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 .
Claims 1-18, (2/23/2024), are pending and under consideration by the Examiner.
Information Disclosure Statements
3. The information disclosure statements (IDS) submitted on 3/7/2024, and 10/15/2025, 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-35 USC § 112(b)
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4a. Claims 1-18 are rejected 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 which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1, line 4, is vague and indefinite because it recites “comprising an amino acid sequence of SEQ ID NO:27” rather than the proper “ comprising the amino acid sequence of SEQ ID NO:27”, because a specific amino acid sequence is recited in the claim.
Claims 2-18 are rejected as vague and indefinite insofar as they depend on the above rejected claim 1 for its limitations.
Claim rejections-Double Patenting
Non-statutory double patenting rejection (obviousness-type)
5. 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).
5a. Claims 1-18 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-22 of US Patent No. 11,945,852 (‘852).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 in ‘852 (having the same five inventors as the instant application) recites a method of treating a condition selected from the group consisting of atopic dermatitis, Systemic Lupus Erythematosus (SLE) and vitiligo, in a subject in need thereof, the method comprising administering to the subject an effective amount of a pharmaceutical composition comprising a polypeptide comprising amino acid sequence of SEQ ID NO: 27, and a pharmaceutically acceptable carrier.
Instant independent claim 1 recites a method of treating vitiligo, in a subject in need thereof, comprising increasing T regulatory cell proliferation in the subject by administering to the subject an effective amount of a pharmaceutical composition comprising a polypeptide comprising an amino acid sequence of SEQ ID NO: 27, and a pharmaceutically acceptable carrier.
Claims 1-18, in the instant application are a species of claims 1-22 in the ‘852 patent and encompass subject matter recited in the claims of the ‘852 patent because a method as recited in instant claims 132-159 is encompassed by the method of claims 1-22 of the ‘852 patent, and in both applications the same polypeptide 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.
5b. Claims 1-18 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of US Patent No. 11,779,632 (‘632).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 in ‘632 (having the same five inventors as the instant application) recites a method of increasing T regulatory cell proliferation in a subject, the method comprising administering to the subject a pharmaceutical composition comprising a peptide comprising amino acid sequence of SEQ ID NO: 27.
Instant independent claim 1 recites a method of treating vitiligo, in a subject in need thereof, comprising increasing T regulatory cell proliferation in the subject by administering to the subject an effective amount of a pharmaceutical composition comprising a polypeptide comprising an amino acid sequence of SEQ ID NO: 27, and a pharmaceutically acceptable carrier.
Claims 1-18 in the instant application are a species of claims 1-20 in the ‘632 patent and encompass subject matter recited in the generic claims of the ‘632 patent because a method as recited in instant claims 1-18 is encompassed by the method of claims 1-20 of the ‘632 patent, and in both applications the same polypeptide 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.
Conclusion
No claim is allowed.
Claims 1-18 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.
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1674
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