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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114.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 November 26, 2025 has been entered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 3, 10, 13, 16 – 17, 19, 21 – 22, 29, and 32 - 34 are currently pending in the instant application. Claims 3, 32, 33, and 34 have been amended in the response filed November 26, 2025. Claims 4, 30, 31, and 35 have been canceled in the response filed November 26, 2026. (Claims 1-2, 5 – 9, 11 – 12, 14 – 15, 18, 20, and 23 – 27 were previously canceled.).
The terminal disclaimer filed on November 26, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of the full statutory term of U.S. Patent Application No. 17/753,875 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on November 26, 2025 has been considered. An initialed copy of the IDS accompanies this Office Action.
Priority
The present application filed March 16, 2022, is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2020/027456, filed April 9, 2020, which is a CON of 16/388,776, filed April 18, 2019, now US Patent 10,772,914.
Therefore, the earliest possible priority for the instant application is April 18, 2019.
Withdrawn Objections/Rejections
Nonstatutory Double Patenting
The rejection of claims 3, 4, 10, 13, 16 – 17, 19, 21 – 22, 29, and 30 – 35 is withdrawn on the grounds of nonstatutory double patenting of the claim in United States Patent No. 10772914 B1. Although the claims are not identical, they are not patentably distinct from each other because claims Claims 3, 4, 10, 13, 16 – 17, 19, 21 – 22, 29, and 30 – 35 are anticipated by claims 1 – 13 of US 10,772,914 B1.
The terminal disclaimer filed November 26, 2025 has been accepted.
In view of the terminal disclaimer, the rejection is withdrawn, and thus, applicant’s arguments are moot.
Claim Rejection - 35 USC § 112(a) Scope of Enablement
The rejection of claims 3, 4, 10, 13, 16 – 17, 19, 21 – 22, 29, and 30 – 35 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn.
Applicant has amended the claim to overcome the 35 USC § 112(a) Scope of Enablement rejection.
In view of the withdrawn rejection, Applicant’s arguments are moot.
Maintained Objections/Rejections
Claim Rejection - 35 USC § 112(b)
The rejection of claim 34 is maintained, and claim 33 is newly 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 33 and 34 are indefinite as being dependent on canceled claim 4.
MPEP § 608.01(n) Dependent Claims [R-10.2019] Subsection V. “If the base claim has been canceled, a claim which is directly or indirectly dependent thereon should be rejected as incomplete. If the base claim is rejected, the dependent claim should be objected to rather than rejected, if it is otherwise allowable.”
New Objections/Rejections
Claim Rejections - 35 USC § 102
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.
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.
Claims 10, 13, 16 – 17, 19, 21, and 22 are rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated by Sentman et al. (hereinafter referred to as “Sentman”) (US 20180085400 A1, published March 29, 2018).
Regarding claims 10, Sentman teaches immune cells engineered to express a CAR (instant claim 19).
Regarding claim 13, Sentman teaches a pharmaceutical composition comprising immune cells which expresses a CAR and a pharmaceutically acceptable carrier (claim 39).
Regarding claim 16 and 22, Sentman teaches a method of treating a disease comprising administering to a subject in need of treatment immune cells, thereby treating a disease (claim 53).
Regarding claims 17, 19, and 22, Sentman teaches that the method is used to treat cancer, wherein the cancer is Hodgkin’s lymphoma (claim 58 and 59).
Sentman also teaches that there was IFN-γ secretion in the T cell and tumor co-cultures (Paragraph [0136]).
Examiner comments:
Claim 10 of the instantly filed application is a product by process claim, and claims 13, 16 – 17, 19, and 21 – 22 are dependent on claim 10.
The applicant is reminded that
“Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps” (MPEP 2113).
[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." (MPEP 2113).
The as-Filed Specification teaches:
Populations of immune cells generated/expanded in accordance to the methods 0204] a) comprises cells which produce IFNγ in response to stimulation with peptide(s) corresponding to one or more EBV lytic antigens; [0205] b) comprises cells which produce IFNγ in response to stimulation with peptide(s) corresponding to one or more EBV lytic antigens, and comprises cells which produce IFNγ in response to stimulation with peptide(s) corresponding to one or more EBV latent antigens; [0206] c) comprises cells which produce IFNγ in response to stimulation with EBV-infected cells; [0207] d) cytolytic activity against autologous EBV-infected cells; [0208] e) anticancer activity against EBV-positive cancer in vivo; [0209] f) inhibition of growth of an EBV-positive tumor in vivo; and [0210] g) reduction of metastasis of EBV-positive cancer in vivo (Paragraph [0203]).
Even though the immune cells taught by Sentman are made using a different process as compared to the process taught by claim 1 of the instant invention, the structure of these cells still read on the instant inventions. As noted supra, these cells secrete IFN-γ (reading on the property taught in Paragraph [0204] of the as-Filed Specification), and treat Hodkins’ lymphoma, an EBV-positive cancer (reading on the property taught in Paragraph [0208] of the as-Filed Specification). Thus, the rejection is appropriate.
Conclusion
Claims 10, 13, 16 – 17, 19, 21, 22, 33, and 34 remain rejected.
Claims 3, 29, and 32 are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYOMA SHAILESH THAKKER whose telephone number is (571)272-2954. The examiner can normally be reached M-F 8:30 - 5:30 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, Maria Leavitt can be reached on (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VYOMA SHUBHAM TIWARI/ Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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