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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/31/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 67-71, 73-75, 77-80, 91-97 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 67 recites “values of the one or more of the electrical impedance, the resistance and the conductance sensed or measured at the distal end of the catheter body are indicative of whether the distal end of the catheter body is located in the common bile duct or in the pancreatic duct of the subject, based on differences in electrical properties between contents of the common bile duct and the pancreatic duct” in lines 11-15. It is unclear what is being modified by the phrase, “based on differences in electrical properties between contents of the common bile duct and the pancreatic duct”. If the phrase is meant to modify the values, it is unclear how values of electrical impedance, resistance, and conductance can be based on differences in electrical properties of contents. Although the values may vary based on electrical properties of bile or pancreatic juices, there is no plain and ordinary meaning for the values being based on differences in electrical properties of contents. Additionally, it is unclear how values being indicative of a location is based on differences. For the purposes of examination, the recitation will be interpreted such that the values vary based on electrical properties of the contents of the common bile duct and the pancreatic duct. The Examiner suggests modifying the claim to include structure configured to discriminate between whether the distal end of the catheter body is located in the common bile duct or the pancreatic duct based on the values of the one or more of the electrical impedance, the resistance and the conductance. However, the Examiner notes that the specification does not appear to provide written description of any structure configured for performing the discrimination.
Claims 68-71, 73-75, 77-80, 91-97 are rejected by virtue of their dependence from claim 67.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 67-71, 74, 75, 79, 91, and 93-96 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0214764 A1 (Wilder) (previously cited) in view of US 2015/0150624 A1 (Petersohn) (previously cited) and evidenced by Acid-Base Composition of Pancreatic Juice and Bile (Gamble).
With regards to claim 67, to the extent that it can be argued that all features taught by Wilder are not provided in a single embodiment, Wilder discloses a variety of alternative and additional embodiments that are provided in a variety of combinations so that the benefits of these various features can be utilized. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the various features in the alternative and additional embodiments so as to derive the benefits of these features, as suggested by Wilder ([0022]).
The above combination of Wilder teaches an endoscopic retrograde cholangiopancreatography (ERCP) catheter (Fig. 2 depicts a device for accessing a body lumen; ¶ [0016] discloses that the embodiments may be described with specific reference to medical devices and systems for selective access to, aligning with, cannulation, and/or cutting of the opening to the common bile duct (CBD) or pancreatic duct (PD) during an ERCP; Figs. 1A, 1B and ¶ [0024] depict an ERCP procedure in which the endoscopic accessory 100 is advanced through a working channel of duodenoscope 140) comprising: an elongated catheter body comprising a multiplicity of internal lumens (Fig. 2 and ¶ [0025] disclose a flexible elongate tube 200 with a number of lumens which may extend along the tube 200, the lumens comprising a contrast lumen 202, guidewire lumen 204, conductive wire lumen 206, and articulation wire lumen 212), said lumens extending from a proximal end of the elongated catheter body to a distal end of the elongated catheter body opposite the proximal end (¶ [0026] disclose the lumens may be extended through a proximal end of the tube to the distal end of the tube), said distal end is configured to be positioned within the common bile duct (CBD) or the pancreatic duct of a subject (¶ [0016] discloses that the embodiments may be described with specific reference to medical devices and systems for selective access to, aligning with, cannulation, and/or cutting of the opening to the common bile duct (CBD) or pancreatic duct (PD) during an ERCP), said multiplicity of internal lumens comprising at least a first lumen comprising an opening at a tip of the distal end of the catheter body (Fig. 2 and ¶ [0025] depict a guidewire lumen 204 having an opening on the tip of distal end 200d) and configured to allow passage therethrough of a first guidewire (Fig. 2 and ¶ [0025] depict the guidewire lumen 204 is configured to accept a guidewire); and at least one sensor configured to sense or measure one or more of electrical impedance, resistance, conductance and/or electrical signal, at the distal end of the catheter (¶ [0025] disclose a conductive wire 208 with an electrode 210; ¶ [0039] discloses the distal end of one or more wires may be configured to deliver real-time feedback information (e.g., an electrical resistance, impedance, a current, etc.) (a sensor being a device that measures a physical property)).
The above combination is silent regarding whether values of the one or more of the electrical impedance, the resistance, and/or the conductance sensed or measured at the distal end of the catheter are indicative of whether the distal end of the catheter is located in the common bile duct or in the pancreatic duct of the subject.
