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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/22/2025 has been entered.
Response to Amendment
As of the reply filed 9/22/2025, claims 1, 6, and 8-33 are currently pending. Claims 2-5 and 7 are canceled. Claims 1 and 26 have been amended.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 26 (see Remarks pages 8-12) have been considered but are moot because the new ground of rejection relies upon a new reference to teach the amended limitations.
Claim Objections
Claim 26 is objected to because of the following informalities:
Claim 10, lines 5 and 9-10 are the same limitation, “the at least one inflation port in communication with one of the one or more inflation lumens”, which is redundant. It is recommended that one of these limitations be deleted.
Appropriate correction is required.
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.
Claims 1, 6, 8-14, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (PGPub US 2006/0085023 A1) in view of Joye et al. (US PGPub 2002/0010460 A1) and Lachenmeier (PGPub US 2006/0192054 A1).
With respect to claim 1, Davies et al. discloses a balloon catheter (see Fig. 27) comprising:
a catheter shaft (208) extending between proximal and distal end portions along a shaft axis (PP [0004]: "Catheters having inflatable balloon attachments"), the catheter shaft includes:
a first inflation lumen (210) and a second inflation lumen (212) each extending through the catheter shaft (208)
at least one inflation port (PP [0116]: " A coupling device 230, such as a conventional syringe luer, may be used to couple the catheter tube 208 to a syringe 214 used to inflate the fiber-reinforced balloon 10") in communication with the first inflation lumen and the second inflation lumen (210 and 212); and
a balloon assembly (10, see also Figs. 2-3 and 14) coupled with the catheter shaft and in communication with the at least one inflation port (PP [0005]: "The present invention is directed to a non-compliant medical balloon suitable for angioplasty and other medical procedures"), the balloon assembly (see Fig. 4) includes:
a balloon membrane (55 in Fig. 14, PP [0049]: "With reference to FIG. 2, a fiber reinforced medical balloon may include a base layer 100. The base layer 100 may be in the shape of a standard medical balloon, ore any other suitable shape. A standard polymeric balloon may function as a base layer 100 for the fiber-reinforced medical balloon 10") having a balloon body, a balloon exterior, a balloon interior, a balloon proximal nose and a balloon distal nose coupled with the catheter shaft (see Figs. 2-3)
an interlaced jacket (55 in Fig. 14) coupled along an exterior of the balloon membrane and coupled with the catheter shaft (208), the interlaced jacket bonded over the balloon exterior at one or more bond locations around a perimeter of the balloon membrane (57 and 59 in Fig. 14, PP [0055]: "a thin coating of an adhesive 126 is applied to the inflated polymer balloon base layer 100 or to the polymer-coated mandrel 122 prior to applying the first layer inelastic fibers 12. The adhesive 126 binds the fibers 13 sufficiently to hold them in position when the fibers 13 are placed on the base layer balloon 100. In accordance with one embodiment, a very thin coat of 3M-75 adhesive 126 is applied to the base layer balloon 100. 3M-75 is a tacky adhesive available from the 3M Company, Minneapolis, Minn.") and the one or more bond locations are spaced from each of the proximal end of the balloon proximal nose and the distal end of the distal nose (the adhesive is applied as a layer across the entire balloon);
wherein the interlaced jacket includes interlaced filaments extending at diverging angles relative to the shaft axis (PP [0091]: "With reference to FIG. 14, a fiber-reinforced balloon 55 in accordance with one embodiment is shown. It will be apparent to those having skill in the art that the fibers 57 of the first fiber layer 56 and the fiber 59 of the second fiber layer 58 may be positioned at any appropriate angle. Placing the fiber 57 of the first fiber layer 56 and the fibers 59 of the second fiber layer 58 parallel to each other will result in a balloon 55 with less strength than a balloon 55 where the fibers 57 and 59 are positioned relatively at an angle").
However, Davies et al. fails to disclose
a supplemental balloon coupled along an exterior of the balloon membrane and coupled with the catheter shaft, the interlaced jacket and the supplemental balloon bonded over the balloon exterior at one or more bond locations;
wherein the second inflation lumen is in communication with the supplemental balloon;
wherein the interlaced filaments include decoupled spans between the one or more bond locations; or
wherein the interlaced jacket is configured to operate independently of the balloon membrane along the decoupled spans, permitting movement of the interlaced jacket relative to the balloon membrane.
