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 amendments filed on 6/13/2025 have been entered.
Any rejection found in the previous office action and not provided herein have been withdrawn based upon Applicant’s amendments to the claims.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3 and 6-14 in the reply filed on 25 September 2024 is acknowledged. Upon review, examination is extended to include Group II, claim 4.
Claim 5 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 25 September 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 25 September 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Claims 7 and 14 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 25 September 2024.
Claims 1-4, 6, and 8-13 are under examination.
Claim Rejections - 35 USC § 102/103
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 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, 2, 4, 6, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yamada (JP 2009-155333, cited by Applicant in the IDS filed 25 January 2022)(newly applied as necessitated by amendment).
Regarding claims 1, 2, 4, 6, and 12, 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 wasabi include horseradish (Armoracia rusticana) (e.g., paragraph [0008]). 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). 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). Using horseradish (Armoracia rusticana) as a raw material also showed the same results (e.g., paragraph [0024]). Regarding claim 13, Yamada discloses the composition in the form of a food (e.g., paragraphs [0025]-[0026]).
Yamada does not expressly teach an extract of horseradish obtained by subjecting horseradish to an enzymatic treatment and/or an acid hydrolysis treatment, and an extraction; or to an enzymatic treatment and/or an acid hydrolysis treatment, and the method not including an extraction. However, it should be noted that the claims constitute Product-by-Process type claims. In Product-by-Process type claims, the process of producing the product is given no patentable weight since it does not impart novelty to a product when the product is taught by the prior art. See In re Thorpe, 227 USPQ 964 (CAFC 1985); In re Marosi, 218 USPQ 289, 292-293 (CAFC 1983) and In re Brown, 173 USPQ 685 (CCPA 1972). Consequently, even if a particular process used to prepare a product is novel and unobvious over the prior art, the product per se, even when limited to the particular process, is unpatentable over the same product taught in by the prior art. See In re King, 107 F.2d 618, 620, 43 USPQ 400, 402 (CCPA 1939); In re Merz, 97 F.2d 599, 601, 38 USPQ 143-145 (CCPA 1938); In re Bergy, 563 F.2d 1031, 1035, 195 USPQ 344, 348 (CCPA 1977) vacated 438 US 902 (1978); and United States v. Ciba-Geigy Corp., 508 F. Supp. 1157, 1171, 211 USPQ 529, 543 (DNJ 1979). Finally, since the Patent Office does not have the facilities for examining and comparing Applicant's composition with the compositions of the prior art reference, the burden is upon Applicant to show a distinction between the material, structural and functional characteristics of the claimed composition and the composition of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). Therefore, the invention of Yamada anticipates the claimed invention.
With respect to the USC 102/103 rejection above, please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s claimed extract is different and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
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.
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, 12, and 13 remain rejected under 35 U.S.C. 103 as being unpatentable over Yamada (JP 2009-155333, cited by Applicant in the IDS filed 25 January 2022).
The teachings of Yamada are set forth above. The invention of Yamada is delineated above (see paragraph 13, above).
Specifically regarding claim 3 (and more generally regarding the remaining claims), Yamada does not specifically teach reduction of breathlessness. However, Yamada teaches administration of the same composition (horseradish extract) in amounts sufficient to achieve similar purpose (“exercise efficiency improvement” and “endurance improvement”), and mice and humans to which the extract was administered likely had increased oxygen utilization based on the results achieved (e.g., see Examples 1 and 2), and thus a reduced shortness of breath in a water tank or during exercise was highly likely. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to administer horseradish extract for the same or similar purpose of reducing breathlessness, with a reasonable expectation of success.
Claims 1-4, 6, and 8-13 remain rejected under 35 U.S.C. 103 as being unpatentable over Richards (WO 2017/053583, cited by Applicant in the IDS filed 22 November 2022) 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).
The teachings of Yamada are set forth above. The invention of Yamada is delineated above (see paragraph 13, above).
Regarding claims 1, 4, 6, and 8, Richards teaches methods for improving athletic performance, preventing fatigue, reducing recovery time after exercise, and/or boosting energy by administering flavonoid composition (e.g., abstract; paragraph [0002]). Suitable flavonoids include flavonols, such as quercetin and kaempferol (e.g., paragraphs [0003], [0044], [0053]). Therefore, the selection of kaempferol amounts to picking and choosing from a finite list of identified, predictable solutions, with a reasonable expectation of success. Additionally, while Richards does not specifically recite the phrases “improvement in physical activity efficiency” (instant claim 1) and “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 does not specifically teach the kaempferol is obtained or in the form of horseradish extract (instant claims 1, 4). However, Bilyk generally teaches horseradish is known to contain kaempferol (e.g., see Table 3). Additionally, Yamada teaches wasabi extracts, including horseradish (Armoracia rusticana) (e.g., paragraph [0008]), improve physical activitiy efficiency and reduce fatigue (e.g., see paragraph [0006]; Examples 1 and 2; and discussion at paragraph 10, above).
