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 (IDS) submitted on 06/07/2022 and 10/11/2023 has been considered by the examiner.
Claim Status
A complete action on the merits of claims 1-20 follows below.
Claim Objections
Claim 20 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only--, and/or, --cannot depend from any other multiple dependent claim. It is noted that claim 10 is also formatted in a multiple dependent form “The radio-frequency ablation catheter according to claim 1 or 2”. See MPEP § 608.01(n). Accordingly, the claim 20 has not been further treated on the merits.
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.
Claims 1-20 are 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.
Claim 1 recites the limitation “are electrically conducted to the plurality of supports” in line 19. It is at most unclear what is meant by “electrically conducted” here. For analysis, it is interpreted to be electrically connected; however, clarification and appropriate correction is required.
Claim 9 recites the limitation “the insulating layers are configured to shield a signal”. It is at most unclear what signal is being claimed and what element generates the signal. It is further unclear how the insulating layers are configured to shield that signal. Clarification and appropriate correction is required.
Claims 2-8 and 10-20 are rejected due to dependency over claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 20 claims “a radiofrequency ablation system, comprising a radiofrequency ablation catheter according to any one of claims 1 to 19” since claim 1 is already directed to “a radiofrequency ablation catheter applied to a radiofrequency ablation system” it is unclear how claim 20 is further limiting the claimed limitations of either of claims 1 to claim 19. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4-5, 7-15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Elliot (2011/0125147) in view of the teaching of Lee (6,235,023).
Regarding claim 1, Elliot teaches a radiofrequency ablation catheter applied to a radiofrequency ablation system (system and method for ablation of tissue), comprising a needle tube portion and a handle portion (probe and handle Fig. 1), wherein
the handle portion comprises a sleeve (29) and a booster (handle member 28), wherein the sleeve is sleeved on top of the booster, the booster is slidably arranged at one end of the sleeve, the booster is provided with a conductive joint (electrical connector 38),
and the conductive joint is used for an external radiofrequency ablation system (RF generator 6);
the needle tube portion comprises a puncture tube (cannula 12), and electrode tube (shaft 20),
wherein
the puncture tube is fixed at the other end of the sleeve (Fig. 2), the electrode tube is slidably disposed within the puncture tube ([0032] a shaft 20 slidably disposed within the cannula 12), one end of the electrode tube is fixed on the conductive joint (proximal end 24 [0033]) the other end of the electrode tube is provided with a plurality of sub-needles (needle electrodes 26), the plurality of sub-needles are configured to transfer a current provided by the conductive joint ([0041] RF current is delivered to the electrode array 27);
the [[signal conduit]] (shaft 20) comprises a plurality of [supports] (needle electrodes 26) and a plurality of temperature sensors (66; [0040]); the other end of the [[signal conduit]] (shaft 20) is provided with the plurality of [supports] (needle electrodes 26 as shown in Fig. 4 distal end), and the plurality of [supports] (needle electrodes 26) are positioned on one sides of the plurality of sub-needles and the plurality of temperature sensors are disposed on the plurality of [supports] (66 on 26, [0040]) and are electrically conducted to the plurality of [supports] (needle electrodes 26), and the plurality of temperature sensors are configured to detect temperatures near the plurality of sub-needles and transmit them to the radiofrequency ablation system by means of the signal conduit ([0044]);
While Elliot provides for the plurality of needle electrodes and temperature sensors, the Examiner interprets some of electrodes 26 of the plurality of electrodes to be the plurality of supports due to the fact that they are configured to hold/support a sensor capable of receiving and delivering a temperature signal as supported by [0040] and some needle electrodes configured that are to deliver RF energy are interpreted to be the plurality of sub-needles; however, it appears that either all of the needle electrodes comprise a sensor as evidenced by [0040] or neither comprise a sensor as shown in Fig. 3; therefore, Elliot does not teach only select ones of needle electrodes having temperature sensors to be interpreted to be the plurality of supports configured to support a sensor. However, Lee teaches an ablation device where in Fig. 2b sensors 36 can be coupled to all or some of the electrodes 46, 48, 50, an/or 52. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add temperature sensors to some and not all the electrodes of Elliot such that those needle electrodes supporting a sensor are interpreted to be support members and those needle electrodes not having a sensor are interpreted to be the needle electrode (see Col. 6 lines 31-38 of Lee).
Furthermore, Elliot is silent about specifically teaching a slidable signal conduit and fixed on one end at a conductive joint in addition to the slidable electrode tube. However, Lee teaches introducer 12 and provides first and second sets 42 and 44 are coupled to electrode advancement member 30 and can be simultaneously or individually deployed from distal end 14 (Col. 6 lines 24-27). Lee provides the electrodes of energy delivery device 16 can be deployed simultaneously, in pairs, in sets and one at a time. An electrode advancement member 30 is coupled to energy delivery device 16. Electrode advancement member 30 can be actuated by the physician by movement of a proximal end 32 relative to a longitudinal axis of introducer 12 (Col. 4 lines 30-36). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a slidable signal conduit on one side of the electrode tube since Lee provides the electrodes and supports can be selectably advanced.
