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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
Acknowledgement is made to the amendment received 12/02/2025.
Acknowledgement is made to the amendment of claim 1.
Acknowledgement is made to the cancellation of claims 6-7, 15, and 20.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 1-5, 8-14, and 16-19 are pending. A complete action on the merits appears below.
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, 9, 16, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wittenberger (US 20120029494 A1) in view of Dobak (US 5957963 A) and Cao (US 20060287650 A1).
Regarding claim 1, Wittenberger teaches an apparatus (Fig. 2; medical device 14) for providing therapy to tissue (¶[0014]) comprising:
a flexible shaft (Fig. 2; elongate body 26) with a distal end and a proximal end; and
a planar therapy structure (¶[0017] teaches the medical device as including a distal portion for treating tissue comprising first and second treatment regions as seen in Fig. 2; first treatment region 34 and second treatment region 44), where the planar therapy structure is coupled to the distal end of the flexible shaft (¶[0017] & [0020]), where the planar therapy structure comprises:
a plurality of electrodes (¶[0017], [0019], and [0021] teach the treatment regions as containing electrodes and conductive regions for radiofrequency ablation of tissue) positioned along a length of the planar therapy structure (¶[0017], [0019], [0021] further teaches the elements which are conductive regions for radiofrequency ablation of tissue, also referred to as electrodes, are located along a length of the treatment region as broadly as is currently claimed),
an expansion chamber (Fig. 3; the interior of second treatment region 44 [0021] teaches fluid being delivered into the second treatment region by fluid expansion) extending through the length of the planar therapy structure (¶[0021] teaches the interior portion which receives fluid which expands within said region as occurring along a length of the treatment region), the expansion chamber comprising i) an end wall (Fig. 3; wall 52) at a proximal end of the expansion chamber and ii) an outer wall (Fig. 3; second treatment region 44 is located within the region interior of face 45 and surface 47),
an inlet (Fig. 3; a tube for delivering fluid for expansion is located through an opening within proximal wall 52) to receive a pressurized coolant from a supply line (¶[0021]), the inlet comprising an opening through the end wall of the expansion chamber (¶[0022]),
an inlet tube (Fig. 3; fluid injection lumen 48) coupled to the inlet, the inlet tube disposed within the expansion chamber and extending through the planar therapy structure the inlet tube comprising a plurality of openings (Fig. 3; apertures 50) defined in a wall of the inlet tube, wherein the plurality of openings are configured to discharge the pressurized coolant into the expansion chamber such that the pressurized coolant cools the outer wall of the expansion chamber and cools an outer surface of the planar therapy structure to facilitate cryogenically ablating tissue (¶[0021]- [0022]), and
an outlet (¶[0022]) to receive a de-pressurized coolant from the expansion chamber.
However, Wittenberger fails to teach the planar therapy structure as being a hoop comprising: an arcuate expansion chamber and the inlet tube extending through the hoop.
Dobak teaches an apparatus for performing hypothermia of a selected organ having a flexible catheter containing an expansion element near the distal tip of the catheter where a compressed refrigerant is pumped to vaporize and expand to cool a flexible heat transfer element in the distal tip of the catheter (¶Abstract).
Dobak further teaches the heat transfer element as being shaped in a straight tubular shape at room temperature but trained to take on a coiled tubular shape at a lower temperature so as to allow for an easier insertion of the catheter assembly through anatomy of the patient to the target treatment site and then to take on the coil shape which enhances the heat transfer capacity while limiting the length of the heat transfer element (Col. 7, Lines 10-30).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided the planar therapy structure containing an expansion chamber of Wittenberger as being hoop shaped, wherein the expansion chamber is arcuate and extends through said hoop, as is taught by Dobak, to produce the predictable result of having a shape which enhances heat transfer capacity while limiting length within the target site of the patient, as is taught by Dobak.
Wittenberger as modified further fails to teach the hoop as being a planar hoop and subsequently that the expansion chamber cryogenically ablates tissue in a planar circumferential pattern corresponding to the planar hoop.
Cao teaches an ablation catheter which provides fluid to a distal end of the catheter (Abstract).
Cao further teaches the distal end of the catheter as having a generally circular or c-shaped configuration so as to accurately orient the ablating section within the cardiac cavity for the procedure to be performed ([0056]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the hoop as incorporated into Wittenberger to be generally circular or c-shaped, as is taught by Cao, to produce the predictable result of a distal end of an ablation catheter which provides fluid along a generally circular configuration so as to accurately orient the ablating section within the cardiac cavity for the procedure to be performed.
Regarding claim 2, Wittenberger further teaches the apparatus of claim 1, wherein the plurality of openings each have a corresponding size to control a flow rate of the coolant from the inlet into the expansion chamber (¶[0021]).
