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 .
Applicant' s arguments, filed 5/29/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 5/29/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-4, 8-12, 14-20, and 25-26 are the currently pending claims . Claims 23 and 24 have been newly cancel. Claims 25 and 26 have been newly added. Claims 5-7, 13, and 21-22 have been previously canceled.
Election/Restrictions
Newly submitted claim 25 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 25 is drawn to a species in which the stop comprises a first component extending from an inner surface of the distal portion and a second component extending from an outer surface of the proximal portion. This species corresponds to a telescoping arrangement in which the proximal portion is received within the distal portion at the stop interface.
The claims previously presented and acted upon on the merits are being examined as directed to the elected invention, including the species of claim 15 in which the distal portion is configured to move within the shaft in response to tissue resistance. Applicant’s remarks, filed on 5/29/2026, confirm that this is the orientation being relied upon for the elected invention. Newly presented claim 25, by contrast, recites a stop having a first component extending from an inner surface of the distal portion and a second component extending from an outer surface of the proximal portion, corresponding to a reversed telescoping stop-interface species in which the proximal portion is received within the distal portion at the stop interface. This reversed stop-interface species is not readable on the elected claim 15 species and would require materially different consideration of reversed stop structures. Accordingly, claim 25 is withdrawn from consideration under 37 CFR 1.142(b) as being drawn to a non-elected invention by original presentation.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 25 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added 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.
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.
Claims 1-4, 8-12, 14-20, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Rankin et al. (US 20170035991 A1), hereto referred as Rankin, and further in view of Beeckler et al. (EP 3808266 A1), hereto referred as Beeckler, and further in view of Meredith (US 20140018665 A1), hereinafter Meredith.
Regarding claim 1, Rankin teaches a probe for insertion into a patient (Rankin, ¶[0055]: “Knowing the degree of contact... between the catheter and the tissue... as the catheter is advanced within a patient”, showing that Rankin discloses a catheter probe intended for insertion into a patient and detecting tissue contact during advancement) comprises: an elongate body comprising a distal portion and a proximal portion, the distal portion shaped for insertion into a tissue of the patient, the proximal portion coupled to the distal portion to advance the distal portion with advancement of the proximal portion (Rankin, Fig. 4; ¶[0056]: “The catheter 110 can comprise an elongated tubular member having a proximal end 115 connected with the handle 114 and a distal end 116 configured to be introduced within... the body”; ¶[0055]: “the catheter is advanced within a patient”; ¶[0059]: “the distal end 116 of the catheter 110 engages tissue 117”, showing that Rankin teaches an elongate catheter body with proximal and distal portions, where the distal portion is shaped for insertion into the patient and engagement with tissue, and advancement of the proximal portion advances the distal portion toward the tissue); a spring coupling the distal portion and the proximal portion (Rankin, Abstract: “a proximal segment containing a proximal hub, a distal segment containing a distal hub, and a spring segment that extends from the proximal segment to the distal segment”; ¶[0006]: “a spring segment that extends from the proximal segment to the distal segment”; ¶[0075]: proximal ends of struts 151 to 153 are attached to attachment portion 146 of proximal hub 141, distal ends of struts 151 to 153 are attached to attachment portion 147 of distal hub 142, and “the length of the spring segment 112 may be defined as the length of the plurality of struts 151-153 that is not overlapped by either of the proximal hub 141 or the distal hub 142”; ¶[0076]: “one or more of the struts will be compressed when the distal segment 113 moves relative to the proximal segment 111”, and “one or more of the other struts will be stretched when the distal segment 113 moves relative to the proximal segment 111”; claim 1: “a spring segment that extends from the proximal segment to the distal segment”, and “flex[es] at the preformed bends when the distal segment moves relative to the proximal segment”, showing that Rankin expressly teaches a spring segment coupling the proximal and distal portions and allowing relative motion between them); one or more sensors supported with the elongate body and coupled to the distal portion of the elongate body (Rankin, FIG. 4; ¶[0078]: "the struts 151-153 are circumferentially arrayed around the proximal hub 141 (and likewise can be circumferentially arrayed around the distal hub 142 in the same manner)... Any number of strain sensors... can be located on the struts", showing that the sensors are supported with the elongate body on struts that are structurally arranged with, and coupled through, the distal hub 142 of the distal portion; ¶[0075]: "Distal ends of the plurality of struts 151-153 can be attached to the attachment portion 147", and "... this is the portion of the distal end 116 which is configured to bend due to a force", showing that Rankin's strain-sensor-supporting structure is part of the distal end assembly and is mechanically coupled to the distal-side structure ("distal hub 142") via the attachment portion 147 such that force applied at the distal end is transmitted into the struts on which the sensors are supported); the one or more sensors configured to detect a tissue resistance on the distal portion related to the advancement of the proximal portion (Rankin, ¶[0076]: "one or more of the struts will be compressed when the distal segment 113 moves relative to the proximal segment 111 while one or more of the other struts will be stretched when the distal segment 113 moves relative to the proximal segment 111... Which struts elongate or compress depends on the direction of the force... Based on the different amounts of stretching and compressing... and which struts... compress and which