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
This action is entered in response to Applicant's amendment and reply of 4/29/26. The claims 1-23 are pending. The claims 1, 22 are amended.
Response to Arguments
Applicant’s arguments, filed 4/29/26 with respect to the rejections of claims 1-20 under 35 U.S.C. 103 as being unpatentable over Konstantino (US2012/0059401) in view of Tilson (WO2014/063039) have been fully considered but they are not persuasive. Applicant argues, Konstantino does not disclose the first balloon being secured to the first frame member when the first balloon is in an unpressurized condition. Examiner disagrees, the device of Konstantino as modified by Tilson has teaches the claimed functions of the first balloon being secured to the first frame member when the first balloon is unpressurized. As previously stated in the previous non-final rejection response to arguments mailed 2/5/26, “secure” under broadest reasonable interpretation is to “fasten firmly to another object” from Collins Dictionary. Since the first frame member and the first balloon are connected together by the balloon being within and connected to the frame and also the frame connected to the distal and proximal side of the balloon as stated in paragraph [0028], the components are interpreted as secured to each other. Applicant states the balloon is not fastened to the expandable ring by the definition provided. Examiner makes notice, the structures are fastened by being connected to the distal side or proximal side of the balloon as stated in paragraph [0028] of Konstantino. Where one of ordinary skill in the art would understand the structures are fastened by the connection. Applicant argues, nowhere does Konstantino teach the balloon is fastened to the expandable ring 18. Examiner makes notice, it appears Applicant is interpreting the limitation narrower than the actual claimed limitation. The claim does not recite the first frame member having struts that are fastened to the balloon along an outer surface of the strut as it appears Applicant is arguing. The claim merely recites the first balloon being secured to the first frame members, where this limitation is broadly interpreted as any securement of the first balloon to the first frame member such as by the connection to the distal or proximal side of the balloon as stated in paragraph [0028].
With regard to claim 22, Applicant further argues, Konstantino nor Tilson teach or suggest the claimed zigzag shape of the elongate inflatable first balloon that zigzags along and corresponds to the zigzag shape of the first frame member. Examiner makes notice, it appears Applicant is interpreting the limitation narrower than the actual claimed limitation. The claim does not recite the claim zigzag shape of the first balloon and the zigzag shape of the first frame member being aligned with apexes that overlie. The claim merely recites the zigzag shapes of the first balloon and the first frame member correspond to each other. This limitation is given its broadest reasonable interpretation as the structures corresponding to each other in some manner. Where the zigzags of the frame member of Konstantino and the zigzags of the balloon of Tilson, both zigzag along a radial axis extending outward from the center axis and therefore are interpreted as corresponding.
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 of this title, 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 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over Konstantino (US2012/0059401) in view of Tilson (WO2014/063039).
Regarding claim 1, Konstantino discloses an inflatable dilatation device (angioplasty balloon catheter, [0003]) including:
a tubular frame including a first frame member (first ring 18, see annotated Fig. 2A) that zigzags circumferentially (see Fig. 3A, [0034]) to enable the first frame member to expand circumferentially during radial expansion of the tubular frame (capable of enabling the first frame member to expand circumferentially by the bend in the material 18 being straightened as shown in Fig. 3B);
from a contracted condition in which each turn of the first frame member defines an acute angle (see Fig. 3A where the zig-zags form an acute angle at each turn of the frame 18);
towards an expanded condition in which the angle defined by at least two turns of the first frame member increases from the respective acute angle (zigzags are stretched and therefore the angle between turns increases, [0034]); and
an elongate inflatable first balloon (12) that: is secured to the first frame member ([0028]); and expands along the first frame member ([0032]),
and is secured to the first frame member when: the first balloon is not pressurized and the first frame member is in the contracted condition (see Fig. 2B1, [0031]); and the first balloon is inflated and the first frame member is in the expanded condition (see Fig. 2B2, [0032]).
such that inflation of the first balloon causes the first balloon and the first frame member circumferentially to expand in unison from a contracted condition to an expanded condition ([0032]) as a consequence of the first balloon being secured to the first frame member in both of the contracted condition and the expanded condition (the balloon is secured to the first frame in both conditions, [0028]).
