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 June 2, 2026.
Status of Claims
Amendment of claims 1, 10 and 19, and cancellation of claim 9 is acknowledged.
Claims 1-2, 6-8, 10-12, 14 and 16-22 are currently pending and are the subject of this office action.
Claims 2, 6 and 16-22 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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Claims 10-12 were further withdrawn since they don’t encompass the elected species (a compound of Formula (I)).
Claims 1, 7-8 and 14 are under examination as they relate to the compound of Formula (I) (species elected).
Priority
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Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 112 (New Rejection not Necessitated by Amendment)
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 1 and 7-8 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 7-8 recite:
R4 is linear or branched C1-C6 alkyl, benzoyl, phenoxy, trifluoromethanesulfonyloxy, Also, according to a preferred embodiment R4 is in position 3 or 4 on the phenyl ring, more preferably it is 3-nenzoyl, 4-isobutyl or 4-trifluoromethanesulfonyloxy,
R5 is H or linear or branched C1-C3 alkyl, preferably it is H
R6 is linear or branched C1-C6 alkyl, preferably it is CH3 or trifluoromethyl
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat.
App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131
USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the instant case claim 1 recites the broad recitation: “R4 is linear or branched C1-C6 alkyl, benzoyl, phenoxy, trifluoromethanesulfonyloxy”, and the claim also recites: Also, according to a preferred embodiment R4 is in position 3 or 4 on the phenyl ring, more preferably it is 3-nenzoyl, 4-isobutyl or 4-trifluoromethanesulfonyloxy, which is the narrower range/limitation.
Same with: “R5 is H or linear or branched C1-C3 alkyl” and preferably it is H, and
“R6 is linear or branched C1-C6 alkyl” and preferably it is CH3 or trifluoromethyl.
Claim Rejections - 35 USC § 103 (New Rejection not Necessitated by Amendment).
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(s) 1, 7-8 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zimran et. al. (F1000Research (2019) 8:1-15, cited by Applicant).
For claims 1, 8 and 14, Zimran teaches regarding new treatments of myelofibrosis: (See page 6, right column first paragraph):
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REPARIXIN
Before the effective filing date of the claimed invention, it would have been prima facie obvious for the skilled in the art to treat myelofibrosis comprising administering a composition comprising the CXCR1/2 inhibitor reparixin (which anticipates the general formula (I) in claim 1), since a clinical trial for the treatment of myelofibrosis comprising the administration of reparixin is already planned, thus resulting in the practice of claims 1, 8 and 14 with a reasonable expectation of success.
For claim 7, 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 the CXCR1/2 inhibitor reparixin, thus resulting in the practice of claim 7 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
June 5, 2026.
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