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
The amendment after non-final office action filed October 29, 2025 is acknowledged. Claims 2-5. 7-8, 13, 15, 17-18, 20-26, 28, 31-32 were cancelled, claim 1 was amended, claims 35-38 were newly added and claims 1, 6, 9-12, 14, 16, 19, 27, 29-30, 33-38 are pending.
*After further review, a second Non-final follows.
Election/Restrictions
The restriction requirement was deemed proper and made FINAL previously. Claims 9-10, 27 and 29-30 remain withdrawn from consideration as being drawn to a non-elected invention/species. Claims 1, 6, 11-12, 14, 16, 19 and 33-38 are examined on the merits of this office action.
Withdrawn Objections/Rejections
The rejection of claims 1, 6-7, 11-12, 14, 16, 19, 33-34 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in view of Applicant’s arguments filed October 29, 2025.
The rejection of claim 7 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of Applicant’s arguments filed October 29, 2025.
.
Maintained/Revised Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 6, 11-12, 14, 16, 19, 33-38 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 12, 14, 16-18, 20 of co-pending Application No. 16/954696 (reference application) in view of Fan (Oncotarget. 2017 Mar 14; 8(11): 17475–17490, cited previously) and Bauer (see below rejection, cited previously).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a method of treating an individual with sarcopenia the method comprising administering high protein (whey protein) and an spermidine (see claim 1). The instant application further claims the protein is at least about 60 energy % and at least 50 wt% of protein is whey (see claim 1); protein from an animal source or milk protein (see claims 11-12); 50% weight of protein is whey (claim 1); free form amino acids or non-hydrolyzed protein (see claim 16); molecular weight of protein from 1-20 kDA (claim 19); including carbohydrate and fat (claim 33) and not greater than 30 energy % for carbohydrate; spermidine in amount of 0.05-4 wt% (claim 36); administered at least two days a week (claim 37) and administered with a meal (claim 38).
Co-pending application 16/954696 claims “A method of sarcopenia in an individual in need thereof, the method comprising administering an effective amount of a composition comprising a high amount of casein, at least 60 energy % and 24 energy % carbohydrate.” (see claim 1). Co-pending application 16/954696 further claims wherein free form amino acids are included (claims 12 and 14); wherein the protein has a formulation selected from the group consisting of (i) at least 50% of the protein has a molecular weight of 1-5 kDa, (ii) at least 50% of the protein has a molecular weight of 5-10 kDa and (iii) at least 50% of the protein has a molecular weight of 10-20 kDa (claim 17). Co-pending application 16/954696 is silent to including an autophagy inducer such as spermidine. However, Fan teaches that “Spermidine has been identified as a potent and specific inducer of autophagy for expending lifespan due to the hypoacetylation of histone, which can provide protection for aging process of several tissues including heart, brain and skeletal muscle, thereby accomplishing the longevity”.
It would have been obvious before the effective filing date of the claimed invention to use spermidine in the composition of Co-pending application 16/954696 for inducing autophagy. One of ordinary skill in the art would have been motivated to do so given spermidine is known to induce autophagy which can provide protection for aging process of several tissues including heart, brain and skeletal muscle, thereby accomplishing the longevity. Furthermore, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). But see In re Geiger, 815 F.2d 686, 2 USPQ2d 1276 (Fed. Cir. 1987) (“Based upon the prior art and the fact that each of the three components of the composition used in the claimed method is conventionally employed in the art for treating cooling water systems, the board held that it would have been prima facie obvious, within the meaning of 35 U.S.C. 103, to employ these components in combination for their known functions and to optimize the amount of each additive....Appellant argues... hindsight reconstruction or at best,... obvious to try’.... We agree with appellant.”). One of ordinary skilled in the art would have been motivated to combine the two (high protein and spermidine) each known to be useful for the same purpose, with a reasonable expectation that at least here will be an additive effect. Furthermore, it would have been obvious to optimize the amount of casein/protein and carbohydrate content to achieve optimal therapeutic effectiveness.
