DETAILED ACTION
This action is pursuant to claims filed 2/25/2026. Claims 4-9, 12-13, 15-20, 23-24, and 27-30 are pending. Claims 10, 11, 21, 22, 25, and 26 have been cancelled by the applicant. A non-final action on the merits of claims 4-9, 12-13, 15-20, 23-24 is as follows.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/25/2026 has been entered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the helical shape of half of a single spiral and two-thirds of a single spiral must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 (i.e., changing from AIA to pre-AIA ) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 8, 19, 27 and 29 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Ditter et al. (hereinafter ‘Ditter’, US 20130006238 A1).
Regarding independent claim 8, Ditter discloses a catheter (catheter shown in Fig. 1), comprising:
an insertion probe ([0049]: catheter 10 has an insertion shaft 12), having a distal end (distal end 14 in Fig. 19) configured for insertion into a lumen of a human subject (the catheter is for insertion into the heart through ascending vena cava as seen in Fig. 22);
a resilient tube (distal assembly 17 in Figs. 1, 2, 18), extending distally from the distal end of the insertion probe (the distal assembly 17 extends distally from the distal end of 14 as shown in Figs. 1, 2, and 18) and having, when unconstrained, a helical shape having less than a single spiral and an axis that is collinear with a longitudinal axis of the distal end of the insertion probe ([0099]: as shown in Fig. 18, the distal assembly 17 includes a curved portion that has a semi-circular form 22’ which has generally the same structure and construction as the helical form 22, except the semi-circular form subtends an angle no greater than about 180 degrees), the resilient tube configured with an internal lumen (Fig. 14 shown the inner lumen of the distal assembly 17);
a plurality of electrodes (plurality of electrodes 19 in Fig. 2), fixedly attached to the resilient tube (electrodes 19 are fixedly attached to the distal assembly as seen in Fig. 2), configured to transfer ablation energy to the human subject ([0015]: the electrodes are ablation electrodes), each electrode configured with an ellipsoidal outer shell (the outer shell of the electrode forms an ellipsoidal shape with parts 65 and 67 as seen in Figs. 13 and 14 as consistent with Fig. 2A of the instant application) with a longitudinally extending bore in defining a generally toroidal volume (the electrode has a longitudinally extending bore and a toroidal volume as seen in Figs. 13 and 14) in communication with the internal lumen (the electrode is in communication with the internal lumen through hole 68 as seen in Fig. 14), the outer shell configured with irrigation holes (the outer shell has irrigation holes 69 as seen in Fig. 13 and 14); and
multiple temperature sensors, each temperature sensor affixed to a respective electrode ([0082]: the wire pairs inclusive of their respective constantan wire can function as temperature sensors sensing the temperature of each electrode; constantan wire 41 is connected to the electrodes as seen in Fig. 14).
Regarding claim 27, Ditter discloses the catheter of claim 8, wherein the helical shape has about half of a single spiral ([0099]: semi-circular form subtends an angle no greater than about 180 degrees).
Regarding independent claim 19, Ditter discloses a method, comprising:
providing an insertion probe ([0049]: catheter 10 has an insertion shaft 12is provided - inherent that this step occurred based on the fact that the device is provided in the drawings), having a distal end (distal end 14 in Fig. 19) configured for insertion into a lumen of a human subject (the catheter is for insertion into the heart through ascending vena cava as seen in Fig. 22);
extending a resilient tube (distal assembly 17 is extended from the distal end 14 in Fig. 2) distally from the distal end of the insertion probe (the distal assembly 17 extends distally from the distal end of 14 as shown in Fig. 2), the resilient tube having, when unconstrained, a helical shape having less than a single spiral and an axis that is collinear with a longitudinal axis of the distal end of the insertion probe ([0099]: as shown in Fig. 18, the distal assembly 17 includes a curved portion that has a semi-circular form 22’ which has generally the same structure and construction as the helical form 22, except the semi-circular form subtends an angle no greater than about 180 degrees), the resilient tube configured with an internal lumen (Fig. 14 shown the inner lumen of the distal assembly 17);
fixedly attaching a plurality of electrodes (plurality of electrodes 19 attached to resilient tube in Fig. 2 – step is inherent because the electrodes are fixedly attached), configured to transfer ablation energy to the human subject ([0015]: the electrodes are ablation electrodes), to the resilient tube, each electrode configured with an ellipsoidal outer shell (the outer shell of the electrode forms an ellipsoidal shape with parts 65 and 67 as seen in Figs. 13 and 14 as consistent with Fig. 2A of the instant application) with a longitudinally extending bore in defining a generally toroidal volume (the electrode has a longitudinally extending bore and a toroidal volume as seen in Figs. 13 and 14) in communication with the internal lumen (the electrode is in communication with the internal lumen through hole 68 as seen in Fig. 14); and
fixedly attaching multiple temperature sensors, each to a respective electrode ([0082]: the wire pairs inclusive of their respective constantan wire can function as temperature sensors sensing the temperature of each electrode; constantan wire 41 is connected to the electrodes as seen in Fig. 14 – the electrodes being attached to the temperature sensor wire 41 inherently discloses the step of fixedly attaching the temperature sensor).