Regarding claim 4, Wittenberger further teaches the apparatus of claim 1, wherein the apparatus is configured to provide the therapy to endocardial tissue of a myocardium via an intravascular approach (¶[0007], [0014]).
Regarding claim 9, Wittenberger teaches a system (Fig. 1; medical system 10) comprising:
a coolant source (Fig. 1; fluid supply 80), wherein the coolant source generates a pressurized coolant;
a coolant control (Fig. 1; control unit 12), wherein the coolant control controls the coolant source and the pressurized coolant (¶[0014], [0021]); and
a catheter (Fig. 2; medical device 14) including a flexible shaft (Fig. 2; elongate body 26) having a distal end, wherein the catheter is coupled with the coolant source (¶[0021]) and the catheter comprises:
a planar therapy structure (¶[0017] teaches the medical device includes two treatment regions for providing therapy to a treatment site these regions being taught in Fig. 2; first treatment region 34 and second treatment region 44), where the planar therapy structure is coupled with the distal end of the flexible shaft (¶[0017] & [0020] teach the treatment regions as being located at the distal portion of the elongate body), where the planar therapy structure comprises:
a plurality of electrodes (¶[0017], [0019], and [0021] teach the treatment regions as containing electrodes and conductive regions for radiofrequency ablation of tissue) positioned along a length of the planar therapy structure,
an expansion chamber (Fig. 3; the interior of second treatment region 44 [0021] teaches fluid being delivered into the second treatment region by expanding the fluid) extending through the planar therapy structure, the expansion chamber including an end wall (Fig. 3; wall 52) at a proximal end of the expansion chamber, the expansion chamber including an outer wall (Fig. 3; second treatment region 44 is located within the region interior to face 45 and surface 47),
an inlet (Fig. 3; a tube for delivering fluid for expansion is located within an opening within the proximal wall 52) to receive the pressurized coolant from the coolant source (¶[0021]), the inlet comprising an opening through the end wall of the expansion chamber (¶[0022]),
an inlet tube (Fig. 3; fluid injection lumen 48) coupled to the inlet, the inlet tube disposed within the expansion chamber and extending through the planar therapy structure (¶[0021] teaches the injection lumen as being in fluid communication with an interior of the second treatment region 44), the inlet tube comprising a plurality of openings (Fig. 3; apertures 50) in a wall to wherein the plurality of openings are configured to discharge the pressurized coolant into the expansion chamber such that the pressurized coolant cools the outer wall of the expansion chamber and cools an outer surface of the planar therapy structure to facilitate cryogenically ablating tissue (¶[0021]- [0022]), and
an outlet (¶[0022]) to receive a de-pressurized coolant from the expansion chamber.
However, Wittenberger fails to teach the planar therapy structure as being a hoop comprising: an arcuate expansion chamber and the inlet tube extending through the hoop.
Dobak teaches an apparatus for performing hypothermia of a selected organ having a flexible catheter containing an expansion element near the distal tip of the catheter where a compressed refrigerant is pumped to vaporize and expand to cool a flexible heat transfer element in the distal tip of the catheter (¶Abstract)
Dobak further teaches the heat transfer element as being shaped in a straight tubular shape at room temperature but trained to take on a coiled tubular shape at a lower temperature so as to allow for an easier insertion of the catheter assembly through anatomy of the patient to the target treatment site and then to take on the coil shape which enhances the heat transfer capacity while limiting the length of the heat transfer element (Col. 7, Lines 10-30).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided the planar therapy structure containing an expansion chamber of Wittenberger as being hoop shaped, wherein the expansion chamber is arcuate and extends through said hoop, as is taught by Dobak, to produce the predictable result of having a shape which enhances heat transfer capacity while limiting length within the target site of the patient, as is taught by Dobak.
Wittenberger as modified further fails to teach the hoop as being a planar hoop and subsequently that the expansion chamber cryogenically ablates tissue in a planar circumferential pattern corresponding to the planar hoop.
Cao teaches an ablation catheter which provides fluid to a distal end of the catheter (Abstract).
Cao further teaches the distal end of the catheter as having a generally circular or c-shaped configuration so as to accurately orient the ablating section within the cardiac cavity for the procedure to be performed ([0056]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the hoop as incorporated into Wittenberger to be generally circular or c-shaped, as is taught by Cao, to produce the predictable result of a distal end of an ablation catheter which provides fluid along a generally circular configuration so as to accurately orient the ablating section within the cardiac cavity for the procedure to be performed.
Regarding claims 16-17 and 19, the method steps are the same as described as the steps the apparatus and system are configured to perform and therefore taught in the same way as seen in claims 1-2, 4, and 9.
