DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election, without traverse, of Group I (claims 132-142, and 148-151) in the reply filed on 11/10/2025 is acknowledged.
Pursuant to an amendment filed on 11/10/2025, amended claims, 132, 134, (11/10/2025), and new claims 152-155, (11/10/2025), are under consideration by the Examiner.
Claims 1-131, 133, and 135-151 have been canceled.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 9/23/2025, 1/14/2025, 8/8/2024, are in compliance with the provisions of 37 CFR 1.97 and have been considered by the examiner.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section”.
Claim rejections-Double Patenting
Non-statutory double patenting rejection (obviousness-type)
The non-statutory 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 non-statutory double patenting rejection is appropriate where the claims at issue 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 non-statutory 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 non-statutory 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.
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).
4a. Claims 132, 134, and 152-155 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-33 of US Patent No. 11,845,800 (‘800).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 in ‘800 (having the same 10 inventors as the instant application) recites a method for reducing the incidence of one or more asthma exacerbations in a subject suffering from moderate-to-severe severely persistent asthma comprising administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of an antibody or an antigen-binding fragment thereof that specifically binds to interleukin-4 receptor (IL-4R), wherein the antibody or antigen-binding fragment thereof comprises heavy chain complementarity determining region (HCDR) sequences of SEQ ID NOs:148, 150 and 152, and comprises light chain complementarity determining region (LCDR) sequences of SEQ ID NOs:156, 158 and 160, and wherein the pharmaceutical composition is an add-on maintenance treatment administered in combination with a background therapy, and wherein the subject has an eosinophilic phenotype comprising a blood eosinophil level of at least 300 cells per microliter, and/or a sputum eosinophil level of at least 3%.
Instant independent claim 132 recites a method for treating moderate to severe asthma that reduces the incidence of one or more asthma exacerbations or improves one or more asthma-associated parameter(s) in a subject with moderate to severe asthma comprising sequentially administering to the subject a single initial dose of a pharmaceutical composition comprising a full antibody that specifically binds an interleukin-4 receptor (IL-4R), wherein administration of the single initial dose is followed by one or more secondary doses of the pharmaceutical composition comprising the antibody, and wherein the antibody comprises the heavy chain variable (HCVR)/ light chain variable region (LCVR) sequence pair of SEQ ID NOs: 162/164 (which comprise the heavy chain CDRs SEQ ID NO:148, 150, 152 and the light chain CDRs SEQ ID NO:156, 158, 160 in the ‘800 patent).
Claims 132, 134,152-155, in the instant application are a species of claims 1-33 in the ‘800 patent and encompass subject matter to which the claims in the ‘800 patent are generic because a method as recited in instant claims 132, 134, and 152-155 is encompassed by the method of claims 1-33 of the ‘800 patent, and in both applications the same antibody is administered to treat the same condition. However, the instant claims are obvious from the patented claims because the instant claims are directed to one specific embodiment encompassed by the patented claims. The instant method is included in the method claims of the patent and both sets of claims are of overlapping scope. It would have been obvious to one of ordinary skill in the art at the time the present invention was made, that a method as recited in the instant claims, was included in the method as recited in the patented claims. Furthermore, it would have been obvious to one of ordinary skill in the art, in this case, a pulmonologist, to monitor the dosage and have the motivation and ability to optimize the best administration dosage and schedule of administration, a single initial dose followed by one or more secondary doses to obtain the best and efficacious course of treatment. Times of dosage, like dosage of administration, are “result effected variables”, that have an effect on the outcome of a method. Furthermore, such determination would have been well-within the skill set of one of ordinary skill in the art.
The patented claims if infringed upon would also result in infringement of the claims of the instant application. Allowance of the pending claims, therefore, would have the effect of extending the enforceable life of the allowed claims beyond the statutory limit.
