DETAILED ACTION
Claims 6-10, 12-13 and 15 are currently pending and under examination.
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
Applicant’s Informational Disclosure Statement, filed on 09/05/2025 and 12/16/2025 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Withdrawn Rejections
The prior rejection of claims 6-7 and 10 over US 2012/0015019 under 102 has been withdrawn as a result of Applicant’s claim amendment to include a water soluble primer layer being specifically human serum proteins.
Examiner’s Note
Applicant's amendments and arguments filed 11/24/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 11/24/2025, it is noted that claims 6, 9-10, 12 and 15 have been amended and no new matter or claims have been added.
New Rejections:
The following rejections are newly applied based on Applicant’s claim amendments.
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 9-10 and 12 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.
Regarding claim 9, the phrase "including any" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 9 recites “including any pharmaceutically acceptable salts and hydrates, as well as any stereoisomers, mixtures of stereoisomer and racemates” leads to unclear metes and bounds as it is unclear if it trying to limit the derivates of rapamycin or to any of the previously named compounds. Additionally, the language of “including any pharmaceutically acceptable salts and hydrates” and “as well as any stereoisomers” add to ambiguity of the claim as to what is defined by the scope. It is unclear if the “as well as any steriosomers, mixtures of steriosomer and racemates” are an additional “drug” to be selected from or trying to limit the previously named drugs. The combination of “including any pharmaceutically acceptable salts and hydrates” and “as well as any” leads to the scope of the claim has unclear metes and bounds. It would be remedial to include “thereof” language to properly refer back to the compound being modified as a salt, hydrate, stereoisomer and mixtures of stereoisomers and racemates.
Regarding claim 10, the language of “including any pharmaceutically acceptable salts and hydrates” and “as well as any stereoisomers” add to ambiguity of the claim as to what is defined by the scope. It is unclear if the “as well as any stereoisomers, mixtures of steriosomer and racemates” are an additionally “drug” to be selected from or trying to limit the previously claim structure. The combination of “including any pharmaceutically acceptable salts and hydrates” and “as well as any” leads to the scope of the claim has unclear metes and bounds. It would be remedial to include “thereof” language to properly refer back to the compound being modified as a salt, hydrate, stereoisomer and mixtures of stereoisomers and racemates.
Regarding claim 12, claim 12 is dependent on canceled claim 11. Dependency on a canceled claim leads to unclear scope and the metes and bounds of the instant claim are unclear. For examination purposes claim 12 will be examined as being dependent on claim 6.
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.
Claim(s) 6-9, 12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/015019 (previously applied) in view of WO 2018/114992 (previously applied).
Regarding claim 6, the limitation of a medical device having a coating layer comprising a plurality of drug microspheres is met by the ‘019 publication teaching forming a coating that involves the in-situ formation of drug microspheres. The coating applied to a medical device such as a catheter (abstract).
The limitation of wherein the microspheres have an average diameter of 1 to 20 um is met by the ‘019 publication teaching the drug present in microspheres wherein the majority of particles are less than or equal to 30 microns ([0082], [0105], [0107]). As MPEP 2144.05 recites “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 optimization”.
The limitation of wherein the coating layer consist of a plurality of drug microspheres is met by the ‘019 publication teaching the formation of microspheres on the surface of the device wherein all solvents are removed ([0009], [0011]).
Regarding claim 7, the limitation of wherein the medical device is a balloon catheter having a balloon is met by the ‘019 a catheter balloon (abstract).
Regarding claim 8, the limitation of wherein the microspheres have an average diameter of 3 to 10 um is met by the ‘019 publication teaching the drug present in microspheres wherein the majority of particles are less than or equal to 30 microns ([0082], [0105], [0107]). As MPEP 2144.05 recites “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 optimization”.
Regarding claims 9-10, the limitation of wherein the drug microsphere consisting of at least one of rapamycin is met by the ‘019 publication teaching rapamycin [0085].
Regarding claim 15, the limitation of wherein the medical device is a balloon catheter having a balloon and wherein the primer layer is applied on the balloon and the coating layer consist of drug microspheres is applied on the primary layer and wherein the balloon does not comprise any additional layer is met by teaching drug releasing microspheres coated on a balloon catheter (abstract). The coating solutions may be deposited directly onto the surface of the substrate or the coating solution may be deposited onto a pre-existing coating on the surface of the device such as a primer layer. The primer layer typically a polymer exhibits good adhesion characteristics with regard to the material of the substrate [0108]. No additional coating layer are taught.
The ‘019 publication does not specifically teach wherein the medical device comprises a primer layer comprising a water-soluble material and wherein the water soluble material is a protein which is selected from water soluble human serum proteins (claim 1) wherein the water-soluble material is a protein having a molecular weight of between 50 to 200 kD (claim 12).
