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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 104-106) in the reply filed on 12/30/2025 is acknowledged.
The restriction requirement is made Final.
Claims 84-110 are currently pending.
Claims 84-103 and 107-110 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/30/2025.
Claims 104-106 have been examined on their merits.
Claim Objections
Claims 104 and 105 are objected to because of the following informalities:
Claim 104 recites the abbreviation HUVEC and claim 105 recites the abbreviation DMSO.
An abbreviation should be preceded in its first occurrence by the specific identity of the entity which said abbreviation is intended to represent. Thereafter, the use of the abbreviation in the claims will be understood.
Appropriate correction is required.
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 104-106 are rejected under 35 U.S.C. 103 as being unpatentable over Ginsberg et al (US 2017/0360988) in view of Shao, Yi (WO 2015/062267 A1, using a machine translation).
Regarding claims 104-106, Ginsberg disclose a therapeutic composition comprising E4ORF1+ HUVEC cells together with a carrier solution such as a physiological saline solution, cell suspension medium, cell culture medium, or the like, including those suitable for therapeutic administration (page 1 para 4, page 7 para 54, para 56). These cells may be cryopreserved as well (page 8 para 63). Kits comprising the therapeutic composition are also suggested (page 9 para 69).
Ginsberg do not specifically disclose wherein the carrier solution contains dextran 40, human serum albumin, and DMSO or the concentration of the cells to be combined with the carrier solution.
Shao disclose a stock solution for cryopreserving human cells (abstract). In some embodiments the solution contains dextran 40, human serum albumin, physiological saline and DMSO (page 2 of the machine translation). The cells listed for use with the solution are indicated as not being limited to a specific cell type, and can include human cell lines (page 2). The cells are added to the solution at a concentration of 0.5 x 107 cells/ml to 2.5 x 107 cells/ml (page 2) which overlaps with Applicant’s claimed range.
One of ordinary skill in the art would have been motivated to use the stock solution for cryopreservation of Shao with the cells of Ginsberg because Shao indicate that their stock solution is suitable and beneficial to use with human cell lines intended for therapeutic use. One of ordinary skill in the art would have had a reasonable expectation of success because Ginsberg teach that their cells can be combined with carrier solutions known in the art, such as those containing physiological saline, as long as they are suitable for use in a therapeutic composition and Shao indicate that the cell type used with their solution is not limited and can be used with human cell lines.
The cell concentration range disclosed by Shao overlaps and includes the claimed cell concentration range and thus renders it obvious. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. (MPEP 2144.05)
The inclusion of the kit with the therapeutic cell and stock solution would have been obvious because Ginsberg teach and suggest that this is a suitable option. Sterile packaging would be obvious to avoid contamination of the cell product which is intended for therapeutic use. The instructions for administering the therapeutic composition to a subject are not given patentable weight as nonfunctional printed matter does not distinguish a claimed product (see MPEP 2112.01 (III)).
Therefore, the combined teachings of Ginsberg et al and Shao render obvious Applicant’s invention as claimed.
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 104-106 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 70-88 of copending Application No. 18/041080 in view of Ginsberg et al (US 2017/0360988) and Shao, Yi (WO 2015/062267 A1, using a machine translation).
The claims of the copending application include compositions containing E4ORF1+ endothelial cells, such as HUVECs, and further include human serum albumin and DMSO. The copending claims do not all include a density of about 5 million cells/ml, physiological saline, dextran 40, and sterile packaging in a kit.
Ginsberg disclose a therapeutic composition comprising E4ORF1+ HUVEC cells together with a carrier solution such as a physiological saline solution, cell suspension medium, cell culture medium, or the like, including those suitable for therapeutic administration (page 1 para 4, page 7 para 54, para 56). These cells may be cryopreserved as well (page 8 para 63). Kits comprising the therapeutic composition are also suggested (page 9 para 69).
Shao disclose a stock solution for cryopreserving human cells (abstract). In some embodiments the solution contains dextran 40, human serum albumin, physiological saline and DMSO (page 2 of the machine translation). The cells listed for use with the solution are indicated as not being limited to a specific cell type, and can include human cell lines (page 2). The cells are added to the solution at a concentration of 0.5 x 107 cells/ml to 2.5 x 107 cells/ml (page 2) which overlaps with Applicant’s claimed range.
One of ordinary skill in the art would have been motivated to use the stock solution for cryopreservation of Shao with the cells of the copending claims because Shao indicate that their stock solution is suitable and beneficial to use with human cell lines intended for therapeutic use. One of ordinary skill in the art would have had a reasonable expectation of success because Ginsberg teach that endothelial cells, such as HUVEC, can be combined with carrier solutions known in the art, such as those containing physiological saline, as long as they are suitable for use in a therapeutic composition and Shao indicate that the cell type used with their solution is not limited and can be used with human cell lines.
The cell concentration range disclosed by Shao overlaps and includes the claimed cell concentration range and thus renders it obvious. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. (MPEP 2144.05)
With regard to the concentrations of HUVECs in the composition, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05).
The selection of specific concentrations clearly would have been a routine matter of optimization and experimentation on the part of the artisan of ordinary skill, said artisan recognizing that the amount and viability of the cells would have been affected by these concentrations.
The inclusion of the kit with the HUVEC cell and stock solution would have been obvious because Ginsberg teach and suggest that this is a suitable option. Sterile packaging would be obvious to avoid contamination of the cell product which is intended for therapeutic use. The instructions for administering the therapeutic composition to a subject are not given patentable weight as nonfunctional printed matter does not distinguish a claimed product (see MPEP 2112.01 (III)).
Therefore, the combined teachings of the copending claims, Ginsberg et al and Shao render obvious Applicant’s invention as claimed.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Slepushkin et al., “Autologous T cell Manufacturing Processes”, US 2008/0274091
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631