collected and freeze-dried to obtain the phycocyanin enzymatically degraded product.
The supernatant obtained by enzymatic degradation of phycocyanin with enzyme SD-NY10 is not representative of the genus of “phycocyanin enzymatically degraded product” which broadly encompasses degradation products of phycocyanin with any enzyme. In the instance, where the enzyme is a protease, different proteases will yield different degradation products. Furthermore, the contents of the supernatant obtained by enzymatic degradation of phycocyanin with enzyme SD-NY10 was not disclosed in the specification.
The supernatant obtained by enzymatic degradation of spirulina or phycocyanin with enzyme SD-NY10 increased muscle mass and alleviated the suppression of expression of Myh13, Myh2, My12, and Myh6 associated with the production of myosin, which is a muscle structural protein, and Tnni1 and Tnnc1 associated with the production of troponin, which is a muscle structural protein. Also, alleviation was recognized in the suppression of expression of Itm2a as a muscle satellite cell marker associated with myogenesis and Neu2 associated with myoblast differentiation. Therefore, it was recognized that spirulina and phycocyanin have the function of increasing muscle mass and the function of suppressing a decrease in muscle mass.
It was recognized that in the gastrocnemius muscle, the administration of supernatant obtained by enzymatic degradation of spirulina or phycocyanin with enzyme SD-NY10 alleviates, in comparison with the A2 group (medium group), the enhancement of expression of Ddit4, Junb, and Egr1 associated with muscle atrophy and muscle regeneration and Sdc4, Kcnk5, Rasd2 associated with muscle regeneration. Therefore, it was recognized that supernatant obtained by enzymatic degradation of spirulina or phycocyanin with enzyme SD-NY10 have the function of suppressing muscle atrophy. Also, it was supposed from these results that the supernatant obtained by enzymatic degradation of spirulina or phycocyanin with enzyme SD-NY10 similarly exhibit the function of suppressing muscle atrophy.
Enzymes including proteases have different substrates and specific points of cleavage thus yielding different degradation product based on the type of substrate e.g. polysaccharide or protein and also the specific point of hydrolysis in the polysaccharide or protein. See for instance, Verdasco-Marin et al (Catalysis Today, vol. 346, 15 April 2020, pages 121-131) the different type of enzymes and their different activities and yield on the substrate spirulina. See table 1. Each enzyme produced different products. See abstract.
For these reasons, Applicants as of the effective filing date were not in possession of the genus of “spirulina enzymatically degraded product” and of the genus of phycocyanin enzymatically degraded product that have the function of increasing muscle mass, suppressing a decrease in muscle mass, suppressing muscle atrophy and curing, preventing or improving sarcopenia or locomotive syndrome.
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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dsouza et al. IN 201741006191A published 8-24-19 cited in IDS.
Claims 1 and 3: Dsouza et al disclose a composition for increasing muscle mass and suppressing a decrease in muscle mass and a composition for increasing muscle mass and suppressing muscle atrophy,, comprising as an effective component phycocyanin peptide or phycocyanin hydrolysate i.e. phycocyanin enzymatically degraded product. See paragraph 7-9, 12, 15, 16 and 22-31.
The recitation of the intended use of the composition for in increasing muscle mass, for suppressing a decrease in muscle mass, for suppressing muscle atrophy, for curing, preventing or improving sarcopenia or locomotive syndrome must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the composition disclosed by Dsouza et al is the same as the composition disclosed in the instant claims and thus the composition of the Dsouza et al is capable of performing the recited intended uses.
Claims 2 and 4: Dsouza et al disclose the composition according to Claim 3, wherein the enzyme for the phycocyanin enzymatically degraded product are obtained by enzyme action of protease such as pepsin. See paragraph 89-95, 130.
Claims 5 and 9: Dsouza et al disclose the composition is a food composition such as milk. See paragraph 49-88.
Claims 6 and 10: The composition of Dsouza et al is a health food, a functional food, a nutritional supplement food, a supplement, a food with a
health claim, a food for specialized health uses, a functional nutritional food, a food with function claim, or a food for patients.
Claims 7 and 11. The composition of Dsouza et al is a pharmaceutical composition.
Claims 8 and 12: Claim 8 recites the intended uses of the pharmaceutical composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The pharmaceutical composition is capable of performing the intended uses for curing, preventing, or improving sarcopenia or locomotive syndrome.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. US 2006/0099223 May 11, 2006.
Claims 1 and 3: Chen et al disclose a composition for increasing muscle mass and suppressing a decrease in muscle mass and a composition for increasing muscle mass and suppressing muscle atrophy, comprising as an effective component spirulina hydrolysate i.e. spirulina enzymatically degraded product. See claim 1.
The recitation of the intended use of the composition for in increasing muscle mass, for suppressing a decrease in muscle mass, for suppressing muscle atrophy, for curing, preventing or improving sarcopenia or locomotive syndrome must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the composition disclosed by Chen et al is the same as the composition disclosed in the instant claims and thus the composition of the Chen et al is capable of performing the recited intended uses.
