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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 3rd, 2025 has been entered. Claims 35 and 37-55 remain pending in the application. Claims 49-55 remain withdrawn from consideration.
Response to Arguments
Applicant’s arguments, filed September 3rd, 2025, with respect to the rejections under 35 U.S.C. 103 have been 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.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“safety structure limiting a maximum movement of the housing tip” in claim 44;
“guiding structure is configured to prevent rotational movements of the housing tip” in claims 45; and
“guiding structure is configured to limit lateral shifting of the housing tip” in claim 46.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The safety structure is defined as projections and recesses in paragraphs [0036-0039, 0081, 0091] of the instant application publication (US 20210267709 A1).
The guiding structure is defined as projections and recesses in paragraphs [0037-0039, 0081, 0091] of the instant application publication (US 20210267709 A1)
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 35, 41, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti (US 20200008747 A1) in view of Heimbecher (US 20140364848 A1), and further in view of Akata (WO 2015194597 A1).
Regarding claim 35, Lupotti discloses a force sensing device (“medical device … sensing contact force”, Abstract) comprising: a housing tip that is dome shaped (72, fig. 5A); a plurality of sensors stationarily spaced from each other (761-3, figs. 5A & 5D, “equal … spacing”, para. [0053, 0063]); a spring element (75, fig. 5A & 5C, “compressible/stretchable”, para. [0049]) connecting the housing tip to the plurality of sensors (para. [0047, 0049], as seen in figs. 5A &5E-F) such that moving the housing tip and the plurality of sensors relative to each other causes a resilient deformation of the spring element (as seen in figs. 5E-F, “change in thickness”, para. [0049, 0054, 0056]); a plurality of sensor actuators (“74 … multiple transmitter plates (e.g., 741-3, similar to the configuration shown in FIG. 5D)”, para. [0051]) being stationarily mounted to the housing tip (as seen in figs. 5A & 5E-F, para. [0047, 0049]); wherein the spring element is configured to arrange the housing tip in a zero position relative to the plurality of sensors by a spring force of the spring element (unlabeled, but as seen in fig. 5A, (Examiner note: the position when no force is applied)), wherein each sensor actuator of the plurality of sensor actuators is associated with a respective force sensor of the three force sensors (“multiple transmitter plates … better a resolution of directionality”, para. [0051, 0053-0054], figs. 5D & E (Examiner note: transmitter plates 741-3 would correspond to sensors 761-3, respectively)), and wherein the plurality of sensor actuators are coupled to the housing tip (as seen in figs. 5A-F, para. [0047, 0049]) such that moving the housing tip out of the zero position relative to the plurality of force sensors (as seen in figs. 5E-F, “lateral force 71 … change in distance”, para. [0054-0056]), causes at least one sensor actuator of the plurality of sensor actuators to act on its respective force sensor (transmitter plate 74 of the tip 72 to move closer to one of the sensors 76.sub.1 and further away from another sensor 76.sub.”, para. [0051, 0054]). Lupotti further discloses the plurality of sensors 761-3 are capacitive/resistive sensing elements to detect contact force (para. [0048, 0054, 0061]).
Lupotti does not disclose wherein the plurality of sensors comprises three force sensors.
However, Heimbecher directed to a catheter having a plurality of sensors stationarily spaced from each other (“three force sensors ... spaced evenly apart”, para. [0012-0013, 0015]), discloses wherein the plurality of sensors comprises three force sensors (“three force sensors disposed in a common lateral plane and spaced evenly apart”; “trio of force sensors to resolve direction and magnitude of contact forces”, para. [0012-0013, 0015]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti such that the plurality of sensors comprises three force sensors, in view of the teachings of Heimbecher, as such a modification would have been merely a substitution of the sensors 761-3 of Lupotti for the three force sensors spaced evenly apart of Heimbecher to resolve the direction and magnitude of contact forces along the longitudinal axis and laterally.
Lupotti, as modified by Heimbecher hereinabove, does not disclose a spring tensioning structure; wherein the spring tensioning structure is configured to adapt the spring force of the spring element.
