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 .
Election/Restrictions
Applicant's election with traverse of claims 1-6, 8-14, 17-19, and 21-23 in the reply filed on 02/03/2026 is acknowledged. The traversal is on the ground(s) that the claims are all dependent directly or indirectly on claim 1 and do not constitute distinct inventions. This is found persuasive. Claims 8-14, 17-19, and 21-23 are rejoined with claims 1-6 into Group 1.
Claims 7 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected groups, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/03/2026.
Status of the Claims
Claims 7 and 14 are withdrawn. Claim 9 has been cancelled. Claims 1-6, 8, 10-14, 17-19, and 21-23 are pending and examined herein.
Priority
This application, filed 10/28/2022, is a 371 of PCT/IB2021/053516, filed 04/28/2021, which claims benefit of 63/017,960, filed 04/30/2020. This benefit is acknowledged and the claims examined herein are treated as having an effective filing date of 04/30/2020.
Information Disclosure Statement
The Information Disclosure Statements filed 04/11/2023 and 12/20/2024 are acknowledged and have been considered.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-6, 8, 10, 12-14, 19, and 21-22 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2016/0159914 A1, “IL-17 RECEPTOR A IS REQUIRED FOR IL-17C BIOLOGY” (published 06/09/2016, referred to herein as Amgen) as evidenced by “Clonetics human keratinocyte cell systems” by Lonza (published 2011, referred to herein as Lonza).
Regarding claim 1, Amgen teaches a method of identifying an agent that modulates the IL-17 pathway (para. 0056, lines 1-10) comprising contacting a cell with IL-17, contacting the cell with the agent, incubating the cell with IL-17 and the agent, collecting the cell supernatant, and detecting G-CSF in the cell supernatant, and comparing the levels to controls (para. 0199, lines 1-12, para. 0248, lines 1-12, and para. 0257, lines 1-8).
Regarding claims 2 and 19, Amgen teaches collecting the supernatant 24 hours after contacting the cell with IL-17 and the agent (para. 0248, lines 10-12).
Regarding claim 3, Amgen teaches that G-CSF is measured via ELISA, which uses an antibody (para. 0204, lines 1-4).
Regarding claim 5, Amgen teaches that the agent reduces G-CSF levels (para. 0034, Figure 28A and B).
Regarding claim 6, Amgen teaches collecting the cells and detecting expression of genes including DEFB4A and others, and comparing the expression to controls indicating modulation of the IL-17 pathway (para. 0199, lines 1-12 and para. 0201, lines 1-9).
Regarding claim 8, Amgen teaches contacting the cell with IL-17 and the agent concurrently (para. 0199, lines 6-9).
Regarding claim 10, Amgen teaches using recombinant IL-17 (para. 0249, lines 1-12).
Regarding claim 12, Amgen teaches treating the cell with 2, 20, and 200 ng/mL IL-17 (para. 0199, condition #2).
Regarding claims 13 and 14, Amgen teaches the agent is an antibody (para. 0254, lines 1-5).
Regarding claim 21, Amgen teaches that the cell is a keratinocyte (para. 0257, lines 1-2).
Regarding claim 22, Amgen teaches growing keratinocytes as per manufacturer’s instructions, which as evidenced by Lonza, is up to 80% confluence.
Claims 1-2, 5-6, 10, 13-14, 17, and 19 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2009/082624 A2, “ANTAGONISTS OF IL-17A, IL-17F, AND IL-23 AND METHODS OF USING THE SAME” (published 12/10/2008, referred to herein as Lewis).
Regarding claim 1, Lewis teaches a method of identifying an agent that modulates the IL-17 pathway (para. 547, lines 1-4) comprising contacting a cell with IL-17, contacting the cell with the agent, incubating the cell with IL-17 and the agent, collecting the cell supernatant, and detecting G-CSF (para. 546, lines 9-11) in the cell supernatant, and comparing the levels to controls (para. 547, lines 1-16).
Regarding claims 2 and 19, Lewis teaches collecting the supernatant 24 hours after contacting the cell with the agent and IL-17 (para. 547, lines 10-11).
Regarding claim 5, Lewis teaches using an agent that decreases the effects of IL-17, i.e. reducing G-CSF levels (para. 547, lines 1-5).
Regarding claim 6, Lewis teaches collecting the cell (para. 547, lines 10-11) and detecting various biomarkers, including IL-8 and IL-23 among others (para. 546, lines 9-11).
Regarding claim 10, Lewis teaches incubating with recombinant IL-17 (para. 547, lines 1-6).
Regarding claims 13 and 14, Lewis teaches that the agent is an antibody (para. 547, lines 1-4).
