DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/15/2026 has been entered.
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Claims 4 and 22 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species.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.
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).
Claims 1, 7, 15 and 19 all claim a functional property of the composition related to aquaporin(s) of the composition that is first described with an effective filling date of 06 April 2020
The rest of the limitation of claims 1, 3, 5-6, 10, 12, 14-15, 17, 19 and 21 were first described with an effective filing date of 31 December 2010.
As it is unclear what gives the functional property that is first described on 06 April 2020, the claims have been given this filing date as it is the first time these properties are described and claimed.
Response to Amendment and Arguments
The amendment received on 06/15/2026 is acknowledged. Claims 1, 3, 15 and 19 have been amended.
In light of the amendment the objection of claims is obviated. Rejections under 112(b) which remain are reiterated below.
New grounds of rejection are presented below. The prior art rejections over Skiba has currently been withdrawn due to the uncertainty of what the claims cover as noted below, what provides the functional property claimed as noted below in the rejection, and the uncertainty of the priority date as noted above.
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 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 (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.
Claim 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1, 15 and 19 and claims dependent thereon and the limitation “a carbohydrate clathrate component that includes cyclodextrin”, it is unclear what applicant is claiming as the term “include” is typically an open term that can include other things. It is therefore unclear if the carbohydrate clathrate comprises cyclodextrin or if this is an optional alternative and other carbohydrates may be the carbohydrate in the clathrate.
Regarding claims 1, 15 and 19 and claims dependent thereon and the limitation “promotes cellular hydration when ingested by a multicellular organism”, it is unclear what applicant is claiming, the typical purpose of a beverage is in general hydration. It is unclear what applicant is claiming and what it is promoted relative to. A drink of water promotes cellular hydration in comparison to not drinking water, but may not relative to a different composition. It is unclear what function is being claimed and what this function may imply as far as limitations to the claims. Moreover, the claims define one or more claim elements (the hydrating properties of the composition) with respect to an element which is undefined and/or variable (the effect of the composition upon ingestion by an organism), rendering the claims indefinite (see MPEP 2173.05(b)). The effect of the composition on any organism would vary depending on factors, such as the identity of the organism and the state of the organism (e.g., degree of hydration upon ingestion). As such, one of ordinary skill would not be able to reasonable determine whether a particular composition meets the limitation. It is therefore also unclear what the metes and bounds of the invention are.
The courts have indicated that before claimed subject matter can properly be compared to the prior art, it is essential to know what the claims do in fact cover. See, e.g., the following decisions: In re Steele, 305 F 2d. 859, 134 USPQ 292 (CCPA 1962); In re Moore 439 F 2d. 1232, 169 USPQ 236 (CCPA 1969); In re Merat, 519 F 2d. 1390, 186 USPQ 471 (CCPA 1975).
Regarding claims 1, 7, 15 and 19, and claims dependent thereon, and the limitations “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.”, “wherein the multicellular organism contains aquaporins, and the cellular hydration is caused by interaction of the composition with the aquaporins”, “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”, and “and wherein the composition promotes cellular hydration when a 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”, , while functional limitations may be properly used in claims, the boundaries imposed by a functional limitation must be clearly defined to be definite under 35 U.S.C. 112(b). Claim language that merely states a result to be obtained without providing boundaries on the claim scope (e.g., by not specifying any way to achieve those results) is unclear. In the instant case, applicant claims the beverage with the functional limitation of "promotes cellular hydration”. This limitation merely states a functional characteristic (promotes cellular hydration) without providing any indication about how the functional characteristic is provided. It is unclear if the recited functional characteristic follows from (is an inherent property of) the structure recited in the claim, i.e. the components claimed, so it is unclear whether the claim requires some other structure or concentration to achieve this function.
The courts have indicated that before claimed subject matter can properly be compared to the prior art, it is essential to know what the claims do in fact cover. See, e.g., the following decisions: In re Steele, 305 F 2d. 859, 134 USPQ 292 (CCPA 1962); In re Moore 439 F 2d. 1232, 169 USPQ 236 (CCPA 1969); In re Merat, 519 F 2d. 1390, 186 USPQ 471 (CCPA 1975).
Regarding claim 21 and the limitation “amino acids, including L-arginine, citrulline….” it is unclear what applicant is claiming as the term “including” is typically an open term that can include other things. It is therefore unclear if the Markush group claimed is limited to these amino acids or additional amino acids and which ones those might be.
Conclusion
No claim is allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES Z CONSTANTINE whose telephone number is (571)270-5533. The examiner can normally be reached Mon-Fri 9-5.
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/CHARLES Z CONSTANTINE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
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