In the same field of angioplasty balloons (abstract, see angioplasty balloon 28 in Fig. 1), Joye et al. teaches a balloon catheter (10 in Fig. 1) comprising:
a catheter shaft (24) extending between proximal and distal end portions along a shaft axis (see Fig. 1), the catheter shaft (24) includes:
a first inflation lumen (44) and a second inflation lumen (36) each extending through the catheter shaft (24); and
at least one inflation port (see 42 and 38) in communication with the first inflation lumen (44) and the second inflation lumen (36); and
a balloon assembly (30 and 28) coupled with the catheter shaft (24), the balloon assembly includes:
a balloon membrane (30);
wherein the first inflation lumen (44) is in communication with the balloon membrane (30); and
a supplemental balloon (28) coupled along an exterior of the balloon membrane (30) and coupled with the catheter shaft (24);
wherein the second inflation lumen (36) is in communication with the supplemental balloon (28).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Davies et al. device to incorporate the nested balloon structures as taught by Joye et al., with the interlaced filaments of Davies et al. bonded over the outermost angioplasty balloon 28 of the Joye et al. device such that the interlaced jacket and the supplemental balloon are bonded over the balloon exterior at one or more bond locations (note that “are bonded… at one or more bond locations” is broad, the precise arrangement of those bond locations is not claimed therefore the filaments being bonded directly to the supplemental balloon reads on the limitation). One of ordinary skill in the art would have been motivated to perform this modification, by incorporating the secondary balloon and cryoablation structures of Joye et al., in order to inhibit subsequent occurrence of restenosis after the angioplasty procedure has been completed (see PP [0003-0006]). Furthermore, adding cryoablation capabilities to an angioplasty balloon would have been modifying a known device (the balloon of Davies et al.) according to known methods to achieve predictable results (the double-balloon cryoablation device as taught by Joye et al.).
However, Davies et al. as modified by Joye et al. further fails to disclose or teach wherein the interlaced filaments include decoupled spans between the one or more bond locations; or
wherein the interlaced jacket is configured to operate independently of the balloon membrane along the decoupled spans, permitting movement of the interlaced jacket relative to the balloon membrane.
In the field of balloons (abstract), Lachenmeier teaches a balloon membrane (311 in Fig. 5B) and an interlaced jacket (315-316 and 322-325) bonded to the balloon membrane at bond locations around a perimeter of the balloon membrane (PP [0025]: “The fibers and membranes are joined to each other by local bond, whether by application of an adhesive or (if permitted by the fiber properties) by welding (e.g., hot wheel) or other bonding (e.g., pressure sensitive) technique. In order to minimize the adhesive weight, spot welding may be done so that adhesive is only applied at fiber intersections (selected ones, or all), such that the intersections are joined to each other and the two membranes”) and wherein the interlaced jacket (315-316 and 322-325) is configured to operate independently of the balloon membrane (311) along the decoupled spans permitting movement of the interlaced jacket (315-316 and 322-325) relative to the balloon membrane (311), permitting movement of the interlaced jacket (315-316 and 322-325) relative to the balloon membrane (311, see PP [0025], since the fibers are only adhered at specific intersections/spots the interlaced jacket is configured for independent movement with respect to the balloon membrane between those bonded intersections).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Davies et al. and Joye et al. combination to incorporate the teachings of Lachenmeier and include spot bonding. One of ordinary skill in the art would have been motivated to perform this modification in order to minimize the adhesive weight while keeping the interlaced jacket in place (PP [0025] of Lachenmeier).
Regarding claim 6, Davies et al. as modified by Joye et al. and Lachenmeier further discloses wherein the balloon membrane (55 in Fig. 14 of Davies et al., Joye et al. PP [0030]: “Angioplasty balloon 28 may be formed from a variety of materials conventionally used for dilating blood vessels”) is an elastic membrane (Davies et al. PP [0051]: "The base layer balloon 100 is typically formed of a thin film polymeric material, or other suitable materials with high strength relative to film thickness. Polymers and copolymers that can be used for the base balloon 100 include the conventional polymers and copolymers used in cedical balloon construction, such as, but not limited to, polyethylene, (PET), polycaprolactam, polyesters, polyethers, polamides, polyurethanes, polyimides, ABS, nylons, copolymers, polyester/polyether block copolymers, ionomer resins, liquid crystal polymers, and rigid rod polymers", polyethylene is elastic) and the balloon membrane is configured to move relative to the interlaced jacket between the one or more perimeter locations (Lachenmeier PP [0025]: “The fibers and membranes are joined to each other by local bond, whether by application of an adhesive or (if permitted by the fiber properties) by welding (e.g., hot wheel) or other bonding (e.g., pressure sensitive) technique. In order to minimize the adhesive weight, spot welding may be done so that adhesive is only applied at fiber intersections (selected ones, or all), such that the intersections are joined to each other and the two membranes”, the combination of Davies et al. with the spot bonding of Lachenmeier would produce a balloon membrane configured to move relative to the interlaced jacket between the bond locations).
Regarding claim 8, Davies et al. as modified by Joye et al. and Lachenmeier further discloses wherein the interlaced jacket (see Fig. 14 of Davies et al., see also Fig. 1 of Joye et al. with supplemental balloon) extends continuously around the balloon membrane (see Fig. 14 and Figs. 2-3 of Davies et al. and Fig. 1 of Joye et al.).
