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 § 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.
Claim 1-20 is 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.
The terminology “significantly larger” in claim 1, 15 & 16 is a relative term which renders the claim indefinite. The terminology “significantly larger” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Such that a surface area of a distal portion being significantly larger than a surface area of an electrode is seen as indefinite since "significantly larger" is not defined or given a value.
Claims 2-14 & 17-20 are rejected based on the dependence on the independent claims 1, 15 & 16.
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 1-11 & 13-20 are rejected under 35 U.S.C 102(a)(1) as being anticipated by Davies (US 20200352647) herein referred to as Davies.
Regarding claim 1, Davies discloses An electrosurgical device for discretely cutting pericardium that is adjacent myocardium (Figure 1; Figure 2B), the electrosurgical device comprising: an elongate shaft (Figure 1, 102) having a proximal portion including a proximal end and a distal portion including a distal end (Figure 1A, 104 & 108); and at least one electrode configured to cut the pericardium (Figure 1, 112; Paragraph [0041]; wherein the electrode 112 is a puncture electrode such that it is seen to cut the pericardium in Figure 2B), the at least one electrode having a surface area and being located on the distal portion (Figure 1A, 112); wherein the distal portion is electrically insulated from the at least one electrode (Figure 1D, 116) and has a surface area significantly larger than the surface area of the at least one electrode (Figure 1D; wherein electrically insulated portion 116 has a significantly larger surface area than electrode 112), the distal portion being configured to prevent movement of the distal portion into a cut or puncture formed in the pericardium by application of energy to the at least one electrode (Abstract; wherein delivering a single pulse of a pulsed energy through the energy delivery device to a parietal pericardium of the heart to create a void relatively close to the energy delivery device while maintaining the distal end of the puncture device in a substantially stationary position relative to the parietal pericardium)
Regarding claim 2, Davies discloses the electrosurgical device of claim 1 wherein the elongate shaft includes a lumen extending from the proximal end to the distal end (Figure 1D, 120).
Regarding claim 3, Davies discloses the electrosurgical device of claim 1 wherein the at least one electrode is formed of a wire having one or more rectangular, circular, oval, square, or polygonal cross-section (Paragraph [0037]; wherein electrode can be formed of a nitinol wire, Figure 1C; wherein electrode has a polygonal cross section).
Regarding claim 4, Davies discloses the electrosurgical device of claim 1 wherein the at least one electrode is formed of an electrically conductive metal (Paragraph [0037]; wherein electrode can be formed of a nitinol wire)
Regarding claim 5, Davies discloses the electrosurgical device of claim 1, further comprising at least one lead configured to electrically connect the at least one electrode to a control system (Paragraph [0038]; wherein an electrically conductive wire for operatively coupling energy delivery device to a source of energy, such that the source of energy is seen as a part of a control system).
Regarding claim 6, Davies discloses the electrosurgical device of claim 5, wherein the at least one lead extends proximally from the at least one electrode through a lead lumen to the proximal end of the elongate shaft (Paragraph [0038]; wherein electrically conductive wire 114 for operatively coupling energy delivery device to a source of energy, such that the source of energy is on the opposing side of the proximal end of the shaft therefore extends to it through lumen 116 seen in figure 1C).
Regarding claim 7, Davies discloses the electrosurgical device of claim 5, wherein the at least one lead forms the at least one electrode (Paragraph [0037]-[0038]; wherein electrode can be formed of a nitinol wire)
Regarding claim 8, Davies discloses the electrosurgical device of claim 1, further comprising a connector located at the proximal end configured for electrically connecting the electrosurgical device to a control system (Figure 1, 118)
Regarding claim 9, Davies discloses the electrosurgical device of claim 1, wherein the at least one electrode extends longitudinally along the outer surface of the distal portion (Figure 1D. 112)
Regarding claim 10, Davies discloses the electrosurgical device of claim 9, wherein the outer surface tapers towards the distal end (Figure 7)
Regarding claim 11, Davies discloses the electrosurgical device of claim 1 wherein the at least one electrode is located in a recess or groove along the distal portion (Figure 7; wherein electrode 112, is located in recess 701)
Regarding claim 13, Davies discloses the electrosurgical device of claim 1 wherein the at least one electrode is located on a distal face of the elongate shaft (Figure 1D, 112)
Regarding claim 14, Davies discloses the electrosurgical device of claim 1, wherein the at least one electrode comprises a plurality of electrodes (Figure 7, 112 & 705)
Regarding claim 15, Davies discloses An electrosurgical device for discretely cutting pericardium that is adjacent myocardium (Figure 1A; Figure 7), the electrosurgical device comprising: an elongate shaft having a proximal portion including a proximal end and a tapered distal portion including a distal end (Figure 1A, 104 & 108; Figure 7; wherein Figure 7 is the tapered distal portion); and at least one electrode configured to cut the pericardium (Figure 1, 112; Paragraph [0041]; wherein the electrode 112 is a puncture electrode such that it is seen to cut the pericardium in Figure 2B), the at least one electrode having a surface area and extending longitudinally along an outer surface of the distal portion (Figure 1D, 112); wherein the distal portion is electrically insulated from the at least one electrode and has a surface area significantly larger than the surface area of the at least one electrode (Figure 1D; wherein electrically insulated portion 116 has a significantly larger surface area than electrode 112), the distal portion being configured to prevent movement of the distal portion into a cut or puncture formed in the pericardium by application of energy to the at least one electrode (Abstract; wherein delivering a single pulse of a pulsed energy through the energy delivery device to a parietal pericardium of the heart to create a void relatively close to the energy delivery device while maintaining the distal end of the puncture device in a substantially stationary position relative to the parietal pericardium).
