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 IDS form(s) submitted on 3/2/2023 is/are in compliance with the requirements of the provisions of 37 CFR 1.97. Accordingly, the information disclosure(s) are being considered by the examiner.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 1-21, drawn to location detection system with fluid delivery, classified in A61M 2025/0166.
II. Claims 22-43, drawn to method of determining a location within a body, classified in A61B 5/065.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the method can be practiced by a materially different apparatus such as a syringe with an implanted sensor, or laparoscopic/robotic surgery tools.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
There is a serious search and examination burden for the following reasons: Each invention has attained recognition in the art as a separate subject for inventive effort, and also a separate field of search; The inventions would require different fields of search and different search strategies.
During a telephone conversation with Attorney of Record Johney Han on 10/17/2025, a provisional election was made without traverse to prosecute the invention of inventive group I, drawn to claims 1-21. Affirmation of this election must be made by applicant in replying to this Office action. Claims 22-43 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 2-21 are objected to because of the following informalities: Claims 2-21 should have a comma after the claim number from which they each respectively depend. For example: Claim 2, should read “The system of claim 1, wherein the distal”. Appropriate correction is required.
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.
(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) 1-7, 10, 14, and 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0344205 A. to Salamini et al.
In regard to claim 1:
Salamini teaches, a location detection system (claim 3 line 1 “location detection system”), comprising: an elongate body (Figs. 9A and 9F element 910 “stylet”, claim 3 line 2 “elongate body with a lumen”) having a lumen (Fig. 9A and 9F lumen of element 908 “catheter”); wherein the elongate body (Figs. 9A and 9F element 910) is sized for introduction and translation through a catheter lumen (element 910 considered fully capable of introduction and translation through lumen of catheter, Figs. 9A-9J element 908, as recited by para. 97 “Once the stylet/guidewire is placed, the vascular catheter may be advanced so that the distal tip of the catheter is at a known position relative to the distal tip of the stylet/guidewire. The stylet/guidewire may then be removed.”) one or more openings located at or in proximity to a distal end of the elongate body (claim 3 starting line 3 “one or more openings located at or in proximity to a distal end of the elongate body”, Fig. 9F “Fluid injectate exit or port” according to figure and legend thereof); a sensor (Fig. 9F “Distal temp sensor”) positioned at or in proximity to the distal end of the elongate body (claim 3 starting line 5 “a sensor positioned at or in proximity to the distal end of the elongate body”, Fig. 9F “Distal temp sensor” according to figure and legend thereof), wherein the sensor is configured to measure at least one parameter of a mixture of a first fluid and a second fluid after the first fluid is emitted from the one or more openings and into the second fluid (claim 3 starting line 6 “wherein the sensor is configured to measure at least one parameter of a mixture of a first fluid and a second fluid after the first fluid is emitted from the one or more openings and into the second fluid”, para. 91 “Various properties of the temperature vs. time curves may be analyzed to determine the location of the vascular catheter navigation device.”) when the distal end of the elongate body is advanced beyond a distal opening of the catheter lumen (Fig. 9F element 910 “stylet”, “Proximal temp sensor”, and “Distal temp sensor” advanced beyond distal opening “Catheter tip” during use) and a controller in communication with the sensor (claim 3 line 14 “a controller in communication with the sensor”), wherein the controller is configured to receive a signal indicative of the at least one parameter of the mixture and is further configured to obtain a position of the sensor within a body of a subject based upon the signal (Para. 79 “The sensor signals are communicated back to the controller where the sensor signal(s) are analyzed based on the sensor data over time, including data curve slope, magnitude, value, length, variability, standard deviation, shape, etc. For example, the controller can determine whether the distal end of the vascular catheter navigation device is in an artery instead of a vein, based on magnitude and direction of blood flow around the vascular catheter navigation device by measuring and analyzing the measurable parameter” and para. 82 “The controller (not shown) is in communication with sensor 302 via connector 402 which, in this example, runs the length of the catheter back to the controller. Sensor 302 and connector 402 may be incorporated into the vascular catheter or may be incorporated into a stylet that runs through the catheter. Medium 410 is introduced into the vessel at time=x. For example, the medium may be saline at a temperature which is different than that of the body. The parameter measured by the sensor in this example would be temperature. After the injection, at T=x+1, blood flow will carry the medium with the blood flow. Where blood flow 406 flows away from the catheter, the bolus of medium 404 travels away from the catheter tip and away from the sensor. Where blood flow 408 flows toward the catheter, the bolus of medium 410 travels toward and over the catheter tip. This example shows a bolus of fluid, but a stream of fluid may also be used.”).
