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 . 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.
Priority
The instant application claims foreign priority to KR10-2023-0135350 filed on 10/11/2023. The certified copy of the foreign priority application filed on 10/22/2024 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/12/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
Claims 1-6 are pending and being examined on the merits herein.
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) 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Bartos et al. (US20160213673A1 in PTO-892) in view of US20070004650A1 (in PTO-892) and JPH09266767A (in PTO-892, an English translation is included in the PTO-892 and used as the basis for this rejection).
Bartos discloses compositions and formulations comprising dihydrocapsiate, caffeine, and arginine that can be used to increase human endurance during times of physical activity (Abstract).
Bartos discloses their compositions increase or enhance endurance when ingested by sparing glycogen stores, increasing aerobic activity over anaerobic activity during times of physical activity and thereby reducing metabolite buildup that would normally lead to exhaustion and limitations on endurance by a person not ingesting a composition or formulation of the present disclosure (paragraph 0003). Bartos discloses that their compositions allow athletes to work through the warning signals the body has in place, be it exhaustion/fatigue or micro tears in the muscles that actually increase strength when healed (paragraph 0022).
Bartos discloses that UCP-3 (uncoupling protein 3 gene) is important for endurance as UCP-3 is expressed in the skeletal muscle of all mammals and play a role in the transport of free fatty acids (paragraph 0011). Bartos discloses that an increase of ammonia in muscle (which is a byproduct of deamination of AMP in fast-twitch fibers) leads to fatigue due to ammonotoxemia and lactic acidemia (excess lactic acid) (paragraph 0027).
Bartos discloses that their compositions may optionally include other ingredients including green tea catechins, hawthorn, hawthorn flavonoids, gallocatechin gallate, isoquercitrin, and others (paragraphs 0048 and 0043). Bartos teaches their compositions include various food and drink products (paragraph 0061).
Even though Bartos teaches a method of increasing endurance by administering a composition that can optionally include several ingredients such as green tea catechins, gallocatechin gallate, hawthorn, isoquercitrin, and others, the inclusion of these compounds is further supported by the following additional prior arts. Furthermore, Bartos does not disclose a weight ratio of 9:1 to 1:9 gallocatechin gallate:isoquercitrin.
US’650 discloses endurance improving agents, antifatigue agents, and AMPK activators comprising catechins as an active ingredient for physical activities in broad sense, such as exercises requiring endurance, labor requiring repeated muscle exercise, and the like (Abstract and claim 1).
US’650 discloses that catechins encompasses gallocatechin gallate and other catechin compounds (paragraph 0026). US’650 discloses that the catechins are extracted from green tea leaves (paragraph 0027). US’650 discloses that the amount of catechins in their preparations can range from 0.01% to 5 wt% for beverage or food compositions to 0.01 to 95% wt for oral preparations such tables or liquid medicines (paragraph 0039). US’650 discloses that the daily dosages ranges from 100-3000 mg / 60 kg bodyweight (paragraph 0040).
US’650 demonstrates in the Examples (paragraphs 0041-0052) that the administration of catechins significantly improved swimming endurance of mice (Table 3 paragraph 0047) and activated AMPK (Table 4 paragraph 0052).
JP’767 discloses food and beverages containing hawthorn extract that are effective in improving endurance (paragraph 0001). JP’767 discloses that the amount of hawthorn extract included in foods or beverages is 1 to 10% (paragraph 0008).
JP’767 discloses that hawthorn extract contains several components including isoquercitrin and others (paragraph 0009) and further demonstrates in example 4 (paragraph 0018-0019) that a 10% aqueous solution of hawthorn extract contained 5 mg of isoquercitrin and other components.
JP’767 demonstrates in Example 2 (paragraphs 0013-0017) that the mice that were given the hawthorn extract had increased endurance over the control mice group.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the food or drink composition of Bartos by selecting and preparing the amount of gallocatechin gallate as disclosed in US’650 as well as selecting and preparing the amount of hawthorn that contains isoquercitrin as disclosed in JP’767 to arrive at the claimed invention.
One of ordinary skill in the art would have included gallocatechin gallate and hawthorn from within the teachings of Bartos based on guidance from US’650 and JP’767 with a reasonable expectation of success because Bartos teaches their compositions are useful for improving endurance and can optionally include gallocatechin gallate and hawthorn, and both US’650 and JP’767 disclose that gallocatechin gallate and hawthorn are also active components that are useful for improving endurance.