Regarding claim 9, Davies et al. as modified by Joye et al. and Lachenmeier further discloses wherein the interlaced filaments (see Fig. 14 of Davies et al.) extending at diverging angles relative to the catheter shaft are misaligned with the catheter shaft (PP [0091]).
Regarding claim 10, Davies et al. as modified by Joye et al. and Lachenmeier fails to disclose wherein the diverging angles include diverging angles of around 40 to 70 degrees.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Davies et al., Joye et al., and Lachenmeier combination to explicitly include wherein the diverging angles include diverging angles of around 40-70 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” (Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)). In the instant case, the device of Davies et al. would not operate differently with the claimed diverging angles since a variety of values for diverging angles are contemplated (see PP [0091] of Davies et al.). Furthermore, the applicant places no criticality on the range claimed, indicating only that the interlaced filaments are braided at diverging angles while offering other acceptable ranges within the specification that lie outside of the claimed range (present spec. page 18, lines 2-3: “between 30 and 80 degrees, 40 and 70 degrees, 50 and 60 degrees, or the like”). For example, the specification allows for a filament angle of 30 degrees, which is not within the claimed range.
Regarding claim 11, Davies et al. as modified by Joye et al. and Lachenmeier fails to disclose wherein the diverging angles include diverging angles of around 50 to 60 degrees.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Davies et al., Joye et al., and Lachenmeier combination to explicitly include wherein the diverging angles include diverging angles of around 50-60 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” (Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984)). In the instant case, the device of Davies et al. would not operate differently with the claimed diverging angles since a variety of values for diverging angles are contemplated (see PP [0091] of Davies et al.). Furthermore, the applicant places no criticality on the range claimed, indicating only that the interlaced filaments are braided at diverging angles while offering other acceptable ranges within the specification that lie outside of the claimed range (present spec. page 18, lines 2-3: “between 30 and 80 degrees, 40 and 70 degrees, 50 and 60 degrees, or the like”). For example, the specification allows for a filament angle of 30 degrees, which is not within the claimed range.
Regarding claim 12, Davies et al. as modified by Joye et al. and Lachenmeier further discloses wherein the interlaced filaments (57 and 59 in Fig. 14 of Davies et al.) are in one or more interlacing configurations including braiding, weaving, knitting, crocheting, nalbinding, mesh, or non-woven (see Fig. 14 of Davies et al.).
Regarding claim 13, Davies et al. as modified by Joye et al. and Lachenmeier further discloses wherein the interlaced jacket (56 and 58 in Fig. 14 of Davies et al.) is coupled with the balloon membrane at the balloon body (PP [0055]: "a thin coating of an adhesive 126 is applied to the inflated polymer balloon base layer 100 or to the polymer-coated mandrel 122 prior to applying the first layer inelastic fibers 12. The adhesive 126 binds the fibers 13 sufficiently to hold them in position when the fibers 13 are placed on the base layer balloon 100. In accordance with one embodiment, a very thin coat of 3M-75 adhesive 126 is applied to the base layer balloon 100. 3M-75 is a tacky adhesive available from the 3M Company, Minneapolis, Minn.").
Regarding claim 14, Davies et al. as modified by Joye et al. and Lachenmeier further discloses wherein the interlaced jacket (56 and 58 in Fig. 14 of Davies et al., see supplemental balloon in Fig. 1 of Joye et al.) is coupled with the balloon membrane (55) at one or more of the balloon body, along the balloon distal nose, or along the balloon proximal nose (see Fig. 14 and PP [0055], the filaments are coupled along the entire length of the supplemental balloon including the noses, see Fig. 1 of Joye et al., 28 is coupled at 32 and 24).
Regarding claim 24, Davies et al. as modified by Joye et al. and Lachenmeier further discloses wherein the balloon membrane (55 in Fig. 14 of Davies et al., see also membrane base in Figs. 2-3, see 30 in Fig. 1 of Joye et al.) includes a semi-compliant balloon membrane, a non-compliant balloon membrane, or a compliant balloon membrane (Davies et al. PP [0009]: "Therefore, what is needed is a non-compliant medical balloon that can be inflated with pressure such that the balloon maintains its inflated dimensions without further expanding when additional pressure is applied", Joye et al. PP [0030]: “Angioplasty balloon 28 may be formed from a variety of materials conventionally used for dilating blood vessels. Angioplasty balloon 28 will typically comprise a non-distensible material such as polyethylene terephthalate (PET)”).
