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 .
Status of Application
Receipt of Applicant’s remarks and amended claims filed on December 24, 2025 is acknowledged.
Claims 1-11 and 13-22 are pending in this application.
Claims 1 and 5-11 have been amended.
Claim 12 has been cancelled
All pending claims are under examination in this application.
Information Disclosure Statement
Receipts of the Information Disclosure Statement filed on December 24, 2025 is acknowledged. A signed copy is attached to this office action.
Maintained Objections/Rejections
Claim Objections
Claim 16 is objected to because of the following informalities:
Regarding claim 16, the claim recites a mixture of commas (,); colons (:), and semi colons (;) to separate the different embodiments. It is suggested Applicant utilize semi-colons (;) between each embodiment and reform the claim, such as:
16. The pharmaceutical soft gelatin capsule dosage form of claim 1, wherein the dosage form comprises:
talazoparib or a pharmaceutically acceptable salt thereof:
in an amount equivalent to about 0.1 mg talazoparib free base;
in an amount equivalent to about 0.25 mg talazoparib free base;
in an amount equivalent to about 0.35 mg talazoparib free base;
in an amount equivalent to about 0.5 mg talazoparib free base;
in an amount equivalent to about 0.75 mg talazoparib free base; or
in an amount equivalent to about 1 mg talazoparib free base.
Appropriate correction is required.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues:
* The Applicant appreciates the Examiner's suggestion to utilize semi-colons (;) between each embodiment and has amended Claim 16 accordingly. The Applicant respectfully requests that the objection to Claim 16 be withdrawn.
No amendments to the claim was submitted. Therefore, the objection is maintained.
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.
Claims 1-11 and 14-22 are rejected under 35 U.S.C. 103 as being unpatentable over Muldoon et al. (US 2014/0271837) in view of Feng et al. (WO 2017/075091).
Muldoon discloses a pharmaceutical soft gelatin capsule dosage form comprising:
a shell that included gelatin and a plasticizer, and
a fill that include at least one active ingredient, polyethylene glycol, a neutralizing agent and water (abstract).
The fill may optionally include antioxidants, such as tocopherol (paragraph 0042).
Muldoon discloses the gelatin is present in the amount of about 35% to about 85% of the gelatin capsule (paragraph 0024).
The plasticizer is present in an amount of about 10% to about 60% of the gelatin capsule (paragraph 0026).
The active ingredient can be present in the amount of 0.01 mg to about 500 mg depending on the desired dosage (paragraph 0033).
Table 1 discloses 0.1% of DL-a-tocopherol (antioxidant) and 77.30-77.63% of PEG 400 (polyethylene glycol).
The gelatin utilized in the capsules can be type A gelatin, for example acid bone gelatin (paragraph 0022).
Regarding claim 2, examples of plasticizers include sorbitol and glycerin (glycerol) and mixtures thereof. (paragraph 0025).
Regarding claim 3, as noted above, he fill may optionally include antioxidants, such as tocopherol.
Regarding claim 4, as noted above, polyethylene glycol is disclosed in the fill.
Regarding claim 14, Muldoon discloses the gelatin capsule comprises sorbitol special/glycerin blend A810 (paragraph 0049), which comprises anhydrous sorbitol.
Regarding claim 15, Table 1 discloses DL-a-tocopherol, which is also known as all rac-alpha tocopherol.
Regarding claim 18, the gelatin capsule dosage form can be administered orally (paragraph 0018).
Yu discloses the preparation of soft shelled gelatin capsules
Muldoon does not disclose the active ingredient is talazoparib.
Feng discloses the treatment of lung cancer with the administration of talazoparib administered orally, once daily, at a dose of 25 to about 1100 mg/day or about 0.5 to about 2 mg per day, or of about 1 mg/day, or about 0.10 to 0.75 mg/kg/day, or about 0.25-0.30 mg/kg/day (paragraph 0039).
Regarding claims 5-11, the instant claims differ from the references only in the specific percentage selected for the compositions. However, it would have been deemed prima facie obvious to one having ordinary skill in the art at the time of the invention to optimize the percentage of gelatin and plasticizer in the capsule shell, as well as alpha-tocopherol, the solvent, and the active ingredient, to prepare a composition containing the active ingredient in a capsule shell because the determination of a specific percentage having the optimum therapeutic effect is well within the level of one having ordinary skill in the art, and the artisan would be motivated to determine optimum amounts to get the maximum effect of the active compounds. Therefore, the invention as Whole has been prima face obvious to one of ordinary skill in the art at the time the invention was made.
Regarding claim 16, as noted above, talazoparib or a pharmaceutically acceptable salt thereof is administered orally, once daily, at a dose of about 25 to about 1 100 μg/day, or about 0.5 to about 2 mg per day, or of about 1 mg/day, or about 0.10 to 0.75 mg/kg/day, or about 0.25-0.30 mg/kg/day. Dosage figures provided herein refer to the dose of the free base form of talazoparib, or are calculated as the free base equivalent of an administered talazoparib salt form. For example, a dosage of 1 mg of talazoparib tosylate refers to talazoparib tosylate in an amount equal to 1 mg free base equivalent of talazoparib (paragraph 0039).
Regarding claim 17, talazoparib salt form can be talazoparib tosylate (paragraph 0039).
Regarding claims 19-21, the claims recite contingent limitations. Applicant’s attention is directed to MPEP 2111.04 II which discusses broadest reasonable interpretations of the contingent limitations.
Regarding claim 22, as noted above, Feng discloses the treatment of lung cancer.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have incorporated talazoparib into the capsule formulation of Muldoon in order to provide a dosage form having a stable dissolution profile over the time of storage so that an active ingredient may be delivered to the desired site in a manner that provides for consistent dosing (paragraph 0003).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Muldoon et al. (US 2014/0271837) in view of Feng et al. (WO 2017/075091) as applied to claims 1-12 and 14-22 above, and further in view of Brox (WO 8403417).
The teachings of Muldoon and Feng are discussed above.
The Muldoon does not disclose the glycerin is glycerin 85%.
Brox discloses a soft gelatin capsules. The capsules contain glycerol 85% (examples).
It would have been obvious to have used glycerol 85% in the preparation of the capsules in Muldoon since it is routinely utilized in the preparation of soft gelatin capsules.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues:
*Muldoon does not teach a soft gelatin dosage form having talazoparib as the active ingredient. Muldoon does not describe any particular type of gelatin and also does not suggest that the choice of gelatin type might have an impact on the chemical stability of the soft gelatin dosage form.
In contrast to Applicant’s arguments, Type A, acid bone gelatin, is disclosed (paragraph 0022; oo43).
Applicant did not provide any additional arguments regarding the teachings of Brox.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615