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 of the species 1 directed to Figures 1-3 in the reply dated 7/16/2026 without traverse is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regard to claim 6, “further comprising a fluid actuator” is not interpreted to further limit claim 1 which already recites “a conduit configured to extend between the inflatable balloon and a fluid actuator” and “configured to convey movement of the fluid to inflatable balloon from the fluid actuator”. Based on these recitations, the fluid actuator must necessarily already be present and positively recited in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
(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, 6-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gillick (2013/0261729A1).
In regard to claim 1, Gillick discloses a catheter delivery system (fig 2; 122) for delivering a prosthetic heart valve to a native heart valve [0002; fig 2; since the device delivers stent 126, the device is capable of delivering a heart valve which is often supported within a stent], the catheter delivery system comprising:
an inflatable balloon 125 for insertion within a patient's body and configured to be inflated with a fluid within the patient's body [0049: configured to inject inflation fluid into], the inflatable balloon 125 including an outer surface having a retention area for retaining the prosthetic heart valve (see figure 2; stent 126 is placed over balloon 125 and that overlap can be considered a retention area);
an elongate catheter shaft 124 configured to extend within the patient's body and having a distal end portion configured to couple to the inflatable balloon 125 and a proximal end portion (end towards handle 128; fig 2);
a fluid conduit 133 configured to extend between the inflatable balloon 125 and a fluid actuator (inflation device 128 [0052]), and configured to convey movement of the fluid to the inflatable balloon from the fluid actuator to inflate the inflatable balloon to thereby expand the prosthetic heart valve [0052: to pump inflation fluid into the inflation lumen 124 into balloon 125; see fig 2, stent 126 is over balloon 125 and will be expanded];
and a hydraulic shock arrestor 130 (fluid accumulator) configured to mitigate pressure surge within the fluid conduit. [0014: pressure attenuator to control a rate of fluid pressure increase; 0043; 0050]
In regard to claim 2, Gillick discloses the catheter delivery system of claim 1, and further discloses the fluid conduit 133 extends along the elongate catheter shaft 124, and the hydraulic shock arrestor 130 is configured to be positioned on the fluid conduit 133 at a position between the elongate catheter shaft 124 and the fluid actuator 124 (see figure 2; 133 is between the distal portion of 124 and 128).
In regard to claim 6, Gillick discloses the catheter delivery system of claim 1, and further discloses the fluid actuator 128.
In regard to claim 7, Gillick discloses the catheter delivery system of claim 6, and further discloses the fluid actuator 128 is positioned at a proximal end portion of the fluid conduit 124 (see fig 2).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillick (2013/0261729A1) in view of Joergensen (WO2005/068007A2).
In regard to claim 3, Gillick meets the claim limitations as discussed in the rejection of claim 1, but does not teach a guidewire lumen.
Joergensen teaches the elongate catheter shaft 22 includes a guide wire lumen 34 extending along the elongate catheter shaft and configured to receive a guide wire.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the guidewire lumen of Joergensen in the catheter of Gillick because the guidewires will help with positioning of the stent and allows multiple or branched stents to also be placed (abstract).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillick (2013/0261729A1) in view of Willis (WO9533510A1).
In regard to claim 8, Gillick meets the claim 6, and further teaches a tube (portion of 124 between 128 and 133, proximal end) extending from the fluid actuator 128 to the hydraulic shock arrestor 130.
However, Gillick does not teach the tube surrounds the fluid conduit.
Willis teaches a tube connection where a tube 28 surrounds a fluid conduit 25 in a catheter system.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the tube connection of Willis in the catheter of Gillick between the fluid actuator and shock arrestor of Gillick because the connectors are adapted for convenient attachment (pg 9, 3rd paragraph) and allow pieces to be exchanged.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillick (2013/0261729A1) in view of Druma (EP3260069A1).
In regard to claim 10, Gillick discloses the catheter delivery system of claim 6, and further discloses the fluid actuator 128 in configured to inject fluid [0049] but remains silent to how that occurs.
Druma teaches a fluid actuator configured to inject fluid which includes a plunger 70 slidably engaged with a barrel of the fluid actuator 76, the fluid being expelled from the barrel by lowering the plunger through the barrel. (fig 2)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the fluid actuator of Druma in place of the fluid actuator of Gillack because both devices inject fluid into a catheter to inflate a balloon and are therefore functional equivalents. MPEP 2144.06II
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillick (2013/0261729A1) in view of Armer (10702407B1).
In regard to claim 15, Gillick meets the claim limitations as discussed in the rejection of claim 1, and further teaches a frame (stent 126) and that instead various scaffolds, stents or tubular medical devices may be used [0024].
However, Gillick does not teach a heart valve.
