DETAILED ACTION
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 .
Restrictions/Elections
Applicant’s election of the following invention/species without traverse, as set forth in the Reply filed 08 September 2025, is acknowledged:
Applicant elects PSCA as the species of ligand, claim 13 as the species of ligand binding domain, SEQ ID NO: 22 as the species of linking polypeptide, and SEQ ID NO: 17 as the species of chimeric polypeptide.
Status of the Claims
Claims 1, 3-4, 6, 8-10, 12-13, 18-20, 24-25, 31-36, 40, 51-52, 55, 62, 66, 75-76 are currently pending and are the subject of this Office Action.
Withdrawn Claim Rejections
The previous rejections under 35 U.S.C. 112(a), 112(b), and 102 are hereby withdrawn.
New Claim Rejections, Necessitated by Amendment - 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.
Claims 1, 3-4, 6, 8-10, 12-13, 18-20, 24-25, 31-36, 40, 51-52, 55, 62, 66, 75-76 are rejected under 35 U.S.C. 112(b) as failing to set forth the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1, from which claims 3-4, 6, 8-10, 12-13, 18-20, 24-25, 31-36, 40, 51-52, 55, 62, 66, 75-76 depend, recites "wherein the chimeric polypeptide does not comprise a Notch LNR nor HD of a Notch receptor". As set forth in the previous Action, the Notch negative regulatory region (NRR), contains domain consisting of three LIN-12-Notch repeat (LNR) modules and a heterodimerization domain (HD) of the Notch extracellular subunit (NEC) (see para. [0006] of the instant specification). Thus, it is unclear whether a polypeptide comprising one of three, or two of three LNRs meets the requirements of the claim, as the claim language, “a Notch LNR” encompasses the absence of a single LNR. Therefore, the scope of the claims cannot be established.
Maintained 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.
Claims 1, 3-4, 6, 8-10, 12-13, 18-20, 24-25, 31-36, 40, 51-52, 55, 62, 66, 75-76 are rejected under 35 U.S.C. 103 as being unpatentable over Choe1 in view of Rosmalen2, and Hoffman3.
Choe discloses a chimeric polypeptide (see Choe, e.g., at claim 1) comprising, from N-terminus to C-terminus: a) an extracellular ligand-binding domain having a binding affinity for a selected ligand (see Choe, e.g., at claim 1.a.); b) a linking polypeptide (see Choe, e.g., at para. [00128], [00323]; fig. 1A); c) a transmembrane domain comprising one or more ligand-inducible proteolytic cleavage sites (see Choe, e.g., at claim 1.c.); and d) an intracellular domain comprising a transcriptional regulator4; and wherein the chimeric polypeptide does not comprise a Notch NRR (see Choe, e.g., at para. [0043]). Choe discloses the polypeptide comprising a Notch cytoplasmic domain incapable or insufficient to induce downstream Notch signaling, in particular, the polypeptide comprising SEQ ID NO: 164 located C-terminally to the transmembrane domain (TMD)5, which shares 100% sequence identity with the instantly claimed stop-transfer-sequence set forth in SEQ ID NO: 11 (reads on instant claims 1.c., 32, and 34.c.)
Choe further discloses the chimeric polypeptide wherein: the extracellular domain comprises an antigen-binding moiety capable of binding to a ligand on the surface of a cell, including proteins such as cell surface receptors (see Choe, e.g., at para. [00153]; reads on instant claims 3, 8, 10); the polypeptide comprises a sequence with at least 80% identity to instant SEQ ID NO: 17 (Choe discloses a chimeric polypeptide sequence set forth in SEQ ID NO: 235, which shares 93.7% sequence identity with instant SEQ ID NO: 17; see alignment in Fig. 1 below; reads on instant claims 9 and 35).
