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 .
1. Formal Matters
A. In the response filed 12/22/25, Applicants elected the species of SEQ ID NO:54 and 73. However, upon further review, all species have been examined.
B. Claims 1-3, 5-7, 9-12 and 21 are pending and are the subject of this Office Action.
2. Information Disclosure Statement
A. Reference 157 on the 43-page IDS submitted 5/25/23 has been lined through since there is no retrieval date provided.
B. Reference 190 on the 43-page IDS submitted 5/25/23 has been lined through since no date has been provided.
C. Reference 203 on the 43-page IDS submitted 5/25/23 has been lined through since there is no retrieval date provided.
D. Reference 204 on the 43-page IDS submitted 5/25/23 has been lined through since there is no retrieval date provided.
E. References 230-233 on the 43-page IDS submitted 5/25/23 have been lined through since no dates have been provided.
F. Reference 251 on the 43-page IDS submitted 5/25/23 has been lined through since no date has been provided.
G. Reference 268 on the 43-page IDS submitted 5/25/23 has been lined through since no date has been provided.
H. References 17, 18 and 19 on the 14-page IDS submitted 12/22/25 has been lined through since no date has been provided.
I. References 28 and 43 on the 9-page IDS submitted 12/22/25 has been lined through since no date has been provided.
J. References 38 on the 23-page IDS submitted 12/22/25 has been lined through since no date has been provided.
K. References 19, 27 and 30 on the 10-page IDS submitted 12/22/25 has been lined through since no date has been provided.
3. Specification
The use of at least the term Guava® [paragraph 000263], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The Examiner performed a cursory review, but Applicants are urged to perform a more thorough review of the specification.
4. Claim Rejections - 35 USC § 112(a) – scope of enablement
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claim 21 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating autoimmunity and solid tumors, does not reasonably provide enablement for treating any other condition recited in claim 21 (which generically recites “treatment”), nor for prevention of any disease or condition. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The breadth of the claims is excessive with regard to claiming a general “method of treatment” by administering. Applicants’ specification, only provides guidance and working examples of the effects of CD3 antibodies on T cells and solid tumors. Applicants’ exemplified bispecific antibody, targeting CD3-PSMA, provides guidance in the treatment of prostate cancer (Example 5), as well as T-cell proliferation (Example 7). In support of this, the prior art teaches that CD3 antibodies are involved in the treatment of autoimmunity (Chatenoud et al.) and in the targeting of solid tumors (Ishiguro et al.).
However, again, the breadth of claim 21 is excessive since it is not limited to any specific treatment, nor, based on the specification and prior art, is it predictable to one of ordinary skill in the art how to treat any conditions other than autoimmunity and solid tumors.
Furthermore, the term “treatment” is also defined in paragraph [0140] of the specification to encompass prophylaxis, which the specification defines as “completely preventing a disease. Applicants provide no guidance or working examples of achieving this, nor is it predictable to one of ordinary skill in the art how to completely prevent a disease in 100% of the subjects.
Applicants may, without adding new matter, consider using a limitation such as “reducing the likelihood”, or a similar phrase.
These factors lead the Examiner to hold that undue experimentation is necessary to practice the invention as claimed.
5. 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.
A. Claims 1, 2, 5, 6, 7, 9, 10, 11, 12 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Trinklein et al. (U.S. Patent No. 11,505,606) in view of Silva et al., further in view of Arduin et al. and further in view of Liu et al.
The claims are generally drawn to a multispecific antibody comprising various mutations in the first and second heavy chain and further comprising a CD3 antibody.
Claim 5 of Trinklein teaches the instant antibody (patent SEQ ID NO:1 is identical to instant SEQ ID NO:42. Patent SEQ ID NO:19 is identical to instant SEQ ID NO:43), meeting instant claims 1, 6 and 7. See the sequence comparison below. Patent claim 16 meets instant claim 2. Patent claim 4 meets instant claim 5. Column 18, lines 38-40 of Trinklein meet instant claim 9. Patent claims 10 and 11 meet instant claims 10 and 11. Claim 1 of Trinklein teach instant claim 12. Column 4, line 56 – column 5, line 2 meet instant claim 21.
