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 .
The preliminary amendments of 10/07/2024 have been entered in full. Claims 43-45, 72, 96, and 99-113 are pending.
Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 43-45, 72, 96, 108-110, 112, and 113 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 13, 21, 52, 99 and 118-120 of copending Application No. 17830218 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Pending claims 43 and 44 are drawn to a process that includes contacting immune cells with a gene editing tool which comprises any one of several recited guide RNAs. The method of pending claim 44 is the same method as claim 43, differing only by reciting a different intended outcome in the preamble. The outcomes recited in pending claim 45 are inherent to the method. Pending claim 72 is a product-by-process claim wherein the process is the same as in claims 43 and 44.
The copending claims are product-by-process claims, wherein the process includes contacting immune cells with a gene editing tool which comprises a guide RNA which comprises any one of the sequences recited in pending claims 43, 44, 72, and 108-110. The processes recited in the copending claims would anticipate the process recited in pending claims 43 and 44 and in the product-by-process claim 72 and claims dependent therefrom, because they are species of the same process which further comprise additional modifications to the immune cells. drawn to populations of immune cells. Likewise, the compositions of copending claims are species of compositions of the pending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 72, 96, 99-104, 106-108, and 111 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 72 recites “immune cells that express a binding molecule”. As all immune cells inherently express at least one molecule that binds something, the metes and bounds of this limitation are unclear. Claims 96, 99-103, 106-108, and 111 are unclear as they depend from claim 72.
Claim 104 is unclear as it recites “R12, R11, 2A2”. These terms are not meaningful to persons of skill in the art. Their definitions should be made clear by reciting amino acid sequences.
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 72 and 96 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190284553 (Benson; of record).
Claim 72 is a product-by-process claim in which the product is a population of immune cells that exhibit an expression level of a Nuclear Receptor Subfamily 4 Group A Member 3 (NR4A3 gene) and/or NR4A3 protein that is reduced as compared to a reference population of immune cells. The courts have established that if a claimed product in a 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 art product was made by a different process. In re Thorpe., 227 USPQ 964, 966 (Fed. Cir. 1985): In re Marosi, 218 USPQ 289, 292-293 (Fed. Cir. 1983).
Benson teaches compositions comprising immune cells with reduced expression of NR4A3 (claim 303) produced by contacting cells with a guide RNA ([0028] claim 320). Although the disclosed guide RNAs differ from those recited in the instant claims, the cells produced by the Benson method are functionally and phenotypically identical to those of the instant claims, based on the evidence of record.
Conclusion
Claims 43-45, 72, 96, 99-104 and 106-113 are rejected.
Claim 105 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL C GAMETT, Ph.D., whose telephone number is (571)272-1853. The examiner can normally be reached on M-W. Please note the examiner’s part-time schedule. 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, Joanne Hama can be reached on 5712722911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL C GAMETT/Primary Examiner
Art Unit 1647
Prosecution Insights