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 .
DETAILED ACTION
This office action is in response to applicant’s reply filed on October 23, 2025.
Restrictions/Elections.
Applicant’s election of Group I (Claims 1, 7-12 and 14) in the reply filed on October 23, 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a).
Applicant’s election of a compound of formula (I) as the CXCR1/CXCR2 inhibitor is also acknowledged.
Status of Claims
Claims 1-2, 6-12, 14 and 16-22 are currently pending and are the subject of this office action.
Claims 2, 6 and 16-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 23, 2025.
Claims 10-12 are further withdrawn since they don’t encompass the elected species.
Claims 1, 7-9 and 14 are under examination as they relate to the compound of formula (I) (species elected).
Priority
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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.
1) Claim(s) 1 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ebel et. al. (US 2013/0090338) and of Emadi et. al. (Blood (2005) 105:464-473, cited by Applicant).
For claim 1, Ebel teaches a method of treating several diseases, including myelofibrosis (see [0138]) comprising the administration of a composition comprising among others CXCR1 antagonists and/or CXCR2 antagonists (see [0143] and in particular CXCR1/CXCR2 antagonists like SCH-527123 (also known as Navarixin or MK-7123, see [0184]). Ebel further teaches pharmaceutical formulations comprising pharmaceutically acceptable excipients (see page 27 paragraphs [0211]-[0222]).
Further, Emadi teaches that in vitro, addition of CXCR1 or CXCR2 antibodies to MMM (Metaplasia with Myelofibrosis) CD34+ cells cultured under MK liquid culture conditions increases the proliferation and differentiation of MMM CD41+ MK (dystrophic megakaryocytic) cells and restores their polyploidization. These results suggest that these receptors participate in the altered MK growth that features MMM and open new therapeutic prospects to this still incurable disease (see abstract).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to treat myelofibrosis comprising the administration of a pharmaceutical composition comprising an effective amount of a CXCR1/CXCR2 inhibitor as suggested by Ebel. The skilled in the art will be further motivated by the fact that Emadi teaches that in vitro CXCR1 and or CXCR2 inhibitors are effective to revert myelofibrosis, thus resulting in the practice of claims 1 and 8 with a reasonable expectation of success.
2) Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ebel et. al. (US 2013/0090338) and of Emadi et. al. (Blood (2005) 105:464-473, cited by Applicant) as applied to claims 1 and 8 above, further in view of Zimran et. al. (F1000Research (2019) 8:1-15, cited by Applicant).
Ebel and Emadi teach all the limitations of claim 7, except for the subject being irresponsive to or ineligible for Janus Kinase Inhibitor (JAK inhibitor) treatment.
However, Zimran teaches that JAK inhibitors are effective in treating myelofibrosis (see pages 4-5).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to treat myelofibrosis in a subject that has already failed treatment with JAK inhibitors, comprising the administration of a different treatment, like CXCR1/CXCR2 inhibitors, thus resulting in the practice of claim 7 with a reasonable expectation of success.
3) Claim(s) 9 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ebel et. al. (US 2013/0090338) and of Emadi et. al. (Blood (2005) 105:464-473, cited by Applicant) as applied to claims 1 and 8 above, further in view of Zebala et. al. (US 2018/0296580).
Ebel and Emadi teach all the limitations of claims 9 and 14, except for the CXCR1/CXCR2 inhibitor being a compound of formula (I):
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and specifically: R-(-)-2-(4-isobutylphenyl)-propionyl-methansulfonamide (also known as Reparixin):
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However, Zebala teaches that Reparixin or Reparixin L-lysine salt are CXCR1/CXCR2 inhibitors like Navarixin (see Claim 2).
Since Ebel and Emadi teach a method of treating myelofibrosis comprising the administration of a composition comprising a CXCR1/CXCR2 inhibitor like Navarixin, and since Zebala teaches that Reparixin is a CXCR1/CXCR2 inhibitor like Navarixin, before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any CXCR1/CXCR2 inhibitor like Navarixin) for another (Reparixin) with an expectation of success, since the prior art establishes that both function in similar manner, thus resulting in the practice of claims 9 and 14, with a reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
November 5, 2025.