Konstantino fails to disclose the elongate inflatable first balloon zigzags along the first frame member to enable the first balloon, as the first balloon is inflated, to expand circumferentially and straighten at apexes defined by the first balloon as secured to the first frame member. Tilson, in the same field of endeavor, teaches an inflatable dilatation device that includes a balloon used for angioplasty (see Abstract, [00334]) including: a tubular frame (shell 678, [00208]); and an elongate inflatable first balloon (650, see Fig. 24A) that is secured to the first frame member ([00208]); and zigzags along the first frame member (see Fig. 24A, [00195]) such that inflation of the first balloon causes the first balloon and the first frame member circumferentially to expand in unison from a contracted condition to an expanded condition (expands in unison by the frame expanding by the inflation of the balloon, [00148]). Where the balloon includes multiple balloon segments 656 (a segment is interpreted as first balloon, and another segment as a second balloon) that each include their own inflation lumen ([00322]). Tilson teaches the zig-zag arrangement of balloon segments allows fluid flow through the center of the balloon ([0008]; [0209]), where blockage of fluid flow by typical balloons can cause short and longer term health problems and minimize the time the balloon may be inflated [0005-0007]. Tilson further teaches precise shape control [0008], as the different inflation lumens provide the ability to separately inflate different segments of the balloon ([00193]). Tilson further teaches when the balloon is inflated, it expands circumferentially (see Fig. 24A) and straighten at apexes defined by the first balloon as secured to the first frame member (the balloon is interpreted as “straightening” at apexes by the expansion of the balloon at the apex, a portion of the balloon at the top or rounded part of the apex when expanded outward defines a region that straightens, see Fig. 23B, 24B). It would have been obvious to one having ordinary skill in the art to have substituted the balloon segments in the form of a zig-zag pattern of Tilson for the balloon of Konstantino, since the substitution would have yielded predictable results of a balloon for performing angioplasty with the added benefits of allowing fluid flow, preventing damage to the patient, and shape control. The modification results in a first balloon that zigzags along the first frame member.
Regarding claim 2, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 1, the modified invention further discloses wherein at least three apexes defined by the first balloon correspond to at least three apexes defined by the first frame member (apexes of the ring 18 of Konstantino and apexes of the balloon of Tilson correspond to each other by extending in the same direction), and wherein the frame further includes a set of second frame members (see annotated 2A of Konstantino) that extend longitudinally in a first axial direction from apexes on a first side of the first frame member (apexes of the first frame member would extend in the same direction of the second frame members, see annotated Fig. 2A of Konstantino).
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Regarding claim 3, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 2, Konstantino further discloses a third frame member (third ring 18, see annotated Fig. 2A) that: zigzags circumferentially (see Fig. 3A, [0034]); and is axially spaced from the second side of the first frame member (second side of the first frame member is interpreted as the direction away from catheter 26 to distal end, see annotated Fig. 2A).
Regarding claim 4, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 3, Konstantino further discloses a set of fourth frame members (see annotated Fig. 2A) that extend longitudinally between:
longitudinally aligned apexes on a first side of the first and third frame members (apexes of the zig zags of the first and third frame members are aligned by the alignment of the rings along the longitudinal axis, see Fig. 2A; where the first side of both the first and third frame members are toward the proximal end and catheter 26, see annotated Fig. 2A); and longitudinally aligned apexes on a second side of the first and third frame members (apexes of the zig zags of the first and third frame members are aligned by the alignment of the rings along the longitudinal axis, see Fig. 2A; where the second side of both the first and third frame members are toward the distal end and away from catheter 26, see annotated Fig. 2A; where the fourth frame elements are between the third frame member and the first frame member, see annotated Fig. 2A).
Regarding claim 5, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 4, the modified invention further discloses including an elongate inflatable second balloon (one or more of the balloon segments 656 with an inflation lumen separate from the one used to inflate balloon 650, [00322] of Tilson) that is secured to the third frame member (the balloon segment is secured to the constraining frame of Konstantino by the frame surrounding the balloon entirely, [0014] of Konstantino); and zigzags along the third frame member (two or more balloon segments 656 would create a zigzag, where one or more balloon segments 656 may have a separate inflation lumen, [00322] of Tilson; where the zigzag would occur on the third frame member of Konstantino by the balloon segments forming the zigzag pattern along the third frame member 18, see annotated Fig. 2A of Konstantino), such that inflation of the second balloon causes the second balloon and the third frame member circumferentially to expand in unison from a contracted condition to an expanded condition ([0035] of Konstantino).
