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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “254” has been used to designate both a disk-like blunt contact region ([0824]; at least Fig. 2G-4A, 2G-4B) and a substrate ([0858]; at least Figs. 16A-16H, 16-E-A - 16-E-G). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 284 and 285 are objected to because of the following informalities: Claims 284 and 285 recite “the balloon surface” in line 2, respectively. While the balloon inherently has a surface, applicant is requested to amend the claims for consistency purposes. For example, to read “a surface of the inflatable polymeric balloon” or “the outer surface of the polymeric balloon wall”. Appropriate correction is required.
Claim 288 is objected to because of the following informalities: Claim 288 recites “the outer surface of inflatable polymeric balloon” in line 2 which should read “the outer surface of the polymeric balloon wall” for consistency purposes. Appropriate correction is required.
Claims 295 and 296 are objected to because of the following informalities: Claims 295 and 296 recite “the polymeric balloon” which should read either “the inflatable polymeric balloon” or “the polymeric balloon wall” for consistency purposes. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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) 281-283, 288-290 and 293-297 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Madej et al. (US 2021/0153891 A1).
Regarding claim 281, Madej discloses an apparatus (cutting balloon 110; Fig. 5; it is noted reference is made to cutting balloon 10 of Fig. 1 for like parts similar in form and function; [0068]) for treating calcifications on a wall in a patient's body lumen (as the cutting members 20/120 are used to cut or score a lesion in a vasculature; [0042]), the apparatus comprising: a catheter (catheter shaft 18; Fig. 1) comprising a catheter body (outer tubular member 26; Fig. 1) having a proximal end and a distal end (Fig. 1); an inflatable polymeric balloon (balloon 116; Fig. 5) attached to the distal end of the catheter body (see for example, Fig. 1), the inflatable polymeric balloon (116) comprising a polymeric balloon wall (wall of 116) consisting of a single polymeric layer having a wall thickness (as fibers 124 may be positioned on the outer surface of the balloon 116; [0068]; thus, 116 is a single layer and balloon 116 may be made of polymers such as PET, polyester, polyamide, etc; [0045], wherein balloon 16 has the same properties as balloon 116); a plurality of rigid stress-applying features (including cutting members 120 and mounting pads 140) distributed over at least a portion of an outer surface of the polymeric balloon wall (Fig. 5); and a polymeric cover layer (covering 146 which may be a thermoplastic polyurethane [0069]) formed over the plurality of rigid stress-applying features and at least part of the outer surface of the polymeric balloon wall (Fig. 5).
Regarding claim 282, Madej discloses wherein the polymeric cover layer (146) has a thickness no greater than 50% of the wall thickness of the inflatable polymeric balloon (116; Fig. 6).
Regarding claim 283, Madej discloses wherein the polymeric cover layer (146) covers the entire outer surface of the inflatable polymeric balloon (as covering 146 extends around substantially the entire balloon 110; [0069]).
Regarding claim 288, Madej discloses a polymeric base layer (layer of fibers 124) formed over the outer surface of inflatable polymeric balloon (116; as fibers 124 may be positioned on the outer surface of the balloon 116; [0068]) and under at least some of the plurality of rigid stress-applying features (as cutting members 120 extend over the fibers 124 present on the outer surface of the balloon 116; [0069]), wherein the polymeric base layer (124) has a thickness no greater than 50% of the wall thickness of the inflatable polymeric balloon (when 124 is placed on the outer surface of 116, it is still less than 50% the thickness of 116; Fig. 6).
Regarding claim 289, Madej discloses wherein the polymeric base layer (124) comprises at least one of a polymethacrylate, a polyurethane-methacrylate, a polyisobornyl acrylate, an acrylic urethane methacrylate, a methacrylate ester acrylic, a modified methacrylate ester, a polyester, an epoxy adhesive, a phenolic adhesive, a polyvinyl acetate, a polyethylene-vinyl acetate, a polyethylene-methyl acrylate, a polyethylene, an acrylic, a cyanoacrylate, a hybrid cyanoacrylate/epoxy adhesive, a urea-formaldehyde, a polyimide, a natural or synthetic rubber modified with a tackifying resin, a styrene-butadiene rubber latex, a silicone rubber, an anaerobic glue, a mussel adhesive protein, a polydopamine-clay-polyacrylamide, a caulobacter crescentus, Delo Monopox, or combinations thereof (as fibers 24, equivalent to fibers 124, may be constructed from polyester; [0057]).
Regarding claim 290, Madej discloses one or more layers of adhesive (adhesive 142) over the polymeric base layer (124 which is on the outer surface of 116; [0068]; Fig. 6), wherein the one or more layers of adhesive may comprise the same or different materials (the adhesive 142 may comprise TPU; [0072]).
