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 the Preliminary amendment filed on October 19, 2023 is acknowledged.
Claims 18-41 are pending in this application.
Claims 1-17 have been cancelled.
Claims 22, 23, 26, 36, and 38 have been amended.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 18-40) in the reply filed on November 17, 2025 is acknowledged.
Applicant’s election without traverse of:
Drug Delivery System Form: coating on a medical device;
Identification of Active Ingredient (use): vascular disease and restenosis;
Identification of Active agent (type): withdrawn per the amendment to claim 23;
in the reply filed on November 17, 2025 is acknowledged.
Claims 19, 27, and 39-41 are withdrawn.
Claims 18, 20-26, and 28-38 are under examination in this application.
Claim Objections
Claim 26 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 24. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 18, 20-23, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moulas (US 2020/0254152).
Moulas discloses a coating system for medical devices comprising at least one cellulose compound or derivative thereof alone or in combination with other substances. The coating system may further comprise at least one active ingredient intended to treat a disease and the coating has favorable drug eluting properties. The disclosed composition has applications in implantable or non-implantable medical devices such as balloons, stents, grafts, patches and implants of all kinds (abstract).
The medical devices can be made of various different materials such as metals and polymers (paragraph 0003), such as biodegradable metals including magnesium or biodegradable polymers such as polylactide, polyglycolide, and polycaprolactone (paragraph 0031). Additional metals include stainless steel or cobalt chromium alloy or magnesium or zinc or aluminum alloy, or any other alloy (paragraph 0037).
The balloons can be drug eluting balloons, or drug coated ballons, such as those used in angioplasty (paragraph 0008), endovascular balloon, coronary or peripheral balloons (paragraph 0038).
Active agents include steroids (claim 4).
Regarding claim 20, as noted above, the composition is used as a coating on a medical device.
Regarding claim 21, as noted above, the device can be a balloon, a stent, graft, or implant of any kind.
Regarding claim 22, the device can be used for the prevention and/or treatment of restenosis or neointimal formation during or after vascular procedures (paragraph 0014).
Regarding claim 23, examples of active agents to be included include sirolimus and everolimus (paragraph 0036), which are mTOR inhibitors.
Regarding claim 33, examples of cellulose compounds include hydroxyethyl cellulose, cellulose acetate phthalate, hydropropylmethyl cellulose phthalate, cellulose ester derivatives, and cellulose ether derivatives (paragraph 0026).
Moulas, therefore, anticipates the rejected claims.
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 24-26, 28-32, 34, and 35-38 are rejected 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).
The teachings of Moulas are discussed above.
Moulas additionally discloses the mass density of the coating on the medical device is 0.1 to 10 micrograms per square millimeter (claim 10).
Moulas does not disclose the at least one compound of cyclopentaphenanthrene is a zoosterol or derivatives thereof.
McGinity discloses layered pharmaceutical implants for delivery of anti-cancer compounds over a period of time (abstract).
The anticancer compounds include for example everolimus (claim 32), which is a mTOR inhibitor.
The implant comprises a drug containing layer comprising one or more drugs, a hydrophilic polymer, and a biocompatible hydrophobic lipid. The hydrophobic lipid can be steroid (paragraph 0020).
Cholesterol is the preferred steroid (paragraph 0086; claim 12). It is noted cholesterol is a zoosterol and a hydroxysteroid.
The hydrophilic polymer can include a cellulose (paragraph 0081).
Regarding claims 24-26, as noted above, the implant coating preferably comprising cholesterol as hydrophobic lipid. It is noted cholesterol is a zoosterol. As noted in Moulas, disclosed cellulose compounds include cellulose ethers, such as hydroxyethyl cellulose. Both Moulas and McGinty disclose the use of mTOR inhibitors in their respective coatings, such as everolimus.
Regarding claims 28-29 and 34, McGinty discloses the composition comprises 0.1-50% biologically active compounds, 20-95% lipid component, about 5-50% hydrophilic bio adhesive component and 0-50% suitable additives to enhance processing of the wafer or to control the release of the active compound from the implant (paragraph 0033). These percentages would meet the limitations of the ratios of the instant claims.
Regarding claim 30-32, as noted above, cholesterol is a zoosterol and hydroxysteroid.
Regarding claim 35-38, as noted above, Moulas additionally discloses the mass density of the coating on the medical device.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have including cholesterol, as taught by McGinty, in the coating composition of Moulas since lipids are known to retard drug release in order to slow the release of the drug from the implant to improve the therapeutic effect of the drug (paragraph 0016).
Conclusion
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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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