Trinklein does not teach the mutations recited in instant claim 1. However, Silva does teach S228P, which can significantly limit IgG4 antibodies to undergo Fab-arm Exchange and help to improve pharmacological understanding and therapeutic benefit (e.g. page 5462, right column, first full paragraph; Discussion).
Neither Trinklein, nor Silva teach 234A/235A. However, Arduin teach (Abstract; Introduction) these Fc silencing mutations and state –
the substitutions of two leucine (L) residues to alanine (A) at position 234 and 235 (e.g. LALA) were demonstrated to reduce Fc binding to FcgRs…and consequently to decrease ADCC as well to reduce complement binding/activation
None of Trinklein, Silva or Arduin teach T366W, T366S, L368A and Y407V. However, Liu teaches (first paragraph under “Conclusion”) T366W as a knob for IgG4 antibodies and T366S, L368A and Y407V as the hole. Liu teaches that these “knob-into-hole” mutations “allow for the production of bispecific antibodies without causing a change in conformational dynamics or a meaningful change is stability” (second column, first paragraph).
SEQ ID NO:42
Patent No. 11505606
GENERAL INFORMATION
APPLICANT: TENEOBIO, INC.
TITLE OF INVENTION: CD3 BINDING ANTIBODIES
FILE REFERENCE: TNO-0010-US2
CURRENT APPLICATION NUMBER: US/16/332,665A
CURRENT FILING DATE: 2019-03-12
PRIOR APPLICATION NUMBER: 16/332,655
PRIOR FILING DATE: 2019-03-12
PRIOR APPLICATION NUMBER: PCT/US2017/038377
PRIOR FILING DATE: 2017-06-20
PRIOR APPLICATION NUMBER: 62/491,908
PRIOR FILING DATE: 2017-04-28
PRIOR APPLICATION NUMBER: 62/394,360
PRIOR FILING DATE: 2016-09-14
NUMBER OF SEQ ID NOS: 48
SEQ ID NO 1
LENGTH: 123
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 100.0%; Score 654; Length 123;
Best Local Similarity 100.0%;
Matches 123; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLVESGGGLVQPGRSLRLSCAASGFTFDDYAMHWVRQAPGKGLEWVSGISWNSGSIGY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVESGGGLVQPGRSLRLSCAASGFTFDDYAMHWVRQAPGKGLEWVSGISWNSGSIGY 60
Qy 61 ADSVKGRFTISRDNAKNSLYLQMNSLRAEDTALYYCAKDSRGYGDYRLGGAYWGQGTLVT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNAKNSLYLQMNSLRAEDTALYYCAKDSRGYGDYRLGGAYWGQGTLVT 120
Qy 121 VSS 123
|||
Db 121 VSS 123
SEQ ID NO:43
US-16-332-665A-19
Filing date in PALM: 2019-03-12
Sequence 19, US/16332665A
Patent No. 11505606
GENERAL INFORMATION
APPLICANT: TENEOBIO, INC.
TITLE OF INVENTION: CD3 BINDING ANTIBODIES
FILE REFERENCE: TNO-0010-US2
CURRENT APPLICATION NUMBER: US/16/332,665A
CURRENT FILING DATE: 2019-03-12
PRIOR APPLICATION NUMBER: 16/332,655
PRIOR FILING DATE: 2019-03-12
PRIOR APPLICATION NUMBER: PCT/US2017/038377
PRIOR FILING DATE: 2017-06-20
PRIOR APPLICATION NUMBER: 62/491,908
PRIOR FILING DATE: 2017-04-28
PRIOR APPLICATION NUMBER: 62/394,360
PRIOR FILING DATE: 2016-09-14
NUMBER OF SEQ ID NOS: 48
SEQ ID NO 19
LENGTH: 107
TYPE: PRT
ORGANISM: Homo sapiens
Qy 1 EIVMTQSPATLSVSPGERATLSCRASQSVSSNLAWYQQKPGQAPRLLIYGASTRATGIPA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVMTQSPATLSVSPGERATLSCRASQSVSSNLAWYQQKPGQAPRLLIYGASTRATGIPA 60
Qy 61 RFSGSGSGTEFTLTISSLQSEDFAVYYCQQYNNWPWTFGQGTKVEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTEFTLTISSLQSEDFAVYYCQQYNNWPWTFGQGTKVEIK 107
B. Claims 1, 2, 3, 5, 6, 7, 9, 10, 11, 12 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Trinklein et al. in view of van Schooten et al. (WO 2020/206330 – reference 21 on the IDS filed 5/19/23).
