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 30 January 2026 is acknowledged and entered. Following the amendment, claims 13-15 and 17-28 are canceled, claims 1, 3, 9 and 10 are amended, and the new claims 29 and 30 are added.
Note, regarding the new claim 29, which recites “the elevated levels of the biomarkers are present in peripheral blood”, it will be withdrawn from consideration for the following reason: the prior art rejections set forth in the last Office Action were made according to the prior teaching upregulation of various cytokines/factors in the diseased skin of HS patients. Since applicant has received an action on the merits for this regard, and the prior art rejection (103) is still applicable and no generic claim has been found allowable, the new claim 29, directed to measuring the elevated levels of the biomarkers in peripheral blood (considered as a different species), is therefore withdrawn from consideration. Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise include all the limitations of an allowed generic claim as provided by 37 CFR 1.141.
Currently, claims 1-12, 16, 29 and 30 are pending, and claims 1-3, 6-12 and 30 are under consideration. Claims 4, 5, 16 and 29 are withdrawn from further consideration as being drawn to a non-elected invention/species.
Withdrawal of Objections and Rejections:
The rejection of claims 9 and 10 under 35 U.S.C. 112(b), as being indefinite is withdrawn in view of applicant’s amendment.
The prior art rejection of claims 1, 2 and 9-12 under 35 U.S.C. 102(a)(1) as being anticipated by Duca et al. (Int J Mol Sci. 2020 Nov 10;21(22):8436) is withdrawn in view of applicant’s amendment.
Formal Matters:
Information Disclosure Statement
Applicant's IDS submitted on 1/30/2026 is acknowledged and has been considered. A signed copy is attached hereto.
Rejections under 35 U.S.C. §112:
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 1-3, 6, 7 and 9-12 remain rejected, and the new claim 30 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention, for the reasons of record set forth in the last Office Action mailed on 10/30/2025, at pages 3-5.
Applicants argument filed on 30 January 2026 has been fully considered, but is not deemed persuasive for the reasons below.
At page 8 of the response, the applicant argues, citing MPEP 2164.01 and 2163(II)(A)(3), that applicant is not required to disclose what is already known in the art, or to provide the USPTO an exhaustive list of IL-17A- and/or IL-17F-inhibitors in the specification as filed; and what is conventional or well-known is preferably omitted from the specification; and that the specification as filed does describe several antibodies and/or nanobodies as IL-17A- and/or IL-17F-inhibitors, including Sonelokimab, Bimekizumab, Secukinumab, Ixekizumab, Brodalumab, Netakimab, and Izokibep; thus, the specification as filed reasonably conveys to one of ordinary skill in the art that Applicant was in possession of the claimed subject matter at the time of filing.
This argument is not persuasive for the reasons of record and the following: first, MPEP 2164.01 addresses the issue of enablement; therefore, does apply in the instant written description rejection, as the requirement for written description is separate and distinct from the enablement requirement (see MPEP 2163, I., for example). Further, the issue is that the amended independent claim 1 still recites “wherein the IL-17A- and/or IL-17F-inhibitor comprises … or a nanobody”, while the specification, as discussed previously, merely discloses one nanobody to an IL17A/A, an IL17-A/F, and/or an IL-17F/F, i.e., sonelokimab; and no other nanobody meeting the limitations of the claims is ever identified or particularly described in the specification. Among the antibodies disclosed in the specification (mentioned above), only one, sonelokimab, is a nanobody. Furthermore, although applicant is not required to disclose what is already known in the art, or to provide an exhaustive list of IL-17A- and/or IL-17F-inhibitors in the specification, contrary to applicants argument, an “exhaustive” list of nanobodies to IL-17A and/or IL-17F does not exist or known in the art. Therefore, for the reasons of record and above, one skilled in the art would not conclude that the applicant was in possession of the claimed genus of nanobody.
Once again, only the nanobody sonelokimab, but not the full breadth of the claims (“a nanobody”), meets the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
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.
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 1-3 and 6-12 remain rejected, and the new claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Duca et al. (Int J Mol Sci. 2020 Nov 10;21(22):8436), as applied to claims 1, 2 and 9-12 above, and further in view of Clinical Trial NCT05322473 (V1, 4/11/2022); and Navrazhina et al. (J Allergy Clin Immunol. 2022 Jan;149(1):135-144.e12), for the reasons of record set forth in the last Office Action mailed on 10/30/2025, at pages 3-5.