Regarding claim 25, Davies et al. as modified by Joye et al. and Lachenmeier further discloses wherein the balloon assembly (10 in Fig. 27, see also Fig. 14 of Davies et al., see also Fig. 1 of Joye et al.) is configured to transition between a deflated and an inflated configuration (Davies et al. PP [0009]: "Therefore, what is needed is a non-compliant medical balloon that can be inflated with pressure such that the balloon maintains its inflated dimensions without further expanding when additional pressure is applied"):
in the deflated configuration the balloon membrane is at a position relative to the interlaced jacket (when deflated the device of Davies et al. will have the filaments oriented at a first position relative to the balloon membrane, see also Fig. 1 of Joye et al. where 30 and 28 are at a first position relative to one another); and
in the inflated configuration the balloon membrane is moved relative to the interlaced jacket in a first position to distribute pressure across the interlaced jacket (since the combination of Davies et al. and Lachemeier produces the device shown in Figs. 2-3 with the jacket in Fig. 14 of Davies et al. along with the spot bonding of Lachenmeier, the balloon membrane is able to move relative to the jacket and is configured to distribute pressure across the interlaced jacket, Lachenmeier PP [0025]: "In order to minimize the adhesive weight, spot welding may be done so that adhesive is only applied at fiber intersections (selected ones, or all)", when inflated 30 and 28 in Fig. 1 of Joye et al. can also still shift relative to one another to distribute pressure since they are separately inflated).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (PGPub US 2006/0085023 A1) in view of Joye et al. (US PGPub 2002/0010460 A1) and Lachenmeier (PGPub US 2006/0192054 A1) as applied to claim 1 above, and further in view of Nath (Patent No. US 9,402,983).
Regarding claim 15, the combination of Davies et al., Joye et al., and Lachenmeier fails to disclose wherein at least one of the balloon distal nose and the balloon proximal nose include a terraced profile having tapered surfaces with interposing anchor surfaces.
Nath teaches, in the same field of endeavor of expanding balloon catheters (abstract), a catheter (31 in overview Fig. 3) coupled with a balloon (32) wherein the balloon has a balloon distal nose and a balloon proximal nose (labeled below in annotated Fig. 3).
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It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Davies et al., Joye et al., and Lachenmeier combination in view of the teachings of Nath to incorporate a terraced profile on at least one of the balloon distal nose or the balloon proximal nose. One of ordinary skill in the art would have been motivated to perform this modification in order to allow for an abrupt step transition during inflation of the balloon in order to control the diameter of dilation (Nath abstract: “The step transition provides a discontinuous change in diameter from the first diameter to the second diameter along a length of the balloon catheter, which may be abrupt”), which Nath teaches is desirable for balloon catheters, allowing for sequential dilation to a plurality of diameters and providing for tactile feedback during positioning (Nath col. 2, lines 21-25: “The sequentially-stepped surface of the variably expanding dilatation balloon allows the balloon to be expanding to one of a plurality of diameters, and a stepped shape provides for tactile feedback during position of the balloon with a lumen”).
Regarding claim 16, Davies et al. as modified by Joye et al., Lachenmeier, and Nath further teaches wherein the interlaced jacket (see Fig. 14 of Davies et al., 312 and 322 in Fig. 5B of Lachenmeier, see also supplemental balloon 28 in Fig. 1 of Joye et al.) would be capable of conforming to the terraced profile and anchoring along the interposing anchor surfaces taught by Nath, since Lachenmeier teaches that the interlaced filaments (312 and 322) are movably bonded along the balloon membrane (311 of Lachenmeier, see Fig. 14 of Davies et al., Lachenmeier PP [0025]: “The fibers and membranes are joined to each other by local bond, whether by application of an adhesive or (if permitted by the fiber properties) by welding (e.g., hot wheel) or other bonding (e.g., pressure sensitive) technique. In order to minimize the adhesive weight, spot welding may be done so that adhesive is only applied at fiber intersections (selected ones, or all), such that the intersections are joined to each other and the two membranes”, since the fibers are adhered at intersections the interlaced jacket of Davies et al. would be capable of conforming to the terraced profile as taught by Nath, furthermore the supplemental balloon 28 would also be configured to conform since it is able to be inflated separately from angioplasty balloon 30).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (PGPub US 2006/0085023 A1) in view of Joye et al. (US PGPub 2002/0010460 A1) and Lachenmeier (PGPub US 2006/0192054 A1) as applied to claim 1 above, and further in view of Vonderwalde (PGPub US 2011/0190867).
Regarding claim 17, Davies et al. as modified by Joye et al. and Lachenmeier fails to disclose wherein the balloon distal nose includes a blunt profile and the balloon proximal nose includes a tapered profile relative to the blunt profile.
Vonderwalde, in the same field of endeavor of angioplasty balloons (PP [002]), teaches a balloon (38b in Fig. 6b) wherein the balloon distal nose (32) includes a blunt profile (PP [0077]: “less tapered distal end 32”) and the balloon proximal nose (34) includes a tapered profile (PP [0077]: “more tapered proximal end 34”) relative to the blunt profile.
