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
Applicant’s reply filed on 01/23/2026 is acknowledged. Claims 1, 3, 16-17, and 21 have been amended. Claims 2, 7-10, 15 and 19-20 are cancelled. Claims 23-29 are newly added.
Claims 1, 3-6, 11-14, 16-18, and 21-29 are pending and under examination.
Information Disclosure Statement
The information disclosure statements filed 12/12/2024, 02/23/2026, 03/20/2026 have been considered and initialed copies have been enclosed herewith.
Objections and Rejections Withdrawn
The following objections and rejections are withdrawn in view of amendments filed 01/23/2026:
The objection to claims 3, 7-9, and 16-17 for informalities.
The rejection of claims 21 and 22 under 35 U.S.C. 112(a), scope of enablement.
The rejection of claims 1-5 and 13-15 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Loew (WO2019/178362A1).
The rejection of claims 1-5, 9-10, and 13-15 under 35 U.S.C. 103 as being unpatentable over Loew (WO2019/178362A1) in view of Cheung (US20170210819A1).
The rejection of claims 1-5, 11-12, and 13-15 under 35 U.S.C. 103 as being unpatentable over Loew (WO2019/178362A1) in view of Xu (US 2020/0283524 A1).
The rejection of claims 1-6, 13-18, and 21-22 under 35 U.S.C. 103 as being unpatentable over Loew (WO2019/178362A1) in view of Kralovics.
The rejection of claims 1-5, 9-10, 13-15, and 21-22 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 10-20 of copending Application No. 18/840,389 in view of Cheung (US20170210819A1).
The rejection of claims 1-5, 9-15, and 21-22 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 10-20 of copending Application No. 18/840,389 in view of Cheung (US20170210819A1) and further in view of Xu (US 2020/0283524 A1).
The rejection of claims 1-6, 9-10, 13-18, and 21-22 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 10-20 of copending Application No. 18/840,389 in view of Cheung (US20170210819A1) and further in view of Kralovics (US2017/0269092A1).
Rejections Maintained
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 11 and 12 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.
Claim 11 recites mutations Y349C, T366S, L368A, Y407V, S354C, T366W in an H chain, but does not define the numbering system. By providing mutations that are conventionally known in the context of EU numbering and also reciting SEQ ID NOs, it is not clear if the mutations are meant to be in reference to EU numbering or in reference to SEQ ID NO: 209 or 210.
Claim 12 recites that the bispecific antibody of claim 1 comprises a mutated Fc region of SEQ ID NO: 211 with one or more mutations L234A or L235 and it is not clear if those mutations are present in the disclosed Fc sequences. Claim 12 does not claim that the mutations are in the context of EU numbering.
Response to Applicants Arguments
Applicant's arguments filed 01/23/2026 have been fully considered but they are not persuasive.
The applicant argues that claims 11 and 12 are not indefinite because a skilled artisan would have no difficulty in identifying the mutated residues. The claimed mutations are in reference to the well-known EU numbering index, which is a widely-used convention for numbering the amino acid residues in the constant region of immunoglobulin G (IgG) heavy chains. (Remarks, Pg. 14)
In response, while the claimed mutations are known to one having ordinary skill in the art in the context of EU numbering of an IgG antibody, EU numbering is not claimed. Instead, claim 11 recites that the bispecific antibody comprises the Fc region of SEQ ID NO: 209 or 210. Similarly, claim 12 recites “a mutated Fc region of SEQ ID NO: 211” with substitutions at one or more locations to introduce L234A or L235A mutations. EU numbering is not claimed and it is not clear if SEQ ID NO: 211 comprises one or both of the mutations or if the sequence is the wild-type sequence to which the mutations are applied. Of note, SEQ ID NOs: 209, 210, and 211 are not full-length heavy chains as they are each only 217 amino acids long. If they are the base to which the mutations are applied then the EU numbering system cannot be used to claim mutations within these sequences.
As an additional consideration pertaining to claim 11, the claim indicates that a single Fc region can comprise one or more of any of the mutations Y349C, T366S, L368A, Y407V, S354C, or T366W, however, these mutations represent knob and hole mutations where the knob mutations (S354C, T366W) and hole mutations (Y349C, T366S, L368A, Y407V) would not be present on the same chain.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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
Claims 1, 3-6, 11-14, 16-18, 21-22 and newly added 23-29 remain/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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention.
The teachings of the specification and the claimed invention
Independent claim 1 is directed to a bispecific antibody comprising a first domain which specifically binds to a mutant calreticulin protein and second domain which specifically binds to a CD3 antigen. Claim 1 has been amended to provide the sequences of the binding domains required to perform the claimed binding functions, however the claim allows undefined mutations in the CDR binding regions. Dependent claims further disclose required characteristics and functions of the bispecific antibody and do not provide any structure that would facilitate these characteristics and functions.
