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 .
Claim Status
Claims 5-11, 13, 24-44, 46-47, 49, 51, 53, 55-56 are cancelled. Claims 1-4, 12, 14-23, 45, 48, 50, 52, and 54 are pending.
Claims 21-23, 45, 48, 50, 52, and 54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/20/2026.
Applicant elected Invention I, drawn to an IgM-multimerized single-domain antibody that binds receptor tyrosine kinase (ROR1). Within Invention I, applicant elected the following species:
an IgM-multimerized single-domain antibody comprising a CDR set comprising a CDR1 as set forth in SEQ ID NO: 32, a CDR2 as set forth in SEQ ID NO: 20, and a CDR3 as set forth in SEQ ID NO: 33 according to IMGT;
an IgM-multimerized single-domain antibody comprising a sequence having at least 90% sequence identity to the sequence as set forth in SEQ ID NO: 5;
an IgM-multimerized single-domain antibody comprising a sequence as set forth in SEQ ID NO: 5;
a multimerizing fragment comprising the sequence as set forth in SEQ ID NO: 38;
an anti-CD19 binding domain comprising a CDR set comprising a CDRH1 as set forth in SEQ ID NO: 62, a CDRH2 as set forth in SEQ ID NO: 63, and a CDRH3 as set forth in SEQ ID NO: 64, a CDRL1 as set forth in SEQ ID NO: 59, a CDRL2 as set forth in SEQ ID NO: 60, and a CDRL3 as set forth in SEQ ID NO: 61; and
a binding domain of the immune cell engaging molecule binds CD3.
Claims 1-4, 12, and 14-20, drawn to the elected invention and species, are currently under consideration for patentability under 37 CFR 1.104.
Priority
This application claims benefit of Provisional U.S. Application No. 63/388,164 filed on 07/11/2022. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claims 1-4, 12, and 14-20 have an effective filing date of 07/11/2022 corresponding to Provisional U.S. Application No. 63/388,164.
Information Disclosure Statement
The information disclosure statement filed on 08/04/2023 has been considered. Signed copies are enclosed.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 2-3, the phrase "a sequence" renders the claims indefinite because the exact identity of the antibody is unclear as this phrasing includes fragments.
For the purposes of claim interpretation, “a sequence” will be treated as “the sequence.”
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.
Claims 1-3, 12, and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 17, 19-24, and 26 of U.S. Patent No. 12600801 (referred to as Pat. ‘801, filed 2023-07-11, claims priority to PRO 63/388,157 filed 2022-07-11) in view of US 11739154 B2 (referred to as US ‘154, filed 2018-09-10).
Instant claim 1
Instant claim 1 teaches an IgM-multimerized single-domain antibody that binds receptor tyrosine kinase (ROR1), comprising a set of CDRs comprising:
a CDR1 having the sequence as set forth in SEQ ID NO: 6, a CDR2 having the sequence as set forth in SEQ ID NO: 7, and a CDR3 having the sequence as set forth in SEQ ID NO: 8 according to IMGT;
a CDR1 having the sequence as set forth in SEQ ID NO: 9, a CDR2 having the sequence as set forth in SEQ ID NO: 10, and a CDR3 having the sequence as set forth in SEQ ID NO: 11 according to Kabat;
a CDR1 having the sequence as set forth in SEQ ID NO: 12, a CDR2 having the sequence as set forth in SEQ ID NO: 13, and a CDR3 having the sequence as set forth in SEQ ID NO: 11 according to Chothia;
a CDR1 having the sequence as set forth in SEQ ID NO: 14, a CDR2 having the sequence as set forth in SEQ ID NO: 15, and a CDR3 having the sequence as set forth in SEQ ID NO: 8 according to North;
a CDR1 having the sequence as set forth in SEQ ID NO: 16, a CDR2 having the sequence as set forth in SEQ ID NO: 17, and a CDR3 having the sequence as set forth in SEQ ID NO: 18 according to Contact;
a CDR1 having the sequence as set forth in SEQ ID NO: 19, a CDR2 having the sequence as set forth in SEQ ID NO: 20, and a CDR3 having the sequence as set forth in SEQ ID NO: 21 according to IMGT;
