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 .
Applicant's election with traverse of Group II, claims 51-59 in the reply filed on 13 May 2026 is acknowledged. The traversal is on the ground(s) that the claims share a special technical feature: a composition formulated and dosed to produce defined effects on skeletal muscle energy metabolism and skeletal function in a human subject. This feature is not disclosed by the cited prior art. Unity is therefore present, and the restriction requirement should be withdrawn. This is not found persuasive because claim 40 of Group I is drawn to a composition containing choline and succinate in a molar ratio of choline to succinate of 2:1. The cited prior art teaches this composition. The recitation ‘formulated and dosed to produce defined effects on skeletal muscle energy metabolism and skeletal function in a human subject’ is intended effect which is not given patentable weight. The requirement is still deemed proper and is therefore made FINAL. An Action on the merits of Group II, claims 51-59, is contained herein.
Group I, claims 40-50, are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Priority
This application is a 371 of PCT/GB2022/051316 filed 05/25/2022. This application claims foreign priority to UNITED KINGDOM 2107957.9 filed 06/03/2021, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 51-59 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
From the recitation of claim 51 it is not clear if the claim is to a method of improving physical performance or if it is to improve skeletal muscle functions via consumption of the recited composition by a human subject. Claim 51 is examined as a method of improving any one of the skeletal muscle functions recited in the claim via administration of the composition.
The method of claim 55 is also not clear. Claim 55 is drawn to a method of dietary improvement of skeletal muscle function in a human subject, and further recites ‘to reduce symptoms of impaired skeletal muscle energy metabolism in the human subject using the composition as in claim 51. What symptoms of impaired skeletal muscle energy metabolism are treated is unclear. Moreover, claim 59, which depends from claim 55, recites muscle weakness, muscle pain, low muscle tone, exercise and lack of muscular endurance. These recitations are also seen in claim 51. Therefore, claim 55 and dependents thereof are seen as duplicates of claim 51. Claim 55 is examined as being drawn to a method of improvement of skeletal muscle function in a human subject via administration of the recited composition.
Applicant may consider rewording of claims 51, and 55 as ‘A method of improving’ and recite what all are improved so that the intent of the claims is clear.
Claims 52-54, which depend from a rejected base claim that is unclear/indefinite are also rendered unclear/indefinite and are rejected for the same reasons. All claims which depend from an indefinite claim are also indefinite. Ex parte Cordova, 10 U.S.P.Q. 2d 1949, 1952 (P.T.O. Bd. App. 1989).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 51-59 are rejected under 35 U.S.C. 103 as being unpatentable over Andreeva et al (WO 2019/002858 A1; cited in IDS filed 12/01/2023) in view of Andreux et al (WO 2017/109195 A1; cited in IDS filed 12/01/2023), and further in view of GB 993,125; ‘125; cited in IDS filed 12/01/2023), and Biasi (Neurosci Bull, 2011, 27(5), 330-342; cited in IDS filed 12/01/2023).
Andreeva et al’s invention is drawn to a composition comprising choline cation and succinate anion (2-), and nicotinamide or a nicotinamide derivative. The choline cation, succinate anion and nicotinamide are present in a molar ratio of 2:1:0.01 to 2:1:10 (page 4, lines 13-18; page 5, line 25 through page 6, line 1; page 7, lines 5-12; components in the composition of claims 51, 53, 55 and 57, the ratio as in claims 53 and 57). The nicotinamide derivative is nicotinamide riboside or nicotinamide mononucleotide (page 7, lines 15-18; components recited in claims 53 and 57). The composition is for the dietary supplementation of a human subject, and is for restoring/maintaining physical endurance (page 10, lines 1-10; page 11, lines 30-33; method as in claim 51-endurance; claim 55-muscle function, and claim 59-lack of muscle endurance, improving muscle weakness-fatigue is symptom of muscle weakness and lack of muscle endurance).