In the same field of endeavor of sensing catheters, Petersohn teaches values of one or more of the electrical impedance, the resistance, and the conductance sensed or measured at the distal end of the catheter are indicative of whether the distal end of the catheter is located in the common bile duct or in the pancreatic duct of the subject (¶ [0011] discloses measurement of electrical impedance for identifying and locating target tissue; ¶ [0047] discloses target structure may also include or be adjacent to the common bile duct, pancreatic duct). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more wires of above combination of Wilder to incorporate that they are configured to sense values of the one or more of the electrical impedance, the resistance, and/or the conductance sensed or measured at the distal end of the catheter such that the values are indicative of whether the distal end of the catheter is located in the common bile duct or in the pancreatic duct of the subject as taught by Petersohn. The motivation would have been to confirm the location of the distal end, thereby allowing for a better surgical outcome.
In view of the indefiniteness of the recitation of “based on differences in electrical properties between contents of the common bile duct and the pancreatic duct”, the recitation will be interpreted such that the values vary based on electrical properties of the contents of the common bile duct and the pancreatic duct.
The Examiner asserts that the distal end of the wire of ¶ [0039] of Wilder is capable of interacting with both tissue and fluids such that the impedance measurements at the distal end of the wire are capable of reflecting both fluid and tissue characteristics.
Additionally, the Examiner notes that the values of the electrical impedance, the resistance, and/or the conductance sensed by the above combination of Wilder in view of Petersohn will necessarily vary based on electrical properties of the contents of the common bile duct and the pancreatic duct. Because the ionic properties vary between the contents of the common bile duct and the pancreatic duct (see Fig. 1 of Gamble) and electrical impedance, resistance, and conductance reflect the ionic properties, the values of the electrical impedance, resistance, and conductance will also vary based on electrical properties of the contents of the common bile duct and the pancreatic duct.
With regards to claim 68, the above combination is silent regarding whether the multiplicity of internal lumens comprises a second lumen configured to allow passage of at least one of the first guidewire and a second guidewire therethrough, wherein an opening of a distal end of said second lumen is located at a proximal position relative to the opening of the first lumen, thereby allowing the at least one of the first guidewire and the second guidewire passing through the second lumen to be positioned at a different internal body location compared to the first guidewire passing through the first lumen
In a related embodiment, Wilder teaches a multiplicity of lumens comprising a second lumen configured to allow passage of at least one of the first guidewire and a second guidewire therethrough (¶ [0026] discloses one or more lumens may terminate at a proximal exit point for a feature of the device through at least a portion of the lumen, wherein the features may include contrast, guidewire, articulating wire), wherein an opening of a distal end of said second lumen is located at a proximal position relative to the opening of the first lumen (¶ [0026] discloses one or more lumens may terminate at a proximal exit point; See Fig. 2 with regards to the exit point of the guidewire lumen 204 in relation to the proximal exit points of lumens 212 and 206), thereby allowing the at least one of the first guidewire and the second guidewire passing through the second lumen to be positioned at a different internal body location compared to the first guidewire passing through the first lumen (¶ [0026] discloses the lumens may be configured to accept features (e.g., contrast, guidewire, articulating wire) of the device through at least a portion of the lumen; A second guidewire passing through a lumen terminating at a proximal exit point would necessarily be positioned at a different body location compared to the guidewire which exits at the distal tip). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of the above combination of Wilder to incorporate the multiplicity of internal lumens comprises a second lumen configured to allow passage of at least one of the first guidewire and a second guidewire therethrough, wherein an opening of a distal end of said second lumen is located at a proximal position relative to the opening of the first lumen, thereby allowing the at least one of the first guidewire and the second guidewire passing through the second lumen to be positioned at a different internal body location compared to the first guidewire passing through the first lumen as taught by Wilder. The motivation would have been to provide an additional guidewire, which would allow for a more accurate positioning of the catheter.
