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 a response to Applicant’s amendments/remarks after non-final rejection filed 3/31/2025.
As filed, claims 105, 107-110, and 128-178 are pending, wherein claims 128-178 are new; and claims 1-104, 106, and 111-127 are cancelled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/31/2025 has been considered by the Examiner except Cite No. 94 under the section of “OTHER DOCUMENTS”, where it was lined through, because such reference was previously cited in the PTO-892 form mailed on 12/30/2024.
The information disclosure statement (IDS) submitted on 4/11/2025 has been considered by the Examiner.
Priority
The instant application is continuation application of 17/931,377 filed 9/12/2022, which is a continuation application of 16/402,955 filed 5/3/2019, which claims the benefit under 35 USC 119 (e) from US Provisional Applications 62/815,539 filed 3/8/2019 and 62/667,166 filed 5/4/2018.
With respect to the claim for the benefit of an effective U.S. filing date, it is noted that “the written description and drawing(s) (if any) of the provisional application must adequately support and enable the subject matter claimed in the nonprovisional application that claims the benefit of the provisional application. In New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1294, 63 USPQ2d 1843, 1846 (Fed. Cir. 2002), the court held that for a nonprovisional application to be afforded the priority date of the provisional application, 'the specification of the provisional must contain a written description of the invention and the manner and process of making and using it, in such full, clear, concise, and exact terms' to enable an ordinarily skilled artisan to practice the invention claimed in the nonprovisional application" [MPEP 201.11A - emphasis in original].
It is noted that the requirement for support is evaluated for each claim individually such that different claims may be examined with different effective filing dates. In the instant case, the amended claims 105 and 107-110, as well as the newly added claims 128-178, are examined with an effective filing date of 5/4/2018 (the filing date of the ‘166 provisional application; i.e. earliest filing date) because the entire scope of these claims are supported by the ‘166 provisional application.
Should applicant desire that the benefit of an earlier effective filing date be according any of the instant claims, the claims must be amended such that they are fully supported by the ‘656 provisional application.
Election/Restrictions
Regarding the newly added claims 128-178, these claims read on the elected species of 8p11 myeloproliferative syndrome. Accordingly, these claims will be examined herein.
Response to Amendments/Remarks
Applicant’s amendments/remarks, filed 3/31/2025, with respect to claims 105-118 and 102-127, have been fully considered and are entered. The status for each rejection in the previous Office Action is set out below.
The § 102(a)(1) rejection of claims 105-111, 120, 121, 126, and 127 by NCT03011372, as evidenced by Overview and Jackson, is withdrawn per amendments and cancellation of claims 106, 111, 120, 126, and 127.
The § 102(a)(1) rejection of claims 105, 110, and 115 by Wu is withdrawn per amendments and cancellation of claim 115.
The § 102(a)(1) rejection of claims 105, 107, 111, 112, 120-122, 126, and 127 by Verstovsek, as evidenced by Jackson, is withdrawn per cancellation of claims 111, 112, 120-122, 126, and 127. In addition, Verstovsek is removed as prior art because the effective filing date of the abovementioned remaining claims 105 and 107, which is now 5/4/2018, is before the publication date of Verstovsek, which is 5/14/2018.
The § 103(a) rejection of claims 106, 111-115, 120-122, 126, and 127 by NCT03011372/Overview, as evidenced by Jackson; and Wu is withdrawn per cancellation of these claims
The § 103(a) rejection of claims 105 and 107-110 by NCT03011372/Overview, as evidenced by Jackson; and Wu is maintained because the Applicant’s remarks are not persuasive. A person of ordinary skill in the art would recognized that INCB054828 in NCT03011372/Overview is Pemigatinib or instant compound 1 because chemical abstract registry No. 1513857-77-6, hereinafter CAS776 (publication date of 1/7/2014) indicated that INCB054828 is Pemigatinib, and has the same structure as instant compound 1.
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The nonstatutory obviousness-type double patenting (ODP) rejection of claims 105, 107, 110, and 115 by conflicting U.S. Patent No. 9,611,267 is withdrawn per amendments and cancellation of claim 115.
The claim objection of claim 121 is withdrawn per cancellation of the claim.
Claim Rejections - 35 USC § 112 fourth paragraph
The following is a quotation of the fourth paragraph of 35 U.S.C. § 112:
Subject to the following paragraph [concerning multiple dependent claims], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers (emphasis added).
Claims 140-142 and 168-170 are rejected under the fourth paragraph of 35 U.S.C. § 112 and under 37 CFR § 1.75(c), as being of improper dependent form for failing to further limit the subject matter of a previous claim. Applicant is required to cancel the claim(s), or amend the claim(s) to place the claim(s) in proper dependent form, or rewrite the claim(s) in independent form.
Regarding claims 140-142, the claims are dependent upon claim 136. The subject matter in claim 136 is drawn to a method of treating 8p11 myeloproliferative syndrome via instant compound 1, wherein the administration dose of instant compound 1 range from about 0.01 mg/kg to about 100 mg/kg of body weight per day. The subject matter in claims 140-142 is drawn to a limited embodiment of the abovementioned administration dose.
