DETAILED ACTION
Claims 1, 5-13 are currently pending. Claims 1, 5-8 and 12-13 are currently 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 .
Withdrawn Rejections
The objection over claims 3, 5 and 12 with withdrawn based on Applicant amending the claims to “water-soluble” in all instances.
The rejection over claim 7 under 112(b) is withdrawn as a result of Applicant amending the instant claims to remove the term “derivative”.
Examiner’s Note
Applicant's amendments and arguments filed 03/13/2026 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 03/13/2026, it is noted that claims 1, 5, 8 and 12 have been amended and no new matter or claims have been added.
Modified Rejections:
The following rejections have been modified based on Applicant’s claim amendments.
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.
Claim(s) 1, 5-7 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0281912 (previously applied) in view of US 6,315,979 (previously applied), US 2013/0184660 (previously applied) and US 2016/0250388 (previously applied) as evidenced by Sigma Aldrich, (“Bovine Serum Albumin”, previously applied).
Regarding claim 1, the limitation of a method of treating an individual, the method comprising providing a balloon catheter comprising a first coating and a second coating on the balloon’s surface, accessing the space, inserting the balloon catheter into the space, inflating the balloon for an effective amount of time to allow for the release of the second coating into a tissue is met by the ‘912 publication teaching a balloon catheter includes an inflatable balloon defining an inner and outer surface, a first biocompatible layer that includes hyaluronic acid disposed on the balloon surface and a second drug containing layer includes a paclitaxel and urea (abstract). The catheter is taught as advanced by a guidewire into the atherosclerotic lesion, inflated and deflated sometimes repeatedly ([0002], [0014]). The drug is taught as coming into contact with the tissue of a patent and adhering to the tissue [0030]. The first biocompatible layer is taught to be formed of any suitable material that is biodegradable and releasable from the balloon when inflated [0031] and can be of natural origin [0036] and water soluble [0038].
Regarding claims 6-7, the limitation of wherein the second coating comprised of a formulation having a first component an optionally a second component, the first component selected from a group including sirolimus is met by the ‘912 publication teaching the drug containing layer comprise one or more of sirolimus and paclitaxel [0054].
Regarding claim 12, the limitation of wherein the first coating consists of at least one water soluble polymer is met by the first biocompatible layer comprising one or more suitable polymers which include hyaluronic acid which is water soluble and consists essentially of hyaluronic acid ([0036]-[0037], [0039], claim 14).
Regarding claim 13, the limitation of wherein the second coating consists of a formulation having a first component and optionally a second component is met by the drug containing layer comprising paclitaxel and urea and comprises at least 99% of the drug containing layer [0061].
The ’912 publication does not specifically teach the individual having a primary brain tumor, accessing a subdural space in a skull and inserting the balloon catheter (claim 1).
The ‘912 publication does not specifically teach wherein the first coating comprise at least one water soluble polymer that is a protein having an approximate molecular weight between 50 to 200 kD (claim 1), wherein the water-soluble polymer is selected from water-soluble human serum proteins or water-soluble blood proteins (claim 5).
The ‘979 patent teaches surgical procedures to remove tumor leave cells in the area adjacent. These remaining cells can cause recurrence of the cancer (column 1, lines 25-35). A method of using radioiodinated compounds in a catheter for treating the tissue around a tumor cavity after removal of the tumor, especially in vivo in the brain, is described using an implantable catheter (column 4, lines 45-60). The solution is implanted in the device for the desired treatment period then removed to deflate the catheter (column 10, lines 45-50). The implantable apparatus such as a catheter, for treatment of tissue surrounding a cavity left by surgical removal of brain tumor and has an advantage over traditional brachytherapy in that the apparatus is inserted during the same surgical procedure to remove the tumor thus no additional surgy is required. The balloon fills the volume left by the tumor mass and the determination of where to place the radioactivity is less complicated. An incision adjacent to the tumor wherein the inflatable device is filled with radioactive treatment fluid (column 1, lines 45-60).
The ’660 publication teaches catheter useful for penetrating the vascular wall and delver medicaments necessary to tissue proximate the vasculature. Such catheters are useful in delivering site specific medicaments to the tissue (abstract). The catheter can be used to deliver an anti-cancer agent to the brain for treating a brain tumor. Selection of the anti-cancer agents for brain tumors patient depends on several factors and can include Sirolimus ([0071], Table 1).
