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 .
DETAILED ACTION
Applicant’s Request for Reconsideration dated September 17, 2025 is acknowledged.
Claims 19, 20, 22, 23, 25-27 and 35-38 are pending.
Claims 1-18, 21, 24 and 28-34 are cancelled.
Claims 19 and 26 are currently amended.
Claims 35-38 are new.
Claims 19, 20, 22, 23, 25-27 and 35-38 as filed on September 17, 2025 are under consideration.
This action is made FINAL.
Withdrawn Objections / Rejections
Applicant’s arguments have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 26 is objected to because of the following informalities: in the administering clause the phrase “the elderly individual who mobility-limited” should presumably recite “the elderly individual who is mobility-limited”. Appropriate correction is required.
Maintained Grounds of Rejection / New Grounds of Rejection Necessitated by Amendment
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 of this title, 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 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 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 19, 22, 23, 25, 26, 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Leclerc (EP 1,712,140 A1, published October 18, 2006, as evidenced by the machine translation, of record) as evidenced by NIH “Dietary Supplement Ingredient Database: Unit conversions,” 2017, of record, in view of Takaichi et al. (US 2005/0244543, published November 3, 2005, of record); White et al. (US 2009/0291163, published November 26, 2009, of record); Chale et al. “Efficacy of whey protein supplementation on resistance exercise-induced changes in lean mass, muscle strength, and physical function in mobility-limited older adults,” J Gerontol A Biol Sci Med Sci 68(6):682-690, 2013, IDS reference filed August 27, 2020; Jourdan et al. (US 2013/0210780, published August 15, 2013, of record) as evidenced by Wikipedia “Calcifediol,” last edited September 1, 2022, of record; Sanders et al. “Vitamin D deficiency and its role in muscle-bone interactions in the elderly,” Current Osteoporosis Reports 12:74-81, 2014, of record; and Addison et al. “Intermuscular fat: a review of the consequences and causes,” International Journal of Endocrinology 2014, ID 309570, of record.
Leclerc teaches a supplemental food composition intended to be administered orally to prevent and/or limit the frailty syndrome in the elderly (paragraphs [0001], [0082]). Loss of muscle mass or sarcopenia is generally associated with this syndrome; sarcopenia is an involuntary loss of muscle mass and muscle strength with concomitant increase in fat mass (paragraphs [0003]-[0007]). Clinical consequence of sarcopenia include muscle weakness (paragraph [0007]). Slowing the loss of muscle mass depends on maintaining an adequate protein intake; the protein requirements of the elderly can be met by an intake of 15 to 20 grams of protein inclusive of whey protein (paragraph [0015]). Slowing the loss of muscle mass also depends on maintaining an adequate intake of vitamins inclusive of vitamin D and minerals; vitamin D influences muscle metabolism (paragraphs [0017], [0028]).
The composition comprises (paragraph [0040]):
5 to 35 g natural proteins inclusive of whey protein when intended for daily administration (effective amount) (paragraphs [0043]-[0045]), as required by instant claim 25,
3 to 15 g amino acids (paragraphs [0046]-[0048]),
1 to 10 mg ginsenosides (paragraph [0049]),
10 to 20 mg zinc (paragraph [0050]),
10 to 500 g selenium (paragraph [0051]),
a vitamin chosen from inter alia vitamin D in a form such as vitamin D3 in an amount ranging from 1 to 20 g (1 µg = 40 IU as evidenced by NIH, 40 to 800 IU) or/and a B vitamin chosen from inter alia vitamin B5 in the form of calcium D-pantothenate (paragraphs [0052]-[0063]), as required by instant claims 22 and 23, and
1 to 20 mg carotenoid (paragraph [0064]).
Regarding the composition of claims 19 and 26, because the instant specification at paragraph [0030] defines the term “consisting essentially” as meaning the referenced components are at least 75% of the composition, the composition of Leclerc consists essentially of whey protein, vitamin D and calcium as instantly claimed because the amount of the whey protein dominates the composition. The composition of Leclerc can further comprise any other active ingredient and any suitable excipient (paragraph [0075]).
