DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 October 2025 has been entered.
Status
Applicant’s response dated 30 October 2025 to the previous Office action dated 12 August 2025 is acknowledged. Pursuant to amendments therein, claims 1-18 are pending in the application.
The claim rejections under 35 U.S.C. 103 made in the previous Office action is/are withdrawn in view of applicant’s claim amendments, but new (modified) rejection(s) under 35 U.S.C. 103 is/are made herein in view of applicant’s claim amendments.
The double patenting rejection made in the previous Office action is maintained herein.
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.
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) 1-3, 5-9, and 11-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zempleni (WO 2019/236873 A1; published 12 December 2019; of record).
Zempleni discloses a method of treating sarcopenia or muscle loss after injury comprising administering to a mammal in need thereof a nutritional supplement (claim 106) comprising a milk exosome (claim 76) with endogenous and/or exogenous cargo (claims 77-78; abstract) wherein the milk exosome is isolated from bovine milk (claim 2) and further comprises cargo comprising therapeutic agent (claim 11) including nutrients (claim 12) and nutritional agents (claim 14) wherein the milk exosome is formulated into a composition for oral administration to a human (claim 73) wherein the exosomes are in intact form (paragraph [0292]) wherein cargos include carbohydrates and proteins (paragraph [00226]) wherein exosomes include some fat globules (paragraph [00281]) wherein exosomes have a diameter of about 120-250 nm (Figs. 7B, 8B) wherein the human may have a disease, disorder, or condition (paragraph [0138]) such as cancer (paragraph [0140]) or diabetes or ALS (paragraph [0152]) or COPD (paragraph [0143]) or NAFLD (paragraph [00156]) wherein the nutritional supplement or nutraceutical can include vegetable oils (paragraph [00243]) wherein liquid oral compositions may include diluent such as cottonseed oil or corn oil (i.e., fat) (paragraph [00251]) wherein oral compositions may include filler such as lactose, sucrose, or glucose (i.e., carbohydrate) (paragraph [00248]) wherein nutritional supplements can be in liquid or powder form (paragraph [00261]) wherein endogenous mRNA in bovine milk exosome is translated into protein by a mammal, affording the opportunity for treatment of disease or affecting a physiologic condition in the mammal, such as any of the conditions discussed herein (paragraph [00293]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Zempleni as discussed above and to treat sarcopenia or muscle loss after injury (i.e., method for decreasing muscle atrophy and promoting muscle regeneration) in a human in need thereof by orally administering thereto a nutritional supplement comprising intact exosomes with endogenous and/or exogenous cargo and having a diameter of about 120-250 nm isolated from bovine milk and further comprising nutrients including carbohydrates and proteins and fats and vegetable oils and diluent cottonseed oil or corn oil (i.e., fat) and filler lactose, sucrose, or glucose (i.e., carbohydrate) in liquid or powder form wherein the human also has cancer or diabetes or ALS or COPD or NAFLD, with a reasonable expectation of success.
Regarding the claimed recitation of the intact bovine milk exosomes consisting of bovine milk exosomes containing only their endogenous cargo, the intact exosomes with endogenous cargo of Zempleni as discussed above satisfy such limitation. As discussed above, Zempleni teaches that endogenous cargo can be used to treat any of the discussed conditions (see, e.g., paragraph [00293]), which would include sarcopenia or muscle loss after injury. Moreover, it also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine such intact exosomes with endogenous cargo of Zempleni as discussed above with other exosomes with exogenous cargo of Zempleni as discussed above for use in the compositions and methods of Zempleni as discussed above, with a reasonable expectation of success, given that 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 per MPEP 2144.06(I). Such composition reads on the claimed method given that the nutritional composition of the claims comprises (i.e., is open-ended) exosomes consisting of endogenous cargo, and therefore may also contain other exosomes containing exogenous cargo.
Regarding the claimed concentration range of exosomes in claim 3, although Zempleni does not explicitly disclose such concentration range, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize sarcopenia or muscle loss treatment efficacy by varying the concentration of exosomes in the method and composition of Zempleni as discussed above through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Zempleni teaches that exosomes are used to treat sarcopenia or muscle loss.
Regarding the claimed concentration ranges of protein in claims 13 and 16-17, although Zempleni does not explicitly disclose such concentration ranges, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize provision of nutrients by varying the concentration of protein in the method and composition of Zempleni as discussed above through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Zempleni teaches that proteins are used as nutrient cargo in the method and composition of Zempleni as discussed above.