The specification discloses bispecific antibodies set forth in SEQ ID NO: 110—115 (Pg. 84 and 85). The disclosed antibodies have 6 CDRs for each binding domain and the researchers provide evidence in Example 2 that the bispecific antibodies bind calreticulin (Pg. 85) and evidence in Example 3 that bispecific antibodies bind CD3 (Pg. 86).
The state of the relevant art
It is well established in the art that the formation of an intact antigen-binding site in an antibody usually requires the association of the complete heavy and light chain variable regions of a given antibody, each of which comprises three CDRs (or hypervariable regions) which provide the majority of the contact residues for the binding of the antibody to its target epitope. E.g., Almagro et. al., Front. Immunol. 2018; 8:1751 (see Section “The IgG Molecule” in paragraph 1 and Figure 1). While affinity maturation techniques can result in differences in the CDRs of the antibody compared to its parental antibody (page 3 “The IgG Molecule, second and third paragraphs), those techniques involve trial-and-error testing and the changes that maintain or improve affinity are not predictable a priori. E.g., id., (page 6 ending paragraph onto page 7).
The prior art teaches some understanding of the structural basis of antigen-antibody recognition, it is aptly noted that the art is characterized by a high level of unpredictability, since the skilled artisan still cannot accurately and reliably predict the consequences of amino acid substitutions, insertions, and deletions in the antigen-binding domains. For example, the unpredictability of single amino acid changes in an antibody is underscored by Winkler (J Immunol. 2000 Oct 15;165(8):4505-14) who teaches that a single amino acid change in a CDR can result in unpredictable and substantial changes in antibody specificity; see entire document (e.g., the abstract).
Similarly, Herold et al. (Sci Rep. 2017 Sep 25;7(1):12276) performed single- and double-point mutations in exemplary antibodies and found that a single point mutation in the VH CDR region can completely abolish antigen binding (Page 8, Paragraph 1, Line 11).
There are antibodies that bind to a mutated calreticulin known in the art. Stein (Leukemia, 2016 Jan;30(1):131-5) teaches all CALR mutations reported lead to a frameshift generating a new 36 amino-acid C-terminus and generation of a monoclonal antibody (CAL2) to this C-neoterminus by immunizing mice with a representative peptide (abstract). Kralovics (US2015/079091 A1; IDS filed 02/16/2023) teaches a method for diagnosing a myeloid malignancy comprising detecting the presence or absence of one or more mutant alleles in exon 9 of calreticulin (CALR), wherein the presence of one or more mutant alleles indicates a patient has, or is likely to have, a myeloid malignancy (claim 1), as well as calreticulin mutant sequences that comprise SEQ ID NO: 1 in Table 6.
Accordingly, one skilled in the art would be unable to predict or envision a genus of antibodies that bind to a cleaved mutated calreticulin and compete for binding with the antibodies as recited in the instant claims. Since the disclosure fails to describe a sufficient number of species to describe the claimed genus, it is submitted that the written description requirement of 35 U.S.C. 112(a) has not been met.
Claim analysis
Based on the teachings of the specification and the state of the relevant art, the claims have the following written description issues:
Claims 1 and 23-28 are directed to a bispecific antibody with CDRs having at least 80% homology to the recited CDRs. This allows for mutations that could abolish binding specificity.
Claims 1 and 23-28 recite mixing and matching of the CD3 OKT3 mutant CDRs. It is not clear from the disclosure if these CDRs are interchangeable to form functional CD3 binding domains. For example, a sequence search of the prior art and the instant disclosure do not support the existence of a heavy chain variable region comprising HCDRs set forth in SEQ ID NO: 28, 128, and 129, respectively. The claims should recite combinations that are supported by the art or the instant disclosure.
Claim 3 identifies the epitope of the antibodies, but claims undefined deletions, substitutions, and or additions that could abolish binding to the antibodies of claim 1.
Claims 4-6 claim inherent properties of the claimed antibodies, but as the antibodies allow for CDR mutation there is not enough guidance as to how the CDRs can be mutated and maintain these claimed functions/features.
Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, the artisan cannot envision the detailed structure of the encompassed antibodies and therefore Applicant was not in possession of the instant claimed invention. See Regents of the University of California v. Eli Lilly and Co. 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). Adequate written description of genetic material “'requires a precise definition, such as by structure, formula, chemical name, or physical properties,' not a mere wish or plan for obtaining the claimed chemical invention.” Id. 43 USPQ2d at 1404 (quoting Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606). The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter of the claim. Id. 43 USPQ2d at 1406. A description of what the genetic material does, rather than of what it is, does not suffice. Id.
