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 .
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) 1-5 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cottone et al. (US 20190009063 hereinafter “Cottone”) in view of Spencer et al (US 20050163913 hereinafter “Spencer”) and Melder (US 20110251663).
Regarding Claim 1, Cottone teaches a novel drug balloon catheter capable of controlling drug release, comprising a balloon, a catheter, and a drug coating (See [0025] and [0063] teaching a balloon on a catheter with a therapeutic coating), wherein a surface of the balloon is coated with the drug coating (See [0063] teaching the biocompatible matrix is a 'coating' on the balloon), and the drug coating is divided into a first drug coating, a second drug coating, and a third drug coating (See [0063] teaching the balloon may be wrapped multiple times with the biocompatible matrix; it is interpreted that each 'wrapping' is a separate coating, so if the balloon is wrapped three times, there are three drug coatings); each of the first drug coating, the second drug coating and the third drug coating comprises a sustained-release agent of an mPEG-PLGA copolymer (see [0117] teaching Mpeg-PLGA is a part of the coating)
Cottone does not specify release rates of a drug in the first drug coating, the second drug coating, and the third drug coating are different.
Spencer teaches [0017] different agents/coating could have different release rates based on the different drug release kinetics of the therapeutic agent (ex: composition or thickness).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the release rates of the first drug coating, the second drug coating, and the third drug coating of Cottone such that they differ as taught by Spencer. One of ordinary skill in the art would have been motivated to do so in order to targeted different anatomical and/or pathological characteristics of the areas of the target site (Spencer [0014]).
The combination does not specify the first drug coating, the second drug coating, and the third drug coating are horizontally arranged in parallel along a surface of the balloon so as to divide the surface of the balloon into a three-stage structure.
Melder teaches (Fig 8B) a device with multiple portions of coating (420, 422, 424, 426) that are horizontally arranged in parallel along a surface dividing the surface into multiple zones (see [0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first drug coating, second drug coating and third drug coating of Cottone such that the first drug coating, the second drug coating, and the third drug coating are horizontally arranged in parallel along a surface of the balloon so as to divide the surface of the balloon into a three-stage structure as taught by Melder. One of ordinary skill in the art would have been motivated to do so in order to provide the desired number of radial drug layers for the particular application/treatment (Melder [0047]). One of ordinary skill in the art would also recognize this as an alternative arrangement of providing multiple drug coatings to a device than the arrangement as outlined in Cottone, while still providing the same expected results of a drug coating on the device.
The combination of Cottone, Spencer and Melder does not specify wherein in the mPEG-PLGA copolymer, mPEG has a number-average molecular weight of 5,000-80,000, and PLGA has a number-average molecular weight of 1,000-3,000, 3,000-5,000, 5,000-10,000, 50,000-70,000, 100,000-120,000 or a combination thereof.
Cottone does teach in [0085] that the polymers used in the matrix may be of various viscosities and molecular weights.
The instant disclosure describes the parameter of wherein in the mPEG-PLGA copolymer, mPEG has a number-average molecular weight of 5,000-80,000, and PLGA has a number-average molecular weight of 1,000-3,000, 3,000-5,000, 5,000-10,000, 50,000-70,000, 100,000-120,000 or a combination thereof as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as wherein in the mPEG-PLGA copolymer, mPEG has a number-average molecular weight of 5,000-80,000, and PLGA has a number-average molecular weight of 1,000-3,000, 3,000-5,000, 5,000-10,000, 50,000-70,000, 100,000-120,000 or a combination thereof, are considered to be matters of design choice, well within the skill of the ordinary artisan. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of wherein in the mPEG-PLGA copolymer, mPEG has a number-average molecular weight of 5,000-80,000, and PLGA has a number-average molecular weight of 1,000-3,000, 3,000-5,000, 5,000-10,000, 50,000-70,000, 100,000-120,000 or a combination thereof would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 2, the combination of Cottone, Spencer and Melder teaches all elements of claim 1 as described above. Cottone further teaches the drug balloon catheter wherein the drug coating comprises the following raw materials: an active drug (See [0020] teaching rapamycin and paclitaxel as the active agent; the examiner notes these are both examples of an active agent as described in instant application [0015]), an adhesive (See [0092] teaching the matrix includes a bio adhesive), a sustained-release agent (see [0117] teaching mPEG-PLGA is a part of the coating; examiner notes instant application [0023] teaches mPEG-PLA is disclosed as a sustained release agent), and a polyol substance (See [0015] teaching PVA (polyvinyl alcohol), [0095] teaches mannitol and sorbitol; examiner notes instant application [0037-0038] discloses that polyvinyl alcohol, mannitol and sorbitol are considered polyol substance).