The ’388 publication teaches a medical device (see abstract), particularly to coated balloon catheters (see [0002]). The coating includes proteins, such as serum albumin as a preferred additive since it is water-soluble (see [0167]). Other useful proteins include other albumins and immunoglobulins (i.e. at least one water soluble polymer and the water-soluble polymer is a protein, see [0168]). Coating formulations with human serum albumin (i.e. water-soluble human serum proteins) and paclitaxel (see Formulation 16) and human serum albumin and rapamycin (see Formulation 17). As evidenced by Sigma Aldrich, serum albumin has a molecular weight of ~66kD. Balloon catheters were folded, then the folded balloon was sprayed or dipped in a formulation 1-17, dried, and sprayed or dipped again in the formulation until a sufficient amount of drug on the balloon was obtained (see [0270]). Examples where balloon catheters were dipped in a first formulation, dried, then sprayed or dipped again in a different formulation (i.e. wherein the balloon comprises a first coating and a second coating and wherein the first coating has a different composition than the second coating see Example 4). Coating formulations with paclitaxel (see Formulation 16) and rapamycin (see Formulation 17).
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 drug releasing catheter taught by the ‘912 publication for treat a brain tumor as taught by the ‘660 publication because the ‘912 publication teaches a ballon catheter to release an active agent such as sirolimus in the body and the ‘660 publication teaches that sirolimus is used to treat brain tumors. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘912 publication teaches drug releasing catheter to be used in cerebral arteries and comprising sirolimus and the ‘660 publication specifically teaches the use of sirolimus releasing catheters to treat brain tumors. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonably expectation of success as the ‘979 patent teaches the use of catheters to treat the cavity left by a brain tumor wherein additional treatment of the remaining cells is needed and the ‘660 publication teaches the use of a sirolimus releasing catheter to treat brain tumors, thus it would have been obvious to use the sirolimus releasing catheter taught by the ‘912 publication and the ‘660 publication to be implanted in the place removed by the brain tumor to treat the remaining brain tumor cells.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize human serum albumin in place of first biocompatible layer as taught by the ‘388 publication in the balloon catheter of the ‘912 publication. One would be motivated to do so with a reasonable expectation of success as both hyaluronic acid and human serum albumin are water soluble polymers and wherein the ‘912 publication teaches the first biocompatible layer includes proteins and the ‘388 publication teaches a specific protein, human serum albumin, that are successfully utilized for layered coatings on balloon catheters for the delivery of similar hydrophobic active agents. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize a coating consisting of human serum albumin in place of the first biocompatible layer material as taught by the ‘388 publication in the balloon catheter of the ‘912 publication as the ‘912 publication teaches the first biocompatible layer include water soluble polymer and can be proteins and the ‘388 publication teaches water-soluble proteins include serum albumin. One would be motivated to do so with a reasonable expectation of success as both hyaluronic acid and human serum albumin are water soluble natural polymers that are successfully utilized for layered coatings on balloon catheters for the delivery of similar hydrophobic active agents and further the ‘912 publication teaches that in some embodiments the first biocompatible layer consists of hyaluronic acid.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0281912 in view of US 6,315,979, US 2013/0184660 and US 2016/0250388 as evidenced by Sigma Aldrich as applied to claims 1, 5-7 and 12-13 above, and further in view of US 2015/0297662 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1, 5-7 and 12-13 are taught by the combination of the ‘912 publication, the ‘979 patent, the ‘660 publication and the ‘388 publication.
The combination of references does not teach the specific structure of claim 8.
The ‘662 publication teaches rapamycin 40-O-cyclic hydrocarbon esters (see abstract). The 40-O-cyclic hydrocarbon esters have the structure of
PNG
media_image1.png
259
271
media_image1.png
Greyscale
(see [0006]), where the R groups can be selected from:
PNG
media_image2.png
266
233
media_image2.png
Greyscale
(see [0007]). The 40 O-cyclic hydrocarbon esters can be used as a coating, where the coating can be formed from the 40 O-cyclic hydrocarbon esters and a polymer, such as a bioerodable polymer such as polylactic acid, containing the rapamycin ester in entrapped form (see [0009]). Other suitable polymers include poly(caprolactone), poly(trimethylene carbonate), polyester amide, poly(glycolide), polyhydroxyalkanoates including poly(hydroxyvalerate,), poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate), polyorthoester, polyanhydride, poly(glycolic acid) (see [0009]). Rapamycin 40 O-cyclic hydrocarbon esters can be applied as a coating to the surface of the inflatable balloon portion of a percutaneous vascular angioplasty balloon catheter (see [0049]). The use of the rapamycin 40 O-cyclic hydrocarbon esters allows for the coating to be substantially more ductile than one formed from rapamycin (see [0034]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize the 40 O-cyclic hydrocarbon esters of the ‘662 publication in the balloon catheter of the ‘912 publication. One would be motivated to do so with a reasonable expectation of success as the ‘912 publication and the ‘388 publication teaches that the coating can include rapamycin, and the ‘662 publication teaches that the use of the rapamycin 40 O-cyclic hydrocarbon esters allows for the coating to be substantially more ductile than one formed from rapamycin (see [0034]).
