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 .
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 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.
DETAILED ACTION
The amendments filed on 3/25/2026 which claims 9, 14, 22, and 25 were amended is acknowledged. Claims 13 and 24 were canceled.
Claims 9, 14-23, 25-27, and 32-35 are pending in the instant application.
Priority
This application is a 371 of PCT/JP2019/027622, filed on 7/13/2018 which claims priority to the foreign application JP2018132907 filed on 7/12/2019.
Information Disclosure Statement
The information disclosure statement filed 2/7/2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered. While Applicant indicates that the English translation of the office action for the Chinese Application 201980040690.4 includes a summary of these references cited within the IDS, no reference to these could not be located within these documents. If Applicant could directly provide a concise explanation of relevance for these non-English language citations, these references could then be considered by the Examiner.
Withdrawn Objections
The objection to the specification has been withdrawn; applicant removed the hyperlink.
Withdrawn Rejections
The rejection of claims 9, 16-19, 21-23, 27, and 32 under 102(a)(1) has been withdrawn; applicant has incorporated the subject matter of claims 13 and 24 into base claims 9 and 22, respectively, that were not subject to this rejection.
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 32-35 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.
claim 32-35
Claims 32-35 are drawn to “a date when improvement of the attention function is expected” wherein it is unclear if this limitation is based on (i) the anticipation of a scheduled cognitive test, or (ii) if this is based on physiological factors, for example when the peptide reaches maximum serum concentrations post x hours after administration, thus is expected to exert maximal effects on cognitive function. It is also unclear who is making the observation of this improvement of attention function (e.g. the patient, the doctor, etc?). Because it is unclear how this limitation should be interpreted or measured or by whom, these claims are rendered indefinite.
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.
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 9, 14-23, 25-27, and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Ano et al. (US20170209520) in view of Khanna et al. (doi: 10.3899/jrheum.080375), Suda et al. (doi: 10.1016/j.brainres.2008.11.077), Ishii et al. (doi: 10.1038/srep25097), Kawano et al. (doi.org/10.32190/adsonline.3.1_2), and Jabr et al. ("Does Thinking Really Hard Burn More Calories?” Scientific American, July 18, 2012). This rejection has been modified solely to address the amendments.
claim 9, 17, 20-21
Regarding claims 9, 17, and 20-21, Ano teaches a method of enhancing memory, learning, or a cognitive function comprising administering a food product (pg 3, para 0071; claim 3) derived from fermented milk product comprising peptides derived from whey protein (pg 3, para 0072; claim 7). Because improving a cognitive function encompasses enhancing memory and learning, this inherently requires maintaining an attention function, as it is impossible to enhance memory/learning in the absence of focus/attention. Ano teaches the peptides consisting of GTWY (SEQ ID NO: 7) and consisting of WY (SEQ ID NO: 13) as being isolated products post-treatment that were identified as having an enhancing effect on memory, learning, and cognitive function (pg 8, para 0127; Table 3). Ano teaches a control group of mice were injected with scopolamine to induce memory impairment, and the experimental group of mice were fed the whey peptide mixture orally and injected with scopolamine prior to a Y-maze test (pg 5, para 0086). Ano teaches that rodents with an intact short term memory will spend more time in parts of the Y-maze that they have not previously explored (pg 5, para 0087). Ano teaches that rodents of the experimental group exhibited better memory in the Y-maze than the control group (pg 5, para 0093-0094; Fig 1B, 1C). As attention and judgment are both cognitive functions, requiring memory, the method of Ano overlaps with the instantly claimed method of improving, ameliorating, and/or maintaining attention, by eating a food product containing digested whey. Ano teaches their invention enhances memory, learning, and or cognitive functions of humans (pg 3, para 0071), thus encompassing healthy humans. Furthermore, as all humans have an inherent need for improving, ameliorating, and/or maintaining attention, the method of Ano, which is drawn to method of improving cognitive function overall, applies to everyone. The office takes official notice that all healthy human individuals are prone to be fatigued by intellectual work. Ano also teaches food composition comprises 80% by mass of the peptide (pg 4, para 0082).
