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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/23/2025 has been entered.
Response to Amendment
3. This action is responsive to the amendments filed 10/23/2025. Claim 10 has been amended. No claims were canceled or newly added.
Response to Arguments
Applicant’s response with respect to the art rejections have been fully considered but they are not persuasive. In substance, applicant contends that A) Abboud, Ng, and Srivastava fail to teach "positioning the delivery system based on the determination that the delivery system has contacted the wall of the heart chamber in response to sensing the change in pressure within the balloon from the selected inflation pressure". and B) Srivastava fails to disclose or suggest positioning a device in response to a change in balloon pressure C) It would not have been obvious to one of ordinary skill in the art to combine Srivastava with Abboud or Ng and D) The applied references fail to disclose or suggest determining contact “while advancing”.
In response to A), the examiner respectfully disagrees.
At the onset, the examiner directs applicant to the updated rejection below. Additionally, applicant is reminded to view the rejection as a whole. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Abboud was relied upon to disclose advancing the distal portion of the sheath and the balloon toward the wall of the heart chamber (see column 7, lines 55-58). Ng was relied upon for sensing a change in pressure (see paragraphs 0044-0045). Srivastava was relied upon to teach positioning the delivery system based on the determination that the delivery system has contacted the wall (see paragraphs 0103-0104). Thus, the combination of Abboud, Ng, and Srivastava teach the scope of the limitation as currently claimed.
In response to B), the examiner respectfully disagrees.
Applicant contends that Srivastava fails to disclose or suggest positioning a device in response to a change in balloon pressure. Contrary to applicant’s assertions, the office action did not rely upon Srivastava. As was discussed above in the response to argument A, Ng was relied on to teach sensing a change in balloon pressure (see paragraphs 0044-0045). Therefore, the combination of Abboud, Ng, and Srivastava teach the scope of the limitation as currently claimed.
7. In response to C), the examiner respectfully disagrees.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In response to D), the examiner respectfully disagrees.
At the onset, it is important to note the scope of the claims. The Examiner notes that the independent claim does not require the catheter to be in continuous movement to take pressure measurements, but rather “while advancing”. “While advancing” encompasses moving the catheter forward in increments/intervals to check the pressure. This allows a clinician to briefly stop to make adjustments and if necessary, advance the catheter further until a desired final position is reached. Therefore, the combination of Abboud, Ng, and Srivastava still teach the scope of the limitation as currently claimed.
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.
Claims 10-11, 21, 23, and 26 are rejected under 35 U.S.C 103 as being unpatentable over Abboud et al. (US Patent No.: 9808301 B2, – Previously Cited) and further in view of Ng et al. (US Pub.: 2012/0296329 A1, – Previously Cited) and further in view of Srivastava et al. (US Pub.: 2020/0030028 A1 – Previously Cited).
Regarding claim 10, Abboud teaches a method of sensing contact of a delivery system with a wall of a heart chamber, the method comprising: advancing a distal portion of a sheath of the delivery system into the heart chamber (e.g. column 4, lines 59- 62, – “treatment device 22 may be a medical probe, a catheter, a balloon-catheter... pass easily through blood vessels and heart valves”); inflating a balloon coupled to the distal portion of the sheath (e.g. column 7, lines 56-57, – “inflate the expandable membrane 23 inside the heart chamber’) to a selected inflation pressure (e.g. column 12, lines 47-50, – the balloon can be inflated to a desired pressure); advancing the distal portion of the sheath and the balloon toward the wall of the heart chamber (e.g. column 7, lines 55-58); monitoring a pressure within the balloon (e.g. column 5, lines 38-42); determining that the delivery system has contacted the wall of the heart chamber while advancing the distal portion of the sheath and the balloon toward the wall of the heart chamber (e.g. column 2, lines 59-63; column 7, lines 55-58, – the interior of the vessel wherein the vessel is the heart and the contact is to the wall).
