DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . References not included with this Office action can be found in a prior action.
Election/Restrictions
Applicant’s election without traverse of Group I, presently claims 1-3, 5, 7, 10, and 57, in the reply filed on 3/11/2026 is acknowledged.
Claims 9, 16, 17, 19, 21-25, 27, 28, 31, 33-35, 40, 42-47, 49, 52, and 55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.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 3/11/2026
Applicant’s species election in the reply filed on 9/16/2025, and based on the election requirement dated 3/17/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the election requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
It is noted that none of the elected species appear to read on the elected invention of Group I.
Claims 1-3, 5, 7, 10, and 57 are under consideration on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5, 7, 10, and 57 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites a “first antigen-specific T cell line”, which blurs the metes and bounds of the claim because there is no recitation of any second or subsequent antigen-specific T cell line. In other words, the claim implies but does not recite any other antigen-specific T cell line so it is unclear if any second or subsequent antigen-specific T cell is or is not required by the claim. Clarification and/or correction is required.
The term “about” in claim 10 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. [0042] of the specification has been fully considered, but does not clearly set forth a special definition because this portion of the specification recites exemplary conditions as well as “any other value or range of values” and so does not clearly redefine “about” such as to limit the scope of the claim. Correction is required.
In so much that claims 2, 3, 5, 7, 10, and 57 depend from claim 1 and do not resolve the point of confusion, these claims must be rejected with claim 1 as indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 1-3 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haque et al. (The Lancet (2002), 360, 436-442; of record).
Haque teaches a method of prophylactically administering EBV-specific polyclonal and allogeneic cytotoxic T-cells to subjects to control EBV infection in subjects suffering from post-transplantation lymphoproliferative disease (PTLD), wherein the T-cells match at least two HLA alleles in the subjects (e.g. HLA-matching) (“Patients and Methods” on p437-438), anticipating claims 1 and 2. Haque teaches that PTLD is often associated with primary EBV infection or EBV reactivation as caused by the high cumulative dose of immunosuppressive drugs take by the (transplantation) subjects to prevent graft rejection (page 436, the 2nd paragraph of the Introduction), anticipating the embodiment of post-transplantation subjects being at a higher risk of EBV infection and EBV infection posing a greater risk to the subject’s health or life for claim 3. Hague teaches administering the polyclonal and allogeneic cytotoxic T-cells once every two weeks until the tumors caused by PTLD went into remission or were enlarging indication no response by the subject(s) to the cellular therapy (page 438, subheading “CTL infusions and monitoring of patients”), anticipating the embodiment of multiple cell dosages for claim 10.
Claims 1-3, 5, 7, 10, and 57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heslop et al. (Blood (2010), 115(5), 925-935; Reference U).
Helsop teaches a method of prophylactically administering EBV-specific polyclonal and allogeneic cytotoxic T-cells to subjects to control EBV infection in subjects suffering from EBV+ lymphoproliferative disease (LPD or EBV-LPD) after receiving hematopoietic stem cell transplantation (HSCT), wherein the T-cells match at least two HLA alleles in the subjects (e.g. HLA-matching) (Methods of pages 926-927; Table 2, “unrelated donor” for allogeneic sources, for matching at least HLA alleles), anticipating claims 1 and 2. Helsop teaches that Epstein-Barr virus–positive lymphoproliferative disease (EBV-LPD) arises in the immunocompromised host after hematopoietic stem cell or solid organ transplantation and can cause lymphomas in the subjects (the first paragraph of the Introduction on page 925), anticipating the embodiment of post-transplantation subjects being at a higher risk of EBV infection and EBV infection posing a greater risk to the subject’s health or life for claim 3. Helsop teaches that prophylactic (T cell) infusion reduces the EBV load in subjects who showed elevated levels of detectable EBV DNA but who otherwise did not display any symptoms of EBV-LPD prior to (T cell) infusion (page 928, paragraph starting “Elevated EBV-DNA levels are highly…”), anticipating claim 5. Helsop teaches the subjects as being T-cell depleted (page 926, the paragraph starting “Between 1993 and 2005…”), anticipating claim 7. Helsop teaches administering multiple doses of the polyclonal and allogeneic cytotoxic T-cells to the subjects (page 926, the paragraph starting “Of the 114 subjects enrolled…”), anticipating claim 10. Helsop teaches that the polyclonal and allogeneic cytotoxic T-cells are genetically labelled/marked with the retroviral vector GINa to track the infused T cells and that these labeled and infused T cells persist in the treated subjects for up to 105 months (page 929, the paragraph starting “The first 26 patients..”, Table 1 patient UPN 221, and Figure 4), anticipating claim 57.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