Ano does not the subject reporting a 20 mm increase in fatigue after a verbal fluency and Stroop test using the VAS scale to measure fatigue.
Khanna teaches that patients who have rheumatoid arthritis whose fatigue worsens, report a VAS fatigue (VAS-F) score that increases by 1.13-1.26 points on a 10 point scale (abstract). This corresponds to a change of 11.3-12.6 mm.
Suda teaches using the VAS fatigue (VAS-F) test to measure psychological fatigue after conducting a verbal fluency test (abstract) in “twenty-three young, healthy volunteers” (pg 158, col 1, para 2). Suda teaches that the VAS score is negatively correlated with oxygenated hemoglobin concentrations during the verbal fluency test and that the subjective feeling of psychological fatigue is related to decrease reactivities in the brain (abstract). Suda teaches the “VAS from 0 (no fatigue) to 100 (total exhaustion)” (pg 158, col 2, para 2), wherein even amongst these healthy individuals performing a verbal fluency test, about half experienced considerable fatigue with VAS scores in excess of 30 (Fig 2, reproduced below).
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Ishii teaches using the VAS fatigue test (pg 2, para 6) to measure psychological fatigue after conducting a Stroop Test (pg 2, para 5).
It would have been prima facie obvious to combine the teachings of the references, arriving at a method of improving a attention function comprising administering a fermented milk product and measuring the proneness to fatigue using the VAS-F after completing a verbal fluency test or Stroop test because (1) Ano describes the peptides as capable of enhancing a cognitive function; (2) Suda teaches combining VAS-F with a verbal fluency test being an effective way to measure psychological fatigue in healthy human subjects; (3) Ishii teaches combing VAS-F with the Stroop test being an effective way to measure psychological fatigue; and (4) Khanna describes the criteria for which the minimal degradation of fatigue is established. One of ordinary skill in the art would have had a reasonable expectation of success of choosing individual who’s fatigue increased by greater than 13 mm on the VAS-F after the verbal fluency test and the Stroop test as a stressor to test psychological fatigue because those VAS-F values are associated with those experiencing strong fatigue which can occurs in healthy subjects that are administered a cognitive test as taught by Suda.
claim 14
Regarding claim 14, Ano doesn’t teach that intellectual work requires concentration and/or attention.
Jabr teaches that intellectual work, such as taking the SAT exam, induces feelings of exhaustion (pg 2, para 1). Jabr teaches these feelings of exhaustion are induced by periods of intense concentration (pg 2, para 2), such as after completing the SAT (pg 4, para 5). Jabr teaches completing the SAT requires unbroken focus (a.k.a. attention) and constitutes intellectual work (pg 4, para 5). Jabr teaches such intellectual work can be measured by a slight increase in the number of calories than when the mind is at rest (pg 2, para 2). Jabr teaches that volunteers who performed two versions of the Stroop task, in which they had to identify the color of ink in which a word was printed, rather than reading the word itself: In one version, the words and colors matched—BLUE appeared in blue ink; in the tricky version, the word BLUE appeared in green or red ink. Volunteers who performed the more challenging task showed bigger dips in blood glucose, which the researchers interpreted as a direct cause of greater mental effort (pg 3, para 2). Jabr further teaches when someone has trouble regulating glucose properly—or has fasted for a long time—a sugary drink or food can improve their subsequent performance on certain kinds of memory tasks (pg 4, para 4). In summary, Jabr teaches that intellectual work which is defined by the brain consuming measurably more calories, is induced by periods of concentration and/or attention.
It would have been obvious to combine the teachings of the Ano and Jabr, because Ano describes the efficacy of milk peptides for reducing fatigue and enhancing cognition, while Jabr supplies the necessary details that intellectual work is defined by our brains consuming slightly more calories on a task that requires intense concentration and/or attention.
claim 15
Regarding claim 15, Ano does not teach using the POMS2 scale to measure Fatigue-Inertia.
Kawano teaches measuring Fatigue-Inertia using the POMS2 scale to assess the psychological effects of elderly individuals who engaged in physical activity (abstract; (pg 6, para 1). Kawano teaches participants reported Fatigue of 42.8 prior to playing Flying Disc, and a fatigue of 56.9 post-playing flying disc (pg 8, Fig 2).
