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 .
Status of the Claims
The listing of claims filed 26 April 2024 has been examined.
Claims 1-9 and 11-12 are pending.
Claims 2-5 are amended.
Claims 10 and 13-15 are cancelled.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 26 April 2024 is acknowledged and has been considered.
Benefit of Earlier Filing Date
The instant application, filed 26 April 2024, is a national stage application of PCT/EP2022/080035, filed 27 October 2022, which claims the benefit of an earlier filing date to U.S. Provisional Patent Application Serial No. 63/275,690, filed 04 November 2021, and U.S. Provisional Patent Application Serial No. 63/272,958, filed 28 October 2021. Acknowledgment is made of Applicant’s claim.
Claim Rejections - 35 USC § 112(b)
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 8 and 12 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.
Regarding claims 8 and 12, the phrase "preferably" renders these claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 1-3, 5-6, 9, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vazhappilly (WO 2013/086330 A1).
Regarding claims 1-2, Vazhappilly teaches compositions comprising curcumin and docosahexaenoic acid (DHA) as well as methods by which such compositions can be administered to improve cognitive performance and/or memory, enhance memory acquisition, memory retention, and memory recall and reduce brain dysfunction and cognitive decline (p. 1, ¶ [0002]). Vazhappilly discloses exemplary compositions, such as nutritional emulsions, clear liquids, and nutritional powders, which contain DHA and either bioavailable curcumin or curcumin (p. 20-23, Tables 1-4). Vazhappilly states, “The combination improves cognitive performance in an individual, and, in one embodiment, improves a cognitive impairment and/or brain dysfunction associated with age-related cognitive decline or cognitive decline resulting from a neurodegenerative disease.” (Abstract). Furthermore, Vazhappilly indicates curcumin and DHA have therapeutic benefit as anti-inflammatory and anti-amyloidogenic agents, which enables the composition to reduce cognitive impairment and/or brain dysfunction as both neuronal inflammation and amyloid β protein deposition are linked to cognitive impairment and/or brain dysfunction caused by age-related cognitive decline and/or cognitive decline associated with neurodegenerative diseases (p. 5, ¶ [0019]). Additionally, Vazhappilly suggests such compositions are especially useful in older adults and the elderly (p. 5, ¶ [0020]), defining “older adult” as “an individual of at least 45 years of age…” (p. 6, ¶ [0026]). Since the instant Specification defines “elderly” as “…at least 55 years…” and “ageing individual” as “…at least 45 years…” (p. 6, ¶ [0035]), the recited human ages overlaps the ages disclosed by Vazhappilly.
Regarding claim 3, Vazhappilly teaches all of the claimed elements as stated above. The instant Specification states, “…the mammal has a phenotype associated with age-related cognitive impairment. Such a phenotype can include one or more of decreased ability to recall, short-term memory loss, decreasing learning rate, decreased capacity for learning, decreased problem-solving skills, decreased attention span, decreased motor performance, increased confusion, or dementia…” (¶ [0079], [00103]). Vazhappilly discloses the curcumin and DHA-containing composition may be administered to improve memory acquisition, retention, and recall as well as improve cognitive performance (p. 2-3, ¶ [0007-0010]; Claims 5, 7-8, and 15). Furthermore, a skilled artisan would recognize the aforementioned phenotypes may also be linked to neurodegenerative diseases, like Alzheimer’s disease (AD). Vazhappilly discloses the composition may also be administered to individuals having such a neurodegenerative disease, including AD, Huntington’s disease, Parkinson’s disease, dementia, amyotrophic lateral sclerosis, stroke, and schizophrenia (Claims 6 and 16).
Regarding claim 5, Vazhappilly teaches all of the claimed elements as stated above. Furthermore, Vazhappilly indicates the compositions may be administered orally in a suitable solid, liquid, or powder form as well as a water-in-oil emulsion or an oil-in-water emulsion (p. 9, ¶ [0042-0043]; p. 18, ¶ [0073]).
Regarding claim 6, Vazhappilly teaches all of the claimed elements as stated above. Furthermore, Vazhappilly describes a use wherein the composition is administered to an individual as a “…long term, continuous, daily, dietary supplement.” (p 20, ¶ [0078]).
