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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 1/12/2026 is acknowledged. Claims 16-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/12/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 9, 13, and their dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 7 and 13 recite the limitation "the star shape of the proximal inner wedge." There is insufficient antecedent basis for these limitations in the claims, as the claims have not established that the proximal inner wedge has a star shape. It is further unclear how the bumper has a portion that is both a wedge shape and a star shape. Claim 9 recites the limitation "the plurality of valve stops." There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (Pub. No.: US 2013/0030519 A1; hereinafter “Tran”) in view of Zhang (Pub. No. US 2010/0185271 A1).
Tran teaches the following regarding claim 1: a balloon catheter for deploying a prosthetic heart valve through balloon inflation, comprising: an inner shaft (610) defining a guidewire lumen (central lumen through element 610) (Figs. 46-47A); an outer shaft (608) surrounding the inner shaft (Figs. 46-47A) defining an inflation lumen (open space between the inner and outer shafts) between the outer shaft and the inner shaft (Figs. 46-47A; paras. 0147-0148); a distal portion (portion near element 624) at a distal end of the inner shaft (Figs. 46-47A); a balloon (612) disposed at the distal portion (Figs. 46-47A) such that fluid delivered to the balloon via the inflation lumen causes the balloon to inflate (paras. 0147-0148); a multipart retention bumper (614, 618), the multipart retention bumper being secured to the inner shaft inside the balloon (Figs. 46-47A; paras. 0146-0149) and configurable in an interlocked configuration (expanded, attached configuration) (paras. 0148-0149) and a non-interlocked configuration (un-expanded, un-attached configuration) (paras. 0148-0149), the multipart retention bumper including an inner wedge (inner, inclined portions of elements 614, 618) and an outer bumper (outer, end portions of elements 614, 618) (Figs 46-47A).
Regarding claims 1, 2, 7, and 13-14, Tran teaches the limitations of the claimed invention, as described above. Tran further teaches that its multipart retention bumper has a variety of shapes applied to its outer bumper (Figs. 5, 33, 46). However, it does not explicitly recite that the bumper comprises a star shape. Zhang teaches that it is well known in the art that a retention bumper comprises a variety of shapes, including a star shape on the outer, end portion of the bumper (42) (Figs. 3-6; paras. 0047-0051), for the purpose of providing the bumper with the desired geometry needed to properly fit against the surrounding implants and instruments. Zhang further teaches the star shape including a spoked perimeter having one or more spokes forming a plurality of valve stops (Figs. 4-6). The one or more extension arms (at the posterior portions of element 41) are radially aligned with the one or more spokes (at the anterior portions of element 41) (Figs. 4-6). It would have been obvious matter of design choice to one having ordinary skill in the art to modify the bumper of Tran to comprise a star shape, as taught by Zhang, in order to provide the bumper with the desired geometry needed to properly fit against the surrounding implants and instruments. Such a modification would be made with a reasonable expectation of success.
Tran teaches the following regarding claim 2: the balloon catheter of claim 1, wherein the multipart retention bumper is a proximal multipart retention bumper (614), the inner wedge is a proximal inner wedge (inner, inclined portions on element 614), and the outer bumper is a proximal outer bumper (outer, end portions on elements 614), and the balloon catheter further comprises: a distal multipart retention bumper (618), the distal multipart retention bumper being secured to the inner shaft inside the balloon (Figs. 46-47A; para. 0146) and configurable in an interlocked configuration (expanded, attached configuration) (paras. 0148-0149) and a non-interlocked configuration (un-expanded, un-attached configuration) (paras. 0148-0149), the distal multipart retention bumper including a distal inner wedge (inner, inclined portions on element 618) and a distal outer bumper (outer, end portions on elements 618).
Tran teaches the following regarding claim 3: the balloon catheter of claim 2, wherein in the non-interlocked configuration, the proximal inner wedge and the proximal outer bumper of the proximal multipart retention bumper each have a radially unexpanded size adapted to fit within a neck of the balloon during an assembly process (paras. 0146-0149), and wherein in the non-interlocked configuration, the distal inner wedge and the distal outer bumper of the distal multipart retention bumper have radially unexpanded sizes adapted to fit within the neck of the balloon during the assembly process (paras. 0146-0149).
