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
Election/Restrictions
Applicant’s election without traverse of group 1 (claims 1-5 and 12) with species of SEQ ID NO: 2 in the reply filed on 12/1/2025 is acknowledged.
Claims 12, 14-35 and 37-127 have been cancelled.
Claims 1-11, 13, 36, and 128-130 are pending.
Claims 3, 5, 6-11, 13, 36, and 129-130 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species (claim 3 and 5), there being no allowable generic or linking claim.
Claims 1-2, 4, and 128, drawn to an isolated polypeptide or polypeptide complex comprising the amino acid sequence of SEQ ID NO: 2 (elected) or a variant thereof with 1, 2 of 3 amino acid substitutions, additions, or deletions, that impairs binding of anti-CD3 binding domain to CD3, are examined on merits.
In this Office action, terms polypeptide and peptide are interchangeable.
Information Disclosure Statement
The information disclosure statement (s) (IDS) submitted on 9/25/2023, 5/28/2024, and 10/18/2024 are/is considered by the examiner and initialed copies/copy of the PTO-1449 are/is enclosed.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Written Description:
peptide having 1, 2, 3 amino acid substitutions, additions or deletions of SEQ ID NO: 2 that impairs binding of an-anti-CD3 domain to CD3.
Claims 1 and 128 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Possession may be shown. For claimed product the specification must provide sufficient distinguishing identifying characteristics of the genus, including disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, level of skill and knowledge in the art, and predictability in the art or any combination thereof.
The claims are broadly drawn to
An isolated polypeptide or polypeptide complex comprising a peptide that impairs binding of an anti-CD3 binding domain to cluster of differentiation 3 (CD3) wherein the peptide comprises an amino acid sequence selected from SEQ ID NOs: 2 or the peptide comprises 1, 2, or 3, amino acid substitutions, additions, or deletions relative to an amino acid sequence selected from SEQ ID NOs: 2,
A pharmaceutical composition comprising: (i) the polypeptide or polypeptide complex of claim 1.
Thus, the claims are including a genus of fragments, variants of wild type peptide of SEQ ID NO: 2 or peptide complex comprising anti-CD3 antigen binding fragment, which have ability to impair binding of anti-CD3 binding domain to CD3.
The specification teaches that a peptide or a peptide complex that impairs binding of an anti-CD3 binding domain to CD3 in healthy tissue, which could be used for cancer treatment (abstract, [0029+ and 0034+]). The specification then teaches numbers of 14 amino acid peptides including elected SEQ ID NO: 2 (VYCGPEFDESVGCM) and peptide complex comprising anti-CD3-binding domain linked to the peptide of SEQ ID NO: 2 (anti-CD3 -Linker-peptide) ([0003]+ and [0031]+ and figures). The specification also teaches a few of anti-CD3 antibodies linked to the peptide (table 2). The specification teaches in vitro assays of binding of anti-CD3 antibody to the peptide of SEQ ID NO:2 and tumor cell killing with the peptide complex (examples). The specification also contemplates the peptide variants (Z1-Z2-C- Z4-P-Z6-Z7-Zs- Z9-Z10-Z11- Z12- C-Z14) with up to 11 amino acid alternation ([0031] that have the same function as the wild type peptide of SEQ ID NO: 2.
However, the specification does not teach or provide evidence of results that any peptide variant with up to 3 amino acid substitutions, deletions or additions of the peptide SEQ ID NO: 2 that could perform the same function as the wild type of the peptide of SEQ ID NO: 2.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or by describing structural features common the genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.” The Federal Circuit has recently clarified that a DNA molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristic, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “Id. At 1324, 63 USPQ2d at 1613”.
The court has since clarified that this standard applies to compounds other than cDNAs. See University of Rochester v. G.D. Searle & Co., Inc., F.3d ,2004 WL 260813, at *9 (Fed.Cir.Feb. 13, 2004). The instant specification fails to provide sufficient descriptive information in the broadly claimed variants of the peptide of SEQ ID NO: 2 having the function of impairing anti-CD3 binding domain to antigen CD3. The specification does not provide a specific or detail structural characteristics of the variant in sequence defined structure. Thus, one of skill in the art would reasonably conclude that the inventor(s), at the time the application was filed, did not have possession of the claimed invention.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the 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.