Furthermore, in regards to instant claim 2, an ordinary skilled artisan would have performed routine optimization to arrive at the claimed weight ratio of 9:1 to 1:9 gallocatechin gallate:isoquercitrin because US’650 discloses that 0.01% to 5 wt% catechins, which includes gallocathcin gallate, can be included in beverage or food compositions for improving endurance. Furthermore, JP’767 discloses that 1-10% of hawthorn extract is suitable for food or drink compositions for improving endurance and further discloses that 10% hawthorn extract contains 5 mg isoquercitrin. See MPEP 2144.05 II.
In regards to instant claims 3 and 5, it would have also been prima facie obvious before the effective filing date of the claimed invention that the composition as disclosed by the combined teachings of Bartos, US’650, and JP’767 described above can be administered to a subject in need of inhibiting lactic acid accumulation in muscle cells and increasing expression of fatty oxidation-related genes as suggested in Bartos to arrive at the claimed invention.
One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Bartos discloses that lactic acidemia (excess lactic acid) in muscles leads to fatigue and that UCP-3 is important for endurance and is expressed in the skeletal muscle of all mammals and plays a role in the transport of free fatty acids. Furthermore, the combined teachings of Bartos, US’650, and JP’767 described above provide a composition for improving endurance to work through fatigue and increasing aerobic activity as described above.
Lastly, it is noted that the instant specification was examined for unexpected results but were not identified.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bartos et al. (US20160213673A1 in PTO-892) in view of US20070004650A1 (in PTO-892) and JPH09266767A (in PTO-892, an English translation is included in the PTO-892 and used as the basis for this rejection), as applied to claim 1 above, and further in view of Huertas et al. (Oxidative Medicine and Cellular Longevity, 2019 in PTO-892).
The combined teachings of Bartos, US’650, and JP’767 are as described above and teach the method of instant claim 1 as discussed above.
The combined teachings, however, do not teach administering to a subject who needs to increase mitochondria in muscle cells.
Huertas discloses recent findings on exercise-induced mitochondrial adaptations (Abstract).
Huertas discloses that if homeostatic threat is triggered by endurance exercise (i.e., 60-90% VO2max) where the maintenance of ATP production mainly relies on the aerobic pathways, then a number of responses at the cellular (but also systemic) level occur to soften the next homeostatic challenge (last paragraph left column page 5). Huertas discloses that this effect can be seen in endurance trained subjects, which were found to have higher skeletal muscle mitochondrial volume than sedentary subjects. Huertas discloses that the increase in mitochondrial volume seems to be one of the most important effects that improves endurance performance (first paragraph right column page 5).
It would have been prima facie obvious before the effective filing date of the claimed invention that the composition as disclosed by the combined teachings of Bartos, US’650, and JP’767 described above can be administered to the patient population suggested in Huertas to improve endurance performance to arrive at the claimed invention.
One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Huertas teaches that higher skeletal muscle mitochondrial volume is present in endurance trained subjects, and the combined teachings of Bartos, US’650, and JP’767 described above provide a composition for improving endurance as described 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 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/883,178 (‘178) in view of Bartos et al. (US20160213673A1 in PTO-892), US20070004650A1 (in PTO-892), and JPH09266767A (in PTO-892, an English translation is included in the PTO-892 and used as the basis for this rejection).
The claims of ‘178 recite a method for controlling blood sugar, comprising administering an effective amount of Gallocatechin Gallate (GCG) and Isoquercitrin (IQC) to a subject in need thereof (claim 1), wherein Gallocatechin Gallate (GCG) and Isoquercitrin (IQC) are contained in a weight ratio of 9:1 to 1:9 (claim 2), wherein the subject needs to increase expression of citric acid cycle-constituting genes (claim 6), wherein the subject needs to inhibit accumulation of lactic acids in cells (claim 7), and wherein the subject needs to promote aerobic energy metabolism in cells (claim 8).
The claims of ‘178 recite the same administration of CGC and IQC at a ratio of 9:1 to 1:9 as well as a subject in need of increasing aerobic energy metabolism in cells. However, the claims of ‘178 do not recite a method of improving fatigue, exercise performance or endurance.
The teachings of Bartos, US’650, and JP’767 are as described above. Furthermore, the combined teachings of Bartos, US’650, and JP’767 teach a method of improving endurance by administering a composition comprising CGC and IQC as discussed above.
It would have been prima facie obvious before the effective filing date of the claimed invention that the composition recited in ‘178 can be administered for improving endurance as disclosed by the combined teachings of Bartos, US’650, and JP’767 described above to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both the claims of ‘178 and the combined teachings of Bartos, US’650, and JP’767 described above recite compositions comprising effective amounts of CGC and IQC, and the combined teachings of Bartos, US’650, and JP’767 described above provide further guidance that a composition comprising this combination can be used to improve endurance.