However, Akata directed to a pressure-sensitive sensor and a pressure-sensitive catheter having a pressure-sensitive rubber 86, a spring 83, a screw 87 as a pressure adjusting member, and a female screw 84 a of a holding body 84 (fig. 14) discloses the spring element (spring 83, fig. 14), a spring tensioning structure (“screw 87 … pressure adjusting member … and female thread 84a”, lines 554-566, fig. 14); wherein the spring tensioning structure is configured to adapt the spring force of the spring element (“changing screw position … pressure applied … changed”, lines 554-566). Akata further discloses accurate pressure detection is difficult in a range smaller than the load Fa, but accurate pressure detection is possible in a range equal to or greater than the load Fa, and by adjusting the position of the screw the pressure is initially set to a value that is equal to or greater than the load Fa (lines 567-575).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher hereinabove, such that the force sensing device comprises a spring tensioning structure; wherein the spring tensioning structure is configured to adapt the spring force of the spring element, in view of the teachings of Akata, for the obvious advantage of increasing the sensitivity of the system for accurate pressure/force detection by adjusting the setting of an initial pressure on the sensors.
Regarding claim 41, Lupotti, as modified by Heimbecher and Akata hereinabove, discloses the force sensing device of claim 35. Lupotti, as modified by Heimbecher and Akata hereinabove, does not disclose wherein the spring tensioning structure comprises a screw member and a screw socket such that by screwing the screw member into or out of the screw socket the spring force of the spring element is adapted.
However, Akata discloses wherein the spring tensioning structure (lines 554-556, pressure adjusting member) comprises a screw member (lines 554-556, screw 87) and a screw socket (lines 554-556, female thread 84a) such that by screwing the screw member into or out of the screw socket the spring force of the spring element is adapted (lines 554-566, “changing screwing position … pressure applied … changed”). Akata further discloses accurate pressure detection is difficult in a range smaller than the load Fa, but accurate pressure detection is possible in a range equal to or greater than the load Fa, and by adjusting the position of the screw the pressure is initially set to a value that is equal to or greater than the load Fa (lines 567-575).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher and Akata hereinabove, such that the spring tensioning structure comprises a screw member and a screw socket such that by screwing the screw member into or out of the screw socket the spring force of the spring element is adapted, in view of the teachings of Akata, for the obvious advantage of increasing the sensitivity of the system for accurate pressure/force detection by adjusting the setting of an initial pressure on the sensors.
Regarding claim 48, Lupotti, as modified by Heimbecher and Akata hereinabove, discloses the force sensing device of claim 35, wherein the force sensing device includes a distal end (“distal end portion 24”, para. [0025]) and a proximal end proximal end portion 23”, para. [0025]). Lupotti, as modified by Heimbecher and Akata hereinabove, does not disclose wherein the plurality of sensors are configured to sense along an axis extending between the distal and proximal ends of the force sensing device.
However, Heimbecher directed to a catheter 132 having a deformable, elongate shaft having proximal and distal ends and including one or more sensors 134 disposed about the axis 140 (para. [0009, 0088]), discloses wherein the plurality of sensors are configured to sense along an axis extending between the distal and proximal ends of the force sensing device (“force detection in a plurality of dimensions … longitudinal axis (stretching and compression)”, para. [0088], fig. 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher and Akata hereinabove, such that the plurality of sensors are configured to sense along an axis extending between the distal and proximal ends of the force sensing device, in view of the teachings of Heimbecher, as such a modification would have yielded predictable results, namely detecting force along the longitudinal axis (stretching and compression).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Lupotti in view of Heimbecher and Akata, as applied to claim 35 above, and further in view of Wallace (US 20070197939 A1).
Regarding claim 37, Lupotti, as modified by Heimbecher and Akata hereinabove, discloses the force sensing device of claim 35. Lupotti, as modified by Heimbecher and Akata hereinabove, does not disclose the plurality of sensors are unidirectional sensors.
However, Wallace discloses a working catheter with a plurality of sensors that are unidirectional sensors (para. [0113, 0133], force sensors 204 themselves may be uni-directional compression force sensors; force sensors 204 may include unidirectional force sensors). Wallace further discloses that the force sensors 204 are used to measure or observe forces (para. [0114]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher and Akata hereinabove, such that the plurality of sensors are unidirectional sensors, in view of the teachings of Wallace, as such a modification would have been merely a substitution of the sensors of Lupotti for the unidirectional compression force sensors of Wallace to measure or observe forces (Wallace, para. [0114]).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Lupotti in view of Heimbecher and Akata, as applied to claim 35 above, and further in view of Heo (US 20170241827 A1).
Regarding claim 38, Lupotti, as modified by Heimbecher and Akata hereinabove, discloses
the force sensing device of claim 35. Lupotti, as modified by Heimbecher and Akata hereinabove, does not disclose wherein: each of the plurality of sensor actuators is adjustable in its extension towards its respective force sensor.
