The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 has been entered.
Pursuant to the amendment dated 10/13/2025, claims 59 and 60 are cancelled and claims 34, 39, 55 and 56 are amended. No claims are newly added.
Claims 34, 38-40, 43-51, 53, 55-58 and 61 are pending and are examined on the merits herein.
Applicants’ declaration of Aaron Fanning submitted on 10/13/2025 under 37 CFR 1.132, is acknowledged and will be further discussed below.
Priority
The instant application is a 371 of PCT/IB2019/061147, filed on 12/20/2019, which claims foreign priority to New Zealand 751936, filed on 03/21/2019.
Information Disclosure Statement
The information disclosure statements (IDS) dated 10/17/2025 and 10/21/2025 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, the information disclosure statements have been considered by the examiner.
Withdrawn Objection
The objection to claim 39 is withdrawn. Applicant has amended the claim to remove the redundant “is” in item (c).
Withdrawn Rejections
All rejection(s) of record for claim(s) 59 and 60 is/are hereby withdrawn due to the cancellation of said claim(s) rendering said rejection(s) moot.
Applicant’s Amendment, filed 10/13/2025, with respect to the rejection of claims 34, 38-40, 43-51, 53, 55-58 and 61 under 35 U.S.C. 103 as being unpatentable over Daly et al. (Australian New Zealand Clinical Trials Registry, 2017), further in view of Haramizu et al (US 2012/0302513 A1), has been fully considered and is persuasive. The combined prior art does not teach or suggest prescribing an exercise program for at least two days per week. The rejection is hereby withdrawn. The discussion in the affidavit of 10/13/2025 concerned the rejection over Daly/Haramizu. Since this rejection is withdrawn, the affidavit is not relevant to any further rejections citing different prior art.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 34, 38-40, 44, 47, 48, 50, 51, 57, 58 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (PLoSOne, 2014, IDS).
Kim et al. discloses a method for decreasing frailty and increasing physical activity level in women aged 75+ years by administering a composition comprising milk fat globule membrane (MFGM) supplement, in combination with a structured exercise program (60 min training, 2X per week, for 3 months). (Abstract; p. 6) Kim discloses that the composition of the MFGM supplement was 21.5% protein, 44.0% fat, 26.5% carbohydrate, 33.3% phospholipids (8.29% phosphatidylcholine, 8.56% phosphatidylethanolamine, 2.79% phosphatidylinositol, 3.31% phosphatidylserine, 8.03% sphingomyelin, and others), 6.4% ash, and 1.6% moisture, where the composition, in pill form, contained 167 mg of MFGM, and six pills (total 1 g) were ingested in the mornings, prior to activity. (p. 7) Kim reports that the 3-month exercise and nutrition supplementation program had an effect on frailty status improvement after the intervention and follow-up. In particular, the frailty components revealed that exhaustion, low physical activity, and slow walking speed were reversed, but low muscle strength did not significantly change. The percentage of non-frail people was significantly higher in the Ex+MFGM(57.6%) than in the MFGM (28.1%) or placebo (30.3%) groups at post-intervention. Similarly at the follow-up, the percentage of non-frail people was significantly greater in the Ex+MFGM (45.5%) and Ex+Plac (39.4%) groups compared with the placebo (15.2%) group. The Ex+MFGM group was over 4 times more likely to reverse frailty than the placebo group, and the Ex+Plac group also had a high likelihood of reversing frailty with a significant odds ratio (OR) of 3.64 in reference to the placebo group. (p. 12) The adjusted ORs for frailty reversal at both post-intervention and follow-up were greater in the Ex +MFGM group than the Ex+Plac and MFGM only groups. (p. 14)
Kim does not explicitly teach “increasing vitality” or explicitly teach “increasing daily activity and decreasing sedentary time in a subject in addition to the prescribed exercise”.
One of ordinary skill in the art recognizes that vitality and frailty are inverses of one another, thus decreasing frailty is equivalent to increasing vitality. Thus it would be obvious to tone of ordinary skill in the art that the teaching of Kim of decreasing frailty meets the claimed limitation of increasing vitality. With respect to the limitation of increasing daily activity and decreasing sedentary time, in addition to the exercise program, this limitation is considered met by Kim. Kim discloses that low physical activity was reversed in the Ex+MFGM group, where low physical activity was assessed via questionnaire at baseline by answering “true” to at least 3 of the following 4 statements, “I regularly take walks less than once a week,” “I do not exercise regularly,” “I do not actively participate in hobbies or lessons of any sort,” and “I do not participate in any social groups for elderly people or volunteering.”. By reversing low physical activity based on these metrics, participants must then have answered “false” to at least two of the above statements, which indicates that the Ex+MFGM regimen reasonably resulted in more daily walks, more exercise, more hobbies, more socialization, or a combination thereof. Therefore, one would reasonably conclude that by reversing low physical activity, one would necessarily be increasing daily activity and decreasing sedentary time.
