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 .
Terminal Disclaimer
The terminal disclaimer filed on 12/17/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 11,529,351 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 112
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.
Claims 31-40 contain the trademark/trade name “Sprycel”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe dasatinib tablet and, accordingly, the identification/description is indefinite.
Claims 31-40 are 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.
Claim 31 recited the phrase “said disorder is selected from” in line 3. If Markush language was intended, the proper phrasing should read: selected from the group consisting of.
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.
Claims 31-40 are rejected under 35 U.S.C. 103 as being unpatentable over Wertz et al. US 2021/0236489 A1, in view of Shu et al. US 2016/0038496 A1.
Wertz teaches a method of treatment involving the administration of a pharmaceutical composition comprising an amorphous solid dispersion ("ASD") of dasatinib. See abstract. Amorphous dasatinib having less than 1% crystalline is found in paragraphs 0112-0115. Tablet comprising amorphous dasatinib and one or more pharmaceutically acceptable additives including sodium bicarbonate, crospovidone, and the like is found in paragraphs 0134-0150. The claimed pharmacokinetic properties are found in paragraphs 0173-0179 and 0185-0190. The claimed dasatinib dosing is found in paragraph 0171. Co-administering with a gastric acid reducing agent in found in paragraphs 0180-0184.
Wertz is only deficient in the sense that Wertz does not teach the amounts of additives that fall within the claimed range.
Shu teaches a tablet composition comprising colloidal silicon dioxide, sodium stearyl fumarate, and crospovidone. See paragraphs 0047-0057. Tablet further comprises copovidone and mannitol is found in paragraphs 0128 and 0183. The claimed amounts of the additives are disclosed also in the Examples.
Thus, it would have been obvious to one of ordinary skills in the art at the time the invention was made to, by routine experimentation include the additives disclosed in the Shu reference with the expectation to obtain a tablet comprising dasatinib useful in the art. This is because Shu teaches tablet comprising the claimed additives useful for the delivery of dasatinib is known in the art.
Claims 31-40 are rejected under 35 U.S.C. 103 as being unpatentable over Jesson et al. WO 2014003678 A1, in view of Wertz et al. US 2021/0236489 A1.
This rejection has been withdrawn in view of the Amendment filed 12/17/2025.
Response to Arguments
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive.
Applicant argues that while Wertz discloses an amorphous solid dispersion of dasatinib for the same treatment of condition, Wertz does not teach a method that avoid anomalously low systemic exposure profile.
However, Applicant’s arguments are not persuasive for the following reasons:
First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., method that avoid anomalously low systemic exposure profile) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim 31 recited a method of treating a disorder in a patient;
Second, Applicant’s attention is called to the teaching in paragraph 0035, where Wertz teaches an amorphous solid dispersion is to improve the bioavailability of the pharmaceutically active ingredient. This improvement can occur, for example, because of enhanced surface area, improved wettability or dispersibility, increased dissolution rate, or other factors. The term “bioavailability” refers to the rate and extent to which an active ingredient is absorbed from a pharmaceutical composition and becomes available at the site of action. In the case of orally administered pharmaceuticals, bioavailability is generally assessed by monitoring a subject's blood plasma over time for the presence of an active ingredient (or suitable surrogate, such as a metabolite) after administration of a pharmaceutical composition, to evaluate the pharmacokinetic profile. See paragraph 0172;
Further, Wertz teaches the dasatinib ASDs and the pharmaceutical compositions of the present disclosure may provide particular advantages over standard commercial, immediate-release compositions of dasatinib, such as SPRYCEL. For instance, as described herein, the prescribing information for SPRYCEL warns to avoid co-administration with certain gastric acid-reducing agents, because such co-administration can negatively impact blood concentrations of dasatinib, resulting in a possible reduction in efficacy. In contrast, co-administration of the ASDs and pharmaceutical compositions of the disclosure with a gastric acid-reducing agent surprisingly exhibits no such negative effect. As another advantage, pharmaceutical compositions of the disclosure may achieve a reduced inter-subject and/or intra-subject variability, as compared to the variability observed for SPRYCEL. See paragraph 0029; and
As such, the burden is shifted to the Applicant to show that the amorphous solid dispersion taught in Wertz will not exhibit the claimed limitation “wherein the pharmaceutical formulation does not exhibit anomalously low systemic exposure profiles when compared with a Sprycel tablet”.
For at least the above reasons, the rejection over Wertz is maintained.
Conclusion
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615