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 .
DETAILED ACTION
Claims 1-17 are pending and are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/14/2025 and 09/25/2024 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This Application is a continuation application of U.S. patent application Ser. No. 18/483,630, filed on October 10, 2023, which is a continuation application of international patent Application No. PCT/CN2022/086514, filed on April 13, 2022, which claims the priority of the international Application PCT/CN2021/087159, filed on April 14, 2021.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6 -8 , 9-13 and 15-17 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Liao et al. (US 2022/0054441, priority date 07/22/2020, Cited in IDS dated 09/25/2024)
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C.102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Instant claims 1-4, 6 -8 are drawn to a method for promoting glycogen synthase activity and/or augmenting glycogen storage capability in muscle tissue and/or liver tissue of a mammal, comprising administrating to the mammal a therapeutically effective amount of β-aminoisobutyric acid (BAIBA), or a pharmaceutically acceptable salt, ester, or acid thereof, wherein BAIBA is administrated at a dose ranging from about 20 mg/day to about 2000 mg/day, is administrated orally a predefined number of days of pre-exercise.
Instant claims , 9-13 and 15-17 are drawn to a method for promoting glycogen synthase activity and/or augmenting glycogen storage capability in muscle tissue and/or liver tissue of a mammal, comprising administrating to the mammal a therapeutically effective amount of β-aminoisobutyric acid (BAIBA), or a pharmaceutically acceptable salt, ester, or acid thereof, wherein BAIBA is administrated at a dose ranging from about 20 mg/day to about 2000 mg/day, is administrated orally a predefined number of days of after exercise
Liao et al. discloses HFD-fed mice in groups that received L-BAIBA supplementation had higher muscular and hepatic glycogen content relative to mice subjected to the same HFD, with or without exercise, that did not receive L-BAIBA supplementation. Particularly, mice in GB3 and GB4 had increased muscular and hepatic glycogen relative to mice in GB1 and GB2. This Example thus demonstrates that L-BAIBA supplementation can achieve, or even exceed, the beneficial effects on muscular and hepatic glycogen storage capacity of regular exercise, and an exercise regimen combined with L-BAIBA supplementation can have a greater effect on muscular and hepatic glycogen storage capacity than the exercise regimen alone [0086]( claims 1). They disclose compositions comprising BAIBA which are effective at enhancing the beneficial effects of regular exercise [0016]. The method comprises administering a composition comprising β-aminoisobutyric acid (BAIBA), or a pharmaceutically acceptable salt, polymer, ester, or acid thereof, to the subject, wherein the subject is engaged in an exercise regimen [0017] (claim 1). The beneficial effects include educed body fat percentage, reduced weight, lowered blood glucose, decreased blood triglycerides, decreased total blood cholesterol, decreased blood very low-density lipoprotein, decreased blood low density lipoprotein, increased muscular glycogen storage capacity, increased hepatic glycogen storage capacity, improved leptin resistance, improved insulin resistance, and combinations thereof [0018](claim 2) and the exercise regimen may comprise endurance training, resistance training, or both [0019] (claim 3). The composition may be administered orally or as an ingestible composition such as the dietary supplement selected from the group consisting of aqueous solutions, aqueous suspensions, capsules, drops, granules, liquids, mists, powders, syrups, tablets, functionalized foods, beverages, toothpastes, and sublingual articles [0021] (claims 5-9). The composition comprises L-BAIBA as the active pharmaceutical ingredient [0021] and is administered to a subject from about 5 mg/kg/day to about 200 mg.kg/day, from 500 mg to 1500 mg per day [0025] (claim 13).
Therefore, the method and composition disclosed by Liao et al. fully anticipates instant claims 1-4, 6 -8, 9-13 and 15-17.
Claims 1-4 and 9-11 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Fromenty et al. (US 2006/0167098, , Cited in IDS dated 09/25/2024))
Instant claims are as stated above.
Fromenty et al. discloses methods for lowering the blood levels of insulin and/or glucose comprising at least the step of administering to a human or non-human animal in need thereof, as therapeutically active agent, an effective amount of beta.-aminoisobutyric acid [0037] (Claim 10-11). Fromenty et al. discloses their composition as a pharmaceutical composition or a nutritional composition which may be a drink or a powder that can be reconstituted to produce such a drink, also formulated for oral or parenteral administration [0070-0077]. They disclose dosage of 5 mg/kg/day to 1000 mg/kg/day of patient body weight, in particular about 50 mg/kg/day to 500 mg/kg/day [0080]. They disclose where in the BAIBA cand be of configuration L or D or a mixture or L and D configuration (claim 15) and wherein the subject treated is human (claim 16).
