DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the claims and applicant arguments/remarks, filed 04/01/2026, is acknowledged.
Claims 1-8, 10, 12-19 are pending in this action. Claims 9, 11 and 20 have been cancelled previously. Claims 1, 3, 7-8, 10, 12, 17-18 have been amended. Claims 1-8, 10, 12-19 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a continuation of U.S. Patent Application No. 17/020,697, filed September 14, 2020 and now issued as U.S. Patent No. 11,123,291, which claims benefit of provisional U.S. Application No. 62/899,595, filed September 12, 2019; provisional U.S. Application No. 62/944,912, filed December 6, 2019; provisional U.S. Application No. 62/968,591, filed January 31, 2020; and provisional U.S. Application No. 63/012,058, filed April 17, 2020.
Terminal Disclaimer
The terminal disclaimer, filed 02/12/2024, disclaiming the terminal portion of any patent granted on this application, which would extend beyond the expiration date of the prior Patent Nos. 11,123,291, has been reviewed and is accepted. The terminal disclaimer has been recorded. The non-statutory double patenting rejection has been withdrawn.
Information Disclosure Statement
The information disclosure statements, filed 10/13/2025 and/or 10/29/2025, are acknowledged and have been considered. Please see the attached initialed PTO-1449.
Foreign language references listed in the information disclosure statement, filed 10/13/2025, for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
Further, it is noted that the non-patent literature reference, recited in the information disclosure statement, filed 10/29/2025, includes USPTO Office Action for US Patent Application 17/854,297 and the information disclosure statement submitted for this case. In the present case, the examiner has considered all references filed by the applicant, to expedite the prosecution. However, the applicant is informed that the references recited in said information disclosure statement should be resubmitted in a proper format to be printed in the patent. MPEP 1302.12.
Claim Rejections - 35 USC § 112(a)
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 1-8, 10, 12-19 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 enablement requirement.
The claim(s) contains subject matter, which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors to be considered in determining whether a disclosure meets the enablement requirement, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) scope or breadth of the claims; (2) nature of the invention; (3) relative level of skill possessed by one of ordinary skill in the art; (4) state of, or the amount of knowledge in, the prior art; (5) level or degree of predictability, or a lack thereof, in the art; (6) amount of guidance or direction provided by the inventor; (7) presence or absence of working examples; and (8) quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure. MPEP 2164.01(a). In the present case,
(1) Instant claims disclose a method of encapsulating active ingredients by mixing an active ingredient and pluralities of various materials, functional agents, and an aqueous solution(s).
(2) The nature of the invention is directed to a method of making products encapsulating nutrient or other payloads (Specification; Para. 0002), wherein said products may include a plurality of active agents, lipophilic carriers, polymers, emulsifying agents, thickening agents, a source of bioavailability enhancer, and other additives. As best understood, said products/capsules/particles have different shells/layers that allow controlling a release of said active agent(s).
(3) The relative level of skill possessed by one of ordinary skill in the art of polymer science, physical chemistry, and/or biochemical engineering is high, as a majority of lead investigators directing scientific research and development in these particular technological areas possess a Ph.D. in a scientific discipline such as polymer science, physical chemistry, bioengineering, biochemistry, material engineering or the like.
(4) State of the art of polymer science/biomedical engineering/physical chemistry research comprises laborious time-consuming and costly experimental methods comprising synthesis/purification/characterization of perspective compounds; functional and non-functional assays for perspective use of said compounds in combination with other constituents, e.g., in pharmaceutical/medical compositions and/or food products.
(5) Level or degree of predictability of physical properties of multicomponent systems/compositions comprising different phases (e.g., oil-in-water, oil-in-water-in-oil, oil-in-water-in-oil-in-water) and/or polymers is low, given that said properties depend on intra- and inter-molecular interactions of compounds included as well as on thermodynamic and kinetic flexibility of polymers. Regarding the multi-phase emulsions, it is well known in the field that (i) the physical instability of said emulsions results in creaming, flocculation, coalescence, phase inversion (e.g., as caused by the temperature), and Ostwald ripening; (ii) the phase behavior of a mixture with many components should be insensitive to fluctuations in the interactions between each and every pair of components; (iii) for a specific active agent a search is required for potential stabilizers/emulsifiers/surfactants that can be used in combination with other constituents; and (iv) finding suitable countermeasures for the instability of the emulsions presents a difficult challenge given that a variety of substances should be tested and compared (see Choi et al., Leister et al., Madaan et al., Yang et al., Jacobs et al. and references cited therein as cited previously for parent application 17/020,697).
