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 .
Claim Rejections - 35 USC § 102
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.
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 1-3, 6, 8-10, 13, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levendusky et al., US 20120310154, herein referred to as “Levendusky”.
Regarding claim 1, Levendusky discloses a needle firing assembly (Figure 1) comprising: a firing device (Figures 1 and 4: injection apparatus 27); a catheter extending from the firing device (Figure 1: insertion tube 31); a needle extending from the firing device and through an interior of the catheter (Figure 4: needle 79 and [0072]), the needle having a curvature proximate a distal end of the needle opposite the firing device (Figure 4: needle 79 has a curvature); and a suction device in fluid communication with an interior of the catheter (Figure 1: suction source 72 and [0028]), the suction device configured to draw a suction force through a distal end of the catheter opposite the firing device ([0070]), wherein the firing device is configured to move the needle in a forward firing direction relative to the catheter to extend the distal end of the needle through the distal end of the catheter ([0072]-[0073]).
Regarding claim 2, Levendusky discloses the needle firing assembly of claim 1, wherein: the catheter defines a suction channel between an interior surface of the catheter and an exterior surface of the needle ([0028] and Figure 3: passageway 36 and suction chamber 66 and [0072]: “Distal extremity 76b of outer sheath 76 is further advanced through passageway 36 of insertion tube 31 to a desired position for penetrating needle 79 into the targeted tissue within suction chamber 66.”); the suction channel surrounds the needle (Figure 3 and [0072]: “Distal extremity 76b of outer sheath 76 is further advanced through passageway 36 of insertion tube 31 to a desired position for penetrating needle 79 into the targeted tissue within suction chamber 66.”); and the suction device is in fluid communication with the suction channel ([0070]: “Suction source 72 is actuated to draw air from and evacuate suction chamber 66 so as to create a negative pressure within the suction chamber and draw the targeted tissue, that is the portion of wall 177 to be treated, into suction chamber 66”).
Regarding claim 3, Levendusky discloses the needle firing assembly of claim 2, wherein the suction device is coupled to the catheter between the distal end of the catheter and the firing device (Figure 1: suction source 72 is coupled to the catheter between eye piece 41 and side port 46).
Regarding claim 6, Levendusky discloses the needle firing assembly of claim 1, further comprising a puncture assist device provided at the distal end of the needle (Figures 4-5: tissue penetrating tip 81).
Regarding claim 8, Levendusky discloses a needle firing assembly (Figure 1) comprising: a firing device (Figures 1 and 4: injection apparatus 27); a catheter extending from the firing device (Figure 1: insertion tube 31); a needle extending from the firing device and through an interior of the catheter (Figure 4: needle 79 and [0072]); and a suction device in fluid communication with an interior of the catheter (Figure 1: suction source 72 and [0028]) configured to draw fluid through a distal end of the catheter ([0070]), wherein the firing device is configured to move the needle relative to the catheter to extend a distal end of the needle through the distal end of the catheter when in a firing state ([0072]-[0073]) and retract the needle relative to the catheter such that the distal end of the needle is withdrawn from the distal end of the catheter when in a retracted state ([0073]: “Second injection apparatus 146 is subsequently withdrawn from passageway 36 of insertion tube 31, causing needle 79 to withdraw from the tissue within suction chamber 66.”).
Regarding claim 9, Levendusky discloses the needle firing assembly of claim 8, wherein: the needle has a curvature proximate a distal end of the needle opposite the firing device (Figure 4: needle 79 has a curvature); the catheter defines a suction channel between an interior surface of the catheter and an exterior surface of the needle ([0028] and Figure 3: passageway 36 and suction chamber 66 and [0072]: “Distal extremity 76b of outer sheath 76 is further advanced through passageway 36 of insertion tube 31 to a desired position for penetrating needle 79 into the targeted tissue within suction chamber 66.”); the suction channel surrounds the needle (Figure 3 and [0072]: “Distal extremity 76b of outer sheath 76 is further advanced through passageway 36 of insertion tube 31 to a desired position for penetrating needle 79 into the targeted tissue within suction chamber 66.”); and the suction device is in fluid communication with the suction channel ([0070]: “Suction source 72 is actuated to draw air from and evacuate suction chamber 66 so as to create a negative pressure within the suction chamber and draw the targeted tissue, that is the portion of wall 177 to be treated, into suction chamber 66”).
Regarding claim 10, Levendusky discloses the needle firing assembly of claim 9, wherein the suction device is coupled to the catheter between the distal end of the catheter and the firing device (Figure 1: suction source 72 is coupled to the catheter between eye piece 41 and side port 46).
Regarding claim 13, Levendusky discloses the needle firing assembly of claim 8, further comprising a puncture assist device provided at the distal end of the needle (Figures 4-5: tissue penetrating tip 81).
Regarding claim 15, Levendusky discloses a method for puncturing a surface of a vascular entity (Abstract and Figure 9), the method comprising: positioning a needle firing assembly (Figures 1-5) relative to a surface of a vascular entity (Figures 8-9), the needle firing assembly comprising: a firing device (Figures 1 and 4: injection apparatus 27); a catheter extending from the firing device (Figure 1: insertion tube 31); a needle extending from the firing device and through an interior of the catheter (Figure 4: needle 79 and [0072]), the needle having a curvature proximate a distal end of the needle (Figure 4: needle 79 has a curvature), a distal end of the catheter positioned at the surface of the vascular entity (Figures 8-9); and a suction device in fluid communication with an interior of the catheter (Figure 1: suction source 72 and [0028]); operating the suction device to draw fluid through the distal end of the catheter toward the firing device ([0070]); creating a suction force drawing the surface of the vascular entity toward the distal end of the catheter ([0070] and Figure 9); and operating the firing device to move the needle in a forward firing direction relative to the catheter to extend the distal end of the needle through the distal end of the catheter and puncture the surface of the vascular entity ([0072]-[0073]).
