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 Application
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 CFR1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/12/2026 has been entered.
Claims 5-8 and 35-38 are pending as of the response filed on 01/12/2026. Claims 1-4 and 9-34 are cancelled. Claims 5-8 and 35-38 are examined herein.
The 35 U.S.C. § 103 rejections of previous record are withdrawn in consideration of the claim amendments.
Applicants arguments have been fully considered. Applicants arguments are rendered moot since the arguments are based on the 35 U.S.C. § 103 rejections of previous record, which are withdrawn.
A new 35 U.S.C. § 103 rejection is made necessitated by the claim amendments and addresses all the limitations of the amended claims.
Information Disclosure Statement
The information disclosure statement submitted on 03/12/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103 - New
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 5-6, 8 and 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Vazhappilly et al. (WO 2013/086330 A1, publication date 13 June, 2013, hereinafter Vazhappilly), Ridout et al. (The Cellular Sequelae of Early Stress: Focus on Aging and Mitochondria, 2016, hereinafter Ridout), Rosenblat et al. (Inflamed moods: A review of the interactions between inflammation and mood disorders, 25 January 2014, hereinafter Rosenblat) and Zarate Jr. et al. (Glutamatergic Modulators: The Future of Treating Mood Disorders?, 09 December 2010, hereinafter Zarate).
Regarding instant claims 8 and 36-38, Vazhappilly teaches a method for enhancing N Methyl-D-aspartate receptor (NMDAR) dependent hippocampal long-term potentiation (LTP), a physiological correlate or a measure of synaptic plasticity, the method comprising administering to the individual a composition comprising an effective amount of curcumin or bioavailable curcumin and docosahexaenoic acid (i.e., an omega-3 fatty acid) (Paras. [0011]-[0012]); Claim 1; Claim 6; Example 21). Vazhappilly teaches the methods include oral administration of the nutritional compositions that include curcumin or bioavailable curcumin in combination with DHA (Paras. [0029]-[0030]; Paras. [0042]-[0043]; Para. [0076]). Vazhappilly teaches wherein the individual is administered from about 400 milligrams/day to about 2000 milligrams/day of bioavailable curcumin and from about 100 milligrams/day to about 2000 milligrams/day of docosahexaenoic acid (Para. [0054]; Para. [0058]; Claim 4) (these ranges of curcumin and docosahexaenoic acid, an omega-3 fatty acid, either overlap or fall within the instantly claimed 500 mg to 2.5 g of the omega-3 fatty acid per day and 0.01 mg to 2.0 g of the curcumin per day).
Vazhappilly do not teach 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, wherein the effects of the early-life stress are stress-induced or stress-related mood disorder.
Ridout teaches early life stress is associated with reductions in telomere length and maintenance, and affect mitochondrial function (Pg. 388, second column, continued paragraph). Ridout teaches an association of early life stress and adult psychiatric disorders (depression, anxiety, substance use) with mitochondrial changes similar to those seen with aging (Pg. 388, second column, last paragraph- third column, continued paragraph). Ridout teaches early life stress contribute to mechanisms that trigger long-term compensatory responses characterized by chronic stress that manifests as psychiatric disorders (i.e., early life stress results in stress-related mood disorders) (Pg. 388, third column, continued paragraph).
Rosenblat teaches inflammation as a critical mediator in the pathophysiology of mood disorders, such as major depressive disorder (MDD) and bipolar disorder (BD) (Abstract). Rosenblat teaches stress to be a key mediator of inflammation (Pg. 25, second column, continued paragraph). Rosenblat teaches curcumin and omega-3 fatty acids, as potential anti-inflammatory agents for use in mood disorders (Abstract; Pg. 28, second column, first paragraph – third paragraph). Rosenblat teaches these anti-inflammatory agents may present efficacious agents with improved side-effect profiles compared to anti-depressants, mood stabilizers and anti-psychotics in the treatment of mood disorders (Pg. 30, first column, last paragraph).
Zarate teaches the glutamatergic system has been implicated in the pathophysiology of mood disorders, such as bipolar disorder (BPD) and major depressive disorder (MDD) (Abstract; Pg. 2, fourth full paragraph). Zarate teaches modulation of the NMDA and AMPA receptors play an important role in mood regulation (Pg. 3, third full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Vazhappilly, Ridout, Rosenblat and Zarate, to have applied the method of Vazhappilly comprising administering an effective amount of curcumin or bioavailable curcumin and docosahexaenoic acid (i.e., an omega-3 fatty acid) to an individual afflicted with the effects of early-life stress (which is associated with altered mitochondrial function), wherein the effects of the early-life stress is a stress-related mood disorder, to arrive at the instant method claims with a reasonable expectation of success. Vazhappilly teaches a method for enhancing N Methyl-D-aspartate receptor (NMDAR) dependent hippocampal long-term potentiation (LTP), a physiological correlate or a measure of synaptic plasticity, the method comprising administering to the individual a composition comprising an effective amount of curcumin or bioavailable curcumin and docosahexaenoic acid (i.e., an omega-3 fatty acid). Vazhappilly teaches the methods include oral administration of the nutritional compositions that include curcumin or bioavailable curcumin in combination with DHA. Vazhappilly teaches dosage ranges of curcumin and docosahexaenoic acid, an omega-3 fatty acid, that either overlap or fall within the instantly claimed 500 mg to 2.5 g of the omega-3 fatty acid per day and 0.01 mg to 2.0 g of the curcumin per day. Ridout teaches early life stress is associated with mitochondrial dysfunction. Ridout teaches early life stress contribute to mechanisms that trigger long-term compensatory responses characterized by chronic stress that manifests as psychiatric disorders (i.e., early life stress results in stress-related mood disorders). Rosenblat teaches inflammation as a critical mediator in the pathophysiology of mood disorders, such as major depressive disorder (MDD) and bipolar disorder (BD). Rosenblat teaches stress to be a key mediator of inflammation. Rosenblat teaches curcumin and omega-3 fatty acids, as potential anti-inflammatory agents for use in mood disorders. Zarate teaches the glutamatergic system has been implicated in the pathophysiology of mood disorders, such as bipolar disorder (BPD) and major depressive disorder (MDD). Zarate teaches modulation of the NMDA and AMPA receptors play an important role in mood regulation.