Although Leclerc teaches administration of a composition comprising whey protein to the elderly inclusive of the sarcopenic elderly suffering from muscle weakness, Leclerc does not specifically teach an elderly individual (meaning an age of at least 60 years as defined in paragraph [0033] of the instant specification) who is mobility-limited (defined by Short Physical Performance Battery (SPPB) less than or equal to 9 as defined in paragraph [0034]) and vitamin D deficient (defined as a serum level of 9 to 24 ng/mL in paragraph [0035]) as required by claims 19 and 26 and Leclerc does not specifically teach elderly individuals having decreased muscle quality (decreased metabolic quality of skeletal muscle through fat infiltration as defined in paragraph [0045]) as alternatively required by claim 19 and as required by claim 26.
Leclerc does not specifically teach a calcium salt of carbonate, citrate, gluconate, lactate or/and phosphate as required by claims 19 and 26.
Leclerc does not specifically teach a beverage as required by claims 37 and 38.
These deficiencies are made up for in the teachings of Takaichi, White, Chale, Jourdan, Sanders and Addison.
Takaichi teaches compositions for supplying protein inclusive of whey protein and calcium to prevent or ameliorate the reduction of muscle mass with age (title; abstract; claims; paragraphs [0003], [0026]-[0038]). Calcium includes calcium chloride, calcium lactate, calcium citrate, calcium carbonate, calcium pyrophosphate dihydrate, calcium gluconate and the like; calcium activates the function of muscles (paragraphs [0039]-[0048]). The compositions may further comprise vitamin D; vitamin D enhances calcium absorption (claim 3; paragraphs [0016], [0097]-[0100]). The compositions may be in the form of a food or beverage (paragraph [0010]), as required by instant claims 37 and 38.
White teaches a milk-based recovery beverage comprising inter alia milk-based protein inclusive of whey, vitamin D and calcium (title; abstract; claims, in particular 1, 2, 9, 13), as required by instant claims 37 and 38. Vitamin D plays a role in muscle protein synthesis; vitamin D supplementation has been found to increase muscle mass in older adults (paragraph [0011]). Adequate calcium consumption is necessary to optimize the function of vitamin D; in addition, calcium has been shown to improve fat metabolism which may possibly improve loss of body fat with strength training (paragraph [0012]).
Chale teaches whey protein supplementation in mobility-limited older adults affects lean mass, muscle strength and physical function; the age-related loss of muscle mass is termed sarcopenia (title; abstract; page 682, lhc, 1st line of 1st paragraph). Eighty mobility-limited adults aged 70 to 85 years were randomized to receive 40 g whey protein per day (abstract). All participants had a SPPB score less than 10; the SPPB consists of timed standing balance, gait speed, and timed chair-rise assessments (page 683, lhc, “Baseline screening of physical functioning”).
Jourdan teaches nutritional compositions for the stimulation of muscle protein synthesis comprising inter alia vitamin D (title; abstract; claims). Aging is characterized by a high prevalence of vitamin D deficiency (serum vitamin D levels below 25 to 50 nmol/L (below about 10 to 20 ng/mL converting using a molar mass of about 400 as evidenced by Wikipedia)) and insufficiency (levels below 75 nmol/L); low serum 25-(OH)D or calcidiol concentrations are associated with increased risk of sarcopenia in the elderly (paragraphs [0005], [0007]-[0008], [0018], [0038]-[0043]).
Sanders teaches vitamin D deficiency plays a role in intramuscular adipose tissue (IMAT) accumulation in the elderly and may prevent IMAT deposition (title; Figure 1; page 77, “Indirect effects on skeletal muscle function”). Higher vitamin D levels are associated with inter alia reduced frailty and disability (page 76, “Vitamin D and physical performance).
Addison teaches intermuscular adipose tissue (IMAT) (decreased muscle quality as defined in paragraph [0045] of the instant specification) is a significant predictor of both muscle function and mobility function in older adults (title; abstract). Older adults with increased IMAT experience increased levels of muscle weakness and decreased mobility (paragraph bridging pages 1 and 2; Figures 2, 4; pages 4-6, sections 4 and 5). Increased IMAT is also associated with decreased gait speed and difficulty with repeated chair stands (paragraph bridging pages 4 and 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the supplemental food compositions of Leclerc comprising 5 to 35 g natural protein inclusive of whey protein to further comprise calcium inclusive of calcium lactate as taught by Takaichi when the compositions of Leclerc comprise vitamin D because White teaches adequate calcium consumption is necessary to optimize the function of vitamin D. There would be a reasonable expectation of success because the compositions of Leclerc may comprise calcium or/and any other active ingredient.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the supplemental food compositions of Leclerc in view of Takaichi and White to the elderly inclusive of mobility-limited older adults aged 70 to 85 years having muscle weakness and a SPPB score less than 10 as taught by Chale and inclusive of those also suffering from vitamin D deficiency as taught by Jourdan because whey protein supplementation is expected to positively affect muscle mass, muscle strength and physical function (e.g., Chale) and because vitamin D supplementation is expected to positively affect serum vitamin D levels (e.g., Jourdan) and also increase muscle mass in these older adults (e.g., White). The elderly patient population rendered obvious by the combined teachings of Leclerc, Chale and Jourdan are known to suffer from muscle weakness (e.g., Leclerc, Chale).
