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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/5/2026 has been entered.
As filed, claims 105, 107-110, and 128-178 are pending; and claims 1-104, 106, and 111-127 are cancelled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/5/2026 has been considered by the Examiner.
Response to Amendments/Remarks
Applicant’s amendments/remarks, filed 6/5/2026, with respect to claims 105, 107-110, and 128-178, have been fully considered and are entered. The status for each rejection in the previous Office Action is set out below.
The § 112 fourth paragraph rejection of claims 140-142 and 168-170 is withdrawn per amendments.
The § 103(a) rejection of claims 105, 107-110, and 128-178 by the combined teaching of NCT03011372/Overview, as evidenced by Jackson, CAS776, and Kumar; and Wu is maintained because Applicant’s remarks are not persuasive.
Applicants asserted that the synonym “INCB054828” used in NCT03011372/Overview was not associated with the cited CAS registry structure of CAS776 and/or the generic name, pemigatinib, until after the earliest effective filing date of the instant application, which is 5/4/2018. To the extent this assertion rests solely on the statements of counsel, it constitutes as attorney argument and viewed as speculative. See MPEP 716.01(c). However, Applicants have submitted documents (e.g. exhibits A-G) appeared to show the historical CAS Registry Record of CAS776 (e.g. exhibits B and C). The CAS Registry image of CAS776 in exhibits B and C, for instance, constituted documentary submission and are not disregarded solely because they were not attached to a declaration under 37 CFR 1.132. In addition, the submitted image showing prior version of CAS776 do not, on the present record, authenticates the content as an official historical CAS record because CAS itself acknowledged that prior versions of CAS776 are not retained (see exhibit G). Furthermore, the Examiner finds that a person of ordinary skill in the art would recognized that INCB054828 in NCT03011372/Overview is pemigatinib or instant compound 1 because PubChem CID#86705695 further demonstrated that INCB054828 is pemigatinib, and has the same structure as instant compound 1 on 2/2/2015, which is before the earliest effective filing date of the instant application (see snapshot below).
For all these reasons stated above, in addition to the rationale set forth in the previous office action, the 103 rejection is maintained.
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The claim objection of claims 107-109, 129-131, 137-139, 144-146, 151-155, 156-163, 164-170, and 171-178, is withdrawn per amendments and/or remarks.
The claim objection of claim 143 and 171 is withdrawn per remarks.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 105, 107-110, and 128-178 rejected under 35 U.S.C. 103 as being unpatentable over the combined teaching of NCT03011372/Overview, as evidenced by Jackson; ; “Myeloid and Lymphoid Neoplasm With Abnormalities of FGFR1 Presenting With Trilineage blasts and RUNX1 Rearrangement”, hereinafter Kumar; Chemical Abstract Registry No. 1513857-77-6, hereinafter CAS776 and PubChem Compound ID No. 86705695, hereinafter PubChem695; and U.S. Patent Application Publication No. 2013/0338134, hereinafter Wu..
NCT03011372 and Wu can be found in IDS filed 9/20/2024; Overview and Jackson can be found in PTO-892 form mailed on 12/30/2024; Kumar and CAS776 can be found in PTO-892 form mailed on 5/6/2025.
Regarding claims 105, 107-110, 128-135, and 151-163:
Determining the scope and contents of the prior art:
NCT03011372 and Overview, for instance, teaches Pemigatinib (INCB054828) for treating myeloid/lymphoid neoplasm with FGFR1 rearrangement in subject who is refractory/relapsed with documented lymphoid/myeloid neoplasm with 8p11 rearrangement, which is known to lead to FGFR1 activation. The subject is given Pemigatinib once a day by mouth via continuous dosing.
Both myeloid/lymphoid neoplasm with FGFR1 rearrangement; and myeloid and lymphoid neoplasms with abnormalities of FGFR1 were previously known as 8p11 myeloproliferative syndrome, according to evidentiary references Jackson and Kumar, respectively. In addition, INCB054828 was previously known as Pemigatinib or drawn to a compound having a structure of instant formula (1), according to evidentiary references CAS776 and PubChem695.
