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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/27/2026 has been entered.
Response to Arguments
Regarding the previous 112(b) rejection, the amendment to claim 16 is acknowledged and the 112(b) rejection is withdrawn.
Applicant’s arguments, see page 3, filed 04/27/2026, with respect to the rejection(s) of claim(s) 1, 11, and 16 under Ben-Muvhar in view of Jang have been fully considered and are persuasive. The examiner agrees that Jang fails to teach “at least three imaging markers each being positioned between the first end of the central body and the second end of the central body” as required in claims 1, 11, and 16. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ben-Muvhar in view of Fischell et al. (US 5669932).
Claim Objections
Claim 29 is objected to because of the following informalities:
Claim 29, lines 1-2: “the plurality of imaging markers” should recite “the at least three imaging markers”. 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.
Claim(s) 1-3, 8-9, 11-12, 16-21, 25, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Muvhar (US 20060030920) in view of Fischell et al. (US 5669932) [hereinafter Fischell].
Regarding claims 1 and 11, Ben-Muvhar discloses a dilation device (Fig. 2) for an implant (para. 0040), the dilation device comprising:
an inflatable body 200 having a first end 220 and a second end 210 (Fig. 2, para. 0040) and a central body positioned between the first end 220 and the second end 210 (see annotated Fig. 2 below, para. 0040) and having a length (Fig. 2, para. 0007), the central body configured to press an inner surface of the implant to dilate the implant (para. 0038, 0040) and having a profile that decreases in diameter along the length of the central body from the first end 220 to the second end 210 (Fig. 2, para. 0040), the central body having a single continuous profile angle along the length of the central body from a first end of the central body to a second end of the central body (see annotated Fig. 2 below), wherein the central body includes a plurality of segments (see annotated Fig. 2 [1] below), each having a different profile (due to the tapered shape, such that the profile decreases in diameter along the length of the balloon from the most proximal segment to the most distal segment) and being tapered (Fig. 2, para. 0040), each of the plurality of segments having a profile angle that is a same angle (see Fig. 2 of Ben-Muvhar) and each of the plurality of segments having a greatest diameter that is different than a greatest diameter of each other of the plurality of segments (due to the tapered shape, such that the profile angle of each of the plurality of segments decreases in diameter along the length of the balloon, the greatest diameters of each of the plurality of segment would be different from each other).
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Annotated Fig. 2 of Ben-Muvhar
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Annotated Fig. 2 [1] of Ben-Muvhar
However, Ben-Muvhar fails to disclose imaging markers each being positioned between the first end of the central body and the second end of the central body and being spaced from each other along a longitudinal axis of the inflatable body, each of the imaging markers being positioned at a different respective one of the plurality of segments to indicate a position of the greatest diameter of a respective one of the plurality of segments to thereby indicate a diameter that the implant will be dilated to at the greatest diameter.
Fischell in the same field of endeavor of dilation devices used for stent delivery (see Fig. 7, col. 4 lines 55-57: “ FIG. 7 shows a stent delivery catheter system 70 consisting of a guide wire 40, a stent 35 and a balloon angioplasty catheter 80”) teaches that it is known in the art for the device to comprise at least three imaging markers 52-54 each being positioned between a first end of a central body of an inflatable body (interpreted as end associated with marker band 58) and a second end of the central body of the inflatable body (interpreted as end associated with marker band 59) and being spaced from each other along a longitudinal axis of an inflatable body (see Fig. 7, col. 5 lines 22-27: “FIG. 7 shows three radiopaque marker bands 52, 53 and 54 each of which is positioned to indicate respectively the positions of a set of special expandable cells 34L, 34C and 34R of the stent 35 when that stent 35 is fully deployed by the expansion of the balloon 75 to its nominal diameter”.), each of the at least three imaging markers 52-54 being positioned at a different respective one of a plurality of segments of the central body to indicate a diameter that an implant 35 will be dilated (Fig. 7, col. 5 lines 22-27 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in Ben-Muvhar to include the at least three central imaging markers of Fischell in order to allow the user to visually identify the plurality of segments of the central body along the length of the balloon relative to the implant being delivered during use, thereby increasing the accuracy of the placement of the implant (col. 1 lines 42-46: “No existing stent delivery catheter and stent system includes a radiopaque marker that indicates the position of such a special expandable stent cell so that the stent can be accurately aligned with the ostium of the side branch prior to stent deployment”; col. 5 lines 50-54: “FIG. 7 shows three central radiopaque marker bands 52, 53 and 54,…to indicate some specific portion of a stent such as, but not limited to, special expandable cells that can be placed at a side branch artery”).