Therefore, a PHOSITA would have been motivated to use the method of Vazhappilly, that teaches modulation of the NMDA and AMPA receptors comprising orally administering a combination composition of curcumin and an omega-3 fatty acid (say, docosahexaenoic acid) to an individual afflicted with the effects of early-life stress (in preferred dosages), wherein the effects of the early-life stress is a stress-related mood disorder. The motivation being to provide efficacious agents with improved side-effect profiles compared to anti-depressants, mood stabilizers and anti-psychotics in the treatment of mood disorders (Rosenblat, Pg. 30, first column, last paragraph).
The combined teachings of Vazhappilly, Ridout, Rosenblat and Zarate renders the method of instant claim 8, prima facie obvious, wherein the individual is afflicted with a stress-related mood disorder (which is not a neurodegenerative disorder). This satisfies the limitations of instant claim 38.
Regarding instant claims 6 and 35, the combined teachings of Vazhappilly, Ridout, Rosenblat and Zarate renders the method of instant claim 8, prima facie obvious. Vazhappilly teaches wherein the individual is an older adult or an elderly (Para. [0020]; [0026]). Therefore, the limitations of claims 6 and 35 are rendered prima facie obvious.
Regarding instant claim 5, the combined teachings of Vazhappilly, Ridout, Rosenblat and Zarate renders the method of instant claim 8, prima facie obvious. Vazhappilly teaches the compositions are nutritional compositions (Paras. [0015]-[0016]). Vazhappilly teaches the term “nutritional composition” refers to nutritional liquids and nutritional powders that comprise at least one of protein, fat, and carbohydrate and is suitable for oral administration to a human (Para. [0029]). Vazhappilly teaches an embodiment wherein the bioavailable curcumin is a mixture of curcuminoids (i.e., curcumin, demethoxycurcumin and bisdemethoxycurcumin obtained from the rhizomes of Curcuma Longa (Para. [0052]) (i.e., the composition comprises a plant extract that provides at least a portion of the curcumin). Therefore, the limitations of instant claim 5 are rendered prima facie obvious (the disclosure of Vazhappilly meets the limitation drawn to a food product based on the definition in Para. [0032] of instant specification).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Vazhappilly et al. (WO 2013/086330 A1, publication date 13 June, 2013, hereinafter Vazhappilly), Ridout et al. (The Cellular Sequelae of Early Stress: Focus on Aging and Mitochondria, 2016, hereinafter Ridout), Rosenblat et al. (Inflamed moods: A review of the interactions between inflammation and mood disorders, 25 January 2014, hereinafter Rosenblat) and Zarate Jr. et al. (Glutamatergic Modulators: The Future of Treating Mood Disorders?, October 2010, hereinafter Zarate) as applied to claims 5-6, 8 and 35-38 above, and further in view of Wu et al. (Curcumin attenuates surgery-induced cognitive dysfunction in aged mice, 21 February 2017, hereinafter Wu2) and Molfino et al. (The Role for Dietary Omega-3 Fatty Acids Supplementation in Older Adults, 03 October 2014, hereinafter Molfino).
The teachings of Vazhappilly, Ridout, Rosenblat and Zarate are set forth in the obviousness rejection above and incorporated herein by reference.
Regarding instant claim 7, the combined teachings of Vazhappilly, Ridout, Rosenblat and Zarate renders the method of instant claim 8, prima facie obvious. Vazhappilly, Ridout, Rosenblat and Zarate do not teach wherein the individual is a patient in ICU.
Wu2 teaches curcumin significantly prevented cognitive dysfunction in aged mice undergoing surgery (Abstract; Pg. 797, first column, last paragraph). Wu2 teaches curcumin prevented cognitive impairments via multiple targets, possibly by increasing the activity of anti-oxidant enzymes, activation of BDNF signaling, and neutralization of cholinergic dysfunction (Abstract; Pg. 794, first column, last paragraph; Fig. 2).
Molfino teaches the administration of fish oil in critically ill elderly patients in the first 48 h of intensive care unit (ICU) admission increased energy intake and exhibited anti-inflammatory effect (Pg. 4064, last paragraph). Molfino teaches fish and fish oil contain high level of omega-3 polyunsaturated fatty acids (PUFAs) (Pg. 4059, second paragraph). Molfino teaches omega-3 PUFAs modulate inflammation, hyperlipidemia, platelet aggregation, and hypertension (Abstract). Molfino teaches omega-3 PUFAs as key nutrients, safe and effective in the treatment of several negative consequences of aging (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Vazhappilly, Ridout, Rosenblat, Zarate, Wu2 and Molfino, to apply the method of Vazhappilly in the treatment of a patient in the ICU, with a reasonable expectation of success. The motivation being to prevent cognitive dysfunction/reduce systemic inflammation, thereby improving treatment outcomes by preventing and reducing co-morbidities in older adults (Molfino, Abstract; Pg. 4059, second paragraph).
Conclusion
Claims 5-8 and 35-38 are rejected.
No claims are allowed.
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/PADMAJA S RAO/Examiner, Art Unit 1627