Regarding instant claim 36, Fan teaches dosing of spermidine at 5 mg/kg a day. It would have been obvious before the effective filing date of the claimed invention to select spermidine in the claimed weight percent range, as recited in instant claim 36, because Fan teaches effective in vivo spermidine dosing at 5 mg/kg/day producing muscle benefits. Selecting a spermidine concentration in a nutritional formulation sufficient to deliver known effective doses represents routine optimization of a result effective variable (see MPEP 2144).
Regarding instant claims 37-38, Bauer teaches a high protein (about 60%) supplement is provided as a powder that is reconstituted and administered twice daily in addition to meals (see page 742, top right of left column). Regarding instant claim 38, it would have been obvious before the effective filing date of the claimed invention to administer the composition with a meal because supplement timing relative to meals is a routine optimization variable and Bauer teaches administration at meal times (MPEP2144).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicants argue that this stage in examination it would be premature for terminal disclaimers because the instant claims are not otherwise allowable and thus, the final version of the claims is not yet known. Applicants will reconsider when the claims are otherwise allowable. Given that the instant claims are not otherwise allowable, the rejection is maintained.
Claims 1, 6, 11-12, 14, 16, 19, 33-38 are/remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-4, 6-9, 11, 23-30 of Copending Application No. 17/596784 (reference application) in view Andreux (WO2017036993 A, cited previously), Bauer (JAMDA, 2015, pages 740-747, cited previously) and Fan (cited previously).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a method of treating an individual with sarcopenia the method comprising administering high protein (whey protein) and an spermidine (see claim 1). The instant application further claims the protein is at least about 60 energy % and at least 50 wt% of protein is whey (see claim 1); protein from an animal source or milk protein (see claims 11-12); 50% weight of protein is whey (claim 1); free form amino acids or non-hydrolyzed protein (see claim 16); molecular weight of protein from 1-20 kDA (claim 19); including carbohydrate and fat (claim 33) and not greater than 30 energy % for carbohydrate; spermidine in amount of 0.05-4 wt% (claim 36); administered at least two days a week (claim 37) and administered with a meal (claim 38).
Co-pending application 17/596784 claims “A method comprising administering a composition that concomitantly promotes protein synthesis and removal of damaged cellular materials to an individual in need thereof, the composition comprising one or more anabolic amino acids, the composition further comprising one or more autophagy-inducing compounds in a total amount effective for the composition to be at least neutral regarding autophagy” (see claim 30). Co-pending application 17/596784 further claims administering the autophagy inducing agent with protein from plant or animal (see claim 11). Co-pending application 17/596784 claims “wherein the autophagy is induced in skeletal muscle (claim 9); wherein the individual is an ageing individual (claim 6); wherein the individual has sarcopenia or frailty or is at risk of developing sarcopenia or frailty (claim 7); wherein the protein is from animal or plant (claim 11); wherein free form amino acids are included (claim 29). Co-pending application 17/596784 is silent to whey as the protein (or a combo of whey and casein) and the amounts of protein and remove spermidine from the claims.
However, Bauer teaches a method of nutritional treatment of elderly individuals with sarcopenia or at risk of sarcopenia using protein rich nutritional compositions. Bauer teaches a randomized clinical trial in elderly subjects with sarcopenia and administering a nutritional composition with Whey Protein (see “Design and Partcipants” and “Intervention” page 742 and Table 1). Bauer teaches oral administration of formula comprising Whey protein, leucine and vitamin and minerals (see “intervention” and also Supplement Table 1). Bauer teaches that the supplement is provided as a powder that is reconstituted and administered twice daily in addition to meals (see page 742, top right of left column). In particular, Bauer teaches that “leucine-enriched whey protein oral nutritional supplement resulted in improvements in muscle mass and lower-extremity function among sarcopenic older adults” (see abstract). Bauer additionally teaches wherein the protein is 20 grams of whey protein and wherein the amount is greater than 36 energy % and at least 50% of the protein (see “intervention”, right column, last paragraph, supplemental Table 1). For example, 20 grams of protein x 4 (4 calories per gram of protein) is 80; 3 grams of fat (3x9 calories per gram of fat) is 27 grams; and 9 grams carbohydrates (9x4 calories per gram of protein) is 36 calories this resulting in 80/143=55.9 energy % (meeting about 60%).