With regards to claim 69, the above combination teaches or suggests the multiplicity of internal lumens comprises a sensor lumen (Fig. 2 and ¶ [0025] of Wilder disclose a conductive wire lumen 206), and wherein said at least one sensor comprises at least one sensing probe (¶ [0025] of Wilder disclose a conductive wire 208 with an electrode 210, which amounts to a sensing probe; ¶ [0039] of Wilder discloses the distal end of one or more wires (which are capable of being in the lumens) may be configured to deliver real-time feedback information (e.g., an electrical resistance, impedance, a current, etc.)) configured to extend from a proximal end of the sensor lumen to a distal end of the sensor lumen (¶ [0025] of Wilder discloses the conductive wire lumen 206 for a conductive wire 208 extends from the distal portion of the tube 200 toward the proximal end of the tube 200, wherein the electrode 210 is the end of the conductive wire 208, exposed of insulation at the point where the conductive wire 208 exits the conductive wire lumen 206 to the outer surface along the distal portion), and to sense or measure the one or more of: the electrical impedance, the resistance, the conductance and/or the electrical signal, at the distal end of the catheter body (¶ [0039] of Wilder discloses the distal end of one or more wires may be configured to deliver real-time feedback information (e.g., an electrical resistance, impedance, a current, etc.)).
With regards to claim 70, the above combination teaches or suggests said at least one sensor is provided as one or more sensing probes positioned on and/or in the elongated catheter body (¶ [0025] of Wilder discloses the conductive wire lumen 206 for a conductive wire 208 extends from the distal portion of the tube 200 toward the proximal end of the tube 200, wherein the electrode 210 is the end of the conductive wire 208, exposed of insulation at the point where the conductive wire 208 exits the conductive wire lumen 206 to the outer surface along the distal portion), the one or more sensing probes being configured to sense or measure the one or more of: the electrical impedance, the resistance, the conductance and/or the electrical signal, at the distal end of the catheter body (¶ [0039] of Wilder discloses the distal end of one or more wires may be configured to deliver real-time feedback information (e.g., an electrical resistance, impedance, a current, etc.)).
With regards to claim 71, the above combination teaches or suggests the one or more sensing probes comprise a conductive material configured to pass electrical current therethrough (¶ [0025] of Wilder discloses the electrode 210 is the end of the conductive wire 208, exposed of insulation at the point where the conductive wire 208 exits the conductive wire lumen 206 to the outer surface along the distal portion; ¶ [0039] of Wilder discloses the distal end of one or more wires may be configured to deliver real-time feedback information (e.g., an electrical resistance, tissue temperature and/or impedance, a force of the device against a tissue, an activation time, a current, etc.) to a medical professional or computer processor, to manually or automatically adjust, e.g., increase or decrease, the frequency, power, and/or duration of energy being delivered).
With regards to claim 74, the above combination teaches or suggests the catheter is configured to be passed through an endoscope (Figs. 1A, 1B and ¶ [0024] of Wilder depict an ERCP procedure in which the endoscopic accessory 100 is advanced through a working channel of duodenoscope 140; ¶ [0016] discloses that the embodiments may be described with specific reference to medical devices and systems for selective access to, aligning with, cannulation, and/or cutting of the opening to the common bile duct (CBD) or pancreatic duct (PD) during an ERCP; ¶ [0043] of Wilder discloses extending an elongate tube through an endoscope).
With regards to claim 75, the above combination teaches or suggests the catheter is sized to be passed through the duodenal endoscope, through the major duodenal papilla and/or Sphincter of Oddi and/or into the ampulla of Vater of the subject (¶¶ [0016], [0024] of Wilder discloses the medical device accessing a major papilla, Sphincter of Oddi Complex via a duodenoscope) .
With regards to claim 79, the above combination teaches or suggests the distal end of the second lumen is positioned at a side of the distal end of the catheter body(¶ [0026] of Wilder discloses one or more lumens may terminate at a proximal exit point for a feature of the device through at least a portion of the lumen; Fig. 2 of Wilder depicts the exit point of the guidewire lumen 204 being on a side of the distal end of the catheter)
With regards to claim 91, the above combination teaches or suggests wherein the one or more of the sensing probes is positioned on one or more of an external circumference of the catheter body, the distal end of the catheter body, and the tip of the distal end of the catheter body (Fig. 2 and ¶ [0025] of Wilder discloses the electrode 210 is disposed on the outer surface of the tube 200 at the distal end/tip).
With regards to claim 93, the above combination teaches or suggests the second lumen comprises an obstacle, selected from a bump, a distortion in shape of the lumen, a bridge or combinations thereof, located in proximity with the distal opening of said second lumen, configured to aid in directing a guidewire passing through the second lumen, to the different internal body location (¶ [0041] of Wilder discloses distortions in shape of the lumen which may aid in directing a guidewire to different internal body locations).
