Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
The election filed May 27, 2026, is acknowledged. However, after further consideration the species requirements have been WITHDRAWN.
Claims 1-3, 5-9, 12-16 and 18-28 are under examination.
Information Disclosure Statement
The information disclosure statements have been considered.
Claim Objections
Claim 20 is object to for not ending in a period.
Claim Rejections - 35 USC § 112
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 1-3, 5-9, 12-16 and 18-28 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 pre-AIA the applicant regards as the invention.
The claims are indefinite for the following reasons:
Claim 1 recites, “patients non-eligible for allogeneic stem cell transplantation”, which renders the claims indefinite because it cannot be ascertained when a patient is non-eligible for allogeneic stem cell transplantation; and moreover it is not evident how the practitioner necessarily determines whether or not the patient is non-eligible for allogeneic stem cell transplantation. Presumably the criteria that might be used could vary rather substantially and thus it would seem that the decision may be largely subjective in nature; if that is indeed the case, the subject matter that is encompassed by the claim may vary depending upon one's interpretation and presumptions as to the meaning of the patient's non-eligibility or eligibility for allogeneic stem cell transplantation. Notably, depending on who makes the determination a patient may be placed in both groups. For example, one practitioner may determine a patient is eligible, while another determines that the patient is non-eligible. For this reason, it is submitted that the claim fails to delineate the metes and bounds of the subject matter that is regarded as the invention with the requisite clarity and particularity to permit the skilled artisan to know or determine infringing subject matter, so as to satisfy the requirements set forth under 35 U.S.C. § 112, second paragraph.
It is suggested that any limitation be removed from the claims to obviate the rejection.
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.
Claims 12, 24, 26 and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). “[A] sufficient description of a genus ... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. 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. For example, the Federal Circuit has found that possession of a mouse antibody heavy and light chain variable regions provides a structural "stepping stone" to the corresponding chimeric antibody, but not to human antibodies. Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875 (Fed. Cir. 2011).
The teachings of the specification and the claimed invention:
The nature and scope of the claimed invention at issue is methods that recite a genus of compositions that comprises an antibody defined by percent identity to SEQ ID NO:1 or encoded by a nucleic acid defined by percent identity to SEQ ID NO:2.
Notably, because of the percent identity language, multiple amino acids in the antibody CDRs can be modified.
The instant specification discloses a bispecific antibody that binds CD19 and CD3 that has the 12 CDRs as set forth in claim 20, but in claims 12, 24, 26 and 27 these CDRs are not required.
The instant specification has not disclosed any CDR modifications that can be made in the disclosed bispecific antibody that binds CD19 and CD3 that retains the function of this antibody.
State of the Art
It is well established in the art that conventional antibodies have a large repertoire of distinct structures and that a huge variety of antibodies can be made to bind to a single antigen where some antibodies bind different epitopes on the antigen and some bind overlapping or the same epitope which allows them to compete for binding. For example, Lloyd et al (Protein Engineering, Design & Selection, 22:159-168, 2009) teach that hundreds of functional antibody fragments can be isolated from an antibody library that bind to the same antigen wherein these antibodies have distinct heavy and light chain sequences and can bind different epitopes on the antigen (see, e.g., Discussion). Similarly, Edwards et al (J Mol Biol, 14;334(1):103-118, 2003), found that over 1000 antibodies, all different in amino acid sequence, were generated to a single protein with 568 different amino acid sequences identified for the V(H) CDR3 domains of these antibodies (see Abstract).
It is also known in the antibody art that the formation of an intact antigen-binding site in a conventional 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) that provide the majority of the contact residues for the binding of the antibody to its target epitope. See Almagro et al, (Frontiers in Immunology (2018) 8: 1751, pages 1-19), (“The IgG Molecule” (page 3) and Figure 1). Sela-Culang (Frontiers in Immunology (2013) 4: 302, pages 1-13) further teaches, “A major focus in analyzing the structural basis for [antigen] recognition has been in identifying the exact boundaries of the CDRs in a given [antibody]. It is a common practice to identify paratopes through the identification of CDRs” (page 3, left column, “CDRs Identification”).