The combination of Ben-Muvhar and Fischell would result in a product wherein each of the at least three central imaging markers 52-54 of Fischell would be at a different respective one of a plurality of segments of the central body of Ben-Muvhar to indicate a position of the greatest diameter of a respective one of the plurality of segments (see annotated Fig. 2 [1] of Ben-Muvhar above which illustrates each segment defining a location in which its greatest diameter along the tapered body is defined), to thereby indicate a diameter that the implant will be dilated to at the greatest diameter (col. 5 lines 22-26 of Fischell).
Regarding claim 2, modified Ben-Muvhar discloses wherein the profile is a tapered profile (Fig. 2, para. 0040 of Ben-Muvhar).
Regarding claim 3, modified Ben-Muvhar discloses wherein the profile is an angled profile (Fig. 2, para. 0040 of Ben-Muvhar).
Regarding claims 8 and 12, modified Ben-Muvhar discloses wherein at least one of the at least three imaging markers 52-54 each comprise a radiopaque marker (Fig. 7, col. 5 lines 22-23 of Fischell: “FIG. 7 shows three radiopaque marker bands 52, 53 and 54”).
Regarding claim 9, modified Ben-Muvhar discloses wherein at least one of the at least three imaging markers 52-54 is positioned within an interior cavity of the inflatable body (see Fig. 7 of Fischell).
Regarding claim 21, modified Ben-Muvhar discloses wherein each of the plurality of segments has a conical frustum shape (annotated Fig. 2 of Ben-Muvhar above, para. 0040 of Ben-Muvhar).
Regarding claim 25, modified Ben-Muvhar discloses wherein the at least three imaging markers 52-54 are spaced equally from each other (see Fig. 7 of Fischell),
Regarding claim 16, Ben-Muvhar discloses an implant system (Fig. 4, para. 0040, 0043) comprising:
an implant 100 configured to be deployed to a deployment site within a subject (Figs. 1A-B, para. 0037) and having an angled interior profile that faces an interior cavity of the implant (Fig. 1B, para. 0037); and an inflatable body 200 having a central body configured to be positioned within the interior cavity of the implant 100, the central body having a single continuous profile angle along a length of the central body from a first end of the central body to a second end of the central body (see annotated Fig. 2 above), and configured to press towards the implant to dilate the implant 100 (Fig. 4, para. 0038, 0040, 0044-0045), the central body having a profile that is angled to fit the angled interior profile of the implant (Fig. 4., para. 0044-0045), wherein the central body includes a plurality of segments (see annotated Fig. 2 above), each of the plurality of segments having a profile angle that is a same angle (see Fig. 2 of Ben-Muvhar) and each of the plurality of segments having a greatest diameter that is different than a greatest diameter of each other of the plurality of segments (due to the tapered shape, such that the profile angle of each of the plurality of segments decreases in diameter along the length of the balloon, the greatest diameters of each of the plurality of segment would be different from each other).
However, Ben-Muvhar fails to disclose imaging markers each being positioned between the first end of the central body and the second end of the central body and being spaced from each other along a longitudinal axis of the inflatable body, each of the imaging markers being positioned at a different respective one of the plurality of segments to indicate a position of the greatest diameter of a respective one of the plurality of segments to thereby indicate a diameter that the implant will be dilated to at the greatest diameter.
