DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “plurality of lobes” (claim 36) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: line 12 should be amended to -a catheter comprising a fluidic passage operably connected to [[the]] an output of the connector and configured to transmit the second pulse energy-. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 16, 46 and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019200201 A1 to Gurm et al. (Gurm).
Gurm discloses:
Regarding claim 1:
A system for imparting pulsatile energy to cardiovascular tissue (figures 3-9), the system comprising:
(a) a console assembly (70-75) comprising a potential source (75);
(b) a manifold assembly (4/50) operably connected to an output (output connected at 50) of the console assembly (70-75), wherein the manifold assembly (4/50) comprises an oscillator (solenoid 4 which controls the pressure applied to 30/56/51/52) configured to generate pulse energy from energy transmitted from the potential source (75); and
(c) a catheter assembly (400/34/35/3/16/13) operably connected to an output (connected to the output A in figure 1 below) of the manifold assembly (4/50), wherein the catheter assembly (400/34/35/3/16/13) comprises:
(i) a connector (400) operably connecting the catheter assembly (400/34/35/3/16/13) to the manifold assembly (4/50) and configured to transduce a first pulse energy (the first pulse energy is the pulse energy generated by the solenoid 4 when it opens and closes the outlet 8) generated by the manifold assembly (4/50) to a second pulse energy (the second pulse energy is the pulse energy generated by the actuation of 30 which generates a different pulse energy in lines 35/3/16);
(ii) a catheter (16) comprising a fluidic passage (¶0052) operably connected to the output of the connector (400) and configured to transmit the second pulse energy (transmits the second pulse energy from 400 to the ballon 2/13); and
(iii) a heart-tissue-conforming element (ballon 2/13 (identified as 2 in figure 1 and 13 in figure 3)) configured to receive the second pulse energy transmitted through the fluidic passage of the catheter (16) to apply pulsatile energy to cardiovascular tissue (¶0010; ¶0002; ¶0010).
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Figure 1 – figure7 of Gurm, annotated by the examiner
Regarding claim 2:
The system according to claim 1, wherein the heart-tissue-conforming element (ballon 2/13) is configured to engage heart valve tissue (¶0002).
Regarding claim 16:
The system according to claim l, wherein the heart-tissue-conforming element (ballon 2/13) is located at a distal region (distal region defined as furthest from 1 which is the case in figure 3) of the catheter (16).
Regarding claim 46:
The system according to claim l, wherein the catheter (16) comprises a pressure sensor (pressure transducer 31 is connected to 3/16).
Regarding claim 47:
The system according to claim 46, wherein the pressure sensor (31) is located at a distal region (as shown in figure 3 if the distal region is defined as the area closest to 1 then the pressure sensor is located in the distal region) of the catheter (16).
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) 17-19, 25, 33 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019200201 A1 to Gurm et al. (Gurm) as applied to claim 1 above, and further in view of US 20110144742 A1 to Madrid et al. (Madrid).
Regarding claim 17:
Gurm discloses:
The system according to claim l, wherein the heart-tissue-conforming element comprises a balloon (2/13) a distal region (far end of catheter 16 as shown in figure 3) of the catheter (16).
Gurm fails to disclose:
The system according to claim l, wherein the heart-tissue-conforming element comprises a plurality of distal balloons arranged circumferentially around a rigid distal region of the catheter.
Madrid teaches:
A system that includes a catheter (16) with a plurality of balloons (52) arranged at the distal end of the catheter around a central ballon (50). Further, each of the plurality of ballons include and an individual fluidic passage (55). Having a plurality of ballons arranged in the manner described allows for blood to flow past the ballon members when they are inflated (¶0006).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gurm to further include a plurality of ballons arranged around the ballon in Gurm as taught by Madrid to allow for blood to flow past the ballon members as they are expanded (Madrid, ¶0006). This would further include individual fluid passages connected to each balloon to inflate them.
Regarding claim 18:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 17 by Gurm and Madrid:
The system according to claim 17, wherein the distal balloons (see the distal ballons of Madrid incorporated into Gurm) are configured to independently receive pulse energy generated by the manifold assembly (see the pulse energy of Gurm supplied to the balloons).
Regarding claim 19:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 17 by Gurm and Madrid:
The system according to claim 18, wherein
the fluidic passage (see the fluid passage/catheter 16 in figure 3 of Gurm) of the catheter is a first fluidic passage (as described above), and
the catheter assembly comprises a plurality of fluidic passages (see the plurality of passages 55 a part of each plurality of balloons 52 of Madrid incorporated into Gurm), wherein each fluidic passage is operably connected to a corresponding distal balloon (as shown in figure 3 of Madrid).
