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
The amendment filed April 27, 2026, is acknowledged and has been entered. Claims 75 and 80 have been amended.
The election without traverse filed April 27, 2026, is acknowledged and have been entered. Applicant has elected a species of an antibody having a heavy chain sequence of SEQ ID NO: 75 and a light chain sequence of SEQ ID NO: 82 which comprise a heavy chain variable domain of SEQ ID NO: 15 and a light chain variable domain of SEQ ID NO: 16, respectively. Applicant further notes that the elected species of antibody includes a heavy chain CH1-CH2-CH3 sequence of SEQ ID NO: 155 comprising a lysine to cysteine substitution at amino acid position 105 and deletion of a threonine at amino acid positions 106 and 108, and a light chain CL sequence of SEQ ID NO: 157 having a valine to cysteine substitution at amino acid position 98. The elected species of antibody is encompassed by claims 75-77, 79, 80, 85, 86, and 97-102.
Claims 75-102 are pending.
Claims 78, 81-84 and 87-96 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of invention, there being no allowable generic or linking claim.
Claims 75-77, 79, 80, 85, 86, and 97-102 are under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 80 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In this case, claim 80 recites “The nucleic acid of claim 79, wherein the antibody comprises the light chain CL sequence of SEQ ID NO: 157 comprising a valine to cysteine substitution at amino acid position 98, but claim 79 recites that the light chain sequence comprises SEQ ID NO: 82, which already defines the light chain CL sequence.
Therefore, claim 80 fails to further limit the subject matter of the claim upon which it depends. It is suggested that claim 80 be canceled to obviate the rejection.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory 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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 75-77, 79, 80, 85, 86, and 97-102 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-13, 15-21, 24 and 41-60 of copending Application No 17/630, 824 in view of Reilly et al (WO 2017/201204 A1, IDS). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
As drawn to the elected species, the instant claims recite nucleic acids encoding a MET antibody having a heavy chain sequence of SEQ ID NO: 75 and a light chain sequence of SEQ ID NO: 82 which comprise a heavy chain variable domain of SEQ ID NO: 15 and a light chain variable domain of SEQ ID NO: 16, respectively (see claim (see claims 79 and 86). Dependent claims 97-102 recite expression vector(s) comprising said nucleic acids, recombinant cells comprising said expression vectors and methods of producing the antibody by culturing said cells under conditions sufficient for producing the antibody.
The claims of the copending application recite a MET antibody having a heavy chain variable domain of SEQ ID NO: 146 (100% identical to instant SEQ ID NO: 15) and a light chain variable domain of SEQ ID NO: 284 (100% identical to instant SEQ ID NO: 16).
Reilly et al disclose MET antibodies that comprise a heavy chain constant region of SEQ ID NO:82 (100% identical to the heavy chain constant region of instant SEQ ID NO: 75) and a light chain constant region of SEQ ID NO:83 that has a V205C mutation (100% identical to the light chain constant region of instant SEQ ID NO: 82) (see pages 21-22 and 69) used in making antibody drug conjugates. Reilly et al disclose nucleic acids encoding the Met antibodies, expression vector(s) comprising said nucleic acids, recombinant cells comprising said expression vectors and methods of producing the antibody by culturing said cells under conditions sufficient for producing the antibody (see pages 33-36).
Accordingly, in view of the copending claims and the reference, it would have obvious to one of ordinary skill in the art to add the heavy chain constant region and light chain constant region of Reilly to the Met antibody of the copending claims (which would a result in MET antibody having a heavy chain sequence of SEQ ID NO: 75 and a light chain sequence of SEQ ID NO: 82) by engineering nucleic acids that encode such an antibody because such constant regions were known to allow production of MET antibody drug conjugates that can treat cancer. Notably, to make such an antibody, one would need nucleic acids encoding the antibody, expression vectors comprising the nucleic acids and to culture a host cell transformed with the nucleic acid to make the antibody, such that the instant methods, nucleic acids encoding the antibody, expression vectors comprising the nucleic acids and host cells are not patentably distinct from the copending claims. Such nucleic acids and the other claims would be seen as combining elements according to known methods to yield predictable results.
