DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/2/2026 has been entered.
Applicant' s arguments, filed 2/2/2026, 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 2/2/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-4, 8-12, 14-20, 23 and 24 are the currently pending claims hereby under examination. Claims 23 and 24 have been newly added. Claims 5-7, 13, and 21-22 have been canceled.
Claim Interpretation
Claim 15 recites, “the body comprises a shaft and wherein the distal portion is configured to move within the shaft in response to the tissue resistance” in lines 1-2. Paragraph [0056] of the Instant Application similarly describes that “the distal portion 130 may be retracted into the shaft 140.” Taken together, these statements suggest that the distal portion telescopes or moves axially into a housing structure formed by the shaft. However, Figure 7 appears to show the shaft as a narrower inner component, and the distal portion as a surrounding element that slides back over the shaft. This may seem inconsistent with a literal interpretation of “into the shaft.” A person of ordinary skill in the art would understand that the term “into” or “within the shaft” may be interpreted functionally, referring to the relative motion of the distal portion into a retracted position defined by or bounded by the shaft — regardless of whether the distal portion fits inside or over the shaft. Thus, the distal portion may retract over the shaft (as depicted in Figure 7) while still being considered “within the shaft” from a functional containment standpoint. Accordingly, this interpretation harmonizes the claim language and the written description with the figures, and under the broadest reasonable interpretation, “within” includes configurations where the distal portion retracts around or over the shaft as long as it moves into a telescoping or shortened profile defined by the shaft structure. As such, the Examiner is interpreting that either configuration satisfies the claim language.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 23 requires that the plurality of sensors of Claim 1 be "located on a tip of the distal portion in order to map tissue pressure on the distal portion of the probe" (lines 1-2). Claim 1, as interpreted consistent with the specification, requires that the plurality of sensors detect tissue resistance inferred from relative movement between telescopic proximal and distal portions. The specification describes embodiments in which resistance is inferred from relative telescopic movement. Additionally, separate embodiments in which pressure sensors are located on a distal portion or tip are described that directly sense tissue pressure. However, the specification does not describe an embodiment in which the same plurality of sensors both (i) detect resistance based on relative telescopic movement/displacement and (ii) are located on the tip to directly map tissue pressure. The application therefore does not reasonably convey to one of ordinary skill in the art that the inventor had possession of the claimed combination of these sensing architectures at the time of filing. Accordingly, Claim 23 lacks adequate written description support.
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.
Claim 1-4, 8-12, 14-20, and 24 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 1 recites "a plurality of sensors supported with the elongate body and coupled to the distal portion of the elongate body to detect a tissue resistance at a plurality of locations on the distal portion related to the advancement of the proximal portion based on relative movement between the telescopic portions, the plurality of sensors configured to map the tissue resistance at the plurality of locations on the distal portion" in lines 7-10. The specification describes embodiments in which tissue resistance is inferred from relative telescopic movement between a distal portion and a proximal portion (e.g., where displacement or bending between telescopic portions is measured and correlated to force at the distal end). Under a broadest reasonable interpretation consistent with the specification, the Examiner interprets the recited "tissue resistance" in Claim 1 as being inferred from relative movement between the telescopic portions. For purposes of examination and further prosecution, the Examiner further interprets the recited "plurality of locations on the distal portion" as referring to a plurality of physical regions of the distal portion itself, such as different circumferential sides or axial regions of the distal portion to which the inferred resistance is spatially associated (for example, in a bending condition, associating the inferred resistance with a side of the distal portion corresponding to the side under compression). However, even under this interpretation, the claim remains indefinite because it does not particularly point out how resistance inferred from relative movement between only two telescopic portions is "at" a plurality of locations on the distal portion or how such resistance is "mapped" to those locations. The claim does not recite any structural or functional relationship that defines how the inferred resistance is spatially resolved with respect to distinct physical regions of the distal portion. In particular, the claim fails to define what constitutes a "location" on the distal portion in structural terms and fails to define what it means to "map" the inferred resistance to those locations. As a result, one of ordinary skill in the art cannot determine with reasonable certainty the scope of the claimed mapping of tissue resistance at a plurality of locations on the distal portion.
Claims 2-4, 8-12, 14-20, 23 and 24 are rejected by virtue of their dependence from claim 1.
