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 .
Information Disclosure Statement
The Information Disclosure Statements (IDSs) submitted on September 25th, 2024 and March 18th, 2025 has been considered by the examiner, except where lined through.
Election/Restrictions
Applicant's election without traverse of Group II, a method for improving cognitive function, comprising administering a composition comprising paraxanthine or 1-methylxanthine, and chlorogenic acid in the reply filed 07/06/2026 is acknowledged.
Claims 1-4, and 14-20 are withdrawn for not reading on the elected species.
If the elected group is not identified in the art, the search will be expanded to additional groups per MPEP 802.03.
Claims 5-13 are presently examined.
Specification
The disclosure is objected to because of the following informalities:
The acronym, “TBI” is not defined where it first occurred, Pg. 1, [005]
Add a “the” in front of ratio, Pg. 3, [007]
The acronym, “WHO” is not defined, Pg. 5, [018]
Clause 19. misspelled “1-methylxanthine” as “1-methylxanine”, Pg. 29, [0114]
Clause 39. misspelled “1-methylxanthine” as “1-methylxantine”, Pg. 30, [0114]
Clause 44. misspelled “1-methylxanthine” as “1-methylxantine”, Pg. 31, [0114]
Clause 53. misspelled “1-methylxanthine” as “1-methylxantine”, Pg. 32, [0114]
Appropriate correction is required.
Claim Objections
Claim 9 objected to because of the following informalities:
“1-methylxanthine” is misspelled as, “1-methylxantine”
Appropriate correction is required.
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.
Claims 5-8, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Purpura (Martin Purpura et al., “Paraxanthine-Based Bioactive Composition and Method of Use”, WO 2021151094 A1, Pub. Date: 07/29/2021, as cited on the IDS dated 03/18/2025) in view of Saitou (Katsuyoshi Saitou et al., “Effect of Chlorogenic Acid on Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled Trial”, Nutrients, Volume 10, Pgs. 1-14, Pub. Date: 20 September, 2018).
Regarding Claims 5, Purpura teaches administering paraxanthine to enhance cognitive performance (Abstract and Pg. 9, [057]). Purpura discloses “The dosage of paraxanthine may range from about 2 mg to about 800 mg. In another embodiment, the range may be from about 50 mg to about 400 mg” (Pg. 10, [062]).
Regarding Claim 11 and 12, Purpura discloses “One general aspect includes a method of improving working memory in a subject in need thereof comprising administering a paraxanthine containing composition to the subject.” (Pg. 13, [075]).
Regarding Claim 13, Purpura disclosed “Paraxanthine containing compositions enhance striatal dopaminergic tone” (Pg. 8, [056]).
Purpura does not disclose administering chlorogenic acid to enhance cognitive performance.
Saitou discloses a 16-week study that administered chlorogenic acid (CGA) to improve cognitive functions such as attention and motor speed when administered at 300 mg (2.3 Materials, Pg. 3, and Discussion, Pg. 11).
Regarding Claims 7, Purpura disclosed a range of 50 mg to 400 mg of paraxanthine, that overlaps with the range disclosed in instant claim 7, as 200 mg to 400 mg. The courts found that, 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.
Regarding Claims 5-7, and 11-13 it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date, to combine prior art elements paraxanthine, as taught in Purpura, and chlorogenic acid, as taught by Saitou because they both are taught in the art as enhancing cognitive function, and together they would perform the same function as they do separately. One of ordinary skill would have recognized that the results of the combination of paraxanthine and chlorogenic acid, according to known methods would yield a predictable of enhancing cognitive function.
Regarding Claim 8, because it is obvious to combine paraxanthine and chlorogenic acid, in the amounts claimed, as disclosed in Purpura and Saitou, it would be obvious to assume that synergy would result, since the claimed amounts are disclosed in the prior art.
Claims 5, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Purpura (Martin Purpura et al., “Paraxanthine-Based Bioactive Composition and Method of Use”, WO 2021151094 A1, Pub. Date: 07/29/2021, as cited on the IDS dated 03/18/2025) in view of Saitou (Katsuyoshi Saitou et al., “Effect of Chlorogenic Acid on Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled Trial”, Nutrients, Volume 10, Pgs. 1-14, Pub. Date: 20 September, 2018) as in Claim 5 above, and in further view of Labedzki (Andreas Labedski et al., “Differences in caffeine and paraxanthine metabolism between human and murine CYP1A2”, Biochemical Pharmacology, Volume 63, Issue 12, Pub. Date: 15 June 2002, Pgs. 2159-2167).
Purpura and Saitou do not teach 1-methylxanthine administered in a composition for enhancing cognitive function.
Labedski teaches that 1-methylxanthine, bottom left, is the primary metabolite of paraxanthine, bottom right, in humans, followed by 7-methylxanthine, and 1,7-dimethylurate (Abstract and Section 2.2.1, Pg. 2160).
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Paraxanthine and 1-methylxanthine have the same core structure, and only differ by a methyl group attached to Nitrogen in paraxanthine, versus a hydrogen attached to Nitrogen in 1-methylxanthine.