a CDR1 having the sequence as set forth in SEQ ID NO: 22, a CDR2 having the sequence as set forth in SEQ ID NO: 23, and a CDR3 having the sequence as set forth in SEQ ID NO: 24 according to Kabat;
a CDR1 having the sequence as set forth in SEQ ID NO: 25, a CDR2 having the sequence as set forth in SEQ ID NO: 26, and a CDR3 having the sequence as set forth in SEQ ID NO: 24 according to Chothia;
a CDR1 having the sequence as set forth in SEQ ID NO: 27, a CDR2 having the sequence as set forth in SEQ ID NO: 28, and a CDR3 having the sequence as set forth in SEQ ID NO: 21 according to North;
a CDR1 having the sequence as set forth in SEQ ID NO: 29, a CDR2 having the sequence as set forth in SEQ ID NO: 30, and a CDR3 having the sequence as set forth in SEQ ID NO: 31 according to Contact;
a CDR1 having the sequence as set forth in SEQ ID NO: 32, a CDR2 having the sequence as set forth in SEQ ID NO: 20, and a CDR3 having the sequence as set forth in SEQ ID NO: 33 according to IMGT;
a CDR1 having the sequence as set forth in SEQ ID NO: 34, a CDR2 having the sequence as set forth in SEQ ID NO: 23, and a CDR3 having the sequence as set forth in SEQ ID NO: 24 according to Kabat;
a CDR1 having the sequence as set forth in SEQ ID NO: 35, a CDR2 having the sequence as set forth in SEQ ID NO: 26, and a CDR3 having the sequence as set forth in SEQ ID NO: 33 according to Chothia;
a CDR1 having the sequence as set forth in SEQ ID NO: 36, a CDR2 having the sequence as set forth in SEQ ID NO: 28, and a CDR3 having the sequence as set forth in SEQ ID NO: 33 according to North;
a CDR1 having the sequence as set forth in SEQ ID NO: 29, a CDR2 having the sequence as set forth in SEQ ID NO: 30, and a CDR3 having the sequence as set forth in SEQ ID NO: 37 according to Contact;
a CDR1 having the sequence as set forth in SEQ ID NO: 32, a CDR2 having the sequence as set forth in SEQ ID NO: 20, and a CDR3 having the sequence as set forth in SEQ ID NO: 21 according to IMGT;
a CDR1 having the sequence as set forth in SEQ ID NO: 35, a CDR2 having the sequence as set forth in SEQ ID NO: 26, and a CDR3 having the sequence as set forth in SEQ ID NO: 24 according to Chothia; or
a CDR1 having the sequence as set forth in SEQ ID NO: 36, a CDR2 having the sequence as set forth in SEQ ID NO: 28, and a CDR3 having the sequence as set forth in SEQ ID NO: 21 according to North
and a multimerizing fragment of an IgM Fc region.
Claim 1 of Pat. ‘801 teaches a single-domain antibody that binds ROR1, comprising a set of CDRs that are identical to those recited in (i-xviii) of instant claim 1 with the same SEQ ID NOs.
Claim 1 of Pat. ‘801 does not teach a single-domain antibody comprising a multimerizing fragment of an IgM Fc region, reciting “the single-domain antibody is not linked to an IgM Fc region or multimerizing fragment thereof” (last 2 lines).
US ‘154 teaches single-domain antibodies and their modifications, stating “single domain antibodies [sdAbs]… lack an Fc region, and thus sdAb-Fc fusions may be prepared” (¶ 59) and multimerization of the antibody “may be formed using the multimerization domains” (¶ 92).
US ‘154 further teaches “[t]he antibody may be ‘humanized’ using any suitable method known in the art, for example, but not limited to CDR grafting and veneering. Humanization of an antibody comprises replacing an amino acid in the sequence with its human counterpart, as found in the human consensus sequence, without loss of antigen-binding ability or specificity; this approach reduces immunogenicity of the antibody when introduced into human subjects. In the process of CDR grafting, one or more than one of the heavy chain CDR defined herein may be fused or grafted… to other human antibody (IgA, IgD, IgE, IgG, and IgM) or fragment framework regions” (¶ 76, emphasis added).
