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 .
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
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 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/29/2025 has been entered.
Claims 9, 13, 16, 22, 24, and 27 have been amended and claims 28-31 were canceled. Claims 32-35 have been newly added.
Claims 9, 13-27, 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.
Claim Interpretation
Claims 32-35 are drawn to “a date when improvement of the attention function is expected”. For the purpose of applying relevant art, this was interpreted as the date at which (i) an individual desired enhanced cognitive abilities (e.g. the date of a scheduled cognitive test) or (ii) an experimentalist whom scheduled a cognitive test for non-human subjects; because applicant did not specify how this should be interpreted in the instant specification (See instant spec pg 15, para 0044).
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 (Ref 15-17). It has been placed in the application file, but the information referred to therein has not been considered.
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 § 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 9, 16-19, 21-23, 27, and 32 are rejected under 35 U.S.C. 102(a)(1-2) as being anticipated by Ano et al. (WO2015194564). The pre-grant publication, US20170209520, is a 371 of PCT/JP2015/067344 (WO2015194564). Thus US20170209520 has been used as an English translation of this document and the citations below refer to this pre-grant publication. 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).
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).
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 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, 13-27, and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Ano et al. (US20170209520) as applied to claims 9, 16-19, 21-23, 27, and 32 above, and further 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 13
Regarding claim 13, 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) 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 24
Regarding claim 24, 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 33
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 4/29/2025 have been fully considered but they are not persuasive.
102, pg 9, para 2
Applicant argues Ano does not teach the newly added limitation of “wherein the subject is a healthy human individual prone to be fatigued by intellectual work”.
This has been addressed in the modified 102 rejection above.
103; pg 9, para 6
Applicant argues Ano does not teach the newly added limitation of “wherein the subject is a healthy human individual prone to be fatigued by intellectual work”.
This has been addressed in the modified 103 rejection above.
Conclusion
No claims are allowed.
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/L.A.E./
Examiner, Art Unit 1675
/Adam Weidner/SPE, Art Unit 1651