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Claims 1-21, 31, and 42 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.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.
Withdrawn Objections
Objections to the specification for the use of trademarks are hereby withdrawn in view of the substitute specification to remove such iterations filed on 02/17/2026.
Objections to claims 22 and 35 for minor informalities are hereby withdrawn in view of amendments to the claims to address the outstanding issues.
Withdrawn Rejections
Rejections of claims 33, 38, and 40-41 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paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter are hereby withdrawn in view of amendments to the claims.
Rejections of claims 22-30, 32-41, and 43 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or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement are hereby withdrawn in view of amendments to the claims to address the lack of written description in the claims.
Modified Rejections Necessitated by Amendment
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 22-27, 29, 32, 34, 36-41, 43, and new claims 44-52 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, 22-27, 29, 32, 34, 36-41, 43, and new claims 44-52 are rejected as anticipated by Poirier et al.
Claims 22-27, 29, 32, 34, 36-41, 43, and new claims 44-52 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 22-27, 29, 32, 34, 36-41, 43, and new claims 44-52 are rejected as anticipated by ‘844.
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive.
Applicant argues “neither US 10,428,152 nor US 2019/037844 disclose a method for promoting phagocytosis of CD127+ tumor cells using antibodies comprising a constant chain belonging to the subclass of IgG4”. This is not found persuasive.
The teachings of US 10,428,152 and US 2019/037844 disclose the same antibody with the same properties as instantly claimed. Both US 10,428,152 and US 2019/037844 describe the constant chain of the antibody belonging to the subclass of IgG4. Since antibody structure confers function, one of ordinary skill in the art would recognize that the antibody’s structure conveys its function and thus allow it to behave in certain ways, such as those outlined in the instant methods, when used in a method.
While the references are silent of the effects or phagocytotic impacts of the antibody when used in a subject, it is clear that the same antibody would have the same characteristics as the instantly claimed antibody since there is no evidence to the contrary. Note that rejections for anticipation are appropriate when the prior art discloses a method (or product) that appears to be identical except that the art is silent as to an inherent property; see MPEP § 2112(III). In such situations, the burden is on applicant to provide evidence that the prior art product (or method) is not the same or an obvious variant; see MPEP § 2112(V). Given that the composition contains the same sequences as claimed, the prior art compositions would inherently have the claimed dissociation constants, as a product and its properties are inseparable (see MPEP § 2112(I)). It is unclear how Applicant argues that an identical antibody from the prior art could behave in an entirely different manner than that which is claimed.
Additionally, while the references are silent on the intended results from the method of the instant claims, the references teaches the required antibody and disease states. Therefore, the antibodies when administered will produce the same results as the instantly claimed method since one is practicing the active steps, administering the same antibody to the same patient population. MPEP 2145(II) states: “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)” (“The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.”).
Therefore, the rejections are maintained as anticipated.
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 22-27, 29-30, 32, 34, 36-41, 43, and new claims 44-52 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 PTO-892 filed 11/18/2025).
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 22-27, 29-30, 32, 34, 36-41, 43, and new claims 44-52 are rejected as obvious over ‘152 and Britten et al.
Claims 22-27, 29-30, 32, 34, 36-41, 43, and new claims 44-52 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 PTO-892 filed 11/18/2025).
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 22-27, 29-30, 32, 34, 36-41, 43, and new claims 44-52 are rejected as obvious over ‘844 and Britten et al.
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive.
Applicant argues “none of the documents cited disclose the specific use of the claimed anti-CD127-IgG4 antibodies in treating CD127+ cancer by inducing the phagocytosis of CD127+ tumor cells” and that the documents “only disclose the antagonist effect of anti-CD127 antibodies on the IL7/IL7R interaction and in the inhibition of the IL7R signaling pathway”. This is not found persuasive.
As discussed above, the references of the prior art disclose the instantly claimed antibodies and their inherent functions. It is unclear how Applicant asserts that identical antibodies differ in their function. In regards to the documents being “silent” on the induction of phagocytosis of CD127+ tumor cells, Applicant is reminded that it is clear that the same antibody used against the same diseases (leukemia and other blood cancers) would have the same characteristics and would respond to the same treatment as the instantly claimed method since there is no evidence to the contrary. As indicated in the rejections above, the antibody of the prior art is identical to the antibody of the instant claims and as such, confers the same characteristics and functional properties. The prior art references are not required to explicitly list out each function of the claimed product as it is well known in the prior art that structure confers function, and that the anti-CD127 antibody of the prior art would be activate phagocytosis in cells as they share identical antigen binding regions as well as IgG subclasses. Additionally, a reference teaching a product or process may teach claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products.
Therefore, the obviousness rejection is maintained.
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 22-27, 29, 32, 34, 36-41, 43, and new claims 44-52 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 22-27, 29, 32, 34, 36-41, 43, and new claims 44-52 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 22-27, 29, 32, 34, 36-41, 43, and new claims 44-52 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 22-27, 29, 32-, 34, 36-41, 43, and new claims 44-52 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 22-27, 32, 34, 36-37, 43, and new claims 44-52 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.
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims have been sufficiently amended to obviate the double patenting rejections. This is not found persuasive.
Applicant’s arguments that the rejections will be addressed once the claims are deemed otherwise allowable is not found persuasive. The rejections of claims 22-27, 29-30, 32, 34, 36-41, 43, and new claims 44-52 as rejected on the ground of nonstatutory double patenting are maintained.
Conclusion
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 SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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