As stated in the Written Description Guideline (2008), the levels of the skill and knowledge in the art would not be able to identify without further testing which of these fragments or variants could perform the function once the amino acid are substituted or added or deleted based on the lack of knowledge and predictability in the art those of ordinary skill in the art would not conclude that the applicant was in possession of the claimed genus of the fragments or variant based on the teaching of the wild type peptide of SEQ ID NO: 2.
Since the instant specification provides no sufficient descriptive information or representative numbers of variants from the peptide of SEQ ID NO: 2 as claimed, one of skill in the art would reasonably conclude that the inventor(s), at the time the application was filed, did not have possession of the claimed invention.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “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 page 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 at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure(s) and functional attribute(s) of the encompassed genus of functional variants having at least 80% sequence identity as claimed, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Therefore, only the polypeptide consisting of the sequence of SEQ ID NO: 2 and a polypeptide complex comprising the polypeptide linked to an anti-CD3 binding domain, but not the full breadth of the claims, meets the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Applicant may also refer to Written Description Guideline at USPTO website:
http://www.uspto.gov/web/patents/guides.htm
Example 9-protein variant and Example 10 (95% identity)
Improper Markush grouping
Claims 1-2 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 706.03(y).
The Markush grouping of the polypeptide or polypeptide complex is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
each of the polypeptide has unique sequence which is not shared by other sequences. The elected peptide of SEQ ID NO: 2, VYCGPEFDESVGCM, does not have common feature in the sequence with others in the list.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 102
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)(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.
Claim(s) 1-2, 4 and 128 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Campbell et al (WO 2022/094299, filed on Oct 30, 2020) as evidenced by sequence alignment.
The applied reference has a common applicant and inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Campbell et al disclose a peptide (P3 or P4) having identical sequence and length as the instant SEQ ID NO: 2 as evidenced by sequence alignment below. Campbell et al disclose the P3 peptide complexed with anti-CD3 binding domain D to impair D binding to its antigen CD3. Campbell et al disclose that the peptide P3 or P4 could be a variant of CD3 protein having 75-99% sequence identity to a fragment of CD3. Campbell et al further teach a complex comprising the peptide-linker-anti-CD3 binding domain having formula as P3-L3-D--- [0336-346]. Campbell et al teach a pharmaceutical composition comprising the peptide, or the complex thereof and pharmaceutically acceptable excipient [0635-641].
QY=SEQ ID NO: 2
ID BKZ53930 standard; peptide; 14 AA.
DT 16-JUN-2022 (first entry)
DE Antibody construct related P3 peptide, SEQ ID 162.
KW antibody therapy; breast tumor; cancer; carcinoma; cytostatic;
KW hematological neoplasm; leukemia; lung tumor; lymphoma;
KW non-small-cell lung cancer; sarcoma; solid tumor; therapeutic.
CC PN WO2022094299-A2.
CC PD 05-MAY-2022.
CC PF 29-OCT-2021; 2021WO-US057384.
PR 30-OCT-2020; 2020US-0107942P (priority to).
PR 09-DEC-2020; 2020US-0123327P.
PR 09-DEC-2020; 2020US-0123329P.
PR 25-JAN-2021; 2021US-0141268P.
PR 12-MAY-2021; 2021US-0187690P.
PR 12-MAY-2021; 2021US-0187699P.
PR 12-MAY-2021; 2021US-0187719P.
PR 18-MAY-2021; 2021US-0189843P.
CC PA (JANU-) JANUX THERAPEUTICS INC.
CC PI Campbell D,Diraimondo TR;
DR WPI; 2022-58751E/047.
CC PT New multispecific antibody comprising cluster of differentiation 28
CC PT binding domain and programmed death-ligand 1 binding domain, used to
CC PT treat cancer, hematological malignancy, leukemia,lymphoma, and solid
CC PT tumor.
Query Match 100.0%; Score 83; Length 14;
Best Local Similarity 100.0%;
Matches 14; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VYCGPEFDESVGCM 14
||||||||||||||
Db 1 VYCGPEFDESVGCM 14
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
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 (MPEP 9th Ed, Feb 2023).
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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).
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.
