DETAILED ACTION
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 .
Response to Arguments
Applicant’s argument regarding the objection to the drawings has been fully considered. The objection to the drawings has been withdrawn in view of the amendments.
Applicant’s argument regarding the objection to the specification has been fully considered. While some of the trade names and marks used in commerce have been addressed, others remain. Therefore, the objection to the specification is maintained.
Applicant’s argument regarding the rejection of Claim 1 under 35 U.S.C. 103 over Reo in view of Dib has been fully considered but is not persuasive under new grounds of rejection below.
The rejections of Claims 3-4 under 35 U.S.C. 103 over Reo in view of Dib are withdrawn in view of the cancelation of the claims.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted relies on the supposed deficiencies with respect to the rejection of parent Claim 1. Applicant’s argument is moot for the same reasons detailed above.
Specification
The use of the term DuPontTM, DSMTM, BayerTM, and GrilonTM in [0083], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 14 is objected to because of the following informalities: grammatical error. The claim should be amended to “[…] the injection catheter being configured to deliver a therapeutic gel to the endocardial tissue […].” Appropriate correction is required.
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 1 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (“Conceptual Design and Procedure for an Autonomous […]”) in view of Dib et al. (US 20210298785).
Regarding Claim 1, Cheng teaches a system for endocardial injection, (Catheter Design, Inner Operating Catheter (IOC) “The IOC is the main recipient of robotic and autonomous control as it contains the necessary equipment to stabilize, detect, and inject cell solution into the endocardial wall of the LV.”), the system comprising:
a) a first steerable catheter, having a first lumen formed therein (Catheter Design, Conceptual Ensemble “outer catheter guide (OCG) with a lumen large enough to act as […] a passageway for an inner operating catheter (IOC) to pass through” and Catheter Design, Outer Catheter Guide (OCG) “3. A steerable catheter guide […] To further enhance controllability of the guide, pull wires may be added to allow deflection and steerability. The guide can incorporate one or two pull wires for uni- or bidirectional deflection and torque may be applied to provide distal rotation.”); and
b) a second steerable catheter disposed within the first lumen, (Catheter Design, Conceptual Ensemble “inner operating catheter (IOC)”), the second steerable catheter having a second lumen formed therein, (Catheter Design, Inner Operating Catheter (IOC) “The IOC is the main recipient of robotic and autonomous control as it contains the necessary equipment to stabilize, detect, and inject cell solution into the endocardial wall of the LV. The IOC contains four pull wires, a needle, a contact force sensor, and a recording electrode at the tip. […] The catheter’s deflection may carry a semicircular or semiellipsoid curvature with a reach of 3 to 4.5 cm.”), the second steerable catheter being steerable in two offset planes that are offset from the two planes that the first steerable catheter are steerable within (Fig. 6, where the IOC may move in a plane offset from the OCG);
c) an injection catheter disposed within the second lumen, (Fig. 5 “needle lumen”), the injection catheter having a distal end region (Catheter Design, Inner Operating Catheter (IOC) “distal end of the catheter (Fig. 5)”);
d) wherein the distal end region includes a needle section (Catheter Design, Inner Operating Catheter (IOC) “The IOC contains a needle at the distal end”).
However, Cheng does not explicitly teach wherein the distal end region includes an imaging section; and an imaging device configured to be disposed within the imaging section.
In an analogous handle assembly for medical devices field of endeavor, Dib teaches a system for endocardial injection, (Claim 1 “A system for fixing the relative position of at least two surgical devices” and [0092] “Further disclosed embodiments comprise, for example, […] delivering […] active agents to the endocardium”), the system comprising:
a) wherein the distal end region includes an imaging section (Fig. 4 “transceiver 26”); and
b) an imaging device configured to be disposed within the imaging section ([0085] “sleeve 54” and Claim 1 “wherein said surgical devices comprise an imaging unit”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the catheter design of Cheng, specifically the electromagnetic position sensor, with the imaging device design of Dib because the modification allows a user to internally image the area at which the needle operates at, which improves visualization and reduces risk of undesirable events during the procedure, as taught by Dib in [0005].