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 Richards 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 extract 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.
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 evidence otherwise.
Regarding claims 9-11, Richards teaches the composition can include about 10-500 mg of flavonoid, such as about 52 mg of flavonoid (e.g., paragraph [0014]).
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 reasonably expect 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., paragraph [0017]).
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 8-13 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 ‘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). 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.
Response to Arguments
Applicant’s arguments, see Applicant Arguments/Remarks Made in an Amendment, filed 6/13/2025, with respect to the 112(b) rejection have been fully considered and are persuasive. The 112(b) rejection over claim 9 has been withdrawn.
Applicant's arguments filed 6/13/2025 have been fully considered but they are not persuasive.
Applicant argues Yamada teaches a method for preparing wasabi extract, including drying and pulverizing a wasabi sample, and contacting the prepared sample with an extraction solvent, such as water, aqueous solvents containing lower alcohols, etc. Applicant further argues that Yamada does not teach an enzymatic treatment and an acid hydrolysis treatment as required by the present claims as amended. Applicant further argues that with the extraction process taught by Yamada that even if the wasabi comprises "kaempferol aglycone", kaempferol aglycone cannot be extracted sufficiently.
Applicant further argues that the scientific name of the "wasabi" disclosed in Yamada is "Wasabiajaponica" or "Eutrema wasabi", which is a different plant from "horseradish".
However, this is not found persuasive because 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). Thus, Yamada teaches that the instantly claimed horseradish can be used and is selected from a small group of alternatives. The specification of the instant application clearly discloses, “A method of the extraction is not particularly limited, and the extraction may be performed by a method usually used in the field of manufacturing pharmacy or food engineering. For example, the extraction may be performed by using one or more organic solvents selected from the group consisting of ethanol, methanol, butanol, ether, ethyl acetate and chloroform, or a mixed solvent of the organic solvent(s) and water” (See e.g. paragraph 0065). Therefore, the method of extraction would be expected to provide the same extract as claimed, since the specification of the instant application clearly teaches that it doesn’t matter how the extract is obtained. Yamada clearly teaches extraction of the same horseradish with the same solvent system, and thus the extracts are analogous, absent evidence to the contrary. Further, Applicant has not disclosed how the enzymatic extraction is performed, so by pulverizing the plant, enzymes would be broken and thus result in an enzymatic extraction.
Regarding claims 1-4, 6, and 8-13 rejected under 35 U.S.C. § 103 as being unpatentable over Richards (WO 2017/053583, cited by Applicant in the IDS filed 22 November 2022) in view of Bilyk et al. ("Bilyk ", J. Agric. Food Chem., 1985, cited by Applicant in the IDS filed 25 January 2022) and Yamada, Applicant argues that as noted above, claims 1 and 4 as amended recite that the plant-derived extract or processed product is obtained by subjecting a raw material to an enzymatic treatment and/or an acid hydrolysis treatment and that none of the cited references teach or suggest an enzymatic treatment and an acid hydrolysis treatment as required by the present claims and further argues points with respect to Yashida as above.
The response this argument is the same as that above.
Applicant further argues that Richards does not teach horseradish. Richards also does not disclose the enzyme treatment or acid hydrolysis treatment as required by the present claims.
Bilyk merely shows that horseradish contains kaempferol. Applicant further argues that Bilyk does not disclose the enzyme treatment or acid hydrolysis treatment as required by the present claims.
This is not found persuasive because as described in the 103 rejection above, 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, since Richards teaches methods for improving athletic performance, preventing fatigue, reducing recovery time after exercise, and/or boosting energy by administering flavonoid composition (e.g., abstract; paragraph [0002]) and that suitable flavonoids include flavonols, such as quercetin and kaempferol (e.g., paragraphs [0003], [0044], [0053]). Bilyk teaches that horseradish contains kaempferol. Therefore, since the extract appears to be one and the same as that claimed and the extract would be expected to contain kaempferol, which is known to be effective for improving athletic performance, preventing fatigue, reducing recovery time after exercise, and/or boosting energy, it would be expected that the extract and its active kaempferol would have the instantly claimed effect. Therefore, the rejection is maintained for the reasons of record and set forth above.
Applicant argues the same as the above arguments for the double patenting rejection as those for the 103 rejection. The response to these arguments are the same as those set forth above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Amy L. Clark whose telephone number is (571)272-1310. The examiner can normally be reached M-F 8:00am-5:00pm.
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/AMY L CLARK/ Supervisory Patent Examiner, Art Unit 1628