the ligand binding domain is selected from the antibodies/fragments listed in instant claim 13 (see Choe, e.g., at claims 55-56; reads on instant claim 13); the cell is a pathogen or a human cell (see Choe, e.g., at para. [00191], [00273]; reads on instant claim 4); the cell is a human cell and the human cell is a tumor cell or a terminally differentiated cell (see Choe, e.g., at para. [00274], [00314]; reads on instant claim 6); the ligand-inducible proteolytic cleavage site(s) comprises a gamma secretase cleavage site (see Choe, e.g., at para. [00119]; reads on instant claim 18); wherein the transcriptional regulator comprises a transcriptional activator or repressor (see Choe, e.g., at claim 57-58, para. [00202]; reads on instant claim 19); the intracellular domain comprises a nuclear localization sequence and a transcriptional regulator sequence selected from those listed in instant claim 20 (see Choe, e.g., at claim 57-58, para. [00208], [00249]; reads on instant claim 20); and the transmembrane domain sequence set forth in SEQ ID NO: 169 (comprises 100% sequence identity to instantly claimed SEQ ID NO: 27; reads on instant claim 33 and 34.b.).
Choe further discloses recombinant nucleic acids encoding the chimeric polypeptide, a cell comprising the polypeptide, cell culture methods expressing the polypeptide, as well as pharmaceutical compositions comprising the recombinant nucleic acids (see Choe, e.g., at claim 59, para. [00307], [00336]-[00339]; reads on instant claims 36, 40, 51, 52, 76).
Choe further discloses methods for modulating an activity of a cell comprising the steps set forth in instant claim 55, including inhibiting an activity of a target cell comprising administering the recombinant cells for treatment of a health condition (see Choe, e.g., at claims 63-66, para. [00315]-[00318]; reads on instant claims 62, 66, 75).
Regarding claim 35, Choe discloses the chimeric polypeptide set forth in instant SEQ ID NO: 235, which comprises instant SEQ ID NOs: 5, 11, 27, and 12, and shares 93.7% sequence identity with instant SEQ ID NO: 17.
The prior art of Choe differs from the instantly claimed invention as follows: Choe does not expressly teach the chimeric polypeptide comprising the claimed glycine-serine linker in SEQ ID NO: 22.
Per the teachings of Rosmalen and Hoffman, glycine-serine linkers, such as GGS repeat linkers as instantly claimed, are widely used in the art, and are known for improved flexibility due to high glycine content (see Rosmalen, e.g., at the abstract; see Hoffman at Example 19, SEQ ID NO: 51 (which shares 100% identity to instant SEQ ID NO:22); see also GenBase sequence search results for instant SEQ ID NO: 22) (reads on claims 24-25 and 34).
Obviousness Analysis: In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than: the simple substitution of one known element for another to obtain predictable results, namely, the substitution of linkers (e.g., the linker of Choe for the glycine-serine linker of Hoffman) to obtain the predictable results (e.g., improving polypeptide flexibility, as taught by Rosmalen). See (MPEP 2143(I)(B), (G)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably arrive at the claimed polypeptide and methods of the instant application. See (MPEP 2143(I)(D)).
Accordingly, claims 1, 3-4, 6, 8-10, 12-13, 18-20, 24-25, 31-36, 40, 51-52, 55, 62, 66, 75-76 are rejected.
Maintained Claim Rejections - 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.