It would have been obvious for one of ordinary skill in the art before the effective filing date to have modified the Davies et al., Joye et al., and Lachenmeier combination to incorporate the teachings of Vonderwalde and include a blunt distal nose and a tapered proximal nose. One of ordinary skill in the art would have been motivated to perform this modification in order to control the direction of the balloon’s expansion (Vonderwalde PP [0073]: “asymmetrical balloon configured for directional expansion”), as expansion will begin from the more tapered end and proceed towards the blunt end in order to control the direction of displaced plaque or thrombi during an angioplasty procedure (Vonderwalde PP [0020]: “directional expansion of an intraluminal medical device such as a balloon catheter or balloon-expandable stent, such that during expansion material such as plaque or thrombi is directed in a specific direction (as desired by an operator), for example, away from the side branch of a bifurcated blood vessel, away from a narrowing in a blood vessel or towards an embolic protection device”).
Regarding claim 18, Davies et al. as modified by Joye et al., Lachenmeier, and Nath further teaches wherein the interlaced jacket (see Fig. 14 of Davies et al., 312 and 322 in Fig. 5B of Lachenmeier, see also supplemental balloon 28 in Fig. 1 of Joye et al.) would be capable of conforming to at least the blunt profile of the balloon distal nose as taught by Vonderwalde, since Lachenmeier teaches that the interlaced filaments (see Fig. 14 of Davies et al., 312 and 322 in Fig. 5B of Lachenmeier) are movably bonded along the balloon membrane (311 of Lachenmeier, see Fig. 14 of Davies et al., Lachenmeier PP [0025]: “The fibers and membranes are joined to each other by local bond, whether by application of an adhesive or (if permitted by the fiber properties) by welding (e.g., hot wheel) or other bonding (e.g., pressure sensitive) technique. In order to minimize the adhesive weight, spot welding may be done so that adhesive is only applied at fiber intersections (selected ones, or all), such that the intersections are joined to each other and the two membranes”, since the fibers are adhered at intersections the interlaced jacket of Davies et al. would be capable of conforming to the terraced profile as taught by Nath) and since Joye et al. teaches that the supplemental balloon (28 in Fig. 1) is separately inflated and thus able to conform to the balloon membrane (30).
Claims 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (PGPub US 2006/0085023 A1) in view of Joye et al. (US PGPub 2002/0010460 A1) and Lachenmeier (PGPub US 2006/0192054 A1) as applied to claim 1 above, and further in view of Simpson et al. (PGPub US 2010/0023047 A1).
Regarding claim 19, Davies et al. as modified by Joye et al. and Lachenmeier fails to disclose wherein the interlaced jacket includes at least first and second filament densities of the interlaced filament wherein the first filament density is different than the second filament density.
In an analogous field, which is medical balloons, Simpson et al. teaches a reinforcement interlaced jacket coupled to a balloon (505 in Fig. 10) wherein the interlaced jacket includes at least first (510) and second filament densities (515) of the interlaced filaments wherein the first filament density is different than the second filament density (PP [0080]: “In addition, braid may be formed over the ends as indicated at 510. For example, the tube 515 may be teased and the fibers laid over the end”) in order to create relatively stiff and relatively flexible portions (teasing is a practice for disentangling braided or woven configurations which takes advantage of natural pores/openings within a material to undo their cohesion in order to decrease density, thereby imparting different densities to sections 510 and 515).
It would have been obvious for one of ordinary skill in the art before the effective filing date to have modified the Davies et al., Joye et al., and Lachenmeier combination to incorporate the teachings of Simpson et al. and include at least first and second filament densities of the interlaced filament wherein the first filament density is different than the second filament density. One of ordinary skill in the art would have been motivated to perform this modification in order to provide greater control over the strength and stiffness of the interlaced jacket at various positions along the balloon and to maximize strength and flexibility (Simpson et al. PP [0015]).
Regarding claim 20, Davies et al. as modified by Joye et al., Lachenmeier, and Simpson et al. further discloses wherein the first filament density is a first pic count and the second filament density is a second pic count (Simpson et al. PP [0080]: “In addition, braid may be formed over the ends as indicated at 510. For example, the tube 515 may be teased and the fibers laid over the end”, teasing is a practice for disentangling braided or woven configurations which takes advantage of natural pores/openings within a material to undo their cohesion in order to decrease density, as seen in Fig. 10 the first filament density is represented more compactly compared to the second filament density, indicating a difference in density with respect to the tightness of their respective braided configurations).
Regarding claim 21, Davies et al. as modified by Joye et al., Lachenmeier, and Simpson et al. further discloses wherein the balloon membrane proximate at least one of the balloon distal and balloon proximal noses includes the first filament density (510 on ends of balloon 505 in Fig. 10 of Simpson et al.) and the balloon membrane proximate the balloon body includes the second filament density (515 on central section of balloon 505, PP [0080]: “In addition, braid may be formed over the ends as indicated at 510. For example, the tube 515 may be teased and the fibers laid over the end”, teasing is a practice for disentangling braided or woven configurations which takes advantage of natural pores/openings within a material to undo their cohesion in order to decrease density).
