DETAILED ACTION
Claims 1-20 are pending.
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 .
Priority
The instant application filed 4/25/2024 is a Divisional of 17696723, filed 3/16/2022, now U.S. Patent # 11998519 and having 1 RCE-type filing therein. 17696723 is a Continuation in Part of 17572368, filed 1/10/2022, now abandoned. 17572368 Claims Priority from Provisional Application 63137507, filed 1/14/2021.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 7/15/2024 and 11/7/2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the Examiner.
Claim Interpretation
Claim 1 is directed towards neuroprotective composition for prophylactic neuroprotection that prevents or reduces sequelae of traumatic brain injury (TBI), comprising:
a nutritionally or a pharmaceutically acceptable carrier in combination with a branched chain amino acids (BCAA) component and a vitamin component; wherein the BCAA component comprises leucine, valine, and isoleucine, and wherein the leucine, the valine, and the isoleucine are present in the BCAA component at a weight ratio of X:1:1, with X being between 2-4;
wherein the vitamin component comprises vitamin B7 and at least one vitamin selected from the group consisting of vitamin C, vitamin B3, vitamin B5, vitamin B6, vitamin B9, and vitamin B12; and
wherein the sequelae of TBI are selected from cognitive dysfunction, behavioral dysfunction, motor neural dysfunction, vestibular dysfunction, cerebral inflammation, and hyperglycemia; and
wherein the composition is formulated for oral administration and such that a dosage unit, when orally administered to a subject before a TBI, prevents or reduces sequelae of the TBI.
Interpretation of “wherein the sequelae of TBI are selected from cognitive dysfunction, behavioral dysfunction, motor neural dysfunction, vestibular dysfunction, cerebral inflammation, and hyperglycemia.” This is the intended use of the composition; this does not change the composition in any way to lend to patentability and therefore a composition having the BCAAs and vitamins in the effective amounts will anticipate.
Interpretation of “wherein the composition is formulated for oral administration and such that a dosage unit, when orally administered to a subject before a TBI, prevents or reduces sequelae of the TBI.” This again is directed to an intended use, and therefor doesn’t limit the claim to the composition.
Instant claims 19 and 20 state, “19. The composition of claim 1, wherein the TBI is due to a contact sport or combat engagement.
20. The composition of claim 1, wherein the composition is effective to prevent or reduce the sequelae of the TBI when prophylactically administered 10-40 minutes prior to an activity that results in the TBI.”
As the claims are directed to a composition, these claims do not limit the composition of matter claim, and only inform the public to intended use.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-4, 6-7, 9-12, 14-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NOCCO, https://nocco.com/products/ webpage published 12/8/2018 as viewed on the WayBack Machine website.
The NOCCO BCAA+ Drink contains a 4:1:1 ratio Leucine:Valine:Isoleucine as 5000 mg total. Thereby having 3333 mg Leucine, 833 mg or both Valine and Isoleucine. The drink also has vitamins B6, 100% RDA, B12, 100% RDA, Biotin (B7) 100% RDA, Folic Acid (B9) 50% RDA, and Niacin (B3) 80% RDA. The drink is 330 mL. The drink also contains carbohydrates. The drin k is an individual serving.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-6, 7, 9, 13-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Instagram Post of Kevin LEVRONE GOLD BCAA 2:1:1 on November 26, 2020 with evidence from the product website https://www.kevinlevroneshop.com/product/kevin-levrone-gold-bcaa-211-375-g/.
The Kevin LEVRONE GOLD BCAA 2:1:1 contains a 2:1:1 BCAA blend with the ratio Leucine:Valine:Isoleucine as 7000 mg total. Thereby having 3500 mg Leucine, 1750 mg or both Valine and Isoleucine. The supplement also has 80 mg of Vitamin C, 16 mg Niacin (B3) 100% RDA, and 1.4mg Vitamin B6 100% RDA. The supplement is a ready to use powder.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over NOCCO, https://nocco.com/products/ webpage published 12/8/2018 as viewed on the WayBack Machine website; Instagram Post of Kevin LEVRONE GOLD BCAA 2:1:1 on November 26, 2020 with evidence from the product website https://www.kevinlevroneshop.com/product/kevin-levrone-gold-bcaa-211-375-g/; and Schlueter et al. “Vitamin C: Overview and Update,” Journal of Evidence-Based Complementary & Alternative Medicine 16(1) 49-57, 2011; Ross, RDA guidamnce TABLE from Dietary Reference Intakes 2011; and “Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline” 1998.