Patent No. 11,202,801
Claims 1, 3-4, 6, 8-10, 12-13, 18-20, 24-25, 31-36, 40, 51-52, 55, 62, 66, 75-76 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No 11,202,801 (reference patent) in view of Rosmalen (supra) and Hoffman (supra). Although the claims at issue are not identical, they are not patentably distinct from each other as described below.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness Analysis: Regarding claims 1, 3-4, 6, 8-10, 12-13, 18-20, 24-25, 31-36, 40, 51-52, 55, 62, 66, 75-76, the reference patent claims recite essentially verbatim the instant claims, the difference being the chimeric polypeptide comprising a CD8a hinge domain instead of a polypeptide linker. However, the instant specification identifies a protein hinge region as an obvious variant6 of the polypeptide linker (see para. [0069] of the instant specification). The reference patent further discloses SEQ ID NO: 4, which shares 98.6% sequence identity with instantly claimed SEQ ID NO: 17. Accordingly, a skilled artisan would readily appreciate the limitations set forth in the reference patent, as the they are obvious variations described in the specification of the reference patent (see, e.g., MPEP § 804(II)(B)(1), regarding construing the claim using the reference patent disclosure). As set forth above, glycine-serine linkers are well-known in the art, and substituting the GGSGGSGGS linker for the CD8a hinge would amount to no more than: the simple substitution of one known element for another to obtain predictable results, namely, the substitution of linkers (e.g., the hinge of the reference patent for the glycine-serine linker of Hoffman) to obtain the predictable results (e.g., improving polypeptide flexibility, as taught by Rosmalen). See (MPEP 2143(I)(B), (G)).
Accordingly, the instant claims are not patentably distinct relative to the reference claims.
Patent No. 11,617,766
Claims 1, 3-4, 6, 8-10, 12-13, 18-20, 24-25, 31-36, 40, 51-52, 55, 62, 66, 75-76 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No 11,617,766 (reference patent) in view of Choe (supra), Rosmalen (supra) and Hoffman (supra). Although the claims at issue are not identical, they are not patentably distinct from each other as described below.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness Analysis: Regarding claims 1, 3-4, 6, 8-10, 12-13, 18-20, 24-25, 31-36, 40, 51-52, 55, 62, 66, 75-76, the reference patent claims recite essentially verbatim the instant claims, the difference being the chimeric polypeptide comprising a hinge domain instead of a polypeptide linker. However, the instant specification identifies a protein hinge region as an obvious variant7 of the polypeptide linker (see para. [0069] of the instant specification). Accordingly, a skilled artisan would readily appreciate the limitations set forth in the reference patent, as the they are obvious variations described in the specification of the reference patent (see, e.g., MPEP § 804(II)(B)(1), regarding construing the claim using the reference patent disclosure). As set forth above, the instantly claimed sequences are taught by Choe and the glycine-serine linkers are well-known in the art, and substituting the GGSGGSGGS linker for the CD8a hinge would amount to no more than the simple substitution of one known element for another to obtain predictable results, namely, the substitution of linkers (e.g., the hinge of the reference patent for the glycine-serine linker of Hoffman) to obtain the predictable results (e.g., improving polypeptide flexibility, as taught by Rosmalen), as well as combining the prior art elements taught by Choe (namely the polypeptide sequence) with the reference patent according to known methods to achieve predictable results. See (MPEP 2143(I)(A), (B), (G)).
Accordingly, the instant claims are not patentably distinct relative to the reference claims.
Patent No. 11,897,932
Claims 1, 3-4, 6, 8-10, 12-13, 18-20, 24-25, 31-36, 40, 51-52, 55, 62, 66, 75-76 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No 11,897,932 (reference patent) in view of Rosmalen (supra) and Hoffman (supra). Although the claims at issue are not identical, they are not patentably distinct from each other as described below.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness Analysis: Regarding claims 1, 3-4, 6, 8-10, 12-13, 18-20, 24-25, 31-36, 40, 51-52, 55, 62, 66, 75-76, the reference patent claims recite essentially verbatim the instant claims, the difference being the polypeptide linker. The reference patent further discloses SEQ ID NO: 26, which shares 97.8% sequence identity with instantly claimed SEQ ID NO: 17, as well as methods of making and using the polypeptide. Accordingly, a skilled artisan would readily appreciate the limitations set forth in the reference patent, as the they are obvious variations described in the specification of the reference patent (see, e.g., MPEP § 804(II)(B)(1), regarding construing the claim using the reference patent disclosure). As set forth above, glycine-serine linkers are well-known in the art, and substituting the GGSGGSGGS linker for the CD8a hinge would amount to no more than: the simple substitution of one known element for another to obtain predictable results, namely, the substitution of linkers (e.g., the linker of the reference patent for the glycine-serine linker of Hoffman) to obtain the predictable results (e.g., improving polypeptide flexibility, as taught by Rosmalen). See (MPEP 2143(I)(B), (G)).