Regarding claim 29, Ditter discloses the method of claim 19, wherein the helical shape has about half of a single spiral ([0099]: semi-circular form subtends an angle no greater than about 180 degrees).
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.
Claim(s) 4, 6, 12-13, 15, 17, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Zikorus et al. (hereinafter ‘Zikorus’, US20090125009) in view of Fang (US 20130253504 A1).
Regarding independent claim 23, Zikorus discloses a catheter (catheter shown in Fig. 66), comprising:
an insertion probe (insertion probe 1216 in Figs. 66 and 69), having a distal end (end opposite the 1214 in Fig. 66) configured for insertion into a lumen of a human subject ([0292]: the catheter is for applying energy to a hollow anatomical structure; [0294]: the insertion probe 1216 facilitates the introduction of the device), the distal end defining a longitudinal axis (longitudinal axis of insertion probe in Figs. 66 and 69);
a resilient tube (resilient tube 1210 in Fig. 66), extending distally from the distal end of the insertion probe (the resilient tube 1210 extends outward out of the insertion probe 1216 as seen in Fig. 69) and having, when unconstrained, a planar serpentine shape (serpentine shape of distal end 1209 shown in Fig. 69; [0309]: the distal portion is preformed into a planar serpentine shape) contained within a plane that contains the longitudinal axis of the distal end of the insertion probe ([0309]: the serpentine shape is planar; and the longitudinal axis of the serpentine shape is in line with the insertion probe as seen in Fig. 69, thus it is contained within a plane that contains the longitudinal axis of the distal end of the insertion probe), the planar serpentine shape extending generally along the longitudinal axis of the distal end of the insertion probe (the longitudinal axis of the serpentine shape is in line with the insertion probe as seen in Fig. 69); and
a plurality of electrodes , fixedly attached to the resilient tube ([0295]: the distal portion of the device incorporates a set of electrodes), configured to transfer ablation energy to the human subject ([0295]: the electrodes deliver RF energy up to a predetermined temperature or power level to the hollow anatomical structure and thereby generate heat within the hollow anatomical structure; the distal portion is the distal portion 1209 of the resilient tube 1210 in Fig. 69 as described in [0309]).
Throughout the disclosure of Zikorus, different variations of the resilient tube are contemplated. Zikorus further discloses that the resilient tube 1210 contains an inner lumen 1217 as seen in Fig. 67 which is for flushing saline through the device to prevent the buildup of biological material ([0298]-[0299]).
However, Zikorus is silent to the claimed configuration of the resilient tubes comprising straight elements directly connected at corners and each electrode being attached to a respective straight element with each electrode configured with irrigation holes.
Fang teaches a catheter for ablating and/or sensing electrical activity in tubular regions of the body where the spines which carry the electrodes can be straight, curved, or zig-zagged ([Abstract]). The zig-zagged embodiment is shown in Fig. 13B where the spines, which are synonymous with resilient tubes as they define a lumen as seen in Fig. 9, creates the claimed embodiment where distal and proximal straight sections meet directly to form non-zero angles in the corners. The zig-zagged configuration is a known shape in the art for a resilient tube configured to deliver ablation energy and using such a configuration with the device of Zikorus would be within the level of ordinary skill in the art. Furthermore, the instant application does not apply criticality to the zig-zagged configuration as it is simply one of several forms the resilient tube can make as shown in the drawings. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the zig-zagged formation of Fang with the resilient tube of Zikorus as it is simply one of many options for a resilient tube of an ablation catheter.
