Prosecution Insights
Last updated: April 19, 2026
Application No. 17/937,488

PHOSPHOGLYCERATE KINASE 1 (PGK) PROMOTERS AND METHODS OF USE FOR EXPRESSING CHIMERIC ANTIGEN RECEPTOR

Non-Final OA §103§112§DP
Filed
Oct 03, 2022
Examiner
ZHU, JIANJIAN
Art Unit
1631
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Trustees of the University of Pennsylvania
OA Round
1 (Non-Final)
62%
Grant Probability
Moderate
1-2
OA Rounds
3y 8m
To Grant
99%
With Interview

Examiner Intelligence

Grants 62% of resolved cases
62%
Career Allow Rate
46 granted / 74 resolved
+2.2% vs TC avg
Strong +82% interview lift
Without
With
+82.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
70 currently pending
Career history
144
Total Applications
across all art units

Statute-Specific Performance

§101
3.3%
-36.7% vs TC avg
§103
32.9%
-7.1% vs TC avg
§102
18.0%
-22.0% vs TC avg
§112
27.2%
-12.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 74 resolved cases

Office Action

§103 §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 Amendment In the reply filed on 09/10/2025 , Applicant has amended claim 60 and has added new claims 70-77. Election/ Restriction Applicant’s election, with traverse, of Group I I, claims 60, 68-69 and new claims 70-77 , drawn to a cell or a lentiviral vector , in the reply filed on 09/10/2025 is acknowledged. The traversal is on the ground(s) that the search and examination of the groups does not present an undue burden to the Examiner . This is not found persuasive because examiner was able to provide art which satisfied the limitations of the product claims without being able to satisfy the limitations of all the method claims thereby demonstrating that a search and examination burden exists between the restricted groups. Claims 49-59 and 61-67 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim Status Claims 49-77 are pending. Claims 49-59 and 61-67 are withdrawn . Claims 60 and 68-77 are considered on the merits . Priority This application is a CON of 15/543,688 (filed on 07/14/2017 , now patented as US Patent No: 11459390 ), which is a 371 of PCT/US2016/013637 (filed on 01/15/2016 ), which claims benefit from Provisional Application 62/104,440 (filed on 01/16/2015 ) and also claims benefit from Foreign Application PCTCN2015071181 (filed on 01/21/2015 ). The priority claim of the instant application has been granted and the earliest benefit date is 01/16/2015 from the application 62/104,440 . Information Disclosure Statement Applicant has not disclosed all information material to patentability. See MPEP §2001.04 and 37 C.F.R. § 1.56. Applicant is respectfully reminded the individuals covered by 37 C.F.R. § 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question. As set forth by the court in Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). See MPEP §2001.06(b). Furthermore, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Claim Objections Claim s 72 and 73 are objected to because of the following informalities: Claims 72 (b) and 73 (b) recite a list of tumor antigens in which there are repetitive recitations, e.g., claims 72 (b) and 73 (b) recite “MAGE-A1” and “ MAGE A1” in line 10, recite abbreviation “hTERT” in line 13 and its full name “human telomerase reverse transcriptase” in line 15, and recite “ c-Met ” in line 2 and “ c-met ” in 2 nd last line. Appropriate correction is required. 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 60 and 68-77 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 60 recites the broad recitation “ a cell ” in line 1 and the claim also recites “ an immune cell ” in line 2 which is the narrower statement of the limitation. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Furthermore, claim 60 recites the limitation “ the inducible proliferation” in the 2 nd last line. There is insufficient antecedent basis for this limitation in the claim because the limitation “ inducible proliferation” has not been recited before . Additionally, claims 60 , 68 and 69 all recite the phrase “a desired level” in the wherein clause, which renders the claim s indefinite because “desired” is a subjective term. A claim that requires the exercise of subjective judgment without restriction may render the claim indefinite. See MPEP § 2173.05(b). Claims 70 - 77 are rejected as being dependent from claims 68 and 69 but not resolving the ambiguity . Furthermore, claims 70 and 71 recite the phrase “an affinity ( Kd )” in line 1. The use of parentheses renders the claims indefinite because an affinity can be represented by multiple parameters, such as the association constant Ka and the dissociation constant Kd , thus it is unclear whether the limitation “ Kd ” between the parentheses is part of the claimed invention. It is recommended to remove the parentheses. Finally, claim 75 (b) ( i ) recites the limitation “ the WT PGK promoter” . There is insufficient antecedent basis for this