It would have been obvious before the effective filing date of the claimed invention to use whey protein as the protein source for supplementation to the aged population Co-pending application 17/596784. One of ordinary skill in the art would have been motivated to do so given they whey protein (at the amounts described by Bauer) are efficient at improving muscle mass and lower limb function in sarcopenic/gaining population. There is a reasonable expectation of success given that whey is a routinely used protein supplement in aging populations for the purpose of building muscle and strength.
Andreux teaches high protein diets for treating aged populations (sarcopenia, claims 16, 18) comprising 100% of the protein being casein (see Table 5). Andreux additionally teaches “Mixtures of sources of proteins may have particular benefits. For example, two or more of pea protein, whey protein, soy protein and casein may be present. For example sodium caseinate, milk protein concentrate, and soy protein isolate may all be present. Combinations of casein protein and whey protein are especially preferred, for example containing 60 to 90%) w/w whey protein and 10 to 40%> w/w casein protein, for example 65 to 80%> w/w whey protein and 20 to 35%> w/w casein protein, for example 70%> w/w whey protein and 30%> w/w casein protein.” (see page 5, lines 19-25). Andreux teaches also including carbohydrates and fats (see tables 1-3) which are normal additional supplements/food that are provided in formulations for treating aged individuals.
“It is prima facie obvious to combine two compositions (casein and whey as taught by Andreux) each of which is taught by the prior art to be useful for the same purpose (protein source for ageing individuals), in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). But see In re Geiger, 815 F.2d 686, 2 USPQ2d 1276 (Fed. Cir. 1987) (“Based upon the prior art and the fact that each of the three components of the composition used in the claimed method is conventionally employed in the art for treating cooling water systems, the board held that it would have been prima facie obvious, within the meaning of 35 U.S.C. 103, to employ these components in combination for their known functions and to optimize the amount of each additive....Appellant argues... hindsight reconstruction or at best,... obvious to try’.... We agree with appellant.”). One of ordinary skilled in the art would have been motivated to combine the two each known to be useful for the same purpose, with a reasonable expectation that at least here will be an additive effect.
It would have been obvious to optimize the amount of protein/carbohydrate in the diet to achieve optimal therapeutic effectiveness and nutrition in the ageing subjects Co-pending AN 17/596784 in view of Bauer and Andreux and it would have been obvious to try using the amounts of high protein taught by Andreux for the same purpose of treating aged populations. There is a reasonable expectation of success given that Andreux teaches use of casein protein/whey protein and combinations thereof and high concentrations within the scope of the instant claims for treating an aged population.
Regarding including spermidine as the autophagy inducer, Fan teaches that spermidine administration induces autophagy in skeletal muscle and mitigates aging related muscle atrophy (see abstract). Specifically, Fan teaches spermidine treatment in addition to exercise ameliorates skeletal muscle atrophy in aging mice (see abstract and also Table 1). Fan teaches that Spermidine attenuated senescence of skeletal muscle (see Figure 2). Fan additionally teaches that spermidine increases antioxidant activity, reduces oxidative damage in an ageing model (see Figure 4), reduces skeletal muscle apoptosis (see Figure 6) and induces autophagy in skeletal muscle (see Figure 5).
