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 1-4, 6, 8-10, 12-13, 18-20, 23-25, 31-36, 40, 51-52, 55, 62, 66 and 75-76 are currently pending. Claim 12 is withdrawn. Claims 1-4, 6, 8-10, 13, 18-20, 23-25, 31-36, 40, 51-52, 55, 62, 66 and 75-76 are subject to this Office Action. This is the first Office Action on the merits of the claims.
Information Disclosure Statement
The references cited on the information disclosure statement(s) were considered and have been made of record.
Notably, one or more of the disclosure statements filed to date lists the following documents: International Search Report and PCT Written Opinion (see IDS document filed on 06/12/2023).
The listing of the document(s) noted above is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the document(s) noted above have not been considered.
Furthermore, the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the document(s) noted above are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Claim Interpretation
The interpretation of the following terms, as set forth in the claims, is provided below.
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). Accordingly, a Notch receptor which does not comprise a Notch LNR does also not comprise a (entire) Notch NRR.
The stop-transfer-sequence (STS) constitutes a highly-charged domain located C-terminally to the transmembrane domain (TMD), and disposed between the TMD and the intracellular domain (ICD), for the purpose of preventing the ICD from entering the membrane. Any arbitrary single-chain peptide comprising about 4 to about 40 amino acid residues (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20, etc., amino acid residues) can be used as a STS, e.g., the sequence set forth in instant SEQ ID NO: 11 (see para. [0076]-[0078] of the instant specification).
Claim Rejections - 35 USC § 112(a)
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.
Claim 35 is rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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.
Claim 35 recites the chimeric polypeptide comprising an amino acid sequence having at least 80% sequence identity to the claimed SEQ ID NOs, but does not specify where the 20% variation can occur within the sequences set forth in the claim, nor does the instant specification disclose a representative number of examples of the claimed genus, where polypeptides with the variations described actually retain the features required by instant claim 1, from which claim 35 depends. In the case of antibodies/antibody fragments and derivatives, all of which are encompassed by the present claim, even minute changes to the CDR region can impact binding affinities, as evidenced by Vajdos1.
Moreover, the decision arrived at in Amgen v. Sanofi, 872, F.3d 1367 (Fed. Cir. 2017) supports expanded analysis of whether a claim drawn to an antibody being specific for an epitope, even a specific epitope, permits an applicant to pursue all possible antibodies that are capable of being produced against such an epitope. Presently, the claimed chimeric polypeptide is only defined by functional properties of “having a binding affinity for a selected ligand” and the structure of the claimed amino acid sequences set forth in claim 35. In view of the fact patterns detailed in Amgen v. Sanofi, applicants are in possession of the constructs set forth in instant Table 1, all of which bind to CD19; however, “disclosure of an antigen fully characterized by its structure, formula or physical properties does not, without more, provide adequate written description of an antibody claimed by its binding affinity to that antigen” (Amgen v. Sanofi, 872, F.3d 1367 (Fed. Cir. 2017)). Applicants do not identify the shared structural properties that would define the genus beyond the desired functionality; currently, the essential property of binding any ligand (including epitope specificity and binding affinities) are imparted by the anti-CD19 chimeric polypeptides that have been reduced to practice.
Further, a description of the type and number of amino acid reside substitutions that may be made at such identified positions within the sequence would be essential in determining the degree of variability that may be allotted in total sequence identity. This lack of definition complicates the determination of the boundaries of the claimed genus with regard to which, as of yet unidentified, species variants would be anticipated, by one skilled in the art, to fall within the scope of the claims. In view of this uncertainty and the lack of a representative number of examples of the claimed genus, the claim is rejected for lack of adequate written description support.
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.
Claims 32 and 34 is 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.
Claims 32 and 34, which depend from claim 1, recite "wherein the stop-transfer-sequence domain comprises…". There is insufficient antecedent basis for this limitation in the claim, as “stop-transfer-sequence” is first recited in claim 2.
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 (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.
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.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakamoto2.