Fromenty et al. while teaching that the BAIBA is administered to a subject for lowering blood levels of insulin and/or glucose, does not teach the method of promoting glycogen synthase activity and/or augmenting glycogen storage capability or wherein the administration promotes the liver glycogen synthase activity
However, these properties of L-BAIBA will inherently occur in the method of administration to a subject taught by Fomenty et al. since the subject population and the administration of the same composition of L-BAIBA to the subject between the instant claims and Fomenty et al. is the same. Fomenty et al. discloses the active step instantly claimed which is the administration L-BAIBA to subjects, and accordingly, the functional limitations set forth in the instant application will be achieved. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims. In addition, It is also noted that “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As such the instantly claimed mechanistic functions of the L-BIABA to promoting glycogen synthase activity and/or augmenting glycogen storage capability would be present in the L-BIABA taught by Fromenty et al. and would therefore elicit these effects whenever it is administered.
Therefore the method and composition disclosed by Fromenty et al. fully anticipates instant claims 1-4 and 9-11.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Fromenty et al. as evidenced by Adeva-Andany (BBA clinical 5 (2016) 85-100, , Cited in IDS dated 09/25/2024)
Instant claims 1-8 are drawn to a method for promoting glycogen synthase activity and/or augmenting glycogen storage capability in muscle tissue and/or liver tissue of a mammal, comprising administrating to the mammal a therapeutically effective amount of β-aminoisobutyric acid (BAIBA), or a pharmaceutically acceptable salt, ester, or acid thereof, wherein BAIBA is administrated at a dose ranging from about 20 mg/day to about 2000 mg/day, is administrated orally a predefined number of days of pre-exercise.
Instant claims , 9-17 are drawn to a method for promoting glycogen synthase activity and/or augmenting glycogen storage capability in muscle tissue and/or liver tissue of a mammal, comprising administrating to the mammal a therapeutically effective amount of β-aminoisobutyric acid (BAIBA), or a pharmaceutically acceptable salt, ester, or acid thereof, wherein BAIBA is administrated at a dose ranging from about 20 mg/day to about 2000 mg/day, is administrated orally a predefined number of days of after exercise
Fromenty et al. discloses methods for lowering the blood levels of insulin and/or glucose comprising at least the step of administering to a human or non-human animal in need thereof, as therapeutically active agent, an effective amount of .beta.-aminoisobutyric acid [0037] (Claim 10-11). Fromenty et al. discloses their composition as a pharmaceutical composition or a nutritional composition which may be a drink or a powder that can be reconstituted to produce such a drink, also formulated for oral or parenteral administration [0070-0077]. They disclose dosage of 5 mg/kg/day to 1000 mg/kg/day of patient body weight, in particular about 50 mg/kg/day to 500 mg/kg/day [0080]. They disclose where in the BAIBA cand be of configuration L or D or a mixture or L and D configuration (claim 15) and wherein the subject treated is human (claim 16).
Fromenty et al. while teaching that the BAIBA is administered to a subject for lowering blood levels of insulin and/or glucose, does not teach the method of promoting glycogen synthase activity and/or augmenting glycogen storage capability or wherein the administration promotes the liver glycogen synthase activity. Fromenty et al. also does not teach the administration before or after exercise to augment dietary carbohydrate-mediated muscle glycogen.
However, Adeva-Andeny et al. disclose that glycogen synthase is the enzyme which helps in the conversion of glucose to glycogen during exercise in the skeletal muscles. (See figure 1. On page 87). Accordingly, increased activity of glycogen synthase will increase the formation of glycogen and thereby decrease blood glucose levels. Adeva-Andeny further discloses that muscle glycogen content diminishes after exercise in the working muscles and glucose uptake by the contracting muscle increases. Accordingly in the method taught by Fromenty et al, BAIBA administration lowers blood levels of glucose and this process is caused by the increased conversion of glucose to glycogen by glycogen synthase and other enzymes. It is further noted that these properties of L-BAIBA will inherently occur in the method of administration to a subject taught by Fomenty et al. since the subject population and the administration of the same composition of L-BAIBA to the subject between the instant claims and Fomenty et al. is the same. Fomenty et al. discloses the active step instantly claimed which is the administration L-BAIBA to subjects, and accordingly, the functional limitations set forth in the instant application will be achieved. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims. In addition, It is also noted that “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As such the instantly claimed mechanistic functions of the L-BIABA to promoting glycogen synthase activity and/or augmenting glycogen storage capability would be present in the L-BIABA taught by Fromenty et al.