Fang further teaches that the straight elements each comprise an electrode as seen in Fig. 13B. Each straight portion comprises an electrode 28a-d. The electrodes can be selected to deliver ablation energy to the desired tissue ([0052]). The electrodes are irrigated ring electrodes which are further fluidly connected to an inner lumen through holes 122 to the chambers 116 of the electrodes as seen in Fig. 9. Fluid can then be passed into each electrode from the lumen and out of the electrodes through holes 124 ([0058]). Utilizing irrigation channels aids in preventing overheating of the electrodes and helps prevent the formation of a thrombus ([0053]). Therefore, because Zikorus discloses utilizing an inner lumen for irrigation and is silent to the placement and structure of the electrodes, it would have been obvious to one of ordinary skill in the art before the effective filing date to combine the electrodes of Fang with the device of Zikorus so each straight element of the serpentine shape has an ablation electrode which is irrigated to prevent overheating.
Regarding claim 4, the Zikorus/Fang combination discloses the catheter according to claim 23, wherein the planar serpentine shape has a peak-peak value between 2 mm and 6 mm ([0309]: in the expanded serpentine shape, the distal portion has a maximum width of 3mm to 25mm; this range is anticipatory of the claimed range because the claimed range does not have any criticality assigned in the specification of the instant application. See MPEP 2131.03).
Regarding claim 6, the Zikorus/Fang combination discloses the catheter according to claim 23, wherein the ablation energy comprises radiofrequency (RF) energy provided by an RF generator ([0305]: the energy source is an AC power supply like an RF generator).
Regarding independent claim 12, Zikorus discloses a method, comprising:
providing an insertion probe (insertion probe 1216 in Figs. 66 and 69 is provided – inherent that this step occurred based on the fact that the device is provided in the drawings), having a distal end (end opposite the 1214 in Fig. 66) configured for insertion into a lumen of a human subject ([0292]: the catheter is for applying energy to a hollow anatomical structure; [0294]: the insertion probe 1216 facilitates the introduction of the device), the distal end defining a longitudinal axis;
extending a resilient tube (resilient tube 1210 in Fig. 66) distally from the distal end of the insertion probe (the resilient tube 1210 is extended outward out of the insertion probe 1216 as seen in Fig. 70 in the restrained configuration and Fig. 69 in the extended configuration), the resilient tube configured with, when unconstrained, a planar serpentine shape (serpentine shape of distal end 1209 shown in Fig. 69; [0309]: the distal portion is preformed into a planar serpentine shape) contained within a plane that contains the longitudinal axis of the distal end of the insertion probe ([0309]: the serpentine shape is planar; and the longitudinal axis of the serpentine shape is in line with the insertion probe as seen in Fig. 69, thus it is contained within a plane that contains the longitudinal axis of the distal end of the insertion probe), the planar serpentine shape extending generally along the longitudinal axis of the distal end of the insertion probe (the longitudinal axis of the serpentine shape is in line with the insertion probe as seen in Fig. 69); and
fixedly attaching a plurality of electrodes ([0295]: the distal portion of the device incorporates a set of electrodes – inherent that this step occurred based on the structure as the electrodes are attached to the distal portion of the resilient tube), configured to transfer ablation energy to the human subject ([0295]: the electrodes deliver RF energy up to a predetermined temperature or power level to the hollow anatomical structure and thereby generate heat within the hollow anatomical structure), to the resilient tube (the distal portion is distal portion 1209 of the resilient tube 1210 in Fig. 69 as described in [0309]).
Throughout the disclosure of Zikorus, different variations of the resilient tube are contemplated. Zikorus further discloses that the resilient tube 1210 contains an inner lumen 1217 as seen in Fig. 67 which is for flushing saline through the device to prevent the buildup of biological material ([0298]-[0299]).
However, Zikorus is silent to the claimed configuration of the resilient tubes comprising straight elements directly connected at corners and each electrode being attached to a respective straight element with each electrode configured with irrigation holes.
Fang teaches a catheter for ablating and/or sensing electrical activity in tubular regions of the body where the spines which carry the electrodes can be straight, curved, or zig-zagged ([Abstract]). The zig-zagged embodiment is shown in Fig. 13B where the spines, which are synonymous with resilient tubes as they define a lumen as seen in Fig. 9, creates the claimed embodiment where distal and proximal straight sections meet directly to form non-zero angles in the corners. The zig-zagged configuration is a known shape in the art for a resilient tube configured to deliver ablation energy and using such a configuration with the device of Zikorus would be within the level of ordinary skill in the art. Furthermore, the instant application does not apply criticality to the zig-zagged configuration as it is simply one of several forms the resilient tube can make as shown in the drawings. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the zig-zagged formation of Fang with the resilient tube of Zikorus as it is simply one of many options for a resilient tube of an ablation catheter.
