DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group II, claims 50-56 in the reply filed on April 23, 2026 is acknowledged. Because applicant did not distinctly and specifically point out any supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant states claims 38-49 and 57 are withdrawn (Remarks, 1, April 23, 2026); however the text of the claims is not included in the claim listing. Claims 38-49 and 57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 23, 2026.
Claim Listing
“After each claim number, the status identifier of the claim must be presented in a parenthetical expression, and the text of each claim under examination as well as all withdrawn claims (each with markings if any, to show current changes) must be presented.” MPEP 714(II)(C).
Claim Objections
Claim 53 is objected to because of the following informalities: “including” should be “includes”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 50 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being clearly anticipated by Giampapa (US 20140308248).
Giampapa teaches a “PM Dietary Supplement Composition” comprising α-lipoic acid 8-12 mg, Coenzyme Q10 2.8-4.2 mg, Acetyl-L-carnitine 4-6 mg, L-Glutamine 200-300 mg, L-Arginine (as L-arginine HCl) 128-192 mg, and excipients such as microcrystalline cellulose (Tables 2, 4; see title; abstract; claim 1). Regarding “for reducing HbA1c levels…” it is noted that 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. If the prior art structure is capable of performing the intended use, then it meets the claim. MPEP § 2111.02. Here Giampapa teaches “a dietary supplement system for supporting multifunctional anti-aging management”. The formulations of Tables 2 and 4 are capable of being administered orally and therefore could reduce HbA1c levels.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 50-56 are rejected under 35 U.S.C. 103 as being unpatentable over Morris (US 20080213239).
Morris teaches dietary formulations comprising polyunsaturated fatty acids and vitamin E, combined with the five active agents in claim 50 and pharmaceutical carriers and/or excipients (title; abstract; paras.0008-11, 0025, 0028, 0062-64, 0091-93, 0124, 0129, p.16 Exemplary formulation 27; claims 1, 3, 13, 25). Morris teaches administering the formulation “for treating various disorders, including, but not limited to,… diabetes;…” (para.0161; see para.0175). The carrier includes “any of the standard pharmaceutical carriers such as a phosphate buffered saline solution” (para.0010).
Regarding claim 55, Morris teaches the alpha-lipoic acid can be present in a subject formulation in an amount of from about 50 mg to about 1000 mg, including about 600 or about 800 mg (para.0040). The carnitine can be present in a subject formulation in an amount of from about 150 mg to about 3000 mg, e.g., “from about 400 mg to about 450 mg” (para.0041). CoQ can be present in a subject formulation in an amount of from about 4 mg to about 250 mg, e.g., “from about 100 mg to about 125 mg” (para.0064). “[W]here a subject formulation includes … both arginine and glutamine, the arginine and glutamine are each present in an amount of from about 500 mg to about 10 g per unit dose, e.g.,… from about 750 mg to about 1 g, from about 1 g to about 2.5 g,…”, e.g., 1.5 g (para.0124 (emphasis added)).
Morris does not teach a single example formulation precisely as recited in claim 50. However it would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to prepare such a composition. The skilled person would have been suggested to do so because Exemplary formulation 27 comprises all of the five active agents but for L-glutamine, and Morris expressly teaches, “in some embodiments, a subject formulation includes arginine, glutamine, or both arginine and glutamine” (para.0124).
Regarding the percent ranges in claim 54 and the ratios in claim 56, as noted above Morris teaches dosages of each active agent as recited in claim 55. Furthermore “the amounts of additional components such as carnitine and α-lipoic acid, can vary according to various factors, including, e.g., the age of the individual, the weight of the individual, the genetic makeup of the individual, and the severity of symptoms exhibited by the individual to whom a subject formulation is administered” (para.0029). Therefore the skilled person could optimize the relative concentration of each active agent within Morris’s ranges. Optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 50-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. US 11337960.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to thiol-containing alkyl fatty acid formulations for reducing HbA1c levels in mammalian subjects in need thereof containing alpha-lipoic acid, L-carnitine, CoQ10, L-glutamine, and L-arginine as active ingredients, and pharmaceutically acceptable carriers and/or excipients. The differences are that the ‘960 patent claims limit the active agents to the five, and each to a specific dose, whereas the present claims encompass formulations comprising other active agents. However the “consisting of” in the ‘960 claims and the doses anticipate the current claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
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