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 .
Status of Claims
Claims 4-11 and 14-26 are pending.
Claims 4-10 are withdrawn.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C.
120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to
Application Serial No. PCT/CN2020/095956, filed 6/12/2020. The application also claims priority to foreign application number CN201910612157.2, filed on 07/08/2019. An English translation of the foreign priority document was uploaded on 11/20/2025 labeled as “Specification” and “Miscellaneous Incoming Letter” which the Examiner is just noting for the record.
Information Disclosure Statement
All references from IDS(s) received 5/10/2022, 10/19/2022 and 12/20/2023 have been considered unless marked with a strikethrough.
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered and are found persuasive.
In a non-final dated 11/20/2025, Claims 11 and 14-22 were examined upon their merits.
In a non-final dated 11/20/2025, Claims 11 and 14-22 were rejected under 35 U.S.C. 103 and Claim 22 was rejected under 35 U.S.C. 112. In response, the Applicant amended the claims to remove any phrases that including “preferably.” In light of this amendment, the Examiner finds the 112 rejection moot and is withdrawn.
With respect to the 103 rejection, the Applicants argues that the primary reference provided by the Examiner (Dairaighi) fails to explicitly teach the use of CCR6 inhibitors for the recurrence of psoriasis, as stated by the Examiner in the previous office action. The Applicant also argues that the secondary references provided by the Examiner to remedy this deficiency because although they teach connections between CCR6 and psoriasis, the Applicants points out that the secondary reference (“Serezal”) focuses specifically on never-lesional skin from patients with psoriasis. The Examiner argues that because Dairaighi does teach the compounds for psoriasis in general (Claim 26) a person skilled in the art would have a reasonable expectation of success to use it again for recurrent psoriasis. As of currently, the claims do not reflect that recurrent psoriasis and psoriasis would be distinctly different patient populations. Therefore the 103 rejection is maintained. This applies to the newly added claims 23-26 which are dependent on a previously rejected claim.
MAINTAINED REJECTIONS
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.
Claims 11 and 14-26 are rejected under 35 U.S.C. 103 as being unpatentable over Dairaghi, D. et al. (WO2015084842A1; cited in IDS filed 5/10/2022; “Dairaghi”) in view of Serezal, I. et al. (J ALLERGY CLIN IMMUNOL. April 2019, 143, 4, 1444-1454; “Serezal”) and Paradis, T. et al. (Journal of Investigative Dermatology (2008) 128, 628–633; “Paradis”).
Dairaghi teaches small molecule CCR6 inhibitors for use in treating psoriasis (Abstract and Claim 26), as required by instant claims 11 and 14. Dairaghi teaches that CCR6 expression is linked to psoriasis through the activation of T cells. “T cells, such as γδ T cells and TH17 T cells produce IL17 after activation. The pathogenic effects of IL17 have been associated with human diseases such as … psoriasis” (para. 0008), as required by instant claims 11 and 18-20. Dairaghi also teaches treatment in combination with other active agents such as glucocorticoids, a cytokine-suppressing anti-inflammatory agent, or vitamin D3 derivatives (para. 0080), as required by instant claims 15-16.
With respect to instant claim 17, Dairaghi teaches “compounds and compositions of the present invention may be used in combination with other drugs that are used in the treatment, prevention, suppression or amelioration of the diseases or conditions for which compounds and compositions of the present invention are useful. Such other drugs may be administered, by a route and in an amount commonly used therefor, contemporaneously or sequentially with a compound or composition of the present invention.” Therefore, since administration of glucocorticoids as an additional treatment is also taught, as discussed above, Claim 17 is taught by Dairaghi.
Dairaghi fails to explicitly teach the use of CCR6 inhibitors for the recurrence of psoriasis or psoriatic lesions.
Serezal teaches that resident T cells are associated with the recurrence of psoriatic skin and plaques (Backgroun para). Serezal also teaches that CCR6+ T cells produce IL-17 and IL-22 and that CCR6 activates the T cells to produce these factors. The accumulation of T cells and activation by CCR6 results in cell keratinization and therefore, the recurrence of psoriasis (Background and Results para).
With respect to independent claim 11, Serezal fails to explicitly teach the use of CCR6 inhibitors to prevent recurrence of psoriasis, however it would be obvious to a person skilled in the art at the time that through the mechanism taught by Serezal, psoriasis recurrence could be prevented/treated through CCR6 inhibition, such as through the method taught by Dairaghi.
Neither Serezal or Dairaghi explicitly teach that the T cells increase in the lymph nodes of the subject or that CCR6 inhibitions prevents migration or redistribution of the T cells. However, it is known in the art that upon infection, disease, and inflammation, T cells accumulate in the thymus and lymph nodes. Further, Paradis teaches that CCR6 plays an essential role in directing activated T cells, such as through migration and redistribution, to the skin.
Therefore, with respect to claims 18-21, it would be obvious that treatment/prevention of psoriasis recurrence, as taught by Dairaghi and Serezal, would apply to the migration and redistribution of activated T cells, as taught by Paradis.
With respect to claim 22, Serezal teaches examples where patients with psoriasis recurrence that show IL-17+ and/or IFN-gamma+ have a detected CCL20 and CCR6 cell content that is at least one fold higher than that of a healthy subject (Figure 5C-D and Figure 4B/D, respectively), as required by claim 22(iii-iv). Serezal also teaches the total number of CD3+ cells is less than 15% (Figure 4B), as required by claim 22(ii). With respect to claim 22(i), Serezal fails to explicitly teach where the detected IL-17 content is higher than 10-100 pg/ml, however it does teach that the cutoff for protein supernatant detection was 10 pg/mL. Therefore, results with relative quantities of IL-17 would be of at least 10 pg/mL. "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.” Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385,
1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are
consistent with the proper "functional approach" to the determination of obviousness as laid down in
Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement
to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a
reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same
field or a different one based on design incentives or other market forces if the variations are
predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of
ordinary skill to modify the prior art reference or to combine prior art reference teachings to
arrive at the claimed invention.
Applying KSR example rationale (A), it would have been prima facie obvious to extract the method of treating psoriasis with a CCR6 inhibitor, as taught by Dairaghi, and apply it to the treatment of psoriasis recurrence, as taught/motivated by Serezal. A person skilled in the art would have been motivated to do so because Serzal and Dairaghi teach similar mechanisms for the treatment of psoriasis, whether first occurrence or recurrence.
Applying KSR example rationale (G), it would have been prima facie obvious to extract the method of treating psoriasis recurrence with a CCR6 inhibitor, as taught by the combined teachings of Dairaghi and Serezal, arrive at the current invention of inhibiting T cell migration through CCR6 inhibition, as motivated by Paradis.
Therefore, claims 11 and 14-26 would have been obvious to a person skilled in the art at the time.
Conclusion
Claims 11 and 14-26 are rejected.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621