With respect to claim 38, the disclosure of Kim that a 1000 mg MFGM composition was administered daily and 33.3% of the MFGM composition was phospholipids results in administering 333 mg of phospholipids, which meets the “at least about 200 mg”.
With respect to claim 50, Kim meets the limitation of “within about 16 hours of the subject undertaking exercise” because Kim discloses that pills were taken each day in the morning prior to exercise. Since pills were taken every day and subjects can be reasonably assumed to sleep for 6-8 hours every day, it is reasonable to assume that pills were taken within a 16-18 hour window of exercise.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 40, 43, 45, 46 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (PLoSOne, 2014, IDS), in view of Banavara et al. (US 2014/0255538A1, PTO-892).
The disclosure of Kim is referenced as discussed above. Kim does not teach that the administered composition comprises the elements claimed, such as probiotics, vitamin D and calcium.
Banavara et al. discloses nutritional compositions comprising MFGM, as a key ingredient, further comprising protein, lipids, probiotics, calcium and vitamin D, wherein the nutritional composition may be formulated as a milk beverage. (Claims 1, 9, 12; ¶0093-0103, 0120, 0129) Banavara exemplifies the following composition: (Table 2)
PNG
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620
354
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the MFGM based composition of Banavara could be effectively used in the method of Kim, thereby arriving at the instant invention. One would be motivated to modify the method of Kim, to administer the desired MFGM as a milk beverage of Banavara, rather than a pill, because the milk beverage provides a functionally equivalent means of delivering the desired MFGM while simultaneously being a convenient, nutritionally complete, meal-replacement means of delivering the active therapeutic agent. With respect to the ranges of components claims (e.g. protein), given the ranges disclosed by Banavara, the instant ranges overlap those of the prior art. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 55 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (PLoSOne, 2014, IDS), in view of Rinsch et al. (US 2018/0256538A1, PTO-892).
The disclosure of Kim is referenced as discussed above. Kim does not teach that increasing physical activity or decreasing sedentary time, by a certain number of minutes.
Rinsch et al. discloses metrics for assessing sedentary/frail subject versus healthy, active subjects, such that that sedentary lifestyle was defined as having an activity category of I as assessed by the International Physical Activity Questionnaires (IPAQ), which means an activity level of <600 MET (metabolic equivalent unit)-minutes per week). Active elderly were defined as having a normal muscle mass, normal muscle strength, normal physical performance and an activity level of category 2 or 3 as assessed by the IPAQ (activity level >600 MET-minutes per week)… The pre-frail subjects were different from the active subjects in terms of physical performance. In terms of physical activity, the pre-frail subjects were all sedentary, defined by a daily energy expenditure of less than 600 MET minutes per week. A daily energy expenditure of 600 MET minutes per week corresponds to a maximum of 25 minutes of walking per day. The mean daily energy expenditure in the active group was 7926.5 MET minutes per week, which corresponds to 1 hour of vigorous exercise plus 2 hours of cycling per day.(¶0430-0434)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that one could employ the assessment of Rinsch regarding using MET minutes per week, to determine the degrees of frailty reversal in the method of Kim. Since a sedentary individual, as defined by Rinsch, has activity equivalent to 25 minutes of walking per day, and an active individual has activity equivalent to 1 hour of vigorous exercise plus 2 hours of cycling per day, any amount of frailty reversal resulting in an equivalent of more than 25 min of walking per day, would be recognized by one of ordinary skill in the art as moving a sedentary/frail individual towards being classified as a healthy, active individual. Thus, it is reasonable that an improvement of, for example, 10-20 additional minutes of walking per day, or 5 minutes of vigorous exercise per day, relative to the sedentary baseline of 25 walking minutes per day, would be a quantifiable means to assess frailty reversal in the method of Kim. Hence the instant limitations of light physical activity (i.e. walking) being increased by 5-10 minutes or moderate-vigorous physical activity being increased by 1.25-5 minutes, is an observation that would be reasonably expected in the method of Kim, when the metrics of Rinsch are applied.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/ Primary Examiner, Art Unit 1693