(6) Amount of guidance/direction provided by the inventor is low, because the specification does not teach any correlation between structural specificity of polymer(s), functional agents, other additives and required/claimed properties of the claimed structures/capsules/products, and only general statements what can be used/mixed in claimed method are provided. The specification simply directs those skilled in the art to go figure out for themselves combinations of compounds that can be used in combination with an active agent of interest for preparing claimed encapsulates. This implies that one should run tests on a wide spectrum of compounds for providing a working example, or potential candidates. Further, the specification does not provide any guidance in selecting suitable operating parameters (i.e., temperate and time for heat treatments, shear rates, mixing techniques/conditions, etc.), and one skilled in the art would not be aware of any established criteria for producing said claimed encapsulates.
(7) There are no working examples in the instant specification that illustrate how one can chose for a specific active ingredient the specific components to be used in claimed method for providing claimed inherent properties of the final product, e.g., (i) encapsulating an active ingredient (claim 1); (ii) providing a specific release of said active agent from the produced product (claim 18).
(8) Quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure is great. In the present case, for a specific/desired active ingredient one of ordinary skill in the art would have to conduct a myriad number of experiments (i) to determine potential candidates that can be included; (ii) to determine experimental conditions for providing encapsulates (i.e., variation of absolute and relative concentrations of compounds included, optimization of experimental conditions such as temperatures, time of heating, aqueous solution compositions, shear rating, time of mixing, etc.), and (iii) to characterize the inherent properties of produced encapsulates, such as stability acceptable for the use, active agents release after human consumption, etc.
When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation. In conclusion, Genetech, 108 F.3d at 1366 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.” Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997).
Claim Rejections - 35 USC § 112(b)
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 1-8, 10, 12-19 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.
Newly amended claim 1 discloses the use of a 1st lipophilic carrier (in a 1st mixture) and a 2nd lipophilic carrier (in a 4th mixture) that is not clear, because said functional agents/carriers are defined/identified by the same compounds. In the present case, it is unclear could it be the same additives, OR should be different. Similar is applied to the terms first/second/third polymers as well as to the terms first/second materials, as well as to claim 3 regarding the components of the 2nd mixture. Clarification is required.
Newly amended claim 1 discloses a method of encapsulating active ingredients, wherein several elements to be used in the claimed method are identified as first/second/third polymer and/or first/second material. First, it is unclear what is claimed – encapsulating an active ingredient (i.e., singular), OR several active ingredients (i.e., plural). Second, it is noted that “Claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation.” See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Further, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Furthermore, “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Clarification is required.
Newly amended claim 10 (dependent on claim 1) recites the limitation “adding a 4th material” that is unclear. To this point, it is noted that independent claim 1 discloses the use of a 1st material and a 2nd material. No information regarding 3rd material is provided in claim 1. Clarification is required.
Newly amended claim 12 (dependent on claim 1) recites the limitation “the 1st lipophilic carrier comprises triglycerides” that is not reasonably clear. To this point, it is noted that independent claim defines a 1st lipophilic carrier as Markush group, i.e., “selected from the group consisting of triglycerides, …, and vegetable oil”. Therefore, it is unclear how claim 12 narrows the scope of the claim upon which it depends. Similar is applied to claim 17 regarding the limitation “the active ingredient comprises theanine”. Clarification is required.
Claims 2, 4-8, 13-16, 18-19 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
Response to Arguments
Applicant's arguments, filed 04/01/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or rejections have been added to the record to address newly introduced amendments and/or to clarify the position of the examiner. Additional examiner’s comments are set forth next.
In response to applicant’s argument that “many terms in the claims are defined within the claim itself”, it is noted that neither the claims nor the instant specification teaches any correlation between structural specificity of compounds, functional agents, other additives to be used in the claimed method for providing required/claimed properties of the claimed products (i.e., for providing encapsulation of an active ingredient), and only general statements what can be used/mixed in the claimed method are provided see above). Further, the instant specification does not provide any guidance in selecting suitable operating parameters (i.e., temperate and time for heat treatments, shear rates, mixing techniques/conditions, etc.), and one skilled in the art would not be aware of any established criteria for producing claimed structure encapsulating an active ingredient. The specification simply directs those skilled in the art to go figure out for themselves the combinations of compounds that can be used in combination with an active ingredient of interest as well as preparation conditions for preparing claimed structures/encapsulates. Therefore, the examiner maintains the position that the instant specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims, because practice of the claimed invention would require undue experimentation by an artisan of ordinary skill in the art. Applicant is advised to clarify the claim language/scope, the claimed method and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
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 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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