Although 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. Ni (The Protein Journal (2024) 43: 683-696) teaches, “Mutations, even one mutation, introduced in the CDRs through [somatic hypermutation] can change the binding properties and repertoire of antibodies. However, how just one-point mutation can dramatically change the recognition profiles of the antibody is still unclear” (Introduction). Furthermore, while affinity maturation techniques can result in differences in the CDRs of the antibody compared to its parental antibody, those techniques involve trial-and-error testing and the changes that maintain or improve affinity are not predictable a priori (Almagro, pages 3 and 6-7).
Therefore, it is expected that all 6 CDRs of a conventional antibody needs to be grafted into antibody framework regions to retain the requisite specificity and functionality of the parent antibody and that it cannot be known what other antigens any particular moiety will bind other than the one tested.
Claim Analysis
The instant claims are described above.
A skilled artisan in the art would recognize that the specificity of an antibody is dependent upon six specific CDR sequences. In the instant case, the antibody is bispecific and binds to CD19 and CD3, so it comprises six specific CDR sequences that are required for binding to CD19 and six specific CDR sequences that are required for binding CD3. The instant specification does not disclose which CDR residues can be modified to obtain the antibodies of claims 12, 24, 26 and 27.
The disclosure therefore does not show that applicant was in possession of the necessary common attributes or features possessed by the members of the claimed genera. Accordingly, the skilled artisan would not recognize that applicants were in possession of the invention as broadly claimed at the time the application was filed.
It is suggested that the rejection could be obviated by canceling these claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1-3, 5-7, 12, 15-16 and 18-28 are rejected under 35 U.S.C. 102(b) as being anticipated by WO 2005/040220 A1, of record.
WO 2005/040220 A1 (Hofmeister et al.) teaches treating B-lineage acute lymphoblastic leukemia (ALL) or more particularly B-precursor ALL in patients which necessarily includes patients non-eligible for allogeneic stem cell transplantation by administering to the patient the recombinant single chain CD3xCD19 bispecific antibody which comprises the amino acid sequence of SEQ ID NO:1 which comprises the claimed CDR and VH and VL sequences and which is encoded by SEQ ID NO:2; see entire document (e.g., the detailed description such as pages 52 and 76). Hofmeister et al. teaches the antibody is administered in multiple dosages ranging from 0.0001 to 2 mg/kg of body weight or greater which encompasses the claimed doses; see, e.g., “page 65”.
With regard to claims 3 and 5-6, the ALL patients of Hofmeister necessarily comprise the patients of these claims.
With regard to claim 7, the ALL patients of Hofmeister necessarily comprise patients where the treatment results in stable disease.
With regard to claim 7, as the antibody administered is structural indistinguishable from the claimed antibody, it necessarily would have this function.
Claims 1-3, 5-7, 12-13, 15-16 and 18-28 are rejected under 35 U.S.C. 102(e) as being anticipated by U.S. Patent No. 8,524,867-B2, of record.
U.S. Patent No. 8,524,867-B2 (Bernett et al.) teaches treating B-lineage acute lymphoblastic leukemia (ALL) or more particularly B-precursor ALL in patients which necessarily includes adult patients by administering to the patient the recombinant single chain CD3xCD19 bispecific antibody designated MT103/MEDI-538 (Blinatumomab) which comprises the amino acid sequence of SEQ ID NO:1 which comprises the claimed CDR and VH and VL sequences and which is encoded by SEQ ID NO:2; see entire document (e.g., the detailed description). Bernett et al. teaches the disease to be treated is refractory; see, e.g., the background and detailed description. Bernett et al. teaches the antibody is administered in dosages ranging from 0.0001 to 100 mg/kg of body weight or greater which encompasses the claimed doses; see, e.g., “Dosing”. Bernett et al. teaches the antibody is administered by continuous intravenous infusion for at least 4 weeks followed by a treatment-free rest period of at least 2 weeks; see, e.g., "Dosing". Bernett et al. teaches the antibody is administered in multiple cycles; see, e.g., "Dosing".
