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 .
Information Disclosure Statement
The information disclosure statements (IDS), which were all submitted on 11/20/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Regarding claim 1, The term “defined by a remainder” renders the claim indefinite. The term “defined by a remainder” 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.
Regarding claim 2, It is ambiguous whether the term “plurality of electrodes” refers to the same electrodes as stated in claim 1. Hence the term “plurality of electrodes” renders the claim unclear.
Regarding claims 1, 3, 4, 6 and 7, It is ambiguous whether the term “section” in all recitations of the claim are the same or different sections since the reference to the term “section” differs in each claim. Hence, the term “section” renders the claim unclear.
Regarding claim 9, The term “the electrode” renders the claim unclear since it is uncertain which electrode is referred to. It is unclear as to which electrode is referred to. The term “the electrode” 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.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gutbrod et al (US20230105973A1) herein referred to as “Gutbrod”.
Regarding claim 1, Gutbrod teaches: An end effector for a medical device (See FIG 3A where 300A is seen as the end effector for a medical device) comprising: a plurality of spines extending along a longitudinal axis (See FIG 3A where the spines extend along the longitudinal axis 322) to define a basket assembly, ([0104] can be a basket shape) the plurality of spines configured to bow radially outward from the longitudinal axis to define a radius of curvature with respect to the longitudinal axis (See annotated FIG 3A below where they bow radially as they are curved outward from the center) and to transition between an expanded configuration and a collapsed configuration, (See FIG 4A showing collapsed and 4B showing expanded) each spine of the plurality of spines including a section extending radially outward from the radius of curvature defined by a remainder of each spine; (See annotated FIG 3A below where each spine is seen as forming a section) and at least one electrode disposed on the section for each spine of the plurality of spines (See annotated FIG 3A below where
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there is at least one electrode, 310, on each of the plurality of spines).
Regarding claim 2, Gutbrod teaches: The end effector of claim 1, a plurality of electrodes being disposed on each spine of the plurality of spines (See annotated FIG 3A above where there is a plurality of electrodes, (which is seen as having more than 2 electrodes, 310, are seen as a plurality) on each spine of the plurality of spines).
Regarding claim 3, Gutbrod teaches: The end effector of claim 1, each electrode of a plurality of electrodes being disposed on a respective section on each spine of the plurality of spines (See annotated FIG 3A above where there are more than 2 electrodes, which is seen as a plurality, on each spine).
Regarding claim 4, Gutbrod teaches: The end effector of claim 3, the sections of each spine of the plurality of spines configured to cause each respective electrode of the plurality of electrodes to contact tissue prior to the remainder of each spine contacting the tissue when the end effector is brought into contact with tissue ([0140] The end effector makes contact with tissue, electrode first, since tissue contact changes the deformation of the spine, each section of the electrode will not make tissue contact at the same time).
Regarding claim 5, Gutbrod teaches: The end effector of claim 1, the at least one electrode being configured to deliver ablative energy to tissue ([0085] the electrodes deliver ablative energy).
Claims 16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edwards et al (US20030153905A1) herein referred to as “Edwards”.
Regarding claim 16, Edwards teaches: An electrode assembly (See FIG 104 where components 214, 560, 544, 14, 74, 562, and 12 is seen as the electrode assembly) comprising: an electrode body (See FIG 104 and 105 where the electrode body is seen as 14, 74 and 12) extending along a longitudinal axis (See FIG 104 and 105 where the electrode body is oriented along a longitudinal axis) and defining a recess; (See annotated FIG 105 below) an electrode cap disposed at least partially in the recess; (See annotated FIG 105 below) and a spring member disposed in the recess between the electrode body and the electrode cap, (See FIG 104 where the spring, 562, is between the electrode body and electrode cap) the spring member configured to cause the electrode cap to extend outwardly from the electrode body (See FIG 105 where the displaced spring causes the cap to extend out from the electrode body).
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Regarding claim 18, Edwards teaches: The electrode assembly of claim 16, the electrode body further defining a lip extending around the recess, (See annotated FIG 103 below) the lip configured to prevent the electrode cap from being removed from the recess (See annotated FIG 103 below).
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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 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Gutbrod in view of Harlev et al (US20230200901A1) herein referred to as “Harlev”.
