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 .
Claim Status
Claims 1-8 and 10-14 are pending.
Claim 1 is currently amended
Claim 9 is cancelled.
Claims 1-8 and 10-14 have been examined.
Priority
No priority claimed. See filing receipt filed 8/26/2025 and ADS dated 8/22/2025. Thus, the prior art date is the effective filing date of this application on 11/11/2022. In the earlier filing receipt dated 6/11/2025, applicant disclosed this instant application is CIP of 17/115,144 and 17/582,974. The examiner has checked the disclosure of both 17/115,144 and 17/582,974 and found the disclosure of both 17/115,144 and 17/582,974 was insufficient to satisfy written description of this instant claims. Therefore, the prior art date of this instant application is still the effective filing date of this application on 11/11/2022 even if applicant reclaims the priority documents.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/20/2026 is in compliance with the provisions of 37 CFR 1.97. No priority has been claimed in this application; thus, various prior art references cited in the instant IDS are not submitted for consideration even though the references may be submitted in other applications. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Rejection
All rejections of record are withdrawn because the amendment to claim 1 overcomes the rejections of record.
New Ground of rejection
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, 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.
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.
Claims 1-8 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bell et al. (US 2018/0110839 A1, cited in IDS 12/15/2022) in view of Soloman (Abstracts / Neurobiology of Aging 39 (2016) S1-S13), Horiuchiet al. (Neurobiology of Aging 33 (2012) 499–509), and Castro et al. (WO 2020/086469 A1, previously cited 11/6/2025).
Claim 1 is drawn to a method of restoring myelin levels and/or improving nerve conductance comprising administering an effective amount of a plasma fraction to a subject diagnosed with an aging-related condition associated with myelin degeneration.
Bell et al. teach the use of blood plasma fractions as a treatment for aging-associated cognitive disorders in human [Abstract; 0052; claim 14]. Bell et al. teach the treated aging-associated cognitive disorders comprising Alzheimer's disease, Parkinson's disease, frontotemporal dementia, Huntington disease, amyotrophic lateral sclerosis, multiple sclerosis, glaucoma, myotonic dystrophy, vascular dementia, and the like [0056]. Bell et al. teach the blood plasma fraction comprising a substantial concentration of human serum albumin [0066, 0072-0075]. Soloman et al. is cited to show the knowledge level of ordinary skill in the art comprises (i) low serum albumin concentrations with increased risk of cognitive impairment in the elderly population and (ii) more than 90% of circulating amyloid β (Aβ) in the blood is bound to human serum albumin (HSA) and HSA-Aβ complex levels are decreased in Alzheimer's disease (AD) patient’s serum (col 1, last para).
Bell et al. in view of Soloman et al. did not specify the treated subject diagnosed with an aging-related condition associated with myelin degeneration.
Horiuchi et al. teach “Amyloid β1–42 oligomer inhibits myelin sheet formation in vitro” (Title). Horiuchi et al. suggest Aβ oligomer-mediated white matter degeneration, which could impair myelin maintenance and remyelination by adult oligodendroglial progenitor cells (OPCs), resulting in accumulating damage to myelinating axons thereby contributing to neural disconnections in AD (Abstract; p499, col 1). Furthermore, Castro et al. teach plasma protein fraction (PPF) under FDA’s quality standard, as taught by Bell et al. [0072, 0075], able to promote myelin protein expression and induce myelination repair mechanism (p41, para 2, Fig 11). Castro et al. further teach the use of plasma protein fraction (PPF) in promoting or stimulating remyelination and treating diseases related to myelination (p29, para 1).
