DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Action Is Final, Necessitated by Amendment
Applicants' response to the Non-Final Office Action mailed on 07 April 2025, has been entered and the Remarks therein, filed on 07 October 2025, are fully considered here.
This action is a Final Office Action, based on new grounds under 35 U.S.C. §112(a), 35 U.S.C. §102(b), and 35 U.S.C. §103(a)over Skiba et al. in view of Gruber et al., necessitated, in part, by Applicants’ amendment received on 07 October 2025, specifically, amended claims 1, 10, 15 and 19 and canceled claims 2, 8, 9, 11, 13, 16, 18 and 20. See MPEP 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Status of Claims
Claims 1, 3-7, 10, 12, 14-15, 17, 19, 21 and 22 are pending.
Claims 4 and 22 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species. Election was made without traverse in the reply filed on 24 February 2025 to the Restriction/Election Office Action mailed on 23 December 2024.
Claims 1, 3, 5-7, 10, 12, 14-15, 17, 19 and 21 are rejected.
Claims 3, 10, 15 and 21 are objected to.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. §119(e) or under 35 U.S.C. §120, §121, or §365(c) is acknowledged. Applicant has complied with all of the conditions for receiving the benefit of an earlier filing date under 35 U.S.C. §120 or §365(c).
As explained in the Non-Final Office Action mailed on 07 April 2025, claim 7 and those limitations in claims 1, 15 and 19 related to aquaporin(s) have the effective filing date of 06 April 2020 and claims 1, 3, 5-6, 10, 12, 14-15, 17, 19 and 21 have the effective filing date of 31 December 2010.
Application Data Sheet
It was noted in the Non-Final Office Action mailed on 07 April 2025 that the Application Data Sheet (ADS) that had been received 14 January 2022 contained an error. In the "Domestic Benefit/National Stage Information" section (pg. 3) the “Continuity Type” given for the instant application read: “Continuation in part of”. However, this application is a ‘continuation’, not a ‘continuation in part’ of prior application 16/841,631.
It is noted that Applicant filed a corrected ADS on 07 October 2025 which corrects this error.
Drawings
Applicant has not resolved the minor informalities to the drawings cited in the Non-Final Office action mailed on 07 April 2023. Thus, the objection to the drawings is maintained.
(1) The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
FIG. 22A, FIG. 22B, FIG. 22C
It is noted that there are figures cited in the description referred to as Fig. 22a, Fig. 22b and Fig. 22c (i.e., with lower case letters), but none with capital letters (originally-filed specification, pg. 4, lines 21-22 thru pg. 5, lines 1-3).
For the purpose of drawing and specification consistency, the drawings and their citations in the specification should be identical.
(For example, compare to Figures 25A and 25B and their citations in the specification.)
(2) It is noted that Figures 4, 5 and 7-10 are in color (see ‘Supplemental Contents’ folder, Doc Code ‘DRW.SUPP’).
Color photographs and color drawings are not accepted unless a petition filed under 37 CFR 1.84(a)(2) is granted (MPEP 608.01(f)). Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), three sets of color drawings or color photographs, as appropriate, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37CFR 1.84(b)(2) and MPEP 608.02 (VIII). Note that the requirement for three sets of color drawings under 37 CFR 1.84(a)(2)(ii) is not applicable to color drawings submitted via EFS-Web. Therefore, only one set of such color drawings is necessary when filing via EFS-Web.
After review by appropriate personnel the petition will be granted or dismissed accordingly.
Alternatively, black and white drawings may be submitted (as Replacement drawings) in lieu of the color drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) (and/or appropriate amendment to the specification) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
The objections to Claims 3, 11, 13, 16, 18 and 21, in the Non-Final Office Action mailed 07 April 2025, are withdrawn in view of Applicants' amendment received 07 October 2025, in which the cited claims were amended.
Claims 3, 10, 15 and 21 are objected to because of the following informalities:
(1) Claims 3 and 21 recite the term "coenzymeQ10", which should read: "coenzyme Q10"; i.e., there should be a space between 'coenzyme' and 'Q10'.
(2) Claim 15 recites: "A beverage composition that promotes increased lifespan when ingested by a multicellular organism, and further wherein the multicellular organism is a Caenorhabditis elegans nematode, comprising:...", which should read: "A beverage composition that promotes increased lifespan when ingested by a multicellular organism, wherein the multicellular organism is a Caenorhabditis elegans nematode, comprising:..."