4b. Claims 132, 134, and 152-155 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-40 of US Patent No. 11,034,768 (‘768).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 in ‘768 recites a method for treating a subject having severe uncontrolled asthma comprising: administering to the subject a loading dose of an antibody or an antigen-binding fragment thereof that specifically binds to interleukin-4 receptor (IL-4R); and administering to the subject a plurality of maintenance doses of the antibody or the antigen- binding fragment thereof, wherein the plurality of maintenance doses is administered during a treatment phase comprising an induction phase, an oral corticosteroid (OCS) reduction phase, and an OCS maintenance phase, and wherein the antibody or antigen-binding fragment thereof comprises three heavy chain complementary determining region (CDR) sequences comprising SEQ ID NOs: 3, 4, and 5, respectively, and three light chain CDR sequences comprising SEQ ID NOs: 6, 7, and 8, respectively, which are 100% identical to the heavy chain CDRs SEQ ID NO:148, 150, 152 and the light chain CDRs SEQ ID NO:156, 158, 160, in the instant application (which CDRs are included in the heavy chain variable (HCVR)/ light chain variable region (LCVR) sequence pair of SEQ ID NOs: 162/164 recited in the instant claims).
Instant independent claim 132 recites a method for treating moderate to severe asthma that reduces the incidence of one or more asthma exacerbations or improves one or more asthma-associated parameter(s) in a subject with moderate to severe asthma comprising sequentially administering to the subject a single initial dose of a pharmaceutical composition comprising a full antibody that specifically binds an interleukin-4 receptor (IL-4R), wherein administration of the single initial dose is followed by one or more secondary doses of the pharmaceutical composition comprising the antibody, and wherein the antibody comprises the heavy chain variable (HCVR)/ light chain variable region (LCVR) sequence pair of SEQ ID NOs: 162/164 (which comprise the heavy chain CDRs SEQ ID NO:148, 150, 152 and the light chain CDRs SEQ ID NO:156, 158, 160, in the instant application, and which are 100% identical to the heavy chain CDRs SEQ ID NO: 3, 4, 5 and the light chain CDRs SEQ ID NO: 6, 7, 8, in the ‘768 patent).
Claims 132, 134,152-155, in the instant application are a species of claims 1-40 in the ‘768 patent and encompass subject matter to which the claims in the ‘768 patent are generic because a method as recited in instant claims 132, 134, and 152-155 is encompassed by the method of claims 1-40 of the ‘768 patent, and in both applications the same antibody is administered to treat the same condition. However, the instant claims are obvious from the patented claims because the instant claims are directed to one specific embodiment encompassed by the patented claims. The instant method is included in the method claims of the patent and both sets of claims are of overlapping scope. It would have been obvious to one of ordinary skill in the art at the time the present invention was made, that a method as recited in the instant claims, was included in the method as recited in the patented claims. The patented claims if infringed upon would also result in infringement of the claims of the instant application. Allowance of the pending claims, therefore, would have the effect of extending the enforceable life of the allowed claims beyond the statutory limit.
4c. Claims 132, 134, and 152-155 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-30 of US Patent No. 10,137,193 (‘193).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 in ‘193 recites a method for treating persistent asthma in a subject in need thereof comprising administering to the subject a combination therapy comprising:
i) one or more maintenance doses of an inhaled corticosteroid (ICS),
ii) one or more maintenance doses of a long-acting beta-adrenergic agonist (LABA),
iii) a loading dose of about 600 mg of an antibody or an antigen-binding fragment thereof that specifically binds to interleukin-4 receptor (IL-4R) comprising three Heavy chain Complementarity Determining Region (HCDR) sequences comprising SEQ ID NOs: 3, 4, and 5, and three Light chain Complementarity Determining Region (LCDR) sequences comprising SEQ ID NOs: 6, 7, and 8, (which are 100% identical to the heavy chain CDRs SEQ ID NO:148, 150, 152 and the light chain CDRs SEQ ID NO:156, 158, 160, in the instant application), and
iv) one or more maintenance doses of about 300 mg of the antibody or the antigen-binding fragment thereof,
wherein the ICS and LABA are administered for the duration of administration of the antibody or the antigen-binding fragment thereof.
Instant independent claim 132 recites a method for treating moderate to severe asthma that reduces the incidence of one or more asthma exacerbations or improves one or more asthma-associated parameter(s) in a subject with moderate to severe asthma comprising sequentially administering to the subject a single initial dose of a pharmaceutical composition comprising a full antibody that specifically binds an interleukin-4 receptor (IL-4R), wherein administration of the single initial dose is followed by one or more secondary doses of the pharmaceutical composition comprising the antibody, and wherein the antibody comprises the heavy chain variable (HCVR)/ light chain variable region (LCVR) sequence pair of SEQ ID NOs: 162/164.