Therefore, the conflicting claims are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 75-77, 79, 80, 85, 86, and 97-102 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 14-15 and 23-28 of copending Application No 18/535,713 in view of Reilly et al (WO 2017/201204 A1, IDS). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
As drawn to the elected species, the instant claims recite nucleic acids encoding a MET antibody having a heavy chain sequence of SEQ ID NO: 75 and a light chain sequence of SEQ ID NO: 82 which comprise a heavy chain variable domain of SEQ ID NO: 15 and a light chain variable domain of SEQ ID NO: 16, respectively (see claim (see claims 79 and 86). Dependent claims 97-102 recite expression vector(s) comprising said nucleic acids, recombinant cells comprising said expression vectors and methods of producing the antibody by culturing said cells under conditions sufficient for producing the antibody.
The claims of the copending application recite methods that administer a MET antibody drug conjugate having a heavy chain of SEQ ID NO: 75 (100% identical to instant SEQ ID NO: 75) and a light chain of SEQ ID NO: 82 (100% identical to instant SEQ ID NO: 82).
Reilly et al disclose MET antibodies that comprise a heavy chain constant region of SEQ ID NO:82 (100% identical to the heavy chain constant region of instant SEQ ID NO: 75) and a light chain constant region of SEQ ID NO:83 that has a V205C mutation (100% identical to the light chain constant region of instant SEQ ID NO: 82) (see pages 21-22 and 69) used in making antibody drug conjugates. Reilly et al disclose nucleic acids encoding the Met antibodies, expression vector(s) comprising said nucleic acids, recombinant cells comprising said expression vectors and methods of producing the antibody by culturing said cells under conditions sufficient for producing the antibody (see pages 33-36).
Accordingly, in view of the copending claims and the reference, to make such an antibody for use in the claimed copending methods, it would have obvious to one of ordinary skill in the art to engineer nucleic acids that encode such an antibody because the antibody would need to be produced. Notably, to make such an antibody, one would need nucleic acids encoding the antibody, expression vectors comprising the nucleic acids and to culture a host cell transformed with the nucleic acid to make the antibody, such that the instant methods, nucleic acids encoding the antibody, expression vectors comprising the nucleic acids and host cells are not patentably distinct from the copending claims. Such nucleic acids and the other claims would be seen as combining elements according to known methods to yield predictable results.
Therefore, the conflicting claims are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 75-77, 79, 80, 85, 86, and 97-102 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US Patent 12,331,125, IDS in view of Reilly et al (WO 2017/201204 A1, IDS). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
As drawn to the elected species, the instant claims recite nucleic acids encoding a MET antibody having a heavy chain sequence of SEQ ID NO: 75 and a light chain sequence of SEQ ID NO: 82 which comprise a heavy chain variable domain of SEQ ID NO: 15 and a light chain variable domain of SEQ ID NO: 16, respectively (see claim (see claims 79 and 86). Dependent claims 97-102 recite expression vector(s) comprising said nucleic acids, recombinant cells comprising said expression vectors and methods of producing the antibody by culturing said cells under conditions sufficient for producing the antibody.
The claims of the patent recite a MET antibody drug conjugate having a heavy chain of SEQ ID NO: 75 (100% identical to instant SEQ ID NO: 75) and a light chain of SEQ ID NO: 82 (100% identical to instant SEQ ID NO: 82).
Reilly et al disclose MET antibodies that comprise a heavy chain constant region of SEQ ID NO:82 (100% identical to the heavy chain constant region of instant SEQ ID NO: 75) and a light chain constant region of SEQ ID NO:83 that has a V205C mutation (100% identical to the light chain constant region of instant SEQ ID NO: 82) (see pages 21-22 and 69) used in making antibody drug conjugates. Reilly et al disclose nucleic acids encoding the Met antibodies, expression vector(s) comprising said nucleic acids, recombinant cells comprising said expression vectors and methods of producing the antibody by culturing said cells under conditions sufficient for producing the antibody (see pages 33-36).
Accordingly, in view of the copending claims and the reference, to make such an antibody as recited in the claims in the patent, it would have obvious to one of ordinary skill in the art to engineer nucleic acids that encode such an antibody because the antibody would need to be produced. Notably, to make such an antibody, one would need nucleic acids encoding the antibody, expression vectors comprising the nucleic acids and to culture a host cell transformed with the nucleic acid to make the antibody, such that the instant methods, nucleic acids encoding the antibody, expression vectors comprising the nucleic acids and host cells are not patentably distinct from the patented claims. Such nucleic acids and the other claims would be seen as combining elements according to known methods to yield predictable results.
Therefore, the conflicting claims are not patentably distinct from each other.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner can normally be reached on Monday through Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
July 8, 2026
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