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 07/07/2026, is acknowledged.
Applicant has previously elected without traverse the invention of Group I, claims 91-106, 114-119 drawn to a composition comprising arginine, a silicate, and inositol.
Claims 91-102, 104-106, 114-119 are pending in this application. Claim 103 and withdrawn claims 107-113 (drawn to a nonelected species and inventions) have been cancelled. Claims 1-90 have been cancelled previously. Claims 91-102, 104-106, 114-119 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Any rejection or objection not reiterated in this action is withdrawn.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 . 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.
Priority
This application, filed October 28, 2025, claims benefit of provisional U.S. Application No. 63/712,812, filed October 28, 2024.
Specification - MAINTAINED
The lengthy specification (53 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The specification is objected to because of the following informalities:
As stated previously, the specification comprises symbols/acronyms, e.g., d10, d90, d50, ADHD, Dv10, Dv90, Dv50, FWHM, without proper definition (Pages 8-12, 19, 42-43, 46). The symbol/acronym should be given once in parenthesis after the first use of the full term, and then the symbol/acronym is used alone thereafter if needed. Appropriate correction is required.
In response to the applicant’s argument that said symbols/acronyms are well understood/known in the field, it is noted the main purpose of definiteness of language is to provide a clear measure of what the applicant regards as the invention. In the present case, it is unclear, e.g., what is d10 and Dv10, d90 and Dv90, etc., what do the recited acronyms ADHD, FWHM define/imply. Clarification is required.
As stated previously, the specification comprises typographic errors, e.g. “the arginine” (e.g., Page 9) that need to be corrected to “arginine”. Appropriate correction is required.
In response to applicant’s argument that “the arginine” indicate the feature being discussed”, it is noted that “arginine” is a compound having a specific chemical structure (see Wikipedia), not a group of compounds, e.g., as a silicate, i.e., any member of a family of polyatomic anions consisting of silicon and oxygen, or any salt of such anions (see Wikipedia). Therefore, the correction is required.
As stated previously, the specification comprises reference on a publication (e.g., Page 25). The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The use of the trademarks/trade names has been noted in this application (e.g., Page 50). Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
In response to the applicant’s argument that recited trademark name is well known to one skilled in the relevant art, as stated above, the characteristics of the product may change and yet it may continue to be sold under the same trademark/trade name. Therefore, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Correction is required.
Drawings - MAINTAINED
The drawings, filed 10/28/2025 (59 pages), are objected to because in Figs, 2, 35-37, 39-41, 51-54, 57 x-axis and/or y-axis are not identified. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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.
In response to the applicant’s argument that said axes are clearly defined, it is noted that (i) in Fig. 2 it is unclear what % is shown; (ii) in Figs. 35-37. 51-54, 57 “y-axes” are not defined; (iii) in Figs. 39-41 it is unclear “Log” of what parameter is shown/indicated. Clarification is required.
Information Disclosure Statement
The information disclosure statement, filed 07/07/2026, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
The information disclosure statement does not include Certificate Statement and Privacy Act Statement (MPEP 609), and/or does not have a signature of the applicant or representative that is required in accordance with CFR 1.33.
Further, it is noted that patent applications submitted in the Transmittal Letter, filed 07/07/2026, have also be considered.
Claim Objections
Claims 99, 104, 105 are objected to because of the following informalities:
As stated previously, claims 99, 104, 105 comprise the typographic errors “the arginine”, “the inositol” that need to be corrected to “arginine”, “inositol”, respectively. Appropriate correction is required.
In response to the applicant’s argument that said citations further define previously defined claim elements “arginine” and “inositol”, it is noted that “arginine” and/or “inositol” are specific compounds having specific chemical structures (see Wikipedia), not a group of compounds, e.g., as a silicate (i.e., a family of polyatomic anions consisting of silicon and oxygen, or any salt of such anions; see Wikipedia). Therefore, the correction is required
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 91-102, 104-106, 114-119 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.
As stated previously, claim 91 discloses “a composition comprising arginine, a silicate and inositol, wherein the solubility of the composition in water is at least 5 wt% at 20 °C” that is not reasonably clear. Does this limitation imply that said composition has solubility as claimed in any water (e.g., (non)deionized, at various pH, various ionic strengths, etc.) and may include other compounds/components even in large amounts (i.e., comprising)? Claim 91 attempts to define the subject-matter in terms of the result to be achieved, which merely amounts to a statement of the underlying problem, without providing the technical features necessary for achieving this result. The claim language does not set forth well-defined boundaries of the invention, but only states a problem to be solved and/or a result to be obtained. To this point, it is noted that it is well known in the field that properties of multicomponent systems (e.g., compositions/products) depend on compounds included as well as on concentrations and/or distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition/product. 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). Similar is applied to claims 96-97, 101-102. Clarification is required.
In response to the applicant’s argument that the instant specification provides examples of various compositions having different solubility (Table 13), it is noted that claim 91 attempts to encompass compositions comprising arginine, a silicate and inositol and having a specific solubility in water, but it does so without including any materials that cause said result/property. As stated above, 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. Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Clarification is required.
Claim 105 recites the term " heterogeneous” that is unclear, because neither the claims nor the instant specification provides a definition for said term and/or a standard for ascertaining the requisite degree. Without clarification of said term/parameter the metes and bounds of the claimed subject matter are not reasonably clear, and one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Clarification is required.