It would have been obvious before the effective filing date of the claimed invention to use spermidine in the composition of Co-pending application 17/596784 for inducing autophagy. One of ordinary skill in the art would have been motivated to do so given spermidine is known to induce autophagy which can provide protection for aging process of several tissues including heart, brain and skeletal muscle, thereby accomplishing the longevity. Furthermore, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). But see In re Geiger, 815 F.2d 686, 2 USPQ2d 1276 (Fed. Cir. 1987) (“Based upon the prior art and the fact that each of the three components of the composition used in the claimed method is conventionally employed in the art for treating cooling water systems, the board held that it would have been prima facie obvious, within the meaning of 35 U.S.C. 103, to employ these components in combination for their known functions and to optimize the amount of each additive....Appellant argues... hindsight reconstruction or at best,... obvious to try’.... We agree with appellant.”). One of ordinary skilled in the art would have been motivated to combine the two (high protein and spermidine) each known to be useful for the same purpose, with a reasonable expectation that at least here will be an additive effect. Furthermore, it would have been obvious to optimize the amount of casein/protein, carbohydrate content and spermidine to achieve optimal therapeutic effectiveness.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicants argue that this stage in examination it would be premature for terminal disclaimers because the instant claims are not otherwise allowable and thus, the final version of the claims is not yet known. Applicants will reconsider when the claims are otherwise allowable. Given that the instant claims are not otherwise allowable, the rejection is maintained.
New Rejection
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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.
Claim(s) 1, 6, 11-12, 14, 16, 19, 33-38 are rejected under 35 U.S.C. 103 as being unpatentable over Bauer (JAMDA, 16, 2015, pages 740-747) in view of Soda (Experimental Gerontology 44 (2009) 727–732) and Fan (Oncotarget, 2017, Vol. 8, (No. 11), pp: 17475-17490) as evidenced by Ramos (previously cited and attached). *All references cited previously.
Bauer teaches a method of nutritional treatment of elderly individuals with sarcopenia or at risk of sarcopenia using protein rich nutritional compositions. Bauer teaches a randomized clinical trial in elderly subjects with sarcopenia and administering a nutritional composition with Whey Protein (see “Design and Partcipants” and “Intervention” page 742 and Table 1). Bauer teaches oral administration of formula comprising Whey protein, leucine and vitamin and minerals (see “intervention” and also Supplement Table 1). Bauer teaches that the supplement is provided as a powder that is reconstituted and administered twice daily in addition to meals (see page 742, top right of left column). More specifically, Bauer teaches 20.7 grams of Whey protein (20.7x4=82.8 kcal); 9.4 gram of Carbs (9.4x4=37.6 kcal) and 3.0 grams of fat (3.0x9=27 kcal) with total kcal approximately 150 (which is reported in Supplement table 1). Thus, this composition has 55.2% whey protein, 25.1% carbohydrate and 18.0% fat thus meeting the limitations of about 60 energy % of the composition for protein and at least 50 wt% of the source of protein is whey protein. The term “about” is interpreted as +/- 10% (see paragraph 0044) and thus, 55.2% fails within this limitation. Nevertheless, even if it is not considered to meet about 60 energy %, it would have been obvious to one of ordinary skill in the art to adjust the protein energy percentage upward through routine optimization, since Bauer expressly teaches protein enriched formulations for sarcopenic elderly patients and protein energy content is considered a result effective variable (see MPEP2144).
Bauer is silent to including spermidine.
However, Soda teaches dietary administration of polyamine containing food compositions (see Abstract, Methods 2.2 “Chows”). Specifically, Soda teaches dietary administration of polyamine containing food compositions including spermidine (see Table 1; composition analysis) along with protein. The spermidine content ranges from 224 up to 1540 nmol/g of the chow (see Table 1). Soda teaches that oral consumption aged animal models (see Methods and Results) and improvement in age associated pathology and survival through dietary polyamine intake along with protein (see abstract). In particular, Soda teaches that high polyamine supplementation increased life span and attenuated changes in the kidney (glomerulosclerosis) which are associated with age (see conclusion and Figure 2).
Fan teaches that spermidine administration induces autophagy in skeletal muscle and mitigates aging related muscle atrophy (see abstract). Specifically, Fan teaches spermidine treatment in addition to exercise ameliorates skeletal muscle atrophy in aging mice (see abstract and also Table 1). Fan teaches that Spermidine attenuated senescence of skeletal muscle (see Figure 2). Fan additionally teaches that spermidine increases antioxidant activity, reduces oxidative damage in an ageing model (see Figure 4), reduces skeletal muscle apoptosis (see Figure 6) and induces autophagy in skeletal muscle (see Figure 5).
