Prosecution Insights
Last updated: May 04, 2026
Application No. 18/501,908

GENERATION OF CD3 EXPRESSING IMMUNE CELLS FOR USE IN CONJUNCTION WITH CD3 BINDING BISPECIFIC TARGETING AGENTS

Non-Final OA §102§103§112
Filed
Nov 03, 2023
Priority
Nov 04, 2022 — provisional 63/422,919 +1 more
Examiner
AEDER, SEAN E
Art Unit
1642
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Wugen Inc.
OA Round
1 (Non-Final)
57%
Grant Probability
Moderate
1-2
OA Rounds
6m
Est. Remaining
76%
With Interview

Examiner Intelligence

Grants 57% of resolved cases
57%
Career Allowance Rate
794 granted / 1398 resolved
-3.2% vs TC avg
Strong +20% interview lift
Without
With
+19.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
78 currently pending
Career history
1476
Total Applications
across all art units

Statute-Specific Performance

§101
13.8%
-26.2% vs TC avg
§103
25.4%
-14.6% vs TC avg
§102
20.2%
-19.8% vs TC avg
§112
24.5%
-15.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1398 resolved cases

Office Action

§102 §103 §112
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. Claims 1-21 are pending and currently under consideration. Claim Interpretation The specification and claims use the terms “bicistronic receptor”, “bicistronic chimeric receptor”, “ tricistronic receptor”, and “ tricist r onic chimeric receptor”. The terms “bicistronic” and “ tricist r onic ” are commonly used in the art to describe expression vectors, and not products generated by said expression vectors (such as receptors or chimeric receptors) . Without providing an explicit definition, the instant specification uses the terms “bicistronic receptor”, “bicistronic chimeric receptor”, “ tricistronic receptor”, and “ tricist r onic chimeric receptor” to describe products ( receptors or chimeric receptors) generated by bicistronic or tricist r onic expression vectors. This Office Action is interpreting “bicistronic receptor”, “bicistronic chimeric receptor”, “ tricistronic receptor”, and “ tricist r onic chimeric receptor” to encompass receptors and chimeric receptors that could be generated by multi- cistronic expression vectors. 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 appl icant regards as his invention. Claim s 3-21 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. Claims 3-7 and 12-21 are rejected because claims 3-7, 12, 13, and 16 recite “bicistronic chimeric receptor”. The term “bicistronic chimeric receptor” is not used in the art. The specification uses the term “bicistronic chimeric receptor” and indicates possible examples of a “bicistronic chimeric receptor”. However, the metes-and-bounds of the claims are unclear because it is unclear which chimeric receptors would (or would not) be considered “bicistronic”. Neither the specification nor the claims define the term “bicistronic chimeric receptor”. Claims 8-11 are rejected because claims recite “ tr icistronic chimeric receptor”. The term “ tr icistronic chimeric receptor” is not used in the art. The specification uses the term “ tr icistronic chimeric receptor” and indicates possible examples of a “ tr icistronic chimeric receptor”. However, the metes-and-bounds of the claims are unclear because it is unclear which chimeric receptors would (or would not) be considered “ tr icistronic ”. Neither the specification nor the claims define the term “ tr icistronic chimeric receptor”. Claim 18 recites “The engineered T cell of claim 16, wherein the extracellular domain is….” Claim 16 depends on claim 3, which recites two distinct extracellular domains. There is insufficient antecedent basis for “ the extracellular domain ” in claim 18. 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. Claim Rejections - 35 USC § 103 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. Claim(s) 1-13 and 15- 21 is/are rejected under 35 U.S.C. 102 (a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wang et al (WO 2021/004400 A1; 1/14/2021) . Google Patents provides an English translation of Wang et al at: https://patents.google.com/patent/WO2021004400A1/en?oq=2021004400 Wang et al teaches a modified immune cell comprising a CD3 antibody receptor complex comprising a first CD3 recombinant protein and a second CD3 recombinant protein, wherein: the first CD3 recombinant protein comprises (1) a first CD3 epsilon extracellular domain, (2) a first transmembrane domain, (3) a first intracellular domain; and the second CD3 recombinant protein comprises (1) a second CD3 gamma or CD3 epsilon extracellular domain, (2) a second transmembrane domain, and (3) a second intracellular domain (see second full paragraph under Summary of the invention, in particular). Wang et al further teaches said modified immune cell comprising a third CD3 recombinant protein comprising (1) a third CD3 gamma or CD3 epsilon extracellular domain, (2) a third transmembrane domain, and (3) a third intracellular domain . (see thirty-first full paragraph under Summary of the invention, in particular). Wang et al further teaches said immune cell wherein the first and third extracellular domains are different ( see thirty- second full paragraph under Summary of the invention, in particular ). Wang et al further teaches said immune cell wherein the immune cell is a natural killer (NK) cell or T cell (see definition of “immune cell” under Definition of Terms, in particular). Wang et al further teaches said immune cell wherein the immune cell does not express a T cell receptor (Abstract, in particular). Wang et al further teaches said immune cell