Claims 92-95, 98-100, 104, 106, 114-119 are rejected as being dependent on rejected independent claims 91, 96, 101 and failing to cure the defect.
Claim Rejections - 35 USC § 103 - MAINTAINED
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 91-102, 104-106, 114-119 are rejected under 35 U.S.C. 103 as being unpatentable over Wandhwa, CN 104114500 (hereinafter referred to as Wandhwa).
Wandhwa teaches dietary supplement formulations/compositions, e.g., beverages (Abstract; Para. 0010, 0016-0018, 0137 as applied to claims 91, 114) that may include: (i) arginine (Para. 0070, 0118, 0164); silicate, i.e., potassium silicate, sodium silicate (Para. 0076 as applied to claims 91, 95); and inositol (Para. 0084, 0124 as applied to claims 91, 95 96, 0100-0101); (ii) sodium hydroxide, potassium hydroxide (Para. 0078, 0101, 0127 as applied to claim 92, 98); (iii) citric acid, malic acid (Para. 0058, 0064, 0081, 0101, 0127 as applied to claim 116); and (iv) nitrate or salt thereof, e.g., magnesium nitrate (Para. 0060 as applied to claims 106, 0117), and wherein (v) said compositions can be prepared by freeze drying (Para. 0149, 0165 as applied to claims 94, 96).
Therefore, the examiner maintains the positions that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made/filed, because every element of the invention has been taught by the teaching of the reference cited. Regarding the properties of the disclosed formulations, it is noted that the cited prior art teaches formulations/compositions that are substantially the same as the compositions recited by the instant claims, i.e., comprise components as instantly claimed. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. The fact that applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). With regard to the relative concentrations as instantly claimed, it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. 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.
In response to the applicant’s argument that Wandhwa does not recite or exemplify compositions comprising all three recited compounds, it is noted that the fact that cited prior art discloses a multitude of effective combinations does not render any particular combination less obvious. This is especially true because the claimed composition is used for the identical purpose taught by the prior art (e.g., beverages). See In re Corkill 226 USPQ 1005, 1008 (Fed. Cir. 1985); In re Susi 169 USPQ 423, 425 (CCPA 1971). Merck & Co. v. Biocraft Laboratories Inc. 10 USPQ 2d 1843 (Fed. Cir. 1989). Further, a reference is not limited to working examples. In re Fracalossi 215 USPQ 569 (CCPA 1982). A reference is good not only for what it teaches by direct anticipation, but also for what one of ordinary skill might reasonably infer from the teachings. In re Opprecht 12 USPQ 2d 1235, 1236 (Fed. Cir. 1989); In re Bode 193 USPQ 12 (CCPA 1976); In re Lamberti 192 USPQ 278 (CCPA 1976); In re Bozek 163 USPQ 545, 549 (CCPA 1969); In re Preda 159 USPQ 342 (CCPA 1968); In re Van Mater 144 USPQ 421 (CCPA 1965); In re Jacoby 135 USPQ 317 (CCPA 1962); In re LeGrice 133 USPQ 365 (CCPA 1962). Furthermore, it is noted that an inherent feature needs not be recognized by one of ordinary skill in the art at the time of the invention. See Schering Corp. v. Geneva Pharmaceuticals, Inc. (339 F.3d 1373, 1377, 67 U.S.P.Q.2d 1664, 1668) (Fed. Cir. 2003). It is only required that the subject matter is, in fact, inherent in the prior art reference (Schering Corp. v. Geneva Pharmaceuticals, Inc.). Adding to that, “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 5,707,970 A, US 6,156,735 A, US 6,344,444 B1, US 7,576,132 B2, US 10,959,971 B2 (cited in IDS) – teaches compositions comprising arginine, potassium silicate and inositol.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 91-102, 104-106, 114-119 are rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 1, 5-6 of U.S. Patent No. 11,103,000; (2) claims 5-20 of U.S. Patent No. 11,622,571; (3) claim 1 of U.S. Patent No. 11,471,435 B2.
Although the conflicting claims are not identical, they are not patentably distinct from each othe,r because prior patents also claim: Compositions/beverages comprising inositol-arginine-silicate particles having a particle size of less than 125 µm. In the present case, the instant claims are merely broader than prior patent claims that include additional limitation (i.e., specific particle size/distribution) and therefore are more specific. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said prior patents.
Claims 91-102, 104-106, 114-119 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5, 12-30 of copending Application No. 18/192,023.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on that copending application since the referenced copending application and the instant application are claiming common subject matter, as follows: Compositions comprising inositol-arginine-silicate particles having a particle size of less than 125 µm. In the present case, the instant claims are merely broader than copending application claims that include additional limitation (i.e., specific particle size/distribution) and therefore are more specific. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented.
In response to the applicant’s argument that the prior patents and the copending application do not disclose “a solubility in water”, it is noted that the cited prior patents and the application disclose compositions comprising compounds as instantly claimed, wherein said compositions can be used as beverages. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said prior patents and copending application.
Response to Arguments
Applicant's arguments, filed 07/07/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. Applicant is advised to clarify the claimed language, the structure of the claimed composition/product and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
THIS ACTION IS MADE FINAL. 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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