struts... elongate, the magnitude and direction of force can be determined ... In particular, a plurality of strain sensors 161-163... can sense the compression or strain in the plurality of Struts 151-153 to determine the magnitude and direction of the force", showing that Rankin's plurality of sensors detect tissue-contact force information using relative movement between the distal segment and proximal segment, and because the struts are circumferentially distributed, the different strain states across the different struts correspond to different circumferential locations about the distal-end structure; Because the strain sensors are on struts that are circumferentially arrayed about the distal-end structure, each sensor corresponds to a different circumferential location on the distal portion, and the distribution of strain responses across the multiple sensors indicates at which circumferential location(s) tissue resistance is being applied; ¶[0078]: "the struts 151-153 are circumferentially arrayed... (and likewise can be circumferentially arrayed around the distal hub 142 in the same manner)... Any number of strain sensors... can be located on the struts", showing that the plurality of sensors are physically distributed around the distal-end structure at a plurality of circumferential locations, such that tissue resistance acting on the distal end produces a pattern of sensor responses that resolves resistance with respect to those different locations; where "relative movement between portions" is taught in Rankin, and telescoping is supplied by Beeckler as addressed below); an output coupled to the one or more sensors and configured to provide feedback to a user in response to the tissue resistance (Rankin, Abstract: "The catheter further comprises a plurality of sensors configured to output signals indicative of relative movement between the proximal and distal segments for determining a magnitude and direction of the force", ¶[0067]: "the input/output subsystem 129 may support the display 121 to display any information referenced herein, such as a graphic representation of tissue, the catheter 110, and a magnitude and direction of the force experienced by the catheter 110, amongst other options", ¶[0094]: "the output of the force... may provide feedback to the user", demonstrating an output system that provides real-time feedback in response to the detected resistance).
Also regarding claim 1, Rankin teaches or at least suggests the distal portion and the proximal portion being telescopic portions, and Rankin in view of Beeckler further renders this limitation obvious. Specifically, Rankin teaches relative movement between the distal and proximal portions where “the distal segment 113 moves relative to the proximal segment 111” in response to force and the sensors output signals indicative of that relative movement (Rankin, Abstract; ¶[0076]). Rankin also teaches axial compression because “If the force exerted... is coaxial with the longitudinal axis 109, then each of the struts 151-153 will compress in equal amounts” (Rankin, ¶[0089]). Rankin further teaches catheter shaft 132 as part of the elongate catheter body, extending along the spring segment and proximal segment and surrounding the structural and force sensing components, including proximal hub 141, distal hub 142, and struts 151 to 153 (Rankin, FIGS. 3-4). Thus, Rankin teaches an elongate body having a proximal portion that includes catheter shaft 132 and underlying proximal-side structure, and a distal portion coupled to distal segment 113, distal hub 142, and the distal-side portions of struts 151 to 153. Because Rankin teaches that distal segment 113 moves relative to proximal segment 111 in response to force, Rankin teaches or at least suggests that the distal portion moves longitudinally relative to and within the shaft of the proximal portion in response to tissue resistance.
To the extent Rankin does not expressly use the term “telescopic” to characterize this relationship, Beeckler expressly teaches a catheter system in which a shaft is disposed in a sheath and is configured to extend out of and retract relative to the sheath along the longitudinal axis, with sensors positioned on the shaft and sheath to monitor relative displacement (Beeckler, Fig. 2; ¶[0016]). Beeckler therefore teaches telescoping catheter portions in which a distal-side shaft structure moves longitudinally relative to and within a surrounding sheath or shaft structure.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rankin in view of Beeckler to configure Rankin’s relatively movable distal and proximal portions as telescopic portions. The modification would have been possible because Rankin already teaches proximal and distal catheter portions that move longitudinally relative to one another in response to force, and Beeckler teaches a predictable telescoping shaft and sheath arrangement in a catheter system for guiding relative longitudinal movement and monitoring relative displacement. A person of ordinary skill in the art would have been motivated to make the modification to provide guided longitudinal movement between Rankin’s distal and proximal portions during tissue contact while maintaining the force sensing relationship between the portions. The combination would have amounted to the predictable use of a known telescoping catheter structure to guide relative longitudinal movement between catheter portions that already move relative to one another.
Also regarding claim 1, the modified Rankin partially teaches a stop or travel-limiting feature for limiting relative movement between spring-coupled proximal and distal catheter portions, but does not teach that a stop is configured to limit movement of the proximal portion away from the distal portion. Specifically, Rankin teaches that inner tube 140, or another element, may serve to bottom out the bowing of struts 151 to 153 by contact between the bends of the struts and the inner tube 140, thereby preventing potentially damaging over-compression of spring segment 112 (Rankin, ¶[0086]). Thus, Rankin teaches the desirability of including a mechanical travel limit in a force sensing catheter having proximal and distal portions coupled by a spring segment to protect the spring structure and control relative movement between the proximal and distal portions. However, Rankin’s inner tube 140 limits movement in the compression direction and does not expressly teach the claimed stop configured to limit movement of the proximal portion away from the distal portion, in an extension direction.