One of skill in the art would have found it obvious to combine the teachings of the references to arrive at a method of determining fatigue-inertia in individuals after some experimental manipulation such as consuming a fermented milk product or engaging in physical exercise because Kawano uses the POMS2 system to obtain this metric, and establishes that a POMS2 score greater than 56.9 represents a fatigued population of elderly people whom have an expectation of increased fatigue. Thus one of skill in the art would have had a reasonable expectation of success of selecting a population of fatigued people that share the same fatigue POMS2 scores as the elderly, post-exercise.
claim 16
Regarding claim 16, Ano teaches the enzymatic product is administered orally to an adult in a dosage range of 0.02-40g (pg 4, para 0077), thus anticipating the instantly claimed dosage of 0.01-100 g. In the instant case, applicant has not provided any evidence of criticality across the instantly claimed ranges, thus Ano teaches the enzyme decomposition product with sufficient specificity to anticipate the instantly claimed ranges. See MPEP § 2131.03(II). Ano teaches administering the decomposition product to humans (pg 3, para 0071).
claim 18
Regarding claim 18, Ano teaches the composition can comprise 100% by mass of the peptides generated from enzyme-digestion (pg 3, para 0075). Thus meeting the limitation of “consisting of” the enzymatic decomposition product.
claim 19
Regarding claim 19, Ano also teaches food composition comprises one of the neuroactive peptides in an amount of 0.1-1.0% by mass (pg 4, para 0082), thus anticipating the range of 0.01-1.0% GTWY and 0.005-0.5% WY. In the instant case, applicant has not provided any evidence of criticality across the instantly claimed ranges, thus Ano teaches the peptide content with sufficient specificity to anticipate the instantly claimed ranges. See MPEP § 2131.03(II).
claim 22-23
Regarding claims 22 and 23, Ano teaches a method of enhancing memory, learning, or a cognitive function comprising administering a food product (pg 3, para 0071; claim 3) derived from fermented milk product comprising peptides derived from whey protein (pg 3, para 0072; claim 7). Because improving a cognitive function encompasses enhancing memory and learning, this inherently requires maintaining an attention function, as it is impossible to enhance memory/learning in the absence of focus/attention. Ano teaches the peptides consisting of GTWY (SEQ ID NO: 7) and consisting of WY (SEQ ID NO: 13) as being isolated products post-treatment that were identified as having an enhancing effect on memory, learning, and cognitive function (pg 8, para 0127; Table 3). Ano teaches a control group of mice were injected with scopolamine to induce memory impairment, and the experimental group of mice were fed the whey peptide mixture orally and injected with scopolamine prior to a Y-maze test (pg 5, para 0086). Ano teaches that rodents with an intact short term memory will spend more time in parts of the Y-maze that they have not previously explored (pg 5, para 0087). Ano teaches that rodents of the experimental group exhibited better memory in the Y-maze than the control group (pg 5, para 0093-0094; Fig 1B, 1C). As attention and judgment are both cognitive functions, requiring memory, the method of Ano overlaps with the instantly claimed method of improving, ameliorating, and/or maintaining attention, by eating a food product containing digested whey. Furthermore, as all humans have an inherent need for improving, ameliorating, and/or maintaining attention, the method of Ano, which is drawn to method of improving cognitive function overall, applies to everyone. The office takes official notice that all healthy individuals are prone to be fatigued by intellectual work. Ano also teaches food composition comprises one of the neuroactive peptides most preferably in an amount of 0.1-1.0% by mass (pg 4, para 0082), thus anticipating the range of 0.01-1.0% GTWY and 0.005-0.5% WY in claim 22; and the range of 0.05-0.5% GTWY and 0.01-0.1% WY in claim 23. In the instant case, applicant has not provided any evidence of criticality across the instantly claimed ranges, thus Ano teaches the peptide content with sufficient specificity to anticipate the instantly claimed ranges. See MPEP § 2131.03(II).
Ano does not the subject reporting a 20 mm increase in fatigue after a verbal fluency and Stroop test using the VAS scale to measure fatigue.