Regarding Claim 5, the modified system of Cheng teaches all limitations of Claim 1, as discussed above. Furthermore, Dib teaches wherein the imaging section and the needle section are arranged in a side-by-side arrangement (Fig. 4 and [0085] “the energy field will be primarily oriented in a direction perpendicular to the axis 50, and will be radiated whenever the transceiver 26 is activated by the generator”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the catheter design of Cheng with the imaging section of Dib because the modification allows for the user to accurately locate the tip of the needle, as taught by Dib in [0161].
Regarding Claim 6, the modified system of Cheng teaches all limitations of Claim 1, as discussed above. Furthermore, Cheng teaches wherein the needle section has a fluid injection lumen formed therein (Catheter Design, Conceptual Ensemble “An additional lumen also runs from the proximal to the distal end where heparin solution can be injected near the needle opening of the catheter tip”).
Regarding Claim 7, the modified system of Cheng teaches all limitations of Claim 1, as discussed above. Furthermore, Dib teaches wherein the imaging device includes an intravascular ultrasound imaging member ([0096]-[0097] “An ICE (intra-cardiac echocardiography catheter) or AcuNav™ catheter lumen 2 is loaded into hemostasis valve 8 through Touhy knob 10 (FIG. 11). The ICE (intra-cardiac echocardiography catheter) or 4D ICE, or AcuNav™ catheter 2 is loaded into rear track 5 (FIG. 12).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Dib because the modification ensures device guidance, minimizes complications during procedure, and provides real-time visualization.
Regarding Claim 8, the modified system of Cheng teaches all limitations of Claim 1, as discussed above. Furthermore, Dib teaches wherein the imaging device is slidably disposed within the injection catheter ([0056] “The handle assembly comprises sliders (210, 220) operably connected to the surgical devices for adjusting features of the surgical devices (to connect with lumen 1 [230] or lumen 2 [240]).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Dib because the modification ensures device guidance, minimizes complications during procedure, and provides real-time visualization, while allowing the user to control the distance at which the imaging device operates.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable Cheng et al. (“Conceptual Design and Procedure for an Autonomous […]”) in view of Dib et al. (US 20210298785), as applied to Claim 1 above, and further in view of Sorajja (US 20220339437).
Regarding Claim 9, the modified system of Cheng teaches all limitations of Claim 1, as discussed above. However, the modified system of Cheng does not explicitly teach a third steerable catheter having a third lumen formed therein, wherein the first steerable catheter is disposed within the third lumen.
In an analogous pericardial anchoring field of endeavor, Sorajja teaches a third steerable catheter having a third lumen formed therein, wherein the first steerable catheter is disposed within the third lumen ([0291] “The delivery catheter system 50 can be either single, in series, or in telescoped arrangement.” Telescoping catheters with one or more lumens are not novel in the art.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Sorajja because a telescoped arrangement of the catheters provides the advantage of being able to extend distally into potentially smaller and more complex anatomical lumens, enhancing safety of the patient. Telescoping catheters also offer high success in deliverability of treatment to the target region due to their accessibility to anatomy within the patient.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable Cheng et al. (“Conceptual Design and Procedure for an Autonomous […]”) in view of Dib et al. (US 20210298785), as applied to Claim 1 above, and further in view of Emmons et al. (US 20180325592).
Regarding Claim 10, the modified system of Cheng teaches all limitations of Claim 1, as discussed above. However, the modified system of Cheng does not explicitly teach wherein the needle section includes a heating element.
In an analogous microwave treatment field of endeavor, Emmons teaches a system ([0180] “medical component 110”), wherein the needle section includes a heating element ([0195] “Examples of medical component 110 with at least one working element include, but are not limited to steerable[…] ablation catheters using ablative energies such as radiofrequency, microwave, ultrasound”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Emmons because the device allows the user to selectively destroy tissue around the region of interest for treatment.
Regarding Claim 11, the modified system of Cheng teaches all limitations of Claim 1, as discussed above. Furthermore, Emmons teaches wherein the needle section includes a cooling element ([0195] “Examples of medical component 110 with at least one working element include, but are not limited to steerable or non-steerable ablation catheters using ablative energies such as […] cryoablative modalities”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Emmons because the device allows the user to selectively destroy tissue around the region of interest for treatment.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (“Conceptual Design and Procedure for an Autonomous […]”) in view of Dib et al. (US 20210298785), as applied to Claim 1 above, further in view of Kuhn (US 20220395324).
