DETAILED ACTION
This action is in reply to papers filed 12/19/2025. Claims 1-20 are pending and examined herein.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20230322899A1, Published 10/12/2023.
Maintained Rejection(s)
The 112 (b) rejection of claim 19 is maintained. Applicant’s arguments will be addressed following maintained rejection.
The 103 (a) rejection of claims 1-2, 4-9 and 20 as being unpatentable over Brentjens et al. (PgPub US20160045551A1, Published 2/18/2016) is maintained. Applicant’s arguments will be addressed following maintained rejection.
The 103 (a) rejection of claims 10-11 as being unpatentable over Brentjens et al. (PgPub US20160045551A1, Published 2/18/2016) as applied to claims 1-2, 4-9 and 20 and further in view of Julierat et al. (Scientific Reports volume 7, Article number: 39833 (2017)) is maintained. Applicant’s arguments will be addressed following maintained rejection.
The 103 (a) rejection of claims 12-13 as being unpatentable over Brentjens et al. (PgPub US20160045551A1, Published 2/18/2016) as applied to claims 1-2, 4-9 and 20 and further in view of Julierat et al. (PgPub US20170073423A1, Filed 12/19/2014) is maintained. Applicant’s arguments will be addressed following maintained rejection.
The 103 (a) rejection of claims 14-18 as being unpatentable over Brentjens et al. (PgPub US20160045551A1, Published 2/18/2016) as applied to claims 1-2, 4-9 and 20 and further in view of Xiao et al. (WO2020047306A1, Published Ref. 1 in IDS filed 2/25/2023) is maintained. Applicant’s arguments will be addressed following maintained rejection.
Withdrawn Rejection(s)
The 103 (a) rejection of claim 3 as being unpatentable over Brentjens et al. (PgPub US20160045551A1, Published 2/18/2016) as applied to claims 1-2, 4-9 and 20 and further in view of NCBI Database accession no. AY225405.1 (Ref. 1 in IDS filed 2/25/2023) is withdrawn. Applicant’s arguments will be addressed following maintained rejection.
Maintained Rejection(s)
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.
Claim 19 remains 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 19 has been amended to recite in lines 4-7 “modified T cells comprising a first CAR binding a surface molecule of a white blood cell without a second CAR binding a solid tumor antigen, and 3) modified T cells comprising a second CAR binding a solid tumor antigen without the a first CAR binding a surface molecule of a white cell. ” As previously noted, there is no antecedent basis for a “second CAR”. Note that in independent claim 1 there is only the recitation of modified T cells comprising a “CAR”, there is no “first” or “second” CAR. Plainly stated, there is no nexus between the CARs in claim 19 and the CAR in claim 1. Is the first CAR in claim 19 and the CAR in claim 1 the same? Or are there 3 CARs- two in claim 19 and one in claim 1?
Moreover, Applicant’s amendment is confusing. Specifically, element 3 recites, inter alia, “…T cell comprising a second CAR binding a solid tumor antigen without the a first CAR binding a surface molecule of a white blood cell”. What makes the CAR initially recited a ‘second CAR’. The specification does not define the second CAR (or first CAR) to be composed of any specific element. Applicant should consider amending the claims to simply recite a first and second CAR in the order in which they are claimed. For example, for element 3, Applicant should consider amending the claims to recite “and 3) modified T cell comprising a first CAR binding a solid tumor antigen without a second CAR binding a surface molecule of a white blood cell.”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Prior Art Rejection 1
Claim(s) 1-2, 4-9 and 20 remains rejected under 35 U.S.C. 103 as being unpatentable over Brentjens et al. (PgPub US20160045551A1, Published 2/18/2016; Ref. 1 in IDS filed 2/25/2023). The rejection is maintained for the reasons advanced in the previous office action and will not be reiterated herein.
Applicant’s Arguments/Response to Arguments
Applicant argues: Brentjens does not teach or suggest each of the steps recited in the
method of claim 1. As an example, Brentjens does not teach or suggest "introducing a
nucleic acid encoding a chimeric antigen receptor (CAR) and a nucleic acid encoding an
extracellular domain of CD40 into T cells to obtain modified T cells," as recited in claim 1.
Brentjens does not teach or suggest genetically engineering T cells to overexpress the
CD40 extracellular domain on a cell surface as a distinct mechanism for activation.
