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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/09/2025 has been entered.
Applicant’s election without traverse of Group I, a composition of CD106+ cells in the reply filed on 11/15/2024 is acknowledged.
Claims 13-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim.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 11/15/2024.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. JP2019-128517, filed on 07/10/2019.
Information Disclosure Statement
The IDS filed 01/07/2022 has been considered by the Examiner.
Status of Claims
Claims 1, 5, 10, 12, and 29 are under examination.
Claims 2-4, 6-9, 11, and 13-28 are cancelled.
Claim Objections
The objection to claim 6 under 37 CFR 1.75 as being a substantial duplicate of claim 1 has been withdrawn in view of the applicant canceling the claim in the amendments filed 12/09/2025.
Claim Rejections - 35 USC § 112
Rejections to claims 1, 3, 4, 6, 8, and 9 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of applicants amendments on 05/27/2025.
Rejection to claim 11 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph is withdrawn in view of the applicant’s amendments filed on 05/27/2025.
Rejection to claim 2 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends has been withdrawn in view of the applicant canceling the claim in the amendments filed on 12/09/2025.
Claim Rejections - 35 USC § 101
Rejections to claims 1-12 under 35 U.S.C. 101 have been withdrawn in view of applicant’s amendments filed on 05/27/2025
Rejections to claims 1-2, 4-7, 9-10, and 12 35 U.S.C. 101 because the claimed method is directed to natural product without significantly more has been withdrawn in view of the applicants amendments filed 12/09/2025.
Claim Rejections - 35 USC § 102
Rejections to claims 1-9 under 35 U.S.C. 102(a)(2) as being anticipated by Wardell (WO/2018/182817) have been withdrawn in view of applicant’s amendments.
Rejections to claims 6, 8, and 10-12 under 35 U.S.C. 102(a)(2) as being anticipated by Crooks (WO2017075389) have been withdrawn in view of applicant’s amendments.
Rejections to claims 2, 4, 6-7, and 9 under 35 U.S.C. 102(a)(2) as being anticipated by Wardell (WO/2018/182817) have been withdrawn in view of applicant canceling the claims.
Rejection to claims 1, 5, 10, 12, and 29 under 35 U.S.C. 102(a)(2) as being anticipated by Wardell (WO/2018/182817) have been withdrawn in view of the applicant’s amendments.
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.
Claims 1, 5, 10, 12, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Wardell (WO/2018/182817) as evidenced by Oved et al. (EP-2203746-B1).
Regarding claim 1, Wardell recites a population of cells for treating cancer comprising a population of TILS from a tumor of a subject’s tumor sample (page 128, claims 99 and 100). Wardell does not teach that the isolated cells are CD106+, however the specification of the instant application teaches that tumor infiltrating lymphocytes are CD106+ (specification, page 1 paragraph 0003). Wardell notes that in some embodiments the tumor infiltrating lymphocytes (TILs) include a population of T cells (page 3, paragraph 0041). Wardell isolates tumor infiltrating lymphocytes from a patient’s tumor tissue. The instant application also isolates cells from a patient’s tumor, therefore CD106+ cells would be included within the isolated population of TILs of Wardell (page 128, claim 99).Wardell teaches regulatory markers of the TILs are selected from the group consisting of CD137 (4-1BB), CD8a, Lag3, CD4, CD3, PD-1, TIM-3, CD69, CD8a, TIGIT, CD4, CD3, KLRG1, and CD154 which read on the cell markers of the present application (page 28, paragraph 00389). Wardell further teaches they were able to isolate CD8+CD137+(4-1BB) (page 110, table 47), CD8+CD154+ (page 109, Table 45), CD8+PD1+ (page 111, Table 53), and CD8+ TIM3+ cells (page 111, Table 53). While Wardell does not teach the surface marker CD106 it is obvious the TIL population isolated would include CD106+ cells as evidenced by Oved et al. Oved et al. teach methods to determine the responsiveness of tumor isolated lymphocytes for adoptive cell transfer therapies. Oved et al. teach the methods include separating subpopulations of tumor infiltrating lymphocytes based on their cell surface expression. Oved et al. teach the expression markers include CD4 or CD8, a cytokine or chemokine, and an adhesion molecule (page 4, paragraph 0022) which can be CD106 (page 11, table 2, line 35). Oved et al. further makes obvious that the TIL population of Wardell includes cells with CD106 positivity. Wardell further teaches the use of pharmaceutically acceptable carriers or pharmaceutically acceptable excipients are well known in the art (page 16, paragraph 00281). Wardell teaches T cells administered in combination with one or more immune checkpoint regulators (page 42, paragraph 00532).
Regarding claim 5, Wardell teaches the TILs of the composition are genetically engineered with high affinity T cell receptors. The high affinity T cell receptor (TCR) are targeted at a tumor-associated antigen that could be MAGE-1, HER2, or NY-ESO-1 (page 27, paragraph 00385).
Regarding claim 10, Wardell teaches isolation and expansion of T cells from a patient which are further administered in a therapeutically effective dosage to the patient, without manipulation of the T cell receptor they have an endogenous TCR (pages 29-30, J. Metabolic Health of Expanded TILs).
Regarding claim 12, Wardell teaches the cells comprise T cells (page 3, paragraph 0041).
Regarding claim 29, Wardell teaches T cells administered in combination with one or more immune checkpoint regulators which can be a PD-1 inhibitor or PD-L1 inhibitor (page 42, paragraph 00532).
Response to Arguments
Applicant's arguments filed 12/09/2025 have been fully considered but they are not
persuasive.
Applicant’s Arguments: Applicant argues there is nothing in Wardell that suggest CD106+ TILs are obtained. In fact, the claims of Wardell teach CD27, CD28, and CD57 positive TILs are obtained and expanded. Thus, the isolation of CD106+ cells does not necessarily flow from the teachings of Wardell. Accordingly, the methods of Wardell look to isolate and expand a different cell population than the cell population recited in Applicant's claims.
Examiner’s Response: Wardell teaches an embodiment that includes an increased subpopulation which are T cells (page 3, paragraph 0041). While Wardell does not teach the surface marker CD106, it is obvious the TIL population isolated would include CD106+ cells. Oved et al. teach the expression markers of isolated TILs include CD4 or CD8, a cytokine or chemokine, and an adhesion molecule (page 4, paragraph 0022) which can be CD106 (page 11, table 2, line 35). Oved et al. further makes obvious that the TIL population of Wardell includes cells with CD106 positivity. The specification of the instant application teaches that tumor infiltrating lymphocytes are CD106+ (specification, page 1 paragraph 0003) and further the cells isolated from the tumor environment regardless of stimulation are CD106+ (specification, page 7, paragraphs 0007-0008) which would further support that T cells isolated from tumor include cells with CD106 positivity. For Wardell to serve as prior art they must teach a composition which includes the cells claimed in the present application and the tumor isolated T cells of Wardell would include CD106+ cells. At present the T cells of the instant invention cannot be differentiated from the T cells of Wardell.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Catherine L McCormick whose telephone number is (703)756-5659. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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, Tracy Vivlemore can be reached at (571) 272-2914. 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.
/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635
Prosecution Insights