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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 6, 2026 has been entered.
Claims 1-2, 4-5, 7-9, 12, 14-19, 22-23, and 25-26 are currently pending.
Claim Objections
Claims 1-2, 4-5, 7-9, 12, 14-19, 22-23, and 25-26 are objected to because of the following informalities:
Claim 1 recites in part “a non-compliant medical balloon for a balloon catheter having a base balloon” (lines 1-2). The claim additionally recites “wherein the balloon comprises a fiber reinforcement layer surrounding the base balloon at least in sections” (lines 6-7) and “wherein the balloon comprises an outer layer that surrounds the base balloon (line 12). The Examiner suggests amending lines 6-7 and line 12 to recite “the medical balloon” or “the non-compliant medical balloon” to differentiate the claimed “the balloon” from the previously recited “balloon catheter” and “base balloon” and improve clarity.
Claims 2, 4-5, 7-9, 12, 14-19, and 22-23 each recite “the balloon of claim…”. The Examiner suggests amending the preamble of each claim to recite “the medical balloon of claim…” or “the non-compliant medical balloon of claim…” to differentiate the claimed “balloon” from the previously recited “balloon catheter” and “base balloon” and improve clarity.
Claims 2, 4-5, 7-9, 12, 14-19, and 22-23 are additionally objected to due their dependency on claim 1.
Claim 25 recites in part “a non-compliant medical balloon for a balloon catheter having a base balloon” (lines 1-2). The claim additionally recites “wherein the balloon comprises a fiber reinforcement layer surrounding the base balloon at least in sections” (lines 5-6). The Examiner suggests amending lines 5-6 to recite “the medical balloon” or “the non-compliant medical balloon” to differentiate the claimed “balloon” from the previously recited “balloon catheter” and “base balloon” and improve clarity.
Claims 26 recites “the balloon of claim 25”. The Examiner suggests amending the preamble of the claim to recite “the medical balloon of claim 25 or “the non-compliant medical balloon of claim 25” to differentiate the claimed “balloon” from the previously recited “balloon catheter” and “base balloon” and improve clarity.
Appropriate correction is required.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application
filed in Germany on 5/14/2024. It is noted, however, that applicant has not filed a certified copy
of the DE10 2024 113 408.9 application as required by 37 CFR 1.55.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 4-5, 7-9, 12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US 2012/0296363, hereinafter “Davies”) in view of Pepper et al. (US 2016/0151611, hereinafter “Pepper 2016”) and Pepper (US 2015/0080796, hereinafter “Pepper 2015”).
Regarding claim 1, Davies discloses the invention substantially as claimed including a non-compliant medical balloon (500; Figs 5A-F; para [0002, 0042, 0068]) for a balloon catheter (309; para [0045]) having a base balloon (502) and having a film reinforcement layer (514) which comprises film made of a high-molecular polymer, including polyimide, LCP polymer, PET and/or PEEK (para [0069]), and surrounds the base balloon at least in sections (Fig 5D);
wherein the film reinforcement layer (514) is wrapped around the base balloon (502) (para [0068]; Fig 5D);
wherein the balloon comprises a fiber reinforcement layer (510, 512) surrounding the base balloon (502) at least in sections (para [0065-0066]; Figs 5a-c);
wherein the fiber reinforcement layer (510, 512) is arranged between the base balloon (502) and the film reinforcement layer (514) (para [0068]);
wherein the fiber reinforcement layer (510, 512) is formed as a knitted fabric, warp-knitted fabric and/or woven fabric (para [0065]; Figs 5a-d), and
wherein the film reinforcement layer (514) comprises at least one film adhesive strip of film (adhesive 516; para [0068]), which is glued on to reinforce the base balloon (500).
wherein the film reinforcement layer (514) comprises at least one film adhesive strip of film (para [0068] – “a polymer outer coating layer 514 may be applied over fiber reinforcement sleeve 510 as a film”) made of a high molecular weight polymer (para [0069]), which is glued on (para [0068] – “As illustrated in FIG. 5e, outer layer 514 may be secured to base balloon 502 with an adhesive 516 with fibers 514 disposed between the outer layer and the base balloon”) to reinforce the base balloon (500).
