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 .
Response to Amendment
The amendment filed January 21, 2026 has been entered. Claims 1-2, 4-5, 7-9, 12, 14-19, 22-23, and 25-26 are currently pending.
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”) and Neton et al. (US 2017/0259550, hereinafter “Neton”).
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).
However, Davies fails to disclose the balloon comprises an outer layer having a layered structure, as claimed. Pepper 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), reinforcement layers (12, 14), an outer coating layer (16), and “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, as taught by Pepper, for the purpose of providing additional layers of protection. Furthermore, with reference at least to outer coating layer (16), Pepper 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 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.
Furthermore, Davies fails to disclose the film adhesive strip (516) is made of a high molecular weight polymer and extends diagonally to a longitudinal central axis of the base balloon. 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 was made of a high molecular weight polymer 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. Furthermore, Neton discloses a one or more layers combined together with a variety of bonding mechanisms, including adhesive. Neton teaches “If adhesives are used, they can be applied in any suitable manner or pattern including, but not limited to: slots, spirals, spray, and curtain coating” (para [0173]). Thus, a spiral or diagonal pattern is one of a finite number of identified, predictable solutions for applying an adhesive. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further try modifying Davies such that the adhesive was applied in a spiral pattern and thus extend diagonally to a longitudinal central axis of the base balloon in an attempt to provide an improve layered balloon as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp and since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success.
Regarding claim 2, Davies discloses the invention substantially as claimed, as shown above, including wherein the film reinforcement layer (514) is attached at least indirectly to the base balloon by means of an adhesive (adhesive 516; para [0068]). However, Davies not specifically disclose the adhesive comprises a polyimide adhesive strip. Davies teaches “the braided reinforcement 510 is typically impregnated with resin or adhesive such as a polyurethane after positioning” (para [0066], emphasis added). 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 ordinary skill in the art before the effective filing date of the claimed invention to modify Davies such that the adhesive strip (516) was made of polyimide 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 4, Davies fails to disclose the dimensions of the film adhesive strip (516). 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 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 the adhesive strip 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 adhesive strip having the claimed dimensions as evidenced by the broad range of values for the claimed dimensions and since modifying Davies 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, wherein the film reinforcement layer (514) comprises at least one film section wrapped around the base balloon (502) (para [0068]; Fig 5D) and at least one film adhesive strip (516) which is glued on to fix the film section (para [0068]; Fig 5E).
Regarding claim 9, wherein the at least one film adhesive strip (516) and/or the at least one film section, is wrapped around the base balloon (502) in at least one layer (wrapped around in at least one layer – para [0068]; Fig 5E).
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 modify Davies such that the fiber reinforcement layer (510, 512) of the embodiment of Figs 5A-F of 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 (US 2016/0151611), and Neton (US 2017/0259550), as applied to claim 1 above, further in view of Govari et al. (US 2018/0280658, hereinafter “Govari”). Davies and Pepper 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 (US 2016/0151611), and Neton (US 2017/0259550), as applied to claim 1 above, further in view of Elton et al. (US 2014/0336689, hereinafter “Elton”). Davies and Pepper 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 Neton et al. (US 2017/0259550, hereinafter “Neton”).
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);
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).
However, Davies fails to disclose the film adhesive strip (516) is made of a high molecular weight polymer and extends diagonally to a longitudinal central axis of the base balloon. 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 was made of a high molecular weight polymer 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. Furthermore, Neton discloses a one or more layers combined together with a variety of bonding mechanisms, including adhesive. Neton teaches “If adhesives are used, they can be applied in any suitable manner or pattern including, but not limited to: slots, spirals, spray, and curtain coating” (para [0173]). Thus, a spiral or diagonal pattern is one of a finite number of identified, predictable solutions for applying an adhesive. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further try modifying Davies such that the adhesive was applied in a spiral pattern and thus extend diagonally to a longitudinal central axis of the base balloon in an attempt to provide an improve layered balloon as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp and since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success.
Regarding claim 26, as discussed above, 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 filed February 12, 2026 have been fully considered but they are not persuasive.
Applicant argues Davies fails to teach or disclose a film reinforcement layer that is wrapped around the base balloon, as claimed. The Examiner respectfully disagrees and notes Davies clearly teaches the film reinforcement layer (514) surrounds and thus wraps or envelopes the base balloon (502) (Fig 5D; para [0068]). Davies teaches “Referring to FIG. 5d, a polymer outer coating layer 514 may be applied over fiber reinforcement sleeve 510 as a film… 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.” (para [0068]). It is noted the specification does not a provide a special definition for the term “wrap”. Furthermore, the layer (514) may clearly be interpreted as a “reinforcement” layer in that the film is an additional layer that strengthens the structure of the balloon.
Applicant argues the combination of Davies and Neton teaches a film adhesive strip made of a high molecular weight polymer that extends diagonally to a longitudinal central axis of the base balloon, as was recited in claim 25 and now included in amended claim 1. The Examiner respectfully disagrees with Applicant’s narrow interpretation of term spiral “to follow a circular or spiral course”. Merriam-Webster defines spiral as “the path of a point in a plane moving around a central point while continuously receding from or approaching it” or “a three-dimensional curve (such as a helix) with one or more turns about an axis”, which clearly defines a diagonal pattern.
In response to applicant's argument that Neton is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Neton addresses the problem of joining layers of a multilayer material.
Applicant additionally argues the combination of Davies and Pepper fail to teach the limitations regarding the outer layer as claimed. Applicant argues Pepper discloses polyamide as a material only with respect to the coating layer 16 and not the final layer 18, the base balloon, and the fibers. Thus, Applicant concludes neither Davies nor Pepper describe the outer layer has a layered structure, comprising a polyamide layer as the outer layer. The Examiner respectfully disagrees. Pepper teaches the final or outermost layer (18) is a protective layer. While Pepper does not teach a specific material for the final or outermost layer (18), Pepper does teach, with reference at least to outer coating layer (16), 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 have been obvious to one of ordinary skill in the art to modify the combination of Davies and Pepper 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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