Regarding the claimed concentration ranges of fat in claims 14 and 16-17, although Zempleni does not explicitly disclose such concentration ranges, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize provision of nutrients or to optimize dilution of the composition of Zempleni as discussed above by varying the concentration of fat and/or cottonseed oil and/or corn oil in the method and composition of Zempleni as discussed above through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Zempleni teaches that fat is used as nutrient cargo in the method and composition of Zempleni as discussed above, and given that Zempleni also teaches that cottonseed oil or corn oil (i.e., fat) is used as diluent in the method and composition of Zempleni as discussed above.
Regarding the claimed concentration ranges of carbohydrate in claims 15-17, although Zempleni does not explicitly disclose such concentration ranges, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize provision of nutrients or to optimize filler in the composition of Zempleni as discussed above by varying the concentration of carbohydrate and/or lactose and/or sucrose and/or glucose in the method and composition of Zempleni as discussed above through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Zempleni teaches that carbohydrate is used as nutrient cargo in the method and composition of Zempleni as discussed above, and given that Zempleni also teaches that lactose, sucrose, or glucose (i.e., carbohydrate) is used as filler in the method and composition of Zempleni as discussed above.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zempleni as applied to claims 1-3, 5-9, and 11-17 above, and further in view of Brito-de-la-Fuente et al. (US 2020/0061013 A1; published 27 February 2020; of record).
Zempleni is relied upon as discussed above.
Zempleni does not disclose the human as an adult over 40 years of age and does not disclose milk protein concentrate as protein as in claim 4.
Brito-de-la-Fuente et al. discloses nutritional compositions for use in therapy of patients with sarcopenia (title) wherein aging is frequently accompanied by a loss of muscle mass such as after the age of 40 years and sarcopenia can affect all elderly people (paragraphs [0003]-[0005]) wherein the nutritional composition includes protein component to be nutritionally complete (paragraph [0022]) wherein the protein component preferably comprises milk protein concentrate (paragraph [0063]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zempleni and Brito-de-la-Fuente et al. by using the method and composition of Zempleni as discussed above to treat an elderly human over the age of 40 who has sarcopenia as suggested by Brito-de-la-Fuente et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to treat the type of person that frequently has sarcopenia because Zempleni suggests treating a human with sarcopenia and Brito-de-la-Fuente et al. teaches that elderly humans over the age of 40 frequently have loss of muscle mass and sarcopenia.
It also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zempleni and Brito-de-la-Fuente et al. by using the milk protein concentrate of Brito-de-la-Fuente et al. as the protein in the method and composition of Zempleni as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to include therein a suitable preferred protein in nutritional compositions for use in therapy of patients with sarcopenia because Zempleni suggests including protein therein and Brito-de-la-Fuente et al. teaches that milk protein concentrate is a preferred protein in such compositions.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-28 and 31-33 of copending Application No. 18/259,881 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the recitation in the instant claims of “decreasing muscle atrophy and/or promoting muscle regeneration in a subject at risk of muscle atrophy” encompasses any subject since any subject is capable of muscle atrophy and is therefore “at risk” of muscle atrophy, and “decreasing of muscle atrophy and/or promoting muscle regeneration” inherently flows from the method of the ‘881 claims given that at least substantial similarity of the method of the ‘881 claims and the method of the instant claims, and the intact exosomes of the ‘881 claims would naturally have endogenous cargo therein as they are intact.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 30 October 2025 have been fully considered but they are not persuasive.
Applicant argues that the claims of Zempleni require exogenous cargo (remarks page 8). In response, Zempleni also teaches that the cargo can be endogenous and/or exogenous (abstract).
Applicant argues that Zempleni does not teach that endogenous cargo can treat conditions (remarks pages 8-9). In response, Zempleni teaches that endogenous mRNA in bovine milk exosome is translated into protein by a mammal, affording the opportunity for treatment of disease or affecting a physiologic condition in the mammal, such as any of the conditions discussed herein (paragraph [00293]).
Applicant argues that the present claims are directed to decreasing muscle atrophy and/or promoting muscle regeneration in a subject at risk of muscle atrophy whereas the ‘881 claims are directed to enhancing muscle performance in a subject in need of improved physical performance and/or reducing chronic fatigue in a subject recovering or recovered from a viral infection (remarks page 11). In response, the claims are not patentably distinct from each other because the recitation in the instant claims of “decreasing muscle atrophy and/or promoting muscle regeneration in a subject at risk of muscle atrophy” encompasses any subject since any subject is capable of muscle atrophy and is therefore “at risk” of muscle atrophy, and “decreasing of muscle atrophy and/or promoting muscle regeneration” inherently flows from the method of the ‘881 claims given that at least substantial similarity of the method of the ‘881 claims and the method of the instant claims, and the intact exosomes of the ‘881 claims would naturally have endogenous cargo therein as they are intact.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617