Fischell in the same field of endeavor of dilation devices used for stent delivery (see Fig. 7, col. 4 lines 55-57: “ FIG. 7 shows a stent delivery catheter system 70 consisting of a guide wire 40, a stent 35 and a balloon angioplasty catheter 80”) teaches that it is known in the art for the device to comprise at least three imaging markers 52-54 (Fig. 7, col. 5 lines 50-52: “ FIG. 7 shows three central radiopaque marker bands 52, 53 and 54, it may also be advantageous to use 2, 4 or 5 radiopaque marker bands”) each being positioned between a first end of a central body of an inflatable body (interpreted as end associated with marker band 58) and a second end of the central body of the inflatable body (interpreted as end associated with marker band 59) and being spaced from each other along a longitudinal axis of an inflatable body (see Fig. 7, col. 5 lines 22-27: “FIG. 7 shows three radiopaque marker bands 52, 53 and 54 each of which is positioned to indicate respectively the positions of a set of special expandable cells 34L, 34C and 34R of the stent 35 when that stent 35 is fully deployed by the expansion of the balloon 75 to its nominal diameter”.), each of the at least three imaging markers 52-54 being positioned at a different respective one of a plurality of segments of the central body to indicate a diameter that an implant 35 will be dilated (Fig. 7, col. 5 lines 22-27 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in Ben-Muvhar to include the at least three central imaging markers of Fischell in order to allow the user to visually identify the plurality of segments of the central body along the length of the balloon relative to the implant being delivered during use, thereby increasing the accuracy of the placement of the implant (col. 1 lines 42-46: “No existing stent delivery catheter and stent system includes a radiopaque marker that indicates the position of such a special expandable stent cell so that the stent can be accurately aligned with the ostium of the side branch prior to stent deployment”; col. 5 lines 50-54: “FIG. 7 shows three central radiopaque marker bands 52, 53 and 54,…to indicate some specific portion of a stent such as, but not limited to, special expandable cells that can be placed at a side branch artery”).
The combination of Ben-Muvhar and Fischell would result in a product wherein each of the at least three central imaging markers 52-54 of Fischell would be at a different respective one of a plurality of segments of the central body of Ben-Muvhar to indicate a position of the greatest diameter of a respective one of the plurality of segments (see annotated Fig. 2 [1] of Ben-Muvhar above which illustrates each segment defining a location in which its greatest diameter along the tapered body is defined), to thereby indicate a diameter that the implant will be dilated to at the greatest diameter (col. 5 lines 22-26 of Fischell).
Regarding claim 17, modified Ben-Muvhar discloses wherein the implant 100 has a length and the length of the central body is greater than the length of the implant 100 (see Fig. 4, para. 0045 of Ben-Muvhar).
Regarding claim 18, modified Ben-Muvhar discloses wherein the plurality of segments each have a different profile (see annotated Fig. 2 of Ben-Muvhar above; The examiner notes that the different profiles are due to the tapered shape of the balloon, such that the profile decreases in diameter along the length of the balloon from the most proximal segment to the most distal segment).
Regarding claim 19, modified Ben-Muvhar discloses wherein the inflatable body 200 is configured to be in an undeployed configuration (interpreted as the inflatable body in a deflated state, para. 0040) and is configured to be inflated to a deployed configuration (Figs. 2, 5, para. 0040, 0045 of Ben-Muvhar).
Regarding claim 20, modified Ben-Muvhar discloses wherein the inflatable body 200 is configured to not expand beyond a defined profile of the inflatable body upon inflation of the inflatable body (Fig. 2, para. 0040 of Ben-Muvhar).
Regarding claim 29, modified Ben-Muvhar discloses wherein each of the at least three imaging markers 52-54 is positioned at an end portion of the respective one of the plurality of segments (see annotated Fig. 7 of Fischell below which illustrates the three central markers being positioned at end portion of a plurality of segments such that the combination would yield a product wherein the at least three imaging markers of Fischell being positioned at the end portion of the plurality of segments of Ben-Muvhar).
Regarding claim 31, modified Ben-Muvhar discloses wherein the implant is configured to be aligned with one of the at least three imaging markers when the implant is positioned on the central body (Fig. 7, col. 5 lines 22-27 of Fischell).
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Annotated Fig. 7 of Fischell
Claim(s) 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Muvhar (US 20060030920) in view of Fischell et al. (US 5669932) [hereinafter Fischell], as applied to claim 16 above, and further in view of Acaro et al. (US 20190091014) [hereinafter Acaro]].