In contrast, the method of claim 1 generates modified T cells that are structurally
and functionally different from the immunoresponsive cells of Brentjens. As shown in
figure 2 of the specification, non-transduced cells, which represent the endogenous state,
exhibit no detectable surface CD40 expression (0.00%), while T cells generated by the
claimed method exhibited near-uniform, high-level surface expression of the CD40
extracellular domain (approximately 97%-98%). Accordingly, the introducing step recited
in claim 1, which is not disclosed by Brentjens, generates cells that are structurally and
functionally different from the cells of Brentjens, as the immunoresponsive cells of
Brentjens do not express the CD40 extracellular domain on their surface.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. As previously noted, Brentjens teaches an immunoresponsive cell such as a tumor specific T cell comprising a receptor that binds a first antigen and activates the immunoresponsive cell and a receptor that binds a second antigen and stimulates the immunoresponsive cell. Brentjens teaches the first receptor to be a nucleic acid encoding a chimeric antigen receptor. With regards to the second receptor that “stimulates the immunoresponsive cell”, Brentjens teaches this is to mean a signal that results in a robust and sustained immune response. Brentjens goes on to teach that this “stimulation” occurs after T-cell activation or is concomitantly mediated through receptors including, but not limited to, CD28, CD 137 (4-1BB), OX40, CD40 and ICOS. Brentjens further teaches CD40 binds to CD40L, thereby enhancing the immunostimulatory activity of the antigen.
Note that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Thus, when in read in context, it is clear that Brentjens’ teachings embraces genetically modified T-cells comprising a nucleic acid encoding CD40 (in addition to a nucleic acid encoding a CAR) and stimulation of the surface expressed CD40 via a CD40 activator, such as CD40L. Indeed, at para. 139, Brentjens teaches the present invention generally provides cells, including genetically modified immunoresponsive cells (e.g., T cells, Natural Killer (NK) cells, cytotoxic T lymphocytes (CTL) cells) expressing at least a combination of an antigen-recognizing receptor (e.g., TCR or CAR) and either (i) an scFv that binds an immunosuppressive antigen (e.g. αPD-1, αPD-L1, αCTLA-4, or αCD47)); (ii) an scFv that binds an immunostimulatory antigen (e.g. αCD28, αOX-40, αCD40 or α4-1BB) or (iii) CD40L.
Applicant argues: Moreover, the generated modified T cells are activated differently than the immunoresponsive cells of Brentjens. As described in the specification, the flow cytometry analysis indicated that the CD40 activator (K564-CD40L) significantly activated 7429 and 7430 cells, which expressed the CD40 extracellular domain on their surface, as compared to 1234 cells, which were not transfected with the nucleic acid encoding CD40. Specification, paragraph [00211] and figures 4 and 5. Further, the significant increase in activation demonstrates that the claimed method generates modified T cells with a functional capability that is not exhibited by the immunoresponsive cells of Brentjens. Brentjens does not suggest or teach such functional capability or how to obtain modified T cells with such functional capability.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., increase in activation) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues: Furthermore, the state of the prior art underscores the non-obviousness of the method recited in claim 1. As an example, Juillerat (cited by the Office) emphasizes that the risks associated with constitutive receptor expression and proposes regulatory mechanisms, such as hypoxia-sensitive degradation domains, to limit receptor activity due to concerns of toxicity and exhaustion. Studies in this field have reported a prevailing concern that constitutive or high-level receptor expression can be deleterious.
Accordingly, introducing and constitutively expressing a CD40 extracellular domain into
a T cell was not obvious or routine at the priority filing date of the present application.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. A word search for the term ‘deleterious’ in the Juillerat PgPub was not found. In the Juillerat NPL, the only hit for the term was found on Pg. 6 and which states “We hypothesized that the combination of the residual CAR expression in normoxia associated with low antigen expression in healthy tissue should not lead to deleterious cytotoxicity.” This teaching by Juillerat has nothing to do with CD40 expression.
Applicant argues: Additionally, Applicant provides unexpected results showing that CD40L can enhance the activation and expansion of T cells expressing CAR and the CD40 extracellular domain. Specification, paragraphs [00211] and [00212]. The results disclosed in the specification demonstrate that the claimed method provides safe, sustained expansion and effective differentiation into functional effector phenotypes, rather than the adverse outcomes that were expected by the investigators in this field. The unexpected success of the claimed method further supports the non-obviousness of the claimed method over Brentjens.
