Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of claims 22-43 and species: a method for promoting phagocytosis of CD127-positive tumor cells, CD127-positive leukemia, t(1;19), anti-CD127 antibody, acute lymphoblastic leukemia, SEQ ID NO: 6, SEQ ID NO: 8, SEQ ID NO: 10, chemotherapeutic agent, and simultaneous administration in the reply filed 10/03/2025 is acknowledged.
Claims 1-21, 31, and 42 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 10/03/2025.
Claims 22-30, 32-41, and 43 are now under consideration in the instant Office Action.
Specification
The disclosure is objected to because of the following informalities:
The use of the trademarks, which are a trade name or a mark used in commerce, on at least page 33 of the instant specification, has been noted in this application. The terms 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.
Applicant is required to (1) review the entire specification or trademarks, (2) capitalize them and (3) include the proper symbols.
Appropriate correction is required.
Claim Objections
Claims 22 and 35 are objected to because of the following informalities: instant claim 22 is missing a space between the “(i)” and the word “agent”, and instant claim 35 is missing a space between the terms “thereof” and “comprising”. Appropriate correction is required.
Claim 35 is objected to because of the following informalities: the instant claim recites its limitations separated by bulleted letters. See MPEP § 608.01(m), which states when a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate sub combinations or related steps.
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 33 and 40-41 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.
Instant claims 33 and 40-41 contain the phrases “in particular”, “more particularly”, “more preferably” and variations of those phrases. The phrases are exemplary claim language and render the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Instant claim 38 recites the limitation " the second therapeutic agent". There is insufficient antecedent basis for this limitation in the claim.
Claim 41 contains a multitude of trademark/trade names. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. The Examiner suggests the deletion of the trademark names.
Instant claim 41 lists several of the therapeutic agents at least twice. It is unclear why Applicant lists them this way and if they are the same, or if there is a difference at each iteration.
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.
Claims 22-30, 32-41, and 43 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 claims 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 inventors, at the time the application was filed, had possession of the claimed invention.
The instant claims are directed to a method of promoting phagocytosis of CD127-positive tumor cells, wherein the method comprises the administration to the patient of an effective amount of an “anti-CD127 agent” (an “anti-CD127 antibody” or “mimetic”), that has Antibody Dependent Cellular Phagocytosis (ADCP) activity on CD127-positive tumor cells, but does not have Antibody Dependent Cytotoxic Activity (ADCC). Instant claim 36 indicates that the antibody is an “antagonist” of the IL-7R signaling pathway induced by IL-7 and CD127 binding. The terms “anti-CD127 agent”, an “anti-CD127 antibody” and “mimetic” are defined solely in terms of function—i.e. binding to CD127, has ADCP activity and does not have ADCC activity. Additionally, the term “antagonist” is solely described in terms of function—i.e. interfering with IL-7R signaling pathway induced by IL-7 and CD127 binding. The claims therefore encompass structures (“anti-CD127 agent”, an “anti-CD127 antibody” and “mimetic” and “antagonist”) that are claimed solely in terms of the desired functions: binding to CD127, has ADCP activity, does not have ADCC activity, and/or interfering with IL-7R signaling pathway induced by IL-7 and CD127 binding.
Instant claim 35 is included in this rejection because, even though they do disclose anti-CD127 antibodies with 6 CDRs, the claims indicate that the antibodies do not have ADCC activity and do have ADCP activity. It is clear from Poirier et al. (US 10,428,152; in IDS filed 07/21/2023) that antibodies with these same 6 CDRs can either have ADCC activity or not and that ADCC activity is dependent on the isotype of the IgG Fc region (see col. 44, lines 10-18).
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. 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). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of genus must be capable of doing, not of the substance and structure of the members.
For a claim drawn to a genus, the written description requirement 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. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus (see Official Gazette 1241 OG 174, January 30, 2001).
In the instant case, the claims recite a large and structurally varied genus of “anti-CD127 agent”, an “anti-CD127 antibody” and “mimetic” and “antagonist”, each of which are defined solely in terms of the desired function. Any of a plethora of structures that possess the desired function are encompassed by the claims. The specification describes 6 highly similar antibodies, N13B2, N13B2hVL6, N12B3h3, N13BhVL3, N13B2hVL4 and N13B2hVL5 (Table 1 on page 31 of specification). It is also noted that none of these antibodies have a VL chain comprising CDRs of SEQ ID NO: 7, 10 and 11 or 8, 9 and 11 as recited as a possible combination of CDRs in the instant claims. There is no evidence that the 6 antibodies disclosed in the specification are representative of the large genus “anti-CD127 agent”, an “anti-CD127 antibody” and “mimetic” and “antagonist” Applicant has claimed.