Fang further teaches that the straight elements each comprise an electrode as seen in Fig. 13B. Each straight portion comprises an electrode 28a-d. The electrodes can be selected to deliver ablation energy to the desired tissue ([0052]). The electrodes are irrigated ring electrodes which are further fluidly connected to an inner lumen through holes 122 to the chambers 116 of the electrodes as seen in Fig. 9. Fluid can then be passed into each electrode from the lumen and out of the electrodes through holes 124 ([0058]). Utilizing irrigation channels aids in preventing overheating of the electrodes and helps prevent the formation of a thrombus ([0053]). Therefore, because Zikorus discloses utilizing an inner lumen for irrigation and is silent to the placement and structure of the electrodes, it would have been obvious to one of ordinary skill in the art before the effective filing date to combine the electrodes of Fang with the device of Zikorus so each straight element of the serpentine shape has an ablation electrode which is irrigated to prevent overheating.
Regarding claim 13, the Zikorus/Fang combination discloses the method according to claim 12, wherein the straight elements are coupled together as a single linear entity (the plurality of straight elements are highlighted above with the corresponding apparatus claim and they couple to curved sections to form a single linear entity; the claim does not limit that curved elements cannot be coupled between the straight elements).
Regarding claim 15, the Zikorus/Fang combination discloses the method according to claim 12, wherein the planar serpentine shape has a peak-peak value between 2 mm and 6 mm ([0309]: in the expanded serpentine shape, the distal portion has a maximum width of 3mm to 25mm; this range is anticipatory of the claimed range because the claimed range does not have any criticality assigned in the specification of the instant application. See MPEP 2131.03).
Regarding claim 17, the Zikorus/Fang combination discloses the method according to claim 12, wherein the ablation energy comprises radiofrequency (RF) energy provided by an RF generator ([0305]: the energy source is an AC power supply like an RF generator).
Regarding claim 24, the Zikorus/Fang combination discloses the catheter according to claim 23 as described above, wherein the distal straight element, the proximal straight element and the linearly-connected straight element pairs are coupled together as a single entity (a single entity is formed by the pairs as shown in Fig. 69 of Zikorus with the Zig-Zag formation of Fang as described in the combination)
Claim(s) 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over the Zikorus/Fang combination as applied to claims 23 and 12 respectively and described above, in view of Hancock et al. (hereinafter ‘Hancock’, US 20200397497 A1).
Regarding claim 5, the Zikorus/Fang combination discloses the catheter according to claim 23 and described above. Zikorus further discloses the power source may be an AC power supply, DC power supply, or alternate energy source ([0305]).
However, Zikorus is silent to the ablation energy comprising irreversible electroporation (IRE) energy provided by an IRE generator.
Hancock teaches an electrosurgical generator configured to deliver RF energy and an electroporation waveform supply which generates energy causing irreversible electroporation ([0009]). This configuration allows for the same generator to supply RF energy for cutting, ablation, hemostasis, or other effects as well as electroporation waveform for causing IRE in tissue, and thus the same probe can deliver the different energy types ([0009]). This provides for more treatment options for the practitioner during a treatment procedure ([0009]). It would be a straight-forward combination for one skilled in the art to modify the generator of Zikorus to deliver both RF-energy and IRE waveforms since Zikorus has disclosed the ability to deliver AC current, DC current, and various other forms of energy. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the generator of the Zikorus/Fang combination with the generator of Hancock such that the same generator is both an RF and IRE generator that can deliver both RF energy as well as IRE waveforms to allow for the practitioner to have more treatment options during a treatment procedure.
Regarding claim 16, the Zikorus/Fang combination discloses the method according to claim 12 and described above. Zikorus further discloses the power source may be an AC power supply, DC power supply, or alternate energy source ([0305]).
However, Zikorus is silent to the ablation energy comprising irreversible electroporation (IRE) energy provided by an IRE generator.
Hancock teaches an electrosurgical generator configured to deliver RF energy and an electroporation waveform supply which generates energy causing irreversible electroporation ([0009]). This configuration allows for the same generator to supply RF energy for cutting, ablation, hemostasis, or other effects as well as electroporation waveform for causing IRE in tissue, and thus the same probe can deliver the different energy types ([0009]). This provides for more treatment options for the practitioner during a treatment procedure ([0009]). It would be a straight-forward combination for one skilled in the art to modify the generator of Zikorus to deliver both RF-energy and IRE waveforms since Zikorus has disclosed the ability to deliver AC current, DC current, and various other forms of energy. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the generator of the Zikorus/Fang combination with the generator of Hancock such that the same generator is both an RF and IRE generator that can deliver both RF energy as well as IRE waveforms to allow for the practitioner to have more treatment options during a treatment procedure, thus arriving at the claimed method.
