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 .
Claim Objections
Claim 3 is objected to because of the following informalities: It is believed that the compound, “L-lysin” should be written “L-lysine.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112(d):[AltContent: rect]
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 3, 4, and 11-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to set forth the subject matter which the applicant regards as the invention.
Claim 2 recites a ratio of clathrate component to a complex-forming compound in a range of about 5:1 to about 15:1. The claim is indefinite because it does not clearly define the type of ratio (molar, mass, volume, etc.) that is present in the formulation of the components.
Claim 3 recites that the “complex-forming compound is selected from the group consisting of amino acids, including L-arginine,” then proceeds to include in the list other compounds that are not amino acids (creatine, nicotinic acid, nicotinamide, resveratrol, caffeine, etc.). It is unclear whether the complex-forming compound consists of only amino acids (such as L-arginine or L-lysine), or an entirely different class of compounds, or a mixture of both amino acids with non-amino acid compounds.
Claim 4 recites that the complex-forming compound is “selected from the group consisting of any electrolyte, and specifically, from the group consisting of magnesium, sodium, potassium, chloride, calcium, phosphate, and bicarbonate.” It is unclear whether Claim 4 requires an electrolyte from only the listed compounds or from any electrolyte.
Claim 11 is indefinite because it recites a “causing the multicellular organism to ingest an aqueous solution” and “enhancing the intracellular permeation” without defining or explaining how the causing and enhancing steps are accomplished. Furthermore, it is unclear whether the “enhancing” step is a direct result of the “causing” step or a different step entirely. Claims 12-20 are rejected by virtue of their dependency on Claim 11.
Claim 15 recites that “the multicellular organism has lipid bilayer constituents, and further including forming non-covalent inclusion complexes.” It is unclear whether Claim 15 requires that the multicellular organism have non-covalent inclusion complexes between the clathrate component and the lipid bilayer constituents in addition to the lipid bilayer constituents, or if forming the non-covalent inclusion complexes is a step in the claimed method. Clarification of this limitation is requested.
Claims 5 and 8-10 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 recites that the beverage composition “causes cellular hydration in a multicellular organism when a multicellular organism ingests it.” The claim recites an intended use of the beverage composition and fails to further limit the scope of Claim 1, which formerly recites that the composition promotes cellular hydration.
Claims 8-10 recite that the beverage composition’s “promotion” and “cause” of increased lifespan are corroborated by lifespan studies on C. elegans nematodes. Claim 9 recites that the composition causes increased lifespan of the multicellular organism. The claims recite an intended use of the beverage composition and fail to further limit the scope of Claim 7, which formerly recites that the composition promotes increased lifespan of multicellular organisms.
Claim Rejections - 35 USC § 102
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Szente (US 20220323431).
Szente discloses a beverage composition comprising a carbohydrate clathrate component that includes cyclodextrin (e.g. alpha, beta, gamma-cyclodextrin; see claim 14; see instant claim 6) , in a concentration of 0.01-5wt%; a complex-forming compound (e.g. amino acids, L-arginine, citrulline, electrolytes, etc.; see claims 3 and 4; see instant claim 3 and 4) and an aqueous liquid (e.g. still or carbonated water) wherein an inclusion complex is formed with at least some of the clathrate component and at least some of the complex-forming compound, wherein the composition promotes cellular hydration (or increased lifespan) when a multicellular organism ingests it (see claims 1 and 15; see instant claims 1 and 7). The clathrate component and the complex-forming compound are to be in a ratio of about 5:1 to 15:1 (see claim 2; see instant claim 2).
Regarding the outcomes recited by instant claims 1, 5 and 7-10, these claims provide outcomes of an intended use for the claimed composition (e.g. ‘when ingested’, ‘corroborated by lifespan studies’) (see MPEP 2111.02) which are not limiting to the composition as they provide how the composition is used/outcomes of using the composition rather than a structural limitation to the composition itself. However, it is noted that the instantly claimed outcomes are contemplated by claims 1 and 15 of the reference.
Szente discloses a method of promoting increased cellular hydration in multicellular organisms that are capable of intracellular water permeation, the method comprising causing an intracellular organism to ingest an aqueous solution that contains an amount of a carbohydrate clathrate component; and enhancing the intracellular permeation (see [0238-0239]; see instant claim 11). The multicellular organism is to contain aquaporins and the causing step involves interaction of the composition with the aquaporins (see [0241]; see instant claim 12). The hydration is corroborated by a test that uses human-aquaporin-expressed frog oocytes (e.g. single cell Xenopus laevis capable of expressing AGP1 water channels) (see [0242-0243]; see instant claims 13 and 14).