In regard to claim 2:
The system of claim 1, wherein the distal end of the elongate body is positionable at a distance of 5 mm to 40 mm beyond the distal opening of the catheter lumen (Fig. 9H element ee para. 103 “distance ee may range from about 5 mm and about 10 mm... …These distances may be positive or negative.”)
In regard to claim 3:
The system of claim 1, wherein the distal end of the elongate body is positionable at a distance of 10 mm to 20 mm beyond the distal opening of the catheter lumen (Considered a functional limitation due to the use of “positionable” and therefore does not positively recite the distance of the range claimed but merely the capability thereof. Fig. 9F elements cc, para. 101 “Alternatively, distance cc may be a range of about 1 mm to about 100 mm.” and para. 97 “Once the stylet/guidewire is placed, the vascular catheter may be advanced so that the distal tip of the catheter is at a known position relative to the distal tip of the stylet/guidewire. The stylet/guidewire may then be removed.”. As the end of the elongate body is taught to be capable of being positioned at least 100 mm from distal tip, and opening thereof, and is taught to be removable through said distal tip, and opening thereof, it would during removal be positioned within the range of 10 mm to 20 mm. Thus, it is considered fully capable of being positioned within the claimed range. Examiner notes the elongate body is considered capable of being positioned at least 100 mm from the distal tip as the distance from the catheter distal tip to the “proximal temp sensor” is not disclosed but would be in addition to the distance cc as the “proximal temp sensor” is shown distal to the catheter tip by the unknown distance.).
In regard to claim 4:
The system of claim 1, further comprising a proximal sensor (Fig. 9F “Proximal temp sensor”) positioned along the elongate body proximal to the sensor (Fig. 9F “Proximal temp sensor” proximal to “Distal temp sensor”)
In regard to claim 5:
The system of claim 4, wherein the proximal sensor is positionable at a distance of 0 mm to 5 mm beyond the distal opening of the catheter lumen (Considered a functional limitation due to the use of “positionable” and therefore does not positively recite the distance of the range claimed but merely the capability thereof. Fig. 9F element cc, para. 101 “Alternatively, distance cc may be a range of about 5 mm to about 15 mm. " Fig. 9H element ee, para. 103 “Alternatively, distance ee may range from about 0 mm and about 100 mm. These distances may be positive or negative.”, and para. 97 “Once the stylet/guidewire is placed, the vascular catheter may be advanced so that the distal tip of the catheter is at a known position relative to the distal tip of the stylet/guidewire. The stylet/guidewire may then be removed.”. The end of the elongate body is taught to be capable of being positioned at 100 mm (ee) from the distal tip, and opening thereof, and is taught to be removable through said distal tip, and opening thereof. The “Proximal temp sensor” is taught by capable of distance from the distal end of the elongate body of 5 mm to 15 mm. The distance from the distal tip to the “Proximal temp sensor” is equal to ee minus cc or the range of 85 mm to 95 mm. Therefore, during removal the “Proximal temp sensor” would be positioned within the range of 10 mm to 20 mm. Thus, it is considered fully capable of being positioned within the claimed range. Examiner notes the elongate body is considered capable of being positioned at least 100 mm from the distal tip as the distance from the catheter distal tip to the “proximal temp sensor” is not disclosed but would be in addition to the distance cc as the “proximal temp sensor” is shown distal to the catheter tip by the unknown distance.).
In regard to claim 6:
The system of claim 4, wherein the one or more openings are located along the elongate body between the sensor and the proximal sensor (Fig. 9F “Fluid injectate exit or port” located between the “Proximal temp sensor” and “Distal temp sensor”).
