DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 7/24/26 has been entered in full. Claims 1-41 and 48-53 are canceled. New claims 54-72 are added and are the pending claims.
Election/Restrictions
New claims 54-72 belong to Invention I as set forth in the 4/24/26 action.
Applicants’ election of Group I, currently claim 54-72, in the reply filed on 7/24/26 is acknowledged. There is no indication of whether the election is with or without traverse, but because the response did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The elections of (1) food allergy as the species of concurrent allergy; (2) triamcinolone acetonide 0.1% cream as the species of topical corticosteroid (TCS); and (3) “(a) age ≥ years to < 12 years; weight < 30 kg” as the species of patient population, are also acknowledged. Claims 69-72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 54-68 under consideration, as they read upon the elected species.
Specification
The disclosure is objected to because of the following informalities:
The title of the invention is not descriptive because it is directed generally to use of any IL-4R antagonist, but the claims are limited to use of a antagonist antibody. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “METHODS FOR TREATING ATOPIC DERMATITIS BY ADMINISTERING AN IL-4R ANTAGONIST ANTIBODY.
Appropriate correction is required.
Claim Rejections
Double Patenting
The nonstatutory double (NSDP) 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 NSDP 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 (TD) in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on NSDP 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 TD must be signed in compliance with 37 CFR 1.321(b).
The filing of a TD by itself is not a complete reply to a NSDP rejection. A complete reply requires that the TD 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 TD 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 54-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,090,201, issued 9/17/24, and which shares the same applicant and inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The instant application claims priority as a continuation to application 16/985,703, from which issued the ‘201 patent.
Instant independent claim 54 encompasses a method for treating atopic dermatitis comprising administering dupilumab (an IL-4R antagonist) to a subject with moderate-to-severe AD that is ≥ 6 years to < 12 years of age and has a body weight of <30 kg, wherein the dupilumab is administered subcutaneously at an initial dose of 600 mg followed by one or more subsequent doses 300 mg every four weeks (Q4W), and wherein the subject achieves an Investigator’s Global Assessment (IGA) score of 0 or 1 at week 16 of treatment after the initial dose.
Claim 1 of the ‘201 patent encompasses a method for treating atopic dermatitis comprising administering an IL-4R antagonist having the HCDRs of the HCVR of SEQ ID NO: 1 and the LCDRs of the LCVR of SEQ ID NO: 2 to a subject with moderate-to-severe AD that is that is ≥ 6 years to < 12 years of age and in wherein clause (i) has a subject body weight of <30 kg and is administered at an initial dose of 600 following by one or more secondary doses of 300 mg every four weeks (Q4W). This method includes all of the limitations of instant claim 54, except that it does not recite that the antibody is dupilumab, or that the subject achieves an IGA score of 0 or 1 at week 16 of treatment. However, each of these limitations is expressly recited in a dependent claim of ‘201. Dependent claim 15, part (i), further recites that the subject achieves an Investigator’s Global Assessment (IGA) score of 0 or 1 at week 16 of treatment after the initial dose. Dependent claim 19 further recites that the IL-4R antagonist can be dupilumab. See claim 19 of ‘201, which further limits the antibody to dupilumab in the alternative, and claim 15 of ‘201, which includes as part (i) a result of treatment that is an IGA score of 0 or 1 at week 16. Therefore, claim 1 of ‘201 also encompasses these limitations. As such, the method of instant 41 is anticipated by claim 1 of the ‘847 patent, and as such claim 41 is not patentably distinct from the claims of ‘847.
Instant claims 55-68 depend from claim 54 and further limit the respective parent claim to embodiments that correspond to the further limitations of the antibody of the dependent claims of ‘201 as follows:
Instant Claim
Claim of ‘201
55
11
56
7
57
57
58
10
59
12
60
13
61
15
64
20
65
21
66
22
67
23
68
24
As such, the method of instant dependent claims 55-61 and 64-68 are also not patentably distinct from the claims of ‘201.
Instant dependent claims 63 and 64 present further limitations that are not expressly recited by the claims of ‘201. However, each of these further limitations is directed to a wherein clause that has been fully considered in context of the entire claim but does not render the claimed method patentably distinct from a method taught by ‘201 because it simply expresses the intended result of a process step positively recited. See MPEP 2111.04, which states that a "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited" (Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Specifically, in claims 63 and 64, the claims simply express the intended result (corresponding to a reduction in symptoms of atopic dermatitis) of a process step positively recited (administering dupilumab). As such, the method of dependent claims 63 and 64 are each also not patentably distinct from that of the claims of the ‘201 patent.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated-interview-request-air-form.
/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
Prosecution Insights