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 .
Response to Amendments
Applicant's amendments filed 4/30/2026 have been entered. Claims 17-24 have been added. Claims 1-24 remain pending, and are subject to the election requirement dated 3/06/2026. References not included with this Office action can be found in a prior action.
Election/Restrictions
Applicant’s election without traverse of Group II, presently claims 14-24, in the reply filed on 4/30/2026 is acknowledged.
Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/30/2026
Claims 14-24 are under consideration on the merits.
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 14, 16, 21, 22, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCully et al. (US 2018/00570610; provided in the IDS dated 1/18/2024 and hereafter referred to as “McCully 2018”).
McCully 2018 teaches a method comprising: 1) isolating mitochondria from human endothelial colony-forming cells (ECFCs), 2) storing the isolated mitochondria with human endothelial colony-forming cells for 5 hours, and 3) transplantation of the recipient ECFCs (comprising mitochondria) into subjects (Example 12), anticipating claims 14, 16, 21, 22, and 24.
Claims 14, 16, 21, 22, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCully et al. (WO 2017/124037; provided in the IDS dated 4/15/2025 and hereafter referred to as “McCully 2017”).
McCully 2017 teaches a method comprising: 1) isolating mitochondria from human endothelial colony-forming cells (ECFCs), 2) storing the isolated mitochondria with human endothelial colony-forming cells for 5 hours, and 3) transplantation of the recipient ECFCs (comprising mitochondria) into subjects (Example 12), anticipating claims 14, 16, 21, 22, and 24.
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.
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.
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.
Claims 14-19 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over McCully et al. (US 2018/00570610; provided in the IDS dated 1/18/2024 and hereafter referred to as “McCully 2018”).
The teachings of McCully 2018 are relied upon as set forth above in rejecting claims 14, 16, 21, 22, and 24 as anticipated under 35 U.S.C. § 102.
In additional and separate embodiments, McCully 2018 teaches a pharmaceutical composition comprising isolated mitochondria and solution comprising either UW cold storage solution or Histidine-tryptophan-ketoglutarate (HTK) solution and intended for use in organ, tissue, and cell transplantation ([0130]), reading on claim 18. McCully 2018 teaches storing/incubating the mitochondria at a time range of a few minutes, 5 minutes, 10 minutes, or 1 hour and at a temperature range of about 0-4° C ([0143]), reading on claims 15 and alternatively reading on claim 16. McCully 2018 teaches obtained the mitochondria form cells or tissues such as liver tissue (e.g. hepatocytes), skeletal muscle (e.g. muscle cells), heart, brain (e.g. nerve cells), and adipose tissue (e.g. adipocytes) ([0135]), reading on those embodiments of claims 17 and 23. McCully 2017 teaches that 1 x107 mitochondria per ml is effective to visualize the composition comprising isolated human mitochondria injected into the heart (Example 3), reading in-part on the concentration range of claim 19.
Regarding claims 15, 17, 18, and 23, combining separate steps and components taught as useful in a method into a singular method must be held as prima facie obvious, as each step and/or component is taught separately useful for the same purpose. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In this case, McCully 2018 expressly teaches the limitations of these dependent claims as alternative embodiments useful in methods of storing organ, tissue, and/or cells with isolated mitochondria. Therefore, their combination must be held prima facie obvious absent any showing of nonobviousness to the contrary.
Regarding claim 19, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, McCully 2018 teaches that 1 x107 mitochondria per ml is known to be effective to visualize the composition comprising isolated human mitochondria injected into the heart Thus, the burden is shifted back to establish criticality of the claimed mitochondrial concentration range by objective evidence.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over McCully 2018 as applied to claim 14 above, and further in view of Bilstein et al. (US 2015/0104781; provided in the IDS 1/15/2024).
The teachings of McCully 2018 are relied upon as set forth above.
Regarding claim 20, McCully 2018 does not teach wherein preservation solution
comprises histidine at 1 mM to 500 mM, tryptophan at 1 µM to 100 mM, or ketoglutarate at 1 µM to 100 mM.