Claim 9 recites, “the elongate body comprises a first portion and a second portion configured to move relative to the first portion and the plurality of sensors are configured to detect movement of the distal portion relative to the proximal portion" in lines 1-4. The claim introduces “a first portion” and “a second portion” without making clear whether the “first portion” corresponds to the “distal portion” or the “proximal portion,” and likewise without making clear whether the “second portion” corresponds to the “distal portion” or the “proximal portion". The Examiner interprets, under a broadest reasonable interpretation (BRI), that the “first portion” and “second portion” correspond to the recited “distal portion” and “proximal portion” of Claim 1, consistent with the disclosed telescopic embodiments (e.g., the embodiments illustrated in FIGS. 6A and 7, where a proximal portion and a distal portion move relative to each other and a sensor detects that relative movement). However, Claim 9 does not specify which correspondence applies, and as written can be reasonably read as reciting four different portions of the elongate body (first portion, second portion, distal portion, proximal portion), while only specifying relative movement between the first and second portions and separately specifying sensed movement between the distal and proximal portions. Accordingly, it is unclear with reasonable certainty which components are configured to move relative to each other and which movement is detected by the sensors, and one of ordinary skill in the art cannot determine the metes and bounds of Claim 9.
Claims 10-12 and 14 are rejected by virtue of their dependence from claim 9.
Claim 23 recites, “the plurality of sensors are located on a tip of the distal portion in order to map tissue pressure on the distal portion of the probe" in lines 1-2. Claim 23 depends from Claim 1 and Claim 1 requires that the plurality of sensors detect tissue resistance inferred from relative movement between telescopic portions of the elongate body. Thus, under the Examiner’s interpretation, the plurality of sensors of Claim 1 are sensors that detect relative movement between the proximal and distal portions to infer resistance. Claim 23 requires that the same plurality of sensors be located on a tip of the distal portion and be configured to map tissue pressure on the distal portion. The claim set does not define how sensors located on the tip of the distal portion both (i) detect resistance based on relative movement between telescopic portions and (ii) directly map tissue pressure on the distal tip. Accordingly, the structural and functional relationship between Claim 1 and Claim 23 is unclear, and one of ordinary skill in the art cannot determine with reasonable certainty the scope of the claimed plurality of sensors. Claim 23 is therefore indefinite under 35 U.S.C. § 112(b).
Claim 24 recites, “the plurality of sensors are a plurality of pressure sensors" (lines 1-2). Claim 24 depends from Claim 1, which requires that the plurality of sensors detect tissue resistance “related to the advancement of the proximal portion based on relative movement between the telescopic portions". For purposes of examination, and under the broadest reasonable interpretation consistent with the specification, the Examiner interprets Claim 1 as requiring that tissue resistance be determined from relative movement between the telescopic distal and proximal portions, rather than from direct sensing of pressure at the distal surface. As written, Claim 24 is unclear because it does not define how the recited pressure sensors satisfy the requirement that tissue resistance be detected based on relative movement between the telescopic portions. The Examiner interprets the pressure sensors as being arranged to detect force transmitted between the telescopic portions, such that the pressure sensors determine relative mechanical interaction between the telescopic portions from which tissue resistance is inferred. However, Claim 24 does not specify the structural arrangement or functional relationship by which pressure sensing corresponds to detection of relative movement between the telescopic portions. The claim therefore fails to particularly point out how the pressure sensors perform the relative-movement-based resistance detection required by the independent claim.
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, 23 and 24 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.
Regarding claim 1, Rankin teaches that 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 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", showing that Rankin teaches an elongate body with proximal and distal ends, where advancement of the proximal end with the handle advances the distal end into the patient); and a plurality of 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 “[0075] … 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) to detect a tissue resistance at a plurality of locations on the distal portion related to the advancement of the proximal portion based on relative movement between the telescopic portions (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); the plurality of sensors configured to map the tissue resistance at the plurality of locations on the distal portion (Rankin, [0076]: “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”; Rankin, [0092]: “the magnitude and direction of the force … indicates the magnitude and the direction of a force that acts on the distal segment 113 … [and] typically results from the distal segment 113 pushing against tissue”; Rankin, [0093]: “The direction can be represented as a unit vector in a three dimensional reference frame … In some embodiments, a three dimensional mapping function can be used to track the three dimensional position of the distal end 116 of the catheter 110 in the three dimensional reference frame … For example, a line projecting to, or from, the distal segment 113 can represent the direction of the force relative to the distal segment 113”, showing that Rankin’s circumferentially distributed strain-sensor outputs are processed to determine direction and magnitude of tissue-contact force acting on the distal segment and are further configured for representation relative to the distal end, including use of a three dimensional mapping function and a displayed directional representation relative to the distal segment, which corresponds to mapping tissue resistance information with respect to the plurality