However, Davies fails to disclose the balloon comprises an outer layer having a layered structure, as claimed. Pepper 2016 discloses a similar non-complaint medical balloon for a balloon catheter and teaches the balloon may comprise several layers (Fig 8; para [0068-0078]) including a base balloon (100), fiber reinforcement layers (12, 14), a film reinforcement layer (16), and an outer layer (“One or more additional protective layers 18 may be positioned on the outer coating layer 16 to provide additional layers of protection” - para [0078]), wherein the outer protective layer (18) is “generally a homogeneous polymeric or other material layer” and improves resistance to abrasion (para [0086]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Davies such that the balloon comprised an outer layer having a layered structure, or one or more outer protective layers 18, as taught by Pepper 2016, for the purpose of providing additional layers of protection (para [0078]).
Pepper fails to disclose the particular material of the outer layer (one or more additional protective layers 18). However, with reference at least to outer coating layer 16, Pepper 2016 teaches polymers and copolymers that may be used “include the conventional polymers and copolymers used in medical balloon construction. Typical suitable substances may include polyethylene, nylons, polyethylene terephthalate (PET), polycaprolactam, polyesters, polyethers, polyamides, polyurethanes, polyimides, ABS copolymers, polyester/polyether block copolymers, ionomer resins, liquid crystal polymers, and rigid rod polymers” (para [0085], emphasis added). Therefore, it would additionally have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Davies and Pepper 2016 such that the outer protective layered structure comprised polyamide since polyamide is a known conventional polymer used in medical balloon construction and 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.
Finally, Davies fails to disclose the film reinforcement layer comprises at least one film adhesive strip glued on to reinforce the base balloon such that the at least one film adhesive strip extends substantially parallel to one another and diagonally to a longitudinal central axis of the base balloon. Pepper 2015 discloses a similar balloon (Figs 2-3) for a balloon catheter having a base balloon (130) (para [0040]) with a film reinforcement layer (144) (para [0045]) and fiber reinforcement layer (132, 140) arranged between the base balloon and the film reinforcement layer (para [0040-0044]). Pepper 2015 teaches the film reinforcement layer (144) may be applied as a film, similar to Davies, or may be applied as a tape (800) wrapped over the fiber reinforcement layer (para [0058]). As shown in Fig 8, the tape (800) may extend diagonally to a longitudinal central axis of the base balloon when wrapped around the balloon and fiber reinforcement layer, such that adjacent portions of the tape extend substantially parallel to one another (Fig 8; para [0058]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Davies such that the at least one film adhesive strip was applied as a tape that extends diagonally to a longitudinal central axis of the base balloon, as taught by Pepper 2015, since the substitution of one known element (film reinforcement layer applied as a film) for another element (film reinforcement layer applied as a tape extending diagonally) providing the same function (outer reinforcement layer) to yield predictable results would have been obvious to one of ordinary skill in the art. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 at 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). Furthermore, Pepper 2015 teaches at least one film adhesive strip (2015) and fails to teach a plurality of adhesive strips, as claimed. It would have additionally been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination such that the film reinforcement layer comprised a plurality of adhesive strips of film (or a plurality of distinct tape portions) since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 2, Davies as modified by Pepper 2015 teaches the film reinforcement layer (film 514 modified to be a plurality of strips of film or tape 800 by Pepper 2015, which are considered adhesive strips since they are glued on with an adhesive 516) is attached at least indirectly to the base balloon (glued on over fiber reinforcement layer) by means of the plurality of adhesive strips of film, each adhesive strip of film comprising polyimide (Davies para [0069]).
Regarding claim 4, Davies in view of Pepper 2015 fails to disclose the dimensions of the film adhesive strip (tape 800). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination such that each adhesive strip of film has a width of between 1 mm and 4 mm and/or a film thickness of between 6 µm or 7.5 µm and 25 µm, and/or a bonding layer with a layer thickness of 15 µm to 40 µm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify each adhesive strip of the combination to have the claimed dimensions in order to size it appropriately for the intended use since Applicant has placed no criticality on each adhesive strip having the claimed dimensions as evidenced by the broad range of values for the claimed dimensions and since modifying the combination to have the specified dimension would not adversely affect the function of the device. The courts have recognized 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 dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984)).
Regarding claim 5, wherein the film of the film reinforcement layer (514) consists of crystalline and/or amorphous high-molecular polymer (para [0069]).