US ‘154 does not teach a single-domain antibody that binds receptor tyrosine kinase (ROR1).
Single-domain antibody modifications, including a multimerizing fragment of an IgM Fc region, were known and used prior to the effective filing date of the instant application. In addition, the instant application, Pat. ‘801, and US ‘154 are in analogous arts (i.e. single-domain antibodies). Since US ‘154 teach a humanized antibody reduces immunogenicity in human subjects while retaining binding specificity, there is motivation for fusing a single-domain antibody to an IgM Fc region, which also has the capability of multimerizing.
MPEP § 2141(III)(G) states a rationale that may support a conclusion of obviousness includes “[s]ome teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.” MPEP § 2143(I)(G) states this rationale should explain why “[a] person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006).
The teaching, suggestion, or motivation in the prior art (i.e. a humanized antibody reduces immunogenicity in human subjects while retaining binding specificity as taught in US ‘154) would have led one of ordinary skill to modify Pat. ‘801 (i.e. a single-domain antibody that binds ROR1 as taught in Pat. ‘801 wherein the antibody is fused to a multimerizing fragment of an IgM Fc region) to arrive at the claimed invention. There is a reasonable expectation of success as both single-domain antibody modifications, including a multimerizing fragment of an IgM Fc region, were known and used prior to the effective filing date of the instant application. In addition, the instant application, Pat. ‘801, and US ‘154 are in analogous arts (i.e. single-domain antibodies).
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the instant application to fuse a multimerizing fragment of an IgM Fc region to a single-domain antibody as taught in US ’154 in a single-domain antibody that binds ROR1 as taught in Pat. ‘801.
Instant claims 2-3
Instant claims 2-3 teach the IgM-multimerized single-domain antibody that binds ROR1 comprises a sequence with 90% sequence identity to one of the sequences set forth in SEQ ID NOs: 1-5 or comprises one of the sequences set forth in SEQ ID NOs: 1-5.
Claims 2-3 of Pat. ‘801 teach the single-domain antibody that binds ROR1 comprises a sequence with 90% sequence identity to one of the sequences set forth in SEQ ID NOs: 1-5 or comprises one of the sequences set forth in SEQ ID NOs: 1-5. SEQ ID NOs: 1-5 of Pat. ‘801 are identical to SEQ ID NOs: 1-5 of the instant application.
Instant claims 12 and 14
Instant claim 12 teaches the IgM-multimerized single-domain antibody that binds ROR1 comprises at least one binding domain that binds ROR1 and at least one binding domain that binds CD19. Instant claim 14 teaches the anti-CD19 binding domain comprises (i) HCDR1-3 as SEQ ID NOs: 62-64 and LCDR1-3 as SEQ ID NOs: 59-61 or (ii) HCDR1-3 as SEQ ID NOs: 68-70 and LCDR1-3 as SEQ ID NOs: 65-67.
Claim 17 of Pat. ‘801 teach the single-domain antibody that binds ROR1 comprises at least one binding domain that binds ROR1 and a CD19 binding domain. Claim 19 of Pat. ‘801 teaches the anti-CD19 binding domain comprises (i) HCDR1-3 as SEQ ID NOs: 66-68 and LCDR1-3 as SEQ ID NOs: 63-65 or (ii) HCDR1-3 as SEQ ID NOs: 72-74 and LCDR1-3 as SEQ ID NOs: 69-71. These sequences are identical to those of instant claim 14 (SEQ ID NOs: 62-64, 59-61, 68-70, and 65-67 of the instant application are identical to SEQ ID NOs: 66-68, 63-65, 72-74, and 69-71 of Pat. ‘801 respectively).
