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 .
Detailed Action
Pursuant to a preliminary amendment filed on November 15, 2024, claims 1 is currently pending in the instant application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on November 15, 2024 has been considered. An initialed copy of the IDS accompanies this Office Action.
Priority
The present application filed November 15, 2024, is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2023/022158, filed May 15, 2023, which claims the benefit of Provisional Application 63/342,370, filed May 16, 2022.
Therefore, the earliest priority date is May 16, 2022.
Nonstatutory 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 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 38 - 56 of application 18855944. (This application has been published as US 20260055378 A1, published on February 25, 2026). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are wholly encompassed by, and significantly overlap in scope with claims 1, and 38 - 56 of application 18855944.
Claim 1 of application 18855944 is directed to a powder formulation, comprising: reduced glutathione; L-ascorbic acid; a sugar; L-arginine; a buffering agent; and a physically acceptable salt, wherein the powder formulation when reconstituted at a point of use in a saline or sterile water media forms a reconstituted formulation having a pH of about 7.
Newly added claim 54 is directed to a method for preserving a tissue or organ, comprising: reconstituting the powder formulation of claim 1 in a saline or sterile water media to form a reconstituted formulation: and bringing the tissue or organ into contact with the reconstituted formulation.
Instant claim 1 is directed to a method for storing or transporting cells, tissues or organs, comprising: reconstituting a powder formulation in a saline or sterile water media to form a cytoprotectant formulation; extracting the cells, tissues or organs during a biopsy procedure; and bringing the cells, tissues or organs into contact with the cytoprotectant formulation, and storing the cells, tissues or organs in the cytoprotectant formulation, wherein the powder formulation when reconstituted at a point of use in a saline or sterile water media forms a reconstituted formulation having a pH of about 7.
Application 18855944 claims compositions and methods, while the instant application is directed a method. However, double-patenting rejections of claims to a method of use based on a claimed composition are proper. This rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
Claim Rejection - 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, 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 1 is rejected under Jordan et al. (hereinafter referred to as “Jordan”) (US 7393685 B1, published July 1, 2008).
Jordan teaches a method of cultivating cancer cells from human tissue, wherein the tissue is placed in a culture medium for storage (claim 1). Jordan teaches that the medium for cultivating the cancer cells and for storing the cancer cells is identical (claim 3), and that the tissue sample is obtained from an intraoperative biopsy (claim 2). Jordan teaches that the culture medium comprises L-glutathione (i.e. a reducing agent), ascorbic acid (i.e. an antioxidant), D – glucose (i.e. a sugar), acetate (i.e. a buffering agent), and sodium pyruvate (i.e. a salt) (claim 1). (Thus, it is interpreted that Jordan teaches extracting the tissue during a biopsy, bringing the cells into contact with the cytoprotectant formulation, storing the tissue in the cytoprotectant formulation, and the composition of the powder formulation).
Jordan does not specifically exemplify the powder formulation and that the powder formulation is reconstituted at a point of use having a pH of about 7.
However, reconstituting a powder formulation (comprising a reducing agent, an antioxidant, a sugar, a buffering agent, and a physiologically acceptable salt) is well known to a person of ordinary skill in the art.
MPEP 2144 teaches:
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992); see also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); Ex parte Clapp, 227 USPQ 972 (Bd. Pat. App. & Inter. 1985) (examiner must present convincing line of reasoning supporting rejection); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning).
Thus, one of ordinary skill in the art would certainly know how to combine the reagents of the formulation and reconstitute it in saline or sterile water and achieve a pH of 7.
Therefore, claim 1 is rejected.
Conclusion
Claim 1 is rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYOMA SHUBHAM TIWARI whose telephone number is (571)272-2954. The examiner can normally be reached M-F 8:30 - 5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached on (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VYOMA SHUBHAM TIWARI/Examiner, Art Unit 1634
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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