With regards to claim 94, the above combination teaches or suggests the first and/or second lumens are configured to allow passage of one or more medical instruments and/or substances selected from: stent systems, cytology sheaths, dilators balloons, stent extractors, miniscopes, contrast dye, medication, or any combination thereof (¶ [0026] of Wilder discloses the lumens may be configured to accept features (e.g., contrast, guidewire, articulating wire) of the device through at least a portion of the lumen).
With regards to claim 95, the above combination teaches or suggests the proximal region thereof comprises one or more handles or ports for operating, inserting and/or maneuvering one or more of the first guidewire, the second guidewire, the medical instruments and/or the substances (¶¶ [0025], [0039] of Wilder discloses a handle at the proximal end of the elongate tube connected to the articulation wire, and configured to interact with the articulation wire to articulate the distal end of the tube).
With regards to claim 96, the above combination teaches or suggests the ERCP catheter is a sphincterotomy catheter (¶ [0035] of Wilder discloses devices, systems, and methods of the present disclosure may be used as sphincterotomes for cannulation, papillotomy, sphincterotomy, and the like).
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Wilder in view of Petersohn and evidenced by Gamble, as applied to claim 67 above, and further in view of 2021/0137409 A1 (Ben-Haim) (previously cited)
With regards to claim 73, the above combination is silent regarding whether the values of the one or more of the electrical impedance, the resistance, the conductance and/or electrical signal sensed or measured at the distal end of the catheter body are indicative of an inflammatory condition in the bile duct or in the pancreatic duct.
In the same field of endeavor of diagnostic and therapeutic catheters (¶ [0178] of Ben-Haim teaches the catheter being ablation or diagnostic catheters), Ben-Haim teaches values of the one or more of the electrical impedance, the resistance, the conductance and/or electrical signal sensed or measured at the distal end of the catheter body are indicative of an inflammatory condition of the vessel (¶ [0171] discloses impedance measurements being indicative of tissue kind, wherein the tissue kind may include inflammation). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impedance measurements of the common bile duct or the pancreatic duct of the above combination to incorporate that they are indicative of an inflammatory condition as taught by Ben-Haim. The motivation would have been to provide a more complete diagnostic picture of the tissue at the distal end of the catheter.
Claims 77, 78, and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Wilder in view of Petersohn and evidenced by Gamble, as applied to claim 67 above, and further in view of US 2009/0062789 A1 (Rioux) (previously cited).
With regards to claim 77, the above combination is silent regarding a magnetic region on the body of the catheter, wherein the magnetic region comprises an electromagnet.
In a system relevant to the problem of navigating a catheter within the body, Rioux teaches a magnetic region on the body of the catheter, wherein the magnetic region comprises an electromagnet (¶ [0029] discloses a catheter 20 comprising an electromagnet 26 carried by a distal end 24 of the catheter body 21). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of the above combination to incorporate that it comprises a magnetic region on the body of the catheter, wherein the magnetic region comprises an electromagnet as taught by Rioux. The motivation would have been to improve the steerability of the catheter (¶ [0027] of Rioux).
With regards to claim 78, the above combination is silent regarding whether the electromagnet is configured to be activated by a user during a procedure.
In a system relevant to the problem of navigating a catheter within the body, Rioux teaches activation of the electromagnet is configured to be activated by a user during a procedure (¶ [0007] discloses an electrical connector may be electrically coupled to the electromagnet(s), and the magnetic steering mechanism may control the electrical energy delivered from the electrical connector to the electromagnet(s)). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate the electrical connector and magnetic steering mechanism as taught by Rioux. The motivation would have been to provide the elements for controlling the magnetic steerability of the catheter.
With regards to claim 80, the above combination teaches or suggests the catheter comprising the first guidewire (Fig. 2 and ¶ [0025] of Wilder depict a guidewire in the guidewire lumen 204).
The above combination is silent regarding whether the first guidewire comprises a magnetic tip at a distal end thereof, and wherein the magnetic tip of the first guidewire is configured to allow bending or deforming of the distal end of the first guidewire, to aid in directing or navigating the first guidewire to the common bile duct.