Khanna teaches that patients who have rheumatoid arthritis who’s fatigue worsens, report a VAS fatigue (VAS-F) score that increases by 1.13-1.26 points on a 10 point scale (abstract). This corresponds to a change of 11.3-12.6 mm.
Suda teaches using the VAS fatigue (VAS-F) test to measure psychological fatigue after conducting a verbal fluency test (abstract). Suda teaches that the VAS score is negatively correlated with oxygenated hemoglobin concentrations during the verbal fluency test and that the subjective feeling of psychological fatigue is related to decrease reactivities in the brain (abstract).
Ishii teaches using the VAS fatigue test (pg 2, para 6) to measure psychological fatigue after conducting a Stroop Test (pg 2, para 5).
It would have been prima facie obvious to combine the teachings of the references, arriving at a method of improving a attention function comprising administering a fermented milk product and measuring the proneness to fatigue using the VAS-F after completing a verbal fluency test or Stroop test because (1) Ano describes the peptides as capable of enhancing a cognitive function; (2) Suda teaches combining VAS-F with a verbal fluency test being an effective way to measure psychological fatigue; (3) Ishii teaches combing VAS-F with the Stroop test being an effective way to measure psychological fatigue; and (4) Khanna describes the criteria for which the minimal degradation of fatigue is established. One of ordinary skill in the art would have had a reasonable expectation of success of choosing individual who’s fatigue increased by greater than 13 mm on the VAS-F after the verbal fluency test and the Stroop test as a stressor to test psychological fatigue because those VAS-F values are associated with those experiencing strong fatigue.
claim 25
Regarding claim 25, Ano doesn’t teach that intellectual work requires concentration and/or attention.
Jabr teaches that intellectual work, such as taking the SAT exam, induces feelings of exhaustion (pg 2, para 1). Jabr teaches these feelings of exhaustion are induced by periods of intense concentration (pg 2, para 2), such as after completing the SAT (pg 4, para 5). Jabr teaches completing the SAT requires unbroken focus (a.k.a. attention) and constitutes intellectual work (pg 4, para 5). Jabr teaches such intellectual work can be measured by a slight increase in the number of calories than when the mind is at rest (pg 2, para 2). Jabr teaches that volunteers who performed two versions of the Stroop task, in which they had to identify the color of ink in which a word was printed, rather than reading the word itself: In one version, the words and colors matched—BLUE appeared in blue ink; in the tricky version, the word BLUE appeared in green or red ink. Volunteers who performed the more challenging task showed bigger dips in blood glucose, which the researchers interpreted as a direct cause of greater mental effort (pg 3, para 2). Jabr further teaches when someone has trouble regulating glucose properly—or has fasted for a long time—a sugary drink or food can improve their subsequent performance on certain kinds of memory tasks (pg 4, para 4). In summary, Jabr teaches that intellectual work which is defined by the brain consuming measurably more calories, is induced by periods of concentration and/or attention.
It would have been obvious to combine the teachings of the Ano and Jabr, because Ano describes the efficacy of milk peptides for reducing fatigue and enhancing cognition, while Jabr supplies the necessary details that intellectual work is defined by our brains consuming slightly more calories on a task that requires intense concentration and/or attention.
claim 26
Regarding claim 26, Ano does not teach using the POMS2 scale to measure Fatigue-Inertia.
Kawano teaches measuring Fatigue-Inertia using the POMS2 scale to assess the psychological effects of elderly individuals who engaged in physical activity (abstract; (pg 6, para 1). Kawano teaches participants reported Fatigue of 42.8 prior to playing Flying Disc, and a fatigue of 56.9 post-playing flying disc (pg 8, Fig 2).