As such it would have been prima facia obvious to a person of ordinary skill in the art to arrive at the instant claims motivated and guided by the teachings of Fromenty et al. absence of evidence to the contrary.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent 11,766,416 (‘416) and claims 1-20 of US 12,539,286.
Instant claims 1-8 are drawn to a method for promoting glycogen synthase activity and/or augmenting glycogen storage capability in muscle tissue and/or liver tissue of a mammal, comprising administrating to the mammal a therapeutically effective amount of β-aminoisobutyric acid (BAIBA), or a pharmaceutically acceptable salt, ester, or acid thereof, wherein BAIBA is administrated at a dose ranging from about 20 mg/day to about 2000 mg/day, is administrated orally a predefined number of days of pre-exercise.
Instant claims , 9-17 are drawn to a method for promoting glycogen synthase activity and/or augmenting glycogen storage capability in muscle tissue and/or liver tissue of a mammal, comprising administrating to the mammal a therapeutically effective amount of β-aminoisobutyric acid (BAIBA), or a pharmaceutically acceptable salt, ester, or acid thereof, wherein BAIBA is administrated at a dose ranging from about 20 mg/day to about 2000 mg/day, is administrated orally a predefined number of days of after exercise
‘416 claims 1-14 are drawn to a method for improving a benefit of an exercise regimen experienced by a subject, comprising: administering a composition comprising β-aminoisobutyric acid (BAIBA), or a pharmaceutically acceptable salt thereof, to the subject, wherein: the subject is engaged in an exercise regimen, a weight ratio of L-BAIBA to D-BAIBA in the composition is no less than 55/45, or a weight ratio of D-BAIBA to L-BAIBA in the composition is no less than 55/45, and the benefit of the exercise regimen is improved with administration of the composition relative to the same exercise regimen without administration of the composition.
‘286 claims are drawn to a method for improving a benefit of an exercise regimen experienced by a subject, comprising: administering a composition comprising β-aminoisobutyric acid (BAIBA), or a pharmaceutically acceptable salt thereof, to the subject, wherein: the subject is engaged in an exercise regimen, the weight ratio of L-BAIBA relative to D-BAIBA in the composition is not 1, and the benefit of the exercise regimen is improved with administration of the composition relative to the same exercise regimen without administration of the composition.
The instant claimed method of improving glycogen synthase activity will inherently occur in the method claimed by ‘416 and ‘286. It is noted that the active step of administering BAIBA to the subject engaged in exercise routine is the same in instant claims and claims of ‘416 and ‘286 and as such the method instantly claimed will occur in the methods of ‘416 and ‘286 absence of evidence to the contrary. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims. In addition, It is also noted that “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As such the instantly claimed mechanistic functions of the L-BIABA to promote glycogen synthase activity and/or augmenting glycogen storage capability would be present in the L-BIABA taught by ‘416 and ‘286..
.Claims 1-17 are rejected on the ground of nonstatutory double patenting over claim 1-14 of U. S. Patent No 12,171,736 (‘736) since the claims anticipates the instant claims.
Instant claims are as stated above.
‘736 claims are drawn to method for promoting glycogen synthase activity and/or augmenting glycogen storage capability in muscle tissue and/or liver tissue of a mammal, comprising administrating to the mammal a therapeutically effective amount of β-aminoisobutyric acid (BAIBA), or a pharmaceutically acceptable salt, ester, or acid thereof, wherein BAIBA is administrated at a dose ranging from about 20 mg/day to about 2000 mg/day, is administrated orally pre-exercise, and is capable of augmenting dietary carbohydrate-mediated muscle glycogen supercompensation after a predefined number of days of pre-exercise administration.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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). Although the conflicting claims are not identical, they are not patentably distinct from each other because instant claim 1-17 are generic to all that is recited in claims 1-14 of ‘736 , specifically, Claim 1 of ‘736 recites an additional limitation “ is capable of augmenting dietary carbohydrate-mediated muscle glycogen supercompensation after a predefined number of days of pre-exercise administration”, Instant claim 1 is the same as this claim except for this statement. Therefore subject matter disclosed in claims instant claims 1-17 of the instant application are fully taught in claim 1-14 of patent ‘736 and hence anticipates the instant
Conclusion
Claims 1-17 are rejected. No claims are allowed
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691
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