In regards to instant claims 3 and 5, it would have also been prima facie obvious before the effective filing date of the claimed invention that the composition as recited by the combination of the claims of ‘178, Bartos, US’650, and JP’767 described above can be administered to a subject in need of inhibiting lactic acid accumulation in muscle cells and increasing expression of fatty oxidation-related genes as suggested in Bartos to arrive at the claimed invention.
One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Bartos discloses that lactic acidemia (excess lactic acid) in muscles leads to fatigue and that UCP-3 is important for endurance and is expressed in the skeletal muscle of all mammals and plays a role in the transport of free fatty acids. Furthermore, the combination of the claims of ‘178, Bartos, US’650, and JP’767 described above recite a composition for improving endurance to work through fatigue and increasing aerobic activity as described above.
Lastly, it is noted that the instant specification was examined for unexpected results, however the instant claims are not commensurate in the scope with unexpected results as discussed above.
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/883,178 (‘178) in view of Bartos et al. (US20160213673A1 in PTO-892), US20070004650A1 (in PTO-892), JPH09266767A (in PTO-892, an English translation is included in the PTO-892 and used as the basis for this rejection), and Huertas et al. (Oxidative Medicine and Cellular Longevity, 2019 in PTO-892).
The combination of the claims of ‘178, Bartos, US’650, and JP’767 are as described above and recite the method of instant claim 1 as discussed above.
The combined references, however, do not recite a subject who needs to increase mitochondria in muscle cells.
The teachings of Huertas are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention that the composition as recited by the combination of the claims of ‘178, Bartos, US’650, and JP’767 described above can be administered to the patient population suggested in Huertas to improve endurance performance to arrive at the claimed invention.
One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Huertas teaches that higher skeletal muscle mitochondrial volume is present in endurance trained subjects, and as recited by the combination of the claims of ‘178, Bartos, US’650, and JP’767 described above recite a composition for improving endurance as described above.
This is a provisional nonstatutory double patenting rejection.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/663,736 (‘736) in view of Bartos et al. (US20160213673A1 in PTO-892), US20070004650A1 (in PTO-892), and JPH09266767A (in PTO-892, an English translation is included in the PTO-892 and used as the basis for this rejection).
The claims of ‘736 recite composition for inhibiting lipogenesis; inhibiting fat accumulation; promoting fat breakdown; reducing body fat; and/or preventing, improving or treating obesity or metabolic diseases, comprising an effective amount of Gallocatechin Gallate (GCG) and Isoquercitrin (IQC) in a weight ratio of 1:1 to 1:9 (claim 1) and wherein the composition is administered to a subject in need of increasing the expression of one or more genes selected from the group consisting of ACO, CPT, PPARα, tfam, NDUFA9, COX4, ATP5a, UCP1, and UCP2 (claim 5).
The claims of ‘736 recite the same composition comprising CGC and IQC at a ratio of 1:1 to 1:9. However, the claims of ‘736 do not recite a method of improving fatigue, exercise performance or endurance.
The teachings of Bartos, US’650, and JP’767 are as described above. Furthermore, the combined teachings of Bartos, US’650, and JP’767 teach a method of improving endurance by administering a composition comprising CGC and IQC as discussed above.
It would have been prima facie obvious before the effective filing date of the claimed invention that the composition recited in ‘736 can be administered for improving endurance and increasing aerobic activity as disclosed by the combined teachings of Bartos, US’650, and JP’767 described above to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both the claims of ‘736 and the combined teachings of Bartos, US’650, and JP’767 described above recite compositions comprising effective amounts of CGC and IQC, and the combined teachings of Bartos, US’650, and JP’767 described above provide further guidance that a composition comprising this combination can be used to improve endurance and increase aerobic activity.
In regards to instant claims 3 and 5, it would have also been prima facie obvious before the effective filing date of the claimed invention that the composition as recited by the combination of the claims of ‘736, Bartos, US’650, and JP’767 described above can be administered to a subject in need of inhibiting lactic acid accumulation in muscle cells and increasing expression of fatty oxidation-related genes as suggested in Bartos to arrive at the claimed invention.
One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Bartos discloses that lactic acidemia (excess lactic acid) in muscles leads to fatigue and that UCP-3 is important for endurance and is expressed in the skeletal muscle of all mammals and plays a role in the transport of free fatty acids. Furthermore, the combination of the claims of ‘736, Bartos, US’650, and JP’767 described above recite a composition for improving endurance to work through fatigue and increasing aerobic activity as described above.