Meredith, also in the catheter force-sensing field, teaches estimating catheter tip contact force based on deflection of a spring in a compressible catheter tip (Meredith, Abstract; ¶[0015]; ¶[0041]). Specifically, it teaches that distal tip section 16 and proximal tip section 18 are configured to slide relative to one another “within certain limits” (Meredith, ¶[0027]). Meredith teaches that the distal end of proximal tip section 18 has a tapered lip 18a that provides a snap fit with a corresponding tapered sleeve 16a at the proximal end of distal tip section 16, and that the snap fit is such that once assembled the sections 16, 18 “will not come apart with any normal forces expected to be exerted” on the tip (Meredith, ¶[0028]). Meredith further teaches that spring deflection moves distal tip section 16 axially until “the tapered lip on the proximal tip section 18 catches the corresponding sleeve on the inside of the distal tip section 16”, thereby holding the two sections in place in the home state with a fixed distance between the markers (Meredith, ¶[0031]). The tapered lip 18a and corresponding sleeve 16a therefore form a stop that limits axial separation between telescopic proximal and distal portions. Meredith’s tapered lip 18a and corresponding sleeve 16a therefore form a stop that limits axial separation between telescopic proximal and distal portions. In the modified Rankin/Beeckler arrangement, a corresponding separation-limiting stop would have been arranged to limit the claimed movement of the proximal portion away from the distal portion.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Rankin in view of Meredith to include a stop configured to limit movement of the proximal portion away from the distal portion. The modification would have been possible because Rankin already teaches a force sensing catheter having proximal and distal portions coupled by a spring segment, sensors that detect relative movement between the portions, and a mechanical travel limit that prevents potentially damaging over-compression of the spring segment. Rankin further teaches that, when the distal segment moves relative to the proximal segment, one or more struts may be compressed and one or more other struts may be stretched (Rankin, ¶[0076]), and that Rankin’s sensors are used to detect strain or compression in the struts to determine force (Rankin, ¶[0076]). Thus, Rankin’s force sensing structure is subject to both compressive and tensile deformation during use, and Rankin already recognizes the desirability of limiting relative travel to protect the spring structure from damaging over-travel. Meredith teaches that, in a telescoping spring-loaded catheter tip, a cooperating lip and sleeve may be used to limit separation of the telescopic portions under normal forces expected to be exerted on the catheter tip (Meredith, ¶[0028]). Meredith further teaches that the cooperating lip and sleeve hold the sections in place in the home state with a fixed distance between markers (Meredith, ¶[0031]). A person of ordinary skill in the art would have been motivated to add Meredith’s separation-limiting stop, or a corresponding separation-limiting stop, to the modified Rankin catheter because Rankin already recognizes the benefit of mechanically limiting relative travel of spring-coupled catheter portions to protect the spring segment, and excessive separation movement would similarly risk stretching the struts, damaging the spring segment or associated strain sensors, or driving the force sensing structure outside its intended measurement range. The modification does not require bodily incorporation of Meredith’s exact illustrated nesting orientation, but instead applies Meredith’s known separation-limiting stop concept to the modified Rankin/Beeckler telescopic arrangement so that relative travel is limited in the claimed extension direction. Such separation forces would reasonably be expected during catheter navigation and withdrawal, including when the distal portion encounters tissue resistance or becomes caught while the proximal portion is pulled away from the distal portion. The resulting catheter would have had controlled travel in both axial directions, namely a compression limit to protect against over-compression and a separation limit to protect against over-extension, while preserving reliable force sensing feedback. The combination would have amounted to the predictable use of known catheter stop structures for their established purpose of controlling relative movement between spring-coupled catheter portions and protecting the spring and sensing structure from excessive travel.
Regarding claim 2, the modified Rankin teaches that the one or more sensors are configured to be inserted into tissue of the patient (Rankin, Fig. 1A–C; ¶[0056]: “The catheter 110 can comprise an elongated tubular member having a proximal end 115 connected with the handle 114 and a distal end 116 configured to be introduced within a heart 101 or other area of the body”; ¶[0059]: “the distal end 116 of the catheter 110 engages tissue 117… one or more sensors within the distal end 116 of the catheter 110 can sense the degree of bending of the spring segment 112 to determine the magnitude and the direction of the force”, showing that the sensors are disposed on the distal end of the catheter, which is configured to be inserted into the patient and detect resistance during use).