In a system relevant to the problem of navigating a catheter and guidewire within the body, Rioux teaches a guidewire comprising a magnetic tip at a distal end thereof; wherein the magnetic tip of the guidewire is configured to allow bending or deforming of the distal end of the guidewire, to aid in directing or navigating the guidewire to a desired location (¶ [0025] depicts a guidewire 30 comprising a magnetically attractive element 36 disposed on the distal end 34 of the guidewire; ¶ [0031] discloses electromagnet 26 is configured for generating a sufficient magnetic field to deflect (shown in phantom in FIGS. 1-3) or otherwise manipulate the magnetically attractive element and/or tip 36 on the distal end 34 of the guidewire 30). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first guidewire of Wilder of the above combination to incorporate the magnetic system including a magnetic tip at the distal end thereof; wherein the magnetic tip of the guidewire is configured to allow bending or deforming the distal end of the guidewire, to aid in directing or navigating the guidewire to a desired location as taught by Rioux. The motivation would have been to improve the steerability of the catheter assembly.
Claim 92 is rejected under 35 U.S.C. 103 as being unpatentable over Wilder in view of Petersohn and evidenced by Gamble, as applied to claim 67 above, and further in view of US 2015/0297139 A1 (Toth) (previously cited).
With regards to claim 92, the above combination is silent regarding whether the electrical signal is indicative of muscle or nerve activity and is configured to allow electromyography measurements.
In a system relevant to the problem of determining feedback signals during a surgical procedure (¶ [0035] of Toth), Toth teaches an electrical signal is indicative of muscle or nerve activity and is configured to allow electromyography measurements (¶ [0036] discloses feedback signals being related to electromyography; ¶ [0019] discloses one or more sensing elements configured to monitor one or more physiological signals associated with a tissue, the electrophysiological signal being an EMG signal; ¶ [0023] discloses the surgical tool may include a plurality of sensing elements arranged upon and coupled to the distal tip). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more wires for providing feedback of Wild to incorporate that they are configured to sense or measure an electrical signal indicative of muscle or nerve activity and configured to allow electromyography measurements as taught by Toth. The motivation would have been to provide additional feedback signals during the surgical procedure, thereby allowing for a better surgical outcome.
Claim 97 is rejected under 35 U.S.C. 103 as being unpatentable over Wilder in view of Petersohn and evidenced by Gamble, as applied to claim 67 above, and further in view of US 2019/0388002 A1 (Bozsak) (previously cited)
With regards to claim 97, the above combination teaches or suggests the catheter comprising the first guidewire (Fig. 2 and ¶ [0025] of Wilder depict a guidewire in the guidewire lumen 204).
The above combination is silent regarding whether the at least one sensor is positioned at a distal end of the first guidewire or on sides of the distal end of the first guidewire.
In the same field of endeavor of invasive probes for diagnosing and treating a patient, Bozsak teaches at least one sensor configured to sense electrical impedance or on the sides of the distal end of the first guidewire (¶¶ [0033], [0085]-[0086] and Fig. 2 disclose an invasive probe including one or more sensors to measure an impedance of a lesion), the at least one sensor is positioned at the distal end of the first guidewire (Fig. 3 and ¶ [0086] depict the additional sensors 210 being located along a distal end of a guidewire). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one sensors of Wilder of the above combination to incorporate that they are positioned at the distal end of the first guidewire or on the sides of the distal end of the first guidewire as taught by Bozsak. Because both sensor locations are suitable for providing sensing signals at a distal end of an invasive probe, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Response to Arguments
Claim Rejections under 35 U.S.C. §112(b)
In view of the claim amendments filed 07/07/2026, the previous grounds of claim rejections under 35 U.S.C. §112(b) were withdrawn. There are new rejections necessitated by the claim amendments.
Claim Rejections under 35 U.S.C. §103
Applicant's arguments filed 07/07/2026 have been fully considered but they are not persuasive.
On page 9 of the Response filed 07/07/2026, the Applicant asserts:
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This argument is not persuasive. 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., bile duct vs pancreatic duct discrimination) 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). The claim indicates that “the values… are indicative of whether the distal end of the catheter body is located in the common bile duct or in the pancreatic duct”. Therefore, the broadest reasonable interpretation of the claim limitation includes at least one sensor located in either the common bile duct or the pancreatic duct which provides an impedance signal which reflects its position. Petersohn teaches or suggests such a limitation in ¶ [0011] which discloses measurement of electrical impedance for identifying and locating target tissue and ¶ [0047] which discloses target structure may also include or be adjacent to the common bile duct, pancreatic duct. The claim does not actually require the determination of the location of the distal end of the catheter body or the discrimination between the common bile duct and the pancreatic duct.