However, Heo directed to a force sensor and an apparatus comprising the sensor and an adjusting member 120 (sensor actuator) coupled to an upper surface of an elastic structure 110 discloses a sensor actuator (adjusting member 120, figs. 1-2, para. [0051, 0054), wherein the sensor actuator is adjustable in its extension towards its respective force sensor (“initial height … distance value between the sensor … is adjusted”; “an initial value for operating the particular sensor … set by adjusting … 120”, para. [0041-0042, 0051-0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher and Akata hereinabove, such that each of the plurality of sensor actuators is adjustable in its extension towards its respective force sensor, in view of the teachings of Heo, for the obvious advantage of setting an initial value for operating each particular force sensor by adjusting the initial height of each transmitter plate by a screw-type engagement.
Claim 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti in view of Heimbecher and Akata, as applied to claim 35 above, and further in view of Rankin (US 20170035357 A1).
Regarding claim 39, Lupotti, as modified by Heimbecher and Akata hereinabove, discloses
the force sensing device of claim 35. Lupotti further discloses that the sensors 761-3 can be attached to the top of the housing 78 to form an integrated sensor (para. [0049]). Lupotti, as modified by Heimbecher and Akata hereinabove, does not disclose the force sensing device further comprising a sensor support plate on which the plurality of sensors are mounted, wherein the sensor support plate preferably is a printed circuit board.
However, Rankin directed to a force measurement assembly 108 comprising a plurality of sensors 140 discloses a sensor support plate (sensor support 134, fig. 6) on which the plurality of sensors are mounted (“mounted”, para. [0087], fig. 6), wherein the sensor support plate preferably is a printed circuit board (“printed circuit board”, para. [0086-0087]). Rankin further discloses adjacent layers of the force measurement assembly (para. [0089]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher and Akata hereinabove, such that the force sensing device further comprising a sensor support plate on which the plurality of sensors are mounted, wherein the sensor support plate preferably is a printed circuit board, in view of the teachings of Rankin, as such a modification would have yielded predictable results namely, attaching the plurality of sensors to the top of the housing by mounting the sensors in a sensor support layer.
Regarding claim 40, Lupotti, as modified by Heimbecher, Akata, and Rankin hereinabove, discloses the force sensing device of claim 39. Lupotti further discloses the plurality of contact force sensing elements can be mounted on, for example, an elongated medical device 82 including a tubular shaft 90 and a lumen 92. Lupotti, as modified by Heimbecher, Akata, and Rankin hereinabove, does not disclose wherein the sensor support plate is ring-shaped and the plurality of sensors are regularly distributed about a central hole of the ring-shaped sensor support plate.
However, Rankin directed to a force measurement assembly 108 comprising a plurality of sensors 140 discloses wherein the sensor support plate (134, fig. 6) is ring-shaped (“ring … tubular”, para. [0084], as seen in fig. 6) and the plurality of sensors are regularly distributed about a central hole of the ring-shaped sensor support plate (“sensors … circumferentially arrayed about the lumen 137 … 120°”, para. [0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher, Akata, and Rankin hereinabove, such that the sensor support plate is ring-shaped and the plurality of sensors are regularly distributed about a central hole of the ring-shaped sensor support plate, in view of the teachings of Rankin, as such a modification would have yielded predictable results namely, attaching to the elongated medical device having a lumen the plurality of sensors by mounting the sensors in a circumferential array surrounding the lumen on a sensor support layer.
Claims 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti in view of Heimbecher and Akata, as applied to claim 35 above, and further in view of Ruppersberg (US 20180161119 A1).
Regarding claim 42, Lupotti, as modified by Heimbecher and Akata hereinabove, discloses the spring element being connected to the plurality of sensors at one of its longitudinal ends (para. [0047, 0049], as seen in figs. 5A-F) and connected to the housing tip at the other one of its longitudinal ends (para. [0047, 0049], as seen in figs. 5A-F). Lupotti, as modified by Heimbecher and Akata hereinabove, does not disclose wherein the spring element comprises a helical spring.
However, Ruppersberg directed to a force sensing assembly for an elongated medical device having an elastic element 51 discloses wherein the spring element comprises a helical spring (fig. 14, para. [0025-0026, 0083], “elastic element 51 … helical spring”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher and Akata hereinabove, such that the spring element comprises a helical spring, in view of the teachings of Ruppersberg, as such a modification would have been merely a substitution of the compressible capacitive/resistive material of Lupotti for the helical spring of Ruppersburg in order to moveably connect the sensors and the housing tip.
