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
2. The election without traverse filed 08/04/2026 in response to the Office Action of 06/29/2026 is acknowledged and has been entered.
Applicant has elected Group I, claims 1-14 and 28, drawn to a tumor-infiltrating lymphocyte (TIL) engineered to express a membrane- bound interleukin 15 (mbIL15).
3. Claims 1-37 are pending in the application. Claims 15-27 and 29-37 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/04/2026.
Claims 1-14 and 28 are currently under prosecution.
Priority
Applicant’s claim under 35 U.S.C. §§ 119(e) and 365(c) for benefit of the earlier filing date of applications, is acknowledged.
Claim Objections
6. Claim 13 is objected to because of the following informalities:
Claim 13: “any one of claims 9” should be “claim 9”.
Appropriate correction is required.
7. 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.
Claim Rejections - 35 USC § 103
8. 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 of this title, 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.
9. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
10. Claims 1-14 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Hsu et al. (JOURNAL OF SURGICAL RESEARCH, vol. 184, no. 1, 2013, pages 282-289, IDS) in view of Suri et al. (BLOOD, AMERICAN SOCIETY OF HEMATOLOGY, vol. 132, 29 November 2018, page 2045, IDS).
Claims 1-14 and 28 are herein drawn to a tumor-infiltrating lymphocyte (TIL) engineered to express a membrane bound interleukin 15 (mbIL15).
Hsu et al. teach tumor-infiltrating lymphocytes (TILs) were engineered to express
interleukin-15; see entire document, e.g., title, abstract, p. 284-left-hand column-paragraph 4-section 2.5.
Hsu et al. teach that the TIL can expand in the absence of exogenous cytokine IL-2 (instant claims 3-4); see abstract.
Hsu et al. teach that tumor-reactive CD8+ T cells derived from IL-15 transgenic mice treated tumors better than tumor reactive CD8+ T cells that did not secrete IL-15; see page 287-right col.-second paragraph. Hsu et al. teach expansion of TIL-IL-15 cells; see bridging paragraph of left and right col. on page 286.
Hsu et al. teach the potential toxicities of administration of IL-15-transduced
TIL cells; see page 283-left col.-third paragraph.
Hsu et al. do not teach IL-15 is a membrane bound interleukin 15 (mbIL15).
However, this deficiency is remedied by Suri et al.
Suri et al. teach CD19 chimeric antigen receptor (CAR) T cells engineered to express membrane-bound IL 15 (mbIL15) and advantages of mbIL15 engineered T cells, e.g., less cytotoxic effects, and fused mbIL15 to a drug; see entire document, e.g., page 2.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references so as to generate membrane bound IL-15-transduced TIL cells. Given the teachings of Hsu et al., the potential toxicities of administration of IL-15-transduced
TIL cells; thus, a person skilled in the art would have taken into consideration the teachings from Suri et al., the benefits of the expression of mblL15 to lower cytotoxic effects to arrive the instant claimed invention.
Double Patenting
11. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
12. Claims 1-14 and 28 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,058,725. Although the conflicting claims are not identical, they are not patentably distinct from each other because for the following reasons:
Claims 1-14 and 28 are herein drawn to a tumor-infiltrating lymphocyte (TIL) engineered to express a membrane bound interleukin 15 (mbIL15).
Claims 1-21 of U.S. Patent No. 11,058,725 are drawn to a method comprises transducing TIL with a vector comprising membrane-bound IL15 (mbIL15).
In Pfizer, Inc., v. Teva Pharamaceutical USA, inc. (Fed. Cir, 2008), the Court concluded that the safe harbor of section 121 is limited to divisional applications only. The instant application is not filed as a result of a restriction requirement of U.S. Patent No. 11,058,725. The engineered TIL claimed in the claims of the patent is the same as the instantly claimed engineered TIL.
13. Claims 1-14 and 28 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of copending Application No. 18501621. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-14 and 28 are herein drawn to a tumor-infiltrating lymphocyte (TIL) engineered to express a membrane bound interleukin 15 (mbIL15).
Claims 1-16 of copending Application No. 18501621 are drawn to a method comprises tumor infiltrating lymphocytes (TILs) engineered to express a membrane-bound interleukin 15 (mbIL15).
In Pfizer, Inc., v. Teva Pharamaceutical USA, inc. (Fed. Cir, 2008), the Court concluded that the safe harbor of section 121 is limited to divisional applications only. The instant application is not filed as a result of a restriction requirement of copending Application No. 18501621. The engineered TIL claimed in the claims of the copending Application No. 18501621 is the same as the instantly claimed engineered TIL.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
14. No claim is allowed.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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