It would have been obvious before the effective filing date of the claimed invention to modify the protein-rich sarcopenia nutritional composition of Bauer to further include spermidine as taught by Soda and Fan. Bauer teaches whey-protein nutritional formulations for elderly individuals with sarcopenia to improve muscle function. Soda teaches that dietary spermidine/polyamine-rich food compositions improve age-associated pathology and extend lifespan in aged animal models. Fan teaches that spermidine administration in aging models increases autophagy, enhances antioxidative capacity, reduces oxidative damage, and decreases skeletal muscle apoptosis, thereby mitigating muscle atrophy. In view of these teachings, a skilled artisan would have been motivated to include spermidine in Bauer’s nutritional formulation to further reduce oxidative damage in muscle, increase antioxidative defenses, reduce apoptosis, and improve age-related outcomes including lifespan. Additionally, this represents a KSR (See MPEP2143) rationale of combining known elements according to known methods to obtain predictable results and using a known agent for its established beneficial effects in a closely related condition. A reasonable expectation of success would have existed because the cited references demonstrate consistent in vivo skeletal-muscle and aging-related benefits from orally administered spermidine.
Regarding claim 6, Bauer in view of Soda and Fan teach the same method of the instant claims including administering the same composition to the same patient population (sarcopenic patients) and thus, the effects of inducing autophagy would be inherently achieved. Nevertheless, Fan teaches spermidine induces autophagy (see abstract and figure 5).
Regarding claims 11-12, Bauer teaches whey protein as the source. Soda teaches chow compositions comprising casein (milk protein) and other protein sources (See Table 1). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the protein composition of Bauer to include an additional protein source selected from another animal protein, a plant protein, or mixture thereof, as recited in instant claims 11-12, because mixed protein sources were well known in nutritional formulations for elderly and sarcopenic subjects. Soda teaches use of alternative protein sources such as casein in dietary compositions, showing that inclusion or substitution of additional protein types was routine. The modification would have been predictable variation using known protein sources for their established nutritional functions (see MPEP 2143).
Regarding clams 14, 16, Bauer teaches wherein at least a portion of the protein is branched amino acids in free form (see supplementary table 1 of Bauer).
Regarding claim 19, as evidenced by Ramos (page 1 "whey and whey powders: production and uses", "Whey protein fraction is mainly constituted by ß-lactoglobulin (ß-Lg), α-lactalbumin (α-La), immunoglobulins (IGs), bovine serum albumin (BSA), lactoferrin (LF), and lactoperoxidase (LP), representing at least 50%, 20%, 10%, 10%, 3%, and 0.3%, respectively. In table 2, B-lactoglobulin is 18.3 kda thus meeting the limitations of instant claim 19 (iii). It would have been obvious before the effective filing date of the claimed inventio that the whey protein composition of Bauer meets the molecular weight distribution recited in claim 19, because whey protein is known to be predominantly composed of B-lactoglobulin present at about 50% or more of total whey protein and having a molecular weight of about 18 kDA, which falls within the claimed 10-20Kda (see Ramos). Thus, the claimed molecular weight limitation reflects a known inherent characteristic of the whey protein source used in Bauer.
Regarding claim 33, Bauer in view of Soda and Fan teaches a composition comprising protein, spermidine, carbohydrates and fat (see table 1 of Bauer, also see table 1 of Soda). The closed transitional language of claim 33 excludes additional unrecited components but does not impart patentable weight when the prior art composition taught by Bauer in view of Soda and Fan already contains the same recited components.
Bauer teaches a nutritional supplement composition for elderly sarcopenic subjects comprising protein (whey protein), carbohydrate, and fat as macronutrient components (see Bauer, supplement composition table and intervention description). Soda teaches incorporation of spermidine into orally administered food compositions containing protein and other macronutrients. Thus, the combined teachings of Bauer and Soda disclose a nutritional composition including exactly the recited categories of components: protein, carbohydrate, fat, and spermidine. It would have been obvious to one of ordinary skill in the art to formulate the combined composition using these recited components alone because protein, carbohydrate, fat macronutrient formulations represent the standard and foundational structure of nutritional compositions, and adding spermidine as a dietary bioactive to such formulations is expressly taught by Soda. Limiting the formulation to these known macronutrient categories plus spermidine represents a predictable formulation choice using known components for their established nutritional functions, consistent with KSR (combining familiar elements according to known methods to yield predictable results). Omission of optional micronutrients such as vitamins and minerals form an otherwise conventional macronutrient nutritional formulation would have been an obvious formulation variation that does not change the fundamental nutritional properties of the composition.