Because (a) Horiuchi et al. suggest amyloid β1–42 oligomer inhibits myelin sheet formation contributing to neural disconnections in Alzheimer's disease (AD) and Aβ oligomer-mediated white matter degeneration could impair myelin maintenance and remyelination by adult oligodendroglial progenitor cells (Abstract; p499, col 1), (b) Soloman et al. teach more than 90% of circulating amyloid β (Aβ) in the blood is bound to human serum albumin (HSA) and HSA-Aβ complex levels are decreased in Alzheimer's disease, and (c) Castro et al. teach the use of plasma protein fraction (PPF) taught by Bell et al. for promoting or stimulating remyelination and treating diseases related to myelination (p29, para 1), one of ordinary skill in the art would have found it obvious to diagnose myelin damage in a patient with aging-associated cognitive disorders (e.g., AD patients) and administer a plasma protein fraction comprising serum albumin to treat the patient and monitor the treatment effect of restoring myelin levels and/or improving nerve conductance of restored myelin.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine Bell et al. and Soloman et al. because (a) Bell et al. teach the use of blood plasma fractions as a treatment for aging-associated cognitive disorders (e.g., Alzheimer's disease) in human [Abstract; 0052; claim 14] and the blood plasma fraction comprising a substantial concentration of human serum albumin [0066, 0072-0075], and (b) Soloman et al. is cited to show the knowledge level of ordinary skill in the art comprises (i) low serum albumin concentrations with increased risk of cognitive impairment in the elderly population and (ii) more than 90% of circulating amyloid β (Aβ) in the blood is bound to human serum albumin (HSA) and HSA-Aβ complex levels are decreased in Alzheimer's disease (AD) patient’s serum (col 1, last para). The combination would have reasonable expectation of success because both references teach a composition comprising serum albumin.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Bell et al. in view of Soloman et al. and (ii) Horiuchi et al. because (a) Bell et al. in view of Soloman et al. teach administration of a plasma fraction comprising serum albumin able to bind circulating amyloid β (Aβ) and prevent aggregation of amyloid β to treat aging-associated cognitive disorders (e.g., Alzheimer's disease) and (b) Horiuchi et al. suggest amyloid β1–42 oligomer inhibits myelin sheet formation contributing to neural disconnections in Alzheimer's disease (AD) and Aβ oligomer-mediated white matter degeneration could impair myelin maintenance and remyelination by adult oligodendroglial progenitor cells (Abstract; p499, col 1). The combination would have reasonable expectation of success because serum albumin is capable of binding to prevent aggregation of amyloid β.
With respect to claim 2, Bell et al. teach the use of blood plasma fractions as a treatment for aging-associated cognitive disorders in human [Abstract; 0052; claim 14]. Bell et al. teach the plasma fraction as a plasma protein fraction (PPF)[0067].
With respect to claim 3, Bell et al. teach the PPF is a commercial PPF [0068].
With respect to claims 4-5, Bell et al. teach FDA 21 CFR 640.92 requires PPF sterile solution comprising at least 83% albumin, no more than 17% globulins, and no more than 1% gamma globulin [0072, 0075]. Because the ingredients of albumin and gamma globulin are in the same volume of PPF sterile solution, the 83%, 17%, and 1% are interpret as weight ratio. Bell et al. further teach albumin solution comprising at least 95% albumin, no more than 5% globulins (including al , a2 , B , and y globulins ) and other plasma proteins [0081]. Thus, the amount of albumin in PPF is at least 83% but less than 95% (albumin solution), according to FDA standard [0078].
With respect to claims 6-7, Castro et al. teach plasma protein fraction (PPF) under FDA’s quality standard, as taught by Bell et al. [0072, 0075], able to promote myelin protein expression and induce myelination repair mechanism (p41, para 2, Fig 11). Castro et al. further teach the use of plasma protein fraction (PPF) in promoting or stimulating remyelination and treating diseases related to myelination (p29, para 1), reading on restoring myelin levels in claim 6 and improving nerve conductance by promoting or stimulating remyelination in claim 7.
With respect to claim 8, Horiuchi et al. suggest Aβ oligomer-mediated white matter degeneration, which could impair myelin maintenance and remyelination by adult oligodendroglial progenitor cells (OPCs), resulting in accumulating damage to myelinating axons thereby contributing to neural disconnections in AD (Abstract; p499, col 1). Bell et al. teach the use of blood plasma fractions as a treatment for aging-associated cognitive disorders in human [Abstract; 0052; claim 14]. Bell et al. teach the treated aging-associated neurodegenerative diseases comprising Alzheimer's disease, Parkinson's disease, frontotemporal dementia, Huntington disease, amyotrophic lateral sclerosis, multiple sclerosis, glaucoma, myotonic dystrophy, vascular dementia, and the like [0056]. Castro et al. teach plasma protein fraction (PPF) under FDA’s quality standard, as taught by Bell et al. [0072, 0075], able to promote myelin protein expression and induce myelination repair mechanism (p41, para 2, Fig 11). Castro et al. further teach the use of plasma protein fraction (PPF) in promoting or stimulating remyelination and treating diseases related to myelination (p29, para 1)
With respect to claims 10-12, Bell et al. teach PPF or human albumin solution (HAS) derived from a pooled individuals (human albumin derived from human young individuals) [0098], consistent with Castro et al. (p25, para 1).
With respect to claims 13-14, Bell et al. teach the treated subject is a human subject [0096], consistent with Castro’s teaching of treated subject including human and other animals (p12, para 2).
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive because the arguments do not apply to the new ground of rejection based on Bell et al. in view of Soloman, Horiuchiet al., and Castro et al.