Regarding claim 1, Sakamoto teaches Notch1 without LNR (and consequently, without NRR; see claim interpretation above), and a chimeric derivative of DIEGF-NdEGF that lacks LNR (namely DIEGF-NdECD; see Sakamoto, e.g., at Fig.2A and page 285, left hand column second part). These variants were created to explore the roles of LNR in mediating Notch protein processing. These Notch1 derivatives were smaller and retained their susceptibility to constitutive processing at S1 (see Sakamoto, e.g., at Fig.2D).
Claims 1-4, 6, 8-10, 13, 18-20, 31-33, 35-36, 40, 51-52, 55, 62, 66 and 75-76 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choe3.
Regarding claim 1, 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 2, 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).
Accordingly, claims 1-4, 6, 8-10, 13, 18-20, 31-33, 35-36, 40, 51-52, 55, 62, 66 and 75-76 are rejected.
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 1-4, 6, 8-10, 13, 18-20, 23-25, 31-36, 40, 51-52, 55, 62, 66 and 75-76 are rejected under 35 U.S.C. 103 as being unpatentable over Choe (supra) in view of Rosmalen6 and Hoffman7.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection (see “Claim Interpretation” section). Additional claim interpretations are set forth below.
Regarding claims 1-4, 6, 8, 10, 13, 18-20, 31-33, 34.b., 34.c., 35-36, 40, 51-52, 55, 62, 66 and 75-76, the disclosures of Choe are discussed above and are incorporated herein. 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 (see alignment in Fig. 1 below).
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.
Regarding claims 23-25 and 34 (in particular, 34.a.), 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).
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 1-4, 6, 8-10, 13, 18-20, 23-25, 31-36, 40, 51-52, 55, 62, 66 and 75-76 are rejected.
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Fig. 1: Instant SEQ ID NO: 17 (Qy) aligned with Choe SEQ ID NO: 235 (Db).
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 1-4, 6, 8-10, 13, 18-20, 23-25, 31-36, 40, 51-52, 55, 62, 66 and 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 1-4, 6, 8-10, 13, 18-20, 23-25, 31-36, 40, 51-52, 55, 62, 66 and 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 variants8 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 1-4, 6, 8-10, 13, 18-20, 23-25, 31-36, 40, 51-52, 55, 62, 66 and 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 1-4, 6, 8-10, 13, 18-20, 23-25, 31-36, 40, 51-52, 55, 62, 66 and 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 variants9 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 1-4, 6, 8-10, 13, 18-20, 23-25, 31-36, 40, 51-52, 55, 62, 66 and 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 both anticipation and obviousness analyses.
Anticipation Analysis: Regarding claims 1-4, 6, 8-10, 13, and 18-20, the reference patent claims recite essentially verbatim the instant claims, and thus, anticipates the instant claims.
Obviousness Analysis: Regarding claims 23-25, 31-36, 40, 51-52, 55, 62, 66 and 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 1-4, 6, 8-10, 13, 18-20, 23-25, 31-36, 40, 51-52, 55, 62, 66 and 75-76 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 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 both anticipation and obviousness analyses.
Anticipation Analysis: Regarding claims 1-4, 6, 8, 10, 13, 18-20, 36, 40, 51-52, 55, 62, 66 and 75-76, the reference patent claims recite essentially verbatim the instant claims.
Obviousness Analysis: Regarding claims 23-25 and 31-35, 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.
Conclusion
Claims 1-4, 6, 8-10, 13, 18-20, 23-25, 31-36, 40, 51-52, 55, 62, 66 and 75-76 are rejected.
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 - 6PM PT.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 Vajdos et al. “Comprehensive Functional Maps of the Antigen binding Site of an Anti-ErbB2 Antibody Obtained with Shotgun Scanning Mutagenesis”. J Mol Biol. 2002; 320(2):415-428. See, e.g., Figure 2, effects of CDR mutations on binding affinity.
2 Sakamoto et al. "Distinct roles of EGF repeats for the Notch signaling system", EXPERIMENTAL CELL RESEARCH, ELSEVIER, AMSTERDAM, NL, vol. 302, no. 2, 15 January 2005 (2005-01-15), pages 281 – 291.
3 WO2019099689A1; cited on the IDS
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 Rosmalen et al. "Tuning the flexibility of glycine-serine linkers to allow rational design of multidomain proteins." Biochemistry 56.50 (2017): 6565-6574.
7 WO2006125668A2
8 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”
9 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”