(3) Claim 10 recites: "The beverage composition of claim 1, wherein the composition also promotes increased lifespan of the multicellular organism, and further wherein the multicellular organism is a Caenorhabditis elegans nematode", which should read: "The beverage composition of claim 1, wherein the composition also promotes increased lifespan of the multicellular organism, wherein the multicellular organism is a Caenorhabditis elegans nematode."
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
35 U.S.C. § 112(a)
The rejection of Claims 10-13 and 15-18 under 35 U.S.C. §112(a) or 35 U.S.C. §112 (pre-AIA ), first paragraph, as failing to comply with the scope of enablement requirement, in the Non-Final Office Action mailed 07 April 2025, is withdrawn in view of Applicants' amendment received 07 October 2025, in which the cited claims were amended or canceled.
35 U.S.C. § 112(b)
Some of the rejections of Claims 1-3 and 5-21 under 35 U.S.C. §112(b) or 35 U.S.C. §112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention, in the Non-Final Office Action mailed 07 April 2025, are withdrawn in view of Applicants’ amendment received 07 October 2025, in which the cited claims were amended or canceled.
Other rejections have not been resolved by the claim amendments and are thus re-cited here.
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 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 5-7, 10, 12, 14-15, 17, 19 and 21 are rejected under 35 U.S.C. §112(b) or 35 U.S.C. §112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
[Claims 3, 5-7, 10, 12 and 14 are dependent on claim 1, contain the limitations of claim 1, and, therefore, are rejected for the same reason; claim 17 is dependent on claim 15, contains the limitations of claim 15, and, therefore is rejected for the same reason; claim 21 is dependent on claim 19, contains the limitations of claim 19, and, therefore, is rejected for the same reason.]
[These rejections cited in the Non-Final Office Action mailed 07 April 2025.]
Claims 1-3 and 5-21 are indefinite because the metes and bounds of the claimed subject matter are not clear.
(1) Claims 1, 15 and 19 recite relative terms.
Claims 1, 15 and 19 recite the term 'at least some’ of.
The terms ‘some’/'at least some' are relative terms which render the claims indefinite. The terms ‘some' and ' at least some' are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no definition, explanation or description given for the terms ‘some’ and ‘at least some’ (MPEP 2173.05 (b)(I)). This term will be defined by its plain meaning at the discretion of the Examiner, as it applies to the claim language (see MPEP 2111.01).
(2) Claims 1, 3, 15, 19 and 21 contain broad vs narrow limitations in the same claim.
Claims 1, 15 and 19 recite: “…: a carbohydrate clathrate component that includes cyclodextrin,…”
Claims 3 and 21 recite: “…selected from the group consisting of amino acids, including L-arginine, citrulline, creatine, taurine,…L-lysin,…”
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP 2173.05(c). The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the present instance, claims 1, 15 and 19 recite the broad recitation ‘carbohydrate clathrate component’, and the claims also recite ‘cyclodextrin’ which is the narrower statement of the range/limitation. Claims 3 and 21 recite the broad recitation ‘amino acids’, and the claims also recite ‘L-arginine,…, L-lysine’ which are narrower statements of the range/limitation.
Claim Interpretations
(1) Claims 1, 15 and 19 recite intended uses in their preamble language.
Claim 1 recites: “A beverage composition that promotes cellular hydration when ingested by a multicellular organism,…”
Claim 15 recites: “A beverage composition that promotes increased lifespan when ingested by a multicellular organism,…”
Claim 19 recites: “A composition that promotes cellular hydration when ingested by a multicellular organism,…”
The term (i.e., ‘beverage’) and the phrases in bold above are intended uses which merely state the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations. Also, the intended use terminology does not limit the structure or method steps of the claimed invention. Therefore, the phrases as intended uses do not limit the scope of the claimed subject matter. (See MPEP 2111.02 (I)(II).) That is, the intended use recited in the preambles do not result in a structural or manipulative difference between the claimed invention and the prior art. Deletion of the preamble phrase does not affect the structure or steps of the claimed invention (MPEP 2111.02 (II)).
MPEP 707.07 (f)/7.37.09 states: "..., 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...."
On the other hand, intended use language that is described by any prior art reference may be indicated at the discretion of the Examiner.