Over Patents:
1. Claims 1-2, 4 and 128 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-22, and 24 of U.S. Patent No. 11,555,078 (original application 17/544539). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same polypeptide or polypeptide complex that binds to anti-CD3 binding molecule. The claims of ‘078 patent comprising the structure of an antibody, which are narrowly drawn than the instant claims and would thus anticipate the instant claims.
The instant claims are drawn to
An isolated polypeptide or polypeptide complex comprising a peptide that impairs binding of an anti-CD3 binding domain to cluster of differentiation 3 (CD3) wherein the peptide comprises an amino acid sequence selected from SEQ ID NOs: 2 or the peptide comprises 1, 2, or 3, amino acid substitutions, additions, or deletions relative to an amino acid sequence selected from SEQ ID NOs: 2,
wherein the peptide comprises the amino acid sequence of SEQ ID NO: 2,
A pharmaceutical composition comprising: (i) the polypeptide or polypeptide complex of claim 1.
The claims of U.S. Patent ‘078 are drawn to
An isolated polypeptide or polypeptide complex according to Formula I:
A2-A1-L1-P1-H1 (Formula I)
wherein: A1 comprises a first antigen recognizing molecule that binds to an effector cell antigen, wherein the effector cell antigen comprises CD3, wherein A1 comprises complementarity determining regions (CDRs): HC-CDR1, HC-CDR2, and HC-CDR3, wherein the HC-CDR1, the HC-CDR2, and the HC-CDR3 of Ai comprise: HC-CDR1: SEQ ID NO: 1, HC-CDR2: SEQ ID NO: 2, and HC-CDR3: SEQ ID NO: 3; and Ai comprises CDRs: LC-CDR1, LC-CDR2, and LC- CDR3, wherein the LC-CDR1, the LC-CDR2, and the LC-CDR3 of Ai comprise LC-CDR1:SEQ ID NO: 4, LC-CDR2: SEQ ID NO:5, and LC-CDR3: SEQ ID NO: 6;
P1 comprises a peptide that binds to A1 (claim 1),
wherein the P1 peptide comprises the sequence of SEQ ID NO: 19 or 93 (claims 22 and 24).
The P1 peptide sequences of SEQ ID NO: 19 and 93 set forth in claims 22 and 24 have the identical sequence as the instant SEQ ID NO: 2 as sequence alignment:
QY= SEQ ID NO: 2
US-17-544-539-19
Patent No. 11555078
US-17-544-539-93
Patent No. 11555078
GENERAL INFORMATION
APPLICANT: JANUX THERAPEUTICS, INC.
TITLE OF INVENTION: COMPOSITIONS AND METHODS RELATED TO TUMOR ACTIVATED ANTIBODIES
TITLE OF INVENTION: TARGETING PSMA AND EFFECTOR CELL ANTIGENS
FILE REFERENCE: 52426-730.201
CURRENT APPLICATION NUMBER: US/17/544,539
SEQ ID NO 19 and 93
LENGTH: 14
Query Match 100.0%; Score 83; Length 14;
Best Local Similarity 100.0%;
Matches 14; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VYCGPEFDESVGCM 14
||||||||||||||
Db 1 VYCGPEFDESVGCM 14
Both sets of the claims are drawn to the same polypeptide or polypeptide complex comprising the identical sequence linked to an anti-CD3 binding domain. The difference is the claims of ‘078 patent comprises antibody structure with CDR sequences. Thus, the claims ‘078 patent have narrow scope and would anticipate the present claims.
2. Claims 1-2, 4 and 128 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 and 18-26 of U.S. Patent No. 12,433,953 (original application 18/919,094). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to polypeptide or polypeptide complex that binds to anti-CD3-binding molecule. The claims of ‘953 patent comprise the antibody structure, which are narrowly drawn than the instant claims and would thus anticipate the instant claims.
The instant claims are set forth above.
