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 .
Please note that the Examiner for this application has changed. Any inquiry concerning this communication should be directed to ANDREW TERRY MOEHLMAN.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/29/2025, 3/30/2026, and 5/19/2026, are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/18/2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 25 September 2024 is acknowledged. Examination had previously been extended to include Group II, claim 4.
Claim 5 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 9/25/2024.
Applicant’s election without traverse of the species of horseradish extract as the plant-derived extract/product, and food as the form in the reply filed on 9/25/2024 is acknowledged.
Claims 7 and 14 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/25/2024.
Claims 1-4, 6, and 10-13 are pending and have been examined on the merits.
Response to Amendment
Applicant’s remarks and amendments filed 5/18/2026, in response to the final rejection mailed 11/19/2025, are acknowledged and have been fully considered.
Any previous rejection or objection not mentioned herein have been withdrawn based upon Applicant’s amendments to the claims.
Applicant’s amendment to the claims is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Claim Rejections - 35 USC § 103 (modified)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Richards (WO 2017/053583, cited by Applicant in the IDS filed 1/25/2022) in view of Bilyk et al. (“Bilyk ”, J. Agric. Food Chem., 1985, cited by Applicant in the IDS filed 1/25/2022) and Yamada (JP 2009-155333, cited by Applicant in the IDS filed 1/25/2022).
Richards teaches methods for improving athletic performance, preventing fatigue, reducing recovery time after exercise, and/or boosting energy by administering a flavonoid composition (e.g., abstract; paragraph [0002]).
Suitable flavonoids taught in Richards include flavonols, such as quercetin and kaempferol (e.g., paragraphs [0003], [0044], [0053]). Therefore, the selection of an extract comprising kaempferol amounts to picking and choosing from a finite list of identified, predictable solutions, with a reasonable expectation of success. While Richards does not specifically recite the phrases “improvement in physical activity efficiency” (instant claim 1) or “reducing fatigue” (instant claim 4) ipsis verbis, methods of preventing fatigue would necessarily result in reducing fatigue, improving athletic performance with reduced recovery time after exercise, would also be synonymous with improved athletic efficiency. “[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” See MPEP 2144.01.
Richards teaches that the anti-fatigue composition can include about 10-500 mg of flavonoid, such as about 52 mg of flavonoid (e.g. [0014] and [0053]).
Regarding claim 13, Richards teaches that the composition comprising kaempferol may be provided in a pharmaceutically acceptable carrier or in a food composition ([0073];[0083]).
Richards does not expressly teach that the kaempferol is obtained or in the form of horseradish extract (as in the instant claims 1, 6, and 4).
Bilyk teaches that horseradish is generally known to contain kaempferol (e.g. Table 3). Bilyk also teaches a method for extracting flavanols from plants which includes extractions with methanol and a step of acid hydrolysis (e.g. “extracted flavonol glycosides were hydrolyzed to aglycons with 2N HCl”, pg. 2, left col under “Experimental Section”). Such broad steps of extraction, recited here at a high level of generality, are known to the art.
Yamada discloses an anti-fatigue agent containing wasabi extract as an active ingredient (e.g., paragraphs [0001], [0006]; see instant claims 4 and 6). Types of plants and relatives of wasabi discussed in Yamada include horseradish (Armoracia rusticana) (e.g. [0008]).
Yamada teaches dissolving extract of Sawa-wasabi in pure water, administering the same to a mouse orally, and putting the mouse in a water tank (corresponding to a “hypoxia state”; see instant claim 12), the time taken until the mouse was immobilized was longer than for a control group (e.g., example 1). Upon administering the extract to a volunteer orally and having the volunteer exercise on a bicycle ergometer (corresponding to the hypoxia state), the rate of increase in the lactic acid value in the blood was lower than for a placebo group (example 2).
The feature of the time taken until being immobilized in the water tank being prolonged, and the feature of the rate of increase in the uric acid value in the blood due to exercise being lower, correspond to “exercise efficiency improvement” (instant claim 1) and “endurance improvement” (instant claim 2). Yamada also teaches that using horseradish (Armoracia rusticana) as a raw material also showed the same results (e.g., paragraph [0024]).
Regarding claim 13, Yamada discloses the composition may be in the form of a food (e.g., paragraphs [0025]-[0026]).