New Ground of Rejection
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 1-8 and 10-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of U.S. Patent No. 10,245,285 (the ‘285 patent) in view of Bell et al. in view of Soloman, Horiuchiet al., and Castro et al.
Claim 1 of the ‘285 patent disclosed a method comprising administering a blood plasma product to treat cancer.
Claims 3-4 of the ‘285 patent disclosed the blood plasma product is a plasma protein fraction.
Claim 5 of the ‘285 patent disclosed the plasma protein fraction is commercially available.
Claims 1 and 3-5 of the ‘285 patent do not teach administration of the plasma protein fraction to treat a condition associated with myelin degeneration.
The relevancy of Bell et al. in view of Soloman, Horiuchiet al., and Castro et al. as applied to claims 1-8 and 10-14 not repeated here.
Because Bell et al. in view of Soloman, Horiuchiet al., and Castro et al. teach beneficial administration of plasma protein fraction to treat a condition associated with age-related myelin degeneration, one of ordinary skill in the art would have found it obvious to administer to administer plasma protein fraction taught by claims 1 and 3-5 of the ‘285 patent to treat age-related myelin degeneration.
Thus, claims 1 and 3-5 of the ‘285 patent in view of Bell et al., Soloman, Horiuchiet al., and Castro et al. are obvious to the instant claims 1-8 and 10-14.
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive because the arguments do not apply to the new ground of rejection based on Bell et al. in view of Soloman, Horiuchiet al., and Castro et al.
Claims 1-8 and 10-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-7 of U.S. Patent No. 10,525,107 (the ‘107 patent) in view of Bell et al. in view of Soloman, Horiuchiet al., and Castro et al.
Claim 1 of the ‘107 patent disclosed a plasma protein fraction (PPF) composition consists of at least 83 percent but less than 95 percent albumin and no more than 17 percent globulins.
Claim 2 of the ‘107 patent disclosed no more than 1 percent of the total protein shall be gamma globulin.
Claim 4 of the ‘107 patent disclosed the PPF produced from a mammalian blood product.
Claim 5 of the ‘107 patent disclosed the PPF produced from human.
Claim 6 of the ‘107 patent disclosed PPF treated subject as mammal.
Claim 7 of the ‘107 patent disclosed PPF treated subject as human.
Claims 1-2 and 4-7 of the ‘107 patent do not teach administration of the plasma protein fraction to treat a condition associated with myelin degeneration.
The relevancy of Bell et al. in view of Soloman, Horiuchiet al., and Castro et al. as applied to claims 1-8 and 10-14 not repeated here.
Because Bell et al. in view of Soloman, Horiuchiet al., and Castro et al. teach beneficial administration of plasma protein fraction to treat a condition associated with age-related myelin degeneration, one of ordinary skill in the art would have found it obvious to administer to administer plasma protein fraction taught by claims 1-2 and 4-7 of the ‘107 patent to treat age-related myelin degeneration.
Thus, claims 1-2 and 4-7 of the ‘107 patent in view of Bell et al., Soloman, Horiuchiet al., and Castro et al. are obvious to the instant claims 1-8 and 10-14.
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive because the arguments do not apply to the new ground of rejection based on Bell et al. in view of Soloman, Horiuchiet al., and Castro et al.
Claims 1-8 and 10-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 10,905,717 (the ‘717 patent) in view of Bell et al. in view of Soloman, Horiuchiet al., and Castro et al.
Claim 1 of the ‘717 patent disclosed administration of a protein-enriched plasma product to treat a disease.
Claim 4 of the ‘717 patent disclosed the administered plasma fraction is a plasma protein fraction.
Claims 1 and 4 of the ‘717 patent do not teach administration of the plasma protein fraction to treat a condition associated with myelin degeneration.
The relevancy of Bell et al. in view of Soloman, Horiuchiet al., and Castro et al. as applied to claims 1-8 and 10-14 not repeated here.
Because Bell et al. in view of Soloman, Horiuchiet al., and Castro et al. teach beneficial administration of plasma protein fraction to treat a condition associated with age-related myelin degeneration, one of ordinary skill in the art would have found it obvious to administer to administer plasma protein fraction taught by claims 1 and 4 of the ‘717 patent to treat age-related myelin degeneration.
Thus, claims 1 and 4 of the ‘717 patent in view of Bell et al., Soloman, Horiuchiet al., and Castro et al. are obvious to the instant claims 1-8 and 10-14.
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive because the arguments do not apply to the new ground of rejection based on Bell et al. in view of Soloman, Horiuchiet al., and Castro et al.
Claims 1-8 and 10-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,103,530 (the ‘530 patent) in view of Bell et al. in view of Soloman, Horiuchiet al., and Castro et al.
