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 1/5/26 has been entered in full. Claims 42-48, 51-53 and 55-57 are canceled. Claims 41, 54, 58, 60, 62 and 64-65 are amended. New claims 66-95 are added. Claims 41, 49-50, 54 and 58-95 are pending.
Applicants’ election with traverse of monotherapy (no second therapeutic agent) as the species of second therapeutic agent in the reply filed on 1/5/26 is acknowledged.
The traversal is on the grounds that, as amended, “[n]one of the pending claims recite a Markush group for the second therapeutic agent” (page 8). This argument has been considered, and is found persuasive, and the election of species requirement is withdrawn in view of the amended claims.
Claims 41, 49-50, 54 and 58-95 are under consideration.
Specification
The disclosure is objected to because of the following informalities:
The title of the invention is not descriptive because it is directed to a method of treatment of atopic dermatitis with an IL-4R inhibitor of any structure, but the claims are limited to administration of an 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 Anti-IL-4R Antibody”.
Appropriate correction is required.
Claim Objections
Claims 41, 49-50, 54 and 58-95 are objected to for the following informalities:
In independent claim 41, there should be a comma instead of a semi-colon at the end of the second “wherein” clause that concludes the claim, and furthermore there should be an “and” joining the second and third “wherein” clause; i.e., “….every two weeks (Q2W), and”. Compare with the end of line 5 in independent claim 75.
In claims 61 and 91, line 1 of each, “prefilled” should be “pre-filled”.
In claims 64 and 94, line 2 of each, “1.15mL” should be “1.15 mL”.
In claims 65 and 95, line 2 of each, “2.25mL” should be “2.25 mL”.
In independent claim 75, “<18” should be “< 18”. Compare with “≥ 12” and “≥ 60”.
The remaining claim(s) are objected to for depending from an objected claim.
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 41, 49-50, 54, 58-66, 69-70, 73, 75-76, 79-80, 83-85 and 87-95 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,292,847, issued 4/5/22 (cited on the 11/3/23 IDS), 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 16/409,164, which issued as the ‘847 patent.
Instant independent claim 41 encompasses a method for treating moderate-to-severe atopic dermatitis (AD) comprising administering dupilumab to a subject with moderate-to-severe AD, wherein the subject is ≥12 to < 18 years of age and < 60 kg in weight, wherein the dupilumab is administered in an initial dose of 400 mg and one or more secondary doses of 200 mg every two weeks (Q2W), and wherein the subject achieves an Investigator’s Global Assessment (IGA) score of 0 or 1 at week 16 of treatment.
Claim 1 of the ‘847 patent encompasses a method for treating moderate-to-severe AD comprising administering an IL-4R inhibitor to a patient aged ≥12 years to < 18 years with moderate-to-severe AD, wherein the IL-4R inhibitor is an antibody that binds IL-4Rα and comprises HCDR1-3 of SEQ ID NO: 3-5 and LCDR1-3 of SEQ ID NO: 6-8, and wherein for a patient <60 kg, the inhibitor is administered at an initial dose of 400 mg followed by one or more secondary doses of 200 mg, and wherein each secondary dose is administered two weeks after the immediately preceding dose. This method includes all of the limitations of instant claim 41, 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 ‘847. See claim 12 of ‘847, which further limits the antibody to dupilumab, and claim 7 of ‘847, which includes as part (iv) a result of treatment that is an IGA score of 0 or 1 at week 16. Therefore, claim 1 of ‘847 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 independent claim 75 encompasses a method for treating moderate-to-severe AD comprising administering dupilumab to a subject with moderate-to-severe AD, wherein the subject is ≥12 to < 18 years of age and ≥ 60 kg in weight, wherein the dupilumab is administered in an initial dose of 600 mg and one or more secondary doses of 300 mg every two weeks (Q2W), and wherein the subject achieves an IGA score of 0 or 1 at week 16 of treatment.
Claim 1 of the ‘847 patent encompasses a method for treating moderate-to-severe AD comprising administering an IL-4R inhibitor to a patient aged ≥12 years to < 18 years with moderate-to-severe AD, wherein the IL-4R inhibitor is an antibody that binds IL-4Rα and comprises HCDR1-3 of SEQ ID NO: 3-5 and LCDR1-3 of SEQ ID NO: 6-8, and wherein for a patient ≥ 60 kg, the inhibitor is administered at an initial dose of 600 mg followed by one or more secondary doses of 300 mg, and wherein each secondary dose is administered two weeks after the immediately preceding dose. This method includes all of the limitations of instant claim 75, 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 ‘847. See claim 12 of ‘847, which further limits the antibody to dupilumab, and claim 7 of ‘847, which includes as part (iv) a result of treatment that is an IGA score of 0 or 1 at week 16. Therefore, claim 1 of ‘847 also encompasses these limitations. As such, the method of instant 75 is anticipated by claim 1 of the ‘847 patent, and as such claim 75 is not patentably distinct from the claims of ‘847.