Tran teaches the following regarding claim 4: the balloon catheter of claim 2, wherein in the interlocked configuration the proximal inner wedge and the proximal outer bumper of the proximal multipart retention bumper have a radially expanded size adapted to maintain an axial position of the prosthetic heart valve when the prosthetic heart valve is subject to axial force (paras. 0146-0149, where the expanded configuration would be fully capable of maintaining an axial position of the prosthetic heart valve), and wherein in the interlocked configuration the distal inner wedge and the distal outer bumper of the distal multipart retention bumper have a radially expanded size adapted to maintain the axial position of the prosthetic heart valve when the prosthetic heart valve is subject to axial force (paras. 0146-0149, where the expanded configuration would be fully capable of maintaining an axial position of the prosthetic heart valve).
Tran teaches the following regarding claim 5: the balloon catheter of claim 2, wherein the proximal inner wedge is configured to expand a diameter of the proximal outer bumper to a radially expanded size when the proximal inner wedge and the proximal outer bumper are in the interlocked configuration (paras. 0146-0149), and wherein the distal inner wedge is configured to expand a diameter of the distal outer bumper to the radially expanded size when the distal inner wedge and the distal outer bumper are in the interlocked configuration (paras. 0146-0149).
Tran teaches the following regarding claim 6: the balloon catheter of claim 2, wherein the proximal outer bumper is configured to stretch over the proximal inner wedge to achieve the interlocked configuration (paras. 0146-0149, where the outer end of 614 is positioned above the inner, angled wedge when in the expanded configuration), and wherein the distal outer bumper is configured to stretch over the distal inner wedge to achieve the interlocked configuration (paras. 0146-0149, where the outer end of 618 is positioned above the inner, angled wedge when in the expanded configuration).
As best interpreted, Tran teaches the following regarding claim 7: the balloon catheter of claim 2, wherein the star shape of the proximal inner wedge (as taught by Zhang, above, where the star shape would be on the end of the inner wedge) includes a seating hub (central portion of element 614) having one or more stabilization fins (expanding bodies between the slots of element 614) (paras. 0149-0150).
Tran teaches the following regarding claim 8: the balloon catheter of claim 2, wherein in the interlocked configuration an exterior face of a stop portion (exterior angled surfaces of element 614) of the proximal inner wedge is approximately flush with an abutment surface (exterior end surface of element 614) of the proximal outer bumper; and wherein in the interlocked configuration an exterior face of a stop portion of the distal inner wedge is approximately flush with an abutment surface of the distal outer bumper (Figs. 46-47A).
As best interpreted, Tran teaches the following regarding claim 9: the balloon catheter of claim 8, wherein the proximal multipart retention bumper further includes flow recesses (632) between the plurality of valve stops (interpreted as the physical arm bodies between slots 632), the flow recesses being configured to permit longitudinal inflation fluid flow and limit radial inflation fluid flow (Figs. 46-47A, where the open spaces are fully capable of permitting fluid flow).
Tran teaches the following regarding claim 10: the balloon catheter of claim 2, wherein the proximal inner wedge (inner, inclined portion of element 614) and the distal inner wedge (inner, inclined portion of element 618) are substantially non-compressible during steps of manufacture, assembly, and use of the balloon catheter, and wherein the proximal outer bumper and the distal outer bumper are expandable (paras. 0146-0149). Please note that method limitations in article claims have been considered to the extent that it further defines the structure of the claimed device. As presently worded, the scope of the subject matter fails to structurally distinguish the present claim language over the prior art.
Tran teaches the following regarding claim 11: the balloon catheter of claim 2, wherein the proximal inner wedge and the distal inner wedge are over molded to the inner shaft (Figs. 47-47A).
Tran teaches the following regarding claim 12: the balloon catheter of claim 2, wherein the proximal multipart retention bumper and the distal multipart retention bumper are secured to the inner shaft with a space therebetween (area between elements 614 and 618, which would be fully capable of accommodating a heart valve) to accommodate the prosthetic heart valve (Figs. 46-47A).
As best interpreted, Tran teaches the following regarding claim 13: the balloon catheter of claim 2, wherein the star shape of the proximal inner wedge (as taught by Zhang, above, where the star shape would be on the end of the inner wedge) includes a ridged tapered body (elevated, expanded portion of element 614) having one or more extension arms (physical arm bodies between slots 632).
As best interpreted, Tran teaches the following regarding claim 15: the balloon catheter of claim 14, wherein the proximal multipart retention bumper further includes flow recesses (632) between one or more extension arms radially aligned with the one or more spokes (Figs. 46-47A), the flow recesses being configured to permit longitudinal inflation fluid flow and limit radial inflation fluid flow (Figs. 46-47A, where the open spaces are fully capable of permitting fluid flow).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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