Therefore, Yamada is deemed to teach extracts, including the wasabi-related plant horseradish (Armoracia rusticana) (e.g., paragraph [0008]), that improve physical activity efficiency, and reduce fatigue (e.g., see paragraph [0006]; Examples 1 and 2).
Therefore, prior to the effective filing date of the instant invention, it would have been obvious to one of ordinary skill in the art to combine the teachings of Richards, Bilyk, and Yamada for the predictable result of improving physical activity efficiency and reducing fatigue by administering an extract containing kaempferol from horseradish in a dose within the claimed amounts, thus arriving at the claimed invention.
One skilled in the art would be motivated to do so, with a reasonable expectation of success, because horseradish extract is already known to contain the flavonol kaempferol, as taught by Bilyk, and horseradish extract is also known to have the same or similar results of improving physical activity efficiency and reducing fatigue, as taught by Yamada. One seeking to produce and administer a flavonoid-containing composition including kaempferol such as the one taught in Richards for reduced fatigue would have predictably looked to known natural sources of the compound. The selection of horseradish for the source of the extract thus amounts to a matter of judicious selection among a finite list of alternatives in the art.
Richards teaches administering the flavonoid, which includes kaempferol, in doses of as low as 10mg, including 200mg, and teaches a particular among of 54mg (see [0054]). These values fall within the claimed range of 0.1mg to 200mg of kaempferol.
Regarding claims 2 and 3, it is noted that, while Richards does not specifically recite “improvement in endurance” (instant claim 2) and “reduction of breathlessness (instant claim 3), Yamada teaches the features of the time taken until being immobilized in the water tank being prolonged, and the rate of increase in the uric acid value in the blood due to exercise being lower, both of which corresponding to “endurance improvement” (instant claim 2). Additionally, Richards teaches administration of kaempferol for improving athletic performance and preventing fatigue, and Yamada teaches administration of the same composition (horseradish extract) in amounts sufficient to also achieve similar purposes of exercise efficiency improvement and endurance improvement. Therefore, the skilled artisan would reasonably expect the same composition to reduce breathlessness, absent convincing evidence otherwise.
Regarding claims 10 and 11, Richard teaches using effective amounts of flavonoid including kaempferol, the active ingredient in the anti-fatigue composition, that fall within all of the claimed ranges. The selection of such an amount for the kaempferol in the instant method would thus be obvious because such ranges are expressly taught.
Regarding claim 12, while Richards does not specifically teach administration to a subject who is hypoxic, Yamada teaches that, upon dissolving stem extract of Sawa-wasabi in pure water, administering the same to a mouse orally, and putting the mouse in a water tank (corresponding to a “hypoxia state”; see instant claim 12), the time taken until the mouse was immobilized was longer than for a control group (e.g., example 1). Upon administering the extract to a volunteer orally and having the volunteer exercise on a bicycle ergometer (corresponding to the hypoxia state), the rate of increase in the lactic acid value in the blood was lower than for a placebo group (e.g., example 2). Therefore, the skilled artisan would have reasonably predicted that the composition of the combined prior art may be administered to a subject who is hypoxic, with a reasonable expectation of success.
Regarding claim 13, Richards teaches the composition may be formulated in the form of a food, such as a chewable wafer or gummi chews (e.g. [0017], [0073];and [0083]). Such formulations are known to the art, and would have been predictably resulted in easier administration and/or improved taste.
From the teachings of the cited references, it is apparent that there would have been a reasonable expectation of success in combining the teachings therein to arrive at the claimed invention because the references establish that the flavonoid kaempferol is used in anti-fatigue compositions, that kaempferol can be readily obtained from horseradish, and that the recited extraction methods including acid extraction are known to the art.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, as evidenced by the cited references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 5/18/2026 regarding the rejections under 35 U.S.C. § 103 have been fully considered to that extent that the arguments pertain to the modified rejections above, but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that several of the features upon which applicant relies are not recited in the rejected claims.
Applicant argues that “none of the cited references teach or suggest an enzymatic treatment and an acid hydrolysis treat as required by the present claims.”. However, the claims recite that the treatment is “an enzymatic treatment and/or an acid hydrolysis treatment”.