Regarding Claim 3, the combination of Cottone, Spencer and Melder teaches all elements of claim 2 as described above. The combination does not specify wherein the drug coating comprises the following raw materials in parts by weight: 20-100 parts of the active drug, 10-80 parts of the adhesive, 5-65 parts of the sustained-release agent, and 5-70 parts of the polyol substance. However, this recitation is considered a product by process limitation. Cottone already teaches the drug coating is comprised of the raw materials of active drug, adhesive, sustained-release agent and polyol substance as described in claim 2. The specific weight parts of each raw material that is used to combine together to form the drug coating is considered the process for creating the end result of a drug coating. Since Cottone already teaches the drug coating with these raw materials, Cottone is considered to meet the structural limitations of the claim.
Furthermore, Spencer [0016] teaches that compositions of the first and second therapeutic agents applied could be differed to provide different drug release kinetics. Therefore, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Cottone coating to have the following raw materials in parts by weight: 20-100 parts of the active drug, 10-80 parts of the adhesive, 5-65 parts of the sustained-release agent, and 5-70 parts of the polyol substance, as it involves only adjusting the weight amount/parts of a material disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coating of Cottone by making the following raw materials in parts by weight: 20-100 parts of the active drug, 10-80 parts of the adhesive, 5-65 parts of the sustained-release agent, and 5-70 parts of the polyol substance as a matter of routine optimization since it has been held that “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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, it has been held that “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp”.
Regarding Claim 4, the combination of Cottone, Spencer and Melder teaches all elements of claim 3 as described above. Cottone further teaches the drug balloon catheter wherein in the drug coating, the loading amount of the active drug is 1-10 μg/mm2 (see [0075] " The total surface load of the pharmaceutically active agent on the balloon may range from about 1 μg/mm.sup.2 to about 200 μg/mm.sup.2").
Regarding Claim 5, the combination of Cottone, Spencer and Melder teaches all elements of claim 2 as described above. Cottone further teaches in the drug coating, the adhesive is a liposome (See [0096-0098] teaching a liposome included in the matrix/coating).
Regarding Claim 9, the combination of Cottone, Spencer and Melder teaches all elements of claim 8 as described above. The combination does not specify the drug balloon catheter wherein with respect to the first drug coating, the second drug coating, and the third drug coating, the number-average molecular weights of the PLGAs in the mPEG-PLGA copolymers are all different.
As described above, Cottone does teach in [0085] that the polymers used in the matrix may be of various viscosities and molecular weights. Additionally, Spencer [0016] teaches that compositions of the first and second therapeutic agents applied could be differed to provide different drug release kinetics.
The instant disclosure describes the parameter of wherein with respect to the first drug coating, the second drug coating, and the third drug coating, the number-average molecular weights of the PLGAs in the mPEG-PLGA copolymers are all different as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as wherein with respect to the first drug coating, the second drug coating, and the third drug coating, the number-average molecular weights of the PLGAs in the mPEG-PLGA copolymers are all different are considered to be matters of design choice, well within the skill of the ordinary artisan. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of wherein with respect to the first drug coating, the second drug coating, and the third drug coating, the number-average molecular weights of the PLGAs in the mPEG-PLGA copolymers are all different would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 10, the combination of Cottone, Spencer and Melder teaches all elements of claim 1 as described above. Cottone further teaches the use of the drug balloon catheter according to claim 1 in dilating a blood vessel (see [0112] teaching balloon inflated in a blood vessel).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection takes into consideration the amendments filed 5/1/2026.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Li et al (US 20220016398) teaches a balloon catheter with a drug coated balloon with multiple layers.
Wang et al. (US 20210259976) teaches a balloon catheter with a drug coated balloon with multiple layers.
Toner et al. (US 20050246009) teaches a balloon with multiple drug coatings.
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 NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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