Applicants argument filed on 30 January 2026 has been fully considered, but is not deemed persuasive for the reasons below.
At pages 9-11 of the response, the applicant argues that Duca fails to teach or suggest the claimed method, as Duca fails to teach IL19 at all; and fails to teach that CCL20 and CXCL8 are aberrantly expressed in HS, much less that these molecules may act as biomarkers for a patient population to be treated with an IL17A- and/or IL17F-inhibitor; that Clinical Trial NCT05322473 and Navrazhina fail to compensate for the above deficiencies; that while NCT05322473 teaches to use of SLK for treatment of HS, the Office fails to point to where Clinical Trial NCT05322473 teaches or suggests use of SLK for treatment of a subject having elevated levels of a biomarker, much less a combination of biomarkers as recited; and that Navrazhina teaches that IL-19 and CCL20 cytokines are also upregulated in psoriasis and thus are not specific to HS, much less to a patient population having elevated levels of a combination of biomarkers as recited in claim 1 and/or having one or more draining tunnels in the skin as recited claim 2.
These arguments are not persuasive for the reasons of record and the following: first, applicant's arguments are against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, it is the combined teachings of Duca, NCT05322473 and Navrazhina, which render the claimed methods obvious. While Duca does not teach an elevated level of IL-19 in HS, and NCT05322473 does not teach elevated levels of a biomarker in a HS patient, Navrazhina teaches upregulation of IL-19 and CCL20 cytokines in HS; that IL-1b and IL-17A or IL-17F are strongly upregulated in lesional and perilesional HS skin; and that activation of IL-36 and IL-17C in keratinocytes likely drives the strong upregulation of CXCL1 and CXCL8 chemokines that promote neutrophil chemotaxis. Therefore, it would be instantly obvious to the person of ordinary skill in the art that a HS patient can have elevated levels of cytokines such as IL-6, IL-17A/F, CCL20, CXCL1, CXCL8 (IL-8) and IL-19, and can be treated with sonelokimab in view of the combined teachings of the cited references. Merely collectively testing/verifying various cytokines/factors known in the art to be upregulated in HS does not constitute a novel inventive concept. Further, regarding the argument that Navrazhina teaches that IL-19 and CCL20 cytokines are also upregulated in psoriasis and thus are not specific to HS, it is unclear what point applicant tries to make, since the specification (nor the prior art) does not provide any evidence indicating that upregulated IL-19 and CCL20 are HS specific either.
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. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 71 of copending Application No. 19/122,557 in view of Duca et al. (Int J Mol Sci. 2020 Nov 10;21(22):8436), and Navrazhina et al. (J Allergy Clin Immunol. 2022 Jan;149(1):135-144.e12), for the reasons of record set forth in the last Office Action mailed on 10/30/2025, at page 9, and for the reasons above (in the prior art rejection), and the following:
According to the specification, the IL-17A- and/or IL-17F-inhibitor may comprise an antibody, antibody fragment, or a nanobody (page 27, [0138], for example). In addition, claim 71 of the ‘557 application recites “measuring the level or expression of IL6, PLA2G2A, IL19, PI3, CST7, IL17A, IL17F, …, CCL20, CXCL1, CXCL8, …, and/or EDAR, in a sample”, which would include any or various combinations of factors recited, such as IL6, IL19, IL17A, IL17F, CCL20, CXCL1 and CXCL8. The teachings of Duca and Navrazhina were reviewed in the last Office Action. As such, claim 71 of the ‘557 application, in view of the teachings of Duca and Navrazhina, renders the present claims 1 and 30 obvious.
Applicants argument filed on 30 January 2026 has been fully considered, but is not deemed persuasive for the reasons below.
At page 11 of the response, the applicant argues that claim 1 as amended herein is not obvious over claim 71 of the '557 application in combination with Duca at least in view of the deficiencies present in Duca, which are discussed above with regard to the prior art rejections.
This argument is not persuasive for the reasons of record and above.
This is a provisional nonstatutory double patenting rejection.
Conclusion:
No claim is allowed.
Advisory Information:
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
/DONG JIANG/
Primary Examiner, Art Unit 1674
3/2/26