As stated above, instant claim 35 is included in this rejection because, even though they do disclose anti-CD127 antibodies with 6 CDRs, the claims indicate that the antibodies do not have ADCC activity and do have ADCP activity. It is clear from Poirier et al. that antibodies with these same 6 CDRs can either have ADCC activity or not and that ADCC activity is dependent on the isotype of the IgG Fc region (Col. 44, lines 10-18). Thus, the state of the art shows that anti-CD127 antibodies with the same 6 CDRs can either have or not have the ADCC activity, depending on the Fc region isotype. Thus, not only does the structure of the VH and VL need to given, but the full sequence of the HC and LC would need to be given. Additionally, it is noted that Applicant’s specification does not disclose the types of Fc region isotypes that would lead to antibodies having ADCP activity and not having ADCC activity. In fact, the claims indicate that all isotypes lead to antibodies with the claimed activity. As seen by Poirier et al, this cannot be.
Instant claim 35 is also included in the rejection because none of these exemplified antibodies have a VL chain comprising CDRs of SEQ ID NO: 7, 10 and 11 or 8, 9 and 11. Thus, Applicant does not have possession of antibodies with the aforementioned VL.
In summary, the specification fails to describe at least a substantial number of agents, antibodies, mimetics and antagonists within the genera of “anti-CD127 agent”, an “anti-CD127 antibody” and “mimetic” and “antagonist” claimed and furthermore fails to describe a representative number of agents, antibodies, mimetics and antagonists encompassed by the claims. Moreover, the specification does not describe a correlation between any particular identifying (i.e., substantial) structural feature that describes the presupposed representative species and is shared by at least most of the other members of the genus, and any one particular identifying, shared, functional feature that may be attributed to the presence of the structural feature. This is very relevant in the instant case because it appears that Applicant is attempting to define the antibody, agent, etc. in terms of having ADCP activity but not ADCC activity. In an unpredictable art, as here, the disclosure of only one or a few closely related species does not provide the skilled artisan with a representative number of species sufficient to show applicants were in possession of the claimed genus of antibodies, mimetics, antagonists and agents with have ADCP activity but not ADCC activity. For these reasons, the skilled artisan would not recognize that applicants were in possession of the invention as broadly claimed at the time the application was filed.
Therefore, claims 22-30, 32-41, and 43 are rejected as failing to satisfy the written description requirement.
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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 22-29, 32-41, and 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Poirier et al. (US 10,428,152; in IDS filed 07/21/2023).
Poirier et al. discloses the use anti-CD127 antibodies for the treatment of CD127-positive cancers, wherein the antibody (N13B2) is composed of a VH with CDRs of SEQ ID NO. 10, 12 and 14 or 48 and a VL of CDRs of SEQ ID NO. 16 or 50, 18 or 52 and 20 (these sequences are the same as instant SEQ ID NOs: 3-11, respectively, in claims 35), see abstract, col. 7-8, col. 19-20, 25 and entire reference. The specific antibodies are N13B2-h1, which has instant CDRs of SEQ ID NO. 3-5, 7, 9 and 11, N13B2-H2, which has instant CDRs of SEQ ID NO. 3-5, 7, 9 and 11, and N13B2-h3, which has instant CDRs of SEQ ID NO. 3, 4, 6, 8, 10 and 11 (col. 23-24). Poirier et al. discloses that the isolated antibody or antigen-binding fragment is an antagonist of IL-7R signaling induced by IL-7 (reference’s claim 5). The antibodies have antagonistic properties (col. 17, lines 40-45). The antibodies do not have ADCC activity when IgG4 isotype Fc region is used (col. 19, lines 10-15 and col. 44, lines 10-18). The antibodies can be used in compositions with additional compounds, such as anti-CD3 antibodies (col. 45, lines 25-53, col. 60, lines 5-15), and the compositions are used in the treatment of acute lymphoblastic leukemia (ALL) (col. 33, lines 1-15, col. 33, lines 65-col. 34, line 25). The compounds and compositions are used in patients with the disease (col. 61, lines 1-5) and this reads on the patient being determined to have the disease.