Regarding claim 3, the modified Rankin teaches that the one or more sensors are located on a superior side of the distal portion when the probe has been inserted into the patient (Rankin, Fig. 4–5; ¶[0076]: “The plurality of struts 151-153 are circumferentially arrayed around the longitudinal axis 109… a plurality of strain sensors 161-163… can sense the compression or strain in the plurality of struts 151-153 to determine the magnitude and direction of the force”, showing that the sensors are circumferentially disposed around the distal end of the catheter, and by placement around the circumference of the distal portion, at least one sensor would lie on the superior side when the probe has been inserted into the patient).
Regarding claim 4, the modified Rankin teaches that the one or more sensors are located on the distal portion of the elongate body to engage the tissue and detect the tissue resistance (Rankin, Fig. 1A–C; ¶[0059]: “the distal end 116 of the catheter 110 engages tissue 117… one or more sensors within the distal end 116 of the catheter 110 can sense the degree of bending of the spring segment 112 to determine the magnitude and the direction of the force”, showing that the sensors are disposed on the distal portion of the catheter where they engage the tissue and detect resistance during advancement).
Regarding claim 8, the modified Rankin teaches that the one or more sensors are configured to detect strain or compression of the elongate body between the first portion and the second portion in response to the tissue resistance (Rankin, Fig. 4–5; ¶[0076]: “The plurality of struts 151-153 are circumferentially arrayed around the longitudinal axis 109 such that one or more of the struts will be compressed when the distal segment 113 moves relative to the proximal segment 111 while one or more of the other struts will be stretched… a plurality of strain sensors 161-163… can sense the compression or strain in the plurality of struts 151-153 to determine the magnitude and direction of the force”, showing that the modified Rankin discloses sensors configured to detect strain or compression of the elongate body (spring segment 112 and struts 151-153) between the proximal portion 111 and the distal portion 113 in response to tissue resistance).
Regarding claim 9, Rankin teaches that the one or more sensors are configured to detect movement of the distal portion relative to the proximal portion (Rankin, [0076]: “a plurality of strain sensors 161-163 … can sense the compression or strain in the plurality of Struts 151-153”, where the compression/strain occurs when “the distal segment 113 moves relative to the proximal segment 111”, showing that the plurality of sensors detect the relative movement between the distal and proximal portions; Rankin, Abstract: “The catheter further comprises a plurality of sensors configured to output signals indicative of relative movement between the proximal and distal segments …”, expressly describing sensors configured to detect relative movement between the distal and proximal portions).
Regarding claim 10, the modified Rankin teaches that the proximal portion is configured to move relative to the distal portion in response to a force from the tissue resistance greater than a force from the spring (Rankin, ¶[0006]: “a proximal segment… a distal segment… a spring segment… configured to permit relative movement… flex at the preformed bends… resiliently return… once the force has been removed; and a plurality of sensors configured to output signals indicative of relative movement between the proximal and distal segments”, showing that the modified Rankin discloses proximal and distal portions coupled by a spring segment permitting relative movement in response to tissue force greater than the spring force).
Regarding claim 11, the modified Rankin in view of Meredith teaches that the spring is configured to push the distal portion away from the proximal portion against the stop and wherein the distal portion moves toward the proximal portion in the response to the force of the tissue resistance exceeding the force from the spring in order to decrease movement of the distal portion while the proximal portion advances. Specifically, Rankin teaches a proximal segment 111, a distal segment 113, and a spring segment 112 extending between the proximal segment 111 and the distal segment 113, where the spring segment flexes when the distal segment moves relative to the proximal segment in response to force and “resiliently return[s]” once the force has been removed (Rankin, ¶[0057]). Rankin further teaches that, when the distal segment 113 moves relative to the proximal segment 111, one or more struts are compressed and one or more other struts are stretched, and that the strain sensors sense the compression or strain in the struts to determine the magnitude and direction of the force (Rankin, ¶[0076]). Rankin also teaches that, when the force exerted on the distal end is coaxial with the longitudinal axis, “each of the struts 151-153 will compress in equal amounts” (Rankin, ¶[0089]). Thus, Rankin teaches a spring segment that resists tissue contact force and permits the distal portion to move toward the proximal portion when tissue resistance overcomes the spring force.
Rankin further teaches that the catheter is advanced within the patient and that the distal end 116 of the catheter engages tissue 117 (Rankin, ¶[0055]; ¶[0059]). Accordingly, when the proximal portion is advanced and the distal portion encounters tissue resistance, Rankin teaches that the tissue resistance causes relative movement between the distal segment 113 and the proximal segment 111, such that at least part of the proximal advancement is taken up by compression or flexing of the spring segment rather than corresponding forward movement of the distal portion into the tissue. Rankin therefore teaches decreasing movement of the distal portion while the proximal portion advances in response to tissue resistance exceeding the resisting force of the spring segment.