Instant claims 49-50, 54, 58-66, 69-70, 73, 76, 79-80, 83-85 and 87-95 depend from claim 41 (claims 49-50, 54, 58-66 and 69-73) or claim 75 (claims 76, 79-85 and 87-95) and further limit the respective parent claim to embodiments that correspond to the further limitations of the antibody of the dependent claims of ‘847 as follows:
Instant Claim
Claim of ‘847
49, 84
3
50, 85
4
54, 87
1
58, 88
13
59, 89
14
60, 90
14, 15
61, 91
16
62, 92
14, 17
63, 93
20
64, 94
18
65, 95
19
66, 76
2, part (i)
69, 79
7, part (iv)
70, 80
7, part (iv)
73, 83
7, part (iii)
As such, the method of instant dependent claims 49-50, 54, 58-66, 69-73, 76, 79-85 and 87-95 are anticipated by the corresponding claims of the ‘847 patent, and as such these instant claims are also not patentably distinct from the claims of ‘847.
Claim Rejections - 35 USC § 112(a), written description
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 67-68, 71-72, 74, 77-78, 81-82 and 86 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 because the claim contains new matter. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Per MPEP 2163, "New or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (an adequate description of a genus may not support claims to a subgenus or species within the genus)".
New claims 67-68, 71-72, 74, 77-78, 81-82 and 86 were added in the claim amendments made on 1/5/26. Applicants’ reply states, “Claims 66-95 are added and can find support throughout the original specification, claims and drawings”. However, consideration of the specification, claims and drawings as originally filed does not find support for the subject matter of claims 67-68, 71-72, 74, 77-78, 81-82 and 86.
Specifically, new claims 67 (from which claims 68, 71 and 72 depend) and 77 (from which claims 78, 81 and 82 depend) limit the method of the respective parent claim, which is either claim 66 (for claim 67) or claim 76 (for claim 77), to one wherein “the subject had a baseline Eczema Area and Severity Index (EASI) score of at least 36”. The specification as originally filed on 3/4/22 teaches that EASI “is a composite index with scores ranging from 0 to 72” (¶ 178, published application). Thus, the new claims encompass subjects with EASI scores of 36 to the maximum, i.e., 72. However, nowhere does the specification as originally filed teach a category of subject to be treated that has a baseline EASI score of “at least 36” or “36 and above” or “36 to 72”. There is no conception in the specification as originally filed of a method of treatment that is directed to this specific subset of patients. As such, the introduction of claims directed to this subset of subjects into the claims constitutes new matter.
Likewise, new claims 74 and 86 limit the method of the respective parent claim, which is either claim 41 (for claim 74) or claim 75 (for claim 86), to one wherein “the subject had a baseline Body Surface Area Involvement of Atopic Dermatitis (BSA) score of at least 56%”. The specification describes the score as the percentage of body surface area affected by AD (¶ 181). Thus, the new claims encompass subjects with BSA scores of 56% to the maximum, i.e., 100%. However, nowhere does the specification as originally filed teach a category of subject to be treated that has a baseline BSA score of “at least 56%” or “56% and above” or “56% to 100%”. There is no conception in the specification as originally filed of a method of treatment that is directed to this specific subset of patients. As such, the introduction of claims directed to this subset of subjects into the claims constitutes new matter.
Notes on Patentability
No prior art has been identified that teaches or renders obvious the method of treatment of the instant claims, which is limited to treatment of a subject that has moderate-to-severe atopic dermatitis and is ≥ 12 and < 18 years of age, where the treatment is administration of the antibody dupilumab (an IL-4R inhibitor) at a specific fixed-dose regimen of either 400 mg followed by 200 mg every two weeks (if the patient is less than 60 kg) or 600 mg followed by 300 mg every two weeks (if the patient is 60 kg or more). This same invention was found patentable in parent application 17/687,051, which issued as U.S. Patent 11,292,847.
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.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674