Regarding claims 9 and 11-12, Vazhappilly teaches all of the claimed elements as stated above. Furthermore, Vazhappilly indicates the composition can be produced in accordance with well-known manufacturing methods in the nutrition industry (p. 20, ¶ [0080]; p. 17, ¶ [0070=0072]). Vazhappilly discloses nutritional powders containing the DHA and curcumin-containing composition may be, “…prepared by spray drying methods in separate batches, and are reconstituted with water prior to use to the desired target ingredient concentrations.” (p. 22-23, ¶ [0084]). Additionally, Vazhappilly teaches the composition may contain other ingredients, like proteins, lipids, and carbohydrates (p. 14, ¶ [0059]). Vazhappilly discloses exemplary compositions (p. 23, Table 4) containing maltodextrin, a carbohydrate (p. 15, ¶ [0062]), as well as HO sunflower oil, a lipid (p. 16, ¶ [0065]). As detailed above, Vazhappilly suggests such compositions are especially useful in older adults and the elderly (p. 5, ¶ [0020]).
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.
Claims 1-6, 9, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Vazhappilly (WO 2013/086330 A1) in view of Boutry (WO 2020/094555 A1).
Regarding claims 1-6, 9, and 11-12, Vazhappilly teaches all of the claimed elements as stated above. Furthermore, Vazhappilly indicates cognitive decline commonly occurs in relation to neurodegenerative diseases and such cognitive dysfunction may cause social and/or occupational functioning to become impaired (p. 2, ¶ [0004]).
Vazhappilly does not explicitly link improved social behavior to the composition.
Boutry teaches compositions, comprising curcumin and an omega-3 fatty acid, which may be administered to an older adult or an elderly individual and can be used in improving mood or managing stress (Abstract) or treating a cognitive disorder, cognitive dysfunction, age-related neuronal dysfunction, or an anxiety disorder. Boutry states the omega-3 fatty acid may be a long-chain polyunsaturated fatty acid, like DHA (p. 11, ¶ [0001]).
Boutry does not explicitly teach an exemplary composition comprising curcumin and DHA.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Vazhappilly would have found it prima facie obvious to enhance the emotional health of a mammal by administering the composition disclosed by Vazhappilly based on the teachings of Boutry because Boutry teaches a composition comprising curcumin and an omega-3 fatty acid, like DHA, can be used to manage stress or treat an anxiety disorder.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Vazhappilly (WO 2013/086330 A1) in view of Pan (WO 2009/088433 A1).
Regarding claims 7-8, Vazhappilly teaches all of the claimed elements as stated above. Furthermore, Vazhappilly discloses a method wherein an individual may consume 1-3 servings of the nutritional composition per day. The servings may be a single, undivided dose or may be divided into multiple servings which may be administered two or more times per day (p. 19, ¶ [0078]). The instant Specification defines the term “unit dosage form” as, “…physically discrete units suitable as unitary dosages for human and animal subjects, each unit containing a predetermined quantity of the composition… in an amount sufficient to produce the desired effect… with a pharmaceutically acceptable diluent, carrier, or vehicle.” (¶ [0059]).
Vazhappilly does not explicitly teach a specific, exemplary unit dosage form such as a tablet or capsule.
Pan teaches compositions and methods for enhancing cognitive function (p. 1, ¶ [0002]), the composition comprising an unsaturated fatty acid, like DHA, and at least one nitric oxide-releasing compound (Claim 5). The compositions may be administered to a human or companion animal, specifically an aging animal (Claims 2-4). Additionally, Pan suggests the compositions can be administered in any suitable delivery form, like a powder, granule, suspension, chew, treat, snack, pellet, pill, capsule, or tablet (p. 10, ¶ [0052]; p. 14, ¶ [0069]) and contain pharmaceutically acceptable carriers, diluents, or excipients (p. 15, ¶ [0080]).
Pan does not explicitly teach a composition comprising curcumin.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Vazhappilly would have found it prima facie obvious to prepare a unit dosage form comprising DHA and curcumin and administer said dosage form to an ageing human or dog based on the teachings of Pan. Both Vazhappilly and Pan disclose compositions administered to improve cognition. Thus, a PHOSITA would have been motivated to prepare a unit dosage form as described by Pan containing the composition comprising DHA and curcumin as disclosed by Vazhappilly (MPEP 2143(I)(C)). A skilled artisan would recognize unit dosage forms are preferred due to the ease with which such dosage forms may be administered to individuals.
Non-Statutory 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 1-9 and 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 10,744,100, Claim 1 of U.S. Patent No. 10,980,854, Claim 1 of U.S. Patent No. 11,376,297, and Claim 1 of U.S. Patent No. 11,648,285 in view of Vazhappilly.
Patent ‘100 claims, “A method of reducing a loss of muscle functionality in an individual, increasing muscle functionality in an individual, and/or improving recovery of muscle functionality after muscle atrophy in an individual, the method consisting essentially of administering an effective amount of a combination of curcumin and omega-3 fatty acid to the individual.”
Patent ‘100 does not claim a method of enhancing cognitive or emotional health by administering a composition comprising either spermidine or ellagic acid or DHA and curcumin.