To the extent Rankin does not expressly teach the spring pushing the first portion away from the second portion against the claimed stop, Meredith teaches this feature in the same catheter force-sensing field. Meredith teaches a compression spring 22 mounted between distal tip section 16 and proximal tip section 18, where spring 22 is compressed when force on the tip 14 moves distal tip section 16 toward proximal tip section 18 along the sliding or longitudinal axis (Meredith, ¶[0029]). Meredith further teaches that, even in the “home state”, spring 22 has some deflection exerting a force on distal tip section 16 away from proximal tip section 18, and that this deflection moves distal tip section 16 axially until the tapered lip on proximal tip section 18 catches the corresponding sleeve on the inside of distal tip section 16, holding the two sections in place in the home state with a fixed distance (Meredith, ¶[0031]). Meredith also teaches that, during use, the catheter tip presses against target tissue, causing the compressible tip to compress, moving the distal tip section toward the proximal tip section and decreasing the distance between markers on the tip assembly (Meredith, ¶[0037]). Meredith therefore teaches a spring configured to push a first telescopic portion away from a second telescopic portion against a stop, and to allow the first portion to move toward the second portion when tissue resistance exceeds the force from the spring.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the modified Rankin/Beeckler catheter according to Meredith such that the spring pushes the first portion away from the second portion against the separation-limiting stop and permits the first portion to move toward the second portion when tissue resistance exceeds the spring force. The modification would have been possible because Rankin already teaches a force-sensing catheter having proximal and distal portions coupled by a resilient spring segment, Rankin teaches that tissue resistance causes relative movement between the distal and proximal portions, and Meredith teaches a known spring-loaded telescoping catheter tip in which a spring biases the telescoping portions against a stop in a home state and compresses under tissue contact force. A person of ordinary skill in the art would have been motivated to make the modification to provide a defined home-state relationship, preserve a known force-sensing baseline, limit excessive separation travel, and allow tissue contact force to be absorbed by spring compression so that advancement of the proximal portion does not cause equal additional advancement of the distal portion into the tissue. The combination would have amounted to the predictable use of a known spring-biased stop arrangement in a force-sensing catheter to control relative movement between spring-coupled catheter portions.
Regarding claim 12, the modified Rankin teaches that the spring comprises one or more of a coil spring, a torsion spring, a leaf spring or a bendable extension (Rankin, ¶[0006]: “a spring segment comprising a plurality of struts, each strut comprising a preformed bend, wherein the plurality of struts are configured to… flex at the preformed bends when the distal segment moves relative to the proximal segment in response to the force, and resiliently return… once the force has been removed”, showing that Rankin discloses a spring segment formed by bendable strut extensions, which falls within the scope of a leaf spring or bendable extension as recited in the claim).
Regarding claim 14, the modified Rankin teaches that the probe further comprises a switch configured to transition between an open configuration and a closed configuration and generate the output in response to the force from the tissue resistance greater than the force from the spring (Rankin, ¶[0065]: “The control unit 120 can include a force sensing subsystem 126… Such components can include signal processors, analog-to-digital converters, operational amplifiers, comparators, and/or any other circuitry for conditioning and measuring one or more signals”, showing that Rankin discloses circuitry such as comparators that function as switches which transition between states. When the distal segment 113 moves relative to the proximal segment 111 and flexes the spring struts in response to tissue resistance, the comparators activate to generate an output, indicating that the force from the tissue resistance has exceeded the spring force that normally maintains the struts in their pre-biased state).
Regarding claim 15, the modified Rankin teaches that the elongate body comprises a shaft and wherein the distal portion is configured to move within the shaft in response to the tissue resistance. Specifically, Rankin teaches catheter shaft 132 as part of the elongate catheter body, extending along the spring segment 112 and proximal segment 111 and surrounding the structural and force sensing components, including proximal hub 141, distal hub 142, and struts 151 to 153 (Rankin, FIGS. 3-4). Rankin further teaches that the distal segment 113 moves relative to the proximal segment 111 in response to force and that, when the distal segment 113 moves relative to the proximal segment 111, one or more struts are compressed and one or more other struts are stretched (Rankin, Abstract; ¶[0076]). Rankin also teaches that the strain sensors sense compression or strain in the struts to determine the magnitude and direction of the force, and that the force is produced when the distal end 116 engages tissue 117 (Rankin, ¶[0059]; ¶[0076]).
Thus, Rankin teaches an elongate body comprising a shaft 132, a proximal portion including the shaft 132 and underlying proximal-side structure, and a distal portion coupled to distal segment 113, distal hub 142, and the distal-side portions of struts 151 to 153. Because Rankin teaches that distal segment 113 moves relative to proximal segment 111 in response to tissue-contact force, and because the shaft 132 surrounds the spring segment and the structural components that move relative to one another, Rankin teaches or at least suggests that the distal portion is configured to move within the shaft in response to the tissue resistance.