(2) Claims 1, 15 and 19 recite functional limitations, as ‘wherein’ clause-type language.
A claim term is functional when it recites a feature “by what it does rather than by what it is”…(MPEP 2173.05(g)).
Claims 1 and 19 recite: “…; and wherein the composition promotes cellular hydration of the multicellular organism when the multicellular organism ingests it, and further wherein the composition promotes cellular hydration in single cell Xenopus laevis human-aquaporin-expressed frog oocytes having expressed human aquaporin AQP-1 water channels.”
Claim 15 recites: “…; and wherein the composition promotes increased lifespan of the multicellular organism when the multicellular organism ingests it, and further wherein the composition promotes cellular hydration in single cell Xenopus laevis human-aquaporin-expressed frog oocytes having expressed human aquaporin AQP-1 water channels.”
The functional limitations appear to be inherent characteristics of the claimed (beverage) composition.
It is well known that claim scope is not limited by claim language that suggests or makes optional, but does not limit a claim to a particular structure. In addition, when a structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent (MPEP 2112.01 (I)). That is, the ‘wherein’ clause-type language simply expresses the intended result of a process step (i.e., ingests) positively cited (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) (MPEP 2111.04 (I)).
(3) Claims 1, 15 and 19 recite the phrase ‘promotes cellular hydration’.
Claims 10 and 15 recite the phrase ‘promotes increased lifespan’.
Claim 5 recites the phrase ‘causes cellular hydration’.
Claims 12 and 17 recite the phrase ‘causes increased lifespan’.
However, it is not clear how the activity of promoting cellular hydration or increased lifespan is different from the activity of causing cellular hydration or increased lifespan. The specification does not describe how the terms mean different activities with regard to the specific subject matter of cellular hydration and increasing lifespan.
For the purpose of compact prosecution, prior art which describes the promotion of cellular hydration and/or increased lifespan will also be considered to show that cellular hydration and/or increased lifespan has been caused (i.e., by the specific experimental activities cited in the prior art reference). Alternatively, prior art which describes causing cellular hydration and/or increased lifespan will also be considered to promote cellular hydration and/or increased lifespan.
Claim Rejections - 35 U.S.C. § 102
The rejection of Claims 1-3, 5, 10, 12, 14-15, 17 and 19-21 under pre-AIA 35 U.S.C. §102(b) as being anticipated by Skiba et al., in the Non-Final Office Action mailed on 07 April 2025, is withdrawn in view of Applicants' amendment received on 07 October 2025, in which claims 1, 15 and 19 were amended.
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 the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 3, 5, 12, 14, 19 and 21 are rejected under pre-AIA 35 U.S.C. §102(b) as being anticipated by Skiba et al. (International Patent Application Publication No. WO 2008/107569 A2 (see NPL as EngMT (English machine translation) for pg./para. numbers).
[This rejection (apart from amended claim numbering) cited in the Non-Final Office Action mailed on 07 April 2025.]
Skiba et al. addresses the limitations of claims 1, 3, 5, 12, 14, 19 and 21.
Regarding claims 1 and 19, pertaining to a (beverage) composition that promotes cellular hydration or increased lifespan when ingested by a multicellular organism, comprising: a carbohydrate clathrate component that includes cyclodextrin, a complex-forming compound; wherein an inclusion complex is formed with at least some of the clathrate component and at least some of the complex-forming compound; the (beverage) composition promotes cellular hydration or increased lifespan of the multicellular organism when the multicellular organism ingests it, and further wherein the composition promotes cellular hydration in single cell Xenopus laevis human-aquaporin-expressed frog oocytes having expressed human aquaporin AQP-1 water channels,
[See Claim Interpretations section- (1) and (2) above.]
Skiba et al. shows an inclusion complex or a mixture of inclusion complexes based on one or more amino acids, their derivatives or salts and at least one cyclodextrin or derivative(s) thereof (pg. 3, para. [005] [complex-forming compound = amino acid; carbohydrate clathrate compound = cyclodextrin]). The described invention also relates to compositions comprising or consisting of an inclusion complex or a mixture of complexes as defined. These compositions may be pharmaceutical, functional food, veterinary, nutraceutical, food or cosmetic compositions (pg. 4, para. [0026] [i.e., an ingestible composition]).