Bilstein teaches storage solutions for the preservation of organs, tissues, or organ systems and based on the known HTK solution (Abstract). Bilstein teaches a typical HTK solution comprising 180.0 mM histidine, 2.0 mM tryptophan, and 1.0 mM ketoglutarate ([0013]), and which is advantageous to inactivate organ function by reducing energy consumption which improves the efficiency of anaerobic energy recovery (of the organ(s) ([0014]), reading on claim 20.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the generic HTK solution of McCully 2018 with the specific HTK solution of Bilstein in McCully 2018’s methods. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both McCully 2018 and Bilstein are directed in-part towards organ storage compositions. The skilled artisan would have been motivated to do so because Bilstein teaches that HTK solution with the specific histidine, tryptophan, and ketoglutarate is advantageous to inactivate organ function by reducing energy consumption which improves the efficiency of anaerobic energy recovery, and so the substitution would thus predictably improve upon the storage methods of McCully 2018.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 14-19 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over McCully et al. (WO 2017/124037; provided in the IDS dated 4/15/2025 and hereafter referred to as “McCully 2017”).
The teachings of McCully 2018 are relied upon as set forth above in rejecting claims 14, 16, 21, 22, and 24 as anticipated under 35 U.S.C. § 102.
In additional and separate embodiments, McCully 2017 teaches a pharmaceutical composition comprising isolated mitochondria and solution comprising either UW cold storage solution or Histidine-tryptophan-ketoglutarate (HTK) solution and intended for use in organ, tissue, and cell transplantation (page 20, line 27 through page 21, line 8), reading in-part on claims 14 and 18, and the intended use of claims 22 and 24. McCully 2017 teaches methods of isolating mitochondria (Example 1), reading in-part on claim 14. McCully 2017 teaches storing/incubating the mitochondria at a time range of a few minutes, 5 minutes, 10 minutes, or 1 hour and at a temperature range of about 0-4° C (page 24, lines 15-19), reading on claims 15 and 16. McCully 2017 teaches obtained the mitochondria form cells or tissues such as liver tissue (e.g. hepatocytes), skeletal muscle (e.g. muscle cells), heart, brain (e.g. nerve cells), and adipose tissue (e.g. adipocytes) (page 22, lines 15-22), reading on those embodiments of claims 17 and 23. McCully 2017 teaches that 1 x107 mitochondria per ml is effective to visualize the composition comprising isolated human mitochondria injected into the heart (Example 3), reading in-part on the concentration range of claim 19.
Regarding claims 15, 17, 18, and 23, combining separate steps and components taught as useful in a method into a singular method must be held as prima facie obvious, as each step and/or component is taught separately useful for the same purpose. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In this case, McCully 2017 expressly teaches the limitations of these dependent claims as alternative embodiments useful in methods of storing organ, tissue, and/or cells with isolated mitochondria. Therefore, their combination must be held prima facie obvious absent any showing of nonobviousness to the contrary.
Regarding claim 19, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, McCully 2017 teaches that 1 x107 mitochondria per ml is known to be effective to visualize the composition comprising isolated human mitochondria injected into the heart Thus, the burden is shifted back to establish criticality of the claimed mitochondrial concentration range by objective evidence.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over McCully 2017 as applied to claim 14 above, and further in view of Bilstein et al. (US 2015/0104781; provided in the IDS 1/15/2024).
The teachings of McCully 2017 are relied upon as set forth above.
Regarding claim 20, McCully 2017 does not teach wherein preservation solution
comprises histidine at 1 mM to 500 mM, tryptophan at 1 µM to 100 mM, or ketoglutarate at 1 µM to 100 mM.
Bilstein teaches storage solutions for the preservation of organs, tissues, or organ systems and based on the known HTK solution (Abstract). Bilstein teaches a typical HTK solution comprising 180.0 mM histidine, 2.0 mM tryptophan, and 1.0 mM ketoglutarate ([0013]), and which is advantageous to inactivate organ function by reducing energy consumption which improves the efficiency of anaerobic energy recovery ([0014]), reading on claim 20.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the generic HTK solution of McCully 2017 with the specific HTK solution of Bilstein in McCully 2017’s methods. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both McCully 2017 and Bilstein are directed in-part towards organ storage compositions. The skilled artisan would have been motivated to do so because Bilstein teaches that HTK solution with the specific histidine, tryptophan, and ketoglutarate is advantageous to inactivate organ function by reducing energy consumption which improves the efficiency of anaerobic energy recovery, and so the substitution would thus predictably improve upon the storage methods of McCully 2017.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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