Regarding claim 26 which further requires the elderly individual to have decreased muscle quality, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to diagnose the elderly patient population rendered obvious by the combined teachings of Leclerc, Chale and Jourdan suffering from vitamin D deficiency, having a SPB score less than 10 indicative of poor balance, gait speed, and diminished chair rise, and known to be weak with IMAT (decreased muscle quality as defined in paragraph [0045] of the instant specification) because Sanders teaches vitamin D deficiency plays a role in IMAT accumulation in the elderly and because Addison teaches increased IMAT is also associated with decreased gait speed and difficulty with repeated chair stands as well as correlating with muscle weakness. Therefore, the combined teachings of the prior art render obvious the identification of the elderly individuals newly claimed.
Regarding the intended use recitations / desired results to be achieved of improving or maintaining muscle quality by reducing intramuscular fat (claim 19) and of increasing muscle density (claim 25) or of treating or preventing muscle weakness by reducing intramuscular fat (claim 26), because the combined teachings of the prior art render obvious the administration of the same composition as instantly claimed to the same patient population as instantly claimed, it is presumed the intended outcomes as instantly claimed are latent to the prior art. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). See MPEP 2145 II. In further support of this presumption, it is expected from Sanders that supplementation with vitamin D will reverse IMAT deposition and it is expected from Addition that improvements in muscle function – inclusive of those expected from the administration of protein inclusive of whey protein -- correlate with decreased IMAT. Therefore, it would also have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the supplemental food compositions of Leclerc in view of Takaichi and White comprising 5 to 35 g natural protein inclusive of whey protein, 1 to 20 ug vitamin D, and calcium inclusive of calcium lactate to the elderly patient population of Leclerc in view of Chale and Jourdan in order to achieve the expected result of improving muscle by decreasing IMAT because Sanders teaches that supplementation with vitamin D will reverse IMAT deposition and because Addition teaches that improvements in muscle function correlate with decreased IMAT.
Regarding claims 37 and 38, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the supplemental food compositions of Leclerc in view of Takaichi and White to take the form of a beverage as taught by Takaichi and by White because it is routine in the art to administer protein in the form of beverage.
Claims 20, 27, 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Leclerc (EP 1,712,140 A1, published October 18, 2006, as evidenced by the machine translation, of record) as evidenced by NIH “Dietary Supplement Ingredient Database: Unit conversions,” 2017, of record, in view of Takaichi et al. (US 2005/0244543, published November 3, 2005, of record); White et al. (US 2009/0291163, published November 26, 2009, of record); Chale et al. “Efficacy of whey protein supplementation on resistance exercise-induced changes in lean mass, muscle strength, and physical function in mobility-limited older adults,” J Gerontol A Biol Sci Med Sci 68(6):682-690, 2013, IDS reference filed August 27, 2020; Jourdan et al. (US 2013/0210780, published August 15, 2013, of record) as evidenced by Wikipedia “Calcifediol,” last edited September 1, 2022, of record; Sanders et al. “Vitamin D deficiency and its role in muscle-bone interactions in the elderly,” Current Osteoporosis Reports 12:74-81, 2014, of record; and Addison et al. “Intermuscular fat: a review of the consequences and causes,” International Journal of Endocrinology 2014, ID 309570, of record as applied to claims 19, 22, 23, 25, 26, 37 and 38, and further in view of Mateus et al. (US 2011/0250310, published October 13, 2011, of record) and Schmitt et al. (WO 2007/110421, published October 4, 2007).
The teachings of Leclerc, Takaichi, White, Chale, Jourdan, Sanders and Addison have been described supra.
They do not teach the whey protein comprises whey protein micelles as required by claims 20 and 27.
They do not teach the micelles have a size smaller than 1 micron as required by claims 35 and 36.
