DETAILED ACTION
Claims 18-41, submitted on December 20, 2023, are pending in the application. Claims 27-37, 39, and 41 are withdrawn. Claims 18-26, 38, and 40 are rejected for the reasons set forth below. No claim is allowed.
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 . 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.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a method of increasing blood flow, in the reply filed on July 14, 2026 is acknowledged. Claims 27-37, 39, and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inven-tion, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 14, 2026. The withdrawn claims will not be considered for rejoinder, so the examiner suggests that they be cancelled. See MPEP1 821.04.
Claim Objections
Claim 18 is objected to because “in need thereof” should be inserted after “administering a composition to a subject.” This will make it clear that the preamble of the claim is incorporated into the body of the claim. See MPEP 2111.02. Appropriate correction is required.
Claim Rejections – 35 USC § 102
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.
Claims 18-19, 22-25, 38, and 40 are rejected under 35 U.S.C. 102(a)(1) as being antici-pated by US 6,706,756 B1 by Fitzpatrick.
Fitzpatrick (cited in applicant’s IDS2) discloses “a method of inducing endothelium-dependent relaxation [EDR] in blood vessels” by administering “epicatechins,” which are “preferably galloylated” (col. 1, ll. 44-53). The compounds include catechin and epicatechin gallate dimers (Figs. 6-7 and the discussion thereof). The “fractions” referred to in the reference (Figs. 6-7) appear to be within the meaning of “excipient or carrier” as required by instant claim 18. The composition may also include a trimer (see, e.g., Fig. 1), which meets the limitations of claim 25. Finally, the “grape juice” disclosed in Fitzpatrick (col. 1, l. 21) appears to be within the meaning of “energy drink” as recited in claim 24, as well as a dietary supplement or nutraceutical product as recited in claim 40. The compounds in question were obtained from concord grapes (col. 2, ll. 34-42), which meets the limitations of claim 38.
Endothelium-dependent vascular relaxation in the manner taught by Fitzpatrick appears be within the meaning of “increasing blood flow” as recited in claim 18 (see, e.g., applicant’s own specification at p. 1, ll. 18-21). The mechanism of action referred to in claims 22-23 would be inherent in this method. The discovery of previously unappreciated properties of the prior art, or of a scientific explanation for the prior art’s functioning, does not render it patentably new to the discoverer. The claiming of a new function or unknown property that is inherently present in the prior art, although not necessarily specifically disclosed therein, i.e., applicant’s discovery or recognition of the subject matter of claims 22-23, does not make the instant claims patentable. See MPEP 2112(I) (something which is old does not become patentable upon the discovery of a new property). Fitzpatrick discloses using the same compounds (various catechin gallates) for apparently the same purpose (inducing endothelium-dependent relaxation or increasing blood flow), so it is a reasonable conclusion that the limitations of claims 22-23 would necessarily be inherent in the teachings of Fitzpatrick. Applicant is reminded that mere recognition of such latent properties in the prior art does not render nonobvious an otherwise known invention. Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. The fact that applicant has apparently recognized other advantages that would flow naturally from following the suggestion of Fitzpatrick “cannot be the basis for patentability when the differences would otherwise be obvious.” See MPEP 2145(II) (prima facie obviousness is not rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art).
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 explained in MPEP 2141 et seq. They 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.
Claims 18-26, 38, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Fitzpatrick as applied to claims 18-19, 22-25, 38, and 40 above.
The disclosure of Fitzpatrick is relied upon as set forth above.
The subject matter of claims 20-21 would have been viewed as a matter of routine exper-imentation within the general teachings of Fitzpatrick and therefore prima facie obvious. Gener-ally, differences in concentration will not support the patentability of subject matter encom-passed by the prior art unless there is evidence indicating such parameters are 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.” See MPEP 2144.05(II)(A) (optimiza-tion within prior art conditions or through routine experimentation). Indeed, appli-cant’s own specification (p. 15, ll. 10-21) admits that “[o]ptimization of such factors is well within the level of skill in the art.” The examiner agrees that it would have been a matter of routine optimization and therefore finds claims 20-21 to be prima facie obvious.
To the extent that Fitzpatrick does not—strictly speaking—disclose administering combi-nations of catechin compounds as required by claims 25-26, using combinations of these compounds within the meaning of the instant claims for inducing EDR appears to be implicit inasmuch as the various fractions (see Figs. 6-7) are themselves mixtures; and if using such combinations is not implicit, it nevertheless would have been prima facie obvious for the reasons discussed in MPEP 2144.06(I) (combining equivalents known for the same purpose). The exam-iner concludes that at least claim 4 is anticipated by, or is at least prima facie obvious over, Fitzpatrick.
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 possi-ble 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 accompa-nied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejec-tion 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 18-26, 38, and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,766,422 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘422 Patent, of which the present application is a continuation, is directed to “[a] method of increasing blood flow in a subject, comprising: administering a composition to a subject, wherein the composition comprises: a therapeutically effective amount of an epigallocatechin gallate dimer and an epicatechin gallate dimer; and a pharmaceutically acceptable excipient or carrier” (emphasis added). On the other hand, the first independent claim of the instant application is directed to “[a] method of increasing blood flow in a subject, comprising: administering a composition to a subject, wherein the composition comprises: a therapeutically effective amount of an epigallocatechin gallate dimer or an epicatechin gallate dimer; and a pharmaceutically acceptable excipient or carrier” (emphasis added). The combination product claimed in the ‘422 Patent is within the scope of the instant claims. The instant claims are broader in scope, and are anticipated by the claims of the ’422 Patent. The examiner suggests a terminal disclaimer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
September 17, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
2 See the information disclosure statement (IDS) submitted on August 8, 2024.
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