Regarding Claims 5, and 9, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to take the teachings of Purpura regarding administering paraxanthine to enhance cognitive function, and substitute 1-methylxanthine, because paraxanthine has a known use in the art, and 1-methylxanthine is a known metabolite of paraxanthine with the same core structure. One of ordinary skill would be motivated to substitute 1-methylxanthine for paraxanthine to enhance cognitive function because both compounds share the same core, and would be expected to perform a similar function that one of ordinary skill would be motivated to optimize.
Regarding Claim 10, because it is obvious to substitute 1-methylxanthine for paraxanthine in composition with chlorogenic acid, in the amounts claimed, as disclosed in Purpura, Saitou, Labedzki and it would be obvious to assume that synergy would result, since the claimed amounts are disclosed in the prior art, and there is a motivation to substitute.
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 5-13 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-11 of copending Application No. 19/706,673, herein ‘673 in view of Saitou (Katsuyoshi Saitou et al., “Effect of Chlorogenic Acid on Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled Trial”, Nutrients, Volume 10, Pgs. 1-14, Pub. Date: 20 September, 2018) ), and in further view of Labedzki (Andreas Labedski et al., “Differences in caffeine and paraxanthine metabolism between human and murine CYP1A2”, Biochemical Pharmacology, Volume 63, Issue 12, Pub. Date: 15 June 2002, Pgs. 2159-2167).
Regarding instant Claim 5-8, Claim 6 and 7 in copending application ‘673 discloses:
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Regarding instant Claims 11-13, Claims 10 and 11 in copending application ‘673 disclose:
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Claims 6, 7, 10, and 11 in copending application ‘673 do not disclose chlorogenic acid in a composition with paraxanthine.
Saitou discloses a 16-week study that administered chlorogenic acid (CGA) to improve cognitive functions such as attention and motor speed when administered at 300 mg (2.3 Materials, Pg. 3, and Discussion, Pg. 11).
Copending application ‘673 and Saitou, do not teach 1-methylxanthine administered for enhancing cognitive function.
Regarding Claims 5, 9, and 10, Labedski teaches that 1-methylxanthine, bottom left, is the primary metabolite of paraxanthine, bottom right, in humans, followed by 7-methylxanthine, and 1,7-dimethylurate (Abstract and Section 2.2.1, Pg. 2160).
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Paraxanthine and 1-methylxanthine have the same core structure, and only differ by a methyl group attached to Nitrogen in paraxanthine, versus a hydrogen attached to Nitrogen in 1-methylxanthine.
Regarding instant Claims 5 and 7, copending application ‘673 disclosed a range of 50 mg to 800 mg of paraxanthine, that overlaps with the range disclosed in instant claim 5, as 50 mg to 400 mg, and instant claim 7, as 200 mg to 400 mg. The courts found that, 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.
Regarding instant Claims 5-7, and 11-13 it would have been prima facie obvious for one of ordinary skill in the art, to combine prior art elements paraxanthine, as taught in copending application ‘673, and chlorogenic acid, as taught by Saitou, because they both are taught in the art as enhancing cognitive function, and together they would perform the same function as they do separately. One of ordinary skill would have recognized that the results of the combination of paraxanthine and chlorogenic acid, according to known methods would yield a predictable of enhancing cognitive function.
Regarding Claims 5, and 9, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to take the teachings of in copending application ‘673 regarding administering paraxanthine to enhance cognitive function, and substitute 1-methylxanthine, as taught in Labedski, because paraxanthine has a known use in the art, and 1-methylxanthine is a known metabolite of paraxanthine with the same core structure. One of ordinary skill would be motivated to substitute 1-methylxanthine for paraxanthine to enhance cognitive function because both compounds share the same core, and would be expected to perform a similar function that one of ordinary skill would be motivated to optimize.
Regarding Claims 8 and 10, because it is obvious to combine paraxanthine and 1-methylxanthine with chlorogenic acid, in the amounts in the instant claims, as disclosed in in copending application ‘673, Saitou, and Labedski, it would be obvious to assume that synergy would result, since the instantly claimed amounts are disclosed in the prior art and copending application.
This is a provisional nonstatutory double patenting rejection.
Claims 5-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33, 34, and 37 of U.S. Patent No. 12667574, herein ‘574, in view of Saitou (Katsuyoshi Saitou et al., “Effect of Chlorogenic Acid on Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled Trial”, Nutrients, Volume 10, Pgs. 1-14, Pub. Date: 20 September, 2018) and in further view of Labedzki (Andreas Labedski et al., “Differences in caffeine and paraxanthine metabolism between human and murine CYP1A2”, Biochemical Pharmacology, Volume 63, Issue 12, Pub. Date: 15 June 2002, Pgs. 2159-2167).
Regarding instant Claims 5-7, Claim 33 in U.S. Patent No. ‘574 discloses:
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Regarding instant Claims 11-13, Claims 34, and 37 in U.S. Patent No. ‘574 disclose:
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Claims 33, 34, and 37 in U.S. Patent No. ‘574 does not disclose chlorogenic acid in a composition with paraxanthine.