Regarding claim 293, Madej discloses wherein the polymeric balloon wall, the polymeric cover layer, or both comprise at least one of a polymethacrylate, a polyurethane- methacrylate, a polyisobornyl acrylate, an acrylic urethane methacrylate, a methacrylate ester acrylic, a modified methacrylate ester, a polyester, an epoxy adhesive, a phenolic adhesive, a polyvinyl acetate, a polyethylene-vinyl acetate, a polyethylene-methyl acrylate, a polyethylene, an acrylic, a cyanoacrylate, a hybrid cyanoacrylate/epoxy adhesive, a urea-formaldehyde, a polyimide, a natural or synthetic rubber modified with a tackifying resin, a styrene-butadiene rubber latex, a silicone rubber, an anaerobic glue, a mussel adhesive protein, a polydopamine- clay-polyacrylamide, a caulobacter crescentus, Delo Monopox, or combinations thereof (balloon 116 may be made of polymers such as PET, polyester, polyamide, etc; [0045], wherein balloon 16 is equivalent to balloon 116 and fibers 24, equivalent to fibers 124, may be made from polyester; [0057]).
Regarding claim 294, Madej discloses an adhesive (adhesive 124) over the outer surface of the polymeric balloon wall (116) and under at least some of the plurality of rigid stress-applying features (Fig. 6; [0072]).
Regarding claims 295-296, Madej discloses wherein a bottom-most surface of each of the plurality of rigid stress-applying features (120, 140) is directly bonded to the polymeric balloon (116) through an adhesive layer (142), a base layer (124), or both ([0072]-[0073]).
Regarding claim 297, Madej discloses a spot of adhesive (142) under the plurality of rigid stress-applying features (120, 140; Fig. 6).
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 284-285 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madej et al. (US 2021/0153891 A1) in view of Schneider et al. (US 2017/0333686 A1).
Regarding claims 284-285, Madej fails to disclose wherein the polymeric cover layer comprises axial strips or circumferential strips over the balloon surface.
However, Schneider teaches an apparatus (catheter balloon 10; Figs. 4-6) comprising a catheter (catheter shaft 40), an inflatable balloon (balloon 30), a plurality of rigid stress-applying features (raised wedges 22); and a polymeric cover layer (polymer matrix 70) that may cover the rigid stress-applying features (wedges; [0039]) and at least a portion of the balloon (Fig. 6; [0039]). The polymeric cover layer is an additive material that may be added to the outside of the balloon in strips ([0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymeric cover layer of Madej to be selectively applied over the rigid stress-applying features and at least part of the outer surface of the polymeric balloon wall in axial or circumferential strips in light of the teachings of Schneider. The claim would have been obvious because a particular known technique of adding a polymeric layer in strips over a balloon was recognized as part of the ordinary capabilities of one skilled in the art and would yield the predictable result of covering at least a portion of the balloon. It would have been an obvious matter of design choice to apply the strips axially or circumferentially, since applicant has not disclosed that axial or circumferential strips solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with axial or circumferential strips.
2. Claim(s) 286-287 and 291-292 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madej et al. (US 2021/0153891 A1) in view of Mertens (US 2022/0176084 A1).
Regarding claims 286-287 and 291, Madej fails to explicitly disclose wherein the polymeric cover layer has a hardness less than that of the inflatable polymeric balloon, wherein the polymeric cover layer has a hardness greater than that of the inflatable polymeric balloon, and wherein the polymeric balloon wall has a Shore D hardness in a range from 60D to 80D and the polymeric cover layer has a Shore D hardness in a range from 50D to 65D.
However, Mertens discloses an apparatus (balloon catheter 10) comprising a catheter (elongate member 14) a balloon (balloon 12) and a polymeric cover layer (layer 40; Fig. 3C), wherein the balloon (12) is made of nylon ([0020]) and the polymeric cover layer (40) is made of acrylic polymers ([0055]). Applicant states that nylons have a Shore D hardness in a range from 60D to 80D and acrylics have a Shore D hardness in a range from 50D to 65D ([0037]). Thus, the nylon polymeric balloon and acrylic polymeric cover layer of Mertens have shore hardnesses in the claimed ranges which allow for the polymeric cover layer to have a hardness of either less than or greater than that of the inflatable polymeric balloon.
It would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of Madej to be made of nylon and the polymeric cover layer of Madej to be made of an acrylic as taught by Mertens, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. As disclosed by applicant and discussed above, the nylon polymeric balloon and acrylic polymeric cover layer of modified Madej have shore hardnesses in the claimed ranges which allow for the polymeric cover layer to have a hardness of either less than or greater than that of the inflatable polymeric balloon.
Regarding claim 292, modified Madej discloses wherein the polymeric cover layer (40 of Mertens) is made of an acrylic (acrylic polymers; [0055] of Mertens).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Aggerholm et al. (US 9,409,001 B2) is noted for teaching a balloon covered.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771