With regard to claims 3 and 5-6, Bernett et al. teaches, “[allogeneic] bone marrow (stem cell) transplantation is rarely used as a first-line treatment for CLL due to its risk”. Accordingly, absent a showing of any difference, the patient that is treated using antibody is at least initially considered “non-eligible” for allogeneic stem cell transplantation.
With regard to claim 7, the ALL patients of Bernett necessarily comprise patients where the treatment results in stable disease.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1 and 13-14 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 8,524,867-B2, of record.
U.S. Patent No. 8,524,867-B2 (Bernett et al.) teaches that which is set forth in the above rejection of the claims under 35 U.S.C. 102(e).
Although Bernett et al. teaches the antibody is administered in multiple cycles, as noted in the above rejection, Bernett et al. does not expressly teach administering at least 3 cycles after determination of a MRD negative status.
Nonetheless, it would have been prima facie obvious to one ordinarily skilled in the art at the time of the invention to have treated ALL in a MRD positive status using multiple cycles even after determining the patient to be in a MRD negative status. This is because the detection of MRD (i.e., small numbers of residual leukemia cells in the patient) is limited by problems with sensitivity and accordingly one would be motivated to continue to treat the patient with 3 cycles even after residual leukemic cells cannot be detected because cancer cells may still be present.
Claims 1-3, 5-9, 12-13, 15-16 and 18-28 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 8,524,867-B2, of record and Peham et al. (Br. J. Haematol. 2002 May; 117 (2): 315-21), of record, or U.S. Patent No. 8,524,867-B2 and Cole-Sinclair et al. (Baillieres Clin. Haematol. 1994 Jun; 7 (2): 183-233), of record.
U.S. Patent No. 8,524,867-B2 (Bernett et al.) teaches that which is set forth in the above rejection of the claims under 35 U.S.C. 102(e).
Bernett et al. does not expressly teach MRD is measured with quantitative detection of at least one cytogenetic abnormality or rearrangement associated with ALL, or more particularly a t(4;11) translocation using PCR.
Peham et al. teaches analysis of MRD in patients with t(4;11) leukemias by quantitative detection of the cytogenetic abnormality using PCR; see entire document (e.g., the abstract and Figure 1).
Cole-Sinclair et al. (Baillieres Clin. Haematol. 1994 Jun; 7 (2): 183-233) reviews genetic changes associated with ALL and their relevance for diagnosis and detection of minimal residual disease by identifying a t(4;11) translocation which can be done by PCR; see entire document (e.g., the abstract and pages 188 and 193).
It would have been prima facie obvious to one ordinarily skilled in the art at the time of the invention to have treated t(4;11) MRD in an ALL patient, as in accordance with the teachings of Bernett et al., by administering to the ALL patient a composition comprising a therapeutically effective amount of a CD3xCD19 bispecific antibody and monitor the effectiveness of the treatment by quantitative detection of the cytogenetic abnormality as in Peham et al. or Cole-Sinclair et al above the detection limit. One ordinarily skilled in the art would have been motivated to do so in order to treat the disease and access the effectiveness of the treatment.
With particular regard to claim 9, although the references do not expressly teach the ALL patient shows a signal for the cytogenetic abnormality above the detection limit, it would have been understood that the signal for the cytogenetic abnormality must be above the detection limit or otherwise the cytogenetic abnormality could not be detected or quantified. Since MRD occurs when very small numbers of leukemia cells remain in the patient’s body following initial treatment, it is imperative that such cells be detected using assays that are highly sensitive; it follows that the more sensitive the assay used to detect remaining leukemia cells the better able the practitioner is to detect the presence of MRD. Detecting MRD is important since a patient with MRD is not completely cured and the disease may relapse unless further treated.
Claims 1-3, 5-7, 12-16 and 18-28 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO 2005/040220 A1, of record and WO 2007/068354 A1, of record.