Instant claims 15-20
Instant claims 15-16 teach the IgM-multimerized single-domain antibody that binds ROR1 wherein at least one binding domain binds an immune cell engaging molecule that activates a B cell, T cell, natural killer (NK) cell, or macrophage. Instant claim 17 teaches the T cell is a CD3 T cell, a CD4 T cell, a CD8 T cell, a central memory T cell, an effector memory T cell, and/or a naive T cell. Instant claims 18-19 teach the binding domain of the immune cell engaging molecule binds CD3, CD28, CD8, NKG2D, CD8, CD16, KIR2DL4, KIR2DS1, KIR2DS2, KIR3DS1, NKG2C, NKG2E, NKG2D, NKp30, NKp44, NKp46, NKp80, DNAM-1, CD11b, CD11c, CD64, CD68, CD119, CD163, CD206, CD209, F4/80, IFGR2, Toll-like receptors 1-9, IL-4Ra, or MARCO. Instant claim 20 teaches the anti-CD3 binding domain comprises HCDR1-3 as SEQ ID NOs: 78-80 and LCDR1-3 as SEQ ID NOs: 75-77.
Claims 20-21 of Pat. ‘801 teach the single-domain antibody that binds ROR1 also binds an immune cell engaging molecule that activates a B cell, T cell, natural killer (NK) cell, or macrophage. Claim 22 of Pat. ‘801 teaches the T cell is a CD3 T cell, a CD4 T cell, a CD8 T cell, a central memory T cell, an effector memory T cell, and/or a naive T cell. Claims 23-24 of Pat. ‘801 teaches the binding domain of the immune cell engaging molecule binds CD3, CD28, CD8, NKG2D, CD8, CD16, KIR2DL4, KIR2DS1, KIR2DS2, KIR3DS1, NKG2C, NKG2E, NKG2D, NKp30, NKp44, NKp46, NKp80, DNAM-1, CD11b, CD11c, CD64, CD68, CD119, CD163, CD206, CD209, F4/80, IFGR2, Toll-like receptors 1-9, IL-4Ra, or MARCO. Claim 26 of Pat. ‘801 teaches the anti-CD3 binding domain comprises HCDR1-3 as SEQ ID NOs: 82-84 and LCDR1-3 as SEQ ID NOs: 79-81. These sequences are identical to those of instant claim 20 (SEQ ID NOs: 78-80 and 75-77 of the instant application are identical to SEQ ID NOs: 82-84 and 79-81 Pat. ‘801 respectively).
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12600801 (referred to as Pat. ‘801, filed 2023-07-11, claims priority to PRO 63/388,157 filed 2022-07-11) in view of US 11739154 B2 (referred to as US ‘154, filed 2018-09-10), US 20210380701 A1 (referred to as US ‘701, published 2021-12-09), US 11401337 B2 (referred to as US ‘337, filed 2018-04-06), and US 20200239572 A1 (referred to as US ‘572, published 2020-07-30).
Instant claims 1 and 4
Instant claim 1 is unpatentable over claim 1 of Pat. ‘801 in view of US ‘154 as delineated above.
Instant claim 4 teaches the multimerizing fragment comprises one of the sequences set forth in SEQ ID NO: 38 or SEQ ID NOs: 40-48.
The claims of Pat. ‘801 and US ‘154 do not teach these sequences.
US ‘701 teaches IgM multimerizing antibodies (¶ 0003, “Antibodies and antibody-like molecules that can multimerize, such as IgA and IgM antibodies”) and their sequences. SEQ ID NOs: 38 and 40-42 of the instant application are SEQ ID NOs: 3, 6, 1, and 60 of US ‘701 respectively (see table below for a summary).
US ‘701 does not teach a single domain antibody that binds ROR1 nor SEQ ID NOs: 43-48.
US ‘337 teaches IgM multimerizing antibodies (¶ 2, “Antibodies of the IgM isotype are multimeric”) and their sequences. SEQ ID NO: 43 of the instant application is SEQ ID NO: 4 of US ‘337 (see table below for a summary).
US ‘337 does not teach a single domain antibody that binds ROR1 nor SEQ ID NOs: 38, 40-42, and 44-48.
US ‘572 teaches IgM multimerizing antibodies (¶ 0003, “Antibodies and antibody-like molecules that can multimerize, such as IgA and IgM antibodies”) and their sequences. SEQ ID NOs: 44-48 of the instant application are SEQ ID NOs: 13, 14, 34, 31, and 32 of US ‘572 respectively (see table below for a summary).
US ‘572 does not teach a single domain antibody that binds ROR1 nor SEQ ID NOs: 38 and 40-43.