of circumferential locations on the distal portion; Additionally, Rankin’s determination and display of force direction relative to the distal segment, based on which circumferentially located struts compress or elongate and by how much, constitutes mapping the tissue resistance with respect to the plurality of circumferential locations on the distal portion, not merely reporting a force magnitude without spatial reference) and the probe comprises an output operatively coupled to the plurality of sensors 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 partially teaches that the distal portion and the proximal portion are telescopic portions. Specifically, Rankin teaches a probe for insertion into a patient as shown above and further teaches that the probe includes sensors supported with the elongated body that detect resistance based on relative movement (Rankin, [0076]: "sensors 161-163 sense strain when the distal segment 113 moves relative to the proximal segment 111 in response to a force generated by contact between the catheter and tissue"). Rankin also teaches that the distal portion can move relative to the proximal portion and that sensors measure strain in struts under applied force, including axial compression (Rankin, [0076], [0088], [0089]: "If the force exerted... is coaxial with the longitudinal axis 109, then each of the struts 151-153 will compress in equal amounts"). Figure 4 of Rankin further illustrates that the distal end effectively slides over the inner tube 140 fixed relative to the proximal end, providing a telescoping-like effect even though the mechanism is implemented by strut deformation (Rankin, FIG. 4). This establishes relative axial motion, approximating telescoping, and supports that extending the proximal hub into a sheath would make this telescoping effect more definitive. However, Rankin does not explicitly teach telescoping portions.
Beeckler teaches a catheter system with a shaft disposed in a sheath, the shaft extending and retracting telescopically relative to the sheath, with sensors positioned on the shaft and sheath to monitor relative displacement (Beeckler, FIG. 2, [0016]: "The sheath extends a long a longitudinal axis. The shaft is disposed in the sheath and configured to extend out of the sheath along the longitudinal axis, with the shaft including an expandable member connected to a distal portion of the shaft. The first location sensor is coupled to the shaft... The second location sensor is coupled to a distal portion of the sheath... so that a location or direction of movement of the shaft with respect to the sheath can be obtained...").
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 the proximal and distal probe portions as telescopic members. The modification would have been possible because Rankin already discloses proximal and distal segments that move relative to one another and measure resistance through strain, and Figure 4 illustrates a telescoping-like effect. Beeckler provides a telescoping shaft arrangement with sensors for monitoring relative displacement. It would have been obvious to combine these teachings because both address relative movement and sensing in catheter systems, and Beeckler supplies a predictable telescoping mechanism. The benefit of the combination would be to provide a structurally stable telescoping probe architecture, which improves control during insertion while simultaneously enabling precise detection of tissue resistance and delivering immediate feedback to the user. This yields safer and more reliable clinical performance, reducing the risk of excessive force or tissue damage.
Regarding claim 2, the modified Rankin teaches that the plurality of 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 plurality of 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 plurality of 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 plurality of 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 elongate body comprises a first portion and a second portion configured to move relative to the first portion (Rankin, [0059]: “When the distal segment 113 engages tissue 117 … the distal segment 113 moves relative to the proximal segment 111 … while the spring segment 112 bends”, showing relative movement between a distal portion/segment and a proximal portion/segment of the elongate body; 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”, further showing that the distal and proximal portions are configured to move relative to each other during use); and the plurality of 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 first portion is coupled to the second portion with a spring and wherein the second portion is configured to move relative to the first 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 teaches that the spring is configured to push the first portion away from the second portion against a stop and wherein the first portion moves toward the second portion in 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 (Rankin, Fig. 3; ¶[0057]: “the struts … flex at the preformed bends when the distal segment moves … in response to the force, and resiliently return … once the force has been removed”; ¶[0086]: “the inner tube 140 can limit the degree of compression of the struts 151-153 to prevent over-compression of the spring segment 112”, showing that the inner tube constrains motion to keep the distal and proximal portions coupled and ensures the distal portion advances with the proximal portion; ¶[0088]: “FIG. 9A shows the strut 151 in an unstrained state… FIG. 9B shows the strut 151 in a stretched state… FIG. 9C shows the strut 151 in a compressed state… the strut 151 will resiliently return to the pre-biased state shown in FIG. 9A once the force is removed”, showing that the modified Rankin discloses a proximal segment 111 and distal segment 113 coupled by a spring segment of pre-bent struts that extend outward to bias the two portions apart. When the struts return to their fully extended pre-bent geometry, they create an effective stop that functions as a mechanical limit, preventing over-extension and keeping the two portions together under spring force. When tissue resistance exceeds the spring force, the distal segment is displaced toward the proximal segment, compressing the spring and limiting forward extension even as the proximal portion continues to advance. Additionally, the modified Rankin notes that over-compression is constrained by contact with the inner tube (¶[0086]), reinforcing controlled segmental motion).