With respect to the limitation that the antibodies do have ADCP activity, the antibodies of the reference have the same structure as that are instantly claimed by Applicant, have no ADCC activity and are used for the treatment for ALL. Thus, since the structure is the same and the use is the same, it is inherent that the antibodies of the reference and the claimed invention have the same properties—i.e. ADCP activity.
Therefore, claims 22-29, 32-41, and 43 are rejected as anticipated by Poirier et al.
Claims 22-29, 32-41, and 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Poirier et al. (US 2019/0375844, in IDS filed 07/21/2023, hereinafter ‘844) or US 11,098,128 (in IDS filed 07/21/2023). US 11,098,128 is the patent issued off of US 2019/0375844.
‘844 discloses the use anti-CD127 antibodies for the treatment of CD127-positive cancers, wherein the antibodies (N13B2, N13B2-h1, N13B2-H2 and N13B2-h3) are composed of a VH of SEQ ID NO: 7 (which contains instant CDRs of SEQ ID NO. 3, 4 and 6) and VL of SEQ ID NO: 8-12 (which contains instant CDRs of SEQ ID NO. 8, 10 and 11) (abstract, para. 3-9,12-26, 53-60, 99-102 and entire reference). The antibodies have antagonistic activity (para. 73). The antibodies can either have or do not have ADCC activity (para 82, 113). The antibodies are of the IgG1-IgG4 isotype (para 91). The antibody or antigen-binding fragment thereof is an antagonist of IL-7R signaling induced by IL-7 (reference’s claim 4). The antibodies can be used in compositions with additional compounds, such as anti-CD3 antibodies (para 103), and the compositions are used in the treatment of acute lymphoblastic leukemia (ALL) (para 106-108, 114-118). The compounds and compositions are used in patients who suffer from the disease (para 109) and this reads on the patient being determined to have the disease.
With respect to the limitation that the antibodies do have ADCP activity, the antibodies of the reference have the same structure as that claimed by applicant, have no ADCC activity and are used for the treatment for ALL. Thus, since the structure is the same and the use is the same, it is inherent that the antibodies of the reference and the claimed invention have the same properties—i.e. ADCP activity.
Therefore, claims 22-29, 32-41, and 43 are rejected as anticipated by ‘844.
Claim Rejections - 35 USC § 103
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:
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.
Claims 22-30, 32-41, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Poirier et al. (US 10,428,152, in IDS filed 07/21/2023, hereinafter ‘152), in view of Britten et al. 2019 (in instant PTO-892).
The teachings of the ‘152 patent have been discussed above.
However, ‘152 is silent on the treatment of the acute lymphoblastic leukemias with t(1:19) cytogenetics. Britten et al. remedies this deficiency.
Britten et al. discloses that JAK-STAT pathway mutated ALL, BCR-ABL1-like ALL, and B cell precursor ALL bearing one the following cytogenetics: t(1;19), t(12,21) are all known forms of ALL and are known in the art. Britten et al discloses that ALL with MLL-rearrangements is known in the art (entire reference). Pages 11-13 disclose that BCR-ABL1-like ALL, and B cell precursor ALL bearing one the following cytogenetics: t(1;19), t(12,21), and hyperdiploid karyotypes are known forms of ALL.
Since ‘152 discloses the combination treatment of ALL and since Britten et al. discloses that /or JAK-STAT pathway mutated ALL, BCR-ABL1-like ALL, and B cell precursor ALL bearing one the following cytogenetics: t(1;19), t(12,2), are all forms of ALL, it would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to use the anti-CD127 antibodies of the primary reference for the treatment of the different forms of ALL. The combination therapy is further supported by ‘152 because they specifically address the combination of CD127 antibodies and the second therapeutic agents. The instant claims are amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition that is to be used for the very same purpose since the idea of combining them flows logically from their having been individually taught in the prior art. Applying the same logic to the instant claims, given the teachings of the prior art, it would have been obvious to combine the agents because the idea of doing so would have logically followed from their having been individually taught in the prior art to be useful as anti-cancer agents. One of ordinary skill in the art would have reasonably expected to obtain a therapeutic benefit upon the combination of the agents since they had been demonstrated in the prior art to be reasonably predictive of treating ALL.
With respect to the limitation that the antibodies do have ADCP activity, the antibodies of the reference have the same structure as that claimed by applicant, have no ADCC activity and are used for the treatment for ALL. Thus, since the structure is the same and the use is the same, it is expected that the antibodies of the reference and the claimed invention have the same properties—i.e. ADCP activity.
Therefore, claims 22-30, 32-41, and 43 are rejected as obvious over ‘152 and Britten et al.