Regarding claim 34, Bauer teaches 20.7 grams of Whey protein (20.7x4=82.8 kcal); 9.4 gram of Carbs (9.4x4=37.6 kcal) and 3.0 grams of fat (3.0x9=27 kcal) with total kcal approximately 150 (which is reported in Supplement table 1). Thus, this composition has 55.2% whey protein, 25.1% carbohydrate and 18.0% fat thus meeting the limitations of not greater than 30 energy % for carbohydrates. Regarding claim 36, the nutritional supplement of Bauer in view of Soda and Fan meets the limitation of a dietary supplement as its being administered as part of a diet to the subjects.
Regarding claim 36, Soda teaches spermidine concentrations in food compositions of approximately 0.002-.022 wt% (see Table 1) corresponding to 160-1540 nmol/g spermidine. Fan teaches dosing of spermidine at 5 mg/kg a day. It would have been obvious before the effective filing date of the claimed invention to select spermidine in the claimed weight percent range, as recited in instant claim 36, because Soda teaches defined spermidine concentration sin food compositions and Fan teaches effective in vivo spermidine dosing at 5 mg/kg/day producing muscle benefits. Selecting a spermidine concentration in a nutritional formulation sufficient to deliver known effective doses represents routine optimization of a result effective variable (see MPEP 2144).
Regarding claims 37-38, Bauer teaches that the supplement is provided as a powder that is reconstituted and administered twice daily in addition to meals (see page 742, top right of left column). Regarding claim 38, it would have been obvious before the effective filing date of the claimed invention to administer the composition with a meal because supplement timing relative to meals is a routine optimization variable and Bauer teaches administration at meal times (MPEP2144).
New Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1, 6, 11-12, 14, 16, 19, 33-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-15, 17-18 of co-pending Application No. 18/199523 (reference application) in view of Fan (Oncotarget. 2017 Mar 14; 8(11): 17475–17490, cited previously) and Bauer (see below rejection, cited previously).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a method of treating an individual with sarcopenia the method comprising administering high protein (whey protein) and an spermidine (see claim 1). The instant application further claims the protein is at least about 60 energy % and at least 50 wt% of protein is whey (see claim 1); protein from an animal source or milk protein (see claims 11-12); 50% weight of protein is whey (claim 1); free form amino acids or non-hydrolyzed protein (see claim 16); molecular weight of protein from 1-20 kDA (claim 19); including carbohydrate and fat (claim 33) and not greater than 30 energy % for carbohydrate; spermidine in amount of 0.05-4 wt% (claim 36); administered at least two days a week (claim 37) and administered with a meal (claim 38).
