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 .
Specification
The abstract of the disclosure is objected to because it should be 150 words or less. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 11 objected to because of the following informalities: "an radial direction" in line 9 should read "a radial direction". Appropriate correction is required.
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 8-9 and 11 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.
Claim 8 recites “a tubular structure . . . a tapered resilient member or a multi-ridge clamp” as types of proximal support members. Claim 8 also recites “the tubular structure, the resilient member or the multi-ridge clamp” as types of distal support members. It is unclear, by use of the “a” and “the” articles if the proximal and distal support members are the same unitary item or if they are single and separate sets of options. For the purposes of examination, the examiner is assuming the applicant meant each of the supports are one of a tubular structure, a tapered resilient member or a multi-ridge clamp in which the aforementioned claim requirements should be rewritten as:
“The delivery catheter of claim 3, wherein the proximal support member and/or the distal support member is one of a tubular structure open at both ends, a tapered resilient member or a multi-ridge clamp.”
Dependent claim 9 is likewise rejected.
Claim 11 recites the limitation "the indentation stripes" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 10 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Madrid (US 2012/0209375 A1).
Regarding claims 1 and 10, Madrid teaches 1. (Original) A delivery catheter (fig. 22), comprising a catheter (210, sheath, fig. 22), a balloon structure (250, expansion device, fig. 24) and a guidewire tube (258, inner tube, fig. 24), wherein: the balloon structure is disposed at a distal end of the catheter (fig. 24); and the guidewire tube is inserted within the catheter and the balloon structure (fig. 24),
wherein the balloon structure comprises an expandable component (252, inner balloon member, fig. 24) and a balloon body (254, outer balloon member, fig. 24), wherein the expandable component is disposed within the balloon body so as to be expandable therein (fig. 24), the expandable component sleeved over a distal end of the guidewire tube (fig. 24), wherein an implant is sleeved over the balloon body and is axially restrained over a middle portion of the expandable component during delivery (208, prosthetic device, fig. 22, ¶ [0111], ¶ [0162]).
The phrase “the expandable component is configured to provide . . . and a proximal end thereof into communication” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the inner balloon member is considered to be capable of providing a radially outward support force from a middle portion of the balloon body during an expansion so as to bring an internal environments of the balloon body at a distal end and a proximal end thereof into communication.
Regarding claims 2 and 13, Madrid further teaches the implant comprises an artificial valve (¶ [0021] and ¶ [0157]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3-9 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madrid in view of Kutscher (US 2005/0209674 A1).
Regarding claims 3 and 14, Madrid fails to teach a proximal support and a distal support. However, Kutscher discloses a balloon catheter system that teaches the balloon structure further comprises a proximal support member (760, expansion control member, fig. 25B) and a distal support member (768, expansion control member, fig. 25B) which are both provided within the balloon body (when connected to the expandable component), wherein each of the proximal and the distal support members has a same axial direction as the expandable component (fig. 25), wherein: the proximal support member is sleeved over a proximal end of the expandable component (fig. 25A); and the distal support member is sleeved over a distal end of the expandable component (fig. 25A), and wherein the artificial valve is axially restrained between the proximal and distal support members during delivery (the valve is centrally placed on the balloon structure and would be restrained between the supports that are on the proximal and distal ends of the expandable component).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the balloon structure of Madrid to include a proximal and distal support as taught by Kutscher in order to maintain the outer profile of the balloon (Kutscher, ¶ [0235]).
Regarding claims 4 and 15, Madrid further teaches an inflatable balloon body (¶ [0162]) comprising a first section, a second section and a third section, that are sequentially connected from a proximal end to a distal end thereof (see annotated fig. 24, below), the second section is located between the proximal and distal support members (see annotated fig. 24, below), and wherein the artificial valve is arranged over the second section during delivery (fig. 21).
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Madrid fails to teach the alignments of the supports and inflatable balloon body. However, Kutscher further teaches the first section is inserted within the proximal support member (fig. 25A) and is proximally connected to an inner wall of the catheter (Madrid, fig. 22 and fig. 24, the support is connected to the inner wall of the catheter 210 through the balloons, the implant and the interconnecting fluid when in the compressed configuration and is connected on the proximal end of the device); the third section is inserted within the distal support member (fig. 25A) and is distally connected to an outer wall of the guidewire tube (Madrid, fig. 22 and fig. 24, the support is connected to the guidewire tube 256 and is connected on the distal end of the device). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the support and inflatable balloon body alignment of Madrid to include the first section is inserted within the proximal support member and is proximally connected to an inner wall of the catheter; the third section is inserted within the distal support member and is distally connected to an outer wall of the guidewire tube as taught by Kutscher in order to maintain the outer profile of the balloon (Kutscher, ¶ [0235]).