The teachings of Trinklein are seen in the above rejection. Trinklein does not teach the mutations in claim 1, nor the sequence in claim 3. However, van Schooten does teach these mutations (paragraph [0087] as well as a bivalent CD3 antibody comprising instant SEQ ID NO:54 and 55 (SEQ ID NO:84 and 85, respectively, below), meeting instant claims 1 and 12. See also Figures 5A-5C in conjunction with, for example, claim 37. Methods of treating are also taught (claim 60).
SEQ ID NO:54
ID BIK57857 standard; protein; 229 AA.
XX
AC BIK57857;
XX
DT 26-NOV-2020 (first entry)
XX
DE IgG4 hinge-CH2-CH3 mutant S228P/F234A/L235A/T366S/L368A/Y407V SEQ: 84.
XX
OS Homo sapiens.
OS Synthetic.
XX
CC PN WO2020206330-A1.
XX
CC PD 08-OCT-2020.
XX
CC PF 03-APR-2020; 2020WO-US026686.
XX
PR 05-APR-2019; 2019US-0830130P.
XX
CC PA (TENE-) TENEOBIO INC.
XX
CC PI Van Schooten W, Clarke S, Dang K, Buelow B;
XX
DR WPI; 2020-98049G/087.
XX
CC PS Disclosure; SEQ ID NO 84; 84pp; English.
XX
SQ Sequence 229 AA;
Query Match 100.0%; Score 1233; Length 229;
Best Local Similarity 100.0%;
Matches 229; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ESKYGPPCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ESKYGPPCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWY 60
Qy 61 VDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISK 120
Qy 121 AKGQPREPQVYTLPPSQEEMTKNQVSLSCAVKGFYPSDIAVEWESNGQPENNYKTTPPVL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 AKGQPREPQVYTLPPSQEEMTKNQVSLSCAVKGFYPSDIAVEWESNGQPENNYKTTPPVL 180
Qy 181 DSDGSFFLVSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK 229
|||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 DSDGSFFLVSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK 229
SEQ ID NO:55
AC BIK57858;
XX
DT 26-NOV-2020 (first entry)
XX
DE Human IgG4 hinge-CH2-CH3 mutant S228P/F234A/L235A/T366W SEQ: 85.
SQ Sequence 229 AA;
Query Match 100.0%; Score 1243; Length 229;
Best Local Similarity 100.0%;
Matches 229; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ESKYGPPCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ESKYGPPCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWY 60
Qy 61 VDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISK 120
Qy 121 AKGQPREPQVYTLPPSQEEMTKNQVSLWCLVKGFYPSDIAVEWESNGQPENNYKTTPPVL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 AKGQPREPQVYTLPPSQEEMTKNQVSLWCLVKGFYPSDIAVEWESNGQPENNYKTTPPVL 180
Qy 181 DSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK 229
|||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 DSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK 229
C. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Trinklein et al., in view of Silva et al., further in view of Arduin et al., further in view of Liu et al. and further in view of van Schooten et al.
The teachings of Trinklein, Silva, Arduin and Liu are seen in paragraph A of this section. None teach thee sequences in claim 3. However, van Schooten, also discussed in paragraph B of this section, does.
6. Nonstatutory 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.
U.S. Patent No. 12,180,298
A. Claims 1, 6, 7, 10-12 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-15 and 19 of U.S. Patent No. 12,180,298 (17/601,417) in view of Silva et al., further in view of Arduin et al. and further in view of Liu et al. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a multispecific antibody which bind CD3. The antibodies have the same HCVD and LCVD (patent SEQ ID NO:65 and 66 vs instant SEQ ID NO:42 and 43, respectively). The antibodies of ‘298 would be expected to have, or it would have been obvious to have had, heavy chain subunits and a light chain constant region, based on the desired structure/function, meeting claims 10 and 11. Instant claim 12 is met by patent claim 1, which is drawn to PSMA (instant claim 12 being generic). The pharmaceutical composition of patent claim 19 makes the method of treatment of instant claim 21 obvious.