The previously cited reference “Bilyk” does indeed recite an acid hydrolysis step that produces aglycons (“extracted flavonol glycosides were hydrolyzed to aglycons with 2N HCl”, pg. 2) and the rejection above has been modified to reflect this finding. Further, such steps of acid hydrolysis and/or enzymatic hydrolysis are well-known and established steps of treatment in the art. Because these known treatment steps are recited at a high level of generality, they do not appear to amount to a critical distinction, absent evidence of unexpected results.
Applicant also appears to argue that the increased aglycone content in accordance with the claimed invention is not taught in the cited references, however this is not expressly recited in the claims and thus is not found relevant to the rejections of record. 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).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to Applicant’s arguments, broadly, it is reiterated that Richards teaches methods for improving athletic performance, preventing fatigue, reducing recovery time after exercise, and/or boosting energy by administering flavonoid composition (abstract; [0002]) and that suitable flavonoids include flavonols, such as quercetin and kaempferol ([0003], [0053]). Bilyk indeed teaches that horseradish contains kaempferol, which appears to be recognized in the art. Since the extracts known in the art appear to be the same as that so instantly claimed and the extract would be expected to contain kaempferol, which is taught to be effective for improving athletic performance, preventing fatigue, reducing recovery time after exercise, and/or boosting energy, it would be expected that an extract which is essentially the same, having the active ingredient kaempferol would have the instantly claimed effect.
Applicant argues that Yamada primarily pertains to extracts of wasabi, but this is not found persuasive as Yamada also expressly teaches that using horseradish (Armoracia rusticana) as a raw material also showed the same results as the anti-fatigue composition containing kaempferol from wasabi (e.g., paragraph [0024]). Yamada clearly teaches that “the wasabi used in the present invention is a plant belonging to the family Cruciaceae, and examples thereof include river wasabi or field wasabi (Wasabia japonica Matsum), horseradish ( Armoracia rusticana Gaertn.), lily wasabi ( Wasabiatenuis Matsum.), and Siberian wasabi ( Cardamyezoensis Maxim. )” (See e.g. paragraph 0008 of the translation on page 4).
Because both wasabi and horseradish are established in the art to contain the flavonoid kaempferol, the selection of either as the source of the material for administration to prevent fatigue, increase endurance, and/or to treat hypoxia would have naturally flowed from the teachings in the art. Thus, Yamada teaches that the instantly claimed horseradish can be used as a source of kaempferol, selected from a small group of alternatives. Further, there is no indication in the art or the instant disclosure that the source of the kaempferol has a critical effect on the results of the administration, and indeed, in the instant disclosure, multiple potential plant sources of this compound are expressed as suitable sources.
MPEP 2141.II.C establishes that "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle."Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ."Id. at 418, 82 USPQ2d at 1396.
In regard to Applicant’s argument pertaining to the amount of the kaempferol in the plant-derived extract, it is noted that Richards teaches administering effective amounts of flavonoids for improving athletic performance, preventing fatigue, reducing recovery time after exercise, of which the amount of the flavonoid are within the amounts so instantly claimed. Richards expressly includes kaempferol as a suitable alternative, and a particular embodiment taught in Richards is of about 52 mg in the composition ([0053]). Thus, the selection and providing of kaempferol, taught in both Richards and Yamada to be effective against fatigue, in the claimed amounts would have been obvious to one of ordinary skill, as explained above.
Further, MPEP § 2144.05 describes that the determination of suitable or effective concentration of a known composition (or performing a known method) 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, in view of the absence of any convincing evidence of unexpected results or the criticality of the claimed ranges, the determination of an effective concentration for the kaempferol would have been prima facie obvious.
The rejection of claims 1-4, 6, and 10-13, as being obvious over the combination of Richards (WO 2017/053583), Bilyk et al. (“Bilyk ”, J. Agric. Food Chem., 1985) and Yamada (JP 2009-155333) is thus maintained, as modified above.
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 1-4, 6, and 10-13 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,048,683 in view of Bilyk et al. (“Bilyk ”, J. Agric. Food Chem., 1985, cited by Applicant in the IDS filed 25 January 2022) and Yamada (JP 2009-155333, cited by Applicant in the IDS filed 25 January 2022).