Regarding claim 6, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 5, Konstantino further discloses wherein a set of fifth frame members (see annotated Fig. 2A) that extend longitudinally in a second axial direction from apexes on a second side of the third frame member (extend in a second direction from a second side of the third frame member that is toward the distal end and away from catheter 26; see annotated Fig. 2A).
Regarding claim 7, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 6, the modified invention discloses wherein:
the apexes on both sides of the first balloon correspond to the apexes on both sides of the first frame member (the apexes of the substituted first balloon segment correspond to the apexes on both sides of the first frame member by the apexes of the balloons being on both sides of the first frame member, see annotated Fig. 2A of Konstantino, where the substituted balloon structure 650 of Tilson as in Fig. 17 would be within the constraining frame 14 of Konstantino); and
the apexes on both sides of the second balloon correspond to the apexes on both sides of the third frame member (the apexes of the two or more balloon segments of the second balloon correspond to the apexes on both sides of the third frame member by the apexes of the second balloon being on both sides of the third frame member, see annotated Fig. 2A of Konstantino, where substituted balloon structure 650 of Tilson as in Fig. 17 would be within the constraining frame 14 of Konstantino).
Regarding claim 8, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 7, Konstantino further discloses wherein the tubular frame includes:
a first ring (ring at the proximal end, see Fig. 2B2) at a first axial end of the tubular frame; and a second ring (ring at distal end, see Fig. 2B2) at a second axial end of the tubular frame, which first and second rings do not expand in sympathy with expansion of the first or third frame members (the rings at the distalmost and proximalmost end are shown not to expand from Fig. 2B1 to Fig. 2B2).
Regarding claim 9, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 8, Konstantino further discloses wherein: the set of second frame members extend from the first frame member to the first ring (see annotated Fig. 2A); and the set of fifth frame members extend from the third frame member to the second ring (see annotated Fig. 2A).
Regarding claim 10, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 9, Konstantino further discloses wherein the second, fourth and fifth frame members are linear (the members are linear by being straight beams, [0033], see annotated Fig. 2A).
Regarding claim 11, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 10; yet, is silent regarding the first balloon is adhered to the first frame member; and the second balloon is adhered to the third frame member. Tilson further teaches adhesive used to bond the shell 678 to balloon 650 ([00303]), where the adhesive is coated to the entirety of the balloon ([00302]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to have the balloon adhered to the frame member, as taught by Tilson, in order to bond the balloon to the constraining frame to form the annular balloon structure and prevent balloon movement within the frame ([00303]). Where the first balloon would be adhered to the first frame member and the second balloon adhered to the second frame member by adhesive applied to the entirety of the balloon in the same manner as described in Tilson ([00302]).
Regarding claim 12, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 11, the modified invention discloses wherein:
between each alternating turn of the first frame member, the first balloon is adhered to the first frame member at least 3 spots that are spaced from each other (entirety of balloon is coated in an adhesive, [00302] of Tilson, therefore the constraining frame of Konstantino would be adhered to the balloon at multiple locations); and
between each alternating turn of the third frame member, the second balloon is adhered to the third frame member at least 3 spots that are spaced from each other (entirety of balloon is coated in an adhesive, [00302] of Tilson, therefore the constraining frame of Konstantino would be adhered to the balloon at multiple locations).
Regarding claim 13, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 12, Tilson further teaches wherein:
the first balloon defines an inlet at a first axial end of the first balloon (see Fig. 17, [00322] of Tilson), in use, to inflate the first balloon; and the second balloon defines an inlet at a first axial end (see Fig. 17, [00322] of Tilson) of the second balloon, in use, to inflate the second balloon.