Armer teaches the prosthetic heart valve (fig 3B), wherein the prosthetic heart valve includes a frame 100 and a plurality of leaflets 150 coupled to the frame (fig 3B) delivered by a balloon catheter system (fig 9).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the heart valve stent of Armer in place of the stent of Gillick since this would allow the surgeon to deliver a growth stent which can maintain radial strength across a range of diameters as the patient grows (abstract). Both stents are delivered via balloon catheter within the vascular system of a patient.
Claim(s) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saar (2019/0015642A1) in view of Gillick (2013/0261729A1).
In regard to claim 16, Saar teaches a method of delivering a prosthetic heart valve to a native heart valve (abstract: transcatheter delivery of prosthetic heart valves), the method comprising:
extending an elongate catheter shaft 402 of a catheter delivery system within a portion of a patient's body (see fig 12), the catheter delivery system including:
an inflatable balloon 400 coupled to a distal end portion of the elongate catheter shaft 402 and configured to be inflated with a fluid [0005], the inflatable balloon 400 including an outer surface having a retention area for retaining the prosthetic heart valve 310, a fluid actuator 130 configured to move the fluid to inflate the inflatable balloon [0005],
positioning the inflatable balloon at the native heart valve 422 within the patient's body 420 (fig 12-13);
and inflating the inflatable balloon 400 utilizing the fluid actuator 130 with the prosthetic heart valve 410 positioned on the outer surface of the inflatable balloon to thereby expand the prosthetic heart valve 410 at the native heart valve 410 (fig 13).
However, Saar does not teach a hydraulic shock arrestor or a fluid conduit as claimed.
Gillick teaches a hydraulic shock arrestor 130 configured to mitigate pressure surge within the fluid conduit 124 (fig 2) [0014: modulates fluid pressure increase; 0040: control over inflation rate; 0043: pressure attenuator; 0044: pressure control over when pressure exceeds a maximum pressure]; and a fluid conduit 133 extending between the inflatable balloon and the fluid actuator and configured to convey movement of the fluid to the inflatable balloon from the fluid actuator. (extends on the body of the catheter between an actuator 128 and balloon 125 and will therefore be in the same position when substituted into the catheter of Gillick)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the shock arrestor and connected fluid conduit of Gillick in the catheter of Saar because control over the inflation rate will mitigate implant damage during deployment [0040].
In regard to claim 17, Saar meets the claim limitations as discussed in the rejection of claim 16, but does not teach the hydraulic shock arrestor as claimed.
Gillick further teaches the hydraulic shock arrestor 130 is a water hammer arrestor. A water hammer arrestor does not refer to a specific structure, only a shock arrestor capable of stopping a water hammer. Since the hydraulic shock arrestor of Gillick prevents surges in pressure, the device is capable of stopping a water hammer which causes spikes in pressure. [0014: modulates fluid pressure increase; 0040: control over inflation rate; 0043: pressure attenuator; 0044: pressure control over when pressure exceeds a maximum pressure]
In regard to claim 18, Saar meets the claim limitations as discussed in the rejection of claim 16, but does not teach the hydraulic shock arrestor as claimed.
Gillick further teaches the hydraulic shock arrestor 130 is configured to mitigate pressure surge caused by rapid cessation of flow of the fluid. Since the arrestor 130 mitigates pressure surges [0014: modulates fluid pressure increase; 0040: control over inflation rate; 0043: pressure attenuator; 0044: pressure control over when pressure exceeds a maximum pressure], the device is capable of mitigating pressure surges caused by the rapid cessation of the flow of fluid. If a certain structure is being used to mitigate certain types of pressure surges, it is suggested to claim the particular structure itself.
In regard to claim 19, Saar meets the claim limitations as discussed in the rejection of claim 16, wherein the fluid actuator 130 includes a plunger 122 slidably engaged within a barrel 110 of the fluid actuator, [0005].
However, Saar does not teach the hydraulic shock arrestor as claimed.
Gillick further teaches the hydraulic shock arrestor 130 is configured to mitigate pressure surge caused by the plunger bottoming out within the barrel. Since the arrestor 130 mitigates pressure surges [0014: modulates fluid pressure increase; 0040: control over inflation rate; 0043: pressure attenuator; 0044: pressure control over when pressure exceeds a maximum pressure], the device is capable of mitigating pressure surges caused by the plunger bottoming out.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saar (2019/0015642A1) in view of Gillick (2013/0261729A1) and further in view of Bowes (2017/0360560A1).
In regard to claim 20, Saar meets the claim limitations as discussed in the rejection of claim 16, but remains silent to what type of native heart valve the device is implanted into.
Bowe teaches the native heart valve is an aortic heart valve. (see title [00199: advanced into the aorta])
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the valve in the native aorta because this allows a damaged aortic valve to be replaced [0119].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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