Instant claims 8 and 18.were not addressed in the 102 rejections above. Instant Claim 8 requires;
wherein the vitamin C is present in an amount of 200 mg (+/- 10%),
the vitamin B3 (niacin) is present in an amount of 16 mg (+/- 10%),
the vitamin B5 (pantothenic acid) is present in an amount of 5 mg (+/- 10%),
the vitamin B6 (pyridoxine) is present in an amount of 10 mg (+/- 10%),
the vitamin B7 (biotin) is present in an amount of 30 mg (+/- 10%),
the vitamin B9 (folate) is present in an amount of 400 mcg (+/- 10%),
and the vitamin B12 (cobalamin) is present in an amount of 50 mcg (+/- 10%) per dosage unit.
Instant Claim 18 states, wherein the composition comprises the vitamin C, the vitamin B3 (niacin), the vitamin B5 (pantothenic acid), the vitamin B6 (pyridoxine), the vitamin B9 (folate), and the vitamin B12 (cobalamin).
Both NOCCO and LEVRONE GOLD BCAA teach a combination of leucine enriched BCAA supplements with added B vitamins, and LEVRONE also adds and vitamin C.
NOCCO has vitamins B6 at 100% RDA, B12 at 100% RDA, Biotin (B7) at 100% RDA, Folic Acid (B9) at 50% RDA, and Niacin (B3) at 80% RDA.
LEVRONE has 80 mg of Vitamin C, 16 mg Niacin (B3) 100% RDA, and 1.4mg Vitamin B6 100% RDA.
Based on these 2 supplemnts the combination of vitamins and BCAA amino acids is known in the art, and one would look to add the Ross RDA of vitamins to the supplements in known safe amounts for ease of administraion, as one would be motivated to take one drink/supplement to arrive a safe amount of vitamins in their supplement intake.
One would look to the RDA guidamnce TABLE and find:
Vitamin C is in the range of 15-120 mg (instant claim 200 mg (+/- 10%));
Vitamin B3 (niacin) is in the range of 2-17 mg (instant claim 16 mg (+/- 10%));
Vitamin B5 (pantothenic acid) is present in an amount of 1.7-7 mg (instant claim 5 mg (+/- 10%);
Vitamin B6 (pyridoxine) is in the range of 0.1-2 mg (instant claim 10 mg (+/- 10%);
Vitamin B7 (biotin) is in the range of 5-35 mg (instant claim 30 mg (+/- 10%);
Vitamin B9 (folate) is in the range of 65-500 (instant claim 400 mcg (+/- 10%);
Vitamin B12 (cobalamin) is in the range of 0.4-2.8 (instant claim 50 mcg (+/- 10%) .
The only vitamins that are outside the recommended intake are Vitamin C is in the range of 15-120 mg (instant claim 200 mg (+/- 10%)); Vitamin B6 (pyridoxine) is in the range of 0.1-2 mg (instant claim 10 mg (+/- 10%); Vitamin B12 (cobalamin) is in the range of 0.4-2.8 (instant claim 50 mcg (+/- 10%).
Therefore the range of these 3 vitamins is low based on the standard recommended daily intake, but these numbers are in line with commonly available multivitamins and supplements and below the upper limits in the guidance in the art.
Regardless, Vitamin C is known to have dosing at higher numbers including up to 200 mg. Schlueter, teaches that “many experts believe that the recommended intakes
for vitamin C (45 to 90 mg daily) are several orders of magnitude too low to support optimal vitamin C functionality.” Then discusses the intake and studies ranging from 20 mg to 2000 mg in dosing.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
In the case of Vitamin C at 200 mg, Applicant has not shown this to be significant to the efficacy of the composition, as such this is found obvious.
This logic holds for both Vitamin B6 (pyridoxine) and Vitamin B12 (cobalamin). As when we look to the guidance in the “Dietary Reference Intakes” (see page 182 for B6 and page 346 for B12) we see that the upper limit for these two vitamins are much higher than Applicant’s specific amount. Therefore at this time, theses values are prima facie obvious as the amount of tis ingredient is not shown to be significant to the invention.
See MPEP 2144.05 as the rationale and how to potentially overcome this prima facie case of obviousness.
Therefore claims 1-20 are obvious based on the prior art 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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/300,233 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘233 application is directed to the same composition of matter containing BCAA rich in leucine and some vitamins.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
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/MICHAEL J SCHMITT/ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
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