Regarding Claim 13, the modified system of Cheng teaches all limitations of Claim 1, as discussed above. However, the modified system of Cheng does not explicitly teach wherein the needle section is configured to deliver a therapeutic gel to endocardial tissue.
In an analogous intramyocardial infusion field of endeavor, Kuhn teaches a system for endocardial injection ([0050] “injection catheter” and [0051] “The target location may comprise the myocardium. The target location may comprise an area at or adjacent the endocardial surface of the heart.”), wherein the needle section is configured to deliver a therapeutic gel to endocardial tissue ([0039] “The injection catheter may comprise a fluid reservoir in fluid-communication with the injection needle and configured for the delivery of electroconductive material through the injection needle to a target location,” [0051] “The target location may comprise the myocardium. The target location may comprise an area at or adjacent the endocardial surface of the heart,” [0059] “The electroconductive material may comprise a conductive choline-based bio-ionic liquid (Bio-IL) conjugated hydrogel.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the fluid delivery with the teachings of Kuhn because hydrogels exhibit a wide range of highly tunable physical properties, remarkable in vitro and in vivo biocompatibility, and high electrical conductivity without the need for additional conductive components. The physical properties of ECHs, such as their mechanical properties, water uptake capability, porosity, and degradation rate can influence tissue regeneration in vivo, as taught by Kuhn in [0059]. The electroconductive material may comprise a fluid suspension of carbon nanotube particles. The electroconductive material may comprise a fluid suspension of graphene particles, as taught by Kuhn in [0059].
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (“Conceptual Design and Procedure for an Autonomous […]”) in view of Dib et al. (US 20210298785) and Kuhn (US 20220395324).
Regarding Claim 14, Cheng teaches a system for endocardial injection, (Catheter Design, Inner Operating Catheter (IOC) “The IOC is the main recipient of robotic and autonomous control as it contains the necessary equipment to stabilize, detect, and inject cell solution into the endocardial wall of the LV.”), the system comprising:
a) a steerable catheter assembly including two or more steerable catheters nested together and steerable in different lateral directions (Catheter Design, Conceptual Ensemble “outer catheter guide (OCG) with a lumen large enough to act as […] a passageway for an inner operating catheter (IOC) to pass through” and Catheter Design, Outer Catheter Guide (OCG) “3. A steerable catheter guide […] To further enhance controllability of the guide, pull wires may be added to allow deflection and steerability. The guide can incorporate one or two pull wires for uni- or bidirectional deflection and torque may be applied to provide distal rotation,” Catheter Design, Conceptual Ensemble “inner operating catheter (IOC)”), the second steerable catheter having a second lumen formed therein, (Catheter Design, Inner Operating Catheter (IOC) “The IOC is the main recipient of robotic and autonomous control as it contains the necessary equipment to stabilize, detect, and inject cell solution into the endocardial wall of the LV. The IOC contains four pull wires, a needle, a contact force sensor, and a recording electrode at the tip. […] The catheter’s deflection may carry a semicircular or semiellipsoid curvature with a reach of 3 to 4.5 cm,” and Fig. 6); and
b) an injection catheter disposed within the steerable catheter assembly, (Fig. 5 “needle lumen”).
However, Cheng does not explicitly teach the injection catheter being configured to a therapeutic gel to endocardial tissue [sic]; wherein the injection catheter has a distal end region with an imaging section and a needle section disposed adjacent to the imaging section; an imaging device slidably disposed within the injection catheter; and wherein the imaging device includes an ultrasound transducer configured to be disposed along the imaging section.
