DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 12/15/2025 have been received and entered into the case. Claims 1-13 and 17-18 have been canceled. Claims 14-16 and 19-24 are pending, Claims 20-24 have been withdrawn, and Claims 14-16 and 19 have been considered on the merits, insofar as they read on the elected species of an umbilical cord, and acute respiratory distress syndrome (ARDS). All arguments have been fully considered.
Withdrawn Rejections
Rejections under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn in view of applicant’s amendments.
Rejections of Claim 19 on the judicially-created basis that they contain an improper Markush grouping of alternatives are withdrawn in view of applicant’s amendments.
Rejections of Claims 14-16 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Chang et al (US 2017/0087187 A1; 3/30/2017. Cited on IDS) are withdrawn in view of applicant’s amendments.
Rejections of Claims 17-18 under 35 U.S.C. 103 as being unpatentable over Qian et al (Stem Cell Reviews and Reports. 2021;17:411-427. Cited on IDS) in view of Chang et al (US 2017/0087187 A1; 3/30/2017. Cited on IDS) are withdrawn in view of applicant’s amendments – Claims 17-18 have been canceled.
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 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Qian et al (Stem Cell Reviews and Reports. 2021;17:411-427. Cited on IDS) in view of Chang et al (US 2017/0087187 A1; 3/30/2017. Cited on IDS).
The instant claims recite a method for treating acute respiratory distress syndrome (ARDS), the method comprising: administering an effective amount of a pharmaceutical composition comprising exosomes derived from thrombin-treated stem cells as an active ingredient to an individual in need thereof.
Qian teaches in acute respiratory distress syndrome (ARDS), exosomes derived from mesenchymal stem cells (MSC-exos) increased the expression of M2 macrophages chemokine CCL18 and CCL22 and M2 marker CD 206 and promote the anti-inflammatory response through mitochondrial transfer and oxidative phosphorylation of macrophages (p.417 col right – para 2). Qian teaches MSCs treated with thrombin can increase the number of exosomes, and thrombin-MSC-exos can improve immunosuppressive effects (p.415 col left – para 3).
Qian does not teach administering an effective amount of a pharmaceutical composition comprising exosomes derived from thrombin-treated stem cells as an active ingredient (claim 14), wherein said stem cells are mesenchymal stem cells derived from an umbilical cord (claim 16).
However, Qian does teach exosomes derived from thrombin-treated mesenchymal stem cells, and such exosomes promote an anti-inflammatory response in ARDS. Chang teaches thrombin-treated mesenchymal stem cells are administered as a pharmaceutical composition (para 0039), and a preferable dosage depends on conditions and weights of individuals, progression of diseases, drug types, administration paths and administration periods, which may be appropriately selected by those of ordinary skill in the art (para 0041). Chang teaches stem cell-derived exosomes have outstanding therapeutic effects, including inhibiting cell death due to inflammation in nerve cells, and substantially reducing inflammatory cytokine levels due to inflammatory reactions (para 0014), said stem cells are mesenchymal stem cells, derived from the umbilical cord (para 0027), and thrombin treated, which promotes exosome secretion from mesenchymal stem cells (para 0046).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to administer an effective amount of a pharmaceutical composition comprising exosomes derived from thrombin-treated stem cells as an active ingredient to treat ARDS, since Qian and Chang both disclose that exosomes derived from thrombin-treated stem cells act as anti-inflammatory agents, Qian discloses that such exosomes are a promising therapeutic candidate for treating ARDS, and Chang discloses that such exosomes are administered as a pharmaceutical composition to inhibit cell death and to substantially reduce inflammatory cytokine levels. In addition, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the amount of a pharmaceutical composition comprises exosomes derived from thrombin-treated stem cells based on conditions and weights of individuals, progression of diseases, drug types, administration paths and administration periods, as evidenced by Chang. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to administer an effective amount of a pharmaceutical composition comprising exosomes derived from thrombin-treated stem cells as an active ingredient for treating ARDS with a reasonable expectation of success.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Qian et al (Stem Cell Reviews and Reports. 2021;17:411-427. Cited on IDS) in view of Chang et al (US 2017/0087187 A1; 3/30/2017. Cited on IDS) as applied to claims 14-16 above, further in view of Lin et al (Crit Care Clin. 2011;27(3):705-718.).
References cited above do not teach the pharmaceutical composition further comprises a gene (claim 19).
However, Qian does teach exosomes derived from thrombin-treated stem cells are a promising therapeutic candidate for treating ARDS. Lin teaches that gene therapy is a potentially powerful approach to treat a variety of diseases related to ARDS (Abstract), and it is likely that combinations of approaches will be used for successful treatment (p.8 para 2).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate a gene to treat ARDS, since Qian discloses that exosomes derived from thrombin-treated stem cells are a promising therapeutic candidate for treating ARDS, and Lin discloses that gene therapy is a potentially powerful approach to treat a variety of diseases related to ARDS and combinations of approaches will be used for successful treatment. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate a gene for treating ARDS with a reasonable expectation of success.
Response to Arguments
Applicant argues that there is no motivation to combine cited references, and that there is no reasonable expectation of success.
These arguments are not found persuasive because Qian and Chang both teach exosomes derived from thrombin-treated stem cells have outstanding therapeutic effects including reducing inflammation, Qian does teach that exosomes derived from thrombin-treated stem cells promote an anti-inflammatory response in ARDS, and Chang does teach that exosomes derived from thrombin-treated stem cells are administered as a pharmaceutical composition to inhibit cell death and to substantially reduce inflammatory cytokine levels. Therefore, before the effective filing date of the claimed invention, a skill in the art would administer exosomes derived from thrombin-treated stem cells to treat ARDS, since ARDS is characterized by inflammation, and exosomes derived from thrombin-treated stem cells reduce inflammation.
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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759