The claims of U.S. Patent ‘953 are drawn to
An isolated polypeptide or polypeptide complex according to Formula I:
A2-A1-L1-P1-H1 (Formula I)
wherein: A1 comprises a first antigen recognizing molecule that binds to an effector cell antigen, wherein the effector cell antigen comprises CD3, wherein A1 comprises complementarity determining regions (CDRs): HC-CDR1, HC-CDR2, and HC-CDR3, wherein the HC-CDR1, the HC-CDR2, and the HC-CDR3 of Ai comprise: HC-CDR1: SEQ ID NO: 1, HC-CDR2: SEQ ID NO: 2, and HC-CDR3: SEQ ID NO: 3; and Ai comprises CDRs: LC-CDR1, LC-CDR2, and LC- CDR3, wherein the LC-CDR1, the LC-CDR2, and the LC-CDR3 of Ai comprise LC-CDR1:SEQ ID NO: 4, LC-CDR2: SEQ ID NO:5, and LC-CDR3: SEQ ID NO: 6;
P1 comprises a peptide that binds to A1 (claim 1),
wherein the P1 peptide comprises the sequence of SEQ ID NO: 25 or 811 set forth in claims 12 and 13).
The peptide sequences of SEQ ID NO: 25 and 811 (claims 12 and 13) have the identical sequence as the instant SEQ ID NO: 2 as sequence alignment below:
QY=SEQ ID NO: 2
US-18-919-094-25
Patent No. 12433953
US-18-919-094-811
Patent No. 12433953
APPLICANT: JANUX THERAPEUTICS, INC.
TITLE OF INVENTION: COMPOSITIONS AND METHODS RELATED TO TUMOR ACTIVATED ANTIBODIES
TITLE OF INVENTION: TARGETING EGFR AND EFFECTOR CELL ANTIGENS
FILE REFERENCE: 52426-738.831
CURRENT APPLICATION NUMBER: US/18/559,201
SEQ ID NO 25 and 811
ALIGNMENT:
Query Match 100.0%; Score 83; Length 14;
Best Local Similarity 100.0%;
Matches 14; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VYCGPEFDESVGCM 14
||||||||||||||
Db 1 VYCGPEFDESVGCM 14
Both sets of the claims are drawn to the same polypeptide and polypeptide complex comprising the identical polypeptide sequence or the sequence linked to an anti-CD3 binding domain. The difference is the claims of ‘953 patent comprising the antibody structure with CDR sequences that have narrow scope and would anticipate the present claims.
Over Applications:
1. Claims 1-2, 4 and 128 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 9, 25, 36-37, 69, 89-92 of copending Application No. 18/256271. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same polypeptide or polypeptide complex that binds to anti-CD3-binding molecule. The claims of ‘271 application comprise the antibody structure, which are more narrowly drawn than the instant claims and would thus anticipate the instant claims.
The instant claims are set forth above.
The claims of application ‘271 are drawn to
An isolated polypeptide or polypeptide complex according to Formula I:A2-A1-L1-P1-H1 (Formula I) wherein: Ai comprises a first antigen recognizing molecule that binds to an effector cell antigen, wherein the effector cell antigen comprises CD3, wherein Ai comprises complementarity determining regions (CDRs): HC-CDR1, HC-CDR2, and HC-CDR3, wherein the HC-CDR1, the HC-CDR2, and the HC-CDR3 of Ai comprise: HC-CDR1: SEQ ID NO: 1, HC-CDR2: SEQ ID NO: 2, and HC-CDR3: SEQ ID NO: 3; and Ai comprises CDRs: LC-CDR1, LC-CDR2, and LC- CDR3, wherein the LC-CDR1, the LC-CDR2, and the LC-CDR3 of Ai comprise LC-CDR1:SEQ ID NO: 4, LC-CDR2: SEQ ID NO:5, and LC-CDR3: SEQ ID NO: 6;Pi comprises a peptide that binds to A1;L1 comprises a linking moiety that connects A to P1…..
wherein P1 comprise the sequence of SEQ ID NO: 27 or 216 set forth in claims 69 and 92.
The peptide sequences of SEQ ID NO: 27 and 216 (claims 69 and 92) have the identical sequence as the instant SEQ ID NO: 2 as sequence alignment below:
US-18-256-271-27
Sequence 27, US/18256271
US-18-256-271-216
Sequence 216, US/1825627
APPLICANT: JANUX THERAPEUTICS, INC.
