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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/1/25 has been entered.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 12/1/25. Claims 15-18 and 20-25, 27-35 are pending. The claim 15, 23, 30, and 31 are amended. Claims 1-14, 19, 26 are canceled. Claims 32-35 are newly presented.
Response to Arguments
Applicant’s arguments, filed 7/21/25 with respect to the rejections of claims 15-18, 20-31 under 103 as being unpatentable over Madrid (US2012/0209375) in view of Aggerholm (US2016/0175567) have been fully considered and the amendments does not appear to overcome the previous rejection. After, further review of the amendment, it appears the amendment is not sufficient to overcome the previous rejection. Madrid in paragraph [0156] states “the inner balloon member 192 can be expanded to stabilize or secure the prosthetic device on the inner balloon member 192 (FIG. 19B). Then, by expanding the outer balloon member 198, the prosthetic device can be fully deployed within an annulus (FIG. 19C)”. Therefore, the inner balloon member 192 (interpreted as the proximal and distal balloon shoulders) is expanded prior to the outer balloon 198 (main balloon). Where the “non-inflated” state as claimed, is interpreted as any state of the balloon prior to full expansion of the outer balloon 198, which occurs after expansion of the inner balloon member 192 ([0156]). Where the outer balloon 198 is at least capable of being pleated or folded in the same manner as claimed, and since the limitation is functional and the component need only the capability of performing the claimed function, the rejection has been maintained. A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114. Examiner advises Applicant further amend to positively recite the pleats as a component of the main balloon.
Claim Rejections - 35 USC § 103
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.
Claims 15-18, 20-25, 27-32, 34, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Madrid (US2012/0209375) in view of Aggerholm (US2016/0175567).
Regarding claim 15, Madrid discloses a balloon catheter for an endovascular delivery system, comprising:
a proximal balloon shoulder (proximal shoulder of balloon 192) mounted on an inner shaft (mounted on a shaft as shown in Fig. 19A) of the balloon catheter, the proximal balloon shoulder comprising a compressible, hollow shell having a wall defining a first interior space (proximal shoulder of balloon 192 is hollow by being an inflatable balloon and compressible by having a compressed delivery configuration, see Fig. 19A, [0156]);
a distal balloon shoulder (distal shoulder of balloon 192) mounted on the inner shaft (mounted on a shaft as shown in Fig. 19A), the distal balloon shoulder comprising a compressible, hollow shell having a wall defining a second interior space (distal shoulder of balloon is hollow by being an inflatable balloon and compressible by having a compressed delivery configuration, see Fig. 19A, [0156]); and
an inflatable, main balloon (outer balloon 198) that encloses the proximal balloon shoulder and the distal balloon shoulder (see Fig. 19A, [0156]) within a main interior space of the main balloon,
wherein the proximal balloon shoulder and the distal balloon surround the inner shaft such that the first and second interior spaces of the proximal and distal balloon shoulders are fluidly isolated from the main interior space of the main balloon (the outer balloon 198 and inner balloon 192 are expanded separately and are therefore fluidly isolated from each other, [0155], where the balloons can be inflated individually, [0126]),
and wherein prior to inflation of the main balloon, the proximal balloon shoulder and the distal balloon shoulder are in an inflated state and the main balloon is in a non-inflated state, pleated and folded around the proximal and distal balloon shoulders (where the “non-inflated” state as claimed, is interpreted as any state of the balloon prior to full expansion of the outer balloon 198, which occurs after expansion of the inner balloon member 192, [0156]; where the outer balloon 198 is at least capable of being pleated and folded in the same manner as claimed, and since the limitation is functional and the component need only the capability of performing the claimed function)
Madrid does not explicitly disclose the proximal and distal balloon shoulder are sealed around the inner shaft. Aggerholm teaches a balloon catheter assembly having an inner balloon 40 and an outer balloon 70 that entirely envelops the inner balloon 40 (see Abstract). The inner balloon 40 is inflated separately of the outer balloon 70 ([0042]). Where the inner balloon 40 is sealed to the catheter 12 (inner shaft) ([0035]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have the proximal balloon shoulder and distal balloon shoulder sealed around the inner shaft in order to provide inflation to the shoulders in a fluid tight manner ([0035]).
