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
Claim Status
Applicant’s amendment filed June 25, 2025 has been received and entered.
Claims 21, 24, and 26-28 have been amended.
Claims 22-23 and 36-39 have been canceled.
Claims 1-20 were previously canceled.
Claims 40-41 have been added.
Claims 21, 24-35, and 40-41 are pending and under consideration.
Information Disclosure Statements
The information disclosure statements (IDSs) submitted on March 20, 2025 and June 25, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
In view of the Applicant’s amendment, the previous objections to the claims are withdrawn.
Claim Rejections
In view of the Applicant’s claim amendments, the previous grounds of rejection have been updated. The following are updated grounds of rejection necessitated by Applicant’s claim amendments. Applicant’s arguments relevant to the updated grounds of rejection will be addressed below.
Claim Rejections - 35 USC § 112 - Updated
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.
Claims 21 and 24-35 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See MPEP § 2163.
The instant claims are drawn to a polynucleotide that encodes a chimeric antigen receptor (CAR) comprising an anti-fluorescein scFv, wherein the CAR comprises the amino acid sequence of residues 23-706 of SEQ ID NO:2 or 23-709 of SEQ ID NO:3 or an amino acid sequence that has at least 95% sequence identity to the amino acid sequence of residues 23-706 of SEQ ID NO:2 or 23-709 of SEQ ID NO:3.
The claims encompass a large genus of structurally distinct polypeptides that are encoded from the polynucleotide recited in the preamble. Specifically, claim 21 recites a polypeptide that has 95% identity to residues 23-706 of SEQ ID NO:2 (684 residues) or 23-709 of SEQ ID NO:3 (687 residues), which would allow for up to 35 and 37 substitutions in each polypeptide, respectively. Claim 26 further recites the polypeptide comprises a selectable marker that has 95% sequence identity to the amino acid sequence of residues 707-1065 of SEQ ID NO:2 or 710-1068 of SEQ ID NO:3, while claim 28 recites the signal peptide that has 95% sequence identity to the amino acid sequence of residues 1-22 of SEQ ID NO:2 or SEQ ID NO: 3, which further multiplies the possibilities. The disclosure recites the first and last amino acids of SEQ ID NO: 2 and SEQ ID NO: 3, however, does not specify what residues can be substituted, therefore it can be considered that the inventions defined by claims 21 and 24-35 encompass countless possible substitutions (i.e., one substitution, or a string of substitutions). However, the disclosure only generated two CAR variants, E2-CAR and 4M5.3 CAR, which is not predictive of the full genus.
It is well known that protein folding and formulation are complex and fairly unpredictable processes, in such that substituting even one amino acid within the sequence can change the structure and function of said protein. Therefore, it would be difficult for one of ordinary skill in the art to envisage a polypeptide having that much variability while still maintaining the function of the recited anti-fluorescein scFv, further comprising an EGFRt CAR construct. Thus, one cannot readily extrapolate the properties of the polynucleotide that encodes an anti-fluorescein scFv, further encoding an EGFRt selectable marker to other possible sets of mutations encompassed by the claims, as the properties of the polynucleotide encoding a CAR comprising residues 23-706 of SEQ ID NO:2 or 23-709 of SEQ ID NO:3, further comprising residues 707-1065 of SEQ ID NO:2 or 710-1068 of SEQ ID NO:3, are not predictive of the full genus of CAR constructs that can be generated.
The instant application has not provided a sufficient description showing possession of the necessary functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus of polypeptides encompassing various structures, specificities and functions. Further, the Court has interpreted 35 U.S.C. § 112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe, Inc., 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002). In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 48 USPQ2d 1398 (Fed Cir. 1997)).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with
reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession
of the invention. The invention is, for purposes of the 'written description’ inquiry, whatever is now
claimed." (See Vas-Cath, p. 1117). The specification does not "clearly allow persons of ordinary skill in
the art to recognize that [he or she] invented what is claimed." (See Vas-Cath, p. 1116). Also, it is noted that the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., Inc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Meeting the written description threshold requires showing that the applicant was in
“possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support
need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein
v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning —
i.e., what the written description and knowledge in the art would lead one to speculate as to
modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also
ensures that when a patent claims a genus by function, the specification recites sufficient materials to
accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3.