Szente discloses that the multicellular organism of the method is to have lipid bilayer constituents, further including forming non-covalent inclusion complexes between the clathrate component and the lipid bilayer constituents (see [0244]; see instant claim 15).
Szente discloses that the multicellular organism comprises phospholipids such as glycosphingolipids, sphingomyelin, phosphatidylcholine and phosphatidyl ethanolamine as well as linear phospholipids (see [0245-0246]; see instant claims 16 and 17).
Szente discloses that the multicellular organism comprises membrane lipids and proteins, where the causing results in a temporary disintegration of the membrane lipids and proteins (see [0247]; see instant claim 18).
Szente discloses that the multicellular organism comprises lipid packing, where the causing results in loosening of lipid packing (see [0248]; see instant claim 19).
Szente discloses that the multicellular organism comprises membrane proteins, wherein the causing results in untightening of membrane proteins in an area that includes the membrane proteins (see [0249]; see instant claim 20).
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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7, 10, 12, 14, 15 and 17of copending U.S. Patent Application No. 17/576722 (20220323431 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in all the applications are drawn to a beverage composition that promotes cellular hydration when ingested by a multicellular organism comprising: a carbohydrate clathrate component that includes cyclodextrin in a concentration of 0.01- 5% w/w; a complex-forming compound, in a concentration that is less than the clathrate component; an aqueous liquid component, chosen from the group consisting of still and carbonated aqueous liquids; wherein an inclusion complex is formed with at least some of the clathrate component and at least some of the complex-forming compound; and wherein the composition promotes cellular hydration of the multicellular organism when the multicellular organism ingests it.
It is noted that the claims of the instant application do not include any discussion about a system that promotes cellular hydration when ingested by a multicellular organism in addition to a beverage composition; however, the scope of the claims in the cited application is overlapping, and the differences are considered to be obvious. Thus, the claims of the reference patent are not patentably distinct over the instantly claimed subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-12 and 15-17 of copending U.S. Patent Application No. 17/884516 (US 20220378774 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in all the applications are drawn to a method of promoting increased cellular hydration in a multicellular organism that is capable of intracellular water permeation, comprising: causing the multicellular organism to ingest an aqueous solution that contains an amount of a carbohydrate clathrate component; and enhancing the intracellular permeation. Both sets of claims recite the interaction of the composition with aquaporins and the corroboration of the cellular hydration by tests with human-aquaporin-expressed frog oocytes and single cell Xenopus laevis AGP1 water channels. Both sets of claims recite the lipid bilayer constituents of the multicellular organism, as well as the linear phospholipids chosen from the group consisting of glycosphingolipids, sphingomyelin, phosphatidylcholine, and phosphatidyl ethanolamine. Both sets of claims recite the temporary disintegration of the membrane lipids and proteins, the loosening of lipid packing, and the untightening of membrane proteins.
It is noted that the claims of the instant application do not include any discussion about the change in protein structure and function, the enhanced membrane permeation of nutrients and water into the cellular layers, the binding of the clathrate component to cholesterols, and the use of video microscopy in the swelling assay as a part of the method. However, the scope of the claims in the cited application is overlapping, and the differences are considered to be obvious. Thus, the claims of the reference patent are not patentably distinct over the instantly claimed subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10610524.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the pending and patented claims are directed to a beverage composition that promotes cellular hydration when ingested by a multicellular organism comprising: a carbohydrate clathrate component that includes cyclodextrin in a concentration of 0.01- 5% w/w; a complex-forming compound (e.g. amino acids); and an aqueous liquid component, chosen from the group consisting of still and carbonated aqueous liquids; wherein an inclusion complex is formed with at least some of the clathrate component and at least some of the complex-forming compound; and wherein the composition promotes cellular hydration of the multicellular organism when the multicellular organism ingests it. The major difference between the present invention and that of the patent is the patent limits the concentration of the complex-forming compound to between 5-8% and wherein the inclusion complex is formed with at least 25% of the clathrate component. However, these differences are considered obvious as the present claims are broader in scope than those of the patent, would necessarily be obviated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached 0700-1800.
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/KYLE A PURDY/ Primary Examiner, Art Unit 1611