In regard to claim 7:
The system of claim 1, further comprising one or more leads coupled to the sensor, wherein the one or more leads are embedded within an outer wall of the elongate body (Para. 106 “FIG. 10 shows an embodiment of the vascular catheter navigation device which can be used with any catheter, or in other words, where the temperature sensor(s), the injectate lumen, the controller, and locking mechanism are included with the stylet/guidewire”, para. 107 “The controller may be located near the proximal end of the stylet, or may be located several inches or feet from the proximal end of the stylet. Temperature sensor leads 1024 are also shown”. Fig. 10 demonstrates the temperature sensor leads embedding into the elongate body wall, at least upon initial entry. Para. 106 “guidewire/stylet 1001.”. Para. 106, “distal thermocouple 1012 and proximal thermocouple 1010,” considered to be previously cited “Distal temp sensor” (element 1012) and “Proximal temp sensor” (element 1010). Para. 22 “Temperature sensors may include thermocouples”. Figs. 10, 11C, and 11D, elements 1008 (distal tip wall), 1006 (tip portion and wall thereof), elements 1012 and 1010 embedded within element 1008, para. 106 “This embodiment may include a tip portion 1006, such as a molded urethane, nylon, silicone, or other polymer portion, for embedding the temperature sensor(s)”. The temperature sensor leads would be connected to the temperature sensor thermocouples 1012, and 1010. Therefore, the temperature sensor leads are also considered to at least be embedded within the wall of the tip portion near thermocouple elements 1012, 1010 that are embedded within the wall of tip portion 1006. Examiner notes para. 106 “FIG. 10 shows an embodiment of the vascular catheter navigation device which can be used with any catheter, or in other words, where the temperature sensor(s), the injectate lumen, the controller, and locking mechanism are included with the stylet/guidewire. FIG. 10 shows an embodiment with two thermocouples, distal thermocouple 1012 and proximal thermocouple 1010”. Embodiment shown in Fig.10-11A are considered to be further details of the two-temperature sensor stylet relied upon in Fig. 9F. Para. 109 “FIG. 11A is a cross section of the stylet such as that shown in the embodiment of FIG. 10. Two temperature sensors are shown here, but the device may include one, or more than two sensors.”).
In regard to claim 10:
The system of claim 7, wherein the one or more leads are coupled to the sensor through at least one opening defined within the outer wall (Fig. 10 element 1024 considered to pass through at least one hole defined in the outer wall as it is shown outside and must be connected to thermocouple elements 1002 and 1012. Elements 1002, 1012 shown at the distal end of element 1006 in the outer wall with lines (considered to be the leads) passing through the wall and moving inward. As the leads start outside of the elongate body, they must pass through a hole to reach the interior of the wall of element 1006. Embodiment shown in Fig.10-11A are considered to be further details of the two-temperature sensor stylet relied upon in Fig. 9F. Para. 109 “FIG. 11A is a cross section of the stylet such as that shown in the embodiment of FIG. 10. Two temperature sensors are shown here, but the device may include one, or more than two sensors.”).
In regard to claim 14:
The system of claim 7, further comprising a proximal sensor positioned along the elongate body proximal to the sensor (Fig. 10 “thermocouple 1010”), wherein the proximal sensor comprises at least one proximal electrode (Thermocouple 1010 considered to read upon this limitation as a thermocouple is made of two dissimilar electrical conductors (electrodes) forming a temperature sensing circuit. Embodiment shown in Fig.10-11A are considered to be further details of the two-temperature sensor stylet relied upon in Fig. 9F. Para. 109 “FIG. 11A is a cross section of the stylet such as that shown in the embodiment of FIG. 10. Two temperature sensors are shown here, but the device may include one, or more than two sensors.”).
In regard to claim 16:
The system of claim 1, further comprising at least one electrode (Fig. 10 element 1012 “distal thermocouple”) positioned at or in proximity to the distal end of the elongate body (Thermocouple 1012 considered to read upon this limitation as a thermocouple is made of two dissimilar electrical conductors (electrodes) forming a temperature sensing circuit. Embodiment shown in Fig.10-11A are considered to be further details of the two-temperature sensor stylet relied upon in Fig. 9F. Para. 109 “FIG. 11A is a cross section of the stylet such as that shown in the embodiment of FIG. 10. Two temperature sensors are shown here, but the device may include one, or more than two sensors.”).