However, Abboud does not explicitly teach determining that the delivery system has contacted the wall by sensing a change in pressure within the balloon from the selected inflation pressure; and positioning the delivery system based on the determination that the delivery system has contacted the wall of the heart chamber in response to sensing the change in pressure within the balloon from the selected inflation pressure.
Ng, in a same field of endeavor of catheters, discloses inflating a balloon to a selected inflation pressure (e.g. paragraphs 0044-0045, – inflating balloon to a preset volume and then contact force/pressure is measured); determining that the delivery system has contacted the wall by sensing a change in pressure within the balloon from the selected inflation pressure (e.g. paragraphs 0044-0045, – determining the pressure between the wall of the vessel and the balloon. Examiner notes that the technique is applied to a vessel of a human body and is applicable to any other vessel of a human body).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Abboud to include determining that the delivery system has contacted the wall by sensing a change in pressure within the balloon from the selected inflation pressure, as taught and suggested by Ng, for the purposes of ensuring treatment to the patient is more effective as well as to enhance tissue and electrode contact for both ablation and neural assessment (Ng, paragraph 0044).
However, Abboud in view of Ng does not explicitly teach positioning the delivery system based on the determination that the delivery system has contacted the wall of the heart chamber in response to sensing the change in pressure within the balloon from the selected inflation pressure.
As discussed above, Abboud and Ng together teach determining that the delivery system contacts the wall of the heart chamber and sensing change in pressure within the balloon from the selected inflation pressure. Srivastava, in a same field of endeavor of catheters and pressure sensing devices, discloses positioning the delivery system based on the determination that the delivery system has contacted the wall (e.g. Fig. 12; paragraphs 0103-0104, 0108).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Abboud and Ng to include positioning the delivery system based on the determination that the delivery system has contacted the wall, as taught and suggested by Srivastava, in order to ensure the safety of the procedure thereby allowing clinician to make appropriate adjustments so that the electrodes of the delivery system are properly positioned/oriented (Srivastava, paragraph 0104).
Regarding claim 11, Abboud in view of Ng in view of Srivastava teaches the method of claim 10 as discussed above, and Abboud further teaches wherein sensing the change in pressure within the balloon includes sensing an increase in pressure within the balloon (e.g. column 2, lines 52-57; column 5, lines 38-42).
Regarding claim 21, Abboud in view of Ng in view of Srivastava teaches the method of claim 10 as discussed above, and Ng further teaches further comprising: determining a contact force between the delivery system and the wall (e.g. paragraph 0045); and determining whether the delivery system is in proper contact or improper contact with the wall based on the determined contact force (e.g. paragraphs 0044-0045, 0051).
Regarding claim 23, Abboud in view of Ng in view of Srivastava teaches the method of claim 21 as discussed above, and Ng further teaches wherein determining the contact force includes processing signals from a pressure sensor fluidly coupled to the balloon (e.g. Fig. 7 – element 106; paragraphs 0044-0045, 0051).
Regarding claim 26, Abboud in view of Ng in view of Srivastava teaches the method of claim 10 as discussed above, and wherein positioning the delivery system comprises stopping advancement of the distal portion of the sheath and the balloon.
Abboud still teaches positioning the delivery system of a sheath and the balloon as discussed in the rejection of claim 10. However, Abboud and Ng do not explicitly teach stopping advancement of the distal portion. Srivastava does teach stopping advancement of the distal portion (e.g. paragraphs 0104, 0110).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Abboud, Ng, and Srivastava to include stopping advancement of the distal portion, as taught and suggested by Srivastava, in order to provide the clinician performing the procedure with an indication of when the proper placement has been achieved.
Claims 12 is rejected under 35 U.S.C 103 as being unpatentable over Abboud and further in view of Ng and further in view of Srivastava and further in view of Franklin et al. (US Pub.: 2018/0236203 A1, – Previously Cited).
Regarding claim 12, Abboud in view of Ng in view of Srivastava teaches the method of claim 10 as discussed above, and Abboud further teaches wherein monitoring the pressure within the balloon (e.g. column 2, lines 52-57; column 5, lines 36-44).