Claims 2 and 4: Chen et al disclose the spirulina enzymatically degraded product are obtained by enzyme action of protease such as pepsin, trypsin, papain and other proteases. See claim 2.
Claims 5 and 9: Chen et al disclose the composition is a food composition.
See abstract, paragraph 7, 11, 13, 21, 32 and 33.
Claims 6 and 10: The composition of Chen et al is a health food, a functional food, a nutritional supplement food, a supplement, a food with a
health claim, a food for specialized health uses, a functional nutritional food, a food with function claim, or a food for patients.
Claims 7 and 11: The composition of Chen et al et al is a pharmaceutical composition.
Claims 8 and 12: Claim 8 recites the intended uses of the pharmaceutical composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The pharmaceutical composition is capable of performing the intended uses for curing, preventing, or improving sarcopenia or locomotive syndrome.
Claim(s) 1, 3 and 5-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rabie et al. CA2631266 5/31/2017.
Claims 1 and 3: Rabie et al disclose a composition for increasing muscle mass and suppressing a decrease in muscle mass and a composition for increasing muscle mass and suppressing muscle atrophy, comprising as an effective component spirulina and phycocyanin. See paragraph 58 and table 1.
The recitation of the intended use of the composition for in increasing muscle mass, for suppressing a decrease in muscle mass, for suppressing muscle atrophy, for curing, preventing or improving sarcopenia or locomotive syndrome must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the composition disclosed by Rabie et al is the same as the composition disclosed in the instant claims and thus the composition of the Rabie et al is capable of performing the recited intended uses.
Claims 5 and 9: Rabie et al disclose the composition is a food composition.
See paragraph 72.
Claims 6 and 10: The composition of Rabie et al is a health food, a functional food, a nutritional supplement food, a supplement, a food with a
health claim, a food for specialized health uses, a functional nutritional food, a food with function claim, or a food for patients.
Claims 7 and 11: The composition of Rabie et al et al is a pharmaceutical composition.
Claims 8 and 12: Claim 8 recites the intended uses of the pharmaceutical composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The pharmaceutical composition is capable of performing the intended uses for curing, preventing, or improving sarcopenia or locomotive syndrome.
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 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/273,779 (‘779). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘779 claims disclose:
The ‘779 claims disclose a composition comprising as an effective component at least one selected from the group consisting of spirulina, phycocyanin, a spirulina enzymatically degraded product, and a phycocyanin enzymatically degraded product.
The recitation of the intended use of the composition for in increasing muscle mass, for suppressing a decrease in muscle mass, for suppressing muscle atrophy, for curing, preventing or improving sarcopenia or locomotive syndrome must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the composition disclosed by the ‘779 claims is the same as the composition disclosed in the instant claims and thus the composition of the ‘779 claims is capable of performing the recited intended uses.
The ‘779 claims disclose the enzyme for the spirulina enzymatically degraded product and the phycocyanin enzymatically degraded product are obtained by enzyme action of protease.
The ‘779 claims disclose the composition is a food composition.
The ‘779 claims disclose composition is a health food, a functional food, a nutritional supplement food, a supplement, a food with a health claim, a food for specialized health uses, a functional nutritional food, a food with function claim, or a food for patients.
The ‘779 claims disclose the composition is a pharmaceutical composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
AAA
Claims 1, 3 AND 5-1212 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/008,698 (‘698). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘698 claims disclose:
A composition comprising as an effective component at least one selected from the group consisting of spirulina extract (spirulina extract).
The recitation of the intended use of the composition for in increasing muscle mass, for suppressing a decrease in muscle mass, for suppressing muscle atrophy, for curing, preventing or improving sarcopenia or locomotive syndrome must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the composition disclosed by the ‘698 claims is the same as the composition disclosed in the instant claims and thus the composition of the ‘698 claims is capable of performing the recited intended uses.
The ‘698 claims disclose the composition is a food composition.
The ‘698 claims disclose composition is a health food, a functional food, a nutritional supplement food, a supplement, a food with a health claim, a food for specialized health uses, a functional nutritional food, a food with function claim, or a food for patients wherein the food is used for CTL activation
The ‘779 claims disclose the composition is a pharmaceutical composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Duplicate Claims
Applicant is advised that should claims 1-2 and 5-8 be found allowable, claims 3-4 and 9-12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The contents of the composition of claim 1 and dependent claims and the contents of the composition of claim 3 and dependent claims are the same. The difference between these claims is found in the intended use of the composition found in claim 1 which recites “a composition for increasing muscle mass and suppressing a decrease in muscle mass” and found in claim 3 “a composition for increasing muscle mass and suppressing a muscle atrophy”. These recited intended uses do not lend a structural difference to the underlying composition. Therefore, claim 1 and claim 3 are duplicates of each other despite the slight difference in the wording of the intended use recitation in the preamble of the claims.
Status of Claims
Claims 1-12 are rejected.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645