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(NCT03011372, pg. 2)
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(NCT03011372, pg. 5)
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(CAS776, structure of INCB054828, known as Pemigatinib)
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(PubChem695, structure of INCB054828, known as Pemigatinib)
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(Overview, pg. 7)
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(Kumar, pg. 738, right column, 1st paragraph)
Wu, for instance, teaches Pemigatinib as inhibitors of one or more FGFR enzymes, which are useful in the treatment of FGFR-associated disease such as myeloproliferative neoplasm. The abovementioned compound can be administered in a pharmaceutical composition, wherein such composition can be in the form of a tablet.
In addition, the abovementioned pharmaceutical composition can be formulated into a unit dosage form containing from about 10 to about 30 mg of Pemigatinib.
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(abstract)
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(pg. 98, paragraph 0831, Example 126)
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(pg. 138, paragraph 1148)
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(pg. 139, Table 1-continued, Ex. No. 126)
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(pg. 34, paragraph 0347)
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(pg. 34, paragraph 0348)
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(pg. 32, paragraph 0318)
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(pg. 35, paragraph 0351)
Ascertaining of the difference between the prior art and the claim at issue:
NCT03011372/Overview, as evidenced by Jackson, Kumar, CAS776, and PubChem695, for instance, did not explicitly teach Pemigatinib in a pharmaceutical composition, such as tablet.
Wu, for instance, did not explicitly teach Pemigatinib for treating 8p11 myeloproliferative syndrome.
Finding of prima facie obviousness --- rationale and motivation:
With respect to this difference, MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary 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."
Based on the teachings of the MPEP and KSR above, by employing the rationale in (A) above, it would have been obvious for one of ordinary skill in the art to modify the process of NCT03011372/Overview, as evidenced by Jackson; CAS776; and Kumar, specifically the pharmaceutical composition and the daily dose, to include tablet and about 10 mg, respectively, as taught by the process of Wu, in order to arrive at the instantly claimed process because there’s a reasonable expectation of success that about 10 mg of Pemigatinib in tablet form can be used in a daily dose for treating 8p11 myeloproliferative syndrome of NCT03011372/Overview, as evidenced by Jackson, CAS776, and Kumar (i.e. predictable results), since both NCT03011372/Overview, as evidenced by Jackson, CAS776, and Kumar; and Wu are drawn to the same compound for treating similar diseases.
In addition, typical problems encounteredd in drug delivery include insufficient solubility, etc. These problems can be solved by exploring various pharmaceutical composition of active drug compounds, such as tablet as taught by Wu. Thus, a person of ordinary skill in the art is highly motivated to explore obvious pharmaceutical composition, such as tablet as taught by Wu, in search for the best drug with an optimal pharmacological (i.e., good solubility, etc.) profile.
Regarding claims 136-150 and 164-178:
Determining the scope and contents of the prior art:
The combined teaching of NCT03011372/Overview, as evidenced by Jackson, Kumar, CAS776, and PubChem695; and Wu, for instance, teaches the abovementioned process.
Ascertaining of the difference between the prior art and the claim at issue:
The combined teaching of NCT03011372/Overview, as evidenced by Jackson, Kumar, CAS776, and PubChem695; and Wu, for instance, did not explicitly teach an administration dose of up to 10% by weight of Pemigatinib in tablet or an administration dose of 0.01 mg/kg to about 100 mg/kg of body weight per day for Pemigatinib in tablet.
Finding of prima facie obviousness --- rationale and motivation:
The Examiner does not find the abovementioned administration doses of Pemigatinib in tablet as result-effective variable because the Applicant fails to demonstrate this parameter to impart any unexpected or novel aspect to the instant method (i.e. no comparative example). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. Accordingly, this parameter is viewed as routine experimentation to optimize the instant method, and not a patentable distinction.
Claim Objections
Claims 168-170 and 176-178 are objected to because of the following informalities:
Regarding claims 168-170 and 176-178, the claims recite the phrase, “is administered as a unit dosage form comprising”.
For consistency, such expression can be clarified by reciting -- is administered as the unit dosage form comprising --.
Appropriate correction is required.
Conclusion
Claims 105, 107-110, and 128-178 are rejected.
Claims 168-170 and 176-178 are objected.
Claims 1-104, 106, and 111-127 are cancelled.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
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