In regard to claim 17:
The system of claim 16, wherein the controller is configured to sense electrocardiogram signals from the body via the at least one electrode (Para. 26 “Various mediums and/or parameters may be used in combination in some embodiments. For example, light (visible and/or not visible) and temperature may both be used. In addition, other sensors may be used to aid in locating the catheter, including electro cardiogram (ECG). Pressure, as disclosed in U.S. provisional patent application 62/492,739 filed on May 1, 2017, and incorporated herein in its entirety by reference, may also be used in combination with these embodiments.”, para. 235 “Other technologies may also be used in conjunction with the sensor readings from the vascular catheter. For example [sic] ECG readings, ultrasound readings, Doppler readings, x-ray readings, inductive current technology, pressure readings, etc. Some, all or no readings may be augmented via a turbulence inducer. These, and other, other types of readings may be used in conjunction with the sensor readings by the controller to determine the location of the vascular catheter navigation device distal tip.” (Emphasis added), para. 236 “For example, any of the conductive components of the vascular navigation device may be used as an ECG lead. Another ECG lead may be placed on the patient's skin. For example, the guidewire stylet stiffener, coil, enclosure, thermocouple leads, sensor leads, thermocouple, endcap, conduit, etc. may be used as an ECG lead. Alternatively, a separate ECG lead may be added to the system.”).
In regard to claim 18:
The system of claim 17, wherein the controller is further configured to determine the position of the sensor within the body of the subject based upon the electrocardiogram signals (para. 235 “Other technologies may also be used in conjunction with the sensor readings from the vascular catheter. For example [sic] ECG readings, ultrasound readings, Doppler readings, x-ray readings, inductive current technology, pressure readings, etc. Some, all or no readings may be augmented via a turbulence inducer. These, and other, other types of readings may be used in conjunction with the sensor readings by the controller to determine the location of the vascular catheter navigation device distal tip.” (Emphasis added)
In regard to claim 19:
The system of claim 1, wherein the controller is further configured to determine the position of the sensor within the body of the subject based upon an electrocardiogram signal (para. 235 “Other technologies may also be used in conjunction with the sensor readings from the vascular catheter. For example [sic] ECG readings, ultrasound readings, Doppler readings, x-ray readings, inductive current technology, pressure readings, etc. Some, all or no readings may be augmented via a turbulence inducer. These, and other, other types of readings may be used in conjunction with the sensor readings by the controller to determine the location of the vascular catheter navigation device distal tip.” (Emphasis added)
In regard to claim 20:
The system of claim 1, further comprising a disposable infusion pump in fluid communication with the elongate body (Para. 230 “The system may be fully disposable. A fully disposable system primary package includes: syringe, syringe pump, the syringe filled with the fluid of choice, a controller, a user interface which can exist as any combination of display, alert, and lights, catheter, stylet/guidewire, and introduction mechanism. All of these elements may be fully disposable. By doing so, the chance of infection will be reduced” (emphasis added) Fully disposable syringe pump considered to read upon the disposable infusion pump).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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) 8, 15, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0344205 A. to Salamini et al.
In regard to claim 8:
The system of claim 7, taught by Salamini as described in parent claim rejection above.
Salamini teaches the coiled configuration shape in an alternative embodiment, wherein the one or more leads are embedded in a coiled configuration within the outer wall (Fig. 11D Para. 111 “FIG. 11C shows an embodiment in which the stylet coil is made all, or in part, out of the temperature sensor wires. FIG. 11D is a side view of the embodiment shown in FIG. 11C).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the shape of the leads of the 9F embodiment to be a coiled configuration shape as taught by Fig. 11D. This would have been motivated by reducing the chance for the stylet to puncture or penetrate a vascular wall. This problem is taught by Salamini para. 7 “This can be a dangerous situation. Fourth, a catheter may advance up against, or embed in, a vessel wall which can prevent fluid delivery or fluid draw”. Modifying the shape of the stylet end into a helical coil would increase the chance the tip would deflect and therefore reduce the chances the tip would penetrate as the helical coil shape would have some spring like give.
In regard to claim 15:
The system of claim 7, taught by Salamini as described in parent claim rejection above.