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, with respect to the elongated body comprises a shaft and wherein the distal portion is configured to move within the shaft in response to the tissue resistance, the modified Rankin teaches an elongate body with proximal segment and distal segment that telescope relative to each other as shown above in claim 1 and claim 8. However, the modified Rankin only discloses that the distal portion is constrained by an inner tube and does not expressly disclose that the distal portion is configured to move within a shaft. Beeckler teaches a catheter in which a distal assembly is disposed to move within a surrounding sheath, explicitly providing the shaft-within relationship (Beeckler, ¶[0016]). In this context, Beeckler’s sheath operates in the same manner as a claimed shaft by housing and guiding the motion of an inner member. 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 Beeckler to configure the distal portion of Rankin’s catheter to move within a shaft in response to tissue resistance. Such a modification is feasible because the modified Rankin already discloses axial constraint by the inner tube, and Beeckler shows the established design practice of providing a telescoping sheath/shaft arrangement to house and guide distal movement. Combining these teachings would have been an obvious design choice to ensure controlled and reliable telescoping motion of the distal portion within a defined shaft-like structure. The benefit of the combination would be to provide a mechanically guided shaft-sheath structure that prevents misalignment, ensures controlled movement under tissue resistance, protects the inner workings, and maintains accurate sensor feedback during operation.
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 plurality of 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 plurality of 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 plurality of 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 plurality of sensors are 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 24, the modified Rankin does not explicitly teach that the plurality of sensors are a plurality of pressure sensors. Rather, the modified Rankin teaches detecting tissue-contact loading by sensing deformation/strain in struts to determine the magnitude and direction of force experienced by the distal end during tissue engagement (Rankin, [0076], [0092]). It does not explicitly describe the plurality of sensors as “pressure sensors.”
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Rankin such that the sensors comprise pressure sensors, because pressure sensors and strain sensors are well-known, interchangeable transducers for detecting tissue-contact loading and producing signals indicative of applied force/pressure, and substituting one known force/pressure sensing transducer for another yields predictable results while maintaining the same overall function of providing signals representative of tissue-contact resistance. Such a modification would have been feasible by replacing or supplementing the strain gauges on the struts with pressure sensing elements located on a force-bearing structure in the distal end such that applied tissue-contact loading generates corresponding sensor output. The benefit of the modification would be to provide an alternative sensing implementation for detecting tissue-contact loading, which can improve packaging flexibility and robustness of the sensing system while still providing the user feedback regarding tissue resistance encountered during advancement (Rankin, [0076], [0092]).
The Relation between the prior art and claim 23
Claim 23 is not rejected over the prior art. Because Claim 23 depends from Claim 1, Claim 23 incorporates the requirement that the plurality of sensors detect tissue resistance related to advancement “based on relative movement between the telescopic portions.” Claim 23 further recites that “the plurality of sensors are located on a tip of the distal portion in order to map tissue pressure,” which appears to require a different sensing architecture. The specification describes these sensing approaches as distinct, and the claim language does not provide a basis to reconcile them in a single, reasonable construction consistent with the specification. Therefore, the Examiner cannot determine the scope of Claim 23 with reasonable certainty so as to apply the prior art to this claim. As a result, a meaningful analysis of obviousness under 35 U.S.C. § 103 cannot be performed until the sensor architecture and its relationship to Claim 1 is clarified.
Response to Arguments
Election by Original Presentation
Applicant's arguments filed 2/2/2026, pages 5-6, regarding the previous Election by Original Presentation have been fully considered . In view of the claim amendments filed on 2/2/2026, the claims have been considered.
Objections
Applicant's arguments filed 2/2/2026, page 6, regarding the previous Objections of claim 19 have been fully considered and are persuasive. The previous Objections have been withdrawn.
Claim Interpretation
Applicant's arguments filed 2/2/2026, page 6, regarding the previous Claim Interpretation of claim 15 have been fully considered but are not persuasive. Applicants statement that they do not acquiesce in the examiner's interpretation of claim 15 is acknowledged. However, since no substantive argument or evidence has been provided to rebut the examiner's construction, the interpretation set forth in the office action is maintained.
35 U.S.C. §103
Applicant's arguments filed 2/2/2026, pages 6-10, regarding the previous 103 Rejections of claims 1-12 and 14-20 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:
Argument: Applicant asserts that Rankin’s sensors are not “coupled to the distal portion", because Rankin places the sensors at the spring segment between the distal segment and the proximal segment.
