/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 .
DETAILED ACTION
This office action is in response to applicant’s communication of 10/03/2025. Currently claims 1-7, and 9-14 are pending and rejected below. Applicant has reopened to apply new prior art of Dugas to the rejection.
Claim Rejections - 35 USC §103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over McClain et al (US 2012/0177742 A1) in view of Dugas et al. (US 2010/0331965 A1).
McClain discloses a balloon catheter (para [0010][0063-0064]) comprising:an inflatable balloon defining an inner surface and an outer surface; a biocompatible layer releasably disposed on the exterior outer surface of the balloon, wherein the biocompatible layer comprises a polysaccharide (examiner is of the position that Hyaluronic acid disclosed in para [0238] is a well known polysaccharide and polymer); and a second drug containing layer disposed on the biocompatible layer, the drug containing layer comprising one or more drugs, wherein the biocompatible layer is positioned between the exterior outer surface of the balloon and the drug containing layer.
Examiner is of the position that there are numerous discussions and teachings of the McClain device containing multiple “coatings” (McClain para. 0011, 20, 45, 134, 205, 276-284 discussing multi layer coatings). Examiner is of the position that these “coatings” would be considered first, second, and multiple layers. Further examiner is of the position that a PHOSITA would know to include duplicate and multiples of known layers in order to deliver various drugs to a patient (for providing multiple drugs from multiple layers at a given time). Examiner is of the position that a PHOSITA would known and McClain teaches multiple layers of active ingredient coating layers are known. Examiner is of the position that a PHOSITA would known that they may take a multicoating layered balloon catheter with a first layer of a Hyaluronic Acid (polysaccharide) and containing addition second drug layers (as taught by McClain).
McClain discloses the claimed invention except for explicitly stating the first layer is Polysaccharide and the other outer layer is a drug layer. Dugas teaches that it is known to use the first layer is Polysaccharide and the other outer layer is a drug layer as set forth in paragraphs [0016], [0019], [0086], [0096] to provide an effective and efficient means to treat a patient via a balloon catheter in a location within the body of a patient to treat a disease. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by McClain with the first layer is Polysaccharide and the other outer layer is a drug layer as taught by Dugas, since such a modification would provide the system with the first layer is Polysaccharide and the other outer layer is a drug layer for providing an effective and efficient means to treat a patient via a balloon catheter in a location within the body of a patient to treat a disease.
Dugas paragraph [0086] states:
“The catheter balloon is typically coated with layers one or more of the polymers disclosed elsewhere in this specification particularly where the drug is sequestered within one or more of the polymer coating materials. Preferred polymer coating materials include Poly L-Lactide polymer (PLLA), poly(lactide-co-glycolide) (PLGA), poly(l-lactide-co-trimethylene carbonate), poly(d,l-lactide-co-trimethylene carbonate), polyvinyl alcohol (PVA) and polyalkylene glycols (PAG) such as polyethylene glycol (PEG), albumin, gelatin, starch, cellulose, dextrans, polysaccharides, fibrinogen, poly(D,L lactide), poly(D,L-lactide-co-glycolide), poly(glycolide), poly(hydroxybutyrate), poly(alkylcarbonate), poly(orthoesters) and any of the polymers disclosed herein for use in covalent binding of drugs having a nucleophilic group (e.g. hydroxyl or amino) available for reaction with a complementary electrophilic group of the polymer material. The selected polymer coatings can be mixed, combined or covalently bound to the selected bioactive drug in any desired concentration of selected drug. Two or more polymers can be combined with each other to form a polymer matrix. The balloon can contain multiple coatings or layers of such polymers, at least one of the layers or coatings containing a selected drug.”
Dugas paragraph [0096] states:
“In some embodiments, the coating can include a primer layer and/or a topcoat layers or sub-layers. The primer layer will be beneath the drug/therapeutic substance layer and the topcoat layer above it. Both the primer layer and the topcoat layer can be without any drugs/therapeutic substances. In some embodiments, some drug may incidentally migrate into the primer layer or region. The topcoat layer reduces the rate of release of the drug and/or provides for biobeneficial properties.”
Note that these paragraphs state that a first layer may be a “polysaccharide” and that there may be two or more layers of polymers and at least one of those layers may contain the selected drug. Examiner is of the position that this teaching is that any and/or all of the layers may contain the drug which would teach a first layer of a polysaccharide and an addition outer drug layer. Or a primer layer of the polymer saccharide layer and an outer drug containing additional layer.
Claims 2-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over McClain et al (US 2012/0177742 A1) in view of Dugas et al. (US 2010/0331965 A1) in view of Speck et al. (US 2011/0295200 A1).
McClain teaches a balloon catheter comprising: an inflatable balloon defining an inner surface and an outer surface (see para [0010], [0027][0044][0053]); a first biocompatible layer comprising hyaluronic acid releasably disposed on the exterior surface of the balloon; and a second drug containing layer disposed on the first biocompatible layer, the second drug containing layer comprising paclitaxel and urea (See para [0238] for list of drugs, further not the use of multiple “coatings” as in para [0205-0206]). Examiner is of the position that multiple coatings are known and a PHOSITA would chose a Hyaluronic acid first coating and paclitaxel and urea second coating as these are well known and disclosed group of active agents to Include to treat a patient dependent on the ailment to be treated [0238]).
Concerning the polysaccharides the first layer see para [0267], [0269], and [0283].
Dugas teaches that a first layer may be a “polysaccharide” and that there may be two or more layers of polymers and at least one of those layers may contain the selected drug. Examiner is of the position that this teaching is that any and/or all of the layers may contain the drug which would teach a first layer of a polysaccharide and an addition outer drug layer. Or a primer layer of the polymer saccharide layer and an outer drug containing additional layer (as set forth in paragraphs [0016], [0019], [0086], [0096]).