Additionally, Ng teaches wherein monitoring the pressure within the balloon includes fluidly coupling a pressure sensor to the balloon (e.g. paragraphs 0044-0045).
However, Abboud in view of Ng in view of Srivastava does not explicitly teach that the pressure sensor is a digital pressure sensor.
Franklin, in a same field of endeavor of catheters, discloses that the pressure sensor is a digital pressure sensor (e.g. abstract, paragraph 0266, – the inflation control system is connected to the balloon catheter. The pressure sensor can be digital or analog).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Abboud, Ng, and Srivastava to include a digital pressure sensor, as taught and suggested by Franklin, for the purpose of providing the medical practitioner with more accurate information regarding the pressure in order to prevent overinflation of the balloon.
Claims 13 is rejected under 35 U.S.C 103 as being unpatentable over Abboud and further in view of Ng and further in view of Srivastava and further in view of Farhadi et al. (US Pub.: 2018/0177986 A1, – Previously Cited).
Regarding claim 13, Abboud in view of Ng in view of Srivastava teaches the method of claim 10 as discussed above, and Abboud further teaches wherein inflating the balloon includes fluidly connecting a syringe to the balloon and actuating the syringe to drive a fluid into the balloon (e.g. column 6, lines 34-37; column 10, lines 4-7, – “re-inflate the expandable membrane or balloon of catheter via syringe” The syringe can drive fluids (i.e. liquids, gases).
However, Abboud in view of Ng in view of Srivastava does not explicitly teach and wherein monitoring the pressure within the balloon further includes fluidly disconnecting the syringe from the balloon after inflating the balloon.
Farhadi, in a same field of endeavor of catheters, discloses and wherein monitoring the pressure within the balloon further includes fluidly disconnecting the syringe from the balloon after inflating the balloon (e.g. paragraph 0043).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Abboud, Ng, and Srivastava to include wherein monitoring the pressure within the balloon further includes fluidly disconnecting the syringe from the balloon after inflating the balloon, as taught and suggested by Farhadi, for the purpose of making the system more versatile and flexible by allowing the connection/disconnection of the syringe from the balloon.
Claims 14 is rejected under 35 U.S.C 103 as being unpatentable over Abboud and further in view of Ng and further in view of Srivastava and further in view of Lewinsky et al. (US Pub.: 2006/0106321 A1, – Previously Cited).
Regarding claim 14, Abboud in view of Ng in view of Srivastava teaches the method of claim 10 as discussed above. However, Abboud in view of Ng in view of Srivastava does not explicitly teach wherein the selected inflation pressure is 100 pounds per square inch.
Lewinsky, in a same field of endeavor of catheters, discloses wherein the selected inflation pressure is 100 pounds per square inch (e.g. paragraphs 0073, 0078, – the inflation pressure of the balloon can be between 6 and 20 atmospheres. 6.8046 atmospheres is equal to 100 pounds per square inch (psi)).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Abboud, Ng, and Srivastava to include selecting an inflation pressure of 100 pounds per square inch, as taught and suggested by Lewinsky, for the purpose of providing the benefit of ensuring that the final dimension of the balloon will be negligibly affected by the external pressure from the tissue walls and ensures that the balloon reaches and maintains its desired inflation dimension (Lewinsky, paragraph 0074).
Claims 15 is rejected under 35 U.S.C 103 as being unpatentable over Abboud and further in view of Ng and further in view of Srivastava and further in view of Klaiman et al. (US Pub.: 2011/0245859 A1, – Previously Cited).
Regarding claim 15, Abboud in view of Ng in view of Srivastava teaches the method of claim 10 as discussed above. However, Abboud in view of Ng in view of Srivastava does not explicitly teach wherein the method further comprises providing a visual and/or auditory indication that the delivery system has contacted the wall.