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: the ‘912 publication (Melder) in view of the ‘979 patent (Simon) and the ‘660 publication (Swiss)
Applicant argues insertion into the subdural space requires accessing the space through the skull, it is not accessible through vessels or tissue. The ‘912 publication teaches inserting a balloon into a vessel and inflating the balloon within the vessel. Subdermal is not the same as subdural. The ‘660 publication teaches penetrating vascular wall to deliver a therapeutic agent. The ‘979 patent teaches implantable catheter with an inflatable balloon near a tumor or within a resection cavity after surgical tumor removal therefore one would not be motivated to deliver a drug to the subdural space.
In response, the use of subdermal for subdural was a typographical error corrected above. The ‘979 patent teaches surgical procedures to remove tumor (column 1, lines 25-35) wherein a catheter is used for treating tissue around a tumor cavity after removal of the tumor, specifically in the brain, using an implantable catheter (column 4, lines 45-60). Thus the ‘979 patent teaches use of the catheter to delivery drug to the brain tumor area after brain tumor removal, thus delivery via a catheter to the subdural space in the brain or the area below the dural.
Applicant argues the ‘979 publication teaches a first layer of hyaluronic acid and a second layer of that is a drug layer disposed on the first. The ‘979 patent fails to teach a first layer which is a polysaccharide and not a protein. The ‘979 patent fails to teach the claimed surface coating wherein the second coating is transferred from the balloon surface into tissue. One of skill would not be motivated to combine the noted prior art to reach the claimed invention because the combination fails to teach or even suggest the first coating being a protein and the second coating applied on top of the first.
In response, the ‘912 publication teaches the first biocompatible layer is a suitable biocompatible polymer such as a protein ([0036]-[0037]). the ‘912 publication teaching a balloon catheter includes an inflatable balloon defining an inner and outer surface, a first biocompatible layer that includes hyaluronic acid disposed on the balloon surface and a second drug containing layer includes a paclitaxel and urea (abstract). One of ordinary skill in the art before the filing date of the claimed invention would have a reasonably expectation of success as the ‘979 patent teaches the use of catheters to treat the cavity left by a brain tumor wherein additional treatment of the remaining cells is needed and the ‘660 publication teaches the use of a sirolimus releasing catheter to treat brain tumors, thus it would have been obvious to use the sirolimus releasing catheter taught by the ‘912 publication and the ‘660 publication to be implanted in the place removed by the brain tumor to treat the remaining brain tumor cells.
103: the ‘912 publication (Melder) in view of the ‘979 patent (Simon) and the ‘660 publication (Swiss) and in further view of the ‘388 publication (Wang)
Applicant argues the ‘388 publication teaches human serum albumin as a coating component wherein HSA is used as a first additive for binding a drug. The use of HSA as an additive is disclosed in Formulations 16 and 17 in the ‘388 publication. In contrast the claims as amended recite applying HSA as a first coating layer on the balloon catheter followed by the drug in a second coating layer. One of skill in the art would not be motivated to combine the noted prior art to reach the claimed invention because the combination fails to teach or even suggest that hyaluronic acid discoed by the ‘912 publication be replaced by HAS according to the ‘388 publication. Hyaluronic acid is not a protein but a polysaccharide.
In response, the ‘912 publication teaches a first coating layer which may be a protein applied as a coating layer consisting essentially of the material, wherein the material is water soluble ([0036]-[0038], claim 14). The ‘388 publication teaches a water-soluble additive used on a medical device as a coating on a balloon catheter (abstract). The coating includes proteins, such as serum albumin as a preferred additive since it is water-soluble (see [0167]-[0168]). Coating formulations with human serum albumin (i.e. water-soluble human serum proteins) and paclitaxel (see Formulation 16) and human serum albumin and rapamycin (see Formulation 17). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize a coating consisting of human serum albumin in place of the first biocompatible layer material as taught by the ‘388 publication in the balloon catheter of the ‘912 publication as the ‘912 publication teaches the first biocompatible layer include water soluble polymer and can be proteins and the ‘388 publication teaches water-soluble proteins include serum albumin. One would be motivated to do so with a reasonable expectation of success as both hyaluronic acid and human serum albumin are water soluble natural polymers that are successfully utilized for layered coatings on balloon catheters for the delivery of similar hydrophobic active agents and further the ‘912 publication teaches that in some embodiments the first biocompatible layer consists of hyaluronic acid.
Applicant argues the ‘662 publication does not cure the deficiencies of the ‘912 publication (Melder) in view of the ‘979 patent (Simon) and the ‘660 publication (Swiss).
In response, Applicant’s arguments regarding the ‘912 publication, the ‘979 patent and the ‘660 publication are addressed above as first presented.
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
Prosecution Insights