DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s response and amendments received June 16, 2026 are acknowledged.
Claim 10 has been canceled.
Claims 1-9 and 11-19 are pending in the instant application.
Applicant’s election of the invention of group I, drawn to chimeric antibodies that bind VSIG2, presently claims 1-4, in the reply filed on June 16, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 5-9 and 11-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 16, 2026.
Claims 1-4 are under examination in the instant office action as they read on chimeric antibodies that bind VSIG2 and comprise a heterologous moiety.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. More specifically, the current title “Chimeric receptors and methods of their use” is too generic as it does not even indicate the antigen/ligand to which said receptors bind, which in the instant case appears to be VSIG2. Submission of a new or amended title that is more commensurate in scope with the inventions as presently claimed is suggested.
Claim Objections
Claim 4 is objected to concerning issues regarding sequence compliance. As per ST.26, it is no longer permissible to assign SEQ ID numbers to polypeptide sequence shorter than four consecutive, non-degenerate residues. Claim 4 recites “SEQ ID NO:19” which is absent in the actual sequence listing (i.e. skipped/blank) which is proper as Table 1 of the instant specification indicates this sequence should be “GGS”. Note that identification of a polypeptide sequence smaller than 4 residues anywhere (i.e. claims, specification, figures, etc.) by use of a SEQ ID number is not permitted. Thus, claim 4 cannot recite “SEQ ID NO:19”. Such a recitation must be canceled, and if applicant whishes such a limitation to be present “GGS” must be recited in its place. Note that Table 1 in the specification should also be amended to remove identifying GGS as “SEQ ID NO:19”. It must be stressed that the sequence listing is 100% fine as there is no need for SEQ ID numbers to be consecutive (i.e. skipping a sequence by having no sequence information associated with the number is question, as applicant has already done, is permissible. Thus, while the sequence listing presently is okay, both the claims and the text of Table 1 need to be amended to remove “SEQ ID NO:19” to be fully compliant with the sequence rules under ST.26. See also 37 CFR 1.831-1.835. 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 1 and 4 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 independent claim 1, applicant specifies that the claimed chimeric proteins comprise antigen binding domains specific for VSIG2 and recites that such binding domains comprise CDR sequences identified either by specific individual SEQ ID numbers for each CDR (see part (a)) or are the CDRs contained within longer VH and VL sequences which are specified by SEQ ID number (parts (b) and (c)). However, the claim also recites “optionally wherein the amino acid sequences of the CDR-H1, the CDR-H2, the CDR-H3, the CDR-L1, the CDR-L2, and the CDR-L3 of the reference antibody are defined based on the Kabat or Chothia numbering scheme”. Such a recitation has many problems. First, such limitations are recited as being “optional” and while artisans reasonably are well-versed in molecular biology and identification of CDR sequences with VH and VL sequences using any number of art definitions for the beginning and end points, the claim specifically recites Kabat or Chothia. Are the claims intended to be limited to these two numbering schemes (in which case they are not optional at all, and note that numbering schemes in addition to Kabat or Chothia are known and in use in the art) or do they serve as examples of possible numbering schemes and thus are not limiting? Applicant is reminded that as per MPEP § 2173.05(d) examples are not to be recited in claims because it is unclear whether such limitations are part of the claimed invention. Further, the phrase in question recites “of the reference antibody” yet no preceding part of the claim identifies anything as being a “reference” antibody. Thus, to what exactly is applicant referring to by such language? Applicant is remined that artisans should not have to guess or make assumptions about what is or is not part of applicant’s claimed invention.
Similarly, claim 4 recites many “optional” phrases, all of which are potentially of narrower scope than the one that precedes it. Thus, are the “optional” limitations examples (which should not be recited, see again MPEP § 2173.05(d)) or required? Notably, the first “optional” phrase recites the VH and VL of the scFv are separated by a linker, while the second optional explicitly the possibilities for such an arrangements (i.e. VH-linker-VL or VL-linker VH are the only possible options both of which are explicitly recited) while the third recites exact SEQ ID numbers for scFv (i.e. SEQ ID NOs:69-74) and linkers (SEQ ID NOs:19-35). Such recitations create confusion as it is unclear what, if any, limitation(s) need to be met to satisfy the claim. For example, if the art teaches a scFv with the structure VH-linker-VL, but such art does not comprise any of the recited SEQ ID numbers, does it satisfy the recited limitations? By some interpretations yes, but others no and as such confusion clearly arises. Amendment of the claims to remove “optional” language is one possibly way to obviate this rejection.
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 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 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/128,245. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate that which is presently claimed.
Specifically, the copending claims recite antibodies and chimeric proteins comprising antibodies that bind VSIG2 (see all copending claims, particularly copending claims 1 and 8). Notably such constructs are recited as comprising biological sequences that match those recited in the instant claims (see enclose sequence alignments) as well as linker containing scFv comprising such sequences (see particularly copending claims 6 and 7). Given that the copending claims are more narrowly constructed as compared to the instant claims, the copending claims necessarily anticipate the breadth of that which is presently claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/471,943. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate that which is presently claimed.
Specifically, the copending claims recite antibodies and chimeric proteins comprising antibodies that bind VSIG2 (see all copending claims, particularly copending claims 1 and 4). Notably such constructs are recited as comprising biological sequences that match those recited in the instant claims (see enclose sequence alignments) as well as linker containing scFv comprising such sequences (see particularly copending claim 3). Given that the copending claims are more narrowly constructed as compared to the instant claims, the copending claims necessarily anticipate the breadth of that which is presently claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
Prosecution Insights