wherein the transmembrane domains are selected from a group comprising CD8 a , NKG2D, DAP10 , CD3 e , CD3 d , and CD3 g (see eleventh full paragraph under Summary of the invention and definitions of “first CD3 recombinant protein” and “second CD3 recombinant protein” under Definition of Terms , in particular). Wang et al further teaches said immune cell wherein the signaling domain can be CD3 z and can form a T cell receptor-CD3 complex with T cell receptor subunits CD3 g , CD3 d , and CD3 e (see eighteenth paragraph under Definition of terms, in particular) and wherein the signaling domain can further comprise an intracellular costimulatory signal transduction domain comprising 4-1BB (claims 14 and 22, in particular), 2B4, or OX40 (line 16 under Summary of the invention, in particular). Wang et al further teaches a polynucleotide vector encoding the CD3 antibody receptor complex and cells comprising said vector (see eight to eleventh paragraphs prior to Description of the drawings, in particular). The extracellular domains of the CD3 antibody receptor complex of Wang et al is capable of binding a ny T cell engager specific for CD3. Wang et al further teaches the modified immune cell can be combined with anti-CD3 and anti-CD19 bispecific antibodies to kill tumor cells (first paragraph under Summary of the invention, in particular). Wang et al further teaches a method of treating tumors comprising administering a subject with tumors the modified immune cells in a pharmaceutical composition comprising the bispecific antibodies (see Method and use section before Example section, in particular). Such a method induces an “immune response” to the tumors within the subject because the bispecific antibody links the modified immune cell to tumor cells. In regards to a rejection under 35 U.S.C., Wang et al does not demonstrate every claimed embodiment; however, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to treat a subject with cancer comprising administering just any modified immune cell with just any CD3 recombinant protein s encompassed by Wang et al in combination with a bispecific antibody that binds CD3 and a tumor antigen (such as CD19) a tumor of the subject because Wang et al teaches a method of treating tumors comprising administering to a subject with tumors such modified immune cells in a pharmaceutical composition comprising such bispecific antibodies (see Method and use section before Example section, in particular). This is an example of s ome teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference teachings to arrive at the claimed invention . See MPEP 2143. Claim Rejections - 35 USC § 103 Claim(s) 1-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (WO 2021/004400 A1; 1/14/2021) as applied to claim s 1-13 and 15-21 above, and further in view of Szymczak et al (Nature Biotechnology, 2004, 22( 5): 589-594) and Kamiya et al (JCI, 2019, 129(5): 2094-2106) . Teachings of Wang et al are discussed above . Wang et al does not specifically teach a method wherein the modified immune cells of Wang et al that are NK cells do not express NKG2A . However, these deficiencies are made up in the teachings of Szymczak et al and Kamiya et al . Szymczak et al teaches use of multicistronic vectors to express CD3 signaling complex proteins (Fig. 1, in particular). Kamiya et al teaches that tumors can become resistant to NK cells and that blocking expression of NKG2A in NK cells overcomes such tumor resistance to the NK cells (Abstract, in particular) . One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method comprising the method of Wang et al to treat a subject with cancer comprising administering a modified NK immune cell with just any CD3 recombinant proteins encompassed by Wang et al expressed by multicistronic vectors in combination with a bispecific antibody of Wang et al that binds CD3 and a tumor antigen (such as CD19) of the subject wherein the modified NK cell has blocked NKG2A expression because Wang et al teaches treating cancer in subjects by administering to the subjects such modified NK immune cells that are targeted to tumors using the bispecific antibodies specific for tumor antigen and recombinantly expressed CD3 proteins, Szymczak et al teaches use of multicistronic vectors to express CD3 proteins in cells (Fig. 1, in particular) , and Kamiya et al teaches that tumors can become resistant to NK cells and that blocking expression of NKG2A in NK cells overcomes such tumor resistance to the NK cells (Abstract, in particular). This is an example of Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine prior art reference teachings to arrive at the claimed invention . See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SEAN E AEDER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-8787 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9am-6pm ET . 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, FILLIN "SPE Name?" \* MERGEFORMAT Samira Jean-Louis can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (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. /SEAN E AEDER/ Primary Examiner, Art Unit 1642
Read full office action

Prosecution Timeline

Nov 03, 2023
Application Filed
Apr 01, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
57%
Grant Probability
76%
With Interview (+19.7%)
3y 0m (~6m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1398 resolved cases by this examiner. Grant probability derived from career allowance rate.

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