Patent ‘854 claims, “A method of treating obesity in an animal in need thereof comprising orally administering to the animal in need thereof a nutrient blend comprising… turmeric root powder… and docosahexaenoic acid…”
Patent ‘854 does not claim a method of enhancing cognitive or emotional health by administering a composition comprising either spermidine or ellagic acid or DHA and curcumin.
Patent ‘297 claims a composition comprising turmeric root powder and DHA.
Patent ‘297 does not claim a method of enhancing cognitive or emotional health by administering a composition comprising either spermidine or ellagic acid or DHA and curcumin.
Patent ‘285 claims a pet food comprising turmeric root powder and DHA.
Patent ‘285 does not claim a method of enhancing cognitive or emotional health by administering a composition comprising either spermidine or ellagic acid or DHA and curcumin.
Vazhappilly teaches compositions comprising curcumin and docosahexaenoic acid (DHA) as well as methods by which such compositions can be administered to improve cognitive performance and/or memory, enhance memory acquisition, memory retention, and memory recall and reduce brain dysfunction and cognitive decline (p. 1, ¶ [0002]).
Vazhappilly does not explicitly teach a method of treating, reducing an incidence of, and/or reducing a severity of effects from early-life stress associated with altered mitochondrial function or a reduced mitochondrial density in an individual, a method of treating obesity in an animal in need thereof comprising administering a nutrient blend comprising turmeric root powder and DHA, or a composition or pet food comprising turmeric root powder and DHA.
A PHOSITA would have been motivated to improve cognitive ability by administering a composition comprising curcumin and DHA as disclosed by Vazhappilly because Patents ‘100, ‘854, ‘297, and ‘285 all disclose compositions containing turmeric root powder, which contains curcumin, or curcumin as well as an omega-3 fatty acid, which includes DHA. A skilled artisan would recognize curcumin is the principal bioactive ingredient in turmeric root powder and recognize DHA is an omega-3 fatty acid. A PHOSITA would have had a reasonable expectation of success in improving cognitive ability using such a composition because Vazhappilly teaches such compositions are useful in improving cognitive ability.
Because claims 1-9 and 11-12 in the instant application would have been obvious over claim 1 of U.S. Patent No. 10,744,100, claim 1 of U.S. Patent No. 10,980,854, claim 1 of U.S. Patent No. 11,376,297, and claim 1 of U.S. Patent No. 11,648,285 in view of Vazhappilly, claims 1-9 and 11-12 in the instant application are not patentably distinct from claim 1 of U.S. Patent No. 10,744,100, claim 1 of U.S. Patent No. 10,980,854, claim 1 of U.S. Patent No. 11,376,297, and claim 1 of U.S. Patent No. 11,648,285.
Claims 1-9 and 11-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 6, 8, and 36-38 of copending Application No. 17/291,055.
Application ‘055 claims a method of treating, reducing an incidence of, and/or reducing a severity of effects from early-life stress associated with altered mitochondrial function or a reduced mitochondrial density in an individual in need thereof, the method comprising orally administering a composition comprising curcumin and an omega-3 fatty acid (Claim 8), which can be DHA (Claim 36). The individual is can be an older adult (Claim 6) or elderly (Claim 35).
Application ‘055 does not claim a method of enhancing cognitive function and emotional health in a mammal, the method comprising orally administering a composition comprising curcumin and DHA.
Vazhappilly teaches compositions comprising curcumin and docosahexaenoic acid (DHA) as well as methods by which such compositions can be administered to improve cognitive performance and/or memory, enhance memory acquisition, memory retention, and memory recall and reduce brain dysfunction and cognitive decline (p. 1, ¶ [0002])..
Vazhappilly does not explicitly teach a method of treating, reducing an incidence of, and/or reducing a severity of effects from early-life stress associated with altered mitochondrial function or a reduced mitochondrial density in an individual in need thereof.
A PHOSITA would have been motivated to improve cognitive ability by administering a composition comprising curcumin and DHA as disclosed by Vazhappilly because Application ‘055 discloses a composition containing curcumin as well as an omega-3 fatty acid, which includes DHA. A PHOSITA would have had a reasonable expectation of success in improving cognitive ability using such a composition because Vazhappilly teaches such compositions are useful in improving cognitive ability.
Because claims 1-9 and 11-12 in the instant application would have been obvious over claims 6, 8, and 36-38 of copending Application No. 17/291,055 in view of Vazhappilly, claims 1-9 and 11-12 in the instant application are not patentably distinct from claims 6, 8, and 36-38 of copending Application No. 17/291,055.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/B.L.B./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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