In Response: Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Because Applicant’s arguments were not found persuasive, the rejection is maintained.
Prior Art Rejection 2
Claims 10-11 remain rejected under 35 U.S.C. 103 as being unpatentable over Brentjens et al. (WO2014134165A1, Published 9/4/2014; Ref. 1 in IDS filed 2/25/2023) as applied to claims 1-2, 4-9 and 20 above, and further in view of Julierat et al. (Scientific Reports volume 7, Article number: 39833 (2017); Ref. 2 in IDS filed 2/25/2023). The rejection is maintained for the reasons advanced in the previous office action and will not be reiterated herein.
Applicant’s Arguments/Response to Arguments
Applicant argues: Juillerat does not suggest or teach "introducing a nucleic acid
encoding a chimeric antigen receptor (CAR) and a nucleic acid encoding an extracellular domain of CD40 into T cells to obtain modified T cells," as recited in claim 1. Thus, Juillerat fails to remedy the deficiencies of Brentjens or Brentjens 'WO165 as noted above with regard to independent claim 1. Therefore, claims 10-11 are also allowable over the cited documents of record for at least their dependency from an allowable base claim, and also for the additional features that each recites.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. Arguments drawn to "introducing a nucleic acid encoding a chimeric antigen receptor (CAR) and a nucleic acid encoding an extracellular domain of CD40 into T cells to obtain modified T cells," have been previously addressed and will not be addressed herein.
Because Applicant’s arguments were not found persuasive, the rejection is maintained.
Prior Art Rejection 3
Claims 12-13 remain rejected under 35 U.S.C. 103 as being unpatentable over Brentjens et al. (WO2014134165A1, Published 9/4/2014; Ref. 1 in IDS filed 2/25/2023) as applied to claims 1-2, 4-9 and 20 above, and further in view of Julierat et al. (PgPub US20170073423A1, Filed 12/19/2014; Ref. 2 in IDS filed 2/25/2023), hereinafter referred to as Julierat (b). The rejection is maintained for the reasons advanced in the previous office action and will not be reiterated herein.
Applicant’s Arguments/Response to Arguments
Applicant argues: The Office cites Juillerat 'US423 as allegedly teaching the respective features of dependent claims 10-11. However, Juillerat 'US423 does not teach or suggest "introducing a nucleic acid encoding a chimeric antigen receptor (CAR) and a nucleic acid encoding an extracellular domain of CD40 into T cells to obtain modified T cells," as recited in claim 1. Thus, Juillerat 'US423 fails to remedy the deficiencies of Brentjens or Brentjens 'WO165 as noted above with regard to independent claim 1.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. Arguments drawn to "introducing a nucleic acid encoding a chimeric antigen receptor (CAR) and a nucleic acid encoding an extracellular domain of CD40 into T cells to obtain modified T cells," have been previously addressed and will not be addressed herein.
Because Applicant’s arguments were not found persuasive, the rejection is maintained.
Prior Art Rejection 4
Claims 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Brentjens et al. (WO2014134165A1, Published 9/4/2014; Ref. 1 in IDS filed 2/25/2023) as applied to claims 1-2, 4-9 and 20 above, and further in view of Xiao et al. (WO2020047306A1, Published Ref. 1 in IDS filed 2/25/2023). The rejection is maintained for the reasons advanced in the previous office action and will not be reiterated herein.
Applicant’s Arguments/Response to Arguments
Applicant argues: As discussed above, claim 1 is allowable over Brentjens and Brentjens 'WO165, individually or in combination. The Office cites Xiao as allegedly teaching the respective features of dependent claims 14-18. However, the Office has not shown that Xiao teaches or suggests "introducing a nucleic acid encoding a chimeric antigen receptor (CAR) and a nucleic acid encoding an extracellular domain of CD40 into T cells to obtain modified T cells," as recited in claim 1. Thus, the Office has not shown that Xiao remedies the deficiencies of Brentjens or Brentjens 'WO165 as noted above with regard to independent claim 1. Therefore, claims 14-18 are also allowable over the cited documents of record for at least their dependency from an allowable base claim, and also for the additional features that
each recites.
Response: Applicant’s arguments have been fully considered, but are not found persuasive. Arguments drawn to "introducing a nucleic acid encoding a chimeric antigen receptor (CAR) and a nucleic acid encoding an extracellular domain of CD40 into T cells to obtain modified T cells," have been previously addressed and will not be addressed herein.
