DETAILED OFFICE ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment filed on 05 December 2025 is acknowledged and entered. Following the amendment, claim 41 is canceled, claims 30, 38-40, 42, 52 and 55 are amended, and the new claim 58 is added.
Currently, claims 30-40, 42-52 and 55-58 are pending, and are under consideration. The species election requirements set forth in the Office Action mailed on 4/11/2025 are withdrawn.
The indicated allowability of claims 43-47, 49, 51, 56 and 57 in the last Office Action is withdrawn in view of new grounds of rejection, which are set forth below.
Withdrawal of Objections and Rejections:
All objections and rejections of claim 41 are moot as the applicant has canceled the claim.
The rejection of claims 30, 31, 34, 35, 37, 39, 40, 42, 52 and 55 under 35 U.S.C. 112(b), as being indefinite is withdrawn in view of applicant’s amendment.
The lack of written description rejection of claims 30-35, 37, 39, 40, 42, 52 and 55 under 35 U.S.C. 112(a) is withdrawn in view of applicant’s amendment.
Formal Matters:
Claims
Claims 38, 39, 42, 50, 51 and 55 are objected to for the following informalities, appropriate correction is required:
Claims 38, 39, 42, 50, 51 and 55 recite “the nemolizumab”; the following is suggested: “nemolizumab”, deleting “the” as nemolizumab is a specific name.
Rejections under 35 U.S.C. §112:
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.
Claims 32, 33, 44 and 45 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 32 is indefinite for the recitation “at least about 6 months” as neither the claim nor the specification defines the term. Therefore, it is unclear as to what time period is covered by the term “at least about”; for example, is 5.5 months “at least about 6 months”? “At least” implies a minimum; while “about” suggests a range around the number, rendering the combination "at least about" logically contradictory. The metes and bounds of the claim, therefore, cannot be determined. Deleting “at least” or “about” is suggested. Claims 33, 44 and 45 are similarly indefinite for the recitation “at least about”.
Double Patenting Rejections:
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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 30-40, 42-52 and 55-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-9, 11-18, 20-22, 24 and 25 of U.S. Patent No. 11,236,157. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-5, 7-9, 11-18, 20-22, 24 and 25 of the ‘157 patent are directed to a method of treating skin lesions and pruritus in a subject having chronic prurigo (CP), including the chronic prurigo that is prurigo nodularis (PN), with an effective amount of nemolizumab or an equivalent thereof, wherein the subject does not have atopic dermatitis (claims 1 and 13, for example); wherein the subject has at least about 20 nodules on his/her body with a bilateral distribution, has prurigo lesions on upper limbs, or has been diagnosed of PN for at least about 6 months (claims 2, 3 and 14-16, for example); wherein the pruritus has been assigned a score of at least 4 or at least 7 on the Numerical Rating Scale (NRS) (claims 4, 5, 17 and 18, for example); wherein the effective amount is, among others, about 30 mg, about 60 mg, or doses between (claims 7 and 20); wherein the nemolizumab is administered according to a flat dosing regimen, or a loading dose regimen (claims 8, 9, 21 and 22), is administered subcutaneously (claims 11 and 24), and is administered, among others, once every four weeks (claims 12 and 25). Thus, claims 1-5, 7-9, 11-18, 20-22, 24 and 25 of the ‘157 patent anticipate the present claims 30, 31, 37 and 40 or render the claims obvious. Therefore, the claims at issue are not patentably distinct from each other.
Conclusion:
No claim is allowable,
Advisory Information:
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/DONG JIANG/
Primary Examiner, Art Unit 1674
1/28/26