The patent does not teach the mutations of claim 1. However, Silva, Arduin and Liu do (the teachings are seen above under 35 USC 103). It would have been obvious to have paired the antibody of the patent with Silva, Arduin and Liu for the reasons discussed above under 35 USC 103.
B. Claims 2 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12,180,298 (17/601,417) in view of Silva et al., further in view of Arduin et al., further in view of Liu et al. and further in view of claims 4 and 16 of U.S. Patent No. 11,505,606.
The teachings of Silva, Arduin and Liu are seen above under 35 USC 103. None of these, nor the ‘298 patent teach the lack of a CH1 domain (instant claim 2), nor a human VH framework and human Vkappa framework (instant claim 5). However, ‘606 does. See claims 16 and 4, respectively.
C. Claims 3 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12,180,298 (17/601,417) in view of van Schooten (WO 2020/206330).
The teachings of van Schooten are seen above under 35 USC 103 (rejection B). Neither this, nor the ‘298 patent teach the sequences in claim 3, nor a monovalent or bivalent CD3 antibody. However, van Schooten does.
U.S. Patent No. 11,505,606
D. Claims 1, 2, 5, 6, 7, 10, 11, 12 and 21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 7, 10, 11, 16, 27 and 28 of U.S. Patent No. 11,505,606 (16/332,665) in view of Silva et al., further in view of Arduin et al. and further in view of Liu et al. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a multispecific antibody comprising a CD3-binding component and a non-CD3-binding component (patent claims 1 and 2 and instant claim 12, claim 12 being generic). Patent claim 1(i)A and the recited light chain are identical to SEQ ID NO:36-41 in instant claim 1. Additionally, patent SEQ ID NO:1 and 19 are identical to instant SEQ ID NO:42 and 43, respectively (see patent claim 5, 7 and instant claims 6, 7). Patent claim 16 meets instant claim 2. Patent claim 4 meets instant claim 5. Patent claims 10 and 11 meet instant claims 10 and 11, respectively.
Though the patent does not claim treatment, claims 27 and 28 render instant claim 21 obvious.
E. Claims 3 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,505,606 (16/332,665) in view of van Schooten (WO 2020/206330).
The teachings of van Schooten are seen above under 35 USC 103 (rejection B). Neither this, nor the ‘606 patent teach the sequences in claim 3, nor a monovalent or bivalent CD3 antibody. However, van Schooten does.
U.S. Patent No. 11,421,027
F. Claims 1, 6, 7 and 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 8, 11 and 14 of U.S. Patent No. 11,421,027 (17/492,444) in view of Silva et al., further in view of Arduin et al. and further in view of Liu et al. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to essentially the same bispecific antibodies comprising an identical CD3-bind component (patent SEQ ID NO:1 and 19 are identical to instant SEQ ID NO:42 and 43, respectively) and a non-CD3-binding component (the instant claims being generic). Patent claim 1, 8, 11 and 14 meet instant claim 1, 6 and 7. The antibodies of ‘027 would be expected to have, or it would have been obvious to have had, heavy chain subunits and a light chain constant region, based on the desired structure/function, meeting claims 10 and 11.
G. Claims 2 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,421,027 (17/492,444) in view of Silva et al., further in view of Arduin et al., further in view of Liu et al. and further in view of claims 4 and 16 of U.S. Patent No. 11,505,606.
The teachings of Silva, Arduin and Liu are seen above under 35 USC 103. None of these, nor the ‘027 patent teach the lack of a CH1 domain (instant claim 2), nor a human VH framework and human Vkappa framework (instant claim 5). However, ‘606 does. See claims 16 and 4, respectively.
H. Claims 3 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,421,027 (17/492,444) in view of van Schooten (WO 2020/206330).
The teachings of van Schooten are seen above under 35 USC 103 (rejection B). Neither this, nor the ‘027 patent teach the sequences in claim 3, nor a monovalent or bivalent CD3 antibody. However, van Schooten does.
U.S. Patent No. 11,390,681
I. Claims 1, 2, 6, 7 and 9-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 13, 15 and 16 of U.S. Patent No. 11,390,681 (17/347,553) in view of Silva et al., further in view of Arduin et al. and further in view of Liu et al. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to essentially the same bispecific antibodies comprising an identical CD3-bind component (patent SEQ ID NO:49 and 56 comprise instant SEQ ID NO:43 and 42, respectively). The antibodies of ‘681 would be expected to have, or it would have been obvious to have had, heavy chain subunits and a light chain constant region, based on the desired structure/function, meeting claims 10 and 11. Patent claims 6 and 16 meet instant claim 2. Patent claims 4 and 5 meet instant claim 9. CD19 is a tumor-specific antigen, meeting instant claim 12.
J. Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,390,681 (17/347,553) in view of Silva et al., further in view of Arduin et al., further in view of Liu et al. and further in view of claim 4 of U.S. Patent No. 11,505,606.
The teachings of Silva, Arduin and Liu are seen above under 35 USC 103. None of these, nor the ‘027 patent teach a human VH framework and human Vkappa framework (instant claim 5). However, ‘606 does.
K. Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,390,681 (17/347,553) in view of van Schooten (WO 2020/206330).
The teachings of van Schooten are seen above under 35 USC 103 (rejection B). Neither this, nor the ‘553 patent teach the sequences in claim 3. However, van Schooten does.
U.S. Patent No. 11,186,639
L. Claims 1, 2, 6, 7 and 9-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 13, 15 and 16 of U.S. Patent No. 11,186,639 (17/308,946) in view of Silva et al., further in view of Arduin et al. and further in view of Liu et al. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to essentially the same bispecific antibodies comprising an identical CD3-bind component (patent SEQ ID NO:49 and 56 comprise instant SEQ ID NO:43 and 42, respectively). The antibodies of ‘639 would be expected to have, or it would have been obvious to have had, heavy chain subunits and a light chain constant region, based on the desired structure/function, meeting claims 10 and 11. Patent claims 6 and 16 meet instant claim 2. Patent claims 4 and 5 meet instant claim 9.
J. Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,186,639 (17/308,946) in view of Silva et al., further in view of Arduin et al., further in view of Liu et al. and further in view of claim 4 of U.S. Patent No. 11,505,606.
The teachings of Silva, Arduin and Liu are seen above under 35 USC 103. None of these, nor the ‘639 patent teach a human VH framework and human Vkappa framework (instant claim 5). However, ‘606 does.
K. Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,390,681 (17/347,553) in view of van Schooten (WO 2020/206330).
The teachings of van Schooten are seen above under 35 USC 103 (rejection B). Neither this, nor the ‘639 patent teach the sequences in claim 3. However, van Schooten does.
Application No. 18/393,099
L. Claims 1, 2, 6, 7 and 9-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 87-97 and 109-126 of copending Application No. 18/393,099 (reference application) in view of Silva et al., further in view of Arduin et al. and further in view of Liu et al. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to polynucleotides and methods of making the instantly claimed bispecific antibodies comprising an identical CD3-bind component (patent SEQ ID NO:49 and 56 comprise instant SEQ ID NO:43 and 42, respectively).
Both recite heavy and light chains, which would comprise any constant region. Both also recite a bivalent configuration, as well as lacking the CH1 domain. The instant claims are generic to the copending claims; therefore, BCMA, or any defined sequences would have been obvious.
Copending claims 98-108 are not currently included since the instant claims do not recite SEQ ID NO:75. However, any amendment to the instant claims to recite this sequence may warrant a double patenting rejection.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
M. Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/393,099 (reference application) in view of van Schooten (WO 2020/206330).
The teachings of van Schooten are seen above under 35 USC 103 (rejection B). Neither this, nor the copending application teach the sequences in claim 3. However, van Schooten does.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
N. Claim 5 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/393,099 (reference application) in view of Silva et al., further in view of Arduin et al., further in view of Liu et al. and further in view of claim 4 of U.S. Patent No. 11,505,606.
The teachings of Silva, Arduin and Liu are seen above under 35 USC 103. None of these, nor the ‘639 patent teach a human VH framework and human Vkappa framework (instant claim 5). However, ‘606 does.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
7. Prior Art of Interest Not Relied Upon
Zhang et al. teaches that removing the CH1 domain removes binding of light chain to the heavy chain, with the advantages of small size, high solubility, and deep tissue penetration for research and therapy. Conventional IgG antibodies rely on the CH1 domain to pair with a light chain, but removing it allows the variable heavy (VHH) domain to function as a single antigen-binding unit.
8. Conclusion
No claim is allowable.
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/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647