Regarding claim 17, Lewis teaches using an antibody with an IC50 of less than 1 µM (para. 406, lines 1-4, Table 20).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Amgen in view of Einhorn et al., “HTRF: a technology tailored for biomarker determination—novel analytical detection system suitable for detection of specific autoimmune antibodies as biomarkers in nanogram level in different body fluids.” EPMA Journal (published 11/27/2015, referred to herein as Einhorn).
The teaching of Amgen, as applied to claim 1 above, is applied herein.
Regarding claim 4, Amgen teaches measuring G-CSF using an ELISA assay (para. 0199, lines 9-12).
However, Amgen does not teach using a homogenous time-resolved fluorescence assay.
Einhorn teaches using a homogenous time-resolved fluorescence assay for the detection of biomarkers (Abstract). Einhorn teaches that the homogenous time-resolved fluorescence assay has a number of advantages over a traditional ELISA assay (Table 9) including having a lower process time and cost.
It would have been obvious to one of skill in the art before the effective filing date of the claimed invention to modify the method taught by Amgen by substituting the ELISA assay to measure G-CSF with a homogenous time-resolved fluorescence assay, as taught by Einhorn. An artisan would have been motivated to make this change in order to save time and cost, as taught by Einhorn. An artisan would have had a reasonable expectation of success in making this change because both ELISA assays and homogenous time-resolved fluorescence assays are used to measure biomarkers in biological samples, as taught by Einhorn, which is the intended use of these assays in the method taught by Amgen.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Amgen in view of Kattah et al., “Cytokines Secreted in Response to Toll-like Receptor Ligand Stimulation Modulate Differentiation of Human Th17 Cells” Arthritis & Rheumatism (published June 2008, referred to herein as Kattah).
The teaching of Amgen, as applied to claim 1 above, is applied herein.
Regarding claim 11, Amgen teaches incubating the cells with IL-17.
However, Amgen does not teach incubating the cells with T helper cell conditioned media.
Kattah teaches that IL-17 is secreted by T helper 17 cells into T helper 17 cell conditioned media (Abstract “Results”, p. 1619, col. 2, para. 1, lines 16-19). Kattah teaches that this supernatant comprises additional factors, such as IL-22 (p. 1619, col. 2, para. 1, lines 16-19).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Amgen by substituting the recombinant IL-17 with the T helper 17 cell conditioned media taught by Kattah. An artisan would have been motivated to make this change because the use of the T helper 17 cell conditioned media would expose the cells to a more comprehensive set of Th17 cytokines, which would more closely approximate the in vivo environment cells encounter in the body. This would facilitate a more detailed analysis of activation of the IL-17 activation pathway. An artisan would have a reasonable expectation of success in making this change because active IL-17 is present in the T helper 17 cell conditioned media and would be capable of activating the IL-17 pathway in the cells used in Amgen.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Amgen in view of Liu et al., “Binding site elucidation and structure guided design of macrocyclic IL-17A antagonists” Scientific Reports (published 08/16/2016, referred to herein as Liu).
The teaching of Amgen, as applied to claim 1 above, is applied herein.
Regarding claim 18, Amgen teaches the use of candidate agents in their method to screen for IL-17 antagonists (para. 0151, lines 1-6) that can be any molecule, including “small organic molecules including known drugs and drug candidates” (para. 0154, lines 1-10).
However, Amgen does not teach the specific use of the compounds claimed in claim 18.
Liu teaches the claimed structure IL-17Ai-1 (Figure 1, Structure “3”, as disclosed in the instant specification p. 16, Table 1). Liu teaches that this structure is a IL-17A antagonist that binds to IL-17A (Figure 6C legend). Liu teaches that this compound is useful in keratinocyte-based bioassays for IL-17A inhibition and is useful as an in vitro tool to study disease-relevant interactions of IL-17A with its receptor (p. 8, para. 3, lines 3-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the compound taught by Liu as an IL-17A antagonist agent in the method taught by Amgen. An artisan would have been motivated to use this compound and have a reasonable expectation of success because, as taught by Liu, this compound is useful in keratinocyte-based bioassays for IL-17A inhibition, such as a method taught by Amgen, and is useful as an in vitro tool to study disease-relevant interactions of IL-17A with its receptor, which is the stated goal of the method taught by Amgen.
Allowable Subject Matter
Claim 23 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 23 is considered free over the prior art. The closest prior art is considered to be Amgen and Lewis, as described above under 35 U.S.C. 102. Briefly, Amgen and Lewis both disclose methods of identifying agents that modulate the IL-17 pathway by detecting the levels of G-CSF and further detecting a panel of genes, some of which are listed in the panel of claim 23. However, neither document teaches a panel consisting of the genes listed in claim 23. Further, Examiner has not found a teaching or motivation in the art to use a panel in the claimed method consisting of the genes listed in claim 23 in the methods taught in the prior art.
Conclusion
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 April 30, 2026
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