Claims 22-30, 32-41, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Poirier et al. (US 2019/0375844 or US 11,098,128 in IDS filed 07/21/2023), in view of Britten et al. 2019 (in instant PTO-892).
The teachings of the ‘844 patent have been discussed above.
However, ‘844 is silent on the treatment of the acute lymphoblastic leukemias with t(1:19) cytogenetics. Britten et al. remedies this deficiency.
Britten et al. discloses that JAK-STAT pathway mutated ALL, BCR-ABL1-like ALL, and B cell precursor ALL bearing one the following cytogenetics: t(1;19), t(12,21) are all known forms of ALL and are known in the art. Britten et al discloses that ALL with MLL-rearrangements is known in the art (entire reference). Pages 11-13 disclose that BCR-ABL1-like ALL, and B cell precursor ALL bearing one the following cytogenetics: t(1;19), t(12,21), and hyperdiploid karyotypes are known forms of ALL.
Since ‘844 discloses the combination treatment of ALL and since Britten et al. discloses that /or JAK-STAT pathway mutated ALL, BCR-ABL1-like ALL, and B cell precursor ALL bearing one the following cytogenetics: t(1;19), t(12,2), are all forms of ALL, it would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to use the anti-CD127 antibodies of the primary reference for the treatment of the different forms of ALL. The combination therapy is further supported by ‘844 because they specifically address the combination of CD127 antibodies and the second therapeutic agents. The instant claims are amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition that is to be used for the very same purpose since the idea of combining them flows logically from their having been individually taught in the prior art. Applying the same logic to the instant claims, given the teachings of the prior art, it would have been obvious to combine the agents because the idea of doing so would have logically followed from their having been individually taught in the prior art to be useful as anti-cancer agents. One of ordinary skill in the art would have reasonably expected to obtain a therapeutic benefit upon the combination of the agents since they had been demonstrated in the prior art to be reasonably predictive of treating ALL.
With respect to the limitation that the antibodies do have ADCP activity, the antibodies of the reference have the same structure as that claimed by applicant, have no ADCC activity and are used for the treatment for ALL. Thus, since the structure is the same and the use is the same, it is expected that the antibodies of the reference and the claimed invention have the same properties—i.e. ADCP activity.
Therefore, claims 22-30, 32-41, and 43 are rejected as obvious over ‘844 and Britten et al.
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 22-29, 32-41, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,428,152, hereinafter ‘152. Although the claims at issue are not identical, they are not patentably distinct from each other because the only difference between the two sets of claims is the scope. Specifically, the scope of the claims is broader in the instant application because the antibody is not limited to the specific antibody of ‘152. The antibody of ‘152 is composed of a VH with CDRs of SEQ ID NO: 10, 12 and 14 or 48 and a VL of CDRs of SEQ ID NO: 16 or 50, 18 or 52 and 20 (these sequences are the same as applicant’s SEQ ID NO: 3-11, respectively, in claim 35). In view of Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010), the Examiner is allowed to look at the specification of the patent to determine the use of the claimed compound. The method in ‘152 discloses method of treating ALL patients with the disease (reads on the patient being determined to have the disease) using the claimed patent compound in compositions either alone or with additional compounds, such as anti-CD3 antibodies (col. 45, lines 25-53, col. 60, lines 5-15, col. 61, lines 1-5, col. 33, lines 1-15, col. 33, lines 65-col. 34, line 25). ‘152 discloses the same CD127 antibodies as the instant claims and that the isotypes of the antibodies can be IgG1-IgG4 (para. 92).
With respect to the limitation that the antibodies do have ADCP activity, the antibodies of the reference have the same structure as that claimed by applicant, have no ADCC activity and are used for the treatment for ALL. Thus, since the structure is the same and the use is the same, it is inherent that the antibodies of the reference and the claimed invention have the same properties—i.e. ADCP activity.
Claims 22-29, 32-41, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,098,128, hereinafter ‘128. Although the claims at issue are not identical, they are not patentably distinct from each other because the only difference between the two sets of claims is the scope. Specifically, the scope of the claims is broader in the instant application because the antibody is not limited to the specific antibody of the patent. The antibodies of the patent are composed of antibodies having a VH of SEQ ID NO: 7 (which contains instant CDRs of SEQ ID NO: 3, 4 and 6) and VL of SEQ ID NO: 9-12 (which contains instant CDRs of SEQ ID NO: 8, 10 and 11). The ‘128 claims state that the isotype can be IgG1-IgG4 and that the antibodies can be used in combination therapy. In view of Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010), the Examiner is allowed to look at the specification of the patent to determine the use of the claimed compound. The method in the patent discloses method of treating ALL patients with the disease (reads on the patient being determined to have the disease) using the claimed patent compound in compositions either alone or with additional compounds, such as anti-CD3 antibodies (para 103, 106-108 and 114-118).