In general, absent at least the conserved structure provided by all six CDRs of a parental antibody in the context of appropriate VH and VL framework sequences, the skilled artisan generally would not be able to visualize or otherwise predict, a priori, what an antibody with a particular set of functional properties would look like structurally. One of skill in the art would neither expect nor predict the appropriate functioning of the antibodies as broadly as is claimed. There is no disclosure of a correlation between structure and function that would allow those of skill in the art to recognize other members of the claimed genus from the disclosure.
Claims 3-6, 11-14, 16-18, and 21-29 are dependent on claim 1 or require the antibody of claim 1 and do not provide limitations that overcome the written description rejection.
Response to Applicants Arguments
The applicant argues that the rejection is obviated in view of amendments to claim 1 which provide structural description of the six CDRs of the binding domains of the bispecific antibody. (Remarks, Pg. 14)
In response, as described in the updated rejection above, claiming the CDRs based on 80% homology to the sequences allows for mutations such as deletions, substitutions, and additions in the CDRs that could abolish binding, and therefore does not fulfill the written description requirement.
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.
Application No. 17/434,619 (Notice of Allowance mailed 01/06/2026)
Claims 1, 3-6, 13-14, 16-18, 21-22 and newly added 23-28 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 15-20 of copending Application No. 17/434,619 in view of Cheung (US20170210819A1, published 07/27/2017, IDS filed 03/19/2025).
Regarding instant claims 1, 3-6, and 23-28, pertaining to a bispecific antibody comprising a first domain which specifically binds to a mutant calreticulin protein, ‘619 claims 1 and 3 disclose the anti-mutant calreticulin binding domain of the instant invention.
Application ‘619
Instant
SEQ ID NO: 17, 18, 19
SEQ ID NO: 5
SEQ ID NOs: 10, 11, 12
SEQ ID NO: 2
SEQ ID NO: 26, 27, 28
SEQ ID NO:8
SEQ ID NOs: 13, 14, 15
SEQ ID NO: 3
SEQ ID NO: 20, 21, 22
SEQ ID NO: 6
SEQ ID NO: 16, 17, 18
SEQ ID NO: 4
SEQ ID NO: 29, 30, 31
SEQ ID NO: 9
SEQ ID NO: 19, 20, 21
SEQ ID NO: 5
SEQ ID NO: 23, 24, 25
SEQ ID NO: 7
SEQ ID NO: 22, 23, 24
SEQ ID NO: 6
SEQ ID NO: 32, 33, 34
SEQ ID NO: 10
SEQ ID NO: 25, 26, 27
SEQ ID NO: 7
Regarding instant claims 16 and 17, pertaining to a method for detecting a mutant calreticulin protein, ‘619 claims 7-10 disclose a method for detecting mutant CALR protein comprising contacting the antibody with a sample.
Regarding instant claim 18, pertaining to a diagnostic method for a myeloproliferative neoplasm, ‘619 claims 10 and 11 disclose a method for diagnosing a myeloproliferative neoplasm comprising detecting a mutant calreticulin polypeptide in a sample.
Regarding instant claims 21 and 22, pertaining to a method for treatment of a hematologic tumor, ‘619 claim 12 discloses a therapeutic method for treating a myeloproliferative neoplasm.
‘619 does not disclose (1) the antibody is bispecific with a second domain which specifically binds CD3, (2) the sequence of the second binding domain, (3) that the antibody is humanized, or (4) a pharmaceutical composition comprising the antibody.
Regarding instant claims 1, 3-6, and 23-28, pertaining to the CDRs and the VH/VL of the second binding domain, Cheung discloses the CD3 scFv SEQ ID NO: 19 (Pg. 108, claim 8) which comprises:
Instant heavy chain CDRs set forth in instant SEQ ID NOs: 28, 29, 30
Instant heavy chain CDRs set forth in instant SEQ ID NOs: 31, 32, 33
Instant VH set forth in in SEQ ID NO: 8
Instant VL set forth in SEQ ID NO: 9
The alignment of Cheung SEQ ID NO: 19 and the instant claimed sequences is shown below:
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973
1466
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Regarding instant claim 13, pertaining to the antibody type, Cheung teaches the antibody can be chimeric or humanized ([0062], Lines 1-4).
Regarding instant claims 14, pertaining to a pharmaceutical composition comprising the bispecific antibody for treatment or diagnosis of a myeloproliferative neoplasm, Cheung teaches a pharmaceutical composition comprising a therapeutically effective amount of the bispecific antibody and a pharmaceutically acceptable carrier (Pg. 109, claim 63).
