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
Claims 5-8 and 35-39 are pending as of the response filed on 06/17/2026. Claims 1-4 and 9-34 are cancelled. Claim 39 is newly added. Claims 5-8 and 35-39 are examined herein.
In view of the pending claims, the 35 U.S.C. 103 rejection of previous record is maintained. A new ground of rejection is made, necessitated by the claim amendments.
Applicant’s arguments have been carefully considered and are addressed below.
Information Disclosure Statement
The information disclosure statement submitted on 08/05/2026 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 – Maintained
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, of previous record), Ridout et al. (The Cellular Sequelae of Early Stress: Focus on Aging and Mitochondria, 2016, hereinafter Ridout, of previous record), Rosenblat et al. (Inflamed moods: A review of the interactions between inflammation and mood disorders, 25 January 2014, hereinafter Rosenblat, of previous record) and Zarate Jr. et al. (Glutamatergic Modulators: The Future of Treating Mood Disorders?, 09 December 2010, hereinafter Zarate, of previous record).
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, of previous record), Ridout et al. (The Cellular Sequelae of Early Stress: Focus on Aging and Mitochondria, 2016, hereinafter Ridout, of previous record), Rosenblat et al. (Inflamed moods: A review of the interactions between inflammation and mood disorders, 25 January 2014, hereinafter Rosenblat, of previous record) and Zarate Jr. et al. (Glutamatergic Modulators: The Future of Treating Mood Disorders?, October 2010, hereinafter Zarate, of previous record) 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, of previous record) and Molfino et al. (The Role for Dietary Omega-3 Fatty Acids Supplementation in Older Adults, 03 October 2014, hereinafter Molfino, of previous record).
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).
Claim Rejections - 35 USC § 103 – New necessitated by amendment
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.
Claim 39 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, of previous record), Ridout et al. (The Cellular Sequelae of Early Stress: Focus on Aging and Mitochondria, 2016, hereinafter Ridout, of previous record), Rosenblat et al. (Inflamed moods: A review of the interactions between inflammation and mood disorders, 25 January 2014, hereinafter Rosenblat, of previous record) and Zarate Jr. et al. (Glutamatergic Modulators: The Future of Treating Mood Disorders?, October 2010, hereinafter Zarate, of previous record) as applied to claims 5-6, 8 and 35-38 above, and further in view of Finley (US 8,652,518 B2, patent date 18 February, 2014, of previous record).
The teachings of Vazhappilly, Ridout, Rosenblat and Zarate are set forth in the obviousness rejection above and incorporated herein by reference.
Regarding instant claim 39, 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 omega-3 fatty acid is at least one of α-linolenic acid or eicosapentaenoic acid.
Finley teaches methods for the treatment of diseases or conditions associated with oxidative stress, inflammation, and metabolic dysregulation, comprising orally administering therapeutically effective amounts of a composition comprising eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and curcumin (Col. 4, Lns. 34-43; Claim 11; Claim 19). Finley teaches the methods and compositions are effective in mitigating the deleterious effects of oxidative stress while positively influencing the rate of mitochondrial biogenesis and energy production (Col. 5, Lns. 19-27). Finley teaches the methods increase the level of antioxidants in a subject (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 and Finley, to have substituted or included eicosapentaenoic acid into the composition of Vazhappilly, to arrive at the method of instant claim 39 with a reasonable expectation of success (the use of the transitional phrase “comprising” allows for administration of additional ingredients besides curcumin and an omega-3 fatty acid). The combined teachings of Vazhappilly, Ridout, Rosenblat and Zarate renders obvious a method of treating the effects of early-life stress associated with mitochondrial dysfunction in an individual in need thereof, wherein the effects of the early-life stress is a stress-related mood disorder, comprising orally administering an effective amount of curcumin or bioavailable curcumin and docosahexaenoic acid (i.e., an omega-3 fatty acid) to said subject. Finley teaches methods for the treatment of diseases or conditions associated with oxidative stress, inflammation, and metabolic dysregulation, comprising orally administering therapeutically effective amounts of a composition comprising eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and curcumin. Finley teaches the methods and compositions are effective in mitigating the deleterious effects of oxidative stress while positively influencing the rate of mitochondrial biogenesis and energy production.
According to MPEP 2144.06 (II), “An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)”. In the instant case, docosahexaenoic acid (DHA) of Vazhappilly and the eicosapentaenoic acid (EPA), are both omerga-3 fatty acids that are considered equivalents in the art.
Therefore, a person having ordinary skill in the art would have been motivated to include eicosapentaenoic acid (since the instant claims recite “comprising”) OR alternatively, substitute the docosahexaenoic acid in the composition of Vazhappilly, to arrive at the method of the instant claims, in the absence of any evidence to the contrary. The motivation being to mitigate the deleterious effects of oxidative stress while positively influencing the rate of mitochondrial biogenesis and energy production (Finley, Col. 5, Lns. 19-27).