With respect to the limitation that the antibodies do have ADCP activity, the antibodies of the reference have the same structure as that claimed by applicant, have no ADCC activity and are used for the treatment for ALL. Thus, since the structure is the same and the use is the same, it is inherent that the antibodies of the reference and the claimed invention have the same properties—i.e. ADCP activity.
Claims 22-29, 32-41, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,440,964, hereinafter ‘964. Although the claims at issue are not identical, they are not patentably distinct from each other because the only difference between the two applications is the scope. Specifically, the scope of the claims in ‘964 is broader in that it is not limited to the treatment of CD127-positive cancers. The antibody of ‘964 is composed of a VH with CDRs of SEQ ID NO: 10, 12 and 14 or 48 and a VL of CDRs of SEQ ID NO: 16 or 50, 18 or 52 and 20 (these sequences are the same as applicant’s SEQ ID NO: 3-11, respectively, in claim 35). Claim 4 also states that the treatment is for a patient with the disease and this reads on the patient having been determined to have the disease. The claims also state that the disease is cancer, specifically acute lymphoblastic leukemia. The method in ‘964 discloses method of treating ALL patients with the disease (reads on the patient being determined to have the disease) using the claimed patent compound in compositions either alone or with additional compounds, such as anti-CD3 antibodies (claim 5).
With respect to the limitation that the antibodies do have ADCP activity, the antibodies of the reference have the same structure as that claimed by applicant, have no ADCC activity and are used for the treatment for ALL. Thus, since the structure is the same and the use is the same, it is inherent that the antibodies of the reference and the claimed invention have the same properties—i.e. ADCP activity.
Claims 22-29, 32-41, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,371,502, hereinafter ‘502. Although the claims at issue are not identical, they are not patentably distinct from each other because the only difference between the two applications is the scope. Specifically, the scope of the claims in ‘502 is broader in that it is not limited to the treatment of CD127-positive cancers. The antibodies of ‘502 are composed of a VH with CDRs of SEQ ID NO: 10, 12 and 14 or 48 and a VL of CDRs of SEQ ID NO: 16 or 50, 18 or 52 and 20 (these sequences are the same as applicant’s SEQ ID NO: 3-11, respectively, in claim 35). Claim 4 also states that the treatment is for a patient with the disease and this reads on the patient having been determined to have the disease. The claims also state that the disease is cancer, specifically acute lymphoblastic leukemia. The method in ‘502 discloses method of treating ALL patients with the disease (reads on the patient being determined to have the disease) using the claimed patent compound in compositions either alone or with additional compounds, such as anti-CD3 antibodies (claim 5).
With respect to the limitation that the antibodies do have ADCP activity, the antibodies of the reference have the same structure as that claimed by applicant, have no ADCC activity and are used for the treatment for ALL. Thus, since the structure is the same and the use is the same, it is inherent that the antibodies of the reference and the claimed invention have the same properties—i.e. ADCP activity.
Claims 22-28, 32-37, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-34 of U.S. Patent No. 11,926,671, hereinafter ‘671. Although the claims at issue are not identical, they are not patentably distinct from each other because the only difference between the two applications is the scope. Specifically, the scope of the claims in ‘671 is broader in that it is not limited to the treatment of CD127-positive cancers. The antibodies of ‘671 comprise a VH of SEQ ID NO: 7 (which contains instant CDRs of SEQ ID NO: 3, 4 and 6) and VL of SEQ ID NO: 9-12 (which contains instant CDRs of SEQ ID NO: 8, 10 and 11). Claim 2 also states that the treatment is for a patient with the disease associated with the interleukin-7 (IL-7) signaling pathway and this reads on the patient having been determined to have the disease. The claims also state that the disease is cancer. ‘671’s claims state that the isotype can be IgG1-IgG4.
With respect to the limitation that the antibodies do have ADCP activity, the antibodies of the reference have the same structure as that claimed by applicant, have no ADCC activity and are used for the treatment for ALL. Thus, since the structure is the same and the use is the same, it is inherent that the antibodies of the reference and the claimed invention have the same properties—i.e. ADCP activity.
Conclusion
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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