Examiner response: The argument is not persuasive. Rankin discloses that, when the distal segment 113 engages tissue, the distal segment moves relative to the proximal segment 111 as the spring segment 112 bends (Rankin, [0059]). Rankin further discloses that distal ends of the struts 151–153 (comprising the spring segment) are attached to attachment portion 147, which is part of the distal end structure configured to bend under applied force (Rankin, [0075]). The plurality of strain sensors 161–163 are located on the struts 151–153 and detect compression and elongation of those struts when the distal segment moves relative to the proximal segment (Rankin, [0076]). Under the broadest reasonable interpretation, the recited “distal portion of the elongate body” encompasses the distal-end structure that bends and transmits tissue-contact force, and is not limited solely to the distal segment 113 in isolation. Because the struts are mechanically attached to the distal end through attachment portion 147 and deform in response to forces encountered at the distal segment, the sensors located on those struts are mechanically coupled to the distal portion within the meaning of the claim. The claim does not require that the sensors be mounted directly on the distal segment itself. Rankin’s disclosed structure therefore satisfies the recited coupling, as tissue resistance encountered at the distal end is transmitted into the struts and detected by the plurality of sensors (Rankin, [0059], [0075], [0076]).
Argument: Applicant asserts that Rankin does not disclose mapping tissue resistance at a plurality of locations on the distal segment, because Rankin describes determining a magnitude and a direction of force on the distal segment generally.
Examiner response: The argument is not persuasive. Rankin discloses that the distal segment 113 moves relative to the proximal segment 111 when engaging tissue, and that deformation occurs in a plurality of circumferentially arranged struts 151–153 when the distal segment moves relative to the proximal segment (Rankin, [0059], [0076]). Rankin expressly teaches that “the plurality of struts 151–153 are circumferentially arrayed around the longitudinal axis” and that different struts are compressed or stretched depending on the direction of the force applied to the distal segment (Rankin, [0076]). Rankin further teaches that a corresponding plurality of strain sensors 161–163 are located on the struts to sense compression or elongation of individual struts in order to determine the magnitude and direction of the force (Rankin, [0076]). Because the strain sensors are distributed circumferentially about the distal-end structure, each sensor corresponds to a different circumferential location on the distal portion. The determined force “direction” is derived from the pattern of responses across these circumferentially distributed sensors, which indicates where around the distal-end structure the tissue resistance is acting. Thus, the sensing architecture provides spatially differentiated resistance information corresponding to multiple circumferential locations on the distal portion, not merely an undifferentiated scalar value. Rankin further discloses that the direction of force may be represented relative to the distal segment and displayed, including representation of a line projecting to or from the distal segment to indicate force direction, and that a three dimensional mapping function may be used to track the distal end in a reference frame (Rankin, [0093]). These teachings correspond to mapping resistance information with respect to circumferential location and direction at the distal portion during tissue engagement, rather than merely reporting a force magnitude without spatial reference.
Argument: Applicant asserts Beeckler does not remedy the alleged deficiencies of Rankin.
Examiner response: The argument is not persuasive. Beeckler is relied upon for the teachings identified in the Office Action and is combined with Rankin for the reasons set forth in the rejection. To the extent Applicant’s argument depends on an alleged absence of the amended limitations in Rankin, the rejection, as maintained and clarified herein, establishes that Rankin teaches the sensing architecture and output consistent with the amended limitations, and Beeckler provides additional teachings as applied in the rejection.
Argument: Applicant requests withdrawal of the rejections of all dependent claims and asserts the dependent claims are patentable on their own merits.
Examiner response: The argument is not persuasive. Applicant has not specifically traversed the dependent claim rejections with arguments responsive to the specific findings. Conclusory statements that the dependent claims are patentable on their own merits are not sufficient to overcome the prima facie case.
Argument: Applicant asserts that new Claims 21 and 22 are allowable.
Examiner response: Claims 21 and 22 have been canceled. Accordingly, any arguments directed to Claims 21 and 22 are moot.
To the extent Applicant intended these arguments to apply to newly added Claims 23 and 24, the argument is not persuasive. Claims 23 and 24 depend from Claim 1. Claim 1 remains rejected under 35 U.S.C. §§ 103. As dependent claims, Claims 23 and 24 incorporate all limitations of Claim 1 and therefore stand or fall with Claim 1 unless separately argued. Because Claim 1 is not allowable for the reasons set forth above, Claims 23 and 24 are likewise not allowable at this time, even before considering their additional limitations on their own merits.
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791