Regarding claim 22, Davies et al. as modified by Joye et al., Lachenmeier, and Simpson et al. further discloses wherein the first filament density is greater than the second filament density (Simpson et al. Fig. 10, PP [0080]: “In addition, braid may be formed over the ends as indicated at 510. For example, the tube 515 may be teased and the fibers laid over the end”, teasing is a practice for disentangling braided or woven configurations which takes advantage of natural pores/openings within a material to undo their cohesion in order to decrease density).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (PGPub US 2006/0085023 A1) in view of Joye et al. (US PGPub 2002/0010460 A1) and Lachenmeier (PGPub US 2006/0192054 A1) as applied to claim 1 above, and further in view of Pepper et al. (PGPub US 2014/0277062 A1).
Regarding claim 23, Davies et al. as modified by Joye et al. and Lachenmeier discloses wherein the non-compliant balloon assembly (see Fig. 27 of Davies et al.) is configured for high inflation pressures (PP [0009]: "Therefore, what is needed is a non-compliant medical balloon that can be inflated with pressure such that the balloon maintains its inflated dimensions without further expanding when additional pressure is applied"), yet fails to explicitly disclose wherein the balloon assembly is configured for inflation to at least 20 atmospheres.
However, Pepper et al. teaches, in the same field of endeavor of medical balloons, a balloon assembly (100 in Fig. 1) configured for inflation to at least 20 atmospheres (PP [0024]: “High pressure non-compliant balloons may have rated burst pressures of up to 20 atmospheres or higher”).
It would have been obvious for one of ordinary skill in the art before the effective filing date to have modified the Davies et al., Joye et al., and Lachenmeier combination to incorporate the teachings of Pepper et al. and specifically require a balloon assembly capable of inflating to a pressure of at least 20 atmospheres. One of ordinary skill in the art would have been motivated to perform this modification because, as acknowledged through the teachings of the Pepper et al. reference (see referenced paragraphs above), medical balloons configured to dilate or stretch tissue in a lumen requires the exertion of significant pressure of at least 20 atmospheres. In order to accomplish its purpose of performing angioplasty (Davies et al. PP [0001]: “non-compliant medical balloons used with a balloon catheter in medical procedures such as angioplasty”) it would be obvious for the medical balloon of Davies et al. to inflate to a pressure of at least 20 atmospheres.
Claims 26-28 and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (PGPub US 2006/0085023 A1) in view of Joye et al. (US PGPub 2002/0010460 A1), Lachenmeier (PGPub US 2006/0192054 A1), and Krautkremer et al. (PGPub US 2017/0354802 A1).
With respect to claim 26, Davies et al. discloses a balloon catheter (see Fig. 27) comprising:
a catheter shaft (208) extending between proximal and distal end portions along a shaft axis (PP [0113]: "Catheters having inflatable balloon attachments"), the catheter shaft includes:
one or more inflation lumens (210 and 212); and
at least one inflation port (PP [0116]: " A coupling device 230, such as a conventional syringe luer, may be used to couple the catheter tube 208 to a syringe 214 used to inflate the fiber-reinforced balloon 10") in communication with the one or more inflation lumens (210 and 212); and
a balloon assembly (10, see also Figs. 2-3 and 14) coupled with the catheter shaft and in communication with the at least one inflation port (PP [0001]: "The present invention is directed to a non-compliant medical balloon suitable for angioplasty and other medical procedures"), the balloon assembly (see Fig. 4) includes:
a balloon membrane (55 in Fig. 14, PP [0049]: "With reference to FIG. 2, a fiber reinforced medical balloon may include a base layer 100. The base layer 100 may be in the shape of a standard medical balloon, or any other suitable shape. A standard polymeric balloon may function as a base layer 100 for the fiber-reinforced medical balloon 10") having a balloon body, a balloon exterior, a balloon interior, a balloon proximal nose and a balloon distal nose coupled with the catheter shaft (see Figs. 2-3);
an interlaced jacket (55 in Fig. 14), the interlaced jacket including a jacket proximal end portion (see left portion of 55 in Fig. 14), a jacket distal end portion (see right portion), and a jacket body (see central portion) extending between the jacket proximal end portion and the jacket distal end portion (see Fig. 14), the interlaced jacket (55) bonded over the balloon exterior at one or more bond locations around a perimeter of the balloon membrane (57 and 59 in Fig. 14, PP [0055]: "a thin coating of an adhesive 126 is applied to the inflated polymer balloon base layer 100 or to the polymer-coated mandrel 122 prior to applying the first layer inelastic fibers 12. The adhesive 126 binds the fibers 13 sufficiently to hold them in position when the fibers 13 are placed on the base layer balloon 100. In accordance with one embodiment, a very thin coat of 3M-75 adhesive 126 is applied to the base layer balloon 100. 3M-75 is a tacky adhesive available from the 3M Company, Minneapolis, Minn.") and the one or more bond locations are spaced from each of the proximal end of the balloon proximal nose and the distal end of the balloon distal nose (the adhesive is applied as a layer across the entire balloon, therefore these bond locations are spaced from the proximal and distal nose);
wherein the interlaced jacket includes:
first interlaced filaments (57) positioned proximate to the proximal end portion and the distal end portion (57 extends across the entire balloon therefore they are positioned proximate to the proximal and distal end portions) and second interlaced filaments (59) positioned along the jacket body (59 extends across the entire balloon therefore they are positioned along the jacket body), each of the first interlaced filaments (57) and second interlaced filaments (59) extending at diverging angles relative to the shaft axis (PP [0091]: "With reference to FIG. 14, a fiber-reinforced balloon 55 in accordance with one embodiment is shown. It will be apparent to those having skill in the art that the fibers 57 of the first fiber layer 56 and the fiber 59 of the second fiber layer 58 may be positioned at any appropriate angle. Placing the fiber 57 of the first fiber layer 56 and the fibers 59 of the second fiber layer 58 parallel to each other will result in a balloon 55 with less strength than a balloon 55 where the fibers 57 and 59 are positioned relatively at an angle").
