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. Claims 87-97 are pending and currently under prosecution.
Priority
3. Applicant’s claim under 35 U.S.C. §§ 120 and 365(c) for benefit of the earlier filing date of application, is acknowledged.
4. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file of 15/733,076.
5. 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 § 102
6. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claims 87-97 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN105153315A (published on 12/16/2015, IDS, hereafter ‘315 patent) evidenced by machine-translation of CN105153315A.
Claims 87-97 are herein drawn to a method of expanding a T cell population, comprising: (a) introducing a nucleic acid encoding a chimeric antigen receptor (CAR) into the T cell population, thereby producing a first CAR-expressing cell population, wherein the CAR comprises (i) an antigen interacting domain capable of binding a B cell surface protein; (ii) a transmembrane domain; and (iii) an intracellular signaling domain; and (b) contacting the first CAR-expressing cell population with a B cell surface protein, thereby producing an expanded and/or activated immune cell population, wherein said B cell surface protein is CD19, CD20, or CD22.
‘315 patent teaches genetically modifying immune cells to express first-CAR, wherein the first-CAR binds an antigen (e.g., CD19, CD20 or CD22), the first CAR comprising transmembrane region and intracellular domain, wherein the intracellular domain comprising CD3ζ, wherein the immune cells are T cells; see entire document, e.g., claims 1-10, [0004-0013] and [0025] of machine-translation of CN105153315A.
For claims 89 and 93, ‘315 patent teaches that the intracellular activation signal is transmitted by the ITAM (immunoreceptortyrosine-based activation motifs) signal chain of CD3ζ; see [0005], [0031] of machine-translation of CN105153315A.
For claims 94-96, ‘315 patent teaches wherein the CAR comprising a co-stimulatory domain (e.g., CD28); see [0013], [0032] of machine-translation of CN105153315A.
For claims 90 and 97, a wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited, MPEP 2111.04.
Although the ‘315 patent does not expressly state the CAR-CD19, CAR-CD20 or CAR-CD22 binds to B cell surface protein, given that CD19, CD20 and CD22 are B cell surface proteins; it is inherent that CARs of the ‘315 patent would bind to B cell surface proteins.
8. Claims 87-97 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mueller et al. (WO 2017210617, filed on June 2, 2017).
Claims 87-97 are herein drawn to a method of expanding a T cell population, comprising: (a) introducing a nucleic acid encoding a chimeric antigen receptor (CAR) into the T cell population, thereby producing a first CAR-expressing cell population, wherein the CAR comprises (i) an antigen interacting domain capable of binding a B cell surface protein; (ii) a transmembrane domain; and (iii) an intracellular signaling domain; and (b) contacting the first CAR-expressing cell population with a B cell surface protein, thereby producing an expanded and/or activated immune cell population, wherein said B cell surface protein is CD19, CD20, or CD22.
Mueller et al. teach a method of making immune cells (e.g., T cells) expressing CAR-anti-CD19 antibody, comprises introducing a nucleic acid encoding the CAR, wherein the CAR comprising an anti-CD19 antibody, a transmembrane domain, and an intracellular signaling domain and costimulatory domain; see entire document, e.g., abstract, pages 2, 29-31 and 45. Mueller et al. teach that the method further comprises expanding and/or activating the immune cells by contacting said CAR-expressing cell with a CAR ligand, wherein the CAR ligand is a CAR antigen molecule which is CD19; see pages 277-278.
For claims 89 and 91-93, Mueller et al. teach the intracellular signaling domain (e.g., CD3 zeta) comprises an immunoreceptor tyrosine-based activation motif (ITAM); see page 78.
For claims 94-96, Mueller et al. teach that the costimulatory domain is a functional signaling domain obtained from a protein selected from the group consisting of MHC class I molecule, TNF receptor proteins, Immunoglobulin-like proteins, cytokine receptors, integrins, signaling lymphocytic activation molecules (SLAM proteins), activating NK cell receptors, or Toll ligand receptor; e.g., OX40, CD2, CD7, CD27, CD28, CD30, CD40, CDS, ICAM-1, LFA-1 (CD11a/CD18), 4-lBB (CD137), B7-H3; see pages 44-45.
For claims 90 and 97, a wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited, MPEP 2111.04.
Double Patenting
9. 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.
10. Claims 87-97 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,866,731. Although the conflicting claims are not identical, they are not patentably distinct from each other because for the following reasons:
Claims 87-97 are herein drawn to a method of expanding a T cell population, comprising: (a) introducing a nucleic acid encoding a chimeric antigen receptor (CAR) into the T cell population, thereby producing a first CAR-expressing cell population, wherein the CAR comprises (i) an antigen interacting domain capable of binding a B cell surface protein; (ii) a transmembrane domain; and (iii) an intracellular signaling domain; and (b) contacting the first CAR-expressing cell population with a B cell surface protein, thereby producing an expanded and/or activated immune cell population, wherein said B cell surface protein is CD19, CD20, or CD22.
Claims 1-14 of U.S. Patent No. 11,866,731 are drawn to a modified immune cell expresses a chimeric antigen receptor (CAR) comprising (i) an antigen interacting domain capable of binding a B cell surface protein; (ii) a transmembrane domain; and (iii) an intracellular signaling domain, wherein said B cell surface protein is selected from CD19, CD20, and CD22.
U.S. Patent No. 11,866,731 teaches a method of expanding a T cell population, comprising: (a) introducing a nucleic acid encoding a chimeric antigen receptor (CAR) into the T cell population, thereby producing a first CAR-expressing cell population, wherein the CAR comprises (i) an antigen interacting domain capable of binding a B cell surface protein; (ii) a transmembrane domain; and (iii) an intracellular signaling domain; and (b) contacting the first CAR-expressing cell population with a B cell surface protein, thereby producing an expanded and/or activated immune cell population. See col. 8-lines 47-57.
It is noted that 35 USC § 121 does not provide protection for continuation or continuation in-part applications, and this application is a continuation of U.S. Patent No. 11,866,731. See 92 USPQ2d 1289 Amgen Inc. v. F. Hoffmann-La Roche Ltd. (Fed. Cir. 2009) and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. 518 F.3d 1353 (Fed. Cir. 2008).
11. Claims 87-97 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 34-42 and 45-59 of copending Application No. 17/429835. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
Claims 87-97 are herein drawn to a method of expanding a T cell population, comprising: (a) introducing a nucleic acid encoding a chimeric antigen receptor (CAR) into the T cell population, thereby producing a first CAR-expressing cell population, wherein the CAR comprises (i) an antigen interacting domain capable of binding a B cell surface protein; (ii) a transmembrane domain; and (iii) an intracellular signaling domain; and (b) contacting the first CAR-expressing cell population with a B cell surface protein, thereby producing an expanded and/or activated immune cell population, wherein said B cell surface protein is CD19, CD20, or CD22.
Claims 34-42 and 45-59 of copending Application No. 17/429835 are drawn to a method comprising a modified therapeutic immune cell (e.g. T cell), wherein the immune cell expresses CAR-CD19, wherein the CAR comprises CD3ζ, and a co- stimulatory molecule (e.g., CD28).
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
12. No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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, Samira Jean-Louis can be reached on 571-270-3503. 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.
/YAN XIAO/Primary Examiner, Art Unit 1642
Prosecution Insights