The dosages may vary from 10mg to 4000mg per serving and can be in one or more servings of 25-2000mg per serving (page 10, line 15 through page 11, line 2; limitation of claims 52 and 56). The composition may further include creatine, glycine and arginine (page 8, lines 19-23; as in claims 54 and 58).
Andreeva et al does no expressly teach that its composition is for improving the skeletal muscle characteristics as in the instant claims.
Andreux et al teaches the use of nicotinamide riboside in compositions for use in improving muscle performance and muscle function in healthy individuals including elderly individuals (page 4, lines 15-22; component in claims 53 and 57). The improvement in performance may be measured by the time spent to walk or run a certain distance, chair stands or another test to measure physical performance (page 17, line 18 through page 18, line 7; page 20, lines 7-16; page 21, lines 17-18; page 24, lines 1-2). This teaching tells one of ordinary skill in the art that nicotinamide riboside can be used for improvement of skeletal muscle functions as in the instant claims. Since nicotinamide riboside is used in combination with another agent for improving muscle function it means that nicotinamide riboside can be used in combination with choline and succinate for the same purpose since Andreeva teaches that choline and succinate is used for restoring/maintaining physical endurance, which is related to muscle function.
‘125 teaches that succinate ion in the form of succinate of methylcolamine plays an important role in reducing fatigue (page 1, lines 54-61). Fatigue is a syndrome which involves disturbances affecting the organism not only at the muscle level but also at the nervous level (page 1, lines 41-45). Methylcolamine in the form of succinate is the precursor of choline, and reduces nervous fatigue (page 2, lines 3-6). In view of this teaching one of ordinary skill in the art will recognize that choline and succinate as taught by Andreeva will ameliorate disturbances and functions affecting an individual at the skeletal muscle level.
According to Biasi choline is used to synthesize the neurotransmitter Ach, which is needed to keep muscles active. Daily intake of choline is associated with positive effects like vigor and less fatigue before and after athletic performance (page 334, right col., first full paragraph). This tells one of ordinary skill in the art that choline is needed for improving skeletal muscle performance and can also be used for improving other characteristics like skeletal muscle strength and/or skeletal muscle endurance and promote healthy muscle function as in claims 51, 55 and 59. The artisan would have a reasonable expectation that choline, succinate, and the other components as in claims 53, 54, 57 and 58 can be used in the claimed methods of improvement in view of the combined teachings of the prior art.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, the ingredients recited in the instant claims are known in the art for use in a method of improving skeletal muscle performance and can also be used for improving other characteristics like skeletal muscle strength and/or skeletal muscle endurance and promote healthy muscle function. Thus, it is obvious to combine prior art elements and arrive at the claimed methods to yield predictable results by making the instant composition comprising the ingredients and using them in the claimed methods.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. Product and method improvement is the motivation. The artisan will also be motivated to use the instant composition comprising the recited components since the art suggests that the components art useful in improving skeletal muscle performance and can also be used for improving other characteristics like skeletal muscle strength and/or skeletal muscle endurance and promote healthy muscle function.
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 obviousness-type 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); 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 conflicting 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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 51-59 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 12-20 of copending Application No. 18/394,525 (‘525) in view of Andreeva et al (WO 2019/002858 A1; cited in IDS filed 12/01/2023), and further in view of Andreux et al (WO 2017/109195 A1; cited in IDS filed 12/01/2023), GB 993,125; ‘125; cited in IDS filed 12/01/2023), and Biasi (Neurosci Bull, 2011, 27(5), 330-342; cited in IDS filed 12/01/2023).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 51, 55 and 59 are drawn to a method of improving skeletal muscle tone, skeletal muscle strength and/or skeletal muscle endurance, skeletal muscle function, skeletal muscle autophagy, and/or reduce one or more of skeletal muscle weakness, muscle pain, low muscle tone, exercise intolerance and lack of muscle endurance via administration of a composition comprising choline and succinate in a molar ratio of choline to succinate of 2:1. Dependent claims 52-54, and 56-58 recite limitations drawn to dosage, and additional ingredients present in the composition.