Regarding claim 16, Levendusky discloses the method of claim 15, wherein: the catheter defines a suction channel between an interior surface of the catheter and an exterior surface of the needle ([0028] and Figure 3: passageway 36 and suction chamber 66 and [0072]: “Distal extremity 76b of outer sheath 76 is further advanced through passageway 36 of insertion tube 31 to a desired position for penetrating needle 79 into the targeted tissue within suction chamber 66.”); the suction channel surrounds the needle (Figure 3 and [0072]: “Distal extremity 76b of outer sheath 76 is further advanced through passageway 36 of insertion tube 31 to a desired position for penetrating needle 79 into the targeted tissue within suction chamber 66.”); and the suction device is in fluid communication with the suction channel ([0070]: “Suction source 72 is actuated to draw air from and evacuate suction chamber 66 so as to create a negative pressure within the suction chamber and draw the targeted tissue, that is the portion of wall 177 to be treated, into suction chamber 66”).
Regarding claim 17, Levendusky discloses the method of claim 16, wherein the suction device is coupled to the catheter between the distal end of the catheter and the firing device (Figure 1: suction source 72 is coupled to the catheter between eye piece 41 and side port 46).
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-5, 11-12, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Levendusky in view of Kunis, US 20150258270, herein referred to as “Kunis”.
Regarding claims 4 and 11, Levendusky discloses the needle firing assemblies of claims 3 and 10, respectively, but does not explicitly disclose an assembly wherein the suction device comprises a syringe.
However, Kunis teaches a needle firing assembly (Figure 1) wherein the suction device comprises a syringe ([0008]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the needle firing assembly disclosed by Levendusky so that the suction device comprises a syringe as taught by Kunis to maintain negative pressure for extended periods of time during the procedure (Kunis [0090]).
Regarding claims 5 and 12, Levendusky discloses the needle firing assemblies of claims 3 and 10, respectively, but does not explicitly disclose an assembly wherein the suction device comprises an external vacuum motor.
However, Kunis teaches a needle firing assembly (Figure 1) wherein the suction device comprises an external vacuum motor ([0038]: “In (C), a negative pressure or vacuum begins to pull on the septum, e.g., the FO, such as by a syringe or pump which is in pressure communication with an interior 31 of the funnel In (D), the negative pressure increases, and the funnel 24 begins to flare out even more.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the needle firing assembly disclosed by Levendusky so that the suction device comprises a syringe as taught by Kunis to pull septal tissue inward toward the needle and pierce the septal wall for access to the left atrium (Kunis [0052]).
Regarding claim 18, Levendusky discloses the method of claim 16, but does not explicitly disclose a method wherein the suction device comprises a syringe.
However, Kunis teaches a method (Figure 1) wherein the suction device comprises a syringe ([0008]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Levendusky so that the suction device comprises a syringe as taught by Kunis to maintain negative pressure for extended periods of time during the procedure (Kunis [0090]).
Regarding claim 19, Levendusky discloses the method of claim 16, but does not explicitly disclose a method wherein the suction device comprises an external vacuum motor.
However, Kunis teaches a method (Figure 1) wherein the suction device comprises an external vacuum motor ([0038]: “In (C), a negative pressure or vacuum begins to pull on the septum, e.g., the FO, such as by a syringe or pump which is in pressure communication with an interior 31 of the funnel In (D), the negative pressure increases, and the funnel 24 begins to flare out even more.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Levendusky so that the suction device comprises a syringe as taught by Kunis to pull septal tissue inward toward the needle and pierce the septal wall for access to the left atrium (Kunis [0052]).
Claims 7, 14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Levendusky (Figures 1-5) in view of Embodiment B of Levendusky (Figures 13-15).
Regarding claims 7 and 14, Embodiment A of Levendusky discloses the needle firing assemblies of claims 6 and 13, respectively, but does not explicitly disclose an assembly wherein the puncture assist device comprises a radiofrequency cutting device located at the distal end of the needle.
However, Embodiment B of Levendusky teaches a needle firing assembly (Figure 13) wherein the puncture assist device comprises a radiofrequency cutting device located at the distal end of the needle (Figure 13 and [0099]: “Radio frequency from radio frequency generator and controller 252 is supplied to needle member 247 for ablating the tissue within suction chamber 66.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the needle firing assembly disclosed by Embodiment A of Levendusky so that the puncture assist device comprises a radiofrequency cutting device located at the distal end of the needle as taught by Embodiment B of Levendusky to ablate the tissue and thus change the compliance of the targeted tissue (Levendusky [0097]).
Regarding claim 20, Embodiment A of Levendusky discloses the method of claim 16, wherein the needle firing assembly further comprises a puncture assist device provided at the distal end of the needle (Figures 4-5: tissue penetrating tip 81), but does not explicitly disclose a method wherein the puncture assist device comprises a radiofrequency cutting device located at the distal end of the needle.
However, Embodiment B of Levendusky teaches a method (Figure 13) wherein the puncture assist device comprises a radiofrequency cutting device located at the distal end of the needle (Figure 13 and [0099]: “Radio frequency from radio frequency generator and controller 252 is supplied to needle member 247 for ablating the tissue within suction chamber 66.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Embodiment A of Levendusky so that the puncture assist device comprises a radiofrequency cutting device located at the distal end of the needle as taught by Embodiment B of Levendusky to ablate the tissue and thus change the compliance of the targeted tissue (Levendusky [0097]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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