DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/08/2026 has been entered.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claims 1, 3-12, and 14-17 are pending (claim set as filed on 06/08/2026).
Priority
This application is a CON of application no. 16/841,646 (now abandoned) filed on 04/06/2020, which is a CIP of application no. 14/932,929 (now US Patent no.10,610,524) filed on 11/04/2015, which is a CON of application no. 12/983,234 (now abandoned) filed on 12/31/2010.
Terminal Disclaimer
The terminal disclaimer filed on 05/31/2023 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent no. 10,610,524 (application no. 14/932,929) has been reviewed and is accepted. The terminal disclaimer has been recorded.
Maintained Rejections
Claim Rejections - 35 USC §103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-12, and 14-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Szente (Cyclodextrins as Food Ingredients, 2004) in view of Flynn (US 2008/0221169 A1) - previously cited references.
Szente’s general disclosure relates to the utilization of cyclodextrins and cyclodextrin complexes in the food industry (see abstract). Szente discloses that cyclodextrins are inexpensive enzyme-modified starch derivatives and are completely metabolized by the colon microflora (see page 137: Introduction). Szente discloses that β-cyclodextrin (βCD) has been a known and well-recognized flavor carrier and protectant in numerous food products and widely used in human nutrition (see page 137, right col.). Szente further discloses adding various amounts of β-cyclodextrin in combination with many types of flavors in aqueous solutions and suspensions such as coffee, tea, or hot beverages (see page 139, left col. & page 141).
Regarding claim 1’s preamble patient population, claim interpretation: a human is considered to meet the claim’s limitation of “a multicellular organism that has cells with cell membranes, lipid packing associated with the cell membranes, aquaporins, and is capable of intracellular water permeation” (see instant specification at page 13).
Regarding claim 1’s limitation pertaining to the carbohydrate clathrate component, claim interpretation: the β-cyclodextrin is a specie that reads on the claimed phrase of a carbohydrate clathrate component (as noted on page 2 of the specification); since Szente teaches βCD in an aqueous solution as beverage formulations, one of ordinary skill in the art would have at once envisage said beverage will be intended for human consumption thereby meeting the limitation of “causing the multi-cellular organism to ingest”. Szente teaches that natural food coloring components can be stabilized by adding 0.2% β-CD (see page 140, left col.).
Regarding claim 1’s limitation and claims 16-17 pertaining to the hydration-effecting agent and complex-forming component, Szente teaches a powdered juice consisting of anhydrous glucose, sodium L-aspartate, DL-alanine, citric acid and inorganic salts, resulted in a product of excellent stability (see page 140, left col.). Szente teaches caffeine/CD complex can be prepared in aqueous solution such as coffee (see page 141, right col.). Szente teaches sugars and amino acids for food (see page 140, left col.).
Regarding claim 1’s remaining limitations, claim interpretation: the reference of Szente is silent in regards to the wherein clauses and “thereby, causing interaction … enhancing the intracellular permeation because of the causing step” but these limitations are interpreted to be inherent results that happens after the first limitation/step is performed. In other words, wherein an inclusion complex is formed and an enhancement of intracellular permeation will naturally happen after a person drinks the beverage comprising the carbohydrate clathrate component (e.g., cyclodextrin). This reasoning is supported by the instant specification which discloses that the solution/composition will interact with the organism’s aquaporin water channels to thereby promote intracellular permeation and hydration (see instant specification at pages 5 and 31). The MPEP at 2112.02 (I): Process Claims states that a prior art composition anticipates a claimed process if the composition carries out the process during normal operation. Moreover, claim language such as “wherein”, “thereby”, or “whereby” clauses in a method claim is not given weight when it simply expresses the intended result of a process step positively recited (MPEP 2111.04). In other words, enhancing intracellular permeation and cellular hydration are inherent properties of the carbohydrate clathrate component (e.g., cyclodextrin).
Regarding claims 4-12, claim interpretation: these dependent claims either recite statements describing the mechanism of intracellular water permeation (in other words, they are merely explaining how it works, e.g. interaction with aquaporins, non-covalent formation, and causing results in disintegration, loosening lipid packing, untightening, changes in structure, binding to cholesterols) and/or stating the inherent features of a human multicellular organism (e.g. aquaporins, phospholipid bilayer constituents, membrane cholesterols/lipids/proteins). All of these features are met by the prior art because Szente teaches the claimed process for the reasons explained above. This reasoning is supported by the instant specification which discloses all these endogenous properties of a human cell (see instant specification at pages 30-31) and discloses, for example, “the cyclodextrin-based beverages influence the cellular hydration with a mechanism of temporary and reversibly changing the cell membrane lipid packing and the membrane fluidity, due to the non-covalent inclusion complex formation”. The MPEP at 2112.01 states that “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties Applicant discloses and/or claims are necessarily present”.