Accordingly, the instant claims are not patentably distinct relative to the reference claims.
Patent No. 12,065,479
Claims 1, 3-4, 6, 8-10, 12-13, 18-20, 24-25, 31-36, 40, 51-52, 55, 62, 66, 75-76 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No 12,065,479 (reference patent) in view of Rosmalen (supra) and Hoffman (supra). Although the claims at issue are not identical, they are not patentably distinct from each other as described below.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness Analysis: Regarding claims 1, 3-4, 6, 8-10, 12-13, 18-20, 24-25, 31-36, 40, 51-52, 55, 62, 66, 75-76, the reference patent claims recite essentially verbatim the instant claims, the difference being the polypeptide linker. The reference patent further discloses SEQ ID NO: 492, which shares 94.5% sequence identity with instantly claimed SEQ ID NO: 17, as well as methods of making and using the polypeptide. Accordingly, a skilled artisan would readily appreciate the limitations set forth in the reference patent, as the they are obvious variations described in the specification of the reference patent (see, e.g., MPEP § 804(II)(B)(1), regarding construing the claim using the reference patent disclosure). As set forth above, glycine-serine linkers are well-known in the art, and substituting the GGSGGSGGS linker for the CD8a hinge would amount to no more than: the simple substitution of one known element for another to obtain predictable results, namely, the substitution of linkers (e.g., the linker of the reference patent for the glycine-serine linker of Hoffman) to obtain the predictable results (e.g., improving polypeptide flexibility, as taught by Rosmalen). See (MPEP 2143(I)(B), (G)).
Accordingly, the instant claims are not patentably distinct relative to the reference claims.
Response to Arguments
Applicant's arguments filed 11 May 2026 have been fully considered.
Applicant's arguments regarding previous claim rejections under 35 U.S.C. 112, and 102 have been fully considered and are persuasive. Therefore, in light of Applicant’s claim amendments, the previous claim rejections under 35 U.S.C. 112 and 102 are withdrawn.
In response to applicant's arguments against references individually or less than all references relied upon by the Examiner (see, e.g., Reply p. 9-11), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is neither disputed nor dispositive of obviousness that the primary references, taken alone, fail to satisfy the claimed invention, because no rejections over such individual references have been made.
Furthermore, the present claims incorporate broad functional language (e.g., “ligand-inducible proteolytic cleavage sites”) and further defines the chimeric polypeptide by what it is not (i.e., “wherein the chimeric polypeptide does not comprise a Notch LNR”) rather than by what it is (e.g., a chimeric polypeptide comprising a Notch transmembrane domain and a glycine-serine linker instead of Notch LNR, as set forth in the examples, Example 10 in particular). Absent unexpected results, it would have been obvious to one of ordinary skill in the art to simply substitute the linker of Choe for the glycine-serine linker of Hoffman to obtain the predictable results of improving polypeptide flexibility, as taught by Rosmalen. See (MPEP 2143(I)(B), (G)). Accordingly, the previous claim rejections under 35 U.S.C. 103 are maintained.
Examiner acknowledges Applicant’s allegation of unexpected results (see Reply, p. 11-13). If Applicant means to allege the existence of unexpected results, Applicant is directed to MPEP §716, §716.01, and §716.02. To establish unexpected results, the evidence must establish that the expected results occur to an unexpected extent (see, e.g., MPEP § 716.02(a)(I)), on the basis of statistically and practically significant evidence (see, e.g., MPEP § 716.02(b)(I)), which is fully explained (see, e.g., MPEP § 716.02(b)(II)), commensurate in scope with the claimed invention (see, e.g., MPEP § 716.02(d)), and wherein a comparison of the claimed invention with the closest prior art of record is provided (see, e.g., MPEP § 716.02(e)). Furthermore, even if evidence satisfying MPEP §§ 716.02, 716.02(a), 716.02(b), 716.02(d), and 716.02(e) is set forth on record, such evidence may not be sufficient to rebut prima facie obviousness because the evidence of expected and unexpected results must be weighed (see, e.g., MPEP § 716.02(c)(I)) and the totality of the record considered (see, e.g., MPEP § 716.02(f)), including teachings in the prior art and evidence of expected results which weigh in favor of a determination of obviousness (see, e.g., MPEP § 716.02(c)(II)).