Regarding clam 16, Madrid/Aggerholm makes obvious the balloon catheter of claim 15, Madrid further discloses wherein the proximal balloon shoulder and the distal balloon shoulder are formed together as one piece with a central connection portion (central portion of “dog bone” shape of balloon 192, see Fig. 19B, [0156]) extending therebetween.
The limitation “blow molded” is being treated as a product by process limitation, in that “blow molding” refers to the process of forming the balloons and not to the final product created. As set forth in MPEP 2113, “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product in the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695,698,227 USPQ 964,966 (Fed. Cir. 1985). Examiner has evaluated the product claim giving limited weight to the method of its manufacture. Therefore, in this case, blow molding is directed to the method of making a balloon and not to the final product made. It appears that the product disclosed by Madrid would be the same as that claimed; especially since both applicant’s product and the prior art product have the same final structure of a balloon with two shoulder portions formed together as one piece with a central connection portion.
Regarding claim 17, Madrid/Aggerholm makes obvious the balloon catheter of claim 15, Madrid further discloses wherein the proximal balloon shoulder and the distal balloon shoulder are each spaced axially apart from one another (the distal shoulder of balloon 192 and the proximal shoulder of balloon 192 are spaced apart axially by the “dog bone” shape, see Fig. 19B, [156]).
The limitation “blow molded as a separate piece” is being treated as a product by process limitation, in that blow molding as separate pieces and then coupling them together as disclosed in [0125] of the instant specification refers to the process of forming the balloons and not to the final product created. As set forth in MPEP 2113, “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product in the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695,698,227 USPQ 964,966 (Fed. Cir. 1985). Examiner has evaluated the product claim without giving much weight to the method of its manufacture. Therefore, in this case, blow molding as a separate piece is directed to the method of making a balloon and not to the final product made. It appears that the product disclosed by Madrid would be the same as that claimed; especially since both applicant’s product and the prior art product have the same final structure of a balloon with two shoulder portions that are spaced axially apart from one another.
Regarding claim 18, Madrid/Aggerholm makes obvious the balloon catheter of claim 17, the modified invention discloses wherein the proximal balloon shoulder and the distal balloon shoulder are each fully enclosed and sealed around the inner shaft and inflatable (Aggerholm teaches the balloon shoulders being sealed to the inner shaft, ([0035]); Madrid discloses the balloon 192 are enclosed by the outer balloon 198 and inflatable, [0156]).
Regarding claim 20, Madrid/Aggerholm makes obvious the balloon catheter of claim 15, Madrid further discloses wherein the proximal balloon shoulder and the distal balloon shoulder each include a collar portion (round portion of shoulders) and a shaft portion (neck portion of shoulders), the collar portion extending radially outward from the shaft portion (see annotated Fig. 19B).
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Regarding claim 21, Madrid/Aggerholm makes obvious the balloon catheter of claim 15; yet, does not explicitly disclose wherein the proximal balloon shoulder has a proximal end and a distal end that are each sealed around the inner shaft. Aggerholm further teaches the balloon 140 can be inflated to have two separate rounded bulges 145, therefore having separate inflated volumes ([0051]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have modified the single balloon defining the proximal balloon shoulder and distal balloon shoulder sealed to the inner shaft of Madrid/Aggerholm to be two separate balloons sealed to the inner shaft as taught by Aggerholm in order to provide two separate visible markers so that the implant can be more precisely positioned ([0051]).
