DETAILED ACTION
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 .
Response to Remarks and Amendments
Applicants’ response and amendments filed December 30, 2025 has been entered. All rejections and objections not explicitly maintained herein are withdrawn. The rejections below constitute the full set of rejections being applied to the instant claims.
With regard to the rejection of claims 15-16 under 35 USC 112(b), the rejection is withdrawn in view of the amendment to claim 1 such that the independent claim contains proper antecedent basis for all terms in the dependent claims.
With regard to the rejection of claims 1-12 and 15-16 under 35 USC 112(a), the rejection is withdrawn in view of the amendment to delete the unlimited recitation of “BTK mediated disorders” and import the particular cancerous diseases recited in claim 1.
With regard to the rejection of claims 1-3 and 5-16 under 35 USC 102(a)(1), the rejection is withdrawn in view of the deletion of the term “about” from the recited dosage in the claims. The Woyach reference does not anticipate a dosage of 80 – 160 mg.
With regard to the rejection of claims 1-16 under 35 USC 103, the rejection is withdrawn in view of the various claim amendments. The newly presented amendment is necessitated by the claim amendments.
Election/Restrictions
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As indicated above, the examiner searched the compound based on the elected species above, wherein: the elected species was found to be rendered obvious by the prior art. Therefore, the scope of the search and consideration was expanded in accordance with MPEP 803.02 to also include the compounds described in the rejections herein. Since this scope was not found to be allowable, the scope of the search and examination was not extended further, although any additional anticipatory compounds in the same prior art, discovered incidental to the examination of the elected species, are also included in the rejections herein.
Status of Claims
Currently, claims 1-11 and 15-23 are pending in the instant application and under consideration herein. Claims 17-23 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention and/or species.
Claims 1-11 and 15-16 read on an elected invention and species and are therefore under consideration in the instant application to the extent that they read on the elected embodiment.
Claim Rejections - 35 USC § 103
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) 1-11 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/358233 (“the ‘233 publication”) in view of WO 2021/097213.
Determining the scope and contents of the prior art
The ‘233 publication teaches a method of treating a BTK mediated disorder, comprising administering to a subject in need thereof (paragraph [0009]) a compound of instant formula (I) (paragraph [0221]). The reference discloses that BTK mediated disorders include cancers, B-cell lymphoma, leukemia, and other hematological malignancies. Additionally, the ’233 publication teaches that the compound inhibits kinase activity of a mutant BTK, such as drug-resistantmutant BTK harboring a drug-resistance mutation, for example C481S mutation. The prior art further directs towards the treatment of patients not responding to a BTK inhibitor or relapsing after initial treatment with a BTK inhibitor. The instantly claimed compound is more potent than several other BTK inhibitors, including ibrutinib. Regarding the claimed dosage, the prior art teaches that dosages range from about 0.01mg/kg per day to about 5000 mg/kg per day, thereby completely encompassing the dosage range recited in the instant claims.
Ascertaining the differences between the prior art and the claims at issue
The difference between the instant invention and the prior art is that the prior art does not teach a specific example where the dosage range or length of treatment is disclosed.
Resolving the level of ordinary skill in the pertinent art
To this end, it is noted that 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."
The ‘213 publication teaches the treatment of CLL, SLL, NHL, DLBCL, FL, MCL, Hodgkin’s lymphoma, B-ALL, Burkitt’s lymphoma and Waldenstrom’s macroglobulinemia comprising administration of a BTK inhibitor (Abstract). The instantly claimed compound is taught as Compound 11 (Table 2, p. 19). The ‘213 publication teaches that the therapeutically amount of BTK inhibitor for treatment of the claimed conditions includes 100 mg and 120 mg in a list of finite dosages (paragraph [120], claim 16). The ‘213 publication also provides for a 28-day treatment cycle and administration once or twice daily (paragraph [0108] – [0109]). Thus, at the very least, the art contains a teaching of treatment length and suggestion for the relative area within the broad dosage range for a person of ordinary skill to optimize dosage.
MPEP 2144.05(I) provides that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005) (claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention). Thus, the prior art ranges render the dosages of the instant claims obvious.
Accordingly, based on the teachings of the MPEP and KSR above, by employing the rationale in (B), (D), (E) or (G) above, it would have been obvious for one of ordinary skill in the art to treat the particular cancers recited in the instant claims and taught by the ‘233 publication, utilizing a compound of Formula (I) at a dosage of as claimed. The ’233 publication discloses that dosage can range from about 0.01mg/kg per day to about 5000 mg/kg per day, with The ‘213 publication narrowing down the range for experimentation, such that it would have been considered routine optimization to arrive at the dosages and schedule recited in the instant claims. There would have been a reasonable expectation of success in treating these diseases since the same Compound was already known in the art for the treatment of diseases associated with BTK. The instantly claimed invention would have therefore been obvious to a person of ordinary skill before the filing of the instantly claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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