It would have been obvious to one having ordinary skill in the art (1) to combine the anti-mutant calreticulin binding domain into a bispecific antibody with a second domain which specifically binds CD3, (2) that the CD3 binding region comprises the sequences of Cheung, (3) that the antibody is human, humanized or chimeric, and (4) that the antibody would be formulated into a pharmaceutical composition. One would have been motivated to do so because (1) Cheung teaches the general motif of a TAAxCD3 bispecific antibody, (2) Cheung discloses the CD3-specific scFv sequences as part of a functional bispecific antibody, (3) human, humanized, and chimeric antibodies can be used in treating humans, and (4) formulating in pharmaceutical composition is required for use in treatment. There would be an expectation of success in using the anti-CD3 binding domain of Cheung in a bispecific antibody construct with the anti-mutant calreticulin binding domain of ‘619 because Cheung provides a functional TAA x CD3 antibody construct to which a mutant calreticulin binding domain can be readily integrated.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-6, 11-14, 16-18, 21-22, and newly added 23-29 remain/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 15-20 of copending Application No. 17/434,619 and Cheung (US20170210819A1) as applied to claims 1, 3-6, 13-14, 16-18, 21-22 and newly added 23-28 above, and further in view of Xu (US 2020/0283524 A1, published 09/10/2020).
As described in the rejection above, the combined teachings of ‘619 and Cheung disclose a bispecific antibody that binds a mutant calreticulin protein and CD3.
The combined teachings of ‘619 and Cheung do not teach (1) the Fc set forth in instant SEQ ID NO: 209 or SEQ ID NO: 210 (claim 11) or (2) mutated Fc region set forth in instant SEQ ID NO: 211 (claim 12).
These deficiencies are taught by Xu.
The disclosure of Xu is directed to bispecific antigen binding polypeptides comprising a first and second antigen binding moiety.
Regarding instant claim 11, wherein an amino acid at one or more positions selected from the group consisting of 349, 354, 366, 368, and 407 in a constant region of an H chain are replaced by Y349C, T366S, L368A, Y407V, S354C, or T366W, and wherein the bispecific antibody comprises an Fc region of SEQ ID NO: 209 or 210, Xu discloses the Fc regions in SEQ ID NO: 24 and SEQ ID NO: 22 which correspond to instant SEQ ID NO: 209 and SEQ ID NO:210. The alignments are shown below.
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660
640
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756
739
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Regarding instant claim 12, wherein the bispecific antibody comprises a mutated Fc region of SEQ ID NO: 211 with substitution of an amino acid at one or more positions selected from the group consisting of 234 and 235 in a H-chain Fc region to each introduce L234A or L235A mutation, Xu discloses the Fc region in SEQ ID NO: 238, which corresponds to instant SEQ ID NO: 211. The alignment is shown below:
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660
646
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Regarding instant claim 29, wherein the bispecific antibody according to claim 1 further comprises a knob-into-hole dimerization module comprising two hetero Fc chains, Xu teaches the bispecific polypeptide complex of their disclosure comprises a first and second heterodimerization domain that associates via knobs-into-holes (Pg. 101, claim 55).
It would have been obvious to one having ordinary skill in the art to use the Fc regions of Xu in the bispecific antibody of ‘619 and Cheung to arrive at the claimed invention. One would have been motivated to do so because Xu provides exemplary Fc regions suited for use in bispecific constructs. Doing so constitutes simple substitution of one known element for another to obtain predictable results. There would be an expectation of success because Xu provides evidence of a successful bispecific construct comprising the disclosed Fc regions.
This is a provisional nonstatutory double patenting rejection.
Response to Applicant’s Remarks
The applicant argues that the double patenting rejections over co-pending Application Nos. 17/434,619 and 18/840,389 do not apply based on amended claim 1.
In response, the rejection over 18/840,389 has been withdrawn because the current claim set of 18/840,389 does not disclose the instantly claimed CALR-specific CDR sequences. However, co-pending application 17/434,619 does provide the sequences of the calreticulin antibody and the obviousness double patenting rejections are maintained herein.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112(d)
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 13 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.
Claim 13 recites the bispecific antibody according to claim 1 is a human antibody, a humanized antibody, a chimeric antibody of an animal-derived antibody and a human antibody, or a synthetic antibody. The specification teaches the CDRs of the anti-CALR antibody binding region of claim 1 are rat CDRs (Specification, Pg. 81, Test Example 1). The CDR regions of anti-CD3 OKT3 antibodies are mouse CDRs. Therefore, the bispecific antibody according to claim 1 cannot be a human antibody.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROL ANN CHASE whose telephone number is (571)270-0934. The examiner can normally be reached Monday-Friday 9:00am-6:00pm.
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/CAROL ANN CHASE/Examiner, Art Unit 1646
/HONG SANG/Primary Examiner, Art Unit 1646
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