Salamini teaches the coiled configuration shape in an alternative embodiment, wherein the one or more openings (Fig. 11C element 1016, para. 106 “injection lumen 1016 can also be seen”) are located along the elongate body between the one or more leads embedded in the coiled configuration (Fig. 11D Para. 111 “FIG. 11C shows an embodiment in which the stylet coil is made all, or in part, out of the temperature sensor wires. FIG. 11D is a side view of the embodiment shown in FIG. 11C).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the shape of leads of the 9F embodiment to be a coiled configuration shape as taught by Fig. 11D. This would have been motivated by reducing the chance for the stylet to puncture or penetrate a vascular wall. This problem is taught by Salamini para. 7 “This can be a dangerous situation. Fourth, a catheter may advance up against, or embed in, a vessel wall which can prevent fluid delivery or fluid draw”. Modifying the shape of the stylet end into a helical coil would increase the chance the tip would deflect and therefore reduce the chances the tip would penetrate as the helical coil shape would have some spring like give.
In regard to claim 21:
The system of claim 1, taught by Salamini as described in parent claim rejection above.
Salamini teaches in an alternative embodiment, further comprising one or more additional sensors in communication with the controller (Para. 209 “The optical measuring embodiment can also be used with the use of fiber optics (plastic, glass or other,) or light pipes where the actual detector and emitter are located in the controller and the light pipe or fiber optic communicates information collected at or near the catheter tip with the controller located outside the patient. This can be performed with fiber optic lines which are about 0.1 mm to about 0.5 mm in diameter or about 0.5 mm to about 4 mm in diameter. The fiber optic cable(s) may have an insulated coating. In some embodiments, a single optical fiber may be used to measure temperature.”), wherein the one or more additional sensors are positioned along a catheter defining the catheter lumen (Considered to be placed along the catheter due to para. 209 “fiber optics (plastic, glass or other,) or light pipes where the actual detector and emitter are located in the controller and the light pipe or fiber optic communicates information collected at or near the catheter tip with the controller located outside the patient”. The light pipe, or fiber optic, is considered part of the sensor as the optic measuring embodiment would not function as taught without this component. Therefore, as the light pipe, or fiber optic, is positioned along the length of the catheter and positioned near the catheter lumen the sensor is considered to be at least in part positioned along the catheter.).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the catheter of the 9F embodiment to include the optical measuring embodiment. This would have been motivated by Salamini para. 27 “Embodiments that incorporate more than one type of sensor may be used either in each situation (vein vs. artery, vessel branch, vessel wall, catheter in heart or past heart), or different sensors may be used in different situations. For example, pressure may be used to determine when the catheter tip is in the heart, where temperature may be used to determine whether the catheter is in an artery. Or, for example, ECG can be used to determine if the catheter is in the cavo-atrial junction but temperature can be used to determine if the catheter has gone down an azygous or unintended vein branch.”. Salamini teaches using different sensor’s to better detect different locations.
Claim(s) 9 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0344205 A. to Salamini et al. in view of US Re. 35,924 to Winkler
In regard to claim 9:
The system of claim 7, taught by Salamini as described in parent claim rejection above.
Salamini does not appear to explicitly disclose the electrode band as claimed. Winkler teaches, wherein the sensor comprises at least one pair of electrodes configured as a band (Fig. 1 elements 30a and 30).
It would have been obvious to one of ordinary skill in the art prior to the effective date of filing, to modify the sensor taught by Salamini to be at least a pair of electrodes as taught by Winkler. This would have been motivated by improving location detection taught by Salamini by the incorporation of multiple electrodes. Winkler col 14:14-34 demonstrate the various benefits to using multiple electrodes. Specifically, “superior electrical contact with the tissue” referenced with respect to tissue ablation, however one of ordinary skill in the art would also see improved superior electrical contact with the tissue as a benefit to mapping and location detection as well.
In regard to claim 11:
The system of claim 7, taught by Salamini as described in parent claim rejection above.
Salamini does not appear to explicitly disclose the at least one electrode is crimped to at least one electrode as claimed. Winkler teaches, wherein the sensor comprises at least one electrode which is crimped upon the elongate body such that the at least one electrode is electrically coupled to the one or more leads (Fig. 1 elements 30 and 30a, col 3:3-5, col 5:10-15, Fig. 4A-4D element 51, col 6:45, and Col 7:15-25).