Claim 12 of ‘525 is drawn to a method for increasing skeletal muscle mass in a human subject by providing to the subject a composition comprising choline and succinate in a molar ratio of choline to succinate of 2:1. Dependent claims 13-20 recite limitations drawn to dosage, additional components that can be present in the composition, ratio of choline to succinate to at the at least one nicotinamide component, composition provided as sports beverage to healthy, physically active subjects and/or subjects engaged in sports, and the type of muscle disorders, which includes decline in muscle function, muscle function disorder, muscle wasting, muscle fatigue, and physical fatigue.
There is overlap of the method of the instant claims with those of ‘525.
The teachings of the secondary references are set forth above.
The copending claims of ‘525 differ from the instant claims in that the instant claims do not recite increasing skeletal muscle mass. Andreux teaches that its composition which has nicotinamide riboside is useful for increasing muscle mass, reduction in muscle wasting and improving muscle function (page 3, lines 12-20).
Although the claims of '525 are drawn to increasing muscle mass, one of ordinary skill in the art would readily recognize that the method and the composition including the additional components taught by '525 could be employed in the instant invention with a reasonable expectation of success in view of the teachings of ‘525 and the secondary references.
The use of a composition comprising known components in methods of use taught/suggested in the prior art is not seen to render the instantly claimed method unobvious over the art. Once the components have been shown to be old, the burden is on the applicant to present reason or authority for believing that the same composition cannot be used in the instant methods.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 51-59 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 6-10 of U.S. Patent No. 11,571,415 (‘415) in view of Andreeva et al (WO 2019/002858 A1; cited in IDS filed 12/01/2023), and further in view of Andreux et al (WO 2017/109195 A1; cited in IDS filed 12/01/2023), GB 993,125; ‘125; cited in IDS filed 12/01/2023), and Biasi (Neurosci Bull, 2011, 27(5), 330-342; cited in IDS filed 12/01/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 51, 55 and 59 are drawn to a method of improving skeletal muscle tone, skeletal muscle strength and/or skeletal muscle endurance, skeletal muscle function, skeletal muscle autophagy, and/or reduce one or more of skeletal muscle weakness, muscle pain, low muscle tone, exercise intolerance and lack of muscle endurance via administration of a composition comprising choline and succinate in a molar ratio of choline to succinate of 2:1. Dependent claims 52-54, and 56-58 recite limitations drawn to dosage, and additional ingredients present in the composition.
Claims 6-10 of ‘415 are drawn to a method wherein in a method of increasing in a human the mean level of at least one of NAD or ATP or phosphocreatine via administration of a composition comprising choline cation and succinate anion and nicotinamide in a ratio of about 2:1:0.01 to about 2:1:10, the individual is selected from a human suffering from fatigue, frequency and period of administration, and the composition being in the form of beverage or food.
Claims 6-10 of ‘415 differ from the instant claims in that the instant claims do not recite that the administration of the composition is also for increasing in a human the mean level of at least one of NAD or ATP or phosphocreatine. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention that the composition taught for use in the method of ‘415 can also be used in the instant method in view of the teachings of the secondary references.
In the instant case ‘415 teaches administering the claimed composition to a human subject experiencing fatigue. Although the claims of '415 do not teach fatigue in relation to skeletal muscle function, one of ordinary skill in the art would readily recognize that the composition taught by '415 could be used in the instant methods with a reasonable expectation of success, especially in view of Andreux, ‘125 and Biasi. The use of known agents in methods of use taught in the prior art is not seen to render the instantly claimed method unobvious over the art. Once the use has been shown to be old, the burden is on the applicant to present reason or authority for believing that the composition of the prior art cannot be used in the claimed method.
Conclusion
1. Elected claims 51-59 (Group II) are rejected.
2. Group I, claims 40-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
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