WO 2005/040220 A1 (Hofmeister et al) teaches that which is set forth in the above rejection of the claims under 35 U.S.C. 102(b).
WO 2007/068354 A1 (Baeuerle et al.) teaches treating B cell leukemias such as ALL in patients which necessarily includes adult patients by administering to the patient a recombinant single chain CD3xCD19 bispecific antibody; see entire document (e.g., the detailed description such as page 16). Baeuerle et al. teaches that the antibody can be used in treatments comprising 4 weeks of continuous intravenous infusion followed by 4 weeks infusion free and repeating the sequence more than three times (see e.g., pages 19 and 20.
Accordingly, it would have been prima facie obvious to one ordinarily skilled in the art at the time of the invention to treat adult patients with ALL with a bispecific antibody comprising SEQ ID NO:1 comprising 4 weeks of continuous infusion followed by at least 2 weeks infusion free and repeating the sequence more than three times after determination of MRD negative status. This is because the detection of MRD (i.e., small numbers of residual leukemia cells in the patient) is limited by problems with sensitivity and accordingly one would be motivated to continue to treat the patient with 3 cycles even after residual leukemic cells cannot be detected because cancer cells may still be present.
Applicant is reminded that it is a common objective in the art to establish a dose that is both safe and effective, so as achieve optimal therapeutic effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). See In re Peterson, 65 USPQ2d 1379 1382 (CA FC 2003): “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”
It follows that one ordinarily skilled in the art at the time of the invention would have been motivated to use the teachings of Baeuerle et al. as guidance in selecting a dose that is both safe and effective, so as achieve optimal therapeutic effect and maximal benefit in treating ALL.
Absent a showing of any unobvious differences, it is therefore submitted that the process suggested by the prior art would render obvious the process that is claimed.
This position is reasonable since parameters such as dosing, scheduling and routes of delivery, which are used to treat any given condition, may be expected to differ from those that are used most effectively to treat another condition. In general, these parameters that are used most efficaciously can only be determined in clinical trials designed to determine those parameters. The Office, however, does not have the facilities or resources for conducting clinical trials to determine if therapeutic agents are used effectively in particular regimens, as in accordance with the claims; so, in the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed process is different than that taught and/or suggested by the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA, 1977) and Ex parte Gray, 10 USPQ2d 1922 1923 (PTO Board of Patent Appeals and Interferences, 1988 and 1989).
Claims 1-3, 5-9, 12-16 and 18-28 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO 2005/040220 A1, of record and WO 2007/068354 A1, of record, as applied to claims 1-3, 5-7, 12-16 and 18-28 above, and further in view of Peham et al. (Br. J. Haematol. 2002 May; 117 (2): 315-21), of record or Cole-Sinclair et al. (Baillieres Clin. Haematol. 1994 Jun; 7 (2): 183-233), of record.
WO 2005/040220 A1 and WO 2007/068354 A1 teach and suggest that which is set forth in the above rejection under 35 U.S.C. 103(a).
WO 2005/040220 A1 and WO 2007/068354 A1 do not expressly teach MRD is measured with quantitative detection of at least one cytogenetic abnormality or rearrangement associated with ALL, or more particularly a t(4;11) translocation using PCR.
Peham et al. teaches analysis of MRD in patients with t(4;11) leukemias by quantitative detection of the cytogenetic abnormality using PCR; see entire document (e.g., the abstract and Figure 1).
Cole-Sinclair et al. (Baillieres Clin. Haematol. 1994 Jun; 7 (2): 183-233) reviews genetic changes associated with ALL and their relevance for diagnosis and detection of minimal residual disease by identifying a t(4;11) translocation which can be done by PCR; see entire document (e.g., the abstract and pages 188 and 193).
