DETAILED ACTION
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 .
2. Amended claims 1, 122, (7/17/2026), and previously presented claims 6-15, 123-132 are pending under consideration by the Examiner.
Claims 2-5, and 16-121 have been canceled.
Claim rejections-Provisional Double Patenting
Non-statutory double patenting rejection (obviousness-type)
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 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 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.
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).
3a. Claims 1, 6-15, 122-132 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 61, 66-73, of copending Application No. 18/443,459 (‘459).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 61 in ‘459 recites a method of reducing incidence of atopic dermatitis comprising administering to a subject in need thereof a therapeutically effective amount of an anti- IL-13 antibody, or antigen binding fragment thereof, thereby reducing incidence of atopic dermatitis in the subject, wherein the anti-IL-13 antibody comprises an antigen binding domain comprising six CDRs: CDR-H1, CDR-H2, CDR-H3, CDR-1, CDR-L2, and CDR-L3, wherein:
(a) CDR-H1 comprises residues 31-37 of SEQ ID NO:2;
(b) CDR-H2 comprises residues 52-67 of SEQ ID NO:2;
(c) CDR-H3 comprises residues 100-112 of SEQ ID NO:2;
(d) CDR-L1 comprises residues 24-34 of SEQ ID NO:3;
(e) CDR-L2 comprises residues 50-56 of SEQ ID NO:3; and
(f) CDR-L3 comprises residues 89-97 of SEQ ID NO:3.
Instant claim 1 recites a method of treating atopic dermatitis comprising administering to a subject in need thereof 360 mg of an anti- IL-13 antibody, or antigen binding fragment thereof, thereby treating atopic dermatitis in the subject, wherein the anti-IL-13 antibody comprises an antigen binding domain comprising six CDRs: CDR-H1, CDR-H2, CDR-H3, CDR-1, CDR-L2, and CDR-L3, wherein:
(a) CDR-H1 comprises residues 31-37 of SEQ ID NO:2;
(b) CDR-H2 comprises residues 52-67 of SEQ ID NO:2;
(c) CDR-H3 comprises residues 100-112 of SEQ ID NO:2;
(d) CDR-L1 comprises residues 24-34 of SEQ ID NO:3;
(e) CDR-L2 comprises residues 50-56 of SEQ ID NO:3; and
(f) CDR-L3 comprises residues 89-97 of SEQ ID NO:3.
Claims 61, 66-73, in ‘459 are generic to claims 1, 6-15, 122-132 in the instant application and encompasses subject matter to which the instant claims are a species because the method as recited in claims 61, 66-73 in ‘459 encompasses method claims 1, 6-15, 122-132 of the instant application. However, the instant claims are obvious from the claims in ‘459 because the instant claims are directed to one specific embodiment encompassed by the ‘459 claims. The instant method is included in the method claims of ‘459 and 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 would be encompassed by the method claims of ‘459.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim rejections-Double Patenting
Non-statutory double patenting rejection (obviousness-type)
3b. Claims 1, 6-15, 122-132 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-9 of US Patent No. 11,964,005 (‘005).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 in ‘005 (having the same inventors as the instant application) recites a method of treating atopic dermatitis comprising administering to a subject in need thereof a therapeutically effective amount of an anti- IL-13 antibody, or antigen binding fragment thereof, thereby treating atopic dermatitis in the subject, wherein the anti-IL-13 antibody comprises an antigen binding domain comprising six CDRs: CDR-H1, CDR-H2, CDR-H3, CDR-1, CDR-L2, and CDR-L3, wherein:
(a) CDR-H1 comprises residues 31-37 of SEQ ID NO:2;
(b) CDR-H2 comprises residues 52-67 of SEQ ID NO:2;
(c) CDR-H3 comprises residues 100-112 of SEQ ID NO:2;
(d) CDR-L1 comprises residues 24-34 of SEQ ID NO:3;
(e) CDR-L2 comprises residues 50-56 of SEQ ID NO:3; and
(f) CDR-L3 comprises residues 89-97 of SEQ ID NO:3.
Claims 1-9, in ‘005 are generic to claims 1, 6-15, 122-132 in the instant application and encompasses subject matter to which the instant claims are a species because the method as recited in claims 1-9 in ‘005 encompasses method claims 1, 6-15, 122-132 of the instant application. However, the instant claims are obvious from the claims in ‘005 because the instant claims are directed to one specific embodiment encompassed by the ‘005 claims. The instant method is included in the method claims of ‘005 and 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 would be encompassed by the method claims of ‘005.
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.
Conclusion
No claim is allowable.
Claims 1, 6-15, and 122-132 are rejected.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PREMA MARIA MERTZ whose telephone number is (571)272-0876. The examiner can normally be reached on Monday to Thursday from 7:30am to 6:00pm.
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.
/PREMA M MERTZ/ Primary Examiner, Art Unit 1646
Prosecution Insights