Given the claimed broad class of polypeptides, in the absence of sufficient disclosure of relevant identifying characteristics, the patentee must establish “a reasonable structure-function correlation” either within the specification or by reference to the knowledge of one skilled in the art with functional claims. There is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed polypeptides to demonstrate possession. Also, see Amgen Inc. v. Sanofi, Aventisub LLC, No. 2017-1480 (Fed. Cir. 2017). Thus, one of skill in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d 1559, 43, USPQ2d 1398.
Claims 24-25, 27, and 29-35 are included in the rejection because they depend from or otherwise require all the limitations of a rejected independent claim.
Response to Arguments – 35 USC §112(a)
Applicant has argued in the reply received June 25, 2025 (pg. 4-6) that the claims have been amended to recite the specific amino acid sequence of the anti-fluorescein CAR or a sequence that exhibits 95% sequence identity thereto, which is sufficient to show possession of the claimed genus. Applicant further argues that the instant specification defines the first and last amino acid residue for each domain of the CAR (i.e., anti-fluorescein scFv, EGFRt), which allows the CARs to be mapped to SEQ ID NO: 2 and SEQ ID NO: 3. Applicant further submits that the pending claims are analogous to claims at issue in the recent decision Ex parte Keler, 2020 WL 3265323 (Patent Tr. & App. Bd. 2020) ("Keler"), the USPTO Patent Trial and Appeal Board (PTAB), in which it was held the claim at issue complied with the written description requirement.
Applicant's arguments filed June 25, 2025 have been fully considered but they are not persuasive.
As set forth above, an amino acid sequence having 95% identity to residues 23-706 of SEQ ID NO:2 or residues 23-709 of SEQ ID NO:3, results in up to 35 possible amino acid substitutions which can greatly affect the properties of the final protein. In fact, the instant specification states that the only difference between E2-CAR and 4M5.3-CAR, is the scFv sequences used [0523], with E2-CAR having significantly better tumor control, which demonstrates that changes in the anti-fluorescein amino acid sequence can alters activity (i.e., improved tumor response). Further, the 4M5.3 anti-fluorescein antibody was engineered from parent antibody 4-4-20 and contains 14 mutations, 4 of which are responsible for the 1800-fold improvement in binding affinity of 4M5.3 when compared to its parent (Midelfort, 2006; see Abstract). Thus, the prior art teaches that substitution of only 4 amino acids results in a significant difference in activity, so it is hard to envision the claimed scFv having a similar function if up to 35 amino acids can be substituted in SEQ ID NO: 2 and 35 amino acids can be substituted in SEQ ID NO: 2.
Regarding the nonprecedential decision reached in Keller, the claims in question are not analogous to the presently claimed invention. The disclosure of Keller recites a detailed description of acceptable mutations that are covered by the scope of the claims and further recites multiple examples that are representative of the genus. This is in contrast to the instant application that recites that certain identifiable portions of the encoded CARs may be readily substituted, such as by a substitution that would result in no or minimal change to the physical or functional properties of the CAR, and result in a CAR that is an anti-fluorescein scFv as presently claimed [0430]-[0432], because it does not recite where or how many substitutions may occur.
Applicant correctly asserts that one of ordinary skill in the art would be able to identify and test an anti-fluorescein CAR for binding to fluorescein and activity as a CAR, within the structural limits of 95% sequence identity to the amino acid sequence of residues 23-706 of SEQ ID NO:2 or 23-709 of SEQ ID NO:3. As such, a rejection under 35 U.S.C. 112(a) as failing to comply with the enablement requirement would be improper.
Double Patenting - Updated
Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
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.
Claims 21, 29-35, and 40-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 27-28, 36-39, and 40-44 of U.S. Patent No. 11,779,602, in view of Stothard (Biotechniques, 2000; 28(6):1102-1104) (“Stothard”), and further in view of Cooper et al. (WO 2015/164594) (“Cooper”). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims teach a composition comprising CAR T cells that express the identical polypeptide having 100% identity to residues 23-706 of SEQ ID NO: 2 recited in the instant claims.