It would have been obvious to one of ordinary skill in the art prior to the effective date of filing, to modify the sensor taught by Salamini to be at least one electrode crimped upon the body as taught by Winkler. This would have been motivated by improving location detection taught by Salamini by the incorporation of multiple electrodes. Winkler col 14 lines 14 through 34 demonstrate the various benefits to using multiple electrodes. Specifically, “superior electrical contact with the tissue” referenced with respect to tissue ablation, however one of ordinary skill in the art would also see improved superior electrical contact with the tissue as a benefit to mapping and location detection as well. The crimping would have been further motivated by Winkler col 2:50-53 that teaches the electrodes being flush with the outer tube through the use of crimping. This is considered further motivation as it would make the catheter with the electrodes pass through the body vasculature easier without any portion to snag or catch upon the vasculature.
In regard to claim 12:
The system of claim 7, taught by Salamini as described in parent claim rejection above.
Salamini does not appear to explicitly disclose the at least one electrode defining a flat section as claimed. Winkler teaches, wherein the sensor comprises at least one electrode which defines a flat section (Fig. 1 elements 30 and 30a, and Fig. 5 element 53 is flat along the longitudinal axis).
It would have been obvious to one of ordinary skill in the art prior to the effective date of filing, to modify the sensor taught by Salamini to be at least one electrode with a flat section as taught by Winkler. This would have been motivated by improving location detection taught by Salamini by the incorporation of multiple electrodes. Winkler col 14 lines 14 through 34 demonstrate the various benefits to using multiple electrodes. Specifically, “superior electrical contact with the tissue” referenced with respect to tissue ablation, however one of ordinary skill in the art would also see improved superior electrical contact with the tissue as a benefit to mapping and location detection as well. The further motivated by Winkler col 2:50-53 that teaches the electrodes being flush with the outer tube through the use of crimping. This is considered further motivation as it would make the catheter with the electrodes pass through the body vasculature easier without any portion to snag or catch upon the vasculature.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0344205 A. to Salamini et al. in view of US Re. 35,924 to Winkler further in view of US 6,085,394 to Hartman.
In regard to claims 13:
The system of claim 7, taught by Salamini as described in parent claim rejection above.
Salamini does not appear to explicitly teach the electrode having a piercing mechanism as claimed. Winkler teaches, wherein the sensor comprises at least one electrode (Fig. 1 elements 30 and 30a).
It would have been obvious to one of ordinary skill in the art prior to the effective date of filing, to modify the sensor taught by Salamini to be at least one electrode as taught by Winkler. This would have been motivated by improving location detection taught by Salamini by the incorporation of multiple electrodes. Winkler col 14 lines 14 through 34 demonstrate the various benefits to using multiple electrodes. Specifically, “superior electrical contact with the tissue” referenced with respect to tissue ablation, however one of ordinary skill in the art would also see improved superior electrical contact with the tissue as a benefit to mapping and location detection as well. The further motivated by Winkler col 2:50-53 that teaches the electrodes being flush with the outer tube through the use of crimping. This is considered further motivation as it would make the catheter with the electrodes pass through the body vasculature easier without any portion to snag or catch upon the vasculature.
Salamini in view of Winkler does not appear to teach the electrode having a piercing mechanism as claimed. Hartman teaches, a piercing mechanism (Fig.9 elements 40 and 42, and Fig. 10 element 42 side view).
Hartman is considered analogous art as it is working on the same problem of securing material strips to a tube or cylindrical shape. One of ordinary skill in the art of catheters would be familiar with various tube/cylindrical coupling elements and techniques leading them to look at known coupler elements for better securement of a band style electrode.
Hartman teaches the piercing mechanism on a flat coupling band not an electrode. Winkler teaches the electrode as a flat band. It would have been obvious to one having ordinary skill in the art, prior to the effective date of filing, to modify the electrode band of Winkler to include the piercing mechanism taught by Hartman. This would have been motivated by improving securement of the electrode band through the use of the piercing teeth. Considered an improvement upon the securement as the teeth would continue to hold through expansion and contraction of the outer sheath material due to changes in temperature (Hartman col 4:21-31) such as experienced between outside and inside the patient’s body, and through bending of the catheter.
Conclusion
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/M.A.I./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783