Further regarding claims 1 and 19, pertaining to a carbohydrate clathrate component that includes cyclodextrin, in a concentration of 0.01- 5% w/w,
Skiba et al. shows one formulation in which 2.5g of alpha-cyclodextrin in 20ml water is combined with cysteine in solution to form an inclusion complex in a solution which is vacuum dried prior to its use in a composition (pg. 5, para. [0045]). In the described compositions, the complex or the mixture of complexes is present at a concentration of between 0.001 and 25% by weight of the composition (pg. 4, para. [0027]). [Therefore, a composition comprising 0.1% of the complex will contain 0.0025gr of alpha-cyclodextrin or 0.25% [0.001 x 2.5 = 0.0025].]
Further regarding claims 1 and 19, pertaining to a complex-forming compound in a concentration that is less than the clathrate component, wherein the ratio of clathrate component to complex-forming compound is in a range from 5:1 to 15:1,
Skiba et al. shows that the molecular ratio of the amino acid(s), its derivatives or its salts, relative to the cyclodextrin or its derivatives is between 1:0.5 and 1:15 (pg. 4, para. [0025]).
Further regarding claims 1 and 19, pertaining to an aqueous liquid component, chosen from a group which includes still aqueous liquids,
Skiba et al. shows, in one embodiment, a solution of cysteine or in the form of salt or its derivatives is added to a solution of alpha-cyclodextrin in water (pg. 5, para. [0045]).
Regarding claims 3 and 21, pertaining to amino acids [species election],
Skiba et al. shows that the described invention proposes a new presentation of amino acids in the form of a complex by inclusion in cyclodextrin (pg. 3, para. [004]).
Regarding claims 5 and 12, see Claim Interpretations section- (1) and (2) above.
Regarding claim 14, the cyclodextrins used in the context of the described invention are cyclodextrins chosen from alpha-, beta- and gamma cyclodextrin and/or their derivatives in substituted or unsubstituted forms or a hydrated form of the latter or a mixture of these (pg. 4, para. [0024]).
Claim Rejections - 35 U.S.C. § 103
The rejection of Claims 1-3, 5-10, 12, 14-15, 17 and 19-21 under pre-AIA 35 U.S.C. §103(a) as being unpatentable over Skiba et al. in view of Brown as evidenced by and in view of Ozu et al., in the Non-Final Office Action mailed on 07 April 2025, is withdrawn in view of Applicants' amendment received on 07 October 2025.
The rejection of Claims 11, 13, 16 and 18 under pre-AIA 35 U.S.C. §103(a) as being unpatentable over Skiba et al. in view of Brown, and Ozu et al., as applied to claims 1-3, 5-10, 12, 14-15, 17 and 19-21 above, and further in view of Gruber et al., in the Non-Final Office Action mailed on 07 April 2025, is withdrawn in view of Applicants' amendment received on 07 October 2025.
The following is a quotation of pre-AIA 35 U.S.C. §103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 3, 5, 10, 12, 14- 15, 17, 19 and 21 are rejected under 35 U.S.C. §103(a) as being unpatentable over Skiba et al. (International Patent Application Publication No. WO 2008/107569 A2 (see NPL as EngMT (English machine translation) for pg./para. numbers) in view of Gruber et al. ((2009) FEBS Ltrs. 583: 3377-3387).
[Gruber et al. cited in the Non-Final Office Action mailed on 07 April 2025.]
[This rejection cited in view of Applicant's amendment.]
Skiba et al. addresses the limitations of claims 1, 3, 5, 12, 14, 19 and 21 in the 35 USC §102(b) rejection above.
Skiba et al. also addresses some of the limitations of claims 10 and 15, and the limitations of claim 17.
[With regard to claims 10 and 17, see Claim Interpretations section- (1) and (2) above.]
Skiba et al., as applied to claims 1, 3, 5, 10, 12, 14-15, 17, 19 and 21, does not show: 1) the composition promotes increased lifespan of the multicellular organism which is a Caenorhabditis elegans nematode [Claims 10 and 15].