Claim 3, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wittenberger (US 20120029494 A1) in view of Dobak (US 5957963 A) and Cao (US 20060287650 A1), further in view of Wang (US 20170215951 A1).
Regarding claim 3, Wittenberger/Dobak teaches the apparatus of claim 1.
However, Wittenberger/Dobak fails to teach the apparatus wherein each of the plurality of openings further comprise a nozzle wherein each nozzle is selectively activated by a controller.
Wang teaches a system for monitoring and controlling tissue ablation through received real- time feedback data such as temperature (¶Abstract, [0012]). This data is then used by the controller for controlling the application of a fluid connection, through a plurality of openings, to the distal tip (¶[0053], [0097]).
Wang further teaches the apparatus wherein each of the plurality of openings further comprise a nozzle wherein each nozzle is selectively activated by a controller (¶[0099]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of Wang into the device of Wittenberger /Dobak as Wang teaches each aperture being independently controllable as beneficial to customize the ablation shape or geometry (¶[0099]).
Regarding claim 14, Wang in accordance with the above rejection of claim 3, further teaches the system of claim 9, wherein the plurality of openings are selectively activated to control a flow of the coolant from the inlet into the expansion chamber (¶[0099]).
Regarding claim 18, the method steps are the same as described as the steps the apparatus and system are configured to perform and therefore taught in the same way as seen in claims 3 and 14.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wittenberger (US 20120029494 A1) in view of Dobak (US 5957963 A) and Cao (US 20060287650 A1), further in view of Fischer (US 20180185082 A1).
Regarding claim 5, Wittenberger/Dobak teaches the apparatus of claim 1.
However, Wittenberger/Dobak fails to teach the apparatus wherein the planar therapy structure further comprises a first wall portion with a first cross-section and a first thermal conductivity and a second wall portion with a second cross-section and a second thermal conductivity where the first and second cross-sections are different and the first and second thermal conductivities are equal.
Fischer teaches an ablation applicator for ablating tissue with an ablation medium being supplied to the ablation applicator through a variety of openings along a lumen (¶Abstract).
Fischer further teaches the apparatus wherein the planar therapy structure further comprises a first wall portion with a first cross-section and a first thermal conductivity and a second wall portion with a second cross-section and a second thermal conductivity where the first and second cross-sections are different and the first and second thermal conductivities are equal (¶ [0062]- [0069] discusses taking measures to adjust parameters such as wall thickness to adjust the conductivity through the tubular body to the tissue).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of Fischer into the device of Wittenberger/Dobak as Fischer teaches (¶[0033] & [0069] & [0223]- [0225]) the device as utilizing a variety of manners to create a more uniform temperature distribution when ablating or adjusting the temperature of tissue.
Claim 8 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wittenberger (US 20120029494 A1) in view of Dobak (US 5957963 A) and Cao (US 20060287650 A1) further in view of O’Fallon (US 20170143412 A1).
Regarding claim 8, Wittenberger/Dobak teaches the apparatus of claim 1.
However, Wittenberger/Dobak fails to teach the apparatus, wherein the plurality of electrodes are circumferentially positioned about a longitudinal axis of the flexible shaft.
O’Fallon teaches systems and methods for providing and using a catheter (¶Abstract).
O’Fallon further teaches the apparatus further comprises a plurality of electrodes positioned along a length of the structure and circumferentially positioned about a longitudinal axis of the flexible shaft (Fig. 1; the catheter body has multiple ring electrodes 22 disposed along its length).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of O’Fallon into the system of Wittenberger/Dobak as O’Fallon teaches the common use of electrode catheters in medical practice for stimulation, ablation and mapping (¶[0002]).
Regarding claim 10, Wittenberger/Dobak teaches the system of claim 9.
However, Wittenberger/Dobak fails to teach the system wherein the system further comprises a mapping system for generating a map of a location in a body.
O’Fallon further teaches the system wherein the system further comprises a mapping system for generating a map of a location in a body (¶[0040]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to further incorporate the teachings of O’Fallon into the system of Wittenberger/Dobak as O’Fallon teaches the common use of electrode catheters in medical practice for stimulation, ablation and mapping (¶[0002]).
Regarding claim 11, O’Fallon further teaches the system of claim 9, wherein the system further comprises an ablation system for ablating tissue (Fig. 9; system 200), wherein the ablation system comprises a signal generator catheter (Fig. 9; console 202 comprises an RF generator 208 and a driver circuit to drive field generators to generate magnetic fields within the body of the patient and electrical signals ¶[0042]- [0043]) and an electrode (Fig. 1; multi-electrode ablation catheter 10 comprises a tip electrode 12) coupled with a distal end portion of the catheter.
