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 .
Status
Applicant’s response dated 15 April 2026 to the previous Office action dated 27 January 2026 is acknowledged. Pursuant to amendments therein, claims 1-18 are pending in the application.
A new rejection under 35 U.S.C. 112 is made herein in view of applicant’s claim amendments.
The claim rejections under 35 U.S.C. 103 made in the previous Office action is/are withdrawn in view of applicant’s claim amendments, but new (modified) rejection(s) under 35 U.S.C. 103 is/are made herein in view of applicant’s claim amendments.
The double patenting rejection made in the previous Office action is withdrawn in view of the abandonment of application 18/259,881.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2-3 recite the limitation "the intact bovine milk-isolated exosomes" (i.e., “isolated” is not previously recited) in lines 1-2 and 2 respectively. There is insufficient antecedent basis for this limitation in the claims.
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 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 cargo-containing exosomes consisting of intact 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.
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.
Response to Arguments
Applicant's arguments filed 15 April 2026 have been fully considered but they are not persuasive.
Applicant argues that the disclosure of Zempleni regarding the opportunity for treatment of diseases or conditions would not be read as being capable of treating every single disease or condition discussed therein (remarks page 7). In response, such disclosure of Zempleni specifically refers to “any of the conditions discussed herein” (paragraph [00293]), and thus applicant’s argument that such disclosure would not be read as being capable of treating every single disease or condition discussed therein is not persuasive. It is also noted that the instant claims do not even require that the composition be administered to the subject which has muscle atrophy or is at risk thereof, and thus the instant claims do not even require such limitation(s).
Applicant argues that Zempleni fails to provide data or evidence supporting alleged treatments (remarks pages 7-8). In response, the examples in Zempleni provide a large amount of data and evidence indicating natural milk exosomes and contents thereof beneficially impact muscles, such as for example improved grip strength (paragraph [00303]), and thus applicant’s argument is not persuasive.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached on (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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