Saitou discloses a 16-week study that administered chlorogenic acid (CGA) to improve cognitive functions such as attention and motor speed when administered at 300 mg (2.3 Materials, Pg. 3, and Discussion, Pg. 11).
U.S. Patent No. ‘574 and Saitou, do not teach 1-methylxanthine administered for enhancing cognitive function.
Regarding Claims 5, 9, and 10, Labedski teaches that 1-methylxanthine, bottom left, is the primary metabolite of paraxanthine, bottom right, in humans, followed by 7-methylxanthine, and 1,7-dimethylurate (Abstract and Section 2.2.1, Pg. 2160).
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Paraxanthine and 1-methylxanthine have the same core structure, and only differ by a methyl group attached to Nitrogen in paraxanthine, versus a hydrogen attached to Nitrogen in 1-methylxanthine.
Regarding instant Claims 5 and 7, Claim 33 in U.S. Patent No. ‘574 disclosed a range of 50 mg to 800 mg of paraxanthine, that overlaps with the range disclosed in instant claim 5, as 50 mg to 400 mg, and instant claim 7, as 200 mg to 400 mg. The courts found that, 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.
Regarding instant Claims 5-7, and 11-13 it would have been prima facie obvious for one of ordinary skill in the art, to combine prior art elements paraxanthine, as taught in U.S. Patent No. ‘574 and chlorogenic acid, as taught by Saitou because they both are taught in the art as enhancing cognitive function, and together they would perform the same function as they do separately. One of ordinary skill would have recognized that the results of the combination of paraxanthine and chlorogenic acid, according to known methods would yield a predictable of enhancing cognitive function.
Regarding Claims 5, and 9, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to take the teachings of U.S. Patent No. ‘574 regarding administering paraxanthine to enhance cognitive function, and substitute 1-methylxanthine, as taught in Labedski, because paraxanthine has a known use in the art, and 1-methylxanthine is a known metabolite of paraxanthine with the same core structure. One of ordinary skill would be motivated to substitute 1-methylxanthine for paraxanthine to enhance cognitive function because both compounds share the same core, and would be expected to perform a similar function that one of ordinary skill would be motivated to optimize.
Regarding Claims 8 and 10, because it is obvious to combine paraxanthine and 1-methylxanthine with chlorogenic acid, in the amounts in the instant claims, as disclosed in copending application ‘368, Saitou, and Labedski, it would be obvious to assume that synergy would result, since the instantly claimed amounts are disclosed in the prior art and U.S. Patent No. ‘574.
Claims 5-13 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 8-10 of copending Application No. 17/875,368, herein ‘368, in view of Saitou (Katsuyoshi Saitou et al., “Effect of Chlorogenic Acid on Cognitive Function: A Randomized, Double-Blind, Placebo-Controlled Trial”, Nutrients, Volume 10, Pgs. 1-14, Pub. Date: 20 September, 2018).
Regarding instant claims 5-8, Claim 1 in copending application ‘368 discloses:
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Regarding instant claims 9-12, Claims 8-10 in copending application ‘368 discloses:
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Regarding instant claim 13, Claim 11 in copending application ‘368 discloses:
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Claims 1, and 8-11 in copending application ‘368 do not disclose chlorogenic acid in a composition with paraxanthine or 1-methylxanthine.
Saitou discloses a 16-week study that administered chlorogenic acid (CGA) to improve cognitive functions such as attention and motor speed when administered at 300 mg (2.3 Materials, Pg. 3, and Discussion, Pg. 11).
Regarding instant Claim 5 and 7, Claim 1 in copending application ‘368 disclosed a range of 50 mg to about 800 mg of paraxanthine, that overlaps with the range disclosed in instant claim 5, as 50 mg to about 400 mg, and instant claim 7, as 200 mg to about 400 mg.
Regarding instant claim 5 and 9, Claim 10 in copending application ‘368 disclosed a range of 50 mg to about 400 mg of 1-methylxanthine, that overlaps with the range disclosed in instant claim 5 as 50 mg to about 400 mg, and instant claim 9, as 200 mg to about 400 mg.
The courts found that, 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.
Regarding instant Claims 5-7, 9, and 11-13 it would have been prima facie obvious for one of ordinary skill in the art, to combine prior art elements paraxanthine, as taught in copending application ‘368 and chlorogenic acid, as taught by Saitou because they both are taught in the art as enhancing cognitive function, and together they would perform the same function as they do separately. Because copending application ‘368 teaches a method for improving cognitive function in a slow caffeine metabolizer subject (SCM), it falls under the scope of the instant claims’ patient population. One of ordinary skill would have recognized that the results of the combination of paraxanthine, 1-methylxanthine and chlorogenic acid, according to known methods would yield a predictable of enhancing cognitive function.
Regarding Claims 8 and 10, because it is obvious to combine paraxanthine and 1-methylxanthine with chlorogenic acid, in the amounts in the instant claims, as disclosed in copending application ‘368 and Saitou, it would be obvious to assume that synergy would result, since the instantly claimed amounts are disclosed in the prior art and copending application.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIERRA M ROCHELLE whose telephone number is (571)272-9962. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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/C.M.R./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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