The patented claims differ from the instant claims in that they do not recite the polypeptide is encoded by a polynucleotide or that it can be delivered in a lentiviral vector.
Methods for determining the nucleic acid sequence of a protein from its amino acid sequence were well known in the art at the time of invention, including several online platforms that allow anyone with an internet connection to enter DNA or protein sequences for analysis. Reverse Translate tools allow the user to input a protein sequence to generate nucleic acid sequences and identify regions of minimal degeneracy using a codon usage table [pg. 1104]. Therefore, it would have been obvious to skilled artisans to modify the generic methods of the patented claims to use a polynucleotide construct in place of a polypeptide as recited in the instant claims. Artisans would have more than a reasonable expectation of success in doing so given that the prior art of Stothard teaches the DNA sequence of proteins can be determined from their amino acid sequence using reverse translation tools. Furthermore, one of ordinary skill would be motivated to ligate the polynucleotide into an expression vector, such as a lentiviral vector. Cooper teaches methods of constructing CARs for therapeutic use, wherein a lentiviral vector can be used to introduce the chimeric construct into T cells [00128].
One would be motivated to derive the sequence of and isolate the polynucleotide that encodes the anti-fluorescein CAR recited in the patented claims because the composition in the patented claims is effective against cancer. Therefore, it would have been obvious to skilled artisans to obtain the nucleic acid sequence for the polypeptide recited in SEQ ID NO: 2 of the issued claims and introduce into T cells using a variety of viral vectors, including lentiviral vectors as taught by Cooper. As such, the instant claimed invention is an obvious modification of the patented claims in view of Stothard and Cooper.
Claims 21 and 27-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 27-28, 36-39, and 40-44 of U.S. Patent No. 11,779,602, in view of Stothard (Biotechniques, 2000; 28(6):1102-1104) (“Stothard”), in further view of Jensen et al. (WO 2010/025177) (“Jensen”). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims teach a composition comprising CAR T cells that express the identical polypeptide having 100% identity to residues 23-706 of SEQ ID NO: 2 recited in the instant claims.
The patented claims differ from the instant claims in that they do not recite the isolated nucleic acid encodes a signal peptide at least 95% identical to residues 1-22 of SEQ ID NO: 2 and SEQ ID NO: 3.
The teachings of Stothard regarding reverse translation of protein sequences are set forth above.
Jensen teaches methods and compositions for enhanced CARs comprising the human GM-CSFR alpha chain signal peptide (hsp) coding sequence (SEQ ID NO: 7) [00016].
SEQ ID NO: 7 taught by Jensen is 100% identical to the signal peptide comprising residues 1-22 of SEQ ID NO: 2 and SEQ ID NO: 3 as recited in the instant claims. Therefore, it would have been obvious to skilled artisans to modify the generic methods of the patented claims to include a signal peptide as recited in the instant claims. Artisans would have more than a reasonable expectation of success in doing so given that the prior art of Jensen teaches CAR constructs comprising a signal peptide nucleic acid sequence necessary for expression of the polynucleotide. As such, the instant claimed invention is an obvious modification of the patented claims in view of Stothard and Jensen.
Claims 21, 29-35, and 40-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, and 9 of U.S. Patent No. 12,269,862, in view of Stothard (Biotechniques, 2000; 28(6):1102-1104) (“Stothard”), and further in view of Cooper et al. (WO 2015/164594) (“Cooper”). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims teach a composition comprising anti-FITC scFV CAR T cells that express the identical polypeptide having 100% identity to residues 23-706 of SEQ ID NO: 2 recited in the instant claims.
The patented claims differ from the instant claims in that they do not recite the polypeptide is encoded by a polynucleotide or that it can be delivered in a lentiviral vector.