Lastly, it is noted that the instant specification was examined for unexpected results, however the instant claims are not commensurate in the scope with unexpected results as discussed above.
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/663,736 (‘736) in view of Bartos et al. (US20160213673A1 in PTO-892), US20070004650A1 (in PTO-892), JPH09266767A (in PTO-892, an English translation is included in the PTO-892 and used as the basis for this rejection), and Huertas et al. (Oxidative Medicine and Cellular Longevity, 2019 in PTO-892).
The combination of the claims of ‘736, Bartos, US’650, and JP’767 are as described above and recite the method of instant claim 1 as discussed above.
The combined references, however, do not recite a subject who needs to increase mitochondria in muscle cells.
The teachings of Huertas are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention that the composition as recited by the combination of the claims of ‘736, Bartos, US’650, and JP’767 described above can be administered to the patient population suggested in Huertas to improve endurance performance to arrive at the claimed invention.
One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Huertas teaches that higher skeletal muscle mitochondrial volume is present in endurance trained subjects, and as recited by the combination of the claims of ‘736, Bartos, US’650, and JP’767 described above recite a composition for improving endurance as described above.
This is a provisional nonstatutory double patenting rejection.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/823,345 (‘345) in view of Bartos et al. (US20160213673A1 in PTO-892), US20070004650A1 (in PTO-892), and JPH09266767A (in PTO-892, an English translation is included in the PTO-892 and used as the basis for this rejection).
The claims of ‘345 recite a method for improving liver health, comprising administering an effective amount of Gallocatechin Gallate (GCG) and Isoquercitrin (IQC) to a subject in need thereof (claim 1) and wherein the Gallocatechin Gallate (GCG) and Isoquercitrin (IQC) are contained in a weight ratio of 9:1 to 1:9 (claim 5).
The claims of ‘345 recite the same composition comprising CGC and IQC at a ratio of 9:1 to 1:9. However, the claims of ‘345 do not recite a method of improving fatigue, exercise performance or endurance.
The teachings of Bartos, US’650, and JP’767 are as described above. Furthermore, the combined teachings of Bartos, US’650, and JP’767 teach a method of improving endurance by administering a composition comprising CGC and IQC as discussed above.
It would have been prima facie obvious before the effective filing date of the claimed invention that the composition recited in ‘345 can be administered for improving endurance and increasing aerobic activity as disclosed by the combined teachings of Bartos, US’650, and JP’767 described above to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both the claims of ‘345 and the combined teachings of Bartos, US’650, and JP’767 described above recite compositions comprising effective amounts of CGC and IQC, and the combined teachings of Bartos, US’650, and JP’767 described above provide further guidance that a composition comprising this combination can be used to improve endurance and increase aerobic activity.
In regards to instant claims 3 and 5, it would have also been prima facie obvious before the effective filing date of the claimed invention that the composition as recited by the combination of the claims of ‘345, Bartos, US’650, and JP’767 described above can be administered to a subject in need of inhibiting lactic acid accumulation in muscle cells and increasing expression of fatty oxidation-related genes as suggested in Bartos to arrive at the claimed invention.
One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Bartos discloses that lactic acidemia (excess lactic acid) in muscles leads to fatigue and that UCP-3 is important for endurance and is expressed in the skeletal muscle of all mammals and plays a role in the transport of free fatty acids. Furthermore, the combination of the claims of ‘345, Bartos, US’650, and JP’767 described above recite a composition for improving endurance to work through fatigue and increasing aerobic activity as described above.
Lastly, it is noted that the instant specification was examined for unexpected results, however the instant claims are not commensurate in the scope with unexpected results as discussed above.
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/823,345 (‘345) in view of Bartos et al. (US20160213673A1 in PTO-892), US20070004650A1 (in PTO-892), JPH09266767A (in PTO-892, an English translation is included in the PTO-892 and used as the basis for this rejection), and Huertas et al. (Oxidative Medicine and Cellular Longevity, 2019 in PTO-892).
The combination of the claims of ‘345, Bartos, US’650, and JP’767 are as described above and recite the method of instant claim 1 as discussed above.
The combined references, however, do not recite a subject who needs to increase mitochondria in muscle cells.
The teachings of Huertas are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention that the composition as recited by the combination of the claims of ‘345, Bartos, US’650, and JP’767 described above can be administered to the patient population suggested in Huertas to improve endurance performance to arrive at the claimed invention.
One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Huertas teaches that higher skeletal muscle mitochondrial volume is present in endurance trained subjects, and as recited by the combination of the claims of ‘345, Bartos, US’650, and JP’767 described above recite a composition for improving endurance as described above.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
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