Regarding claims 10 and 15, Gruber et al. teaches that the nematode worm Caenorhabditis elegans (C. elegans) is increasingly popular as a model organism for aging studies as well as for testing antioxidants and other compounds for effects on longevity. The described review introduces C. elegans as a model organism and discusses aspects that make it attractive for aging and antioxidant research (pg. 3377, Abstract).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time that the claimed invention was made, to have understood that the beverage composition comprising cyclodextrin, a complex-forming compound (such as amino acids), and an aqueous liquid component, as shown by Skiba et al., as applied to claims 1, 3, 5, 10, 12, 14-15, 17, 19 and 21, could have been used to conduct studies with the nematode Caenorhabditis elegans in order to have determined that the composition, shown by Skiba et al., increased or caused increased lifespan in said nematode [Claims 10 and 15], with a reasonable expectation of success, because Gruber et al. teaches that the nematode worm C. elegans is increasingly popular as a model organism for aging studies as well as for testing compounds for their effects on longevity (MPEP 2143 (I)(G)).
One of ordinary skill in the art would have been motivated to have incorporated C. elegans into a longevity study, because Gruber et al. teaches that nematodes were soon appreciated as convenient model organisms for aging research, in part due to their short lifespan, morphological simplicity, ease of maintenance and of genetic manipulation. In addition, the C. elegans genome has been completely sequenced and contains approximately 18,000 genes, many of which have human homologs. C. elegans has become a widely accepted model and discoveries made in C. elegans have been awarded with Nobel Prizes in 2002 (pg. 3377, column 2, para. 1-2).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 6 and 7 are rejected under 35 U.S.C. §103(a) as being unpatentable over Skiba et al. in view of Gruber et al., as applied to claims 1, 3, 5, 10, 12, 14-15, 17, 19 and 21 above, and further in view of Brown ((2003) Am. J. Physiol. Renal Physiol. 284: F893-F901) as evidenced by Ozu et al. ((2013) Biophys. J. 104: 85-95).
[Brown, and Ozu et al. cited in the Non-Final Office Action mailed on 07 April 2025.]
[This rejection cited in view of Applicant's amendment.]
Skiba et al. in view of Gruber et al., as applied to claims 1, 3, 5, 10, 12, 14-15, 17, 19 and 21 above, do not explicitly show: 1) the multicellular organism is capable of intracellular water permeation, and the ingestion of the composition by the multicellular organism enhances the intracellular permeation [Claim 6]; and 2) the multicellular organism contains aquaporins, and the cellular hydration is caused by interaction of the composition with the aquaporins [Claim 7].
Brown as evidenced by Ozu et al. addresses the limitations of claims 6 and 7, with regard to aquaporin water channels.
Regarding claims 6 and 7, Brown shows the recent advances related to the molecular mechanisms and pathways of aquaporin-2 (AQP2) water channel trafficking (pg. F893, Abstract). The so-called “shuttle hypothesis” of vasopressin action was confirmed by direct observations of water channel (aquaporin) recycling when antibodies against the vasopressin-regulated AQP2 became available (pg. F893, column 1, para. 1). An extensive accumulation of AQP2 at the cell surface has been accomplished within 30 min after inhibition of endocytosis by treatment with methyl-β-cyclodextrin (pg. F896, column 1, para. 1 [nexus to Skiba et al.- cyclodextrins promote solubility]).
Although implied by Brown, the reference does not specifically teach that the aquaporins of cells are exclusively responsible for water uptake by said cells, by way of addressing the limitations of claims 6 and 7.
Ozu et al. teaches that the discovery of aquaporins (AQPs) in 1992 had a significant impact on the study of water transport through biological membranes. Since then, members of the AQP family have been described in all living organisms (pg. 85, column 1, para. 1).
Ozu et al. also shows work showing the osmotic-permeability regulation of human aquaporin 1 (hAQP1) expressed in Xenopus oocyte membranes (pg. 85, Abstract). The study of water transport through AQPs was centered on finding drugs that could modulate the activity of the channel (pg. 85, column 1, para. 2). The described experiments address the osmotic permeability regulation of hAQP1 expressed in Xenopus oocyte membranes. From the data it was concluded that hAQP1 is a constitutively open channel that closes with increments of membrane tension, showing a cooperative effect among monomers, and that this behavior is reversible (pg. 94, column 1, para. 2).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time that the claimed invention was made, to have understood that the beverage composition comprising cyclodextrin, a complex-forming compound (such as amino acids), and an aqueous liquid component, as shown by Skiba et al. in view of Gruber et al., as applied to claims as applied to claims 1, 3, 5, 10, 12, 14, 15, 17, 19 and 21 above, could cause cellular hydration via ingestion of the composition shown by Skiba et al., and that the cellular hydration is associated with the function of aquaporins (e.g., AQP1) [Claims 6 and 7], with a reasonable expectation of success.