Methods for determining the nucleic acid sequence of a protein from its amino acid sequence were well known in the art at the time of invention, including several online platforms that allow anyone with an internet connection to enter DNA or protein sequences for analysis. Reverse Translate tools allow the user to input a protein sequence to generate nucleic acid sequences and identify regions of minimal degeneracy using a codon usage table [pg. 1104]. Therefore, it would have been obvious to skilled artisans to modify the generic methods of the patented claims to use a polynucleotide construct in place of a polypeptide as recited in the instant claims. Artisans would have more than a reasonable expectation of success in doing so given that the prior art of Stothard teaches the DNA sequence of proteins can be determined from their amino acid sequence using reverse translation tools. Furthermore, one of ordinary skill would be motivated to ligate the polynucleotide into an expression vector, such as a lentiviral vector. Cooper teaches methods of constructing CARs for therapeutic use, wherein a lentiviral vector can be used to introduce the chimeric construct into T cells [00128].
One would be motivated to derive the sequence of and isolate the polynucleotide that encodes the anti-fluorescein CAR recited in the patented claims because the composition in the patented claims is effective against cancer. Therefore, it would have been obvious to skilled artisans to obtain the nucleic acid sequence for the polypeptide recited in SEQ ID NO: 2 of the issued claims and introduce into T cells using a variety of viral vectors, including lentiviral vectors as taught by Cooper. As such, the instant claimed invention is an obvious modification of the patented claims in view of Stothard and Cooper.
Claims 21 and 27-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, and 9 of U.S. Patent No. 12,269,862, in view of Stothard (Biotechniques, 2000; 28(6):1102-1104) (“Stothard”), and further in view of Jensen et al. (WO 2010/025177 A1) (“Jensen”). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims teach a composition comprising anti-FITC scFV CAR T cells that express the identical polypeptide having 100% identity to residues 23-706 of SEQ ID NO: 2 recited in the instant claims.
The patented claims differ from the instant claims in that they do not recite the isolated nucleic acid encodes a signal peptide at least 95% identical to residues 1-22 of SEQ ID NO: 2 and SEQ ID NO: 3.
The teachings of Stothard regarding reverse translation of protein sequences are set forth above.
Jensen teaches methods and compositions for enhanced CARs comprising the human GM-CSFR alpha chain signal peptide (hsp) coding sequence (SEQ ID NO: 7) [00016].
SEQ ID NO: 7 taught by Jensen is 100% identical to the signal peptide comprising residues 1-22 of SEQ ID NO: 2 and SEQ ID NO: 3 as recited in the instant claims. Therefore, it would have been obvious to skilled artisans to modify the generic methods of the patented claims to include a signal peptide as recited in the instant claims. Artisans would have more than a reasonable expectation of success in doing so given that the prior art of Jensen teaches CAR constructs comprising a signal peptide nucleic acid sequence necessary for expression of the polynucleotide. As such, the instant claimed invention is an obvious modification of the patented claims in view of Stothard and Jensen.
Response to Arguments – Double Patenting
Applicant has argued in the reply received June 25, 2025 (pg. 8-9) that the nonstatutory double patenting rejections over the conflicting claims of US Patent No. 11,779,602 and US Application No. 18/459,302, now issued as US Patent No. 12,269,862, should be withdrawn because the issued claims are drawn to methods of treating and relate to a different statutory class than the present invention.
Applicant's arguments filed June 25, 2025 have been fully considered but they are not persuasive.
The conflicting claims in the ‘602 and ‘862 patents teach a composition comprising CAR T cells that express the identical polypeptide having 100% identity to residues 23-706 of SEQ ID NO: 2 recited in the instant claims. MPEP § 804(II) states the 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).
Double Patenting - Withdrawn
The terminal disclaimer filed on June 25, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 11,311,576 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter.
The claims drawn to a nucleic acid encoding a chimeric antigen receptor (CAR) with an amino acid sequence comprising residues 23-706 of SEQ ID NO: 2 or residues 23-709 of SEQ ID NO: 3 are free of prior art. In addition, the CAR further comprises a truncated EGFR polypeptide with an amino acid sequence of residues 707-1065 of SEQ ID NO: 2 or residues 710-1068 of SEQ ID NO: 3, which are also free of prior art. The closest prior art, U.S. Patent No. 10,780,118 is directed towards a nucleic acid encoding a chimeric receptor comprising an anti-CD19 scFv + EGFRt selectable marker, however, does not teach or suggest the presently claimed method with specific sequences.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the updated grounds 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/MAUREEN VARINA DRISCOLL/ Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644