If Applicant means to allege the existence of unexpected results commensurate in scope with the requirements of MPEP § 716.02 based upon instant Example 10 and Fig. 5 (see, e.g., Reply at p. 11-13), this is also not persuasive because the requirements of MPEP § 716.02 have not been satisfied. Specifically, MPEP § 716.02(b) is not satisfied because such proffered evidence is not commensurate in scope with the instant claims, which set forth the broad limitation of the chimeric polypeptide comprising “a transmembrane domain comprising one or more ligand-inducible proteolytic cleavage sites”; rather, the examples are highly limited and require the chimeric polypeptide to specifically comprise a Notch transmembrane domain and fail to establish that the observed results persist within the full scope and ranges of compositions presently claimed (see, e.g., MPEP § 716.02(d)). Accordingly, for at least this reason, the proffered data at Examples 10 is insufficient to establish unexpected results commensurate in scope with the requirements of MPEP § 716.02. Accordingly, zero evidence of any unexpected results commensurate in scope with the requirements of MPEP § 716.02 have been placed on record at this time.
Applicant failed to address previous claim rejections under NSDP. While Applicant’s argument that “the skilled person would have had no reason to replace the force sensitive cleavage domain with a glycine-serine linking peptide recited in Hoffman or Rosmalen, which are known in the art not to be cleavage domains”, the instant specification identifies a protein hinge region as an obvious variant of the polypeptide linker (see para. [0069] of the instant specification), and thus, a skilled artisan would readily appreciate the glycine-serine linker as an obvious variant of a CD8a hinge.
Conclusion
Claims 1, 3-4, 6, 8-10, 12-13, 18-20, 24-25, 31-36, 40, 51-52, 55, 62, 66, 75-76 are rejected.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEA S O'BRIEN whose telephone number is (703)756-4793. The examiner can normally be reached Monday - Thursday 9:00AM - 6:30PM PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached on (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 WO2019099689A1; cited on the IDS
2 Rosmalen et al. "Tuning the flexibility of glycine-serine linkers to allow rational design of multidomain proteins." Biochemistry 56.50 (2017): 6565-6574.
3 WO2006125668A2
4 See Choe, e.g., at claim 1.d.-“an intracellular domain comprising a Notch intracellular signaling domain, wherein binding of the first member of the binding pair to a second member of the binding pair, present on a cell, induces cleavage of the non-Notch force sensor cleavage domain at the proteolytic cleavage site, thereby releasing the intracellular domain, and wherein the non-Notch force sensor cleavage domain is selected from the group consisting of: a von Willebrand Factor (vWF) cleavage domain, an amyloid-beta cleavage domain, a CD 16 cleavage domain, a CD44 cleavage domain, a Delta cleavage domain, a cadherin cleavage domain, an ephrin-type receptor or ephrin ligand cleavage domain, a protocadherin cleavage domain, a filamin cleavage domain, a synthetic E cadherin cleavage domain, an interleukin- 1 receptor type 2 (IL1R2) cleavage domain, a major prion protein (PrP) cleavage domain, a neuregulin cleavage domain and an adhesion-GPCR cleavage domain”; reads on instant claim 1.d.; see also claim 57 and [00202].
5 See Choe, e.g., at para. [00126]-[00129]
6 See, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”
7 See, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”
Prosecution Insights