To the extent Rankin does not expressly characterize this relative movement as movement of the distal portion within the shaft, Beeckler expressly teaches a catheter system in which a shaft is disposed in a sheath and is configured to extend out of and retract relative to the sheath along the longitudinal axis, with sensors positioned on the shaft and sheath to monitor relative displacement (Beeckler, Fig. 2; ¶[0016]). Beeckler therefore teaches a catheter arrangement in which a distal-side shaft structure moves longitudinally relative to and within a surrounding sheath or shaft structure.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the modified Rankin’s relatively movable distal portion to move within the shaft as taught or suggested by Rankin and further evidenced by Beeckler, because Rankin already teaches tissue-resistance-driven relative movement between the distal and proximal portions and Beeckler teaches a predictable shaft/sheath catheter arrangement for guiding such longitudinal relative movement. A person of ordinary skill in the art would have been motivated to use this arrangement to guide movement of the distal portion within the shaft while preserving Rankin’s force sensing relationship between the distal and proximal portions.
Regarding claim 16, the modified Rankin teaches that the elongate body comprises a tapered waist between the distal portion and the proximal portion, and the one or more sensors are coupled to the tapered waist to detect strain of the tapered waist (Rankin, Fig. 3–4: showing spring segment 112 connecting proximal segment 111 to distal segment 113, the geometry narrowing between them to form a functional tapered waist; ¶[0091]: describing strain sensors 161–163 positioned on the struts to measure strain during deformation; ¶[0086]: describing how the struts bow inward under force and contact the inner tube 140, confirming the compliant, force-responsive nature of the narrowed spring region; Together these disclosures show that the spring segment functions as both a mechanical transition zone and a sensor target area, fulfilling the claimed tapered waist with strain detection).
Regarding claim 17, the modified Rankin teaches that the one or more sensors are located between the distal portion and the proximal portion to detect the strain or compression of the elongate body in response to the tissue resistance (Rankin, Fig. 3–5; ¶[0076]: “The plurality of struts 151-153 are circumferentially arrayed around the longitudinal axis 109… Based on the different amounts of stretching and compressing of the struts 151-153, and which struts 151-153 compress and which struts 151-153 elongate, the magnitude and direction of force can be determined by the force sensing subsystem 126. In particular, a plurality of strain sensors 161-163… can sense the compression or strain in the plurality of struts 151-153 to determine the magnitude and direction of the force”, showing that strain sensors are positioned between the distal portion 113 and proximal portion 111 on the spring segment to detect strain and compression of the elongate body in response to tissue resistance).
Regarding claim 18, the modified Rankin teaches that the one or more sensors comprise a displacement transducer to measure a displacement of the first portion relative to the second portion (Rankin, Fig. 3–5; ¶[0076]: “Based on the different amounts of stretching and compressing of the struts 151-153, and which struts 151-153 compress and which struts 151-153 elongate, the magnitude and direction of force can be determined by the force sensing subsystem 126. In particular, a plurality of strain sensors 161-163… can sense the compression or strain in the plurality of struts 151-153 to determine the magnitude and direction of the force”, see also ¶[0039], ¶[0055], ¶[0059], ¶[0089],¶[0091]: Rankin is directed to force-sensing catheters and describes a spring segment 112 composed of struts 151–153 positioned between a proximal segment 111 and a distal segment 113. Sensors 161–163 are mounted to the struts and measure dimensional changes in the curved struts in response to tissue resistance. The measured deformation corresponds to displacement of the distal segment relative to the proximal segment. While not explicitly labeled as a “displacement transducer,” these strain sensors implicitly measure displacement between segments, thereby functioning as displacement transducers).
Regarding claim 19, the modified Rankin teaches that the elongate body extends along an elongate axis and the one or more sensors located around the elongate axis to measure axial or bending loads to detect the tissue resistance (Rankin, Fig. 4–5; ¶[0076]: “The plurality of struts 151-153 are circumferentially arrayed around the longitudinal axis 109 such that one or more of the struts will be compressed when the distal segment 113 moves relative to the proximal segment 111 while one or more of the other struts will be stretched… Based on the different amounts of stretching and compressing of the struts 151-153… the magnitude and direction of force can be determined by the force sensing subsystem 126. In particular, a plurality of strain sensors 161-163… can sense the compression or strain in the plurality of struts 151-153 to determine the magnitude and direction of the force”, showing that Rankin discloses multiple sensors arranged around the longitudinal axis that detect axial and bending loads in response to tissue resistance).
Regarding claim 20, the modified Rankin teaches that the plurality of sensors located around the elongate axis are configured to detect a direction of deflection of the elongate body in response to the tissue resistance (Rankin, Fig. 4–5; ¶[0076]: “The plurality of struts 151-153 are circumferentially arrayed around the longitudinal axis 109 such that one or more of the struts will be compressed when the distal segment 113 moves relative to the proximal segment 111 while one or more of the other struts will be stretched… Based on the different amounts of stretching and compressing of the struts 151-153, and which struts 151-153 compress and which struts 151-153 elongate, the magnitude and direction of force can be determined by the force sensing subsystem 126”, showing that Rankin discloses sensors around the elongate axis that determine which struts are compressed or stretched, thereby detecting the direction of deflection of the elongate body in response to tissue resistance).
