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 25 November 2025 for a Continued Examination (RCE) under 37 CFR 1.114 based on parent Application No. 18/921,679 is acceptable, and an RCE has been established. An action on the RCE follows.
Applicant’s amendment filed on 25 November 2025 is acknowledged and entered. Following the amendment, claims 11-14, 16-18 and 21-23 are canceled, claims 24, 25, 48 and 49 are amended, and the new claims 51-61 are added.
Currently, claims 1-3, 5, 7, 8, 10, 24, 25, 41, 43-46 and 48-61 are pending, and claims 24, 25, 41, 43-46, and 48-61 are under consideration. Claims 1-3, 5, 7, 8 and 10 remain withdrawn from further consideration as being drawn to a non-elected species.
Formal Matters:
Claims
Applicant is advised that should claim 59 be found allowable, claim 61 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. 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).
Claim 24 is objected to for the following informalities, appropriate correction is required:
Claim 24 recites “withdrawing treatment of the sonelokimab” in the last line; the following is suggested: “withdrawing treatment of sonelokimab” (delete “the”).
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 24, 25, 41, 43-46, 48, 49 and 50 remain rejected, and the new claims 51-61 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 previous Office Actions mailed on 4/8/2025, and 7/25/2025.
With respect to the new claims 51-61, the independent claim 51 is indefinite for the recitation “administering sonelokimab to a subject … to achieve either (i) an IGA score of 0 - 1 or (ii) a PASI score of 90 - 100, followed by withdrawal of treatment with the sonelokimab for a period of 4 to 20 weeks” because such represents the treatment result or efficacy after the treatment, thus, it is unclear how a patient can be selected prior to the treatment in order for the patient to achieve such a result after the treatment. Treatment result or efficacy cannot be predicted or demanded as it is out of anyone’s control once the therapeutic agents are administered. The metes and bounds of the claim, therefore, cannot be determined. Claims 52-55 are similarly indefinite.
The remaining claims are included in this rejection because they are dependent from the specifically mentioned claims without resolving the indefiniteness issue belonging thereto.
Claims 44 and 45 are further indefinite (besides the reasons discussed previously) for the recitation “which achieves normalization of peripheral/cutaneous IL-17A, IL-17F, CCL20, CXCl1, DEFB4A, CXCL8, LCN2, CAMP, KRT16, IL-13, IL-23, IL-31 and/or IL-22 in the subject by no later than week 24” because there is no specific dermatological condition even recited in the claims other than “an IL-17-dependent dermatological condition”. Therefore, it is unclear what factor(s) or whether any of the other factors recited (besides IL-17A/F) is/are even involved in “an IL-17-dependent dermatological condition”, let alone, all factors recited. The metes and bounds of the claim, therefore, cannot be determined.
Applicants argument filed on 25 November 2025 has been fully considered, but is not deemed persuasive for the reasons below.
At page 7 of the response, the applicant argues that one of skill in the art would immediately know the metes and bounds of the claimed subject matter including, for example, whether or not administration of sonelokimab achieves full skin clearance in a subject, and the specification teaches that full skin clearance in psoriasis relates to an IGA score of 0; and that, regarding claim 24, the Examiner’s rationale is improper, prediction of whether a patient is a responder or a non-responder or a “less-responder” is not relevant to the metes and bounds of the claim, and the claim does not require prediction of response, instead, the claim embraces embodiments in which a subject actually achieves full skin clearance upon administration of sonelokimab according to the recited regimen.
This argument is not persuasive for the reasons of record. A claim of treatment does not require prediction of response, unless the claim requires it, which is the case here, and it does not make sense because the treatment result or efficacy is impossible to control or predict. Contrary to applicants argument that the patient’s response is not relevant to the metes and bounds of the claim, since the claim requires the patient to achieve said response after the treatment, and no treatment would result in 100% efficacy, one of skill in the art would have to know how to select such a patient prior to the treatment in order to meet the efficacy limitation of the claim. However, it is unclear how to select such a patient in the first place. The metes and bounds of the claim, therefore, cannot be determined.
Applicant further argues, on page 7 of the response, that one of skill in the art would immediately know the metes and bounds of the term “subjects” in claim 25, just as the term “subject” in claim 24; and that the “subjects” of claim 25 are subjects which have been treated as recited, specified in claim 24.
This argument is not persuasive for the reasons of record, and the “argument” merely repeats claim 25. A claim for patent is not an efficacy review of a clinical study. In the instant case, it requires any or all patients encompassed by the claim meeting the limitations of the claim, which is defined in claim 24, from which claim 25 is dependent. Therefore, claim 25 does not make sense by reciting a portion of the patient population to achieve certain result. Claim 25 is further indefinite and confusing for the recitation “which achieves a complete clearance of the disease after week 24 in 40% or more of subjects who at week 24 of treatment still exhibited symptoms” because it is unclear 1) what “which” is meant; and 2) what the entire sentence is meant, i.e., the subject being treated achieves a complete clearance, and still exhibited symptoms in the same time? Such does not seem making sense. Deletion of the claim 25 is suggested.