One of skill in the art would have found it obvious to combine the teachings of the references to arrive at a method of determining fatigue-inertia in individuals after some experimental manipulation such as consuming a fermented milk product or engaging in physical exercise because Kawano uses the POMS2 system to obtain this metric, and establishes that a POMS2 score greater than 56.9 represents a fatigued population of elderly people whom have an expectation of increased fatigue. Thus one of skill in the art would have had a reasonable expectation of success of selecting a population of fatigued people that share the same fatigue POMS2 scores as the elderly, post-exercise.
claim 27
Regarding claim 27, Ano teaches the enzymatic product is administered orally to an adult in a dosage range of 0.02-40g (pg 4, para 0077), thus anticipating the instantly claimed dosage of 0.01-100 g. In the instant case, applicant has not provided any evidence of criticality across the instantly claimed ranges, thus Ano teaches the enzyme decomposition product with sufficient specificity to anticipate the instantly claimed ranges. See MPEP § 2131.03(II). Ano teaches administering the decomposition product to humans (pg 3, para 0071).
*claim 32
Regarding claim 32, Ano teaches a method of enhancing memory, learning, or a cognitive function comprising administering the same food product derived from fermented milk whey protein as described in the rejection of claims 9, 17, and 21-22. Because improving a cognitive function encompasses enhancing memory and learning, this inherently requires maintaining an attention function, as it is impossible to enhance memory/learning in the absence of focus/attention. The instantly claimed steps are the same as those in the method of Ano, thus the instantly claimed method of enhancing/ameliorating/maintaining attention comprising administering the composition of Ano, in the same fashion as Ano, necessarily flows from the teachings of Ano that this composition is effective in enhancing memory, learning, or a cognitive function. In other words, the limitation of “enhancing/ameliorating/maintaining an attention function” is the natural result of performing the method of Ano. See MPEP § 2112(IV). Ano teaches administering their fermented milk product once per day, for a total of nine dosages comprising varying quantities of peptide tailored the patient’s body weight, age, and route of administration (pg 4, para 0077), wherein the patient desires to exhibit enhanced cognitive performance upon completion of the method (pg 3, para 0069). Taken together, this satisfies the method step of feeding the peptide composition for 3 to 10 days, wherein the subject is itself, expected to possess enhanced cognitive function upon completion.
*claim 33-35
Regarding claims 33-35, Ano teaches administering the peptide on the same day that the subjects are interrogated for cognitive enhancement, wherein no subsequent peptide administration occurred after conducting the Y-maze test (Fig 1B, reproduced below; pg 5, para 0086). Thus meeting the limitation of terminating treatment on the date the improvement is expected.
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Ano does not teach terminating peptide administration 1-2 days before interrogation of cognitive function (see claim interpretation section regarding “a date when improvement of the attention function is expected”). However, the method of Ano teaches administering the composition over nine days, suggesting that Ano was aware of the peptide and its metabolites having a prolonged effect and/or accumulating in the brain, such that the maximum dose steeply decreases from 4 g to 2 g to 0.2 g on the final 3 days of the dosage regime (pg 4, 0077). Ano also teaches the peptides GTWY are readily absorbed in the body and are able to pass into the blood brain barrier, thereby exhibiting their effects directly on the brain (pg 4, para 0083). Because the composition of Ano comprises the same chemical constituents as the instant composition claimed and Ano teaches a cumulative dosing regimen that steeply reduces over a period of three days, this renders obvious the instantly claimed dosage regime wherein the peptide consumption is halted 1-2 days prior to cognitive function being interrogated. For example, in one embodiment, Ano teaches a dosage regimen comprising 4 g on day seven, 0.02 g on day eight, and 0.02 g on day nine; thus rendering obvious an exemplary dosage regimen of the instant invention comprising 4 g on day seven, 0 g on day eight, and 0 g on day nine using routine optimization. See MPEP § 2144.05 (II)(A). Furthermore, MPEP § 2141 (II)(2)(C) recites ‘“A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418, 82 USPQ2d at 1396.’ In the instant case, a person of skill in the art would have found it obvious to administer a cognitive test at multiple time points in order to monitor the efficacy of the treatment.
Response to Arguments
Applicant’s arguments filed on 3/25/2026 have been fully considered but they are not persuasive. The Declaration provided on 3/25/2026 has been considered.
112, pg 10, para 1
Applicant argues a skilled artisan would understand and determine when the improvement of the attention function is desired (e.g. at the time of taking a test), thus claims 32-35 are not indefinite.