Regarding claim 22, Madrid/Aggerholm makes obvious the balloon catheter of claim 15, wherein the distal balloon shoulder has a proximal end and a distal end that are each sealed around the inner shaft. Aggerholm further teaches the balloon 140 can be inflated to have two separate rounded bulges 145, therefore having separate inflated volumes ([0051]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have modified the single balloon defining the proximal balloon shoulder and distal balloon shoulder sealed to the inner shaft of Madrid/Aggerholm to be two separate balloons sealed to the inner shaft as taught by Aggerholm in order to provide two separate visible markers so that the implant can be more precisely positioned ([0051]).
Regarding claim 23, Madrid discloses a balloon catheter for an endovascular delivery system, comprising:
a proximal balloon shoulder (proximal shoulder of balloon 192) mounted on an inner shaft (mounted on a shaft as shown in Fig. 19A) of the balloon catheter, the proximal balloon shoulder comprising a compressible, hollow shell (proximal shoulder of balloon 192 is hollow by being an inflatable balloon and compressible by having a compressed delivery configuration, see Fig. 19A, [0156]);
a distal balloon shoulder (distal shoulder of balloon 192) mounted on the inner shaft (mounted on a shaft as shown in Fig. 19A), the distal balloon shoulder comprising a compressible, hollow shell (distal shoulder of balloon 192 is hollow by being an inflatable balloon and compressible by having a compressed delivery configuration, see Fig. 19A, [0156]); and
an inflatable, main balloon (outer balloon 198) that encloses the proximal balloon shoulder and the distal balloon shoulder (see Fig. 19A, [0156]);
wherein prior to inflation of the main balloon, the proximal balloon shoulder and the distal balloon shoulder are in an inflated state and the main balloon is in a non-inflated state, pleated and folded around the proximal and distal balloon shoulders (where the “non-inflated” state as claimed, is interpreted as any state of the balloon prior to full expansion of the outer balloon 198, which occurs after expansion of the inner balloon member 192, [0156]; where the outer balloon 198 is at least capable of being pleated and folded in the same manner as claimed, and since the limitation is functional and the component need only the capability of performing the claimed function),
wherein when a prosthetic medical device is mounted over an intermediate portion of the main balloon at a location between the proximal and distal balloon shoulders ([0156]), the proximal and distal balloon shoulders extend radially outward relative to the intermediate portion of the main balloon such that the proximal and distal balloon shoulders maintain an axial position of the prosthetic medical device on the main balloon during delivery of the prosthetic medical device through a patient's vasculature and prior to inflation of the main balloon ([0156]).
Madrid does not explicitly disclose wherein the proximal and distal balloon shoulders are sealed around the inner shaft. Aggerholm teaches a balloon catheter assembly having an inner balloon 40 and an outer balloon 70 that entirely envelops the inner balloon 40 (see Abstract). The inner balloon 40 is inflated separately of the outer balloon 70 ([0042]). Where the inner balloon 40 is sealed to the catheter 12 (inner shaft) ([0035]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have the proximal balloon shoulder and distal balloon shoulder sealed around the inner shaft in order to provide inflation to the shoulders in a fluid tight manner ([0035]).
Regarding claim 24, Madrid/Aggerholm makes obvious the balloon catheter of claim 23, the modified invention discloses wherein the proximal balloon shoulder and the distal balloon shoulder are each fully enclosed ([0156] of Madrid) and free of openings (the modified invention teaches the shoulders being sealed to the inner shaft and therefore free of openings, [0035] of Aggerholm).
Regarding claim 25, Madrid/Aggerholm makes obvious the balloon catheter of claim 23, the modified invention teaches wherein the proximal and distal balloon shoulders are each configured to retain fluid pressure ([0035] of Aggerholm, [0144] of Madrid).
Regarding claim 27, Madrid/Aggerholm makes obvious the balloon catheter of claim 23, Madrid further discloses wherein the proximal balloon shoulder and the distal balloon shoulder each have a collar portion and a transition portion (see annotated Fig. 19C-2) and are formed together as one piece with a central connection portion (central portion of “dog bone” shape of balloon 192, see Fig. 19B, [0156]) extending between and connecting to their respective transition portions.