Regarding claim 25:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 17 by Gurm and Madrid:
The system according to claim 17, wherein in an inflated state the distal balloons (see the plurality of balloons 52 of Madrid incorporated into Gurm) are configured to provide structural rigidity (inherent since the balloons resist deflection or movement of the catheter).
Regarding claim 33:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 17 by Gurm and Madrid:
The system according to claim 17, wherein in an inflated state the distal balloons (see the plurality of balloons 52 of Madrid incorporated into Gurm) are arranged to leave space for fluid to pass between the distal balloons and the catheter (see ¶0006 of Madrid which teaches that the balloons surrounding the central ballon allow for the passage of blood).
Regarding claim 34:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 17 by Gurm and Madrid:
The system according to claim 17, further comprising a membrane (see the membrane 102 of Madrid that has been incorporated into Gurm as part of the plurality of ballon 108) present at the rigid distal region of the catheter configured to cover the distal balloons (as shown in figure 12 of Madrid).
Claim(s) 32, 35 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019200201 A1 to Gurm et al. (Gurm) and US 20110144742 A1 to Madrid et al. (Madrid) as applied to claims 17 or 34 above, and further in view of US 5102402 A to Dror et al. (Dror).
Regarding claim 32:
Gurm and Madrid fails to disclose:
The system according to claim 17, wherein the distal balloons are coated with an active agent.
Dror teaches:
A system that includes a catheter (14) and balloon (10). Further, the balloon includes lobes (16) on the outer surface which include an active agents (column 4, lines 50-64) that aid in dissolving plaque (column 1, lines 20-30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gurm and Madrid to further include lobes with active agent coated on the outer surface of the balloons (incorporated from Madrid) as taught by Dror which releases plaque dissolving drugs into the surrounding tissue (Dror, column 1, lines 20-30).
Regarding claim 35:
Gurm and Madrid fails to disclose:
The system according to claim 34, wherein the membrane is coated with an active agent.
Dror teaches:
A system that includes a catheter (14) and balloon (10). Further, the balloon includes lobes (16) on the outer surface which include an active agents (column 4, lines 50-64) that aid in dissolving plaque (column 1, lines 20-30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gurm and Madrid to further include lobes with active agent coated on the outer surface of the balloon as taught by Dror which releases plaque dissolving drugs into the surrounding tissue (Dror, column 1, lines 20-30).
Regarding claim 36:
Gurm and Madrid fails to disclose:
The system according to claim 17, further comprising a plurality of lobes present on the distal balloons and extending radially beyond the distal balloons.
Dror teaches:
A system that includes a catheter (14) and balloon (10). Further, the balloon includes lobes (16) on the outer surface which include an active agents (column 4, lines 50-64) that aid in dissolving plaque (column 1, lines 20-30).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gurm and Madrid to further include lobes with active agent coated on the outer surface of the balloon as taught by Dror which releases plaque dissolving drugs into the surrounding tissue (Dror, column 1, lines 20-30).
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019200201 A1 to Gurm et al. (Gurm)as applied to claim 1 above, and further in view of US 20090171278 A1 to Hirszowicz et al. (Hirszowicz).
Regarding claim 45:
Gurm fails to disclose:
The system according to claim l, wherein the catheter comprises a guidewire channel.
Hirszowicz teaches:
A system that includes a catheter (1) and a balloon (5aa). The system further includes a guide wire (13; and surrounding guide wire channel) for guide the catheter to its location (¶0127).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gurm to further include a guide wire and the corresponding guide wire channel as taught by Hirszowicz in order to guide the catheter to its proper location (Hirszowicz, ¶0127).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019200201 A1 to Gurm et al. (Gurm) and US 20110144742 A1 to Madrid et al. (Madrid) above as applied to claim 19 above, and further in view of US 5019042 A to Sahota.
Regarding claim 20:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 19 by Gurm and Madrid:
The system according to claim 19, wherein the plurality of fluidic passages comprises fluidic passages external (see the external passages 55 attached to the ballons 53 of Madrid incorporated into Sahota) to the catheter (2/13 of Gurm).
Gurm and Madrid fails to disclose:
The system according to claim 19, wherein the plurality of fluidic passages comprises fluidic passages internal to the catheter.
Sahota teaches:
A system (figure 11) that includes a catheter (14) and a plurality of balloons (70). Further, these balloons are supplied with fluid via passages (88) internal to the catheter.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gurm and Madrid to further include internal passages connected to the balloons as taught Sahota in order to supply fluid to the plurality of balloons.
Allowable Subject Matter
Claims 21-24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20190262035-A1
GURM
See the catheter 32
US-20160278845-A1
Mayse
See balloon 212
US-20140142494-A1
Wallace
See the catheter 100
US-20140163664-A1
Goldsmith
See the catheter 44
US-20230270493-A1
WEINKAM
See the catheter 210
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783