Regarding claim 5, the first embodiment of Madrid fails to teach an indentation stripe. However, a second embodiment taught by Madrid teaches each of the first section and the third section has at least one indentation stripe arranged circumferentially (156, grooves, fig. 15), wherein the at least one indentation stripe is provided on an outer wall of the inflatable balloon body (fig. 15), and wherein an extension direction of the indentation stripe is as same as an axial direction of the inflatable balloon body (fig. 15). Madrid states embodiments are combinable (¶ [0258]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the inflatable balloon body of Madrid' first embodiment to include an indentation stripe as taught by Madrid's second embodiment in order to allow the flow of fluid from the proximal end to the distal end of the device (Madrid, ¶ [0145]).
Regarding claim 6, the first embodiment of Madrid fails to teach at least on indentation spaced axially. However, the second embodiment of Madrid teaches at least on indentation spaced axially (fig. 15). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the inflatable balloon body of Madrid' first embodiment to include at least one indentation spaced axially as taught by Madrid's second embodiment in order to allow the flow of fluid from the proximal end to the distal end of the device (Madrid, ¶ [0145]).
Regarding claim 7, Madrid further teaches a secondary balloon (252, inner balloon member, fig. 24), wherein a distal end of the secondary balloon (see annotated fig. 24, below) and a proximal end of the secondary balloon (see annotated fig. 24, below).
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Kutscher further teaches the distal end of the secondary balloon is inserted within the distal support member (fig. 25A) and is connected to an outer wall of the guidewire tube (Madrid, fig. 22 and fig. 24, the support is connected to the guidewire tube 256); the proximal end of the secondary balloon is inserted within the proximal support member (fig. 25A) communicates with the catheter (Madrid, fig. 22 and fig. 24, the support is communicates with the inner wall of the catheter 210 through the balloons, the implant and the interconnecting fluid). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the support and inflatable balloon body alignment of Madrid to include the distal end of the secondary balloon is inserted within the distal support member and is connected to an outer wall of the guidewire tube, and wherein the proximal end of the secondary balloon is inserted within the proximal support member and communicates with the catheter as taught by Kutscher in order to maintain the outer profile of the balloon (Kutscher, ¶ [0235]).
Regarding claim 8, Madrid fails to teach the proximal and distal support members are a resilient member. However, Kutscher further teaches the proximal support member is a tapered resilient member (fig. 25B) and wherein the distal support member is the resilient member (fig. 25B). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the support members of Madrid to be a tapered resilient member as taught by Kutscher in order to maintain the outer profile of the balloon (Kutscher, ¶ [0235]).
Regarding claim 9, Madrid fails to teach the tapered resilient member(s) comprises a maximum diameter at an end thereof proximal to the artificial valve. However, Kutscher further teaches the tapered resilient member(s) comprises a maximum diameter at an end thereof proximal to the artificial valve (fig. 25B). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the tapered support members of Madrid to have a maximum diameter at an end proximal to the valve as taught by Kutscher in order to maintain the outer profile of the balloon (Kutscher, ¶ [0235]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madrid in view of Kutscher as applied to claim 4 above, and further in view of Bacich (US 2015/0133737 A1) and Vogul (US 2021/0330945 A1).
Regarding claim 11, Madrid teaches crimping the implant onto the balloon structure, wherein the balloon body fits against the inflatable balloon, and wherein the implant is axially restrained between the proximal and distal support members (¶ [0111]);
delivering the implant to a predetermined site (¶ [0023]);
introducing an inflation fluid from a proximal end of the catheter, wherein the inflation fluid then flows through the catheter into the inflatable balloon, wherein the implant initially expands along a radial direction through the inflatable balloon, and wherein the communication between the internal environments of the balloon body at the distal and proximal ends is established (¶ [0114]);
inflating the balloon body to a maximum size so as to fully expand the implant (¶ [0004] and ¶ [0121]); and
releasing the implant to the predetermined site (¶ [0004]).
Madrid and Kutscher fail to teach increasing the pressure to tear the inflatable balloon. However, Vogul teaches a balloon catheter that includes increasingly pressurizing the inflation fluid to cause tearing under an action of the pressure (¶ [0017]), bringing the interior of the inflatable balloon into communication with the exterior thereof (¶ [0018]), wherein the inflation fluid flows at a same rate and a same pressure into the balloon body through the first and third sections (since the indentations stripes would tear at the same pressure this would cause the fluid flow to move at the same rate and pressure when released). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the method of Madrid and Kutscher to include pressuring the inflatable balloon to cause tearing as taught by Vogul in order to gauge the outward pressure on the vessel so as to avoid over inflation of the vessel and avoid release of inflation fluid into the blood stream.
Madrid, Kutscher and Vogul fail to teach an indentation stipe that tears under pressure. However, Bacich discloses a balloon catheter that teaches the use of an indention strip to tear under an action of the pressure (¶ [0117-0118]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the inflatable balloon body of Madrid, Kutscher and Vogul to include an indentation strip as taught by Bacich in order to create a tear or a splits of the balloon (Bacich, ¶ [0118]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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