The limitation “blow molded” is being treated as a product by process limitation, in that “blow molding” refers to the process of forming the balloons and not to the final product created. As set forth in MPEP 2113, “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product in the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695,698,227 USPQ 964,966 (Fed. Cir. 1985). Examiner has evaluated the product claim without giving much weight to the method of its manufacture. Therefore, in this case, blow molding is directed to the method of making a balloon and not to the final product made. It appears that the product disclosed by Madrid would be the same as that claimed; especially since both applicant’s product and the prior art product have the same final structure of a balloon with two shoulder portions formed together as one piece with a central connection portion.
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Regarding claim 28, Madrid/Aggerholm makes obvious the balloon catheter of claim 27, Madrid further discloses wherein the transition portions are tapered and are disposed at a non-perpendicular angle relative to the central connecting portion (where the transition portion of the balloon shoulder is a neck portion that increases in diameter toward the center of the shoulder and is therefore interpreted as tapered, see annotated Fig. 19C-2).
Regarding claim 29, Madrid/Aggerholm makes obvious the balloon catheter of claim 27; yet, does not explicitly disclose wherein the transition portions are disposed substantially perpendicular to the central connecting portion. It would have been an obvious matter of design choice to a person of ordinary skill in the art to have the transition portions be disposed substantially perpendicular to the center connecting portion, since applicant has not disclosed that having the transition portions be perpendicular to the center connecting portion provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with other designs as stated in the instant specification Paragraph [0077].
Regarding claim 30, Madrid/Aggerholm makes obvious the balloon catheter of claim 23, the modified invention further discloses wherein the proximal and distal balloon shoulders define respective interior spaces that are fluidly isolated from an interior space of the main balloon (Aggerholm teaches the balloon shoulders being sealed to the inner shaft and separately inflatable from the outer balloon, [0035], [0042]; Madrid discloses the balloon 192 are enclosed by the outer balloon 198 and separately inflatable, [0126], [0155]-[0156]).
Regarding claim 31, Madrid/Aggerholm makes obvious the balloon catheter of claim 30; yet, does not explicitly disclose wherein the interior spaces of the proximal and distal balloon shoulders are fluidly isolated from each other. Aggerholm further teaches the balloon 140 can be inflated to have two separate rounded bulges 145, therefore having separate inflated volumes ([0051]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have modified the single balloon defining the proximal balloon shoulder and distal balloon shoulder sealed to the inner shaft of Madrid/Aggerholm to be two separate balloons sealed to the inner shaft and fluidly isolated as taught by Aggerholm in order to provide two separate visible markers so that the implant can be more precisely positioned ([0051]).
Regarding claim 32, Madrid/Aggerholm makes obvious the balloon catheter of claim 23; yet, does not explicitly disclose wherein the distal balloon shoulder has a distal end connected to a nose cone. Madrid according to the embodiment of Fig. 20-22 teaches a nose cone 212 can be provided at a distal end of the inner tube 202 (inner shaft) and the balloon 202 extends over a distal end of the inner tube 202 ([0157]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have substituted the shaft of Figs. 19A-19C for the shaft with nosecone of the embodiment of Fig. 20-22, since the substitution would have the same predictable result of providing an inner shaft that extends to a distal end for attachment of the balloons and also provide the added benefit of an atraumatic distal end. Where the modified invention discloses the distal end of the distal balloon shoulder would be connected to the nose cone by the connection of the distal balloon shoulder to the inner shaft.