Regarding claim 15 and limitations pertaining to the concentrations, Szente discloses β-cyclodextrin (βCD) has been a known and well-recognized flavor carrier and protectant in numerous food products (see page 137, adjoining ¶ of left & right col.). Szente teaches that adding various concentrations of β-CD (see page 141). Szente teaches “the ratio of free to complexed guest molecules in an aqueous cyclodextrin solution depends on several factors. The most important ones are stability (or association) constant of the complex, temperature, and concentrations of both components” (see page 140, right col.). The MPEP 2144.05(II) states that “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. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Thus, the ratio of the amount of the clathrate component to the complex-forming compound is deemed to be optimizable parameters within the purview of the ordinary by routine experimentation.
However, Szente does not teach: corroborating enhanced cellular hydration by a test that uses human-aquaporin-expressed frog oocytes, and measures water uptake of the frog oocytes in a swelling assay (claims 1 and 3); or wherein the swelling assay uses video microscopy (claim 14).
Flynn’s general disclosure relates to compounds that modulate water transport by aquaporin channels in cell membranes and methods of using these compound to treat diseases and disorders associated with aquaporin activity (see abstract & ¶ [0005], and [0007]-[0008]).
Flynn teaches “a method for screening compounds for their ability to modulate aquaporin activity based on a water permeability assay in Xenopus oocytes expressing aquaporins which is used to identify, assess, and characterize compounds that either block or stimulate the aquaporin channels including AQP1, AQP4 and AQP9 channels” (see ¶ [0044], [0104]-[0106]; claim interpretation: Xenopus is the taxonomical name for frog as noted by the instant spec at pages 32-33). Flynn further teaches performing swelling assays using phase contrast microscopy and “ability of compounds, analogs and/or agents to block an aquaporin channel was quantified by video-microscopic analyses of cross-sectional area of AQP-expressing oocytes as a function of time in a defined osmotic gradient, allowing the calculation of the water permeability factor” (see ¶ [0053], & and Example 1 at ¶ [0109]-[0117]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to perform video-microscopy swelling assays such as taught by Flynn in the method of Szente. The ordinary artisan would have been motivated to do so is because performing confirmatory safety and efficacy testing of food and drugs are considered to be well-known and routine practices. The MPEP at 2141 provides exemplary rationales that may support a conclusion of obviousness include: (a) combining prior art elements according to known methods to yield predictable results. Hence, utilizing human-aquaporin-expressed frog oocytes to measure swelling assays is already known in the art such as evident by Flynn’s disclosure. In other words, in a basic sense, swelling assays are merely performed by scientists for confirmation of safety and efficacy purposes and does not rise to a patentable significance. Moreover, there would be reasonable consideration to perform the claimed swelling assays for ingredients or beverages that are well-known for the diuretic effects. Therefore, the combined disclosures of Szente and Flynn, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time was invented.
Examiner’s Response to Arguments
Applicant’s amendments and arguments filed on 06/08/2026 have been fully considered but they are not persuasive and deemed insufficient to overcome the prior arts of record.
In response to Applicant’s argument (addressing page 7 of the remarks) that “The Office action states at p. 5, by making reference to the present application rather than to the prior art, that ‘enhancing intracellular permeation and cellular hydration are inherent properties of the carbohydrate clathrate component (e.g., cyclodextrin).’ It is important to note that this conclusion is reached only by the reference to the present application because the Szente reference does not disclose or suggest the use of cyclodextrin for permeation and hydration purposes, whether or not those are “inherent properties”: this argument is not persuasive because the best source to demonstrate an inherency feature is actually the instant specification. The instant specification is not being used as a motivational teaching to illustrate novelty or obviousness from the prior arts (i.e., that would be hindsight reconstruction), but rather merely used to prove a fact of inherent property. For instance, the MPEP 2112.02(I) states that “The Board rejected a claim directed to a method for protecting a plant from plant pathogenic nematodes by inoculating the plant with a nematode inhibiting strain of P. cepacia. A U.S. patent to Dart disclosed inoculation using P. cepacia type Wisconsin 526 bacteria for protecting the plant from fungal disease. Dart was silent as to nematode inhibition but the Board concluded that nematode inhibition was an inherent property of the bacteria. The Board noted that applicant had stated in the specification that Wisconsin 526 possesses an 18% nematode inhibition rating.)”. In other words, it is appropriate to rely on Applicant’s specification to support a fact but not as a reason to build a prior art rejection. Furthermore, “Products of identical chemical composition cannot have mutually exclusive properties … A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present” (MPEP 2112.01(II)).
In response to Applicant’s argument (addressing pages 7-8 of the remarks) that “The present invention is not merely using cyclodextrin for any inherent property, but using a specific combination of a carbohydrate clathrate component with cyclodextrin within a specific concentration range, a hydration-effecting agent, an aqueous liquid, and a complex-forming compound with a specific concentration range. None of these limitations are disclosed in the prior art”: this argument is not persuasive because the primary reference of Szente teaches all these limitations except for the swell assay as indicated in the last office action. Moreover, Szente is directed to food and beverage industry for human nutrition which is reasonably for permeation and hydration purposes. The claims employ language that describes features or properties at a scientific level but said features are inherent properties of the chemical composition.
Conclusion
No claims were allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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