Prosecution Insights
Last updated: April 19, 2026
Application No. 18/552,727

CHIMERIC ANTIGEN RECEPTORS TO TARGET CD5-POSITIVE CANCERS

Non-Final OA §102§112§DP
Filed
Sep 27, 2023
Examiner
BELYAVSKYI, MICHAIL A
Art Unit
1644
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
BOARD OF REGENTS OF THE UNIVERSITY OF TEXAS SYSTEM
OA Round
1 (Non-Final)
64%
Grant Probability
Moderate
1-2
OA Rounds
3y 1m
To Grant
91%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allow Rate
697 granted / 1091 resolved
+3.9% vs TC avg
Strong +27% interview lift
Without
With
+27.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
77 currently pending
Career history
1168
Total Applications
across all art units

Statute-Specific Performance

§101
2.3%
-37.7% vs TC avg
§103
29.0%
-11.0% vs TC avg
§102
9.7%
-30.3% vs TC avg
§112
10.9%
-29.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1091 resolved cases

Office Action

§102 §112 §DP
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 1. Claims 1,2, 9, 19-21,25,28,33, 34 , 36,39,43,45,48,50-53,55,56,62,65,,69,70,84 and 85 are pending. 2. Applicant’s election without traverse of Group I, claims 1,2, 9, 19-21,25,28,33,34 , 36, during the phone interview on 02/26/26 is acknowledged. 3. Claims 39 ,43,45,48,50-53,55,56,62,65,,69,70,84 and 85 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions . Claims 1,2, 9, 19-21,25,28,33, 34 , 36 read on an expression construct that encodes CD5-specific engineered receptor are under consideration in the instant application . 4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. 5. 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. 6. Claim 25 is rejected under 35 U.S.C. 112( a, b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. 7. Dependent claim 7 recites “wherein the cytokines”. There is insufficient antecedent basis for this limitation in the claims, since base Claim 1 does not recite cytokines. Appropriate correction is required. 8 . 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. 9 . 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, 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. 10 . Claim( s) 1 ,2, 19-21,25,28,33,34 , 36 are rejected under 35 U.S.C. 102( a) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US Patent Application 20160361360 , US Patent Application 20240336699 and US Patent Application 20200405811 US Patent Application ‘360 teaches an expression construct encoding CD5-specific CAR. US Patent Application ‘360 teaches that said CAR comprises CD28 transmembrane domain, CD3z e ta signaling domain, hinge region and CSFv targeting region . US Patent Application ‘ 360 further teaches that said CAR can comprise additional CD40L, CD27 costimulatory domains ( see entire document, paragraphs 0006, 0011, 0020, 0060 , 0064 in particular). US Patent Application ‘699 teaches an expression construct encoding CD5-specific CAR. US Patent Application ‘ 699 teaches that said CAR comprises CD28 transmembrane domain, CD3zeta signaling domain, hinge region and CSFv targeting region. US Patent Application ‘ 699 further teaches that said CAR can comprise additional CD27 costimulatory domains and suicide gene ( see entire document, paragraphs 0005, 0011, 0012, 0013, 0014, 0082, in particular). US Patent Application ‘811 teaches an expression construct encoding CD5-specific CAR. US Patent Application ‘ 811 teaches that said CAR comprises CD28 transmembrane domain, CD3zeta signaling domain, hinge region and CSFv targeting region. US Patent Application ‘811 further teaches that said CAR can comprise additional CD27 costimulatory domains and suicide gene ( see entire document, paragraphs 0014, 0016, 0020, 0021, 0050, 0053 in particular). Claims 21, 28,33 34 and 36 are included because it would be conventional and within the skill of the art to : ( i ) determine an optimal type of hinge region; (ii) determine a polypeptide of interest other than the CD5-specific receptor. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller , 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A. It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch , 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc. , 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). The reference teaching anticipates or , the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary. 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 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer . 12. The claim s 1,2, 19-21,25,28,33, 34 , 36 are provisionally rejected on the grounds of nonstatutory double patenting of the claim s of copending Application No s . 18/693894, 18/750233; 17/309,315; 17/233,157; 16/632,762 Although the conflicting claims are not identical, they are not patentably distinct from each other because claim s of copending Application No s . 18/693894, 18/750233; 17/309,315; 17/233,157; 16/632,762 each recited an expression vector comprising a sequence encoding CD5-specific CAR and comprising CD28 intracytoplasmic domain and CD 3zeta signaling domain This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented. 13. Claim 9 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. 13 . Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch can be reached on 571/ 272-8149 The fax 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). /MICHAIL A BELYAVSKYI/ Primary Examiner, Art Unit 1644
Read full office action

Prosecution Timeline

Sep 27, 2023
Application Filed
Feb 26, 2026
Examiner Interview (Telephonic)
Mar 01, 2026
Non-Final Rejection — §102, §112, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
64%
Grant Probability
91%
With Interview (+27.2%)
3y 1m
Median Time to Grant
Low
PTA Risk
Based on 1091 resolved cases by this examiner. Grant probability derived from career allow rate.

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