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.
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 17-25 and 32-36 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.
Regarding claim 17:
The claim limitation “wherein the heart-tissue conforming element comprises a plurality of distal balloons arranged circumferentially around a rigid distal region of the catheter” (emphasis added by the examiner) in lines 1-3 are unclear. A plurality of winged balloons has been established in claim 1 (on which this claim depends) and its unclear if this limitation of claim 17 establishes additional balloons or is referring the same balloons. For the sake of examination, the office has assumed that they refer to the same balloons since there is not embodiment with multiple sets of balloons at the distal end of the catheter. However, the applicant should amend the claim to clarify.
Claims 18-25 and 32-35 are rejected due to their dependence on claim 17.
Regarding claim 36:
The claim limitation “wherein the winged balloons are arranged to orient the heart-tissue conforming element relative to heart valve leaflets or heart valve commissures” (emphasis added by the examiner) in lines 3-4 are unclear. The limitation describes the winged balloons as if they are a separate structure from the heart-tissue conforming element when claim 1 indicates the heart-tissue conforming element comprises the winged balloons. For the sake of examination, the office has assumed that the heart-tissue conforming element comprises the winged balloons and they can be oriented relative to the valve leaflets.
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, 2, 16-19, 25, 33, 34, 36, 46 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019200201 A1 to Gurm et al. (Gurm) in view of US 20110144742 A1 to Madrid et al. (Madrid).
Regarding claim 1:
Gurm discloses:
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);
wherein the heart-tissue-conforming element comprises:
a single mid-radius balloon (13 (in figure 3) and 2 in ¶0010).
Gurm fails to disclose:
Wherein the heart-tissue-conforming element comprises:
(A) a single mid-radius balloon present at a distal region of the catheter with a plurality of winged balloons extending radially beyond the mid-radius balloon and arranged to engage heart valve leaflets or heart valve commissures; or
(B) a plurality of mid-radius balloons present at a distal region of the catheter with a plurality of winged balloons extending radially beyond the mid- radius balloons and arranged to engage heart valve leaflets or heart valve commissures.
Madrid teaches:
A system (figures 3 and 40) that includes a catheter (16 or 836) with a plurality of winged balloons (52 or 840) arranged at the distal end of the catheter around a central ballon (50). Further, each of the plurality of winged 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). Further, the balloons can be arranged to engage an expansion device (810) with a heart valve (802, 806 and 804) as shown in figures 39-40.
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 winged balloons 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. This would further allow for the balloons to engage heart valve leaflets (802, 804 and 806)
PNG
media_image1.png
454
830
media_image1.png
Greyscale
Figure 1 – figure7 of Gurm, annotated by the examiner
Regarding claim 2:
Gurm discloses:
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:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Gurm and Madrid:
The system according to claim 1, wherein the heart-tissue-conforming element is located at a distal region of the catheter winged balloons are cylindrical (see the cylindrical balloons 836/53 of Madrid incorporated into Gurm).
Regarding claim 17 (as best understood by the examiner, see the 35 USC 112(b) rejection above for the claim interpretation):
Gurm discloses:
The system according to claim 1, wherein the heart-tissue- conforming element comprises a plurality of distal balloons (see the plurality of balloons 836/53 of Madrid arranged around a central balloon incorporated into Gurm) arranged circumferentially around a rigid distal region of the catheter (see catheter 16 of Gurm with the balloons of Madrid arranged around the balloon 13/2 at the distal end).
Regarding claim 18:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 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 1 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 1 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 1 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 1 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).
Regarding claim 36 (as best understood by the examiner, see the 35 USC 112(b) rejection above for the claim interpretation):
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Gurm and Madrid:
The system according to claim 1, wherein the winged balloons (see the plurality of balloons 836/53 of Madrid arranged around a central balloon incorporated into Gurm) are arranged to orient the heart-tissue conforming element relative to heart valve leaflets or heart valve commissures (see figures 39 and 40 which shows the winged balloons 836 arranged within the heart valve leaflets (802/804/806) to apply the prosthetic valve 832 as shown in figure 41).
Regarding claim 46:
Gurm discloses:
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:
Gurm discloses:
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(s) 32 and 35 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).
Claim(s) 45 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 claim 1 above, and further in view of US 20090171278 A1 to Hirszowicz et al. (Hirszowicz).
Regarding claim 45:
Gurm and Madrid 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 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: claims 236-239 is/are allowed primarily because the prior art of record cannot anticipate Applicant' s claimed invention by a single reference nor render Applicant' s claimed invention obvious by the combination of more than one reference.
Furthermore, the prior art of record does not teach “wherein each fluidic passage is operably connected to a corresponding distal balloon, the connector is a first connector, and the catheter assembly comprises a plurality of connectors, wherein each connector is operably connected to a corresponding fluidic passage of the catheter” as within the context of the claimed invention as disclosed and within the context of the other limitations present in claim 236.
Therefore, the prior art of record cannot anticipate Applicant' s claimed invention by a single reference nor render Applicant' s claimed invention obvious by the combination of more than one reference.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 5/6/26 have been fully considered but they are not persuasive.
Regarding the 35 USC 103 rejection of claim 1:
The applicant has argued that the amendments to claim 1 are not taught by Gurm and further that Gurm cannot be modified by Madrid to read on the amended claim. However, the office does not agree that the combination of Gurm and Madrid does not read on claim 1. While the office agrees that the Gurm reference alone no longer reads on the amended to claim (agree with arguments on page 14 of the remarks) the office has maintained the combination of Gurm and Madrid since the combination reads on the amended claim 1. The applicant has argued that the combination of Gurm and Madrid is improper since it discloses balloons that allow blood to flow past and further does not show balloons engaged with heart valve leaflets (see page 15 of the remarks). However, the Madrid reference does show balloons that engage with heart valve leaflets (see figures 39-41; ¶0163-0178) to deploy a prosthetic valve 832. For this reason, the combination of Gurm and Madrid reads on the amended to claims and the above rejection is made/maintained.
Regarding the drawing objections:
The applicant’s amendments to the claims have addressed the drawing objection and for this reason the drawing objection is withdrawn.
Regarding the claim objections:
The applicant’s amendments to the claims have addressed the claim objections and for this reason they have been withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WESLEY G HARRIS/Examiner, Art Unit 3783
Prosecution Insights