Regarding claim 6, Gutbrod discloses: The end effector of claim 3, further comprising a location sensor configured to detect a position ([0071] a navigation sensor which is seen as a position sensor to determine the location of the electrode assembly) however, Gutbrod does not explicitly disclose: disposed on each respective section.
Harlev discloses: a sensor disposed on each respective section and configured to detect a position of the section (See FIG 10 where the sensors, 126, [0157] which can be position sensors, are disposed on [0100] each cell defined by struts, which is seen as sections).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensors disclosed in Gutbrod to include additional sensors disposed on each section as disclosed in Harlev. The motivation being this allows for determining if the deployable portion is accurately deployed or deformed (Harlev [0129]).
Regarding claim 7, Gutbrod discloses: The end effector of claim 6, however, Gutbrod does not explicitly disclose: each location sensor disposed on the section underneath a respective electrode of the plurality of electrodes.
Harlev discloses: each location sensor disposed on the section underneath a respective electrode of the plurality of electrodes ([0128] the sensors can be positioned along the inner portion which is seen as underneath).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the location of the sensor as disclosed in Gutbroad to place it underneath as disclosed in Harlev. The motivation being to allow for improved measuring conditions (Harlev [0128]).
Claims 8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gutbrod in view of Edwards.
Regarding claim 8, Gutbrod discloses: The end effector of claim 1, each electrode comprising: an electrode body defining a lumen extending therethrough (See annotated FIG 3A above) however, Gutbrod does not explicitly disclose: a recess; an electrode cap disposed at least partially in the recess; and a spring member disposed in the recess between the electrode body and the electrode cap, the spring member configured to cause the electrode cap to extend outwardly from the electrode body.
Edwards discloses: a recess; (See annotated FIG 105 above) an electrode cap disposed at least partially in the recess; (See annotated FIG 105 above) and a spring member disposed in the recess between the electrode body and the electrode cap, (See FIG 104 where the spring, 562, is between the electrode body and electrode cap) the spring member configured to cause the electrode cap to extend outwardly from the electrode body (See FIG 105 where the displaced spring causes the cap to extend out from the electrode body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode as disclosed in Gutbrod to include a recess, an electrode cap and a spring as disclosed in Edwards. The motivation being replacing one known element, the electrodes of Gutbrod, with another known element, the electrodes of Edwards with the predictable result of making the electrode deployable and allows ablation to be performed on a hollow organ (Edwards [0008]).
Regarding claim 10, Gutbrod discloses: The end effector of claim 8, however, Gutbrod does not explicitly disclose: the electrode body further defining a lip extending around the recess, the lip configured to prevent the electrode cap from being removed from the recess.
Edwards discloses: the electrode body further defining a lip extending around the recess, (See annotated FIG 103 above) the lip configured to prevent the electrode cap from being removed from the recess (See annotated FIG 103 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode as disclosed in Gutbrod to include a lip as disclosed in Edwards. The motivation being replacing one known element, the electrodes of Gutbrod, with another known element, the electrodes of Edwards with the predictable result of making the electrode deployable and allows ablation to be performed on a hollow organ (Edwards [0008]).
Regarding claim 11, The end effector of claim 8, the lumen configured to receive a spine of the plurality of spines (See Gutbrod annotated FIG 3A above where the plurality of spines passes through the lumen of each of the electrodes).
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gutbrod in view of Edwards in further view of Harlev.
Regarding claim 12, Gutbord in view of Edwards discloses: The end effector of claim 8, comprising a position sensor (Gutbrod [0071] a navigation sensor which is seen as a position sensor) and configured to output a current when subjected to an electromagnetic field to detect a position of the electrode (Gutbrod [0071] the data which is seen as current is used to detect the position when exposed to a magnetic field) however, Gutbord in view of Edwards does not explicitly disclose: a sensor disposed on the electrode body.
Harlev discloses: a sensor disposed on the electrode body (See FIG 10 where the electrode body is seen as 124 and the position sensors 126 are disposed on the electrode body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode as disclosed in Gutbord in view of Edwards to include it disposed on the electrode body as disclosed in Harlev. The motivation being to allow for forming a robust mechanical connection (Harlev [0128]).
