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
Status of Application
1. Receipt of the Request for Continued Examination (RCE) under 37 C.F.R. 1.114, the Amendment and Applicants’ Arguments/Remarks, all filed 10 March 2026 are acknowledged.
Claims 1, 7, 9 and 10 are currently pending. Claims 2-6 and 8 were previously cancelled. There are no claim amendments. Claims 1, 7, 9, and 10 are examined on the merits within.
Continued Examination Under 37 C.F.R. 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 March 2026 has been entered.
Maintained Rejections
Claim Rejections – 35 U.S.C. 103
3. 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.
4. Claim(s) 1, 7, and 9-10 is/are again rejected under 35 U.S.C. 103 as being unpatentable over Blatter et al. (U.S. Patent No. 9,796,721).
Regarding instant claims 1, Blatter et al. teach (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide, i.e., acalabrutinib. See abstract. Each of the solid forms of the BTK inhibitor of Formula I can be combined with a carrier, such as a capsule, with binders, fillers, lubricants, surfactants, etc. See column 26, lines 37-67 and column 27, lines 1-67. The crystalline acalabrutinib is Form III. See Example 3. The composition includes microcrystalline cellulose, starch, etc. See column 26, lines 56-65. The composition includes alginic acid, polyvinyl pyrrolidone, pregelatinized starch, etc. See column 26, lines 56-65. The composition may include talc. See column 27, lines 1-4. The composition may comprise calcium stearate, magnesium stearate, etc. See column 27, lines 29-43. Less than 1% lubricant (magnesium stearate) can be used in the formulation. See column 27, line 29-43. Disintegrants may be present in amount of 0.5 to 15% (croscarmellose sodium or crospovidone). See column 27, lines 5-28. The BTK inhibitor of Formula 1 is present in amounts of 0.0001 to 50%. See column 24, lines 40-60.
Regarding instant claims 7 and 9-10, which recite product-by-process limitations, the Examiner notes “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
It would have been well within the purview of the skilled artisan to combine Acalabrutinib, diluent, disintegrant, glidant, and lubricant, and modify the amounts of each, to achieve the desired physical properties and therapeutic effect to optimize the formulation.
Double Patenting
5. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
6. Claims 1, 7, and 9-10 are again provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 19/121621 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and Application 19/121621 are directed to formulations of Acalabrutinib including diluents, lubricants, binders, and disintegrants. The only difference lies in the fact that Application 19/121621 is directed to the salt form, Acalabrutinib maleate, and a tablet instead of a capsule as instantly claimed. The instant claimed invention includes pharmaceutically acceptable salts thereof. In addition, it would have been well within the purview of the skilled artisan to modify the delivery device, i.e., tablet, capsule, suspension, etc., as a matter of design choice for ease of administration.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants’ arguments filed 10 March 2026 have been fully considered but they are not persuasive.
7. Applicants argued, “Blatter describes Form III as poorly crystalline with an irregular habit, that it is hygroscopic, and has a water content that varies continuously with humidity. Thus one would expect it to provide poor properties for a commercial formulation. The teaching that Form III is metastable is a teaching away. Example 6 showing stability over a much longer period of six months was unexcepted. It is incorrect to conclude from Greco that metastable polymorphs would necessarily be expected to have improved dissolution rates. Example 6 describes the specific capsule composition of Form III compared to Calquence capsules. The results show comparable, if not more, rapid drug release than Calquence. Total impurities remained low through a 6 month storage period. Based on the teachings of Blatter, a skilled artisan would not have expected such results.”
In response to applicants’ arguments, the claims are directed to a stable capsule formulation comprising (i) 30-50% crystalline Form III of Acalabrutinub, (ii) 20-80% of mannitol, microcrystalline cellulose or lactose, (iii) 5-20% of sodium starch glycolate, crospovidone or croscarmellose sodium, (iv) 0.5-5% of colloidal silicon dioxide or talc and (v) 0.5-5 % magnesium stearate or sodium stearyl fumarate.
Blatter et al. specifically states that each of the solid forms of the BTK inhibitor of Formula I can be combined with a carrier, such as a capsule, with binders, fillers, lubricants, surfactants, etc. See column 26, lines 37-67 and column 27, lines 1-67. One crystalline acalabrutinib is Form III. See Example 3. Thus Blatter et al. envisions combining Form III in a capsule with binders, fillers, lubricants, surfactants, etc.
Regarding component (i): The BTK inhibitor of Formula 1, which as stated above, can be Form III, is present in amounts of 0.0001 to 50%. See column 24, lines 40-60. This range overlaps that of 30-50%.
Regarding component (ii): Microcrystalline cellulose can be added as a binder, a filler and/or disintegrant. Table 49 incorporates 15-35% of microcrystalline cellulose. This overlaps the 20-80% claimed.
Regarding component (iii): Disintegrants may be present in amount of 0.5 to 15% (croscarmellose sodium or crospovidone). See column 27, lines 5-28. This overlaps the 5-20%.
Regarding component (iv): Talc or silica gel may be added in amounts of less than 1 %. This reads on 0.5-5%.
Regarding component (v): The composition may comprise magnesium stearate in an amount of less than 1% lubricant. See column 27, line 29-43. Table 49 further includes 0.05-1%. This reads on 0.5-5%.
Since Blatter et al. teach that any form can be used in the formulation and includes the claimed ingredients in the claimed amounts, it would have been obvious to pick from these known effective ingredients in the known effective amounts to arrive at the claimed invention. The resultant product should function in the same manner, i.e., comparable, if not more, rapid drug release than Calquence and total impurities remained low through a 6 month storage period.
Even if one were not to expect a stable formulation, Blatter et al. teach that any form can be formulated in capsule with additional ingredients. Thus the stability should be inherent. The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In reMay, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds, as well as a method of using them for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the inventors had merely found a new property of the compound and such a discovery did not constitute a new use. The court went on to reverse the obviousness rejection of claims 2-5 and 7-10 which recited a process of using a new compound. The court relied on evidence showing that the nonaddictive property of the new compound was unexpected.). See also In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966) (The claim was directed to a process of inhibiting light degradation of polypropylene by mixing it with one of a genus of compounds, including nickel dithiocarbamate. A reference taught mixing polypropylene with nickel dithiocarbamate to lower heat degradation. The court held that the claims read on the obvious process of mixing polypropylene with the nickel dithiocarbamate and that the preamble of the claim was merely directed to the result of mixing the two materials. “While the references do not show a specific recognition of that result, its discovery by appellants is tantamount only to finding a property in the old composition.” 363 F.2d at 934, 150 USPQ at 628 (emphasis in original)).
If one were not to expect a stable formulation, are there ingredients or processing steps missing from the claim that are required to achieve stability in a formulation that was not expected to be stable?
Thus this rejection is maintained.
8. Applicant has requested that the provisional rejections be held in abeyance until patentable subject matter is identified. However, this request cannot be considered, especially in view that no patentable subject matter has yet been identified.
However, as stated previously, with regards to effective filing date, the obviousness double patenting rejection may be withdrawn once allowable subject matter is determined due to the effective filing date of the ‘621 application being after that of the instant application.
Thus this rejection is maintained.
Conclusion
9. All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Correspondence
10. No claims are allowed at this time
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615