It would have been prima facie obvious to one ordinarily skilled in the art at the time of the invention to have treated t(4;11) MRD in an ALL patient, as in accordance with the teachings of WO 2005/040220 A1 and WO 2007/068354 A1, by administering to the ALL patient a composition comprising a therapeutically effective amount of a CD3xCD19 bispecific antibody and monitor the effectiveness of the treatment by quantitative detection of the cytogenetic abnormality as in Peham et al. or Cole-Sinclair et al. above the detection limit. One ordinarily skilled in the art would have been motivated to do so in order to treat the disease and access the effectiveness of the treatment.
With particular regard to claim 9, although the references do not expressly teach the ALL patient shows a signal for the cytogenetic abnormality above the detection limit, it would have been understood that the signal for the cytogenetic abnormality must be above the detection limit or otherwise the cytogenetic abnormality could not be detected or quantified. Since MRD occurs when very small numbers of leukemia cells remain in the patient’s body following initial treatment, it is imperative that such cells be detected using assays that are highly sensitive; it follows that the more sensitive the assay used to detect remaining leukemia cells the better able the practitioner is to detect the presence of MRD. Detecting MRD is important since a patient with MRD is not completely cured and the disease may relapse unless further treated.
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 1-3, 5-9, 12-16 and 18-28 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-34 US Patent 8,840,888, of record in view of WO 2005/040220 A1, of record and WO 2007/068354 A1, of record. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
The instant claims are drawn to a method of treating acute lymphoblastic leukemia with a cd19xcd3 bispecific antibody.
The claims of the patent are drawn to a method of treating B-lineage acute lymphoblastic leukemia with a cd19xcd3 bispecific antibody that is MT103 which comprises the instantly claimed SEQ ID NO:1 and is encoded by SEQ ID NO:2 (see claim 30 and 32).
WO 2005/040220 A1 and WO 2007/068354 A1 disclose that which is set forth above.
Accordingly, the claimed inventions are so substantially similar that for the most part, the claimed subject matter of the patent anticipates the claimed subject matter of the instant application and any minor differences in the subject matter claimed in the instant application would be seen as an obvious variation of the subject matter claimed in the patent based on the teachings of WO 2005/040220 A1 and WO 2007/068354 A1 based on the record and reasoning above which is herein incorporated by refernce in its entirety.
Claims 1-3, 5-9, 12-16 and 18-28 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 US Patent 10,662,243, of record in view of WO 2005/040220 A1, of record and WO 2007/068354 A1, of record. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
The instant claims are drawn to a method of treating acute lymphoblastic leukemia with a cd19xcd3 bispecific antibody.
The claims of the patent are drawn to a method of treating B-lineage acute lymphoblastic leukemia with a cd19xcd3 bispecific antibody which comprises the instantly claimed SEQ ID NO:1(see claim 1 and 12).
Accordingly, the claimed inventions are so substantially similar that for the most part, the claimed subject matter of the patent anticipates the claimed subject matter of the instant application and any minor differences in the subject matter claimed in the instant application would be seen as an obvious variation of the subject matter claimed in the patent based on the teachings of WO 2005/040220 A1 and WO 2007/068354 A1 based on the record and reasoning above which is herein incorporated by refernce in its entirety.
Claims 1-3, 5-9, 12-16 and 18-28 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-21 US Patent 11,597,766 in view of WO 2005/040220 A1, of record and WO 2007/068354 A1, of record. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
The instant claims are drawn to a method of treating acute lymphoblastic leukemia with a cd19xcd3 bispecific antibody.
The claims of the patent are drawn to a method of treating B-lineage acute lymphoblastic leukemia with a cd19xcd3 bispecific antibody which comprises the instantly claimed SEQ ID NO:1 and is encoded by SEQ ID NO:2 (see claim 14 and 21).
Accordingly, the claimed inventions are so substantially similar that for the most part, the claimed subject matter of the patent anticipates the claimed subject matter of the instant application and any minor differences in the subject matter claimed in the instant application would be seen as an obvious variation of the subject matter claimed in the patent based on the teachings of WO 2005/040220 A1 and WO 2007/068354 A1 based on the record and reasoning above which is herein incorporated by refernce in its entirety.
Conclusion
No claim is 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 works a flexible schedule.
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
June 25, 2026
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