Regarding claim 43, Lupotti, as modified by Heimbecher, Akata, and Ruppersburg hereinabove, discloses the force sensing device of claim 42. Lupotti, as modified by Heimbecher, Akata, and Ruppersburg hereinabove, does not disclose wherein the spring tensioning structure comprises a screw member and a screw socket such that by screwing the screw member into or out of the screw socket the spring force of the spring element is adapted and wherein the screw member extends along the helical spring.
However, Akata directed to directed to a pressure-sensitive sensor and a pressure-sensitive catheter having a pressure-sensitive rubber 86, a spring 83, a screw 87 as a pressure adjusting member, and a female screw 84 a of a holding body 84 (fig. 14) discloses wherein the spring tensioning structure (lines 554-556, pressure adjusting member) comprises a screw member (lines 554-556, screw 87) and a screw socket (lines 554-556, female thread 84a) such that by screwing the screw member into or out of the screw socket the spring force of the spring element is adapted (lines 557-566, “changing screwing position … pressure applied … changed”) and wherein the screw member (fig. 14, 87) extends along the spring (fig. 14, 83) (as seen in figs. 13-14). Akata further discloses accurate pressure detection is difficult in a range smaller than the load Fa, but accurate pressure detection is possible in a range equal to or greater than the load Fa, and by adjusting the position of the screw the pressure is initially set to a value that is equal to or greater than the load Fa (lines 567-575).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher and Akata hereinabove, such that the spring tensioning structure comprises a screw member and a screw socket such that by screwing the screw member into or out of the screw socket the spring force of the spring element is adapted and the screw member extends along the helical spring, in view of the teachings of Akata, for the obvious advantage of increasing the sensitivity of the system for accurate pressure/force detection by adjusting the setting of an initial pressure on the sensors.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Lupotti in view of Heimbecher and Akata, as applied to claim 35 above, and further in view of Romoscanu (US 20200093396 A1).
Regarding claim 44, Lupotti, as modified by Heimbecher and Akata hereinabove, discloses the force sensing device of claim 35, and movement of the housing tip and the plurality of sensors relative to each other (as seen in figs. 5E-F).
Lupotti, as modified by Heimbecher and Akata hereinabove, does not disclose a safety structure limiting a maximum movement of the housing tip and the plurality of sensors relative to each other.
However, Romoscanu discloses a catheter with a safety structure limiting a maximum movement of the housing tip (para. [0052, 0082], “deformation limiters prevent the deformable body from deforming to a yielding point …”; “axial and trans-axial deformation limiters”; “limit the deformation of flat spring 626”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher and Akata hereinabove, such that the force sensing device further comprises a safety structure limiting a maximum movement of the housing tip and the plurality of sensors relative to each other, in view of the teachings of Romoscanu for the obvious advantage of preventing the deformable body from deforming to a yielding point where the calibration between the deformation and the associated force exerted on a catheter tip may no longer be accurate (Romoscanu, para. [0052, 0086]).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Lupotti in view of Heimbecher and Akata, as applied to claim 35 above, further in view of Kostrzewski (US 11103316 B2), and further in view of Barrish (US 20180263688 A1).
Regarding claim 45, Lupotti, as modified by Heimbecher and Akata hereinabove, discloses the force sensing device of claim 35. Lupotti, as modified by Heimbecher and Akata hereinabove, does not disclose a guiding structure predefining possible movements of the housing tip and the plurality of sensors relative to each other, wherein the guiding structure is configured to prevent rotational movements of the housing tip and the plurality of sensors about a longitudinal axis of the force sensing device relative to each other.
However, Kostrzewski discloses a surgical instrument 816 (fig. 8) comprising a guiding structure (fig. 8, col. 15 lines 1-2, longitudinal notch 806 which is interfaced with peg 808), wherein the guiding structure is configured to prevent rotational movements of the housing tip and the plurality of sensors about a longitudinal axis of the force sensing device relative to each other (claim 13, longitudinal notch along its length, wherein the longitudinal notch is sized to fit the peg on the tool support of the surgical instrument, the peg adapted and sized to permit the tool support to slide along the longitudinal axis defined by the tubular structure, and prevent rotational movement relative to the tubular structure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher and Akata hereinabove, such that the force sensing device further comprises a guiding structure, wherein the guiding structure is configured to prevent rotational movements of the housing tip and the plurality of sensors about a longitudinal axis of the force sensing device relative to each other, in view of the teachings of Kostrzewski, in order to prevent rotational movement relative to the tubular structure (Kostrzewski, claim 13).
Lupotti, as modified by Heimbecher, Akata, and Kostrzewski hereinabove, does not disclose the guiding structure predefining possible movements of the housing tip and the plurality of sensors relative to each other.
