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 .
The request filed on 28 July 2025 for a Continued Examination (RCE) under 37 CFR 1.114 based on parent Application No. 18/674,352 is acceptable, and an RCE has been established. An action on the RCE follows.
Applicant’s amendment filed on 28 July 2025 is acknowledged and entered. Following the amendment, claims 3, 13, 15, 22 and 25 are amended.
Currently, claims 1-16 and 20-28 are pending, and claims 1-8, 14-16 and 20-28 are under consideration. Claims 9-13 remain withdrawn from further consideration as being drawn to a non-elected invention/species.
Formal Matters:
Claims
Applicant is advised that should claims 1 and 2 be found allowable, claims 26 and 27 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Although claim 26 recites additional “wherein the patient has a reduced risk of a cardiac adverse event ...”, such would represent an inherent property of the method of claim 1 because the “wherein ...” clause does not in any way alter the method of claim 26 as compared to that of claim 1.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 1-8, 14-16 and 20-28 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, for the reasons of record set forth in the last Office Action mailed on 11/7/2024, at page 4, and for the reasons below.
Claim 1 is indefinite and confusing for the recitation “for at least up to 76 weeks” because it is unclear what it is meant or encompassed. For example, is 74 or 75 weeks or 77 or 78 weeks (for example) “at least up to 76 weeks”? “At least” means a minimum, whereas “up to” means a maximum or at most. When both are used together, it is confusing and does not make sense. Does “for at least up to 76 weeks” mean for at least 76 weeks, or for at most 76 weeks? The metes and bounds of the claim, therefore, cannot be determined. “For at least 76 weeks” or “for up to 76 weeks” is suggested, if either one is intended. Claims 3, 15, 16, 20, 22, 23, 25 and 26 are similarly indefinite.
Claim 16 remains further indefinite for the reasons of record set forth in the last Office Action.
The remaining claims are included in this rejection because they are dependent from the specifically mentioned claims without resolving the indefiniteness issue belonging thereto.
Applicants argument filed on 28 July 2025 has been fully considered, but is not deemed persuasive for the reasons below.
At page 9 of the response, the applicant argues that claims 3, 13, 15, 16, 22, and 25 to recite up to at least 244 weeks.
This argument is not persuasive because claim 16 has not been amended, and the issue of claim 16 has not been addressed in applicants response.
Prior Art Rejections
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8, 14-16 and 20-28 remain rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT01722331 (3/23/2022), and as evidenced by Presta et al. (US 2010/ 0272731 A1, 10/28/2010), for the reasons of record set forth in the previous Office Actions mailed on 11/7/2024, and 2/27/2025.
Applicants argument filed on 28 July 2025 has been fully considered, but is not deemed persuasive for the reasons below.
At pages 10-11 of the response, the applicant argues that the combination of NCT01722331 and Presta would not provide one of skill in the art with a reasonable expectation of success when carrying out the claimed method for up to at least 76 weeks; that Clinical Trial NCT01722331 does not disclose treating up to at least 76 weeks, and Presta does not cure this deficiency; and that the combination of NCT01722331 and Presta cited by the Office fails to provide the skilled worker with a reasoned basis for administering tildrakizumab up to at least 76 weeks; and the Office Action does not provide an articulated rationale with a rational underpinning for administering tildrakizumab up to at least 76 weeks, but simply asserts that extending the treatment out to 76 weeks is merely optimizing a therapeutic regimen and thus routine and obvious.
This argument is not persuasive for the following reasons: first, the instant rejection is the obviousness type of rejection, in which “Prior art is not limited just to the references being applied, but includes the understanding of one of ordinary skill in the art. The prior art reference (or references when combined) need not teach or suggest all the claim limitations, however, Office personnel must explain why the difference(s) between the prior art and the claimed invention would have been obvious to one of ordinary skill in the art. The ‘mere existence of differences between the prior art and an invention does not establish the invention’s nonobviousness.’ Dann v. Johnston, 425 U.S. 219, 230, 189 USPQ 257, 261 (1976). … … The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts. See 35 U.S.C. 103(a). Factors other than the disclosures of the cited prior art may provide a basis for concluding that it would have been obvious to one of ordinary skill in the art to bridge the gap” (MPEP 2141, III.). In the instant case, NCT01722331 teaches the claimed method and regimens without mentioning “for up to at least 76 weeks” (not even sure whether it is at least or at most for 76 weeks). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Given psoriasis is a chronic disease, and the conditions of the patients vary significantly, it is routine in the art for a person skilled in the art to determine a suitable regimen for a patient, which determination is well within the skilled artisan’s purview. Further, there is no evidence in the specification indicating that for at least or at most 76 weeks is critical. In fact, claims 3, 15, 22 and 25 recite “for at least up to 244 weeks”, which indicates that 76 weeks is not critical. Therefore, mere determination or optimization of the length of a known regimen by routine experimentation, such as based on patients condition such as disease severity, tolerance to the treatment, and improvement after the treatment, does not constitute a novel inventive concept.
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 1-8, 14-16 and 20-28 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 14 of copending Application No. 18/158,767. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons of record set forth in the last Office Action mailed on 11/7/2024, at page 7.
On page 12 of the response filed on 28 July 2025, applicant indicated that Applicant acknowledges the provisional rejection, and elects to address this ground of rejection upon notification that the rejection has been made non-provisional, all other conditions for patentability have been met, and the instant claims are otherwise in condition for allowance.
As such, the rejection is maintained. Once again, applicant is reminded that at such time (all other conditions for patentability have been met), filing a terminal disclaimer will overcome the instant rejection. However, Applicant is advised that traversal of the rejection at such time would not be considered timely.
Conclusion:
No claim is allowed.
Advisory Information:
Any inquiry concerning this communication should be directed to Examiner DONG JIANG whose telephone number is 571-272-0872. The examiner can normally be reached on Monday - Friday from 9:30 AM to 7:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on 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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/DONG JIANG/
Primary Examiner, Art Unit 1674
11/14/25