Co-pending application 18/199523 claims “A method of inducing autophagy in an individual in need thereof, the method comprising administering to the individual a composition comprising an effective amount of an autophagy inducer comprising a ketone, wherein the autophagy inducer is administered in combination with a diet rich in protein, wherein the diet rich in protein is (a) at least 60 energy %o of the composition” (claim 1). Co-pending application 18/199523 further claims wherein the individual has sarcopenia (see claim 7); wherein at least a portion of the protein is selected from the group consisting of (i) protein from an animal source, (ii) protein from a plant source and (iii) a mixture thereof (claim 1); wherein at least a portion of the protein is selected from the group consisting of (i) milk protein, (ii) whey protein, (iii) caseinate, (iv) micellar casein, (v) pea protein, (vi) soy protein and (vii) mixtures thereof; wherein the protein has a formulation selected from the group consisting of (i) at least 50 wt.% of the protein is casein, (ii) at least 50 wt.% of the protein is whey protein, (iii) at least 50 wt.% of the protein is pea protein and (iv) at least 50 wt.% of the protein is soy protein (claim 12); wherein at least a portion of the protein is selected from the group consisting of (i) free form amino acids, (ii) unhydrolyzed protein, (iii) partially hydrolyzed protein, (iv) extensively hydrolyzed protein, and (v) mixtures thereof (Claim 13); wherein the protein comprises branched chain amino acids in at least one form selected from the group consisting of (i) free form, (ii) bound to at least one additional amino acid, and (iii) mixtures thereof (claim 14); wherein the protein has a formulation selected from the group consisting of (i) at least 50% of the protein has a molecular weight of 1-5 kDa, (ii) at least 50% of the protein has a molecular weight of 5-10 kDa and (iii) at least 50% of the protein has a molecular weight of 10-20 kDa (Claim 15). Co-pending application 18/199523 is silent to wherein the autophagy inducer is spermidine; the amount of spermidine and carbohydrate; administering twice a week and with a meal.
However, Fan teaches that “Spermidine has been identified as a potent and specific inducer of autophagy for expending lifespan due to the hypoacetylation of histone, which can provide protection for aging process of several tissues including heart, brain and skeletal muscle, thereby accomplishing the longevity”.
It would have been obvious before the effective filing date of the claimed invention to use spermidine in the composition of Co-pending application 18/199523 for inducing autophagy. One of ordinary skill in the art would have been motivated to do so given spermidine is known to induce autophagy which can provide protection for aging process of several tissues including heart, brain and skeletal muscle, thereby accomplishing the longevity. Furthermore, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). But see In re Geiger, 815 F.2d 686, 2 USPQ2d 1276 (Fed. Cir. 1987) (“Based upon the prior art and the fact that each of the three components of the composition used in the claimed method is conventionally employed in the art for treating cooling water systems, the board held that it would have been prima facie obvious, within the meaning of 35 U.S.C. 103, to employ these components in combination for their known functions and to optimize the amount of each additive....Appellant argues... hindsight reconstruction or at best,... obvious to try’.... We agree with appellant.”). One of ordinary skilled in the art would have been motivated to combine the two (high protein and spermidine) each known to be useful for the same purpose, with a reasonable expectation that at least here will be an additive effect. Furthermore, it would have been obvious to optimize the amount of casein/protein and carbohydrate content to achieve optimal therapeutic effectiveness.
Regarding instant claim 36, Fan teaches dosing of spermidine at 5 mg/kg a day. It would have been obvious before the effective filing date of the claimed invention to select spermidine in the claimed weight percent range, as recited in instant claim 36, because Fan teaches effective in vivo spermidine dosing at 5 mg/kg/day producing muscle benefits. Selecting a spermidine concentration in a nutritional formulation sufficient to deliver known effective doses represents routine optimization of a result effective variable (see MPEP 2144).
Regarding instant claims 37-38, Bauer teaches of a high protein supplement (about 60%) for treating sarcopenia is provided as a powder that is reconstituted and administered twice daily in addition to meals (see page 742, top right of left column). Regarding instant claim 38, it would have been obvious before the effective filing date of the claimed invention to administer the composition with a meal because supplement timing relative to meals is a routine optimization variable and Bauer teaches administration at meal times (MPEP2144).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 6, 11-12, 14, 16, 19, 33-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of US Patent No. 12317914 in view of Fan (Oncotarget. 2017 Mar 14; 8(11): 17475–17490, cited previously) and Bauer (see below rejection, cited previously).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims a method of treating an individual with sarcopenia the method comprising administering high protein (whey protein) and an spermidine (see claim 1). The instant application further claims the protein is at least about 60 energy % and at least 50 wt% of protein is whey (see claim 1); protein from an animal source or milk protein (see claims 11-12); 50% weight of protein is whey (claim 1); free form amino acids or non-hydrolyzed protein (see claim 16); molecular weight of protein from 1-20 kDA (claim 19); including carbohydrate and fat (claim 33) and not greater than 30 energy % for carbohydrate; spermidine in amount of 0.05-4 wt% (claim 36); administered at least two days a week (claim 37) and administered with a meal (claim 38).