Brown as evidenced by Ozu et al. shows that aquaporins are water channels; i.e., channels or pathways in the cell membrane responsible for the intracellular transport of water, and also shows that cyclodextrin can increase the accumulation of an aquaporin (specif. AQP2) (MPEP 2143 (I)(G)).
Therefore, it would have been obvious (and one of ordinary skill in the art would have been motivated) to have included a carbohydrate clathrate component that includes cyclodextrin in a composition intended to increase cellular hydration in the organism that ingests it, such as the composition shown by Skiba et al. in view of Gruber et al., as applied to claims 1, 3, 5, 10, 12, 14-15, 17, 19 and 21 above, because by increasing the number of aquaporin channels on the surface of cells, the amount of water to be transported into the cells would be increased; i.e., intracellular water permeation would be promoted or increased (MPEP 2143 (I)(G)).
With regard to the intended use recitation in claims 1, 15 and 19, it would have been further obvious to have shown that cellular hydration can be determined by using Xenopus laevis (frog) oocytes [Claims 1, 15 and 19], because Ozu et al. shows that Xenopus laevis oocytes have been and can be used to demonstrate the potential of extracellular compounds (e.g., drugs) to increase or enhance intracellular permeation (via the presence of aquaporins, specif. hAQP1) (MPEP 2143 (I)(G)).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Double Patenting
The provisional rejection of Claims 1-3 and 19-21 on the ground of nonstatutory double patenting, as being unpatentable over claims 1, 15, 16, 18 and 20 of copending Application No. 17/884,516, in the Non-Final Office Action mailed on 07 April 2025, is withdrawn in view of Applicants’ submission of a terminal disclaimer filed on 07 October 2025. The electronically-submitted terminal disclaimer was approved on 07 October 2025.
The provisional rejection of Claims 1-9, 14 and 19-21 on the ground of nonstatutory double patenting, as being unpatentable over claims 1-9, 14 and 19-21 of copending Application No. 17/942,930, in the Non-Final Office Action mailed on 07 April 2025, is withdrawn in view of the abandonment of Application No. 17/942,930 mailed on 12 June 2025.
Response to Arguments
Applicant’s arguments, pg. 8, filed on 07 October 2025, with respect to the prior art references cited in the 35 U.S.C. §102(b) rejection, and the 35 U.S.C. §103(a) rejections, have been fully considered but they are either not persuasive or are moot, because the arguments do not apply to the references as they are applied in the context of the current rejection, or as new grounds necessitated by Applicant’s amendment, in which claims were 1, 10, 15 and 19 were amended, and claims 2, 8, 9, 11, 13, 16, 18 and 20 were canceled.
1. Applicant remarks (pg. 8, para. 2), with regard to the 102 rejections, that claims 1-3, 5, 10, 12, 14-15, 17 and 19-21 are rejected as being anticipated by Skiba et al. (WO2008/107569). Applicant has amended claims 1, 15, and 19 to recite limitations not disclosed in Skiba.
However, in response to Applicant, Applicant’s argument fails to comply with 37 CFR 1.111(b), because it amounts to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the cited references. Therefore, this argument is not persuasive.
2. Applicant remarks (pg. 8, para. 3), with regard to the 103 rejections, that Applicant amended claims 1, 15, and 19 to recite limitations that are not disclosed or suggested by any prior art reference or by any proper combination of prior art references.
However, in response to Applicant, again, Applicant’s argument fails to comply with 37 CFR 1.111(b), because it amounts to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the cited references. Therefore, this argument is not persuasive.
MPEP 2141 (IV) states, in part: "Once Office personnel have issued a rejection that establishes the Graham factual findings and concludes, in view of the relevant evidence of record at that time, that the claimed invention would have been obvious as of the relevant time, the burden then shifts to the applicant to (A) show that the Office erred in these findings or (B) provide other evidence to show that the claimed subject matter would have been nonobvious. 37 CFR 1.111(b) requires applicant to distinctly and specifically point out the supposed errors in the Office’s action and reply to every ground of objection and rejection in the Office action. The reply must present arguments pointing out the specific distinction believed to render the claims patentable over any applied references." (See 37 CFR 1.111 (b).)
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 extension fee 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 date of this final action.
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/SMP/Examiner, Art Unit 1651
/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651