Regarding claim 2, Elliot in view of Lee teaches the limitations of claim 1 as previously rejected above. Elliot teaches wherein the plurality of temperature sensors are positioned at ends of the plurality of supports ([0040] sensor (not shown) carried at the distal end 60 of the electrode 26).
Regarding claim 4, Elliot in view of Lee teaches the limitations of claim 1 as previously rejected above. Elliot in view of Lee teaches wherein the plurality of supports and the plurality of sub needles are identical in numbers (Elliot Fig. 3 supports can be considered every other needle; Lee: Col. 6 lines 33-34 First and second sets 42 and 44 can include one, two, three, four, five, etc, number of RF electrodes) and are arranged alternately (Lee provides electrodes can have the temperature sensor arranged alternately as shown in Fig. 2b).
Regarding claim 5, Elliot in view of Lee teaches the limitations of claim 1 as previously rejected above. Elliot teaches wherein the plurality of supports are disposed next to the plurality of sub-needles (Elliot shows the plurality of needle electrodes 26 in Fig. 3, in view of the teachings of Lee the support can be every other needle that supports a sensor), and spacings between the plurality of sub- needles and the plurality of supports are identical ([0036] pairs of adjacent needle electrodes 26 can be spaced from each other in similar or identical).
Regarding claim 7, Elliot in view of Lee teaches the limitations of claim 1 as previously rejected above. Elliot teaches further comprising a fixing ring (Fig. 5 tubes 70 [0034]), wherein the fixing ring is positioned within the puncture tube (tubes 70 within cannula 12), and the fixing ring is configured to fix the plurality of supports and the plurality of sub-needles ([0034] “a plurality of delivery lumens 72 extending from its proximal end 24 to its distal end 22. In one embodiment, each electrode 26 is a needle electrode, which resembles the shape of a needle or wire. However, the electrodes 26 may also have other shapes as well. As will be described in further detail below, the lumens 72 provide a means for delivering one or more occlusive elements from the needle electrodes 26” thereby, the fixing ring is configured to fix the plurality of supports and the plurality of sub-needles).
Regarding claim 8, Elliot in view of Lee teaches the limitations of claim 7 as previously rejected above Elliot teaches wherein the fixing ring is provided with a plurality of through holes (Fig. 5), the number of the plurality of through holes is equal to the sum of the number of the plurality of supports and the number of the plurality of sub-needles ([0035] each of the electrodes 26 comprises a lumen 64 that is in communication with a respective lumen 72 of the shaft 20), and the plurality of supports and the plurality of sub-needles are disposed on the plurality of through holes in a penetrating fashion ([0035]).
Regarding claim 9, Elliot in view of Lee teaches the limitations of claim 1 as previously rejected above. Elliot teaches wherein surfaces of the electrode tube are provided with insulating layers and the insulating layers are configured to shield a signal (shaft 20 is within cannula 12 and cannula 12 is preferably covered with an insulative material [0033]). Lee is silent about specifically teaching the signal conduit includes an insulating portions. However, in view of Elliot it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide for insulating layers on the signal conduit to protect the signals that travel from the temperature sensors on the flexible elements to the conductive joint.
Regarding claim 10, Elliot in view of Lee teaches the limitations of claim 1 as previously rejected above. Lee teaches wherein the temperature sensors can be thermistors (Col. 5 line 40 Sensor 36 is of conventional design, including but not limited to thermistors).
Regarding claim 11, Elliot in view of Lee teaches the limitations of claim 1 as previously rejected above. Elliot in view of Lee teaches wherein the plurality of sub-needles are of a flower radial shape, and the plurality of supports are of a flower radial shape (Elliot Fig. 3; Lee Col 6 lines 55-60 Electrodes 18 can be made of conductive solid or hollow straight wires of various shapes such as round, flat, triangular, rectangular, hexagonal, elliptical and the like).
Regarding claim 12, Elliot in view of Lee teaches the limitations of claim 11 as previously rejected above. Lee teaches wherein the lengths of the plurality of sub-needles are the longest in the middle parts and the shortest at the outermost ends, and are gradually shortened from the middle part towards two ends (Fig. 16).
Regarding claim 13, Elliot in view of Lee teaches the limitations of claim 12 as previously rejected above. Elliot teaches wherein the plurality of sub-needles are distributed symmetrically with respect to a central axis of the electrode tube ([0036] he needle electrodes 26 diverge radially outwardly from the cannula 12 in a uniform pattern, i.e., with the spacing between adjacent needle electrodes 26 diverging in a substantially uniform and/or symmetric pattern…pairs of adjacent needle electrodes 26 can be spaced from each other in similar or identical, repeated patterns and can be symmetrically positioned about an axis of the shaft 20), and the lengths of the corresponding sub-needles symmetrical with respect to the central axis of the electrode tube are identical (see claim rejection 4).