The scope of claims 140-142 is broader than scope of claim 136 because claims 140-142 include a different type of administration dose that is outside of the administration dose depicted in claim 136 (e.g. comprising from 0.1 mg to 500 mg vs. 0.01 mg/kg to about 100 mg/kg of body weight per day, etc.) Because the scope of claims 140-142 is broader than claim 136, the claims failed to further limit the subject matter thereof, and fail to comply with the formal requirements set forth in the fourth paragraph of 35 U.S.C § 112.
The Examiner suggests that the claims be amended in a manner such that the scope of claims 140-142 is commensurate with the scope of claim 136.
Regarding claims 168-170, the claims are dependent upon claim 164. The subject matter in claim 164 is drawn to a method of treating myeloid/lymphoid neoplasms associated with abnormalities of FGFR1 via instant compound 1, wherein the administration dose of instant compound 1 range from about 0.01 mg/kg to about 100 mg/kg of body weight per day. The subject matter in claims 168-170 is drawn to a limited embodiment of the abovementioned administration dose.
The scope of claims 168-170 is broader than scope of claim 164 because claims 168-170 include a different type of administration dose that is outside of the administration dose depicted in claim 164 (e.g. comprising from 0.1 mg to 500 mg vs. 0.01 mg/kg to about 100 mg/kg of body weight per day, etc.) Because the scope of claims 168-170 is broader than claim 164, the claims failed to further limit the subject matter thereof, and fail to comply with the formal requirements set forth in the fourth paragraph of 35 U.S.C § 112.
The Examiner suggests that the claims be amended in a manner such that the scope of claims 168-170 is commensurate with the scope of claim 164.
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; Chemical Abstract Registry No. 1513857-77-6, hereinafter CAS776; and “Myeloid and Lymphoid Neoplasm With Abnormalities of FGFR1 Presenting With Trilineage blasts and RUNX1 Rearrangement”, hereinafter Kumar; and Wu.
NCT03011372 and Wu can be found in IDS filed 9/20/2024; and Overview and Jackson; can be found in PTO-892 form mailed on 12/30/2024.
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, according to evidentiary reference CAS776.
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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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(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, CAS776 and Kumar, 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, CAS776, and Kumar; 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, CAS776, and Kumar; 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 107-109 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 105. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
According to the abovementioned evidentiary Jackson, 8p11 myeloproliferative syndrome is associated with eosinophilia and exhibited 8p11 translocation, wherein the translocation is associated with activation of FGFR1.
Claims 129-131 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 128. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
According to the abovementioned evidentiary reference Kumar, myeloid and lymphoid neoplasms with abnormalities of FGFR1 is known as 8p11 myeloproliferative syndrome.
According to the abovementioned evidentiary Jackson, 8p11 myeloproliferative syndrome is associated with eosinophilia and exhibited 8p11 translocation, wherein the translocation is associated with activation of FGFR1.
Claims 137-139 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 136. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
According to the abovementioned evidentiary reference Kumar, myeloid and lymphoid neoplasms with abnormalities of FGFR1 is known as 8p11 myeloproliferative syndrome.
According to the abovementioned evidentiary Jackson, 8p11 myeloproliferative syndrome is associated with eosinophilia and exhibited 8p11 translocation, wherein the translocation is associated with activation of FGFR1.
Claims 144-146 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 143. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
According to the abovementioned evidentiary reference Kumar, myeloid and lymphoid neoplasms with abnormalities of FGFR1 is known as 8p11 myeloproliferative syndrome.
According to the abovementioned evidentiary Jackson, 8p11 myeloproliferative syndrome is associated with eosinophilia and exhibited 8p11 translocation, wherein the translocation is associated with activation of FGFR1.
Claims 151-155 are objected to under 37 CFR 1.75 as being a substantial duplicate of claims 105 and 107-110, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
According to the abovementioned evidentiary reference Kumar, myeloid and lymphoid neoplasms with abnormalities of FGFR1 is known as 8p11 myeloproliferative syndrome.
Claims 156-163 are objected to under 37 CFR 1.75 as being a substantial duplicate of claims 128-135, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
According to the abovementioned evidentiary reference Kumar, myeloid and lymphoid neoplasms with abnormalities of FGFR1 is known as 8p11 myeloproliferative syndrome.
Claims 164-170 are objected to under 37 CFR 1.75 as being a substantial duplicate of claims 136-142, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
According to the abovementioned evidentiary reference Kumar, myeloid and lymphoid neoplasms with abnormalities of FGFR1 is known as 8p11 myeloproliferative syndrome.
Claims 171-178 are objected to under 37 CFR 1.75 as being a substantial duplicate of claims 143-150, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
According to the abovementioned evidentiary reference Kumar, myeloid and lymphoid neoplasms with abnormalities of FGFR1 is known as 8p11 myeloproliferative syndrome.
Claims 143 and 171 are objected to because of the following informalities:
Regarding claims 143 and 171, the claims recite the phrase, “in the form of a tablet comprising up to 10% by weight of Compound 1”.
Such expression can be clarified by reciting -- in the form of a tablet containing up to 10% by weight of Compound 1 --.
Appropriate correction is required.
Conclusion
Claims 105, 107-110, and 128-178 are rejected.
Claims 107-109, 129-131, 137-139, 143, 144-146, 151-155, 156-163, and 164-178 are objected.
Claims 1-104, 106, and 111-127 are cancelled.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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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