Klaiman, in a same field of endeavor of catheters, discloses wherein the method further comprises providing a visual and/or auditory indication that the delivery system has contacted the wall (e.g. paragraphs 0150-0151, – the pressure of the balloon is monitored and the physician is alerted by a monitoring system when tissue contact is made. The alert has to be either visual and/or auditory in order for the clinician to be aware/alerted).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Abboud, Ng, and Srivastava to include providing a visual and/or auditory indication that the delivery system has contacted the wall, as taught and suggested by Klaiman, for the purpose of being able to more efficiently monitor the pressure of the balloon so that the patient is not at risk of being harmed and thus improving safety.
Claims 22 is rejected under 35 U.S.C 103 as being unpatentable over Abboud and further in view of Ng and further in view of Srivastava and further in view of Koblish et al. (International Publication No.: WO 2018/200865 A1, – Previously Cited).
Regarding claim 22, Abboud in view of Ng in view of Srivastava teaches the method of claim 21 as discussed above. However, Abboud in view of Ng in view of Srivastava does not explicitly teach wherein determining whether the delivery system is in proper contact or improper contact with the wall includes comparing the determined contact force to a predetermined desired contact force.
Koblish, in a same field of endeavor of catheters, discloses wherein determining whether the delivery system is in proper contact or improper contact with the wall includes comparing the determined contact force to a predetermined desired contact force (e.g. paragraph 0610).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Abboud, Ng, and Srivastava to include wherein determining whether the delivery system is in proper contact or improper contact with the wall includes comparing the determined contact force to a predetermined desired contact force, as taught and suggested by Koblish, in order to provide the predictable results of the user/clinician being aware/cognizant of whether appropriate force is being used with the catheter so that safe and optimal therapy is provided to the patient (Koblish, paragraph 0610).
Claims 24-25 are rejected under 35 U.S.C 103 as being unpatentable over Abboud and further in view of Ng and further in view of Srivastava and further in view of Apple et al. (US Patent No.: 4331156, – Previously Cited).
Regarding claim 24, Abboud in view of Ng in view of Srivastava teaches the method of claim 10 as discussed above. However, Abboud in view of Ng in view of Srivastava does not explicitly teach wherein monitoring the pressure within the balloon includes detecting variations in amplitude of signals received from a pressure sensor fluidly coupled to the balloon.
Apple, in a same field of endeavor of pressure measuring devices/methods, discloses wherein monitoring the pressure within the balloon includes detecting variations in amplitude of signals received from a pressure sensor fluidly coupled to the balloon (e.g. Fig. 1 – element 24; column 4 lines 52-67, – pressure intensity is construed as amplitude).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Abboud, Ng, and Srivastava to include wherein monitoring the pressure within the balloon includes detecting variations in amplitude of signals received from a pressure sensor fluidly coupled to the balloon, as taught and suggested by Apple, for the purpose of generating the desired cardiac pulse waveform and having the signal outputted on a visual display so that it can be viewed by a clinician/surgeon during surgery and improve treatment (Apple, column 1 lines 33-35; column 5, lines 1-16).
Regarding claim 25, Abboud in view of Ng in view of Srivastava teaches the method of claim 10 as discussed above. However, Abboud in view of Ng in view of Srivastava does not explicitly teach wherein monitoring the pressure within the balloon includes detecting variations in frequency of signals received from a pressure sensor fluidly coupled to the balloon.
Apple, in a same field of endeavor of pressure measuring devices/methods, discloses wherein monitoring the pressure within the balloon includes detecting variations in frequency of signals received from a pressure sensor fluidly coupled to the balloon (e.g. Fig. 1 – element 24; column 4 lines 52-67, – variations in frequency of the pressure).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Abboud, Ng, and Srivastava to include wherein monitoring the pressure within the balloon includes detecting variations in frequency of signals received from a pressure sensor fluidly coupled to the balloon, as taught and suggested by Apple, for the purpose of generating the desired cardiac pulse waveform and having the signal outputted on a visual display so that it can be viewed by a clinician/surgeon during surgery and improve treatment (Apple, column 1 lines 33-35; column 5, lines 1-16).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792