The ‘992 publication teaches drug releasing insertable devices and relates to controlled release of drug from a coated balloon directly into affected tissue regions within the body of the individual (abstract). The drug eluting balloons that have utilized sirolimus or sirolimus derivatives (page 5, lines 17-25, page 10, lines 1-5). The drug eluting device is preferably a balloon catheter comprising a primer drug releasing layer containing a water-soluble material layer and a multi-part drug layer having a first part and a second part wherein the first part comprises a macrocyclic triene immunosuppressive compound (page 7, lines 20-30). The water-soluble material layer is composed of a polymer or protein having an approximate molecular weight of between 50 to 200 kD. The water-soluble material is a polymer or protein having an approximate molecular weight of between 65-70 kD and include blood proteins such as globulins and/or fibrinogens (page 8, lines 5-15) specifically human serum albumin (page 10, lines 1-2). The primer layer is applied to balloon catheter (page 11, lines 20-30, page 12, lines 5-15). The drug layer is applied to the primer layer (page 12, lines 30-page 13, line 15). Specific drugs are taught to include CRC-015 (Table 1).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the active agents and primer layers specifically named by the ‘992 publication for the device of the ‘019 publication because the ‘019 publication teaches rapamycin drugs and a primer layer on a balloon catheter and the ‘992 publication rapamycin drugs used interchangeability with CRC-015 and specifically named primer polymers to be used on balloon catheters. It would have been obvious to one of ordinary skill in the art to use known primer polymers on balloon catheters as taught by the ‘992 publication on the balloon catheter containing a primer layer on a balloon catheter. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use CRC-015 in the microspheres on the balloon catheter of the ‘019 publication because the ‘992 publication teaches rapamycin and CRC-015 to be used on ballon catheters, thus teaching interchangeability of the active agent.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/015019 in view of WO 2018/114992 as applied to claims 6-10, 12 and 15 above, and further in view of US 2012/0143132 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 6-10, 12 and 15 are taught by the combination of the ‘019 publication and the ‘992 publication.
The combination of references does not specifically teach wherein the balloon of the balloon catheter is made of a polyamide material (claim 13).
The ‘132 publication teaches paclitaxel coated catheter balloons (title) wherein the active agent may include rapamycin [0128]. The catheter is taught to be a commercially available dilation catheter with expandable ballon composed of a polyamide ([0139]-[0159]).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use commercially available balloon catheter material for the ballon catheter taught by the ‘019 publication because the ‘132 publication teach commercially available balloon catheters formed of polyamide to be used for drug delivery and the ‘019 publication teaches a balloon catheter used for drug delivery. It would have been prima facie obvious to one of ordinary skill to use a widely available balloon catheter for the balloon catheter taught by the ‘019 publication for the same purpose, drug delivery device.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
112(b):
Applicant argues the defect of claim 10 is cured by way of the currently amended claims. Specifically claim 10 is now focused on at least one compound having a specified structure while the previous rapamycin related language is devoted to claim 9.
In response, Applicant is referred to the newly applied 112(b) rejection above regarding claims 9 and 10 regarding the use of “including any” and “as well as any” leading to unclear metes and bounds.
103:
Applicant argues the ‘019 publication teaches coating layer comprising a plurality of drug microspheres wherein a coating is also formed involving the in-situ formation of drug microspheres. The ‘019 publication teaches majority of the particles cast off from the coated balloon have a diameter of 30 um or less.
In response, the limitation of wherein the medical device is a balloon catheter having a balloon and wherein the primer layer is applied on the balloon and the coating layer consist of drug microspheres is applied on the primary layer and wherein the balloon does not comprise any additional layer is met by the ‘019 publication teaching drug releasing microspheres coated on a balloon catheter (abstract). The coating solutions may be deposited directly onto the surface of the substrate or the coating solution may be deposited onto a pre-existing coating on the surface of the device such as a primer layer. The primer layer typically a polymer exhibits good adhesion characteristics with regard to the material of the substrate [0108]. The ‘019 publication additionally teaches the drug present in microspheres wherein the majority of particles are less than or equal to 30 microns ([0082], [0105], [0107]). As MPEP 2144.05 recites “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 optimization”.
Applicant argues the ‘019 publication teaches a primer layer having good adhesion. The primer layer of the present invention is made from water soluble human serum proteins, whereas the primer layer disclosed in the .019 publication is non-natural polymer. This is critical for a medical device for patients which are weak or allergic to certain non-human polymers. The use of water-soluble human serum proteins yields benefits including dissolve in the blood after dilation of the medical device. Secondly using water soluble human serum proteins as a material reduces the prospects of patient’s contamination, since it is human origin.
In response, it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the active agents and primer layers specifically named by the ‘992 publication for the device of the ‘019 publication because the ‘019 publication teaches rapamycin drugs and a primer layer on a balloon catheter and the ‘992 publication rapamycin drugs used interchangeability with CRC-015 and specifically named primer polymers to be used on balloon catheters. It would have been obvious to one of ordinary skill in the art to use known primer polymers on balloon catheters as taught by the ‘992 publication on the balloon catheter containing a primer layer on a balloon catheter. The use of human serum albumin was taught to provide prompt effective release of the therapeutic agent (page 26, first paragraph). Thus fast effective release of the rapamycin type drug was known from a catheter with the use of a human serum albumin primer layer.
Applicant argues the ‘992 publication teaches a multi-part drug layer including rapamycin derivatives and fatty alcohol or fatty aldehyde or fatty acid or fatty surfactant none of which relate to any embodiments of the instant application. The ‘992 publication includes additionally contaminates teaching away from the disclosure found it the instant application which expressly avoids such elements.
In response, the ‘019 publication teaching drug releasing microspheres coated on a balloon catheter (abstract). The coating solutions may be deposited directly onto the surface of the substrate or the coating solution may be deposited onto a pre-existing coating on the surface of the device such as a primer layer. The primer layer typically a polymer exhibits good adhesion characteristics with regard to the material of the substrate [0108]. Thus the ‘019 publication the use of a drug coating layer on a primer layer applied to a balloon catheter medical device without additionally ingredients.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613