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 .
Claim Status
Claims 1-2,4,7-9,11,13,15,17-19,21-23,25,27,29,31 and 34 are pending in the application.
Election/Restrictions
Applicant’s election with traverse of Group II, claims 21-23, 25 and 27, in the reply filed on Aug. 25, 2025 is acknowledged. The traversal is on the ground(s) that there would not be a serious or undue burden regarding the species. This is not found persuasive because burden is immaterial to a finding of lack of unity of invention pursuant to Patent Cooperation Treaty (PCT) Rule 13.1. See MPEP 1893.03(d). Furthermore, applicant did not distinctly and specifically point out the supposed errors in the main restriction requirement. The restriction and species requirements are still deemed proper and is therefore made final. Applicant’s election is acknowledged of the species of polypeptide comprising SEQ ID NO: 79, SEQ ID NO: 5, SEQ ID NO: 16, and SEQ ID NO: 33. Claims 2,4,7-9,11,13,15,17-19,29,31 and 34 are withdrawn for being directed to non-elected subject matter, and claims 21-23, 25, and 27 have been considered on the merits.
Claim Interpretation
In the claims, the term “Rituximab-binding epitope” is interpreted as a polypeptide bound by the antigen-binding moiety of the monoclonal antibody rituximab or a derivative thereof, e.g., via the CDRs and other parts of the heavy and light variable domains of rituximab.
In the claims, the term stalk (St) sequence is interpreted as a peptide or polypeptide region or domain having any amino acid sequence, as the term “stalk” is neither defined by the claims nor the instant specification, so long as it provides the function of causing the R1 and R2 epitopes to be projected from the cell surface of a cell expressing the polypeptide having the formula R1-L-R2-St.
In claim 21, the term “linked” regarding a polypeptide fusion partner is interpreted to be limited to wherein the linkage comprises a peptide bond between the said polypeptide and the polypeptide fusion partner. Similarly, the term “linker sequence” is interpreted as being limited to a peptide or polypeptide molecule having a sequence and fused via peptide bonds to the proteinaceous components so linked. See instant pg. 6, lines 9-12 and 17-19; pg. 22, lines 28-29).
In claim 23, the terms “transgene of interest” and “protein of interest (POI)” are interpreted as non-limiting regarding the phrase “of interest” because there is no structural feature expressly recited or implied in the claim, such as defined by the instant specification, that would distinguish a transgene or protein “of interest” from any other transgene or protein.
In claim 23, the term “antigen receptor” is interpreted as being limited to a transmembrane protein of the immune system, whether natural or engineered, comprising an extracellular ligand binding moiety of the immunoglobulin superfamily which specifically binds an antigen and transduces a signal into the cytoplasm of the cell expressing it.
Claim Rejections - 35 USC § 112(b)
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 21-23, 25, and 27 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.
In claims 21, 23, and 25, the term “flexible” regarding a proteinaceous linker is a relative term which renders the claim indefinite because neither the claim nor the specification provides a standard for ascertaining the requisite degree of flexibility and thus one of ordinary skill in the art would not be reasonably appraised of the scope of this claim limitation. Claims 22 and 27 are included in this rejection for being dependent on indefinite claim 21.
In claim 23, the phrase “(e.g. a chimeric receptor . . .)” is ambiguous and otherwise unclear as to whether what follows “e.g.” or the entire parenthetical is a limitation(s) or merely optional features.
In claims 23, 25, and 27, the use of the term “preferably” renders the metes and bounds of the claims unclear as to whether the details following “preferably” are claim limitations or merely optional features.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-23, 25, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pule (US20150093401A1).
The claims are interpreted as provided in a previous section.
Regarding claim 21, Pule discloses a nucleic acid ([0133]) encoding a polypeptide (Abstract; [0039]; [0083]-[0087]) having the formula: R1-L-R2-St, wherein (1) R1 and R2 are Rituximab-binding epitopes (e.g., SEQ ID NO: 1 or 6-16 or variant thereof) ([0092]-[0096]), (2) St is a stalk sequence which, when the polypeptide is expressed at the surface of a target cell, causes the R1 and R2 epitopes to be projected from the cell surface (e.g., a CD8 stalk such as SEQ ID NO: 17) ([0102]-[0110]), and (3) L (e.g., spacer sequences (S1 and/or S2) or S1-Q-S2) has a flexible linker sequence connecting the C-terminus of R1 to the N-terminus of R2 ([0014]-[0118]); and wherein the polypeptide is fused to a polypeptide partner (e.g., a POI) ([0127], [0047]-[0050]). Pule discloses wherein the encoded polypeptide does not comprise instant SEQ ID NO: 1 but instead comprises a Q that is a QBEnd10-binding epitope variant relative to instant SEQ ID NO: 1, such as having five mutated residues (SEQ ID NO: 2) ([0039], Abstract; [0081], [0086]-[0087]).
Regarding claim 22, Pule discloses wherein the aforementioned nucleic acid is within a vector ([0136]).
Regarding claim 23, Pule discloses wherein the vector also comprises a transgene encoding a chimeric antigen receptor (CAR) ([0052]; [0048]; [0132]).
Regarding claim 25, Pule discloses wherein the aforementioned polypeptide is expressed by a cell comprising the nucleic acid encoding it ([0141]-[0142], [0134]).
Regarding claim 27, Pule discloses a cell comprising the aforementioned nucleic acid, including wherein the nucleic acid is within a vector ([0143], [0137]).
Thus, Pule anticipates the claimed invention.
Double Patenting
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 21-23, 25, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 21, 23-24, 27-28, and 46 of copending Application No. 18/042,927 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claim 2 is directed to a nucleic acid expression construct comprising a safety switch polypeptide comprising the formula R1-L-R2-St wherein R1 and R2 are rituximab-binding epitopes, St is a stalk sequence that causes R1 and R2 epitopes to be projected from a cell surface upon polypeptide expression by a host cell, L is a flexible linker sequence, and lacking a SEQ ID NO: 1 sequence, such as wherein the RQR8 safety switch sequence has 80-99% sequence identity to instant SEQ ID NO: 1, e.g., consisting of SEQ ID NO: 92 or 93.
Regarding instant claim 22, reference claim 2 differs in that the nucleic acid is not expressly part of a vector; however, reference claims 21 and 23 teach wherein the expression construct is comprised within a vector. Regarding instant claim 23, reference claim 2 discloses that the nucleic acid expression construct comprises a sequence encoding a CAR and a FOXP3 transgene and reference claim 24 teaches the cell co-expresses the safety switch polypeptide and the CAR.
Regarding instant claims 25 and 27, reference claims 23-24 and 27-28 teach wherein the nucleic acid expression construct is comprised within a cell, such as a production host cell or T cell, and wherein the cell co-expresses the CAR and the aforementioned safety switch polypeptide (reference claim 24).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC J ROGERS whose telephone number is (571)272-8338. The examiner can normally be reached Monday - Friday 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore, can be reached on 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC J ROGERS/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638