US Patent No. ‘914 claims A method of treating patients (via inducing autophagy) with sarcopenia (see claims 1 and 5) comprising administering an autophagy inducer (see claims 1, autophagy inducing amino acids) and protein (see claim 1).
US Patent No. ‘914 further claims wherein at least a portion of the protein is selected from the group consisting of (i) protein from an animal source, (ii) protein from a plant source and (iii) a mixture thereof (claim 9); wherein at least a portion of the protein is selected from the group consisting of (i) milk protein, (ii) whey protein, (iii) caseinate, (iv) micellar casein, (v) pea protein, (vi) soy protein and (vii) mixtures thereof (Claim 10); wherein at least a portion of the protein is selected from the group consisting of (i) free form amino acids, (ii) unhydrolyzed protein, (iii) partially hydrolyzed protein, (iv) extensively hydrolyzed protein, and (v) mixtures thereof (Claim 11-12); wherein the protein comprises branched chain amino acids in at least one form selected from the group consisting of (i) free form, (ii) bound to at least one additional amino acid, and (iii) mixtures thereof (claim 17-18); wherein the protein has a formulation selected from the group consisting of (i) at least 50% of the protein has a molecular weight of 1-5 kDa, (ii) at least 50% of the protein has a molecular weight of 5-10 kDa and (iii) at least 50% of the protein has a molecular weight of 10-20 kDa (Claim 1). US Patent No. ‘914 is silent to wherein the autophagy inducer includes spermidine; the amount of spermidine and carbohydrate; administering twice a week and with a meal.
However, Fan teaches that “Spermidine has been identified as a potent and specific inducer of autophagy for expending lifespan due to the hypoacetylation of histone, which can provide protection for aging process of several tissues including heart, brain and skeletal muscle, thereby accomplishing the longevity”.
It would have been obvious before the effective filing date of the claimed invention to use spermidine in the composition of US Patent NO. ‘914 for inducing autophagy. One of ordinary skill in the art would have been motivated to do so given spermidine is known to induce autophagy which can provide protection for aging process of several tissues including heart, brain and skeletal muscle, thereby accomplishing the longevity. Furthermore, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). But see In re Geiger, 815 F.2d 686, 2 USPQ2d 1276 (Fed. Cir. 1987) (“Based upon the prior art and the fact that each of the three components of the composition used in the claimed method is conventionally employed in the art for treating cooling water systems, the board held that it would have been prima facie obvious, within the meaning of 35 U.S.C. 103, to employ these components in combination for their known functions and to optimize the amount of each additive....Appellant argues... hindsight reconstruction or at best,... obvious to try’.... We agree with appellant.”). One of ordinary skilled in the art would have been motivated to combine the two (high protein and spermidine) each known to be useful for the same purpose, with a reasonable expectation that at least here will be an additive effect. Furthermore, it would have been obvious to optimize the amount of casein/protein and carbohydrate content to achieve optimal therapeutic effectiveness.
Regarding instant claim 36, Fan teaches dosing of spermidine at 5 mg/kg a day. It would have been obvious before the effective filing date of the claimed invention to select spermidine in the claimed weight percent range, as recited in instant claim 36, because Fan teaches effective in vivo spermidine dosing at 5 mg/kg/day producing muscle benefits. Selecting a spermidine concentration in a nutritional formulation sufficient to deliver known effective doses represents routine optimization of a result effective variable (see MPEP 2144).
Regarding instant claims 37-38, Bauer teaches a high protein supplement (about 60%) for treating sarcopenia is provided as a powder that is reconstituted and administered twice daily in addition to meals (see page 742, top right of left column). Regarding instant claim 38, it would have been obvious before the effective filing date of the claimed invention to administer the composition with a meal because supplement timing relative to meals is a routine optimization variable and Bauer teaches administration at meal times (MPEP2144).
Conclusion
No claims are allowed.
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/ERINNE R DABKOWSKI/ Examiner, Art Unit 1654