McClain in view of Dugas discloses the claimed invention except for the layer of Paclitaxel with Urea (McClain teaches “urea derivatives”. Speck teaches that it is known to use a coating layer of paclitaxel with urea as a balloon coating layer as set forth in para [0078] to provide a means to promote the release of the drug from the surface. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system and method as taught by McClain in view of Dugas with a coating layer of paclitaxel with urea as a balloon coating layer as taught by Speck, since such a modification would provide the system and method with a coating layer of paclitaxel with urea as a balloon coating layer for providing a means to promote the release of the drug from the surface for greater delivery and more efficient treatment.
Concerning claim 2 and the second drug is an anti-restenosis drug, examiner is of the position that Paclitaxel would be an anti-restenosis drug (as disclosed above).
Concerning claims 3 and 4 see disclosure of paclitaxel (See para [0238] for list of drugs, further not the use of multiple “coatings” as in para [0205-0206]).
Concerning claims 5 and 7 and balloon catheter, wherein the second drug containing layer consists essentially of urea and paclitaxel note obviousness rejection of claim 1 above.
Concerning claim 6 and the urea together comprise 90% or more of the weight of the second drug containing layer. McClain discloses the claimed invention except for the urea comprise 90% weight. It would have been obvious to one having ordinary skill in the art at the time the invention was made to the urea together comprise 90% or more of the weight of the second drug containing layer, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Concerning and 9 and the polysaccharides see para [0267], [0269], and [0283].
Concerning claim 10 and the layer comprising hyaluronic acid consists essentially of hyaluronic acid, (again see rejection of claim 1 and obvious to use disclosed active agents as layers).
Concerning claim 11 and the first biocompatible layer comprises a sheet wrapped around the balloon, (it is examiners position that the coating of McClain in its broadest reasonable reading would be a sheet and be wrapped around the balloon under layer [0020].
Concerning claim 12 and the sheet has a width substantially equal to the outer diameter of the balloon when the balloon is inflated (it is examiner position that the disclosed coatings of McClain would be about equal to the outer circumference/diameter of the underlying balloon).
Concerning claim 13 and the sheet defines a first edge and a second opposing edge along the width of the sheet, wherein the second edge extends beyond the first edge when the sheet is wrapped around the balloon when the balloon is uninflated (it is examiners position that when uninfiated the outer coating would have two edges and one would extend beyond the other).
Concerning claim 14 and a sheath disposed over the balloon to retain the sheet on the balloon (it is examiners position that this sheathing of the balloon and drug delivery is contemplated at para [0104]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7, and 9-14 have been considered an a new ground of rejection is made.
Examiner is of the position that McClain in view of Dugas, and McClain in view of Dugas in view of Speck, teach the claims, as discussed in the rejection above.
Applicant argues that “McClain and Speck fails to teach a biocompatible release layer may be disposed on a surface of a balloon and a drug contain layer may be disposed on the biocompatible layer” (see appeal brief of 10/03/2025 pages 6-13).
Examiner is of the position that as explained in the rejection above Dugas teaches that a first layer may be a “polysaccharide” and that there may be two or more layers of polymers and at least one of those layers may contain the selected drug. Examiner is of the position that this teaching is that any and/or all of the layers may contain the drug which would teach a first layer of a polysaccharide and an addition outer drug layer. Or a primer layer of the polymer saccharide layer and an outer drug containing additional layer (as set forth in paragraphs [0016], [0019], [0086], [0096]).
It is examiner’s position as discussed in the rejection above that McClain in view of Dugas, in view of Speck teach a biocompatible release layer may be disposed on a surface of a balloon and a drug contain layer may be disposed on the biocompatible layer” (note Dugas teaches as discussed above).
Again, amended claim language and stated in the rejection above, of wherein the “…biocompatible layer is positioned between the outer surface of the balloon and the drug containing layer..”. Examiner is of the position that there are numerous discussions and teachings of the McClain device containing multiple “coatings” (McClain para. 0011, 20, 45, 134, 205, 276-284 discussing multi layer coatings). Clearly there is disclosed a balloon that has a surface layer. And further there is teachings that there may be multilple drug layers and/or multiple biocompatible layers and combinations thereof. McClain and any obvious modifications by a PHOSITA would arrive at a three layer balloon with a balloon layer to biocompatible layer to drug layer (and potential more layers above or below each of these layer).
Again, Examiner is of the position that these “coatings” would be considered first, second, and multiple layers. Further examiner is of the position that a PHOSITA would know to include duplicate and multiples of known layers in order to deliver various drugs to a patient (for providing multiple drugs from multiple layers at a given time). Applicant has not provided any evidence to refute the examiners position only argumentative suggestions.
As stated previously, Examiner is of the position that a PHOSITA would known and McClain teaches multiple layers of active ingredient coating layers are known. Examiner is of the position that a PHOSITA would known that they may take a multicoating layered balloon catheter with a first layer of a Hyaluronic Acid (polysaccharide) and containing addition second drug layers (as taught by McClain) and that Speck teaches using a coating layer of paclitaxel with urea (Speck para. [0078]). Examiner is of the position that this modification of a second drug layer to the first Hyaluronic acid layer of McClain would not destroy the delivery of nanoparticles or other intended uses of the balloon catheter of McClain, further examiner is considering the prior art as a whole and not piece meal analysis of the prior art.
The elements disclosed in McClain in view of Dugas in view of Speck and all obvious modifications of a PHOSITA thereof would arrive at are fully capable of satisfying all structural, functional, spatial, and operational limitations in the amended claims, as currently written, and the rejection is made.
It is recommended that applicant amend the claims to greater distinguish over the prior art of record and any obvious modifications thereof.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783