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 .
Claims Status
Claim(s) 1-20 is/are currently pending.
Applicant’s election without traverse of a therapeutic composition comprising: (1) an antibody which binds CD39, wherein the anti-CD39 antibody comprises a heavy chain variable region (VH), wherein the VH further comprises an HCDR1 of SEQ ID NO: 2, an HCDR2 of SEQ ID NO: 25, and an HCDR3 of SEQ ID NO: 46; and a light chain variable region (VL), wherein the VL further comprises an LCDR1 of SEQ ID NO: 76, an LCDR2 of SEQ ID NO: 93, and an LCDR3 of SEQ ID NO: 111; and (2) an adoptive cell therapy comprising: a T cell comprising an anti-CD19 CART cell that binds to a melanoma antigen. in the reply filed on 20Nov2025 is acknowledged.
Claims 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20Nov2025.
Claim(s) 1-13 and 19-20 is/are presented for examination on the merits.
Specification
The use of trade name(s) or mark(s) used in commerce (e.g., Biolegend, Invitrogen, BD, R & D Systems, Themo Fisher, Charles River Laboratories, Miltenyi, Agilent), has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code [e.g., ¶ 0044]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 102
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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-13 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018/223101 A1 (hereinafter “WO101”).
Regarding instant claim(s) 1-7, WO101 teaches articles of manufacture and methods for treatment using adoptive cell therapy (ACT) [e.g., title, abstract]. WO101 further teaches that the ACT is a CD19 direct CAR T cell [e.g., ¶ 0037, 0111, 0122, 0320, 0539, 0796 embodiments 43, 87; examples 1-4]. WO101 teaches the administration of an additional agent wherein said agent is a CD39 antibody [e.g., ¶ 0742, 0750, ].
Regarding instant claim(s) 8-9, WO101 further teaches and embodiment wherein the CAR T cell recognizes gp100 [e.g., ¶ 0037, 0148, 0172, 0242, 0247, 0538].
Regarding instant claim(s) 10-13, WO101 further teaches the CAR comprises an extracellular binding moiety, a transmembrane domain, a CD28 or 4-1BB costimulatory domain, and a CD3z intracellular signaling domain [e.g., ¶ 0016, 0018-0024, 0044, 0149, 0173, 0247].
Regarding instant claim(s) 19, WO101 further teaches the CAR T cell composition comprises CD8+ T cells [e.g., ¶ 0006-0010, 0012, 0021, 0031-0035, 0046-0049, 0093-0094, 0114-0119, 0268].
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) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/223101 A1 (hereinafter “WO101”) as applied to claim 1 above, and further in view of US 2019/0062448 A1 (hereinafter “US448”).
The teachings of WO101 as recited above apply for 1.
WO101 does not expressly teach that the CD39 antibody comprises HCDR1-3 of SEQ ID NOs: 2, 25, and 46, respectively, and LCDR1-3 of SEQ ID NOs: 76, 93, and 111, respectively.
Regarding claim 20, US448 teaches anti-CD39 antibodies and therapeutic uses thereof, including activation, clonal expansion and homing of tumor specific T cells [e.g., title, abstract;¶ 0008]. US448 further teaches the CD39 comprising a VH of SEQ ID NO:180 and VL of SEQ ID NO: 220 [e.g., ¶ 0184], which have the same HCDR1-3 (instant SEQ ID NOs: 2, 25, 46) and LCDR1-3 (instant SEQ ID NOs: 76, 93, 111), see alignment below.
Alignment of HCDR1-3 (instant SEQ ID NOs: 2, 25, 46) with US448 VH of SEQ ID NO: 180:
PNG
media_image1.png
208
561
media_image1.png
Greyscale
Alignment of LCDR1-3 (instant SEQ ID NOs: 76, 93, 111)with US448 VL of SEQ ID NO: 220:
PNG
media_image2.png
215
579
media_image2.png
Greyscale
It would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to substitute the general CD39 antibody of the therapeutic composition comprising an anti-CD39 antibody and an adoptive cell therapy as taught by WO101, with the specific anti-CD39 VH (SEQ ID NO: 180) and VL (SEQ ID NO: 220) taught by US448, in the context of designing and developing a therapeutic composition for treating cancer. A PHOSITA would have been motivated to substitute the general CD39 antibody of the therapeutic composition comprising an anti-CD39 antibody and an adoptive cell therapy as taught by WO101, with the specific anti-CD39 VH (SEQ ID NO: 180) and VL (SEQ ID NO: 220) taught by US448, because WO101 teaches the basic composition comprising an anti-CD39 antibody and US448 further teaches the antigen binding sequence of the CD39 antibody and that anti-CD39 antibody administration results in activation, clonal expansion and homing of tumor specific T cells (which is beneficial for cancer therapy). There would have been a reasonable expectation of success for a PHOSITA to substitute the substitute the general CD39 antibody of the therapeutic composition comprising an anti-CD39 antibody and an adoptive cell therapy as taught by WO101, with the specific anti-CD39 VH (SEQ ID NO: 180) and VL (SEQ ID NO: 220) taught by US448, because WO101 teaches the basic composition comprising an anti-CD39 antibody and US448 further teaches the antigen binding sequence of the CD39 antibody. This rationale aligns with the principle of simple substitution of one known element for another to obtain predictable results, supporting a conclusion of obviousness (see MPEP § 2141).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M CHATTIN whose telephone number is (571)270-0646. The examiner can normally be reached T-F 0600-1600 PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMY M. CHATTIN/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643