Regarding claim 26, the modified Rankin in view of Meredith teaches that the stop is proximal to the spring. As discussed above regarding claim 1, Meredith teaches a separation-limiting stop formed by tapered lip 18a on proximal tip section 18 and corresponding tapered sleeve 16a on distal tip section 16, where the stop limits axial separation between the telescopic proximal and distal portions (Meredith, ¶[0028]; ¶[0031]). Meredith further teaches that compression spring 22 is mounted inside distal tip section 16, with a first end at the proximal end of distal tip section 16 contacting the distal end of proximal tip section 18, and a second end contacting an inside end wall of distal tip section 16 opposite its proximal end (Meredith, ¶[0029]). Thus, Meredith teaches that the separation-limiting stop is located at the proximal end of the distal tip section, while the spring extends distally into the distal tip section from that proximal end. Accordingly, Meredith teaches or at least suggests that the stop is proximal to the spring.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the separation-limiting stop of the modified Rankin catheter to be proximal to the spring as taught or suggested by Meredith. The modification would have been possible because Rankin already teaches proximal and distal catheter portions coupled by a spring segment, Beeckler teaches a telescoping catheter arrangement, and Meredith teaches a spring-loaded telescoping catheter tip in which the separation-limiting stop is positioned at the proximal telescoping interface while the spring extends distally into the compressible tip assembly. A person of ordinary skill in the art would have been motivated to position the stop proximal to the spring because the proximal telescoping interface is the location at which the telescoping portions separate in the extension direction, while the spring remains positioned distally to compress under tissue-contact force for force sensing. This arrangement allows the stop to limit over-extension and protect the spring and associated sensing structure without interfering with the spring compression region used to absorb tissue resistance and provide force feedback. The combination would have amounted to the predictable use of a known stop placement in a spring-loaded telescoping catheter to control relative movement while protecting the spring and sensing structure from excessive travel.
Response to Arguments
Claim Interpretation
Applicant's arguments filed 5/29/2026, page 6, regarding the previous Claim Interpretation of claim 15 have been fully considered . The previous claim interpretation is withdrawn.
35 U.S.C. §112(a)
Applicant's arguments filed 5/29/2026, page 6, regarding the previous 112(a) Rejections of claim 23 have been fully considered and are persuasive. The previous 112(a) rejections have been withdrawn.
35 U.S.C. §112(b)
Applicant's arguments filed 5/29/2026, page 7, regarding the previous 112(b) Rejections of claims 1-4, 8-12, 14-20, and 23-24 have been fully considered and are persuasive. The previous 112(b) rejections have been withdrawn.
35 U.S.C. §103
Applicant's arguments filed 5/29/2026, pages 7-9, regarding the previous 103 Rejections of claims 1-4, 8-12, 14-20, and 23-24 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection. Additionally:
Applicant’s Argument: Applicant argues that Rankin does not teach or suggest the claimed stop because Rankin’s inner tube 140 only limits compression of the spring segment and does not limit movement of the proximal portion away from the distal portion.
Examiner’s Response: Applicant’s argument has been considered but does not render the claims patentable. The argument is moot in view of the new rejection set forth above. The present rejection has been modified and no longer relies on Rankin’s inner tube 140 alone as teaching the claimed stop configured to limit movement of the proximal portion away from the distal portion. Instead, Rankin is relied upon as teaching a force-sensing catheter having proximal and distal portions coupled by a spring segment, sensors that detect relative movement between the portions, and a mechanical travel-limiting feature that prevents potentially damaging over-compression of the spring segment. Meredith is further relied upon as teaching a separation-limiting stop in the same catheter force-sensing field. Meredith teaches a tapered lip and corresponding sleeve that limit separation of telescopic portions under normal forces expected to be exerted on the catheter tip and hold the sections in a home-state relationship. Accordingly, the present rejection addresses the claimed stop using the combined teachings of Rankin, Beeckler, and Meredith, rather than the prior reliance on Rankin alone.
Applicant’s Argument: Applicant argues that Rankin does not teach the distal portion and proximal portion being telescopic portions and that the prior Office action misinterpreted the relationship between the distal and proximal portions.
Examiner’s Response: Applicant’s argument has been considered but does not render the claims patentable. Applicant’s remarks have clarified that the claimed telescopic relationship is being argued as an arrangement in which one of the distal and proximal portions is received within the other, including the species of claim 15 in which the distal portion is configured to move within the shaft. The present rejection has been updated to address the claims under that clarified orientation. Rankin is relied upon as teaching or at least suggesting a telescopic relationship because Rankin teaches that distal segment 113 moves relative to proximal segment 111 in response to force, that coaxial force causes compression of the struts along the longitudinal axis, and that catheter shaft 132 forms part of the elongate catheter body surrounding the spring segment and structural force-sensing components. Thus, Rankin teaches or at least suggests that the distal portion moves longitudinally relative to and within the shaft of the proximal portion in response to tissue resistance. To the extent Rankin does not expressly use the term “telescopic”, Beeckler expressly teaches a catheter shaft disposed in a sheath and configured to extend out of and retract relative to the sheath along the longitudinal axis, with sensors positioned to monitor relative displacement. Thus, the present rejection relies on Rankin for the underlying relative longitudinal movement and Beeckler for the express telescoping catheter shaft/sheath arrangement.
