DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/11/2026 was considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No limitations were interpreted under 35 U.S.C. 112(f).
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 93 and 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 93 recites “a desired location” in line 5, which is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this case, it is unclear when something starts/stops being a desired/undesired location.
Claim 97 recites “the distal end of the first guidewire” in line 3. There is insufficient antecedent basis for this limitation in the claim because the claim does not previously recite a distal end of the first guidewire. For the purposes of examination, the recitation will be interpreted to be “a distal end of the first guidewire”.
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).
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 the location of the distal end of the catheter 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/or the conductance sensed or measured at the distal end of the catheter are indicative of the location of the distal end of the catheter 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 the location of the distal end of the catheter 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.
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 a desired location (¶ [0041] of Wilder discloses distortions in shape of the lumen which may aid in directing a guidewire).
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, as applied to claim 67 above, and further in view of 2021/0137409 A1 (Ben-Haim)
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, 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, as applied to claim 67 above, and further in view of US 2015/0297139 A1 (Toth).
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, as applied to claim 67 above, and further in view of US 2019/0388002 A1 (Bozsak)
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 the distal end of the first guidewire or on the 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
Objections to the Specification
In view of the amendment to the abstract, the objection to the specification was withdrawn.
Claim Objections
In view of the claim amendments filed 01/11/2026, the claim objections were withdrawn.
Claim Rejections under 35 U.S.C. §112(b)
In view of the claim amendments filed 01/11/2026, 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 01/11/2026 have been fully considered but they are not persuasive.
On pages 11-12 of the Response filed 01/11/2026, the Applicant asserts:
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This argument is not persuasive.
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). In this case, it is the combination of Wilder in view of Petersohn which teaches values of one or more of electrical impedance, resistance, and/or conductance sensed or measured at the distal end of the catheter are indicative of the location of the distal end of the catheter 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 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.
On page 12 of the Response, the Applicant asserts that conductive wires and electrodes that may be used for energy deliver or general device feedback is not at least one sensor configured to sense or measure electrical impedance, resistance, conductance, or an electrical signal at the distal end of the catheter body. The Applicant asserts that the “real-time feedback” is generic and does not describe what is measured, how it is measured, or where the measurement occurs.
These arguments are not persuasive.
The broadest reasonable interpretation (BRI) of “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 body” includes any element configured to sense at least one of the parameters at the distal end of the catheter body. Claim 67 does not include any specific sensing architecture or measurement configuration that further limits the BRI of the limitation. The distal end of the wire of Wilder is configured to be placed at the distal end of the catheter (Fig. 2 and ¶ [0025] depict the electrode 210 at the end of the conductive wire 208 being at the distal end of the catheter) and is configured to provide feedback information including tissue impedance (¶ [0039] recites in various embodiments, the distal portion of the elongate tube and/or 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.). The above recitations indicate that the wire is configured for determining a tissue impedance at the distal end of the catheter body, so it amounts to the claimed sensor.
On page 12 of the Response, the Applicant asserts that Wilder does not explain why or how electrical sensing would be incorporated into an ERCP catheter for use during cannulation. The Applicant further asserts that “the Office Action’s position improperly equates generic conductive components with a configured sensor and relies on hindsight reconstruction using Applicant’s disclosure”.
This argument is not persuasive because Wilder provides sufficient guidance for incorporating the electrical sensing. Fig. 2 and ¶ [0025] of Wilder depict a conductive wire 208 including a distal section exposed of insulation that amounts to an electrode 210. Paragraph [0039] discloses that 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.). One of ordinary skill would be capable of understanding, based on the teachings of ¶¶ [0025], [0039], that the electrode of the conductive wire 208 of Fig. 2 and ¶ [0025] is also configured to provide real-time feedback information including tissue impedance. Additionally, one of ordinary skill in the art would know that the use of an cutting/cauterizing electrodes for sensing tissue impedance is known in the art. See, for example, Fig. 4 and Col. 11, lines 44-49 of US 5,749,869 A (Lindenmeier), ¶¶ [0042]-[0043] of US 2007/0129716 A1 (Daw), and Col. 9, lines 23-26 of US 5,423,809 A (Klicek). Finally, the motivation for combining the configurations of ¶¶ [0025], [0039] of Wilder would be to allow for the energy to be modified based on the feedback. See ¶ [0039] of Wilder.
On pages 13-14 of the Remarks, the Applicant asserts that Petersohn does not remedy the deficiencies of Wilder because Petersohn relates to tissue impedance during sensing or ablation and not to ERCP procedures.
This arguments is not persuasive. In response to applicant's argument that Petersohn is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, a problem with which the inventor was concerned includes the determination of the catheter’s and/or guidewire’s distal end in a desired duct location. See the Abstract. One of ordinary skill would therefore look to inventions relevant to the problem of determining a position of a catheter’s and/or guidewire’s distal end relative to a desired location. Petersohn is such a device. See at least ¶ [0011] which discloses that measurement of electrical impedance created in application of such [RF] energy may be useful in identifying and locating target tissue. Fig. 2 and ¶ [0025] depict the electrically conductive segment 38 of the wires 20 for applying the RF energy being located on a distal end of the catheter. Therefore, Petersohn is analogous art.
On pages 13-15, the Applicant asserts that Petersohn does not address bile duct vs pancreatic duct discrimination, does not disclose or suggest that ductal fluids exhibit diagnostically useful differences in their electrical properties, does not teach or suggest using electrical impedance or conductance to determine whether a catheter tip is located in the common bile duct versus the pancreatic duct, and does not teach duct-specific impedance thresholds, or real-time navigation during an ECRP procedure
These arguments are 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; using ductal fluids; determining whether a catheter tip is located in the common bile duct versus the pancreatic duct; duct-specific impedance thresholds; real-time navigation during an ECRP procedure) 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). At most, the claim indicates that “the values… are indicative of the location of the distal end of the catheter body 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 nor the discrimination between the common bile duct and the pancreatic duct.
On page 15 of the Remarks, the Applicant asserts that the Office Actions’ rationale that it would have been obvious to confirm the location of the distal end using impedance values is conclusory and constitutes impermissible hindsight.
This argument is not persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The desire for confirming a location of an device using another sensing modality is known in the art, and one of ordinary skill would understand that confirmation of a location is a rational reason for incorporating impedance measurements.
On pages 15-16 of the Remarks, the Applicant asserts that the modification of Wilder’s electrical components for general feedback, device monitoring, or energy deliver is a re-engineering of the system that weighs against obviousness.
This argument is not persuasive.
First, the above argument amounts to mere attorney argument without sufficient evidence to prove that one of ordinary skill would not be able to modify the components of Wilder. MPEP 2141.03 (I) indicates that a person of ordinary skill in the art is also a person of ordinary creativity, not an automaton, and the "hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art. The Examiner asserts that one of ordinary skill in the art would have been able to modify Wilder, based on the teachings of Petersohn, to arrive at the claimed invention. Additionally, the Examiner asserts that one of ordinary skill in the art would know that the use of an cutting/cauterizing electrodes for sensing tissue impedance is known in the art. See, for example, Fig. 4 and Col. 11, lines 44-49 of US 5,749,869 A (Lindenmeier), ¶¶ [0042]-[0043] of US 2007/0129716 A1 (Daw), and Col. 9, lines 23-26 of US 5,423,809 A (Klicek).
Applicants arguments regarding the dependent claims are not persuasive because claim 67 is not inventive over the combination of Wilder in view of Petersohn for the reasons listed above.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/S.C.K./ Examiner, Art Unit 3791
/JACQUELINE CHENG/ Supervisory Patent Examiner, Art Unit 3791
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