On page 9 of the Response filed 07/07/2026, the Applicant asserts:
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This argument is not persuasive. First, in response to applicant's argument that the values of Wilder are used solely for adjusting energy delivery parameters, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the impedance measured by the sensor of Wilder will necessarily vary based on the measured contents, and the impedance is capable of being used to discriminate between bile duct and pancreatic duct contents. Second, in response to applicant's arguments against the 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). The Examiner asserts that the combination of Wilder in view of Petersohn and evidenced by Gamble teaches or suggests the claimed invention.
On page 10 of the Response filed 07/07/2026, the Applicant asserts:
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These arguments are not persuasive. First, 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., impedance measurements that characterize fluid contents of anatomical ducts) 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). The claim recites “based on difference in electrical properties between contents of the common bile duct and the pancreatic duct”. In this case, broadest reasonable interpretation of the claim limitation includes the tissues of the ducts. Second, in response to applicant's argument that the impedance measurements are not related to the fluid contents, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, on of ordinary skill would understand that the distal end of the wire of ¶ [0039] of Wilder is capable of interacting with both tissue and fluids, such that the impedance measurements are capable of reflecting both fluid and tissue characteristics.
On pages 10-11 of the Response filed 07/07/2026, the Applicant asserts:
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This argument is not persuasive. 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., bile duct vs pancreatic duct discrimination) 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). The claim indicates that “the values… are indicative of whether the distal end of the catheter body is located in the common bile duct or in the pancreatic duct”. Therefore, the broadest reasonable interpretation of the claim limitation includes at least one sensor located in either the common bile duct or the pancreatic duct which provides an impedance signal which reflects its position. Petersohn teaches or suggests such a limitation in ¶ [0011] which discloses measurement of electrical impedance for identifying and locating target tissue and ¶ [0047] which discloses target structure may also include or be adjacent to the common bile duct, pancreatic duct. The claim does not actually require the determination of the location of the distal end of the catheter body or the discrimination between the common bile duct and the pancreatic duct.
The Examiner notes that, in view of the indefiniteness of the recitation of “based on differences in electrical properties between contents of the common bile duct and the pancreatic duct”, the recitation will be interpreted such that the values vary based on electrical properties of the contents of the common bile duct and the pancreatic duct. The values of the electrical impedance, the resistance, and/or the conductance sensed by the above combination of Wilder in view of Petersohn will necessarily vary based on electrical properties of the measured contents of the common bile duct and the pancreatic duct. Because the ionic properties vary between the contents of the common bile duct and the pancreatic duct (see Fig. 1 of Gamble) and electrical impedance, resistance, and conductance reflect the ionic properties, the values of the electrical impedance, resistance, and conductance will also vary based on electrical properties of the contents of the common bile duct and the pancreatic duct.
On page 11 of the Response filed 07/07/2026, the Applicant asserts:
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These arguments are not persuasive because they are not commensurate in scope with the claimed invention. The features upon which applicant relies (i.e., bile duct vs pancreatic duct discrimination based on the differences in resistivity, conductivity, or impedance) are not recited in the rejected claim(s). Instead, the differences in conductivity and resistivity between bile and pancreatic juice appear to be an inherent property of the relationship between bile and pancreatic juice, wherein the relationship is suggested by Fig. 1 of Gamble which depicts different ionic properties between bile and pancreatic juice. Additionally, there is no indication that the differences in resistivity, conductivity, or impedance for common bile duct and pancreatic duct are an unexpected result. The Applicant does not provide any evidence of the state of the art, the level of skill in the art, and the beliefs of those skilled in the art that prove that the relationship is not known or predictable from prior art. At most, the Applicant’s arguments amount to a conclusory statement that the relationship is unexpected. Additionally, the Examiner asserts that one of ordinary skill would be expected to determine, based on Fig. 1 of Gamble, that there are electrical differences between the contents of the common bile and pancreatic ducts which may be reflected in measured impedance, resistivity, or conductivity.
Applicants arguments regarding the dependent claims are not persuasive because claim 67 is not inventive over the combination of Wilder in view of Petersohn and evidenced by Gamble for the reasons listed above.
Conclusion
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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