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 .
Information Disclosure Statement
Information disclosure statements were filed on 08/18/2023 and 05/08/2025.
A Preliminary amendment was filed on 08/18/2023.
Election/Restrictions
Applicant’s election of Group I, claims 1-6 in the reply filed on 04/20/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 7-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/20/2026.
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 4 and 6 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 4 is indefinite in that it seems to read on the mass ratio described by the Hoffman et al reference cited below. But it could also refer to the release rate of the drug from the device , in which case a time element for the loss is missing from the claim. Clarification is required.
Claim 6 is indefinite in the Markush Group of additional drugs in section b) includes Vitamin E and tocopherol, which are equivalent, and bring into question the metes and bounds of claim. Clarification is requested.
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.
Claim(s) 1-3 and 5 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by CN 111 132 101 (CN’101) (cited on the IDS of 05/08/2025 as a European Search Report).
CN’101 discloses a drug loaded medical instrument having a drug coating layer. The device comprises a balloon main body and a coating layer, wherein the drug coating layer is attached to the outer side of the surface of the balloon body. The drug coating layer comprises a water-soluble drug. The drug is preferably at least one selected from the group consisting of rapamycin and everolimus, which are macrolide drugs. The drug coating layer comprises a plurality of elongated bodies which are crystals of a water-soluble drug which exist as crystals having an independent long axis. The long axis of the elongated body being substantially linear, the cross section of the elongated body on the surface forming the right angle with the long axis to form a polygon. The polygon has three edges or more. The length of the elongated body has a long axis measuring 10 um, and a diameter of between 0.1 um to 3 um The ratio is ( 0.1 – 0.3) (see cf D3, [0040] –[0160]; Figs. 1-15). The claims are anticipated by CN’101.
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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20230414839 A1 (Hoffman et al) which has a priority date of 2021-09-16.Hoffman et al. disclose a medical device with a coating that includes a drug on one of the surfaces. The drug is a limus active agent in the form of microcrystals in at least one tri-O-acylglycerol and least one solvent (Abstract). At [0207] crystals are described with prismatic to acicular habit are one-dimensional elongated forms in which the length of the crystal is significantly greater than its diameter. This reads on the limitation of the aspect ratio, although it is not a specific ratio .For example rapamycin crystallizes in the form of rhombohedral prisms [0208]. A rhombohedral crystal structure is a three-dimension lattice where all the edges are equal but not 90 degrees, forming a skewed cube-like unit cell, which reads on claim 2. Antioxidants are included in the formulation at [0047]. Flocculation inhibitors are also included at [0053]. The term “tri-O-acylglycerol refers to a glycerol esterified with three fatty acids ( Triglyceride or glycerol triester or glycerin(triple esterified glycerols) (0055). This reads on PEG as listed in instant claim 5. Other biocompatible materials and polymers such as polyvinylpyrrolidone are listed at [0836]. More polymers are listed a [0950] – [0951]. The glycerols are esterified with fatty acids (organic acids) at [0070]. [Medical devices such as stents ,balloon catheters, and cannulas are listed at [0106]. The mass concentration of the bioactive to coating is 20-25 mg/mL (0154 which meets the requirement of claim 4. Limus active agent refers to macrolide lactones such as everolimus and others listed at [0165 - 0171]. Crystal size ranges from 1 um to 300 um ([0172] – [0173]). Crystals as small as 5 um are listed at [0195]. Organic solvents are listed at [0177]. Suitable antioxidants are listed at [0577] – [0579]. Other bioactives for combination with the limus active agents are listed at [0949], and include anti-inflammatory agents [0948]. The ordinary practitioner would know that prednisone and corticosterone are well known anti-inflammatory agents for inclusion into the composition of the implant. The Hoffman et al reference seems to differ only in setting out the aspect ratio of claim 1. However, it is clear the that the ordinary practitioner would be able to find an aspect ratio suitable for the crystallization of drugs like everolimus and rapamycin given the crystal size according to Hoffman et al, and the known geometry of crystals such as everolimus. There does not appear to be any criticality or unexpected advantage to the claimed aspect ratio over the crystals as described by Hoffman et al. The instant claims would have been obvious to one of ordinary skill in the art at the time of filing given the teachings of Hoffman et al.
Conclusion
No claims are allowed.
Correspondence
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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