DETAILED ACTION
This office action is in response to the Applicant’s filing dated November 13th, 2025.
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 1-14, 16 and 18-22 are pending in the instant application. Acknowledgement is made of Applicant’s remarks and amendments filed on November 13th, 2025. Acknowledgment is made of Applicant’s amendment of claim 21; and the cancelation of claims 15 and 17.
Election/Restrictions
Applicant’s election of Groups I and II in the reply filed on November 13th, 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)).
Claims 21 and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 13th, 2025.
Applicant’s election of a single disclosed formulation of dasatinib anhydrous, lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate in the reply filed on November 13th, 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)).
Claims 12-14, 16 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 13th, 2025.
Claims 1-11 and 19-20 read on the elected species and will be examined herein.
Claim Objections
Claims 3-5, 9 and 11 are objected to because of the following informalities: The claims recite “selected from… and”, but should read “selected from the group consisting of… and” (Markush group format) or “selected from… or” because the current recitation indicates combination of all listed species. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 2 is 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.
Regarding claim 2, the claim recites “an amount that is from about 20% to about 25% less than the amount of dasatinib monohydrate in a bioequivalent pharmaceutical composition”, which is confusing because the “bioequivalent pharmaceutical composition” is not defined, thus it is not clear what the metes and bounds are. To advance the prosecution, the “the amount of dasatinib monohydrate in a bioequivalent pharmaceutical composition” is interpreted as any pharmaceutical amount.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pattihis et al (WO 2017/144109 A1).
Regarding claims 1-3 and 7-9, Pattihis teaches Example 1, which is a pharmaceutical tablet composition for oral administration comprising 140mg of dasatinib anhydrous, as evidenced by XRD data matching an anhydrous dasatinib standard (page 1, line 1; page 5, first full paragraph; pages 7-8; page 13, claims 16 and 19; page 16, Figures 1-2).
Pattihis further discloses an oral dosage form for use in the treatment of leukemia, including Philadelphia chromosome positive Chronic Myelogenous Leukemia (Ph+ CML), Philadelphia chromosome positive Acute Lymphoblastic Leukemia (Ph+ ALL), and lymphoid blast Chronic Myeloid Leukemia with resistance or intolerance to prior therapy (page 7, paragraph 2), providing a specific application and thus a method. The terms “diagnosed” and “therapy” indicate an application to a subject or an in-vivo model.
Thus, the teachings of Pattihis anticipate the pharmaceutical composition and method of instant claims 1-3 and 7-9.
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 4-6, 10-11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Pattihis et al (WO 2017/144109 A1); as evidenced by Martinsen et al (Basic & Clinical Pharmacology & Toxicology, (2005), 96, 94-102), cited for evidentiary purposes only.
Regarding claims 4-6, Pattihis anticipates the pharmaceutical composition and method of claims 1-3 and 7-9 as described in the above rejection. Pattihis further teaches that similarly comprised formulations of dasatinib tablets are known in the art to vary in strength from 5-150mg (page 2, fourth paragraph). It would have been prima facie obvious to one of ordinary skill in the art to utilize the amount of 140mg of dasatinib anhydrous taught by Pattihis as a starting point for optimizing the amount of dasatinib anhydrous utilized to treat Chronic Myeloid Leukemia (CML) and Philadelphia chromosome positive Acute Lymphoblastic Leukemia (Ph+ ALL), since Pattihis teaches dasatinib anhydrous is useful for treating both CML and PH+ ALL (page 7, second paragraph); and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding claims 10-11 and 19, Pattihis anticipates the pharmaceutical composition and method of claims 1-3 and 7-9 as described in the above rejection. Pattihis further discloses dissolution testing data that demonstrates that dasatinib anhydrous formulations exhibit improved dissolution and pharmacokinetic properties when compared to commercially available Sprycel dasatinib monohydrate in a pH 4.5 medium (pages 9-10. Example 3). This pH value falls within the ranges recited in instant claim 11. Martinsen, cited for evidentiary purposes only, defines optimal gastric pH levels in a healthy subject as being <4 (page 95, left column, first paragraph, last sentence); defines hypochlorhydria as having pH levels >4 and <7; and defines achlorhydria as pH levels >7 (page 95, left column, fourth paragraph).
Accordingly, it would have been prima facie obvious to a person of ordinary skill in the art to administer the pharmaceutical composition comprising dasatinib anhydrous, as taught by Pattihis, to subjects with elevated gastric pH, such as those diagnosed with achlorhydria or hypochlorhydria to maintain the higher tablet dissolution of Pattihis than that of Sprycel at an elevated gastric pH, including pH 4.5, as described above, with a reasonable expectation that the improved dissolution and pharmacokinetic properties observed at pH 4.5 would translate to improved therapeutic performance in similar clinical conditions at elevated pH levels.
“[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Taken together, all of this would result in the composition of instant claims 4-6, 10-11 and 19 with a reasonable expectation of success.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Pattihis et al (WO 2017/144109 A1); in view of Cortes et al (Journal of Clinical Oncology, (2016), 34(20), 2333-2040).
Regarding claim 20, Pattihis anticipates the pharmaceutical composition and method of claims 1-3 and 7-9 as described in the above rejection.
Pattihis does not teach a method treating CML or Ph+ ALL comprising administering a pharmaceutical composition comprising dasatinib anhydrous to a subject ≥50 years of age.
Cortes teaches a method of treating patients with CML in a phase III clinical trial, wherein patients were administered 100-140mg of dasatinib daily (page 2333, Abstract; page 2334, left column, Study Design and Treatment). Cortes discloses that dasatinib treated patients had high Molecular Response (MR) rates, and improved therapeutic outcomes when compared to imatinib (page 2338, right column, last paragraph). Cortes further discloses that patients ≥65 years of age received dasatinib treatment (page 2335, right column, last paragraph).
It would have been prima facie obvious to a person of ordinary skill in the art to administer the pharmaceutical composition comprising dasatinib anhydrous as taught by Pattihis in the treatment regimens for Chronic Myeloid Leukemia (CML) as taught by Cortes. Pattihis teaches that pharmaceutical compositions comprising dasatinib anhydrous exhibit improved dissolution and pharmacokinetic properties when compared to dasatinib monohydrate, while Cortes teaches administering dasatinib in clinically effective dosages for treating CML. Combining the teachings of Pattihis and Cortes would have been a predictable use of prior art elements according to their established functions, with a reasonable expectation of success in achieving an effective treatment of CML with improved bioavailability.
“[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Taken together, all of this would result in the method of instant claim 20 with a reasonable expectation of success.
Conclusion
Claims 1-11 and 19-20 are rejected.
No claim is allowed.
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/C.L.J./Examiner, Art Unit 1691
/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691