Regarding claim 7, Davies fails to disclose the dimensions of the film reinforcement layer (514). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Davies such that the film reinforcement layer has a film thickness between 6 µm or 7.5 µm and 25 µm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the film reinforcement layer (514) of Davies to have the claimed dimensions in order to size it appropriately for the intended use since Applicant has placed no criticality on the film reinforcement layer having the claimed dimensions as evidenced by the broad range of values for the claimed dimensions and since modifying Davies to have the specified dimensions would not adversely affect the function of the device. The courts have recognized 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 dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984)).
Regarding claim 8, Davies as modified by Pepper 2015 teaches the film reinforcement layer (film 514 modified to be a plurality of strips of film or tape 800 by Pepper 2015, which are considered adhesive strips since they are glued on with an adhesive 516) comprises at least one film section wrapped around the base balloon (Fig 8 of Pepper 2015) and at least one film adhesive strip (another portion of strip or tape) which is glued on to fix the film section (para [0068], Fig 5E of Davies and para [0058], Fig 8 of Pepper 2015).
Regarding claim 9, wherein the at least one film adhesive strip and/or the at least one film section, is wrapped around the base balloon in at least one layer (wrapped around in at least one layer – para [0068], Fig 5E of Davies and para [0058], Fig 8 of Pepper 2015).
Regarding claim 12, Davies fails to teach the fiber reinforcement layer (510, 512) of the embodiment of Figs 5a-f comprises high modulus polyethylene fibers or consists of high modulus polyethylene fibers. In an alternate embodiment Davies teaches fibers (312) of a fiber reinforcement layer (310) “may be inelastic fiber, typically made of an inelastic fibrous material. An inelastic fiber is a fiber that has very minimal elasticity or stretch over a given range of balloon pressures, Some fibrous materials are generally classified as inelastic although the fibrous material may have a detectable, but minimal, elasticity or stretch at a given balloon pressure” (para [0059]). And teaches “The fibers 312 of braided fiber layer 310 may be high-strength fibers, typically made of a high-strength fibrous material. Some high strength inelastic fibrous materials may include Kevlar, Vectran, Spectra, Dacron, Dyneema, Teflon (PBT), Zylon (PBO), Polyimide (PIM), other ultra high molecular weight polyethylene, aramids, polyesters nylons, and the like” (para [0060]; emphasis added). Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to further modify Davies such that the fiber reinforcement layer (510, 512) of the embodiment of Figs 5A-F comprised high modulus polyethylene fibers or consisted of high modulus polyethylene fibers 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.
Regarding claim 14, wherein the base balloon (502) is made of a semi-compliant material (para [0051]).
Claim(s) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davies (US 2012/0296363), Pepper et al. (US 2016/0151611, hereinafter “Pepper 2016”), and Pepper (US 2015/0080796, hereinafter “Pepper 2015”), as applied to claim 1 above, further in view of Govari et al. (US 2018/0280658, hereinafter “Govari”). Davies, Pepper 2016, and Pepper 2015 disclose the invention substantially as claimed, but fail to disclose the balloon comprises at least one electronic component or sensor, as claimed. Govari discloses a similar balloon for a balloon catheter (Figs 2-4) and teaches the balloon comprises at least one electronic component (44), for example a sensor, and/or at least one electronic circuit (para [0034]), in particular which is/are arranged, preferably fixed, on the outer surface of the balloon (Figs 2, 4). The at least one electronic component (44) is arranged on an outer surface of the balloon, in particular on an outer surface of a conical section of the balloon (along length of balloon, including the conical section – Figs 2, 4; para [0034]). The at least one electronic component (44) includes at least one ultrasonic sensor to measure the position of the balloon with respect to tissue and to map the target tissue (para [0037-0039, 0043-0048]). The at least one electronic circuit (44) is/are processed, in particular printed and/or lithographed, preferably on the film of the outer surface of the catheter (Figs 2, 4; para [0034, 0042]). The at least one electronic circuit (44) can be used as an antenna, in particular as an intravascular antenna (para [0037-0039, 0043-0048]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination to have the claimed at least one electronic component, as taught by Govari, for the purpose of providing an ultrasonic sensor for measuring the position of the balloon relative to tissue.