TITLE OF INVENTION: COMPOSITIONS AND METHODS RELATED TO TUMOR ACTIVATED ANTIBODIES
TITLE OF INVENTION: TARGETING TROP2 AND EFFECTOR CELL ANTIGENS
FILE REFERENCE: 52426-729.601
CURRENT APPLICATION NUMBER: US/18/256,271
CURRENT FILING DATE: 2023-06-07
PRIOR APPLICATION NUMBER: 63/187,719
PRIOR FILING DATE: 2021-05-12
PRIOR APPLICATION NUMBER: 63/123,327
PRIOR FILING DATE: 2020-12-09
SEQ ID NO 27 and 216
ALIGNMENT:
Query Match 100.0%; Score 83; Length 14;
Best Local Similarity 100.0%;
Matches 14; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VYCGPEFDESVGCM 14
||||||||||||||
Db 1 VYCGPEFDESVGCM 14
Both sets of the claims are drawn to the same polypeptide and polypeptide complex comprising the identical polypeptide sequence or the sequence linked to an anti-CD3 binding domain. The difference is the claims of ‘271 application comprising the antibody structure with CDR sequences that have narrow scope and would anticipate the present claims.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
2. Claims 1-2, 4 and 128 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 31-59 of copending Application No. 18/055932 (continuation of US Patent No11,555, 078 original application 17/544539 above). Although the conflicting claims are not identical, they are not patentably distinct from each other because the ‘932 application claims a method of using the same material claimed in the instant application, the claims of the ‘932 application would anticipate the presently claimed invention.
The instant claims are set forth above.
The claims of application ‘932 are drawn to
A method of treating prostate cancer in a subject, the method comprising administering to the subject a therapeutically effective amount of a polypeptide or polypeptide complex according to Formula I:A2-A1-L1-P1-H1 (Formula I) wherein: Ai comprises a first antigen recognizing molecule that binds to an effector cell antigen, wherein A1 comprises an anti-CD3 binding molecule comprising complementarity determining regions (CDRs): HC-CDR1, HC-CDR2, and HC-CDR3, wherein the HC-CDR1, the HC-CDR2, and the HC-CDR3 of Ai comprise: HC-CDR1: SEQ ID NO: 1, HC-CDR2: SEQ ID NO: 2, and HC-CDR3: SEQ ID NO: 3; and Ai comprises CDRs: LC-CDR1, LC-CDR2, and LC-CDR3, wherein the LC-CDR1, the LC-CDR2, and the LC-CDR3 of A comprise LC-CDR1: SEQ ID NO: 4, LC-CDR2: SEQ ID NO: 5, and LC-CDR3: SEQ ID NO: 6;Pi comprises a peptide that binds to A1, wherein Pi comprises an amino acid sequence according to U1-U2-C-U4-P-U6-U7-U8-U9-U10-U11-U2-C-U4 and U1 is selected from D, Y, F, I, N, V, H, L, A, T, S, and P; U2 is selected from D, Y, L, F, I, N, A, V, H, T, and S; U4 is selected from G and W; U6 is selected from E, D, V, and P; U7 is selected from W, L, F, V, G, M, I, and Y; U8 is selected from E, D, P, and Q; U9 is selected from E, D, Y, V, F, W, P, L, and Q; Uio is selected from S, D, Y, T, I, F, V, N, A, P, L, and H; U11 is selected from I, Y, F, V, L, T, N, S, D, A, and H; U12 is selected from F, D, Y, L, I, V, A, N, T, P, S, G, and H; and U14 is selected from D, Y, N, F, I, P, V, A, T, H, L, M, and S;
wherein P1 comprises the amino acid sequence of SEQ ID NO: 93 or 19 (claims 58-59).
The application ‘932 is a continuation of the US Patent 11,555,078. The sequences of SEQ ID NOs: 93 and 19 have identical sequence as instant SEQ ID NO: 2 as sequence alignment set forth above in the parent ‘078 Patent. Since the ‘932 application claims a method of using the same material that is claimed in the instant application, the claimed material of the ‘932 application would anticipate the presently claimed invention.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Applicant is noted that all the peptide sequence alignments can be viewed in ScvUi search results for details.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lei Yao, whose telephone number is (571) 272-3112. The examiner can normally be reached on 8:00am-6:00pm Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEI YAO/Primary Examiner, Art Unit 1642