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
A second request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on April 23, 2025 has been entered.
Claims 19, 20, 22-27, 33 and 34 are pending.
Claims 1-18, 21 and 28-32 are cancelled.
Claims 19 and 26 are currently amended.
Claims 19, 20, 22-27, 33 and 34 as filed on April 23, 2025 are under consideration.
Withdrawn Objections / Rejections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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Priority
The earliest date available to the pending claims is November 16, 2016 as set forth at page 3 of the Final Rejection mailed March 16, 2023.
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 and 26 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 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 and Addison et al. “Intermuscular fat: a review of the consequences and causes,” International Journal of Endocrinology 2014, ID 309570.
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 at least one of mobility-limited (defined by Short Physical Performance Battery (SPPB) less than or equal to 9 as defined in paragraph [0034]) or 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 claims 19 and 26.
These deficiencies are made up for in the teachings of Chale and Addison.
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”).
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 administer the supplemental food composition of Leclerc to mobility-limited older adults aged 70 to 85 years having muscle weakness and a SPPB score less than 10 as taught by Chale because the supplemental food composition of Leclerc is intended to be administered to the elderly in order to prevent and/or limit the frailty syndrome.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that mobility-limited older adults having muscle weakness and a SPPB score less than 10 as taught by Chale is indicative of increased IMAT (decreased muscle quality as defined in paragraph [0045] of the instant specification) because Addison teaches muscle weakness in older adults correlates with increased IMAT and because the SPPB score of Chale quantifies gait speed and chair-raise assessments and Addison teaches increased IMAT is associated with decreased gait speed and difficulty with repeated chair stands. Therefore, the combined teachings of the prior art render obvious the identification of the 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 treating or preventing muscle weakness by reducing intramuscular fat (claim 26), because the combined teachings of Leclerc, Chale and Addison 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.
Claims 20 and 27 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 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 and Addison et al. “Intermuscular fat: a review of the consequences and causes,” International Journal of Endocrinology 2014, ID 309570 as applied to claims 19, 22, 23, 25 and 26 above, and further in view of Mateus et al. (US 2011/0250310, published October 13, 2011, of record).
The teachings of Leclerc, Chale and Addison have been described supra.
They do not teach the whey protein comprises whey protein micelles as required by claims 20 and 27.
This deficiency is made up for in the teachings of Mateus.
Mateus teaches whey protein compositions as nutritional compositions; whey protein may mitigate sarcopenia (title; abstract; paragraphs [0078], [0117], [0121]; claims). 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 (paragraphs [0019], [0049], [0080], [0143]).
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 proteins of the supplemental food composition of Leclerc to comprise whey protein in the form of inter alia micelles as taught by Mateus because micelles are an art recognized form for the administration of whey protein in nutritional compositions. There would be a reasonable expectation of success because Leclerc does not delimit the form of the whey protein.
Claim 24 is 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 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 and Addison et al. “Intermuscular fat: a review of the consequences and causes,” International Journal of Endocrinology 2014, ID 309570 as applied to claims 19, 22, 23, 25 and 26 above, and further in view of White et al. (US 2009/0291163, published November 26, 2009, of record) and Takaichi et al. (US 2005/0244543, published November 3, 2005, of record).
The teachings of Leclerc, Chale and Addison have been described supra.
They do not teach at least a portion of the calcium is carbonate, citrate, gluconate, lactate or/and phosphate as required by claim 24.
This deficiency is made up for in the teachings of White and Takaichi.
White teaches a milk-based recovery beverage comprising inter alia protein, vitamin D and calcium (title; abstract; claims). 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]).
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; paragraphs [0003], [0026]-[0038]; claims). The compositions may further comprise vitamin D (paragraph [0016]). Calcium includes calcium chloride, calcium lactate, calcium citrate, calcium carbonate, calcium pyrophosphate dihydrate, calcium gluconate and the like (paragraph [0045]; also [0039]-[0048]).
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 to comprise calcium when the compositions 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 vitamin D and may comprise 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 substitute calcium sources as taught by Takaichi inclusive of calcium carbonate for the calcium in the supplemental food compositions of Leclerc in view of White because simple substitution of functionally equivalent elements yields predictable results, absent evidence to the contrary. One of ordinary skill in the art would have been motivated to make the substitution because the calcium sources as taught by Takaichi are suitable for nutritional compositions comprising protein inclusive of whey protein for preventing or ameliorating the reduction of muscle mass with age.
Claims 33 and 34 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 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 and Addison et al. “Intermuscular fat: a review of the consequences and causes,” International Journal of Endocrinology 2014, ID 309570 as applied to claims 19, 22, 23, 25 and 26 above, and further in view of Jourdan et al. (US 2013/0210780, published August 15, 2013, of record) as evidenced by Wikipedia “Calcifediol,” last edited September 1, 2022, of record, and 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.