Regarding claim 12, O’Fallon further teaches the system of claim 9, wherein the catheter further comprises an electrode, wherein the electrode is located proximate the distal end (Fig. 1; the catheter body has multiple ring electrodes 22 disposed along its length).
Regarding claim 13, O’Fallon further teaches the system of claim 12, wherein the electrode detects cardiac signals and delivers ablation energy (¶[0002] discusses the radiofrequency electrode catheter as being used to stimulate and map electrical activity in the heart and to ablate sites of aberrant electrical activity).
Response to Arguments
Applicant's arguments filed 12/02/2025 have been fully considered but they are not persuasive.
In response to Applicant’s argument provided in the section labeled “The Combination of Wittenberger, Dobak, and Cao Does Not Teach Each Limitation Recited in Claims 9 and 16” that Wittenberger is directed to a cryoablation medical and that there is no teaching within Wittenberger for the claim limitation of “a plurality of electrodes positioned along a length” as the only the first treatment area 34 is discussed as carrying one or more electrodes, the arguments are currently unpersuasive. The Examiner is bringing attention to all of the sections of the prior art provided for this claim limitation, as the Applicant has only cited to one of the three cited paragraphs, which are provided as teaching this limitation. The cited paragraphs are [0017], [0019], and [0021], where [0017] teaches “the device may include a first treatment region 34 having … one or more electrodes”, [0019] teaches “the first treatment region … includes … electrically conductive portions or electrodes thereon coupled to a radiofrequency generator” and [0020] teaches “the second treatment region may provide … a radiofrequency … energy source”. Based on these citations of the prior art, the cited sections are interpreted to teach “a plurality of electrodes along a length” as broadly as is currently claimed in view of the Examiner’s citation of the distal portion of the medical device, which encompasses the first and second treatment regions, as being the teaching of the claimed planar therapy structure.
Second, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the placement of the electrodes being outside of the one or more expandable elements) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Specifically, the claim rather teaches that the expansion chamber, i.e. the expandable element as taught by Wittenberger, and the electrodes are both positioned at the position of “a length” of the planar therapy structure as broadly as is currently claimed. Further, the only position limitation which is required by the currently provided claim is the limitation of “along a length” of the planar therapy structure, however, as broadly as is currently claimed, any position along this structure as broadly as is currently claimed is along a length of this structure and therefore meets the claim limitation of “along a length” as broadly as is currently claimed, including along a length which may also contain an expandable element or alternatively one which may not.
Third, in response to Applicant’s arguments that Wittenberger does not teach the limitation containing of the electrode being positioned specifically along “the planar hoop” the Examiner agrees and has therefore provided a secondary reference to teach this limitation.
Fourth, in response to Applicant’s arguments that Dobak and Cao do not teach this limitation as they do not have a plurality of electrodes located along the planar hoop, the Examiner is bringing attention to the fact that the “electrodes being positioned along a length” is currently taught by Wittenberger and therefore Dobak and Cao are not being cited to teach this limitation. Further, in response to applicant's arguments against these references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s Arguments in the section labeled “The Combination of Wittenberger, Dobak, and Cao is Improper” that there is no clear motivation from the teachings of the base reference of Wittenberger to modify the device, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Wittenberger does not need to provide an explicit reason to modify its device as there are reasons to modify the device taught by the secondary references as can be found in the obviousness statements provided in paragraphs 22 and 26 above.
In response to Applicant’s arguments found in the section labeled “The Different Modes of Operation would Require a Substantial Redesign or have No Reasonable Expectation of Success” that the teaching of utilizing a planar hoop shape to treat tissue within a patient as is taught by Cao could not have been incorporated into Wittenberger as Cao uses an open-loop system and Wittenberger utilizes a closed-loop system is currently unpersuasive as the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Specifically, that a person having ordinary skill in the art before the effective filing date would have understood that an elongated flexible medical device for insertion into the body of a patient, as is taught by Wittenberger, could have been provided to patient tissue in a shape of a planar hoop. This known use of a flexible distal end of a catheter for insertion into the body of a patient and having a generally circular or c-shaped configuration is taught by Cao as providing the result of accurately orienting an ablating section within the cardiac cavity based on this shape. Therefore, a person having ordinary skill in the art would have understood that this shape of the planar hoop of the elongated flexible medical device would have produced this effect of contacting this cardiac tissue in either one of an open-loop or closed-loop system. For this reason, the difference of fluid dispersion does not provide a teaching away as the open-loop portion of Cao is not required to be bodily incorporated into the closed-loop portion of Wittenberger based on the test for obviousness.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794
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