US Patent No. ‘683 claims a method for improving physical activity efficiency (claim 1) or reducing fatigue (claim 15), comprising administering a composition comprising a kaempferol analog of Formula I or a glycoside thereof to a subject in need thereof (claims 1, 15), wherein the kaempferol analog or a glycoside thereof is kaempferol (claim 5). The improvement in physical activity efficiency may be improvement in endurance (claim 2) or reduction of breathlessness (claim 3). The composition may comprise 0.1 mg to 50 mg, or 0.5 mg to 50 mg, of the kaempferol (claims 6-9). The composition may be administered to a subject who is hypoxic (claim 12), and may be a food or drink (claim 13).
US ‘683 does not specifically claim kaempferol in the form of a horseradish extract (instant claims 1, 4, 6).
However, Bilyk generally teaches horseradish is known to contain kaempferol (e.g., see Table 3). Bilyk also teaches a method for extracting flavanols from plants which includes extractions with methanol and a step of acid hydrolysis (e.g. “extracted flavonol glycosides were hydrolyzed to aglycons with 2N HCl”, pg. 2, left col under “Experimental Section”). Such broad steps of extraction, recited here at a high level of generality, are known to the art.
Additionally, Yamada teaches wasabi extracts, including horseradish (Armoracia rusticana) (e.g., paragraph [0008]), improve physical activity efficiency and reduce fatigue (e.g., see paragraph [0006]; Examples 1 and 2; and discussion at paragraph 10, above).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to combine the teachings of Bilyk and Yamada with US ‘683 and improve physical activity efficiency and reduce fatigue by administering horseradish extract containing kaempferol; thus arriving at the claimed invention.
One skilled in the art would be motivated to do so, with a reasonable expectation of success, because horseradish is already known to contain kaempferol, as taught by Bilyk, and horseradish extract is also already known to have the same or similar results of improving physical activity efficiency and reducing fatigue, as taught by Yamada. Further, the concentrations of kaempferol recited in the reference patent claims are within the same range as required of the instantly recited composition.
Thus, all of the limitations of the instant claims would have been obvious over the subject matter of the ‘683 patent in view of the teachings of Yamada and Bilyk, in consideration of the knowledge and ordinary skill level in the art.
Response to Arguments
Applicant's arguments regarding the double patenting rejections have been fully considered but they are not persuasive.
Applicant argues essentially the same arguments for the double patenting rejection as those for the 103 rejection discussed above. The response to these arguments are essentially the same as those set forth above.
Applicant particularly points out that the reference patent does not require that the extract is produced by means of an enzymatic treatment and an acid hydrolysis treatment. This is not persuasive as the claims recite that the treatment is “an enzymatic treatment and/or an acid hydrolysis treatment”. Further, as discussed above, “Bilyk” does teach an acid hydrolysis step that produces aglycons (“extracted flavonol glycosides were hydrolyzed to aglycons with 2N HCl”, pg. 2) and the rejection above has been modified to reflect this finding.
Further, such steps of acid hydrolysis and/or enzymatic hydrolysis are well-known and established steps of treatment in the art. Because these known treatment steps are recited at a high level of generality, they do not appear to amount to a critical distinction, absent evidence of unexpected results.
Regarding the amount of kaempferol that is provided, the concentrations recited in the reference patent claims include 0.1 mg to 50 mg, or 0.5 mg to 50 mg, of the kaempferol and doses of 1mg to 30mg of the kaempferol or kaempferol analog (see claims 6-11). These amounts are well within the claimed ranges. Regardless, the determination of suitable or effective concentration of a known composition (or performing a known method) 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05).
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yeom et al. (US PGPub No. 20080280335) discloses a method comprising obtaining a plant extract containing kaempferol glycosides from a plant using water or an organic solvent; and hydrolyzing the plant extract using an acid, a base, an enzyme or a microbe producing the enzyme to isolate kaempferol (Abstract, Claims 1-2, [0032]-[0034]). Yeom teaches this method may be useful to mass-produce kaempferol, which is one of main physiological activating ingredients, from a plant, particularly a seed or leaf of green tea (Abstract; [0020]).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW TERRY MOEHLMAN whose telephone number is (571)270-0990. The examiner can normally be reached M-F 9am-5pm EST.
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/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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