In an analogous handle assembly for medical devices field of endeavor, Dib teaches a system for endocardial injection, (Claim 1 “A system for fixing the relative position of at least two surgical devices” and [0092] “Further disclosed embodiments comprise, for example, […] delivering […] active agents to the endocardium”), the system comprising:
a) wherein the distal end region includes an imaging section (Fig. 4 “transceiver 26”); and
b) an imaging device configured to be disposed within the imaging section ([0085] “sleeve 54” and Claim 1 “wherein said surgical devices comprise an imaging unit”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the catheter design of Cheng, specifically the electromagnetic position sensor, with the imaging device design of Dib because the modification allows a user to internally image the area at which the needle operates at, which improves visualization and reduces risk of undesirable events during the procedure, as taught by Dib in [0005].
However, Cheng modified by Dib does not explicitly teach the injection catheter being configured to a therapeutic gel to endocardial tissue [sic].
In an analogous intramyocardial infusion field of endeavor, Kuhn teaches a system for endocardial injection ([0050] “injection catheter” and [0051] “The target location may comprise the myocardium. The target location may comprise an area at or adjacent the endocardial surface of the heart.”), wherein the injection catheter being configured to a therapeutic gel to endocardial tissue [sic] ([0039] “The injection catheter may comprise a fluid reservoir in fluid-communication with the injection needle and configured for the delivery of electroconductive material through the injection needle to a target location,” [0051] “The target location may comprise the myocardium. The target location may comprise an area at or adjacent the endocardial surface of the heart,” [0059] “The electroconductive material may comprise a conductive choline-based bio-ionic liquid (Bio-IL) conjugated hydrogel.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify the fluid delivery with the teachings of Kuhn because hydrogels exhibit a wide range of highly tunable physical properties, remarkable in vitro and in vivo biocompatibility, and high electrical conductivity without the need for additional conductive components. The physical properties of ECHs, such as their mechanical properties, water uptake capability, porosity, and degradation rate can influence tissue regeneration in vivo, as taught by Kuhn in [0059]. The electroconductive material may comprise a fluid suspension of carbon nanotube particles. The electroconductive material may comprise a fluid suspension of graphene particles, as taught by Kuhn in [0059].
Regarding Claim 16, the modified system of Cheng teaches all limitations of Claim 14, as discussed above. Furthermore, Cheng teaches wherein the steerable catheter assembly includes at least one steerable catheter that is steerable in two planes (Fig. 3).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable Cheng et al. (“Conceptual Design and Procedure for an Autonomous […]”) in view of Dib et al. (US 20210298785) and Kuhn (US 20220395324), as applied to Claim 14 above, and further in view of Emmons et al. (US 20180325592).
Regarding Claim 17, the modified system of Cheng teaches all limitations of Claim 14, as discussed above. However, the modified system of Cheng does not explicitly teach wherein the needle section includes a heating element.
In an analogous microwave treatment field of endeavor, Emmons teaches a system ([0180] “medical component 110”), wherein the needle section includes a heating element ([0195] “Examples of medical component 110 with at least one working element include, but are not limited to steerable[…] ablation catheters using ablative energies such as radiofrequency, microwave, ultrasound”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Emmons because the device allows the user to selectively destroy tissue around the region of interest for treatment.
Regarding Claim 18, the modified system of Cheng teaches all limitations of Claim 14, as discussed above. Furthermore, Emmons teaches wherein the needle section includes a cooling element ([0195] “Examples of medical component 110 with at least one working element include, but are not limited to steerable or non-steerable ablation catheters using ablative energies such as […] cryoablative modalities”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the teachings of Emmons because the device allows the user to selectively destroy tissue around the region of interest for treatment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Leeflang is cited for teaching a system for endocardial injection, ([0018], [0040], and [0042]), the system comprising: a first steerable catheter, ([0018]), having a first lumen formed therein, ([0019]), the first steerable catheter being steerable in two planes ([0019] and [0023]); and a second steerable catheter disposed within the first lumen, ([0019]), the second steerable catheter having a second lumen formed therein ([0019]).
Hebert is cited for teaching a system, ([0052]), the system comprising: a first steerable catheter, ([0018]), having a first lumen formed therein, ([0019]), the first steerable catheter being steerable in two planes ([0019] and [0023]); and a second steerable catheter disposed within the first lumen, ([0019]), the second steerable catheter having a second lumen formed therein ([0019]).
THIS ACTION IS MADE FINAL. 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 MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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/MARIA CHRISTINA TALTY/ Examiner, Art Unit 3797
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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