Because Applicant’s arguments were not found persuasive, the rejection is maintained.
Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim 3 is newly rejected under 35 U.S.C. 103 as being unpatentable over Brentjens et al. (WO2014134165A1, Published 9/4/2014; Ref. 1 in IDS filed 2/25/2023) as applied to claims 1-2, 4-9 and 20 above, and further in view of Marshall et al. (WO2005105840A2, Published November 10, 2005).
The teachings of Brentjens et al. is relied upon as detailed above. And although Brentjens teaches CD40, Brentjens fails to teach the extracellular domain of CD40 comprises a nucleic acid encoding SEQ ID NO: 41.
Before the effective filing date of the claimed invention, Marshall et al. teach a nucleic acid sequence encoding a sequence that is 100% identical to SEQ ID NO: 41. See below.
RESULT 1
AED90189
(NOTE: this sequence has 12 duplicates in the database searched.
See complete list at the end of this report)
ID AED90189 standard; protein; 193 AA.
XX
AC AED90189;
XX
DT 26-JAN-2006 (first entry)
XX
DE Human CD40 fusion protein SEQ ID NO 148.
XX
KW Immunosuppressive; Cardiant; Cytostatic; CD40; autoimmune disease;
KW cardiovascular disease; neoplasm; immune disorder; fusion protein.
XX
OS Homo sapiens.
OS Synthetic.
XX
CC PN WO2005105840-A2.
XX
CC PD 10-NOV-2005.
XX
CC PF 28-MAR-2005; 2005WO-US010760.
XX
PR 26-MAR-2004; 2004US-0557092P.
XX
CC PA (FIVE-) FIVE PRIME THERAPEUTICS INC.
XX
CC PI Marshall SA, Linnemann T, Masuoka L, Lee EA, Hestir KF, Chu K;
CC PI Bosch E, Hallenbeck R, Williams LT, Lin H, Behrens D;
XX
DR WPI; 2005-759238/77.
DR N-PSDB; AED90132.
XX
CC PT New isolated polypeptide that is capable of binding a CD40 ligand, useful
CC PT for treating autoimmune diseases, cardiovascular diseases, and
CC PT oncological disease, and an immune cell related disease.
XX
CC PS Example 4; SEQ ID NO 148; 192pp; English.
XX
CC The invention relates to an isolated polypeptide that is capable of
CC binding a CD40 ligand. The polypeptide, methods and compositions are
CC useful for treating a disease selected from diseases arising from
CC undesirable interaction between wild type human CD40 and CD40 ligand;
CC autoimmune diseases; cardiovascular diseases, and oncological disease,
CC and for treating an immune cell related disease, e.g. an autoimmune
CC disease. The present sequence represents the amino acid sequence of a
CC human CD40 fusion protein.
XX
SQ Sequence 193 AA;
Query Match 100.0%; Score 1104; Length 193;
Best Local Similarity 100.0%;
Matches 193; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MVRLPLQCVLWGCLLTAVHPEPPTACREKQYLINSQCCSLCQPGQKLVSDCTEFTETECL 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MVRLPLQCVLWGCLLTAVHPEPPTACREKQYLINSQCCSLCQPGQKLVSDCTEFTETECL 60
Qy 61 PCGESEFLDTWNRETHCHQHKYCDPNLGLRVQQKGTSETDTICTCEEGWHCTSEACESCV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PCGESEFLDTWNRETHCHQHKYCDPNLGLRVQQKGTSETDTICTCEEGWHCTSEACESCV 120
Qy 121 LHRSCSPGFGVKQIATGVSDTICEPCPVGFFSNVSSAFEKCHPWTSCETKDLVVQQAGTN 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LHRSCSPGFGVKQIATGVSDTICEPCPVGFFSNVSSAFEKCHPWTSCETKDLVVQQAGTN 180
Qy 181 KTDVVCGPQDRLR 193
|||||||||||||
Db 181 KTDVVCGPQDRLR 193
It would have been prima facie obvious to use the extracellular domain of CD40 of Marshall in the modified T cells of Brentjens et al. in order to compare the effectiveness of the two extracellular domains in enhancing the immune responses. Thus, the modification would have been prima facie obvious.
Examiner’s Note
Applicant is advised that in response to this Office Action, Applicant must provide a sequence listing as no sequence listing was provided with the instant application. See below.
PNG
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436
1350
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Greyscale
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632