Regarding claim 14, Elliot in view of Lee teaches the limitations of claim 11 as previously rejected above. Lee teaches wherein the lengths of the plurality of supports are the longest in the middle parts and the shortest at the outmost ends, and are gradually shortened from the middle parts towards two ends (Fig. 2b shows deployable members 34 having different lengths with the longest in the middle and the outer supports are shorter).
Regarding claim 15, Elliot in view of Lee teaches the limitations of claim 14 as previously rejected above. Elliot in view of Lee teaches wherein the plurality of supports are distributed symmetrically with respect to a central axis of the signal conduit (Elliot teaches the plurality of supports (needle electrodes) are distributed symmetrically with respect to a central axis [0036], in view of the teachings of Lee the plurality of supports are distributed symmetrically with respect to a central axis of the signal conduit), and the lengths of the corresponding supports symmetrical with respect to the central axis of the signal conduit are identical (Fig. 3).
Regarding claim 20, Elliot in view of Lee teaches a radiofrequency ablation system, comprising a radiofrequency ablation catheter according to any one of claims 1 to 19 (see the claim objection and the 112 rejection above as well as the claim rejection of claim 1).
Claims 3 is rejected under 35 U.S.C. 103 as being unpatentable over Elliot (2011/0125147) in view of Lee (6,235,023), and in further view of Myerson (2018/0055357).
Regarding claim 3, Elliot in view of Babkin teaches the limitations of claim 1 as previously rejected above. Elliot does not teach wherein the temperature sensors are capacitance thermometers. However, Meyerson teaches a medical device for detecting a temperature of a patient and provides that the temperature sensor can be a capacitance temperature sensor [0059]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide for a capacitance temperature sensor since it is a well known temperature sensor in the art as taught by Meyerson.
Claims 6 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Elliot (2011/0125147) in view of Lee (6,235,023) and in further view of Babkin (2019/0209229).
Regarding claim 6, Elliot in view of Lee teaches the limitations of claim 1 as previously rejected above. The combination does not teach wherein the electrode tube further comprises a plurality of metal balls disposed at ends of the plurality of sub-needles.
However, Babkin teaches a device within the same field of invention (monitoring temperature adjacent to an ablation site), wherein elements 18 include ball-like spherical elements for the purposes of prevent the flexible element from puncture the expandable component “the temperature sensors 20 are included on elements that prevent the flexible elements 18 from puncturing the expandable component 14. In some embodiments, the temperature sensors 20 are included on ball-like or spherical elements” [0060]. The balls are electrically connected to the elements.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tip of the sub-needles in Elliot to further include ball like spherical elements to prevent the sub-needles in Elliot from damaging the device or tissue.
In addition, it would have been obvious as a matter of design choice to make the ration of an outer diameter of each metal ball to a diameter of a corresponding needle 1.05:1.01, since such a modification would have involved a mere change in the proportions of components. A change in proportion is generally recognized as being within the level of ordinary skill in the art. In re Reese, 129 USPQ 402.
Regarding claim 16, Elliot in view of Lee and Babkin teaches the limitations of claim 6 as previously rejected above. Elliot teaches wherein the plurality of sub- needles are distributed in a spherical space in a surrounding fashion, and the plurality of supports are distributed in a spherical space in a surrounding fashion ([0036] When deployed from the cannula 12, the array 27 of needle electrodes 26 is placed in a three-dimensional configuration that usually defines a generally ellipsoidal or spherical volume having a periphery with a maximum radius in the range from 0.5 to 3 cm).
Regarding claim 17, Elliot in view of Lee and Babkin teaches the limitations of claim 6 as previously rejected above. The combination provides wherein each of the metal balls has the same latitude relative to the spherical space (Elliot [0036]).
Regarding claim 18, Elliot in view of Lee and Babkin teaches the limitations of claim 6 as previously rejected above. The combination provides wherein each of the temperature sensors has the same latitude relative to the spherical space (Elliot [0036] and [0040]).
Regarding claim 19, Elliot in view of Lee and Babkin teaches the limitations of claim 6 as previously rejected above. The combination teaches wherein the temperature sensors and the metal balls of the same latitude (Elliot markers 66 at the distal end of the element and metal balls of Babkin at the distal end of needles (where the markers of Elliot exist) would provide for temperature sensors and meal balls in the same latitude).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASAMIN EKRAMI whose telephone number is (571)272-9803. The examiner can normally be reached 9:00-5:00.
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/Y.E/Examiner, Art Unit 3794 /KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