At pages 7-8 of the response, the applicant argues that Applicant maintains that “4 weeks or more” in claim 48 cannot be specified any clearer, and an open-ended range is still a range; and that the Examiner does not provide any rationale for why one of skill in the art would not be able to determine whether withdrawal of treatment occurs for a period of “4 weeks or more” in a way that shifts the burden to Applicant to explain how claim 48 is clear and definite.
This argument is not persuasive for the reasons of record. It is unclear as to how one of skill in the art would be able to determine how long is “more”; and what rationale is needed to explain such? As explained previously, “4 weeks or more” could it be interpreted as the withdrawal of the treatment for a limited time period, or forever, or it also indicates that the treatment would resume at some point? The metes and bounds of the claim, therefore, cannot be determined.
At page 8 of the response, the applicant argues that claim 49 has been amended to specify that withdrawal of treatment with the sonelokimab comprises pausing the treatment with the sonelokimab for a period of 4 to 20 weeks, and one of skill in the art would immediately know the metes and bounds of a time period of “4 to 20 weeks.”
This argument is not persuasive for the reasons of record. The issue is not “4 to 20 weeks” per se (previously existed), rather, the issue is that the method is incomplete because
it is unclear whether such indicates that the treatment would resume after the withdrawal period (even if “full skin clearance” (claim 24) remains)? The metes and bounds of the claim, therefore, cannot be determined.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 25, 43, 44, 52-55 and 58 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 25, 43, 44, 52-55 and 58 recite the method to “achieve” certain treatment results, which represents inherent properties of the methods since no one can control such results, and such does not in any way alter the features of the methods themselves (such as active ingredient, method steps, or patient population). Therefore, the claims fail to further limit the subject matter of the claim upon which it depends.
In addition, claim 58 recites “wherein the dose is increased between week 2 and week 24 if the subject has an IGA score of more than 1”, while claim 51, from which claim 58 is dependent, requires the subject being treated to achieve an IGA score of 0 – 1 (though out of anyone’s control), not > 1. Thus, claim 58 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Rejections Over Prior Art:
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.
Claim interpretation: once again, as the claims are indefinite for the reasons above, they are interpreted as the following (for the purpose of the prior art rejection set forth below): claim 24: the limitation “to achieve full skin clearance followed by withdrawal of treatment with the nanobody” is not given patentable weight since such efficacy cannot be predicted, hence, such patients cannot be pre-selected; claim 25: is treated like claim 24 because it is unclear what it is meant; claims 48 and 49: the additional limitations recited are not given patentable weight because they are indefinite and not meaningful (see above rejection under 35 U.S.C. 112(b)); claim 51: is interpreted similarly as that for claim 24, as drawn to a method of treating psoriasis with the recited regimen, wherein the withdrawal based on the efficacy could not be given patentable weight as efficacy is unpredictable; claims 44, 45 and 52-55: the efficacy limitations are not given patentable weight as they represent inherent properties of the claimed method of treatment.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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 24, 25, 41, 43-46, and 48-61 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Clinical Trial NCT03384745 (v1, 12/27/2017), for the reasons of record set forth in the previous Office Actions mailed on 4/8/2025, and 7/25/2025.
Applicants argument filed on 25 November 2025 has been fully considered, but is not deemed persuasive for the reasons below.
At page 8-10 of the response, the applicant argues the cited art fails to teach each and every feature of the claims, such as “to achieve full skin clearance; and then withdrawing treatment of the sonelokimab” as claimed; that the rejection is premised on a claim interpretation that does not give any patentable weight to certain recited claim features, including the achievement of full skin clearance and withdrawal of treatment; that the Clinical Trial NCT03384745 does not include any description or even suggest the ability of sonelokimab admistration to lead to the identification of subjects with continuous absence of the disease after treatment withdrawal rather than rapid reoccurrence of the disease; that the presently claimed subject matter is the concept that certain treatments of chronic inflammatory conditions such as psoriasis may provide long-term disease control in responding patients even after treatment withdrawal, a phenomenon sometimes referred to as “disease modification”; that the implications of the results disclosed in the present application are very meaningful, particularly with regard to real world patient treatment and quality of life; and the ability to modify disease as opposed to continuously “treating” it would be capable of saving unnecessary treatment and the related costs and risks of safety events; and that NCT03384745 provides no hint of an administration regime involving withdrawal of sonelokimab treatment based on achievement of full skin clearance or the ability of sonelokimab to achieve disease modification.
This argument is not persuasive for the reasons of record. While NCT03384745 does not include any treatment result or efficacy, such would be inherent properties of the same method. Further, while efficacy is important and very meaningful, the requirements for patent differs from that for FDA approval, which requires efficacy data. Whereas for patentability, efficacy is not a requirement for prior art enablement (see MPEP 2121 III.).
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
12/13/25