However, Davies et al. fails to explicitly disclose wherein the at least one inflation port is in communication with one of the one or more inflation lumens;
wherein the interlaced jacket includes a supplemental balloon coupled along an exterior of the balloon membrane and coupled with the catheter shaft;
wherein at least one of the first interlaced filaments and the second interlaced filaments are bonded along the balloon exterior, at least one of the first interlaced filaments and the second interlaced filaments include decoupled spans between the one or more bond locations; and
wherein the interlaced jacket is configured to operate independently of the balloon membrane along the decoupled spans permitting movement of the interlaced jacket relative to the balloon membrane.
In the same field of angioplasty balloons (abstract, see angioplasty balloon 28 in Fig. 1), Joye et al. teaches a balloon catheter (10 in Fig. 1) comprising:
a catheter shaft (24) extending between proximal and distal end portions along a shaft axis (see Fig. 1), the catheter shaft (24) includes:
a first inflation lumen (44) and a second inflation lumen (36) each extending through the catheter shaft (24); and
at least one inflation port (see 42 and 38) in communication with the first inflation lumen (44) and the second inflation lumen (36); and
a balloon assembly (30 and 28) coupled with the catheter shaft (24), the balloon assembly includes:
a balloon membrane (30);
wherein the first inflation lumen (44) is in communication with the balloon membrane (30); and
a supplemental balloon (28) coupled along an exterior of the balloon membrane (30) and coupled with the catheter shaft (24);
wherein the second inflation lumen (36) is in communication with the supplemental balloon (28).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Davies et al. device to incorporate the nested balloon structures as taught by Joye et al., with the interlaced filaments of Davies et al. bonded over the outermost angioplasty balloon 28 of the Joye et al. device such that the interlaced jacket and the supplemental balloon are bonded over the balloon exterior at one or more bond locations (note that “coupled along an exterior of the balloon membrane” is broad, the precise arrangement of those coupling locations is not claimed therefore the filaments being bonded directly to the supplemental balloon reads on the limitation). One of ordinary skill in the art would have been motivated to perform this modification, by incorporating the secondary balloon and cryoablation structures of Joye et al., in order to inhibit subsequent occurrence of restenosis after the angioplasty procedure has been completed (see PP [0003-0006]). Furthermore, adding cryoablation capabilities to an angioplasty balloon would have been modifying a known device (the balloon of Davies et al.) according to known methods to achieve predictable results (the double-balloon cryoablation device as taught by Joye et al.).
However, Davies et al. as modified by Joye et al. fails to disclose wherein at least one of the first interlaced filaments and the second interlaced filaments are bonded along the balloon exterior, at least one of the first interlaced filaments and the second interlaced filaments include decoupled spans between the one or more bond locations; and
wherein the interlaced jacket is configured to operate independently of the balloon membrane along the decoupled spans permitting movement of the interlaced jacket relative to the balloon membrane.
In the field of balloons (abstract), Lachenmeier teaches a balloon membrane (311 in Fig. 5B) and an interlaced jacket (315-316 and 322-325) bonded to the balloon membrane at bond locations around a perimeter of the balloon membrane (PP [0025]: “The fibers and membranes are joined to each other by local bond, whether by application of an adhesive or (if permitted by the fiber properties) by welding (e.g., hot wheel) or other bonding (e.g., pressure sensitive) technique. In order to minimize the adhesive weight, spot welding may be done so that adhesive is only applied at fiber intersections (selected ones, or all), such that the intersections are joined to each other and the two membranes”) and wherein the interlaced jacket (315-316 and 322-325) is configured to operate independently of the balloon membrane (311) along the decoupled spans permitting movement of the interlaced jacket (315-316 and 322-325) relative to the balloon membrane (311), permitting movement of the interlaced jacket (315-316 and 322-325) relative to the balloon membrane (311, see PP [0025], since the fibers are only adhered at specific intersections/spots the interlaced jacket is configured for independent movement with respect to the balloon membrane between those bonded intersections).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Davies et al. and Joye et al. combination to incorporate the teachings of Lachenmeier and include spot bonding. One of ordinary skill in the art would have been motivated to perform this modification in order to minimize the adhesive weight while keeping the interlaced jacket in place (PP [0025] of Lachenmeier).