These deficiencies are made up for in the teachings of Mateus and Schmitt.
Mateus teaches whey protein compositions as nutritional compositions; whey protein may mitigate sarcopenia (title; abstract; claims; paragraphs [0078], [0117], [0121]). The whey protein can be in the form of concentrate, isolates, micelles or/and hydrolysates; the whey protein source may be 100% whey protein micelles (claim 3; paragraphs [0019], [0049], [0080], [0143]), as required by instant claims 20 and 27. The whey protein micelles are as described in WO 2007/110421 A2, the disclosure of which is incorporated by reference (paragraph [0091]).
Schmitt, WO 2007/110421 A2, teaches whey protein micelles have an average size less than 1 micron (title; abstract; claims, in particular 1, 14-16), as required by instant claims 35 and 36.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the whey protein content of the supplemental food composition of Leclerc in view of Takaichi and White to comprise whey protein in the form of micelles as taught by Mateus because micelles are an art recognized form for the administration of whey protein in nutritional compositions. It would have been obvious to one of ordinary skill in the art that the whey protein micelles as taught by Mateus have an average size less than 1 micron as taught by Schmitt because Mateus teaches the whey protein micelles are as described in Schmitt. There would be a reasonable expectation of success because Leclerc does not delimit the form or size of the whey protein.
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant at page 7-8 of the Remarks generally alleges the previously applied prior art as applied to the previous configuration of claim limitations does not render obvious the methods recited in the independent claims as currently amended. This is unpersuasive as set forth in the modified grounds of rejection infra.
At page 8 Applicant states piecemeal reconstruction using 7 references is improper. This is unpersuasive because reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991).
At pages 8-9 Applicant alleges it is unreasonable and beyond the skill of the PHOSITA to piece together 7 references. This is unpersuasive because the 7 references evidence it is very well known to administer protein inclusive of whey protein in amounts as instantly claimed to the elderly for the purpose of restoring muscle function, it is very well known to supplement protein with calcium and with vitamin D because both calcium and vitamin D play a role in muscle synthesis, it is very well known that muscle function can be measured with art recognized tests, and it is very well known that muscle function correlates with vitamin D deficiency and with IMAT.
At pages 9-10 Applicant alleges the claims circumscribe an invention. This is unpersuasive as set forth in the modified grounds of rejection infra.
At page 10 Applicant alleges the Examiner has failed to consider the therapeutic benefits of whey protein, vitamin D and calcium. This is unpersuasive because the therapeutic benefits of whey protein, vitamin D and calcium inclusive of decreased IMAT are well known to the prior art.
At page 10 Applicant alleges there is no motivation to select the calcium salts taught by Leclerc. This is unpersuasive because there is no need to select the calcium salts as alleged, rather, Leclerc is in possession of a multitude of embodiments inclusive of those comprising calcium salts. Nonetheless, the rejections of record have relied upon Takaichi and White to render obvious calcium salts as claimed. The modified grounds of rejection infra again rely upon Takaichi and White to render obvious the inclusion of calcium salts as instantly claimed because it is well known in the art that calcium is necessary to optimize the function of vitamin D. At page 11 Applicant alleges this statement is unsupported. This is unpersuasive because White discloses the information summarized in the narrative of the rejection (reproduced in part):
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Applicant’s further disparagement of the disclosure of White for lacking experimental data is unpersuasive. Applicant’s citation to the patient population of White is also unpersuasive. Applicant’s disparagement of the disclosure of Takaichi at page 12 is unpersuasive because it is of no moment what technical problem Takaichi addresses because the prevailing legal standard is whether 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. It is also of no moment what technical problem, if any, Applicant strove to undertake because the reason or motivation to modify a reference may be for a different purpose or to solve a different problem. Applicant’s allegation that Takaichi teaches away from calcium at pages 12-13 is unpersuasive because the compositions of Takaichi require calcium.
At page 13 Applicant cites to the PTAB decision and appears to contend the claims as amended are patentable. This is unpersuasive.
Therefore, the rejections of record are properly maintained in modified form as necessitated by Applicant’s amendments.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bovetto et al. (US 2009/0035437), as cited in paragraph [0042] of the instant specification, discloses the details of the whey protein micelles as newly claimed, e.g., the size distribution (e.g., paragraph [0058]).
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 ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/
Examiner, Art Unit 1619
/M.C.S/Primary Examiner, Art Unit 1600
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