Regarding claim 14, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 13, Tilson further teaches wherein:
the first balloon defines an inlet at a second axial end of the first balloon (see Fig. 17, [00322] of Tilson), in use, to inflate the first balloon; and the second balloon defines an inlet at a second axial end of the second balloon, in use, to inflate the second balloon (see Fig. 17, [00322] of Tilson).
Regarding claim 15, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 14, Tilson further teaches wherein the first balloon and the second balloon are in fluid communication with each other, in use, to equalize pressure within the first and second balloons (balloons can share the same inflation lumen, see Fig. 17, [00322] of Tilson).
Regarding claim 16, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 15, Tilson further teaches wherein:
when the first balloon is in the expanded condition, the first balloon defines an angle of at least 30 degrees at each turn of the first balloon (see Fig. 17, balloon is threaded around pins 45 or 90 degrees, [00196] of Tilson); and
when the second balloon is in the expanded condition, the second balloon defines an angle of at least 30 degrees at each turn of the second balloon (see Fig. 17, balloon is threaded around pins 45 or 90 degrees, [00196] of Tilson).
Regarding claim 17, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 16, Tilson further teaches wherein:
when the first balloon is in the expanded condition, at least 60% of the axial length of the first balloon is laterally spaced from adjacent portions of the first balloon (adjacent portions of the first balloon may be separated by one balloon segment 656, see Fig. 17 of Tilson); and
when the second balloon is in the expanded condition, at least 60% of the axial length of the second balloon is laterally spaced from adjacent portions of the second balloon (adjacent portions of the second balloon may be separated by one balloon segment 656, see Fig. 17 of Tilson).
Regarding claim 18, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 17, wherein the modified invention further discloses both the first and second balloons are disposed radially within the frame (where the balloon segments are within the shell 678 of Tilson as shown in Fig. 24A, see [00208]; and would be constrained by the constraining frame of Konstantino with the substituted balloon of Tilson in the same manner as shown in Fig. 2A).
Regarding claim 19, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 18; yet, is silent regarding wherein the first and second balloons are made of polytetrafluoroethylene. Tilson further teaches wherein the balloons segments have a coating of PTFE ([00229]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to have the balloons made of PTFE as taught by Tilson in order to help bond the balloon to the constraining structure ([00229]).
Regarding claim 20, Konstantino/Tilson makes obvious the inflatable dilatation device according to claim 19, Konstantino further discloses wherein the frame is made of nitinol ([0028] of Konstantino).
Regarding claim 21, Konstantino/Tilson makes obvious the inflatable dilation device according to claim 20, Konstantino further discloses wherein the first frame member defines acute internal angles at the apexes of the first frame member (angles defined by the first frame member 18 are acute angles, see Fig. 3A).
Regarding claim 22, Konstantino/Tilson makes obvious the inflatable dilation device according to claim 1, Konstantino further discloses wherein the first balloon is secured to the first frame member at distinct points of securement (the distinct points of securement points are interpreted as where the first frame member 18 is connected to the balloon catheter at the distal and proximal side of the balloon, [0028]), wherein the distinct points of securement are each spaced apart from one another (the CS can be connected to the balloon catheter at the proximal and distal side of the balloon, [0028]); and wherein the first balloon zigzags along and corresponds to the zigzag shape of the first frame member (where the zigzags of the frame member of Konstantino and the zigzags of the balloon of Tilson, both zigzag along a radial axis extending outward from the center axis and therefore are interpreted as corresponding, where the first balloon zigzags along the first frame member, by having the zigzag shape within the first frame member).
Regarding claim 23, Konstantino/Tilson makes obvious the inflatable dilation device according to claim 22, the modified invention discloses wherein at least three apexes defined by the first balloon correspond to at least three apexes defined by the first frame member (the apexes of the first balloon of Tilson, and the apexes of the first frame member 18 are interpreted as corresponding by being aligned in the same longitudinal direction, see Fig. 24A of Tilson, see Fig. 3A of Konstantino), and including at least one of the distinct points of securement between each adjacent pair of apexes of the first frame member (the securement are interpreted as where the first frame member 18 is connected to the balloon catheter at the distal and proximal side of the balloon, [0028], where the securement points would be between each pair of apexes of the first frame member along a longitudinal axis).
Conclusion
THIS ACTION IS MADE FINAL. 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 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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