However, Davies et al. as modified by Joye et al. and Lachenmeier further fails to explicitly disclose wherein the first interlaced filaments include a first density along the proximal and distal end portions and the second interlaced filaments include a second density different from the first density along the jacket body.
In the analogous field of medical balloons (abstract), Krautkremer et al. teaches a reinforcement interlaced jacket coupled to a balloon (20 over 10 in Fig. 1) wherein the interlaced jacket includes a plurality of filaments (PP [0059]: “The number of fibers can also vary. In some instances, an individual fiber may include a single filament, whereas in other instances two, three, four, five, or more filaments may comprise a single fiber”), wherein the filaments include different densities (PP [0059]: “In some instances, the pattern and/or crossing angles for the fibers may be varied and can be uniform, non-uniform or some combination thereof. The fiber coverage or density on the balloon may also be varied”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the Davies et al., Joye et al., and Lachemeier combination to further include the teachings of Krautkremer et al. and include wherein the first interlaced filaments include a first density along the proximal and distal end portions and the second interlaced filaments include a second density different from the first density along the jacket body. One of ordinary skill in the art would have been motivated to perform this modification because doing so would involve applying a known technique (varying fiber density on a balloon’s interlaced jacket) to a known device (the balloon of Davies et al.) in such a way that would have yielded predictable results. Furthermore, specifically modifying Davies et al. such that the first interlaced filaments and the second interlaced filaments include different densities would have been obvious to try, as there are a finite number of identified solutions (the filaments have the same densities, they have different densities, one has a varying non-uniform density, or both have varying non-uniform densities) that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 27, Davies et al. as modified by Joye et al., Lachenmeier, and Krautkremer et al. further discloses wherein the interlaced jacket (see Fig. 14 of Davies et al., see also 28 in Fig. 1 of Joye et al.) extends continuously around the balloon membrane (see Fig. 14 and Figs. 2-3 of Davies et al., see Fig. 1 of Joye et al., 28 extends around 30).
Regarding claim 28, Davies et al. as modified by Joye et al., Lachenmeier, and Krautkremer et al.et al. further discloses wherein the interlaced filaments (see Fig. 14 of Davies et al.) extending at diverging angles relative to the catheter shaft are misaligned with the catheter shaft (PP [0091]: “It will be apparent to those having skill in the art that the fibers 57 of the first fiber layer 56 and the fiber 59 of the second fiber layer 58 may be positioned at any appropriate angle. Placing the fiber 57 of the first fiber layer 56 and the fibers 59 of the second fiber layer 58 parallel to each other will result in a balloon 55 with less strength than a balloon 55 where the fibers 57 and 59 are positioned relatively at an angle”, see also PP [0059] and Fig. 1 of Krautkremer et al. with filaments 20 diverging).
Regarding claim 29, Davies et al. as modified by Joye et al., Lachenmeier, and Krautkremer et al.et al. further discloses a first inflation lumen and a second inflation lumen (44 and 36 in Fig. 1 of Joye et al.) extending through the catheter shaft (24), the first inflation lumen (44) is in communication with the balloon membrane (30) and the second inflation lumen (36) is in communication with the interlaced jacket (28).
Regarding claim 30, Davies et al. as modified by Joye et al., Lachenmeier, and Krautkremer et al. fails to explicitly disclose wherein the first interlaced filaments have a higher filament density than the second interlaced filaments.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the combination of Davies et al., Joye et al., Lachenmeier, and Krautkremer et al. such that the first interlaced filaments have a higher filament density than the second interlaced filaments. One of ordinary skill in the art would have been motivated to perform this modification because it would have been obvious to try, as there are a finite number of identified and predictable solutions (same filament densities, first interlaced filaments have a density, second interlaced filaments have a higher density) that could have been explored with a reasonable expectation of success, as Krautkremer et al. already contemplates varied filament densities (PP [0059]: “The shape, form and the configuration of the fibers may vary. For example, the fibers may take on different cross-sectional shapes, for example, circular, elliptical or spherical, flat, or some combination thereof. The number of fibers can also vary. In some instances, an individual fiber may include a single filament, whereas in other instances two, three, four, five, or more filaments may comprise a single fiber. In some instances, the pattern and/or crossing angles for the fibers may be varied and can be uniform, non-uniform or some combination thereof. The fiber coverage or density on the balloon may also be varied”).
Regarding claim 31, Davies et al. as modified by Joye et al., Lachenmeier, and Krautkremer et al. fails to explicitly disclose wherein the second interlaced filaments have a higher filament density than the first interlaced filaments.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the combination of Davies et al., Joye et al., Lachenmeier, and Krautkremer et al. such that the second interla