Claims 132, 134,152-155, in the instant application are a species of claims 1-30 in the ‘193 patent and encompass subject matter to which the claims in the ‘193 patent are generic because a method as recited in instant claims 132, 134, and 152-155 is encompassed by the method of claims 1-30 of the ‘193 patent, and in both applications the same antibody is administered to treat the same condition. The recitation of “comprising” language in the instant claims includes the administration of ICS and LABA. However, the instant claims are obvious from the patented claims because the instant claims are directed to one specific embodiment encompassed by the patented claims. The instant method is included in the method claims of the patent and both sets of claims are of overlapping scope. It would have been obvious to one of ordinary skill in the art at the time the present invention was made, that a method as recited in the instant claims, was included in the method as recited in the patented claims. The patented claims if infringed upon would also result in infringement of the claims of the instant application. Allowance of the pending claims, therefore, would have the effect of extending the enforceable life of the allowed claims beyond the statutory limit.
4d. Claims 132, 134, and 152-155 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-19 of US Patent No. 9,574,004 (‘004).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 in ‘004 (having the same 10 inventors as the instant application) recites a method for the treatment of persistent asthma that reduces the incidence of asthma exacerbations or improves one or more asthma-associated parameter(s) in a subject with persistent asthma comprising sequentially administering to the subject a single initial dose of a pharmaceutical composition comprising an antibody or an antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof specifically binds an interleukin-4 receptor (IL-4R), and wherein administration of the single initial dose is followed by one or more secondary doses of the pharmaceutical composition comprising the antibody or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof comprises heavy chain and light chain complementarity determining region (CDR) sequences from a heavy chain variable region (HCVR)/light chain variable region (LCVR) sequence pair of SEQ ID NOs: 162/164.
Instant independent claim 132 recites a method for treating moderate to severe asthma that reduces the incidence of one or more asthma exacerbations or improves one or more asthma-associated parameter(s) in a subject with moderate to severe asthma comprising sequentially administering to the subject a single initial dose of a pharmaceutical composition comprising a full antibody that specifically binds an interleukin-4 receptor (IL-4R), wherein administration of the single initial dose is followed by one or more secondary doses of the pharmaceutical composition comprising the antibody, and wherein the antibody comprises the heavy chain variable (HCVR)/ light chain variable region (LCVR) sequence pair of SEQ ID NOs: 162/164.
Claims 132, 134,152-155, in the instant application overlap in scope with claims 1-19 in the ‘004 patent because both sets of claims are drawn to a method of treating asthma exacerbations with the same antibody. It would have been obvious to one of ordinary skill in the art at the time the present invention was made, that a method of treating asthma exacerbations as recited in the instant claims, was included in the method as recited in the patented claims. The patented claims if infringed upon would also result in infringement of the claims of the instant application. Allowance of the pending claims, therefore, would have the effect of extending the enforceable life of the allowed claims beyond the statutory limit.
Claim rejections-Provisional Double Patenting
Provisional Non-statutory double patenting rejection (obviousness-type)
4e. Claims 132, 134, and 152-155 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 132-159 of co-pending Application No. 19/385,591 (‘591).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 132-159 in ‘591 (having the same 10 inventors as the instant application), claims a method for treating moderate to severe asthma that reduces the incidence of asthma exacerbations or improves one or more asthma-associated parameter(s) in a subject with moderate to severe asthma comprising sequentially administering to the subject a single initial dose of a pharmaceutical composition comprising a full antibody that specifically binds an interleukin-4 receptor (IL-4R), wherein administration of the single initial dose is followed by one or more secondary doses of the pharmaceutical composition comprising the antibody, and wherein the antibody comprises the heavy chain variable region (HCVR)/light chain variable region (LCVR) sequence pair of SEQ ID NOs: 162/164, thereby treating moderate to severe asthma in the subject, which claims are overlapping in scope with claims 132, 134, and 152-155 in the instant application because both sets of claims are drawn to a method of treating asthma exacerbations with the same antibody. It would have been obvious to one of ordinary skill in the art at the time the present invention was made, that a method of treating asthma exacerbations as recited in the instant claims, was included in the method as recited in the ‘591 claims.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Claims 132, 134, and 152-155 are rejected.
Advisory Information
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1674