Applicant’s Argument: Applicant argues that the claimed spring and stop relationship is not taught by Rankin because Rankin’s pre-bent struts do not form the claimed stop and Rankin’s inner tube only limits over-compression.
Examiner’s Response: Applicant’s argument has been considered but does not render the claims patentable. The present rejection does not rely on Rankin’s pre-bent struts as the claimed separation-limiting stop. Rankin is relied upon as teaching the resilient spring segment, tissue-resistance-driven relative movement, and the recognized desirability of limiting spring travel to prevent damage to the spring structure. Meredith is relied upon for the spring-biased home-state relationship in which a compression spring pushes telescoping portions away from one another against a separation-limiting stop, and in which the distal portion moves toward the proximal portion when tissue-contact force exceeds the spring force. Therefore, the rejection addresses the spring and stop relationship using Meredith in combination with Rankin and Beeckler.
Applicant’s Argument: Applicant argues that Rankin does not teach the distal portion configured to move within the shaft in response to tissue resistance.
Examiner’s Response: Applicant’s argument has been considered but does not render the claims patentable. Applicant’s remarks have clarified that claim 15 is directed to the species in which the distal portion is configured to move within the shaft. The present rejection addresses that clarified species. Rankin teaches catheter shaft 132 as part of the elongate catheter body, extending along the spring segment and proximal segment and surrounding the structural and force-sensing components, including proximal hub 141, distal hub 142, and struts 151 to 153. Rankin further teaches that distal segment 113 moves relative to proximal segment 111 in response to force, and that tissue engagement at distal end 116 produces the force detected by the strain sensors. Accordingly, Rankin teaches or at least suggests movement of the distal portion within the shaft in response to tissue resistance. Beeckler further supports this arrangement by teaching a catheter shaft/sheath structure in which a distal-side shaft structure moves longitudinally relative to and within a surrounding sheath or shaft structure.
Applicant’s Argument: Applicant argues that the prior art does not teach or suggest the claimed stop placement, including the stop being proximal to the spring.
Examiner’s Response: Applicant’s argument has been considered but does not render the claims patentable. Meredith teaches the claimed stop placement. Meredith teaches a separation-limiting stop formed by tapered lip 18a on proximal tip section 18 and corresponding tapered sleeve 16a on distal tip section 16. Meredith further teaches that compression spring 22 is mounted inside distal tip section 16, with a first end at the proximal end of distal tip section 16 contacting the distal end of proximal tip section 18 and a second end contacting an inside end wall of distal tip section 16 opposite its proximal end. Thus, Meredith teaches the stop located at the proximal sliding interface of the telescopic tip assembly, with the spring extending distally into the distal tip section from that proximal interface. The present rejection therefore applies Meredith’s known stop arrangement, including its known placement proximal to the spring, to the modified Rankin/Beeckler telescopic force-sensing catheter.
Applicant’s Argument: Applicant’s remarks distinguish Rankin from the amended claims based on the prior Office action’s mapping of Rankin and Beeckler.
Examiner’s Response: Applicant’s arguments have been considered but are moot to the extent they address the prior rejection. The rejection of claim 1 and its dependent claims has been newly applied and supplemented with Meredith. Meredith is relied upon to teach the separation-limiting stop, the spring-biased home-state relationship against the stop, and the stop placement relative to the spring. The present rejection also clarifies the mapping of Rankin’s catheter shaft 132, proximal segment 111, distal segment 113, distal hub 142, and struts 151 to 153 in view of Applicant’s remarks concerning the orientation of the distal and proximal portions. Accordingly, Applicant’s arguments directed to the prior rejection do not overcome the current rejection based on the newly stated combination of Rankin, Beeckler, and Meredith.
Applicant’s Argument: Applicant presents claim 25 as reciting a stop having a first component extending from an inner surface of the distal portion and a second component extending from an outer surface of the proximal portion.
Examiner’s Response: Claim 25 is withdrawn from consideration under 37 CFR 1.142(b) as being drawn to a non-elected invention by original presentation. Claim 25 is drawn to a species corresponding to a telescoping arrangement in which the proximal portion is received within the distal portion at the stop interface. The claims previously presented and acted upon on the merits are directed to the elected invention, including the species of claim 15 in which the distal portion is configured to move within the shaft. Thus, claim 25 is drawn to a different, mutually exclusive telescoping species requiring materially different consideration of reversed stop structures. Accordingly, claim 25 is withdrawn from consideration as being drawn to a non-elected invention by original presentation.
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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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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