Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on Oct. 20, 2025 has been entered.
Claims 1, 3, 6, 17, 24, and 31-34 are pending and examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Applicant’s election of the species urolithin A in the reply filed on Oct. 28, 2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/2/24, 2/2/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This is a new rejection.
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, 3, 6, 17, 24, and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 11337957 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the amounts of urolithin A in 500 or 1000 mg are not taught.
US 11337957 B2 teaches
1. A method of enhancing muscle performance comprising administering to a subject an effective amount of a composition comprising: a) medium-chain triglyceride; wherein the medium-chain triglyceride constitutes 30-80% w/w of the composition; b) micronized urolithin A, having a D.sub.50 size in a range of 0.5 to 50 μm, and a D.sub.90 size in a range of 5 to 100 μm; and c) lecithin, wherein the lecithin constitutes 1-40% w/w of the composition; wherein the composition is formulated for oral administration.
10. The composition of claim 1, wherein the weight ratio between the medium-chain triglyceride component and the urolithin A is in the range of 0.5:1 to 3:1.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising urolithin A in 500 or 1000 mg of the active agent combination for the following reasons. The reference does teach the composition for enhancing muscle performance. US 11337957 B2 teaches weight ratio between the medium-chain triglyceride component and the urolithin A is in the range of 0.5:1 to 3:1. Thus, it would have been obvious to make a concentrated composition containing urolithin A in 500 or 1000 mg for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Claims 1, 3, 6, 17, 24, and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 7-9 of U.S. Patent No. 10695320 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the amounts of urolithin A in 500 or 1000 mg are not taught.
U.S. Patent No. 10695320 B2 teaches
1. A composition comprising: a) medium-chain triglyceride; wherein the medium-chain triglyceride constitutes 30-80% w/w of the composition; b) micronized urolithin A, having a D.sub.50 size in a range of 0.5 to 50 μm, and a D.sub.90 size in a range of 5 to 100 μm; and c) lecithin, wherein the lecithin constitutes 1-40% w/w of the composition; wherein the composition is formulated for oral administration.
2. The composition of claim 1, wherein the weight ratio between the medium-chain triglyceride component and the urolithin is in the range of 0.5:1 to 3:1.
7. The composition of claim 1, wherein the composition is a solid, a semi-solid, or a liquid.
8. The composition of claim 7, wherein the composition is in the form of a softgel.
9. The composition of claim 1, wherein the micronized urolithin A has a D.sub.10 size in a range of 0.5 to 1.0 μm, the D.sub.90 size in the range of 8.2 to 16.0 μm, and the D.sub.50 size in the range of 2.8 to 5.5 μm.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising urolithin A in 500 or 1000 mg of the active agent combination for the following reasons. The reference does teach the composition for enhancing muscle performance. US 11337957 B2 teaches weight ratio between the medium-chain triglyceride component and the urolithin A is in the range of 0.5:1 to 3:1. Thus, it would have been obvious to make a concentrated composition containing urolithin A in 500 or 1000 mg for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Claims 1, 3, 6, 17, 24, and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11166972 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the amounts of urolithin A in 500 or 1000 mg are not taught.
U.S. Patent No. 11166972 B2 teaches
1. A composition comprising: nicotinamide riboside, and urolithin A or a salt thereof; wherein nicotinamide riboside is present in an amount of 20 mg to 5 g; and urolithin A is present in an amount of 10 mg to 5 g.
2. The composition of claim 1, wherein the composition is formulated as a solid, a semi-solid, a powder, or a liquid.
3. The composition of claim 1 wherein the composition is formulated as a medicament, dietary supplement, functional food, functional beverage, specialised nutrition, or medical food.