Regarding claim 34, Madrid discloses a balloon catheter for an endovascular delivery system, comprising:
a proximal balloon shoulder (proximal shoulder of balloon 192) mounted on the inner shaft (mounted on a shaft as shown in Fig. 19A) of the balloon catheter, the proximal balloon shoulder comprising a compressible, hollow shell having a wall defining a first interior space (proximal shoulder of balloon 192 is hollow by being an inflatable balloon and compressible by having a compressed delivery configuration, see Fig. 19A, [0156]);
a distal balloon shoulder (distal shoulder of balloon 192) mounted on the nose cone (mounted on a shaft as shown in Fig. 19A), the distal balloon shoulder comprising a compressible, hollow shell having a wall defining a second interior space (distal shoulder of balloon is hollow by being an inflatable balloon and compressible by having a compressed delivery configuration, see Fig. 19A, [0156]); and
an inflatable, main balloon (outer balloon 198) that encloses the proximal balloon shoulder and the distal balloon shoulder within a main interior space of the main balloon (see Fig. 19C), and the first and second interior spaces of the proximal and distal balloon shoulders are fluidly isolated from the main interior space of the main balloon (the outer balloon 198 and inner balloon 192 are expanded separately and are therefore fluidly isolated from each other, [0155], where the balloons can be inflated individually, [0126]).
Madrid according to the embodiment of Figs. 19A-19C is silent regarding a nose cone arranged over a distal end of an inner shaft, and the distal balloon shoulder is sealed around the nose cone. Madrid according to the embodiment of Fig. 1 teaches a nose piece 32 that can comprise an inflatable balloon, where the balloon portion of the nose cone is interpreted as the distal balloon shoulder and the inner tube that is the wall of the balloon portion extends over is interpreted as the nose cone ([0113]). Where the balloon portion would be sealed to the nose cone by being one integral component. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the distal balloon mounted to the inner shaft for the distal balloon mounted to the nose cone and sealed around the nose cone as taught by the embodiment of Fig. 1, since the substitution would have yielded the same predictable result of a balloon at the distal end of the catheter to expand for holding or delivering a prosthetic heart valve.
Madrid according to the embodiment of Figs. 19A-19C is silent regarding wherein the proximal balloon shoulder is sealed around the inner shaft. Aggerholm teaches a balloon catheter assembly having an inner balloon 40 and an outer balloon 70 that entirely envelops the inner balloon 40 (see Abstract). The inner balloon 40 is inflated separately of the outer balloon 70 ([0042]). Where the inner balloon 40 is sealed to the catheter 12 (inner shaft) ([0035]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have the proximal balloon shoulder and distal balloon shoulder sealed around the inner shaft in order to provide inflation to the shoulders in a fluid tight manner ([0035]).
Regarding claim 35, Madrid/Aggerholm makes obvious the balloon catheter of claim 34, Madrid further discloses wherein the proximal and distal balloon shoulders are inflatable and extend radially outward relative to an intermediate portion of the main balloon (see Fig. 19B) when a prosthetic medical device is mounted over the main balloon and the proximal and distal balloon shoulders are in a non-inflated state ([0156], the inner balloon 192 is expanded to secure the prosthetic heart valve on the inner balloon 192).
Claims 33 is rejected under 35 U.S.C. 103 as being unpatentable over Madrid (US2012/0209375) in view of Aggerholm (US2016/0175567) as applied to claim 23 above, and further in view of Lawinger (US2019/0117242).
Regarding claim 33, Madrid/Aggerholm makes obvious the balloon catheter of claim 23; yet, does not explicitly disclose wherein the inner shaft comprises a first shaft and the balloon catheter comprises a second shaft extending coaxially over the first shaft, and the proximal balloon shoulder has a proximal end that is connected the second shaft. Lawinger teaches a balloon catheter having a first 136 and second 138 balloon ([0090]). Where the balloon 136 (proximal balloon shoulder) can be on an outer sheath 150, while the balloon 138 (distal balloon shoulder) can be on a flexible elongate member 132 (inner shaft) ([0090]). Lawinger further teaches this arrangement is an obvious variant to a first 18 and second 20 balloon both mounted on an inner shaft 12 (see Fig. 2) It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the arrangement of the proximal and distal balloon shoulders mounted on the inner shaft for the arrangement of the proximal balloon shoulder connected to the second shaft and the inner shaft having a first shaft and a second shaft as taught by Lawinger since the substitution would have yielded the same predictable result of a balloon catheter with two separate balloon portions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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