Claim(s) 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over the Zikorus/Fang combination as applied to claims 23 and 12 respectively and described above, in view of Emmons et al. (hereinafter ‘Emmons’, US 20140358140 A1).
Regarding claim 7, the Zikorus/Fang combination discloses the catheter according to claim 1 and described above. Zikorus further discloses the catheter is for applying energy to a hollow anatomical structure ([0292]). The renal arteries and veins are hollow anatomical structures.
However, the Zikorus/Fang combination is silent to the lumen being one of a renal artery and a renal vein of the human subject.
Emmons teaches utilizing an ablation catheter for insertion into the renal arteries of a patient ([0004]). Emmons further teaches that there is a need for devices and methods that can deliver therapeutic energy to vascular regions such as renal artery walls for procedures such as renal denervation to treat conditions such as hypertension ([0007]). Emmons lastly teaches that the catheter devices disclosed may also be used for medical procedures including endovascular cardiac, thoracic cardiac, bronchial, lung, gynecological, gastro-intestinal, spinal, ENT, laparoscopic, and arthroscopic procedures ([0084]). Because both Emmons and Zikorus are used for the insertion into lumens throughout the body, it would be an obvious and straightforward modification to utilize Zikorus in the renal arteries. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the use of Emmons with the device of the Zikorus/Fang combination such that the device is inserted into the renal artery which allows for use in procedures such as renal denervation.
Regarding claim 18, the Zikorus/Fang combination discloses the method according to claim 12 and described above. Zikorus further discloses the catheter is for applying energy to a hollow anatomical structure ([0292]). The renal arteries and veins are hollow anatomical structures.
However, the Zikorus/Fang combination is silent to the lumen being one of a renal artery and a renal vein of the human subject.
Emmons teaches utilizing an ablation catheter for insertion into the renal arteries of a patient ([0004]). Emmons further teaches that there is a need for devices and methods that can deliver therapeutic energy to vascular regions such as renal artery walls for procedures such as renal denervation to treat conditions such as hypertension ([0007]). Emmons lastly teaches that the catheter devices disclosed may also be used for medical procedures including endovascular cardiac, thoracic cardiac, bronchial, lung, gynecological, gastro-intestinal, spinal, ENT, laparoscopic, and arthroscopic procedures ([0084]). Because both Emmons and Zikorus are used for the insertion into lumens throughout the body, it would be an obvious and straightforward modification to utilize Zikorus in the renal arteries. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the use of Emmons with the device of the Zikorus/Fang combination such that the device is inserted into the renal artery which allows for use in procedures such as renal denervation.
Claim(s) 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ditter as applied to claims 8 and 19 respectively.
Regarding claim 9, Ditter discloses the catheter according to claim 8, wherein an outer diameter of the helical shape is ranging from 20mm to 35mm ([0318]).
However, Ditter does not disclose the claimed diameter of 5mm
The instant application does not assign criticality to the diameter being 5 mm. In fact, on page 17 of the instant application, applicant states other examples may have different outer diameters. It would have been an obvious matter of design choice to make the outer diameter of the helical shape 5mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 20, Ditter discloses the method according to claim 19 and described above, wherein an outer diameter of the helical shape is ranging from 20mm to 35mm ([0318]).
However, Ditter does not disclose the claimed diameter of 5mm.
The instant application does not assign criticality to the diameter being 5 mm. In fact, on page 17 of the instant application, applicant states other examples may have different outer diameters. It would have been an obvious matter of design choice to make the outer diameter of the helical shape 5mm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Ditter as applied to claims 8 and 19, respectively.
Regarding claims 28 and 30, Ditter discloses the subject matter substantially as applied to claims 8 and 19 as described above. Ditter further discloses that the spiral can be a full circle or greater ([0049]), or be about half of a circle ([0099]), or have the helical form varied and adjusted ([0050]).
However, Ditter does not explicitly state that the helical coil is two-thirds of a single spiral.