Published US Application
Instant Application SEQ ID NO
Prior art SEQ ID NO
US 20210380701 A1
38
3
40
6
41
1
42
60
US 11401337 B2
43
4
US 20200239572 A1
44
13
45
14
46
34
47
31
48
32
Pat. ‘801, US ‘154, US ‘701, US ‘337, and US ‘572 are considered analogous to the present invention as they are all in the same field of antibodies. It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the application to utilize (i) a multimerizing fragment comprising one of the sequences set forth in SEQ ID NO: 38 or SEQ ID NOs: 40-48 and (ii) a single domain antibody that binds ROR1 comprising the CDRs as delineated in instant claim 1 because:
Pat. ‘801 teaches a single domain antibody that binds ROR1 comprising the CDRs as delineated in instant claim 1,
US ‘701, US ‘337, and US ‘572 teach a multimerizing fragment comprising one of the sequences set forth in SEQ ID NO: 38 or SEQ ID NOs: 40-48, and
US ‘154 teaches a single domain antibody can be fused to a multimerizing fragment of an IgM Fc region in order to reduce immunogenicity in human subjects while retaining binding specificity.
The prior art includes each element prior to the effective filing date of the application, the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference. A person having ordinary skill in the art prior to the effective filing date of the application would be motivated to combine a single domain antibody that binds ROR1 (comprising the CDRs as delineated in instant claim 1 as taught in Pat. ‘801) and a multimerizing fragment (comprising one of the sequences set forth in SEQ ID NO: 38 or SEQ ID NOs: 40-48 as taught US ‘701, US ‘337, and US ‘572) because a single domain antibody can be fused to a multimerizing fragment of an IgM Fc region in order to reduce immunogenicity in human subjects while retaining binding specificity as taught in US ‘154.
MPEP 2143(I)(A) states, “The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).”
US ‘154 teaches a single domain antibody can be fused to a multimerizing fragment of an IgM Fc region, with US ‘701, US ‘337, and US ‘572 teaching the specific sequences for the multimerizing fragment, indicating said modification to a single domain antibody that binds ROR1 would be successful. A person having ordinary skill in the art would recognize the results of the combination were predictable and have a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Art-Free Subject Matter
It is noted that the protein sequences of SEQ ID NOs: 5, 20, 32-33, 59-61, and 62-64 were thoroughly searched corresponding to the limitations of the claims and are free of prior art.
The closest prior art to the above sequences are summarized in the table below. Note that no sequences in the prior art are 100% identical to SEQ ID NOs: 5, 20, 32-33, 59-61, and 62-64 of the instant application.
Application Name
Instant SEQ ID NO
Prior Art SEQ ID NO
Sequence Identity
WO 2017154868 A1
(published 09/14/2017)
5
177
58%
WO 2017154868 A1
(published 09/14/2017)
32, 20, and 33
177
56%
US 20230381233 A1
(filed 09/08/2020)
59-61
51
95%
US 20220298240 A1
(filed 06/21/2019)
62-64
5
96%
The closest prior art to claims 1-4, 12, and 14-20, taking into account the species election, is Yang et al. (Therapeutic potential and challenges of targeting receptor tyrosine kinase ROR1 with monoclonal antibodies in B-cell malignancies, PLoS One, 2011;6[6]:e21018). Yang et al. teach anti-ROR1 monoclonal antibodies, either as Fabs or fused to IgG1 Fc domains (Pg. 1, Abstract, Methodology, “Chimeric rabbit/human Fab and IgG1 were investigated for their capability to bind to human and mouse ROR1”). Yang et al. does not teach the sequences of the instant application, an IgM-multimerized antibody, an anti-CD19 binding domain, nor an anti-CD3 binding domain.
Conclusion
Claims 5-11, 13, 24-44, 46-47, 49, 51, 53, 55-56 are cancelled. Claims 1-4, 12, 14-23, 45, 48, 50, 52, and 54 are pending. Claims 21-23, 45, 48, 50, 52, and 54 are withdrawn from further consideration Claims 1-4, 12, and 14-20 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica M Priest whose telephone number is (571)272-8469. The examiner can normally be reached Mon-Fri 8am-5pm.
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/J.M.P./Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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