4. The composition of claim 3, wherein the composition is formulated as a medicament.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising urolithin A in 500 or 1000 mg of the active agent combination for the following reasons. The reference does teach the composition for treating a muscle-related pathological condition, a neurodegenerative disease, or a mitochondrial disease (see Claim 5). U.S. Patent No. 11166972 B2 teaches urolithin A is present in an amount of 10 mg to 5 g. Thus, it would have been obvious to make a composition containing urolithin A in 500 or 1000 mg for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Claims 1, 3, 6, 17, 24, and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5 and 10 of U.S. Patent No. 10442784 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the amounts of urolithin A in 500 or 1000 mg are not taught.
U.S. Patent No. 10442784 B2 teaches
1. A composition comprising: a) a source of protein; and b) urolithin A.
2. The composition of claim 1, wherein the urolithin A has a D.sub.50 size in the range 0.5 to 50 μm and a D.sub.90 size in the range 5 to 100 μm.
5. The composition of claim 1, wherein the weight ratio between the protein and urolithin A is in the range 2:1 to 5000:1.
10. The composition of claim 1, wherein the composition is in the form of a solid, a semi-solid, a powder or a liquid.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising urolithin A in 500 or 1000 mg of the active agent combination for the following reasons. The reference does teach the composition for treating a muscle-related pathological condition (see Claim 11). U.S. Patent No. 10442784 B2 teaches weight ratio between the protein and urolithin A is in the range 2:1 to 5000:1. Thus, it would have been obvious to make a composition containing urolithin A in 500 or 1000 mg for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Claims 1, 3, 6, 17, 24, and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 9-11 of U.S. Patent No. 10988453 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the amounts of urolithin A in 500 or 1000 mg are not taught.
U.S. Patent No. 10988453 B2
1. A composition comprising: a) a source of protein and b) micronized urolithin A; wherein the micronized urolithin A has a D.sub.50 size in the range 0.5 to 50 μm, and a D.sub.90 size in the range 5 to 100 μm.
4. The composition as claimed in claim 1, wherein the weight ratio between the protein component and the micronized urolithin A is in the range 2:1 to 5000:1.
9. The composition as claimed in claim 1, wherein the composition is in the form of a solid, a semi-solid, a powder or a liquid.
10. The composition as claimed in claim 1 wherein the composition is a medicament, dietary supplement, functional food, functional beverage or medical food.
11. The composition as claimed in claim 10 wherein the composition is a medicament.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising urolithin A in 500 or 1000 mg of the active agent combination for the following reasons. The reference does teach the composition for treating a muscle-related pathological condition (see Claim 12). U.S. Patent No. 10988453 B2 teaches the weight ratio between the protein component and the micronized urolithin A is in the range 2:1 to 5000:1. Thus, it would have been obvious to make a composition containing urolithin A in 500 or 1000 mg for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Claims 1, 3, 6, 17, 24, and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 9-11 of U.S. Patent No. 12297182 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the amounts of urolithin A in 500 or 1000 mg are not taught.
U.S. Patent No. 12297182 B2
1. A composition comprising: a) a source of protein; and b) urolithin A; wherein the urolithin A has a D.sub.90 size in the range 8.2 to 16.0 μm, a D.sub.50 size in the range 2.8 to 5.5 μm, and a D.sub.10 size in the range 0.5 to 1.0 μm.
4. The composition of claim 1, wherein the weight ratio between the protein component and the urolithin A is in the range 2:1 to 5000:1.
9. The composition of claim 1, wherein the composition is in the form of a solid, a semi-solid, a powder or a liquid.
10. The composition of claim 1, wherein the composition is a medicament, dietary supplement, functional food, functional beverage or medical food.
11. The composition of claim 10, wherein the composition is a dietary supplement.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising urolithin A in 500 or 1000 mg of the active agent combination for the following reasons. The reference does teach the composition for treating a muscle-related pathological condition (see Claim 12). U.S. Patent No. 12297182 B2 teaches the weight ratio between the protein component and the micronized urolithin A is in the range 2:1 to 5000:1. Thus, it would have been obvious to make a composition containing urolithin A in 500 or 1000 mg for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655