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davies (US 2012/0296363), Pepper et al. (US 2016/0151611, hereinafter “Pepper 2016”), and Pepper (US 2015/0080796, hereinafter “Pepper 2015”), as applied to claim 1 above, further in view of Elton et al. (US 2014/0336689, hereinafter “Elton”). Davies, Pepper 2016 and Pepper 2015 disclose the invention substantially as claimed, as shown above, but fail to disclose the balloon comprises an MR-visible and/or X-ray-visible marker, as claimed. Elton discloses a similar balloon catheter and teaches “the need is identified for a balloon with radiopacity associated with the balloon itself, which would accurately reveal the position of the balloon before inflation, as well as during and after inflation” (para [0007]). In particular, at least one layer of the balloon comprises at least one X-ray-visible marker (para [0031, 0035]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination to include an X-ray-visible marker, as taught by Elton, for the purpose of visualizing the position of the balloon during the procedure.
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davies (US 2012/0296363) in view of Pepper (US 2015/0080796).
Regarding claim 25, Davies discloses the invention substantially as claimed including a non-compliant medical balloon (500; Figs 5A-F; para [0002, 0042, 0068]) for a balloon catheter (309; para [0045]) having a base balloon (502) and having a film reinforcement layer (514) which comprises film made of a high-molecular polymer, including polyimide, LCP polymer, PET and/or PEEK (para [0069]), and surrounds the base balloon at least in sections (Fig 5D),
wherein the film reinforcement layer (514) is wrapped around the base balloon (502) (para [0068]; Fig 5D – surrounds and envelops base balloon);
wherein the balloon comprises a fiber reinforcement layer (510, 512) surrounding the base balloon (502) at least in sections (para [0065-0066]; Figs 5a-c);
wherein the fiber reinforcement layer (510, 512) is arranged between the base balloon (502) and the film reinforcement layer (514) (para [0068]);
wherein the fiber reinforcement layer (510, 512) is formed as a knitted fabric, warp-knitted fabric and/or woven fabric (para [0065]; Figs 5a-d), and
wherein the film reinforcement layer (514) comprises at least one film adhesive strip of film (para [0068] – “a polymer outer coating layer 514 may be applied over fiber reinforcement sleeve 510 as a film”) made of a high molecular weight polymer (para [0069]), which is glued on (para [0068] – “As illustrated in FIG. 5e, outer layer 514 may be secured to base balloon 502 with an adhesive 516 with fibers 514 disposed between the outer layer and the base balloon”) to reinforce the base balloon (500).
However, Davies fails to disclose the film reinforcement layer comprises at least one film adhesive strip glued on to reinforce the base balloon such that the at least one film adhesive strip extends diagonally to a longitudinal central axis of the base balloon. Pepper discloses a similar balloon (Figs 2-3) for a balloon catheter having a base balloon (130) (para [0040]) with a film reinforcement layer (144) (para [0045]) and fiber reinforcement layer (132, 140) arranged between the base balloon and the film reinforcement layer (para [0040-0044]). Pepper teaches the film reinforcement layer (144) may be applied as a film, similar to Davies, or may be applied as a tape (800) wrapped over the fiber reinforcement layer (para [0058]). As shown in Fig 8, the tape (800) may extend diagonally to a longitudinal central axis of the base balloon when wrapped around the balloon and fiber reinforcement layer (Fig 8; para [0058]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Davies such that the at least one film adhesive strip was applied as a tape that extends diagonally to a longitudinal central axis of the base balloon, as taught by Pepper, since the substitution of one known element (film reinforcement layer applied as a film) for another element (film reinforcement layer applied as a tape extending diagonally) providing the same function (outer reinforcement layer) to yield predictable results would have been obvious to one of ordinary skill in the art. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 at 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Regarding claim 26, in an alternative embodiment, Davies teaches the adhesive comprises urethane (para [0074]). Furthermore, Davies acknowledges choosing different strength adhesives for different portions of the balloon (para [0074]), thus acknowledging the material can be optimized for the intended use. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Davies such that the film adhesive strip included a bonding layer of thermoplastic polyurethane since Davies uses the material in an alternate embodiment and 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. However, Davies fails to disclose the thickness of adhesive. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention further modify Davies such that the bonding layer had a thickness between 15 µm and 40 µm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2, 4-5, 7-9, 12, 14-19, 22-23, and 25-26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new ground(s) of rejection is made in view of Pepper (US 2015/0080796).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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