Regarding claim 26, modified Ben-Muvhar discloses all of the limitations set forth above in claim 16. Modified Ben-Muvhar further discloses “Similarly, balloons of the general type described above may be used to deliver not only device 100, but also other implantable devices for implantation in other body passages of variable diameter, as are otherwise known in the art” (para. 0047 of Ben-Muvhar). However, modified Ben-Muvhar fails to disclose wherein the implant is a prosthetic heart valve.
Acaro teaches that it is known in the art to deliver a tapered prosthetic valve 100 (Figs. 1-2, para. 0088, 0091) by way of a balloon dilation device (para. 0235: “The prosthetic valve 100 can be self-expanding and/or expansion can also be facilitated by expanding a balloon”)
The substitution of one known implant (prosthetic heart valve as shown in Acaro) for another (stent as shown in modified Ben-Muvhar) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since modified Ben-Muvhar discloses that other implantable devices may be used for other locations in the body and since the substitution of the prosthetic heart valve shown in Acaro would have yielded predictable results, namely, allow the dilation balloon of modified Ben-Muvhar to inflate and expand the prosthetic heart valve for use in heart valve replacement surgery (para. 0086 of Acaro).
Regarding claim 27, modified Ben-Muvhar discloses wherein the implant has a tapered interior profile (see Figs. 34 of Acaro, para. 0091).
Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Muvhar (US 20060030920) in view of Fischell et al. (US 5669932) [hereinafter Fischell], as applied to claim 16 above, and further in view of Byrne et al. (US 20150112256) [hereinafter Byrne].
Regarding claim 28, modified Ben-Muvhar discloses all of the limitations set forth above in claim 16. However, modified Ben-Muvhar fails to disclose wherein at least one of the at least three imaging markers is positioned on a wall of the inflatable body.
Byrne in the same field of endeavor of balloon catheters teaches that it is known in the art to position at least one of a plurality of imaging markers on a wall of an inflatable body (Figs. 10-11, para. 0027-0029).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the location of at least one of the plurality of imaging markers in modified Ben-Muvhar to the wall of the inflatable body, as taught by Byrne (see para. 0027, 0029 of Byrne), since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). MPEP 2144.04 VI. C. Shifting the location of the imaging markers of modified Bev-Muvhar would not have modified the operation of the dilation device because the imaging markers would still indicate the position of the greatest diameter of the plurality of segments whether they are located on the catheter shaft or the wall of the inflatable body as the location change does not move the markers along the longitudinal axis, rather it moves them vertically. Thus, the position of the markers relative to the plurality of segments along the longitudinal axis would not change.
Claim(s) 30 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Muvhar (US 20060030920) in view of Fischell et al. (US 5669932) [hereinafter Fischell], as applied to claim 16 above, and further in view of Jang (US 20080188803).
Regarding claim 30, modified Ben-Muvhar discloses all of the limitations set forth above in claim 16. Modified Ben-Muvhar further discloses that the inflatable body 200 is a balloon that is attached to a catheter so that the balloon can be inflated and deflated (para. 0040 of Ben-Muvhar). However, modified Ben-Muvhar fails to specifically disclose further comprising an inflation lumen for the inflatable body, and wherein the at least three imaging markers are positioned on the inflation lumen.
Jang in the same field of endeavor of inflatable dilation devices for delivering a stent (Fig. 3A, para. 0038) teaches that it is known in the art for the dilation device to comprise a catheter shaft 26 containing an inflation lumen 36 for inflating and deflating a balloon 100, wherein a plurality of imaging markers 120, 122, 124 are positioned on the inflation lumen 36 by way of the catheter shaft 26 (see Fig. 3A, para. 0038).
Therefore, the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention (i.e., one skilled in the art would have recognized that the catheter shaft comprising the inflation lumen used in Jang would allow the catheter of Ben-Muvhar to inflate and deflate the inflatable body of the device and provide a way for the imaging markers to be positioned on the inflation lumen by way of the catheter shaft, Fig. 3A, para. 0038 of Jang).
Conclusion
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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