Regarding claim 16, Davies discloses A method for discretely cutting target tissue using radiofrequency energy (Abstract; Paragraph [0033]), the method comprising: providing an electrosurgical device (Figure 1A), the electrosurgical device comprising: an elongate shaft including a proximal portion including a proximal end and a distal portion including a distal end (Figure 1A, 104 & 108); and at least one electrode configured to cut the target tissue (Figure 1, 112; Paragraph [0041]; wherein the electrode 112 is a puncture electrode such that it is seen to cut the pericardium in Figure 2B), the at least one electrode having a surface area and extending longitudinally along an outer surface of the distal portion (Figure 1D, 112); wherein the distal portion is electrically insulated from the at least one electrode and has a surface area significantly larger than the surface area of the at least one electrode (Figure 1D; wherein electrically insulated portion 116 has a significantly larger surface area than electrode 112); advancing the electrosurgical device to a target location within a patient (Abstract; wherein advancing a puncture device towards a heart, the puncture device including an energy delivery device at a distal end of the puncture device); and providing radiofrequency energy to the at least one electrode and forming a cut in the target tissue (Abstract; wherein delivering a single pulse of a pulsed energy through the energy delivery device to a parietal pericardium of the heart to create a void relatively close to the energy delivery device while maintaining the distal end of the puncture device in a substantially stationary position relative to the parietal pericardium); wherein the distal portion contacts tissue adjacent the cut in order to prevent movement of the distal portion into the cut (Abstract; wherein delivering a single pulse of a pulsed energy through the energy delivery device to a parietal pericardium of the heart to create a void relatively close to the energy delivery device while maintaining the distal end of the puncture device in a substantially stationary position relative to the parietal pericardium).
Regarding claim 17, Davies discloses the method of claim 16, wherein the distal portion tapers towards the distal end (Figure 7).
Regarding claim 18, Davies discloses the method of claim 16, wherein the elongate shaft includes a lumen extending from the proximal end to the distal end (Figure 1D, 120).
Regarding claim 19, Davies discloses the method of claim 16, wherein the target tissue is pericardium (Abstract).
Regarding claim 20, Davies discloses the method of claim 19, further comprising advancing a guidewire through the cut into a pericardial space (Paragraph [0096]; wherein a guidewire may be introduced into the pericardial cavity, or a pericardiocentesis needle introduced through cannula or the sheath in order to drain fluid from the pericardial cavity)
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 12 is rejected under 35 U.S.C 103 as being unpatentable over Davies in view of Viswanathan et al. (US 20180085160) herein referred to as Viswanathan.
Regarding Claim 12, Davies discloses the electrosurgical device of claim 1. However, Davies does not explicitly disclose wherein the at least one electrode has a surface area less than 1.0 mm2.
Viswanathan discloses an electrosurgical device (Figure 1, 110) comprising an electrode having a surface area less than 1.0mm2 (Paragraph [0014]; wherein an electrode can have a surface area between 0.5mm2 and 2.0mm2 such that the range covers from 0.5mm to 1mm2). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the surface area of the electrode taught by Davies to be less than 1.0mm2. The motivation being it would be obvious to try different sized electrodes with different surface areas to see which provides the best results of allowing for the tissue to be cut (MPEP 2143 (D)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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