Regarding claim 13, Gutbrod in view of Edwards discloses: The end effector of claim 12, and the position sensor, however, Gutbrod in view of Edwards does not explicitly disclose: sensor being disposed on an inwardly-facing side of the electrode body that faces toward the longitudinal axis.
Harlev discloses: the sensor being disposed on an inwardly-facing side of the electrode body that faces toward the longitudinal axis ([0128] the sensors can be positioned along the outer portion, which is seen as the sensor being disposed on the inwardly facing side that faces the longitudinal axis).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the location of the sensor as disclosed in Gutbroad in view of Edwards to place it underneath as disclosed in Harlev. The motivation being this allows for determining if the deployable portion is accurately deployed or deformed (Harlev [0129]).
Regarding claim 14, Gutbrod in view of Edwards discloses: The end effector of claim 12, the position sensor being a first position sensor, (Gutbrod [0099] the first navigation sensor is seen as a first position sensor) the end effector further comprising a second position sensor, (Gutbrod [0099] the second navigation sensor is seen as a second position sensor) and configured to output a current when subjected to an electromagnetic field to detect a position of the electrode, (Gutbrod [0071] the data which is seen as current is used to detect the position when exposed to a magnetic field), however, Gutbrod in view of Edwards does not explicitly disclose: a sensor disposed on the electrode body.
Harlev discloses: a sensor disposed on the electrode body (See FIG 10 where the electrode body is seen as 124 and the position sensors 126 are disposed on the electrode body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode as disclosed in Gutbord in view of Edwards to include it disposed on the electrode body as disclosed in Harlev. The motivation being this allows for determining if the deployable portion is accurately deployed or deformed (Harlev [0129]).
Regarding claim 15, Gutbord in view of Edwards discloses: The end effector of claim 14, the first position sensor and the second position sensor comprising a dual axis sensor (Gutbrod [0100] the navigation sensors which are seen as position sensors can include inductive sensors, MR sensors, 5-DOF and 6-DOF sensors which are dual axis sensors).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of Meredith (US20140018665A1) herein referred to as “Meredith”.
Regarding claim 17, Edwards discloses: The electrode assembly of claim 16, however, Edwards does not explicitly disclose: comprising a force sensor assembly including a first coil coupled to the spring member and a second coil fixed to the electrode body, the force sensor assembly configured to detect a force applied to the electrode.
Meredith discloses: comprising a force sensor assembly including a first coil coupled to the spring member and a second coil fixed to the electrode body, the force sensor assembly configured to detect a force applied to the electrode ([0041] two tracking coils on either side of a spring which can be used to measure the force applied to the spring).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode as disclosed in Edwards to include the force sensor including a first coil and second coil as disclosed in Meredith. The motivation being this allows for sensing of the contact force which can be used to determine contact between the electrode and the tissue (Meredith [0041]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of Gutbrod.
Regarding claim 19, Edwards discloses: The electrode assembly of claim 16, however, Edwards does not explicitly disclose: the electrode body further defining a lumen configured to receive a spine, the spine configured to support the electrode assembly.
Gutbrod discloses: the electrode body further defining a lumen configured to receive a spine, the spine configured to support the electrode assembly (See annotated FIG 3A above).
It would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to modify the electrode as disclosed in Edwards to include a lumen as disclosed in Gutbrod. The motivation being that the lumen allows the electrodes to be disposed on the spines which allows the ablation to be generated in a target tissue in response to a plurality of electric pulse sequences (Gutbrod [0070]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Edwards in view of Harlev.
Regarding claim 20, Edwards discloses: The electrode assembly of claim 16, however, Edwards does not disclose: further comprising a position sensor disposed on the electrode body and configured to output a current when subjected to an electromagnetic field to detect a position of the electrode.
Harlev discloses: further comprising a position sensor ([0157] the sensors are seen as position sensors since they detect the position of the electrodes) disposed on the electrode body (See FIG 10) and configured to output a current when subjected to an electromagnetic field to detect a position of the electrode ([0167] the measurement from the electric field, which is seen as the current, can be used to detect the position of the electrode).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode as disclosed in Edwards to include a position sensor as disclosed in Harlev. The motivation being that these measurements can be used to determine the displacement (Harlev [0167]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M GANAN-SINGH whose telephone number is (571)272-3194. The examiner can normally be reached Monday to Friday 7:30am to 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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