Examiner respectfully disagrees that the time window in which an effect is observable is flexible enough to be determined at any time point at the leisure of the individual. This argument also fails to address the question of who is assessing the enhancement of cognitive function. For these reasons, these claims are still considered indefinite. Applicant’s study which at best encompasses a window as large as 12 weeks with daily consumption of the test food, is inconsistent with this argument that any time window of effect judged reasonable by any person of skill in the art is reasonable.
103; pg 12, para 1
Applicant argues that not all healthy human individuals are prone to be fatigued by intellectual work, when the phrase “prone to fatigue” is defined in the present application to mean what is presented in the Declaration.
By specifying a 20 mm change in the VAS scale for fatigue after performing a verbal fluency and Stroop test in claim 9 does successfully differentiate this population from the healthy population (as noted in the Declaration, item 7), however the incorporation of the term “healthy” in claim 9 to also label this population creates confusion whether the claim also includes these easily fatigued people and healthy people. Furthermore, the study referred to in item 7 of the Declaration is drawn to a population of individuals with arthritis, thus could not be considered “healthy”. As a result, the art rejection applied that is directed to healthy people is still valid.
103; pg 12, para 3
Applicant argues that Example 2 provides evidence of unexpected results when the food product of the invention is administered to the unhealthy population that exhibits a 20 mm change in VAS scale upon being given a cognitive assessment. This argument is reiterated in the Declaration, items 10-12.
In order to arrive at a verdict of unexpected results, applicant must first identify a trend then explain how the instant example deviates from that trend. In Example 2, the test period was 12 weeks long, wherein one group of healthy individuals was administered a control food and the other group was administered a group of test food of the instant invention to be consumed once per day throughout the test period (instant spec pg 21, para 0060). The cognitive test was administered prior to exposure to the test food, followed by subsequent tests at week 6 and week 12 (pg 22, para 0062). On weeks 6 and 12, the food was ingested 30 minutes prior to the cognitive test. A VAS-fatigue measurement was taken before and after the cognitive test on all three occasions (pg 22, para 0062). Table 3 describes the performance of individuals on (i) the verbal fluency; (ii) words starting with ‘a’; (iii) animal name on day 0, 6, and 12 for both the control and test groups. Table 4 describes the performance of individuals on (iv) stroop test; (v) character color on day 0, 6, and 12 for both the control and test groups. Table 5 describes the change in performance of individuals between day 0-6 and 6-12 on (ii) words starting with ‘a’; (iii) animal name; (v) character color; and (vi) character meaning. This table does not describe any of the measured values. Table 6 describes the change in performance of a cross-section (i.e. stratified) individuals between day 0-6 and 6-12 on (ii) words starting with ‘a’; (iii) animal name; (v) character color; and (vi) character meaning. This table does not describe any of the measured values. “Stratified” in this case, applicant explains is a cross-section of the total population tested that exhibited a greater that 20 mm change in VAS fatigue scale upon being given a cognitive assessment.
Tables 5 and 6 have been converted to graphical representations which fail to demonstrate statistical significance between the control group “C” (solid fill) and test food group “T” (striped fill) across cognitive tests (ii)-(vi), as denoted by the large standard deviations reported. This is partly because applicant did not provide the raw data, but instead provided changes in the number of points between time periods. In the figure legend, cognitive test (ii) is called “words”; test (iii) is called animal; test (vi) is called charam; and test (v) is called “charac”. These data are clustered in two groups: the cluster under “6” indicates the time window between 0-6 weeks, and the cluster under “12” indicates the time window between 6-12 weeks.
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[Chart]
From the data supplied, a person of skill in the art would conclude there was no statistically significant enhancement in performance across any of the cognitive tests in the unstratified population (Table 5) nor in the stratified population (Table 6) at either time window. Because applicant did not provide the complete data from which these changes were measured, a person of skill in the art would be unable to conclude statistical significance as claimed by the applicant. Examiner recommends supplying this data and representing it in a clear fashion to substantiate this argument for surprising results.
Conclusion
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 LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/
Supervisory Patent Examiner, Art Unit 1675
Prosecution Insights