limitation in the claim because base claim 69 does not recite a WT PGK promoter. Claim Rejections - 35 USC § 112(d) The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 75 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 75 (b) (iii) recites the truncated PGK promoter consists essentially of “ a nucleic acid sequence located at positions -521 to -422 of SEQ ID NO: 1 ”. However, base claim 69 (a) recites a truncated PGK promoter consists essentially of a sequence at least 70%, 75%, 80%, 85%, 90%, 95%, or 100% identical to a sequence selected from the group consisting of PGK100 (SEQ ID NO: 2); PGK200 (SEQ ID NO: 3); PGK300 (SEQ ID NO: 4); and PGK400 (SEQ ID NO: 5). It is noted that the sequences in PGK100 , PGK200 , PGK300 and PGK400 are positions -1 to -118, -1 to -221, -1 to -324, and -1 to -422 of SEQ ID NO: 1 , respectively (see instant Fig 3A). Thus, the limitation “a nucleic acid sequence located at positions -521 to -422 of SEQ ID NO: 1” fail s to further limit the subject matter of the claim upon which it depends . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 60, 68-69 and 72-77 are rejected under 35 U.S.C. 103 as being unpatentable over Milone et al., ( Molecular Therapy . 2009; 17 ( 8 ): 1453 - 1464 ) in view of M cBurney et al. , ( Nucleic Acids Research . 1991; 19 ( 20 ): 5755 - 5761 ). With respect to independent claims 60, 68 and 69 , Milone teaches an anti-CD19 CAR T cell engineered by transducing the T cell with a lentiviral vector encoding an anti-CD19 CAR (see e.g., Fig 1 and legend), thus teaches the preamble of claims 60, 68 and 69. In regard to (a) a first nucleic acid sequence encoding a PGK promoter, Milone teaches a lentiviral vector comprising a PGK promoter (see e.g., Fig 1b and p. 1462, right col, para “ Construction of lentiviral vectors with different eukaryotic promoters and CARs ”). In regard to (b) a second nucleic acid sequence encoding a chimeric antigen receptor (CAR) , Milone teaches the lentiviral vectors comprise several types of CARs ( see e.g., Fig 1 a, 1c and p. 1462, right col, para “ Construction of lentiviral vectors with different eukaryotic promoters and CARs ” ). Milone teaches one CAR comprises an single-chain variable fragment that recognizes the human CD19 antigen (i.e., an antigen binding domain), a CD28 transmembrane domain, a 4-1BB intracellular costimulatory domain and a CD3ζ intracellular signaling domain ( see Fig 1a and p. 1462, right col, para 3 ), thus teaches limitation (b). In regard to the wherein clause, Milone test s several eukaryotic promoters , including a wildtype PGK promoter, on their abilit ies to modulate CAR transcription at a desired level and to direct CAR expression in the engineered T cells to promote their expansion (see Fig 1b, 1c, 1d and p. 1455, left col.). However, Milone is silent on the lentiviral vector comprising a truncated PGK promoter comprising at least 100 nucleotides deletion at the 3’ -end or the 5’ -end of a wildtype PGK promoter set forth in SEQ ID NO: 1 in claims 60 and 68, or a truncated PGK promoter consisting essentially of a sequence at least 70% identical to PGK200 or PGK300 in claim 69 . M cBurney tests the PGK promoter activity by fusing fragments of the PGK promoter to a reporter (see e.g., Fig 2) and teaches the human and mouse PGK promoter sequences are highly homologous (p. 5760, right col, para 2 and see alignment in Fig 7). The human PGK promoter sequence in Fig 7 is 100% identical to the sequence of positions -1 to -511 of instant SEQ ID NO: 1 (see modified Fig 7 attached below , with identical sequence underlined. It is noted that instant SEQ ID NO: 1 is in a reverse order to the human PGK promoter sequence shown in Fig 7). Regarding a truncated PGK promoter , M cBurney tests PGK promoter fragments for their activity (see e.g., Fig 2) , in which construct (f) (+80 to -440 in reference and -1 to -521 according to instant sequence) is equivalent to the instant full length PGK promoter (-1 to -521), construct ( i ) (+80 to -212 in reference and -1 to -293 according to instant sequence) is about 90% identical to the instant PGK300 (-1 to -324 , with the difference being sequence length ), and construct (k) (+80 to -120 in reference and -1 to -201 according to instant sequence) is about 90% identical to the instant PGK200 (-1 to -221 , with the difference being sequence length ). The modified Figure 2 of M cBurney and the instant Figure 3A of the present application are attached for comparison. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the immune cell transduced with a lentivirus comprising a CAR driven by different eukaryotic promoters , including a wildtype PGK promoter disclosed by Milone , by substituting with a truncated PGK promoter such as the promoter fragment in construct ( i ) or (k) as suggested by M cBurney with a reasonable expectation of success. Since Milone aims to optimize a CAR T cell by testing different eukaryotic promoters , including a wildtype PGK promoter , to direct CAR expression at a desired level and persistence (see Fig 1b, 1c, 1d and p. 1455, left col.) , and since M cBurney reduces to practice several PGK promoter fragments (i.e., truncated PGK promoters) that have different activities (see e.g., Fig 2), one of ordinary skill in the art would have had a reason to substitute with a truncated PGK promoter , such as the PGK promoter fragment in construct ( i ) or (k) as suggested by M cBurney , in the lentiviral vector of Milone in order to drive CAR expression at various level s to test the CAR persistence in the engineered CAR T cells. Furthermore, because M cBurney teaches different PGK promoter constructs with different extent of truncations have different activities (see e.g., Fig 2), the extent of truncation is therefore considered a result-effective variable, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to apply the claimed truncation , since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch , 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Finally, regarding to the limitation “promoting the inducible proliferation of the engineered immune cell” in claim 60, it must be noted that this limitation is only the results of truncated PGK promoter-driven CAR expression . Therefore, this limitation does not provide any patentable weight in determining patentability of the claimed cell . See MPEP 2111.04 I . Nevertheless, Milone teaches the CAR-T cells expand in vitro following activation with αCD3/αCD28 coated magnetic beads and transduction of the indicated CAR (see Fig 1d and legend), thus teaches the CAR expression in engineered T cells promotes inducible proliferation (following activation with αCD3/αCD28 beads). With respect to claims 72 and 73 directed to the antigen binding domain binding to CD19, as stated supra, Milone teaches the CAR comprises an single-chain variable fragment that recognizes the human CD19 antigen (see Fig 1a and p. 1462, right col, para 3), thus teaches the antigen binding domain binds to CD19. With respect to claims 74 and 75 directed to the truncated PGK promoter comprising at least 150 nucleotide deletion in SEQ ID NO: 1, as stated supra, Milone in view of M cBurney make obvious a truncated PGK promoter construct ( i ) or (k) that comprises a sequence equivalent to a 229 or a 320 nucleotide deletion in instant SEQ ID NO: 1 (see above). With respect to claims 76 and 77 directed to the intracellular signaling domain being a CD3 zeta signaling domain, as stated supra, Milone teaches the CAR comprises a CD3ζ intracellular signaling domain (see Fig 1a “TCR- ζ ” ) . Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary. Claims 70-71 are rejected under 35 U.S.C. 103 as being unpatentable over Milone et al., (Molecular Therapy. 2009; 17(8): 1453-1464) in view of McBurney et al., (Nucleic Acids Research. 1991; 19(20): 5755-5761) , as applied to claims 68 and 69 above, and further evidenced by Imai et al., ( Leukemia . 2004 ; 18 : 676 - 684 ) and Nicholson et al., ( Molecu la r Immunology . 1997; 34 ( 1617 ): 1157 - 1165 ). Claims 70-71 are directed to the CAR having an affinity Kd for its target antigen of less than 10 nM. Regarding the CAR constructs, Milone teaches “ All CARs contain an single-chain variable fragment that recognizes the human CD19 antigen. The cDNA for the CARs … were generated at St Jude’s Childrens Research Hospital. 11 ” (p. 1462, right col, para 3). The reference # 11 referred to by Milone is Imai et al., (Leukemia. 2004; 18: 676-684) . Imai evidences “ The plasmid encoding anti-CD19 scFv was previously reported. 43 ” (p. 677, left col, para “Plasmids”). The reference #43 referred to by Imai is Nicholson et al., (Molecular Immunology. 1997; 34(1617): 1157-1165). Nicholson evidences the anti-CD19 scFv affinity K a being 2.32 x 10 9 M -1 (see e.g., abstract and p. 1161, right col, para “Binding kinetics” and Fig 4). Since K d = 1/K a , Nicholson evidences the anti-CD19 scFv has an affinity K d being 1 / 2.32 x 10 9 M -1 (about 4.3 x 10 -10 M, i.e., 0.43 nM ). Therefore, Imai and Nicholson evidence the CAR used in Milone has an affinity Kd for its target antigen of less than 10 nM. Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary. Double Patenting Rejections 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 60, 68-69 and 72-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 -10 and 19-21 of US Patent No. 11 , 459 , 390 . Although the claims at issue are not identical, they are not patentably distinct from each other. Patent claims recite a cell (reference claim 9), a human T cell (reference claim 10) comprising a lentiviral vector (reference claims 7-8) comprising the nucleic acid molecule encoding a CAR that is operably linked to a truncated PGK promoter having at least 100 nucleotides deletion in a wild-type PGK promoter set forth in SEQ ID NO: 1 (reference claim 1), the deletion being at the 3’ end (reference claim 19) or from the 5’ end (reference claim 20), t he truncated PGK promoter consist ing essentially of a sequence at least 70%, 75%, 80%, 85%, 90%, 95%, or 100% identical to a sequence selected from the group consisting of PGK100 (SEQ ID NO: 2); PGK200 (SEQ ID NO: 3); PGK300 (SEQ ID NO: 4); and PGK400 (SEQ ID NO:5) (reference claim 3), the truncated PGK promoter compris ing 100, 150, 200, 250, 300, 350, or 400 nucleotide deletion in the wild-type PGK promoter set forth in SEQ ID NO: 1 (reference claim 4), the CAR compris ing an antigen binding domain, a transmembrane domain, and an intracellular signaling domain comprising a costimulatory domain and a primary signaling domain (reference claim 1), the costimulatory domain being a 41BB, CD27 or CD28 costimulatory domain, the primary signaling domain being a CD3 zeta signaling domain (reference claim 6), the antigen binding domain bind ing to a tumor antigen selected from the group consisting of: mesothelin, c-Met, CD19, and others (reference claim 2), and the CAR contribut ing to an inducible proliferation of the immune cell, and enhances the immune cell tumor infiltration when compared to an immune cell transduced with a CAR operably linked to a wild-type (WT) PGK promoter or an elongation Growth Factor-1α (EF-1 α) promoter (reference claim 1). The difference between the cited patent claims and the instant claims lies in the fact that the cited patent claims are much more specific. Thus the invention of said claims of the cited patent are in effect “species” of the “generic” invention of the instant claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant application claims are anticipated by cited patent claims, said claims are not patentably distinct. Claims 70-71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 19-21 of US Patent No. 11 , 459 , 390 in view of Nicholson et al., (Molecular Immunology. 1997; 34(1617): 1157-1165). Although the claims at issue are not identical, they are not patentably distinct from each other. Patent claims has been recited above. Specifically, patent claims recite a CAR comprising an antigen binding domain binding to CD19 (see reference claim 2). However, patent claims are silent on the CAR having an affinity Kd for its target antigen of less than about 10 nM. Nicholson teaches construction of a functional CD19 scFv fragment for immunotherapy of leukemia (see e.g., abstract). Nicholson characterizes the anti-CD19 scFv affinity K a being 2.32 x 10 9 M -1 (see e.g., abstract and p. 1161, right col, para “Binding kinetics” and Fig 4). Since K d = 1/K a , Nicholson teaches the anti-CD19 scFv has an affinity K d being 1 / 2.32 x 10 9 M -1 (about 4.3 x 10 -10 M, i.e., 0.43 nM ). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lentiviral vector encoding an anti-CD19 CAR recited in the patent claims, by choosing the anti-CD19 scFv having a Kd of less than about 10 nM taught by Nicholson with a reasonable expectation of success. Since Nicholson reduces to practice the sequence of an anti-CD19 scFv with high affinity (see Fig 1 for sequence and see last para. in p. 1163), one of ordinary skill in the art would have had a reason to choose the anti-CD19 scFv taught by Nicholson in order to construct a lentiviral vector comprising an anti-CD19 CAR for immunotherapy of leukemia . Since the instant application claims are obvious over cited patent claims, in view of Nicholson , said claims are not patentably distinct. Conclusion No claims are allowed. Examiner Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Jianjian Zhu whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0956 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M - F 8:30AM - 4PM (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, James Douglas (Doug) Schultz can be reached on (571) 272-0763. 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. /JIANJIAN ZHU/ Examiner, Art Unit 1631
Read full office action

Prosecution Timeline

Oct 03, 2022
Application Filed
Dec 20, 2025
Non-Final Rejection — §103, §112, §DP (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12577534
TRANSDUCTION AND EXPANSION OF CELLS
2y 5m to grant Granted Mar 17, 2026
Patent 12553039
Targeting Nrip1 to Alleviate Metabolic Disease
2y 5m to grant Granted Feb 17, 2026
Patent 12539317
GENE EXPRESSION SYSTEM FOR PROBIOTIC MICROORGANISMS
2y 5m to grant Granted Feb 03, 2026
Patent 12522645
BCMA-TARGETED CAR-T CELL THERAPY OF MULTIPLE MYELOMA
2y 5m to grant Granted Jan 13, 2026
Patent 12497592
SCAFFOLDS WITH STABILIZED MHC MOLECULES FOR IMMUNE-CELL MANIPULATION
2y 5m to grant Granted Dec 16, 2025
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

1-2
Expected OA Rounds
62%
Grant Probability
99%
With Interview (+82.0%)
3y 8m
Median Time to Grant
Low
PTA Risk
Based on 74 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month