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 .
This Office Action is in response to the paper filed 8 December 2025. Claims 1, 20, and 38 have been amended. Claims 10, 12, and 36 have been cancelled. Claims 1, 2, 4, 5, 7, 13, 16, and 17 remain withdrawn. Claims 20, 23, 28, 30-35, 37, 38, and 43 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/US2021/023165, filed 19 March 2021, which claims priority to U.S. Provisional Application No. 62/992711, filed 20 March 2020.
Withdrawal of Rejections:
The rejection of claims 20, 23, 28, 30-38, and 43 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
The rejection of claims 20, 23, 28, 30-33, 35-38, and 43 under 35 U.S.C. 102(a)(1) as being anticipated by Marban et al., is withdrawn.
The rejection of claims 20 and 34 under 35 U.S.C. 103 as being unpatentable over Marban et al., and further in view of Grattendick et al., is withdrawn.
New Rejections Necessitated by Amendment:
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 20, 23, 37, 38, and 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marban et al. (IDS; US 2015/0203844; Published 2015).
With regard to claim 20, Marban et al. teach a method for treating damaged tissue, including damaged cardiac tissue in a subject (Abs.; Para. 11), wherein damaged cardiac tissue is a symptom and sequelae of COVID-19 respiratory viral infection (see Specification, Para. 3: “COVID-19 patients can develop symptoms, including… various cardiac disease manisfestations [sic] including myocarditis, myocardial infarction and arrhythmias.”). The method including administering to a subject in need of treating damaged tissue, including damage cardiac tissue, an isolated, which is cell-free, population of exosomes derived from cardiosphere-derived cells (CDCs) (Para. 11), the CDC-derived exosomes are present in an amount including about 2x108 to about 3.5x108, about 3.5x108 to about 5x108, about 5x108 to about 7.5x108, or about 7.5x108 to about 1x109 (Para. 73), which are fully encompassed within about 2x108 to about 2x1010 CDC-derived exosomes.
The exosomes are administered in combination with one or more additional agents, including proteins or nucleic acids derived from the exosomes, cells from which the exosomes are derived, and/or pharmaceutical therapy (Para. 69-70, 75). As the administered composition includes the exosomes and the additional agent, the combined composition including the additional agent, is an antiviral and anti-inflammatory agent (Para. 76, 79, 93).
With regard to claim 23, Marban et al. teach that the subject has elevated levels of one or more inflammatory markers or cytokines, as seen by a reduction in inflammatory markers or cytokines following administration (Para. 93).
With regard to claim 37, Marban et al. teach that the CDC-derived exosomes are allogeneic (Para. 67).
With regard to claim 38, Marban et al. teach that the CDCs are administered via injection, intramyocardially, intravenously, and/or via infusion (Para. 71, 74).
With regard to claim 43, Marban et al. teach that the subject additionally has a condition including congestive heart failure, ischemic heart disease, valvular heart disease, or dilated cardiomyopathy, which are cardiorespiratory dysfunctions; coronary heart disease; or diabetes (Para. 6, 12, 54).
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.
Claims 20, 28, 30-33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Marban et al., and further in view of Marban et al. (IDS; US 2012/0253102; Published 2012 hereafter Marban 2012).
The teachings of Marban et al. as applied to claim 20 have been set forth above.
With regard to claims 28, 30-33, and 35, while Marban et al. teach that additional components may be included with the CDC-derived exosomes, it is not specifically taught that the additional component includes an antihistamine, anti-inflammatory agent as claimed, immunosuppressive agent, a cyclooxygenase-2 inhibitor, a cytokine inhibitor as claimed, or a TNF-α inhibitor.
Marban 2012 teach a method for treating injured tissue, including injured cardiac tissue in a subject (Abs.; Para. 23). The method including administering to a subject in need of treating injured tissue, including injured cardiac tissue, a population of cardiosphere-derived cells (CDCs). One or more additional therapeutic agents are further administered with the CDCs, including chlorpheniramine, which is an antihistamine; celecoxib, which is a cyclooxygenase-2 inhibitor; cyclophosphamide, azathioprine, and/or methotrexate, which are an immunosuppressive agent; dexamethasone, cortisone, hydrocortisone, triamcinolone, methylprednisolone, betamethasone, and/or prednisolone, which are an anti-inflammatory agent; an anti-cytokine antibody, with is a cytokine inhibitor; cyclosporin, which is an additional therapeutic; and a TNF-α inhibitor (Para. 125, 192-194).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Marban et al. and Marban 2012, because both teach methods for treating injured tissue, including injured cardiac tissue, in a subject by administering a population of cardiosphere-derived cells (CDCs) and/or components derived thereof and an additional therapeutic component. The inclusion of an additional therapeutic component including chlorpheniramine, which is an antihistamine; celecoxib, which is a cyclooxygenase-2 inhibitor; cyclophosphamide, azathioprine, and/or methotrexate, which are an immunosuppressive agent; dexamethasone, cortisone, hydrocortisone, triamcinolone, methylprednisolone, betamethasone, and/or prednisolone, which are an anti-inflammatory agent; an anti-cytokine antibody, with is a cytokine inhibitor; cyclosporin, which is an additional therapeutic; and a TNF-α inhibitor, is known in the art as taught by Marban 2012. The use of an additional therapeutic component as taught by Marban 2012 in the method of Marban et al. amounts to the simple substitution of one known additional therapeutic component for another, and would have been expected to predictably and successfully provide an additional therapeutic agent to administer with the CDC-derived exosomes to treat additional conditions.
Claims 20 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Marban et al., and further in view of Grattendick et al. (Effects of three anti-TNF-α drugs: Etanercept, infliximab and pirfenidone on release of TNF-α in medium and TNF-α associated with the cell in vitro, International Immunopharmacology, Vol. 8, (2008), pp. 679-687 – Previously Presented).
The teachings of Marban et al. as applied to claim 20 have been set forth above.
With regard to claim 34, Marban et al. teach that the CDC-derived exosomes and additional therapeutic agent can provide the function of a TNF-α inhibitor (Par. 93). However, a specific TNF-α inhibitor, including etanercept or infliximab, is not taught.
Grattendick et al. teach that TNF-α inhibitors that reduce inflammation include etanercept and infliximab (Abs).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Marban et al. and Grattendick et al., because both teach TNF-α inhibitors. Etanercept and infliximab, which are TNF-α inhibitors that reduce inflammation, are known in the art as taught by Grattendick et al. One would have been motivated to utilize etanercept or infliximab as taught by Grattendick et al. in the method of Marban et al., as Marban et al. teach the use of TNF-α inhibitors, and Grattendick et al. teach specific TNF-α inhibitors. The use of etanercept or infliximab would have been expected to predictably and successfully provide further TNF-α inhibitors for use in the method as desired by Marban et al.
Response to Arguments
In view of Applicant’s amendments, all previous rejections have been withdrawn. Therefore, Applicant’s arguments are moot. However, new rejections have been set forth above.
Conclusion
No claims are allowable.
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 JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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