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 June 11, 2026 is acknowledged.
Claims 18-20, 22-25, 27-29, 33-36, 38-40, 42-4341 are pending in this application.
Claims 1-17, 21, 26, 30-32, 37, and 41 have been cancelled.
Claims 18, 20, 22-25, 28-29, 33-36, and 38 have been amended.
Claims 19, 27, and 39-40 are withdrawn.
Claims 42-43 are new.
Claims 18, 20, 22-25, 28-29, 33-36, 38, and 42-43 are under examination in this application.
Withdrawn Objections/Rejections
Claim Objections
The objection to claim 26 under 37 CFR 1.75 as being a substantial duplicate of claim 24 has been withdrawn in view of the cancellation of claim 26.
Claim Rejections - 35 USC § 102
The rejection of claims 18, 20-23, and 33 under 35 U.S.C. 102(a)(1) as being anticipated by Moulas (US 2020/0254152) has been withdrawn in view of the amendment to claim 18 to recite a zoosterol, plant sterol, or sterol ester and at least one active ingredient dispersed within the drug delivery coating.
Claim Rejections - 35 USC § 103
The rejection of claims 24-26, 28-32, 34, and 35-38 under 35 U.S.C. 103 as being unpatentable over Moulas (US 2020/0254152) as applied to claims 18, 20-23, and 33 above, and further in view of McGinity et al. (US 2017/0027864) has been withdrawn in view of the amendment to claim 18 to recite a zoosterol, plant sterol, or sterol ester and at least one active ingredient dispersed within the drug delivery coating.
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 18, 22-25, 28-29, 33-36, 38, and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Flanagan (CA2628405).
Flanagan discloses a medical device with a coating comprising an active form and an inactive form of a therapeutic agent (abstract).
The device can be a stent, such as a balloon expandable stent (paragraph 0091).
Non-polymeric materials used in the coating can include sterols, such as cholesterol, stigmasterol, and beta-sitosterol (paragraph 0081).
Polymeric materials are also incorporated into the coating. Examples include celluloses, such as cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellulose nitrate, cellulose propionate, cellulose ethers, and carboxymethyl cellulose (paragraph 0075).
The therapeutic agent is present in the amount of about 0.5 g/mm2 to about 4 g/mm2 or about 4 to 9% by weight (paragraph 0036).
The amount of polymer is present in the coating of at least 1-5%, at least 5-10%, at least 10-20%, at least 20-30%, at least 30-40%, at least 40-50%, at least 50-60%, at least 60-70, at least 70-80%, at least 80-90%, or at least 90-99% by weight of the coating (paragraph 0040).
The amount of therapeutic agent within the coating at least 5 %, at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, at least 95%, at least 97%, at least 99% or more by weight of the polymeric materials used to form the medical device (paragraph 0052).
Regarding claim 22, as noted above, the sterol can be cholesterol.
Regarding claim 23, other suitable therapeutic agents include everolimus or tacrolimus (claim 17) which are mTOR inhibitors.
Regarding claim 24, as noted above, the cellulose can be carboxymethylcellulose, the sterol can be cholesterol, and additional therapeutic agents include mTOR inhibitors.
Regarding claim 25, as noted above, the cellulose can be carboxymethylcellulose and additional therapeutic agents include mTOR inhibitors.
Regarding claims 28-29, 34-36, and 38, as noted above, the polymer and the therapeutic agents can be present in the amounts ranging from 5-95% respectively. Applicant is reminded that where the general conditions of the claims are met, burden is shifted to applicant to provide a patentable distinction. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454 105 USPQ 233,235 (CCPA 1955).
Regarding claim 33, as noted above, the cellulose can be cellulose ethers.
Regarding claim 42, as noted above, the device can be a stent, such as a balloon expandable stent (paragraph 0091), which is a medical device. Non-polymeric materials used in the coating can include sterols, such as cholesterol, stigmasterol, and beta-sitosterol (paragraph 0081). Polymeric materials are also incorporated into the coating. Examples include celluloses, such as cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellulose nitrate, cellulose propionate, cellulose ethers, and carboxymethyl cellulose (paragraph 0075).
Regarding claim 43, as noted above, the zoosterol can be cholesterol, the active agent can include an mTOR inhibitor, and the cellulose can be a cellulose ether.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Flanagan (CA2628405) as applied to claims 18, 22-25, 28-29, 33-36, 38, and 42-43 above, and further in view of Pinchasik et al. (US 5,449,373).
The teachings of Flanagan are discussed above.
While Flanagan discloses the medical device can be a balloon stent, he is silent of types of balloon stents. He does disclose suitable stents include those of Pinchasik.
Pinchasik discloses articulated stents including peripheral and coronary stents.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have utilized the stents discloses in Pinchasik since Flanagan discloses his coating is suitable for said stents.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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