The instant application does not provide any criticality to the spiral being two-thirds of a single spiral. The instant application simply states that “the helix is not more than a single spiral, so, for example, one example may comprise half a spiral, and another example may comprise two-thirds of a spiral” (Page 17 of the instant application specification). Two-thirds of a single spiral is merely exemplary of the spiral shape, with no criticality to the shape. Therefore, because Ditter discloses adjusting and varying the helical form, it would have been an obvious matter of design choice to make the helical coil of whatever form or shape was desired or expedient, in this case into a spiral that is two-thirds of a single spiral. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Response to Arguments
Applicant’s arguments with respect to the 112b rejection of claim 25 has been fully considered and is persuasive in light of claim 25 being cancelled. The 112b rejection of claim 25 is withdrawn.
Applicant's arguments filed 2/25/2026 regarding claims 8 and 19 have been fully considered but are not persuasive. The applicant argues that Ditter does not disclose the helical shape being less than a single spiral. However, Ditter states, in paragraph [0099],the “semi-circular form 22’ which has generally the same structure and construction as the helical form 22, except the semi-circular form subtends an angle no greater than about 180 degrees.” Thus, Ditter explicitly states that the helix can be less than a single spiral. Therefore, the rection remains.
Applicant’s arguments regarding new claims 27-30 have been fully considered but are not persuasive. Ditter explicitly discloses that the spiral can be 180 degrees in paragraph [0099], which is half of a spiral. Thus, claims 27 and 29 are rejected. Regarding claims 28 and 30, while Ditter does not explicitly state that the helix is two-thirds of a single spiral, Ditter does disclose that the spiral can be varied and adjusted ([0050]). This fact, in combination with the fact that the instant application provides no criticality to the spiral shape, indicates that this is a simple design choice. As stated above, it would have been an obvious matter of design choice to make the helical coil of whatever form or shape was desired or expedient, in this case into a spiral that is two-thirds of a single spiral. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Applicant’s arguments with respect to claim(s) 4, 6, 12-13, 15, 17, and 23-24 have been considered but are not persuasive. Applicant argues that one of ordinary skill in the art would not be motivated to combine the zig-zag shape of Fang with the shape of Zikorus because the intended uses of the shapes are different. This is not persuasive. The shape of Zikorus is approximately zig-zagged already, the elements connecting the corners simply aren’t perfectly straight as seen in Fig. 69. While the zig-zag shape of Fang doesn’t flatten the hollow anatomical structure, the zig-zag shape does allow the spines to lay flatter against the tissue as the applicant has acknowledged ([0072]). This is an obvious benefit to the shape of Zikorus since the focus of the embodiment shown in Fig. 69 is intended to increase contact between the anatomical structure and the distal end of the device ([0309]). Furthermore, Zikorus teaches a wide variety of shapes to accomplish the goal of placing electrodes in contact with a hollow anatomical structure, such as those shown in Figs. 1, 44, 45, 49, 51, 59, 60, and so on. Several of the embodiments are similar to the multi-spine embodiments of Fang. Utilizing a simple shape of the spines of Fang is well within the level of ordinary skill in the art to apply to the distal end of Zikorus. Changing the serpentine shape of Zikorus to have straighter sections and more distinct corners is simply a change of shape of the device and the applicant has provided no criticality to this difference. In fact, the applicant has even provided the rounded edges as an alternative to the sharp zig-zags as shown in Figs. 2A and 2B of the instant application. Thus, the argument that modifying Zikorus to have corners could result in tissue damage is not persuasive, because the applicant discloses the exact same shapes which do not damage the tissue. Furthermore, Zikorus makes no mention that changing the shape would adversely impact the function. In fact, the embodiment shown in Figs. 59 and 60 of Zikorus have defined corners that contact the hollow anatomical structure as well.
Applicant’s arguments discussing the L-shapes of Fang are not persuasive because that is directed to a different part of the device. The L-shape is directed towards the supporting arm, not the spine shape that is used in the combination ([Abstract]).
Additionally, the Applicant argues that the addition of “the planar serpentine shape extending generally along the longitudinal axis of the distal end of the insertion probe” is not disclosed by the prior art. This is not persuasive. As seen in Fig. 69 of Zikorus, the planar serpentine shape extends along the longitudinal axis of the insertion probe. The extension and shape are consistent with Figs. 2A and 2B of the instant application.
Therefore, because modifying Zikorus is simply a change in the shape of the distal end, which Zikorus contemplated throughout the disclosure, which is taught be Fang, and the applicant has provided no criticality to the zig-zag shape, the rejection remains.
Applicant has not provided any direct arguments against the application of Hancock, or Emmons. Therefore, the rejections remain.
Applicant has cancelled all claims to which Werneth was applied.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794