Claim 1 of the ‘530 patent disclosed a method of improving or accelerating postoperative recovery in a subject, the method comprising administering a Plasma Protein Fraction (PPF) to the subject in an amount effective to improve or accelerate postoperative recovery.
Claim 2 of the ‘530 patent disclosed the PPF comprises between 83% to 95% albumin.
Claim 3 of the ‘530 patent disclosed the PPF is a commercially available PPF.
Claims 1-3 of the ‘530 patent do not teach administration of the plasma protein fraction to treat a condition associated with myelin degeneration.
The relevancy of Bell et al. in view of Soloman, Horiuchiet al., and Castro et al. as applied to claims 1-8 and 10-14 not repeated here.
Because Bell et al. in view of Soloman, Horiuchiet al., and Castro et al. teach beneficial administration of plasma protein fraction to treat a condition associated with age-related myelin degeneration, one of ordinary skill in the art would have found it obvious to administer to administer plasma protein fraction taught by claims 1-3 of the ‘530 patent to treat age-related myelin degeneration.
Thus, claims 1-3 of the ‘530 patent in view of Bell et al., Soloman, Horiuchiet al., and Castro et al. are obvious to the instant claims 1-8 and 10-14.
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive because the arguments do not apply to the new ground of rejection based on Bell et al. in view of Soloman, Horiuchiet al., and Castro et al.
Claims 1-8 and 10-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-7 of U.S. Patent No. 11,547,724 (the ‘724 patent) in view of Bell et al. in view of Soloman, Horiuchiet al., and Castro et al.
Claim 1 of the ‘724 patent disclosed administration of a plasma fraction to treat a subject diagnosed with pain.
Claim 5 of the ‘724 patent disclosed the plasma fraction is a plasma protein fraction.
Claim 6 of the ‘724 patent disclosed the plasma protein fraction comprises between 83% to 95% albumin.
Claim 7 of the ‘724 patent disclosed the plasma protein fraction commercially available.
Claims 1 and 5-7 of the ‘724 patent do not teach administration of the plasma protein fraction to treat a condition associated with myelin degeneration.
Claims 1 and 5-7 of the ‘724 patent do not teach administration of the plasma protein fraction to treat a condition associated with myelin degeneration.
The relevancy of Bell et al. in view of Soloman, Horiuchiet al., and Castro et al. as applied to claims 1-8 and 10-14 not repeated here.
Because Bell et al. in view of Soloman, Horiuchiet al., and Castro et al. teach beneficial administration of plasma protein fraction to treat a condition associated with age-related myelin degeneration, one of ordinary skill in the art would have found it obvious to administer to administer plasma protein fraction taught by claims 1 and 5-7 of the ‘724 patent to treat age-related myelin degeneration.
Thus, claims 1 and 5-7 of the ‘724 patent in view of Bell et al., Soloman, Horiuchiet al., and Castro et al. are obvious to the instant claims 1-8 and 10-14.
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive because the arguments do not apply to the new ground of rejection based on Bell et al. in view of Soloman, Horiuchiet al., and Castro et al.
Claims 1-8 and 10-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10-14 of copending Application No. 17/582,974 (the ‘974 application dated 11/18/2025) in view of Bell et al. in view of Soloman, Horiuchiet al., and Castro et al.
Claim 1 of the ‘974 application disclosed administration of an effective amount of a Plasma Protein Fraction of Effluent II/III to reduce a cognitive impairment in a subject with an aging-associated cognitive disorder.
Claim 10 of the ‘974 application disclosed the Plasma Fraction is derived from plasma from a pool of young individuals.
Claim 11-12 of the ‘974 application disclosed the Plasma Fraction is produced from human.
Claim 13-14 of the ‘974 application disclosed the treated subject is human.
Claims 1 and 10-14 of the ‘974 application do not teach administration of the plasma protein fraction to treat a condition associated with myelin degeneration.
The relevancy of Bell et al. in view of Soloman, Horiuchiet al., and Castro et al. as applied to claims 1-8 and 10-14 not repeated here.
Because Bell et al. in view of Soloman, Horiuchiet al., and Castro et al. teach beneficial administration of plasma protein fraction to treat a condition associated with age-related myelin degeneration, one of ordinary skill in the art would have found it obvious to administer to administer plasma protein fraction taught by claims 1 and 10-14 of the ‘974 application to treat age-related myelin degeneration.
Thus, claims 1 and 10-14 of the ‘974 application in view of Bell et al., Soloman, Horiuchiet al., and Castro et al. are obvious to the instant claims 1-8 and 10-14.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is 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.
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/J.L/Examiner, Art Unit 1658
09-April-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights