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 .
The Amendment filed 4/21/26 has been received, entered into the record, and carefully considered. The following information provided in the amendment affects the instant application by:
No claims have been amended, added, or canceled.
Remarks drawn to rejections of Office Action mailed 10/22/25 include:
102(a)(1) rejection: which has been maintained for reasons of record.
Provisional Double Patenting rejection: which has been maintained for reasons of record.
An action on the merits of claims 1-14 is contained herein below. The text of those sections of Title 35, US Code which are not included in this action can be found in a prior Office action.
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.
The rejection of claim(s) 1-11 and 13-14 under 35 U.S.C. 102(a)(1) as being anticipated by DuPont et al. (European Journal of Clinical Nutrition, 2004, vol. 58, pp 947-954) is maintained for reasons of record.
DuPont et al. disclose methods of administering a kaempferol containing soups from curly endive to humans (see materials and subjects on page 948) wherein the dosage was around 9mg (see results on page 947). Since the same compound (kaempferol) was administered in the same amounts (9mg) to the same population (a subject in need thereof) via the same means (orally), one would have expected the same results to occur – to improve dynamic/kinetic visual activity or promote ATP production. The examiner would like to note that DuPont’s methodological step of administering their kaempferol composition would have inherently performed the method as instantly claimed. It is noted that if DuPont, having taken the manipulative steps described therein, had attempted to measure for the results as described in the instant application, DuPont would have uncovered those results, as they are directly correlative to the method as practiced by DuPont. Applicant's discovery of differing effects of a prior art method does not give the discoverer a right to exclude others from practicing the prior arts method of using kaempferol containing products as done in DuPont, as the prior arts method would have inherently performed the method as instantly claimed. See Ex Parte Novitski, 26 USPQ 2d (BNA) 1389. A hypothetical example clarifies this principle. Humans lit fires for thousands of years before realizing that oxygen is necessary to create and maintain a flame. The first person to discover the necessity of oxygen certainly could not have obtained a valid patent claim for "a method of making a fire by lighting a flame in the presence of oxygen." Even if prior art on lighting fires did not disclose the importance of oxygen and one of ordinary skill in the art did not know about the importance of oxygen, understanding this law of nature would not give the discoverer a right to exclude others from practicing the prior art of making fires. EMI v. Cypress Semiconductor, 2001 US Fed. Cir. Ct. of App. It is noted that in the instant case the steps of improving dynamic/kinetic visual acuity and promoting ATP production would be read on by generic administration as these patient populations are not closed as all humans would benefit from improving dynamic/kinetic visual acuity and promoting ATP production as these are not disease states, but rather results that would occur after administration to a normal subject.
Applicant’s arguments filed 4/21/26 have been considered but are not persuasive. Applicants argue that DuPont is drawn to determining the absorption, excretion, and metabolism of kaempferol in humans and to study the pharmokinetic activity of kaempferol from endive over 24 hours. Applicants state their novel biological effects of kaempferol derivatives were shown to improve dynamic/kinetic visual activity and promote ATP production, which are newly discovered by the present inventors and could not be inferred from the generally known effects of the compounds. Applicants argue that dynamic/kinetic visual activity is a specific function and ATP production comprises a highly complex network of metabolic pathways in vivo – neither of which is disclosed in DuPont. Applicants then point to the specification for proof of their work. Applicants stated that there is no scientific or legal basis for denying the novelty of the new medical use as claimed herein.
However, as noted above, the examiner is relying on the well-established rule of inherency – there is nothing different about the patient populations of the prior art and the instant application; and the only active step required herein is orally administering 0.1-200mg/day. If the art meets this process step – administering the same compound in the same amount to the same patient population, inherency is established. This is the case herein. Applicants are administering the same drug, in the same amount, by the same means, to the same population – the results claimed herein would have then necessarily occurred in the prior arts correlative methods of administration. As noted above, all patient populations would be embraced by those needing/benefiting from improving dynamic/kinetic visual acuity as in claim 1; and promoting ATP production as in claim 2 – thus the patient populations of DuPont would met the limitations of “a patient in need thereof”. Incorporating the limitations of claim 12 into claims 1 and 2 would overcome this rejection.
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.
The provisional rejection of claims 1, 3-11, and 13-14 on the ground of nonstatutory double patenting as being unpatentable over claim 5 of copending Application No. 17/433,904 (reference application) is maintained for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are drawn to substantially overlapping subject matter in that both are improving dynamic/kinetic visual activity with the same compounds – kaempferol. The extracts of ‘904 would have the same agents claimed herein, and thus both applications are drawn to administering the same drugs to treat the same thing. See examples of ‘904 showing the extracts therein comprise kaempferol.
Applicants arguments have been considered but are not persuasive. Applicants argue that the active ingredient herein is a single chemical compound and ‘904 uses a plant derived extract. As noted, the compositions of ‘904 comprise the active compounds claimed herein – and the compositions claimed herein use open language and comprise the active compound, thus the additional agents from the extracts of ‘904 are not precluded from being present herein. It is noted that applicants did not argue the extracts of ‘904 comprise differing compounds than claimed herein. As such, both claim sets are drawn to administering the same compounds in the same amounts to the same populations to produce the same results and it is obvious the claims are substantially overlapping.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The art is silent to obtaining the claimed results in a subject who is hypoxic.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TRAVISS C. MCINTOSH III
Primary Examiner
Art Unit 1693
/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693
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