The teachings of Leclerc, Chale and Addison have been described supra.
They do not teach an elderly individual (meaning an age of at least 60 years as defined in paragraph [0033] of the instant specification) who is vitamin D deficient (defined as a serum level of 25(OH)D of 9 to 24 ng/mL in paragraph [0035]) as required by claims 33 and 34.
This deficiency is made up for in the teachings of Jourdan and Sanders.
Jourdan teaches 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], [0039]).
Sanders teach 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).
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 composition of Leclerc to mobility-limited older adults aged 70 to 85 years having muscle weakness and a SPPB core less than 10 as taught by Chale – indicative of increased IMAT as taught by Addison -- inclusive of those suffering from suffering from vitamin D deficiency as taught by Jourdan because the supplemental food composition of Leclerc comprises vitamin D and it is known in view of Sanders that higher vitamin D levels are associated with reduced frailty. One would have been further motivated to do so in order to prevent IMAT deposition in the vitamin D deficient cohort because older adults with increased IMAT experience increased muscle weakness and decreased mobility.
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant’s assertion at page 6 that the art of record fails to render obvious the newly claimed patient population is unpersuasive because muscle weakness is expressly taught by Leclerc as a clinical consequence of sarcopenia and because muscle weakness is implicitly taught by Chale because Chale, as a whole, is drawn to increasing muscle strength. Nonetheless, Addison is newly applied to evidence patients having muscle weakness also have increased IMAT or decreased “quality” as defined in the instant specification.
Applicant’s citation to the PTAB decision at page 6 is unpersuasive as the newly pending claims also do not require the recognition alluded to in the affirmance, rather, the newly pending claims merely contrive a new patient population to whom the composition is administered. As the newly claimed identifying step is not disclosed within the instant specification, the broadest reasonable interpretation of “identifying” merely requires recognition that the elderly patient who is at least one of mobility limited or vitamin D deficient also has muscle weakness or IMAT.
Applicant’s citation to the newly claimed dosage at page 7 is unpersuasive because the PTAB decision affirmed claims 21 and 31. In the affirmance of claim 31 drawn to a dosage of at least 30 g per day, the PTAB expressly cites to the broad disclosure in paragraph 44 of Leclerc as cited in the rejection. Applicant’s citation to alleged Federal Circuit holdings is unpersuasive because Applicant failed to file of a Notice of Appeal to the Court of Appeals for the Federal Circuit. Applicant’s disparagement of Chale as disclosing 20 g per serving is unpersuasive because Chale indisputably discloses 40 g per day and because Chale concludes future examinations of higher doses are warranted (page 689, paragraph bridging columns).
Applicant’s statements page 8 that one would not modify the compositions of LeClerc without efficacy data are unpersuasive because these statements are untethered to the rejections of record. LeClerc clearly teaches to administer the compositions disclosed therein to the elderly and the actual rejections of record articulate rationales to administer the compositions of LeClerc to select cohorts of elderly patients.
Applicant’s citation to the statistics of Chale at page 8 is unpersuasive because the instant specification does not disclose results for whey supplementation without exercise. To the contrary, the exemplary study requires exercise sessions (e.g., paragraph [0084]). Applicant’s citation to paragraph [0007] of the instant specification is unpersuasive because paragraph [0007] summarizes the clinical study of the example which requires exercise sessions. Notably, the clinical trial also only administers 20 g of whey protein micelles per day (e.g., paragraph [0082]) and cannot be relied upon as the clinical trial falls outside the scope of the newly pending claims.
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.
Breuille et al. (US 2014/0249078) teaches whey protein micelles in a daily dose of at least 20 g for use in the treatment of conditions inclusive of loss of muscle mass and/or strength, muscle atrophy and sarcopenia (title; abstract; claims, in particular 1-3, 8; paragraphs [0028], [0040]).
Breuille et al. (US 2014/0256653) teaches whey protein micelles in a daily dose of at least 20 g, preferably at least 30 g enhance protein synthesis in elderly persons (title; abstract; claims, in particular 1-3, 5, 10).
De Stefano et al. “Obesity, muscular strength, muscle composition and physical performance in an elderly population,” Journal of Nutrition, Health and Aging 19(7):785-791, 2015 describes the SPPB and concludes there is an inverse association between SPPB scores and fat infiltration in muscle (title; abstract; page 886, lhc, last full paragraph).
Scott et al. “Vitamin D, muscle function, and falls in older adults: does reduced deposition of intramuscular adipose tissue influence the relationship?” Journal of Clinical Endocrinology & Metabolism 98(1):3968-3970, 2013 teaches a characteristic of aging muscle is increased deposition of adipose tissue within and between the fibers (paragraph bridging pages 3968-3969).
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
/MARIANNE C SEIDEL/Primary Examiner, Art Unit 1600