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 .
Response to Amendment
The response filed June 8, 2026 in response to the Non-final rejection of March 9, 2026 is acknowledged and has been entered.
Claims 1-21 are currently pending. Claims 1-2, 5, 9-10, and 15-21 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 3-4, 6-8, and 11-14 are currently pending and under consideration.
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 Objections
The objection to Claim 3 in the action mailed 03-09-2026 is withdrawn in view of applicant’s amendment.
Rejections Maintained
Claim(s) 3-4, 6-8, and 11-14 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2016090034 (Brogdon et al., published 06/09/2016, Applicant’s IDS) for the reasons of record and for the reasons set forth below.
Applicant’s remarks are directed to the allegation that independent Claim 3 is not anticipated by Brogdon et al. Applicants initially summarize the teachings of Brogdon et al. and argue that Brogdon’s methodology comprises administering a B cell preconditioning agent comprising a CAR molecule that binds a B cell and a cell comprising a CAR molecule that targets a tumor antigen and as such Brogdon does not teach or suggest each of the steps and reagents recited in Claim 3. More specifically, applicants argue (Remarks, page 6) that Brogdon does not teach or suggest “a polyspecific binding molecule PBM, wherein the PBM comprises a least a first binding domain binding a T cell and at least a second binding domain binding a antigen of a white blood cell”.
These arguments have been considered but are not found persuasive as the teachings of Brogdon were clearly set forth and compared to each of the rejected claims in paragraphs 6-12 of the action mailed 03/09/2024. Further, where there were differences between the claim language and the prior art, the examiner set forth how the claims were being interpreted. For example, regarding the term “polyspecific binding molecule” or PBM, the examiner stated (page 4, line 1) that Brogdon taught (Claim 1 or Claim 4, and page 163, line 16) obtaining a “B-cell preconditioning agent” that can be an antibody molecule or a cell-based immunotherapy, including bispecific antibodies such as blinatumomab which binds to CD3 and CD19. The non-final action further pointed out that the currently examined application taught (page 52) that blinatumomab can be a PBM. To be more specific, the current specification states:
161. The method, use, of pharmaceutical composition of any suitable preceding embodiments, wherein the PBM (e.g., polyspecific antibody) is a bispecific antibody or BITE® comprising an scFv binding CD3 and an scFv binding CD19, examples of the bispecific antibody or BITE® include Blinatumomab. Additional information regarding Blinatumomab and other BiTEs can be found at Topp et al., Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL. Blood 2012; 120 (26): 5185-5187, which is incorporated herein by its reference.
Moving on to the arguments on page 7, applicants argue that Claim 3 recites "contacting the modified cells with a population of cells comprising an antigen of white blood cells (WBCs) and the PBM." Applicants argue that the PBM provides a bridge connecting the modified cells and the WBCs, enabling the WBCs to drive expansion and/or activation of the modified cells. In contrast, Brogdon's blinatumomab recruits polyclonal T cells to kill CD19+ B cells, thereby depleting the B cells. Thus, in the method of Brogdon, the B cells are destroyed, while in the claimed method the WBCs are stimulatory partners that drive expansion and activation of the modified cells. This argument has been considered but is not found persuasive because even if the prior art’s method taught a decrease in the level of B cells, the claimed method as a whole allows for any type of white blood cell antigen or any antigen common to white blood cells to be contacted, not just antigens of B cells. The fact of the matter is that each step of Claim 3 is anticipated by Brogdon et al. and claim 3 does not require any measurement or testing of the type of cells that are expanded or activated due to some degree of modification as stated in the preamble of Claim 3. And while applicants argue that the examiner only alleged that the immune system would inherently comprise cells comprising antigens of WBCs, the Office has not shown that the PBM would come into contact with a sufficient population of cells comprising an antigen of WBCs to enable expansion or activation of the modified cells. This argument has been considered but is not found persuasive for the reasons of record. Further, products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
Claims 3-4, 6-8, and 11-14 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, and 5-22 of copending Application No. 16999357 (reference application) for the reasons of record. Applicants merely allege that the claimed method of the ‘357 application requires different reagents for performing different steps for the expansion of different cells. However, applicants do not point to any specific differences and/or patentable distinction between the current claims and the reference application. Thus, Applicant’s arguments have been considered but have not been found persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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.
/GARY B NICKOL/Primary Examiner, Art Unit 1643
Prosecution Insights