Response to Arguments
Applicant argues on pages 5-7 of the remarks dated 06/17/2026 “Indeed, Vazhappilly is completely unrelated to treating effects from early life-stress associated with altered mitochondrial function or a reduced mitochondrial density … Vazhappilly relates to an entirely distinct biochemical pathway and physiological effect than Applicant's presently claimed invention. Accordingly, they would have no reasonable expectation of success for an attempt to apply the method of Vazhappilly to somehow treat effects of early life stress associated with altered mitochondrial function or reduced mitochondrial density”. Applicant argues “Ridout is directed to the effects of early life stress on aging, and makes no mention of stress-induced or stress-related mood disorders. Ridout makes no suggestion whatsoever that a combination of curcumin and an omega-3 fatty acid could alleviate the effects of early life stress”. Applicant argues “Rosenblat teaches the use of traditional anti-inflammatory medications, including acetyl-salicylic acid (ASA), celecoxib, … curcumin and omega-3 polyunsaturated fatty acids, as potential therapeutic targets for treating mood disorders … Rosenblat makes no suggestion that the listed anti-inflammatory agents would be useful in treating a different subset of mood disorders associated with altered mitochondrial function or reduced mitochondrial density”. Applicant argues “Zarate is directed to mood disorders associated with dysfunctions in glutamate levels and regulation, and makes no mention of mood disorders associated with altered mitochondrial function from early-life stress”. Applicant concludes that there would have been no reasonable expectation of success in applying the method of Vazhappilly to the treatment of stress-induced or stress-related mood disorders associated with altered mitochondrial function.
Applicant's arguments have been fully considered but they are not persuasive.
With due respect, Applicants are reminded that the rejection is based on an obviousness rationale and not anticipation. No single reference is expected to teach all of the claimed limitations.
According to MPEP 2145 (IV), “One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually”.
As discussed in the 103 rejection, 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 orally 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 daily dosages of curcumin and docosahexaenoic acid that either overlap or fall within the instantly claimed ranges. Ridout teaches early life stress is associated with reductions in telomere length and maintenance, and affect mitochondrial function. 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 – this section of Ridout is copied below).
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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.
Contrary to Applicant’s assertion, the cited references appear to lead a person of ordinary skill in the art towards a reasonable expectation of success in arriving at the instant invention. Summing up the references, 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 by orally administering to the individual a composition comprising an effective amount of curcumin and docosahexaenoic acid (an omega-3 fatty acid). Ridout teaches early life stress is associated with mitochondrial dysfunction. Ridout teaches an association of early life stress and adult psychiatric disorders (depression, anxiety, substance use – i.e., mood disorders) with mitochondrial changes similar to those seen with aging. 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 administer the composition of Vazhappilly (comprising a combination of curcumin and an omega-3 fatty acid) in a method of treating the effects of an early-life stress induced disorder, such as stress-induced mood disorder (taught to have impaired mitochondrial activity), to arrive at the method of the instant claims with a reasonable expectation of success.
According to MPEP 2144 (I), “The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992); see also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings)”.
Moreover, regarding a reasonable expectation of success, according to MPEP 2143.02, “The reasonable expectation of success requirement refers to "the likelihood of success" in combining or modifying prior art disclosures to meet the limitations of the claimed invention. See Elekta Ltd. v. ZAP Surgical Sys., Inc., 81 F.4th 1368, 1375, 2023 USPQ2d 1100 (Fed. Cir. 2023) and Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367, 119 USPQ2d 1171, 1176 (Fed. Cir. 2016) … Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019)”. In the instant case, the above discussion clearly articulates the reason behind using the combined teachings of Vazhappilly, Ridout, Rosenblat, Zarate, to arrive at the method of the instant claims.
According to MPEP 2145(I), “Arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)” ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness."). See MPEP § 716.01(c) for examples of applicant statements which are not evidence and which must be supported by an appropriate affidavit or declaration.
Additionally, as previously indicated during prosecution, the examiner notes that while instant figures 1-3 appear to show synergy for the combination of omega-3 fatty acid and curcumin towards mitochondrial function (FIG. 3), there is no disclosure of exact weight ratios, concentrations, or dosage amounts of the components, curcumin and omega-3 fatty acid, that actually yield the synergistic effect. It is not clear what the tested range was, for one of ordinary skill in the art to ascertain if the probative value can be extended to a broader range being claimed. Therefore, the evidence is not nearly commensurate in scope with the claims.
According to MPEP 716.02(d), “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”.
It is suggested that Applicant submit further information regarding the combination composition of curcumin and an omega-3 fatty acid that exerts the synergistic effect, to potentially help overcome the obviousness rejection of record.
Conclusion
Claims 5-8 and 35-39 are rejected.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached on 9:00-5:30pm EDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PADMAJA S RAO/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