However, Barrish discloses an articulation system 10 for a catheter 12 predefining possible movements of the housing tip and the plurality of sensors relative to each other (para. [0067], embodiments of articulation system 10 may allow, for example, distal end 24 to be moved with 5 degrees of freedom … resulting catheter tip and/or tool position and orientation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher, Akata, and Kostrzewski hereinabove, such that the force sensing device further comprises predefining possible movements of the housing tip and the plurality of sensors relative to each other, in view of the teachings of Barrish, to enable movement of the distal end in 5 degrees of freedom for positioning and orienting the catheter tip (Barrish, para. [0067]).
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Lupotti in view of Heimbecher, Akata, Kostrzewski, and Barrish hereinabove, as applied to claim 45 above and further in view of Romoscanu.
Regarding claim 46, Lupotti, as modified by Heimbecher, Akata, Kostrzewski, and Barrish hereinabove, discloses the force sensing device of claim 45, and limiting movements of the housing tip and the plurality of sensors relative to each other to five degrees of freedom (Barrish, para. [0067], see claim 45 above). Lupotti, as modified by Heimbecher, Akata, Kostrzewski, and Barrish hereinabove, does not disclose wherein the guiding structure is configured to limit lateral shifting of the housing tip and the plurality of sensors relative to each other.
However, Kostrzewski discloses a surgical instrument 816 (fig. 8) comprising a guiding structure (fig. 8, col. 15 lines 1-2, longitudinal notch 806 which is interfaced with peg 808).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher, Akata, Kostrzewski, and Barrish hereinabove, to further comprise the guiding structure, in view of the teachings of Kostrzewski, in order to prevent rotational movement relative to the tubular structure.
Lupotti, as modified by Heimbecher, Akata, Kostrzewski, and Barrish hereinabove, does not disclose wherein the guiding structure is configured to limit lateral shifting of the housing tip and the plurality of sensors relative to each other, and/or to limit the movements of the housing tip and the plurality of sensors relative to each other to five degrees of freedom.
However, Romoscanu discloses wherein the structure (para. [0084], trans-axial deformation limiter 728 and axial deformation limiting feature 729) is configured to limit lateral shifting of the housing tip and the plurality of sensors relative to each other, and/or to limit the movements of the housing tip and the plurality of sensors relative to each other (para. [0084], to limit the deformation of the leaf springs 726 and the relative spatial movement of distal and proximal portions (730 and 727, respectively,) of deformable body 725, the deformable body may further include deformation limiters).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher, Akata, Kostrzewski, and Barrish hereinabove, such that the guiding structure is configured to limit lateral shifting of the housing tip and the plurality of sensors relative to each other, in view of the teachings of Romoscanu, to prevent the deformable body from deforming to a yielding point where the calibration between the deformation and the associated force exerted on a catheter tip may no longer be accurate (Romoscanu, para. [0052, 0086]).
Lupotti, as modified by Heimbecher, Akata, Kostrzewski, Barrish, and Romoscanu hereinabove, would further disclose wherein the guiding structure is configured to limit the movements of the housing tip and the plurality of sensors relative to each other to five degrees of freedom (Barrish, para. [0067], embodiments of articulation system 10 may allow, for example, distal end 24 to be moved with 5 degrees of freedom … resulting catheter tip and/or tool position and orientation).
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Lupotti in view of Heimbecher, Akata, and Romoscanu, as applied to claim 44 above, and further in view of Kostrzewski, and further in view of Barrish.
Regarding claim 47, Lupotti, as modified by Heimbecher, Akata, and Romoscanu hereinabove, discloses the force sensing device of claim 44. Lupotti, as modified by Heimbecher, Akata, and Romoscanu hereinabove, does not disclose a guiding structure predefining possible movements of the housing tip and the plurality of sensors relative to each other, wherein the guiding structure is configured to prevent rotational movements of the housing tip and the plurality of sensors about a longitudinal axis of the force sensing device relative to each other, and wherein the safety structure and the guiding structure are embodied by at least one projection stationary to one of the housing tip or the plurality of sensors and at least one corresponding recess stationary to the other one of the housing tip and the plurality of sensors, the at last one recess receiving the at least one projection.
However, Kostrzewski discloses a surgical instrument 816 (fig. 8) comprising a guiding structure (fig. 8, col. 15 lines 1-2, longitudinal notch 806 which is interfaced with peg 808), wherein the guiding structure is configured to prevent rotational movements of the housing tip and the plurality of sensors about a longitudinal axis of the force sensing device relative to each other (claim 13, longitudinal notch along its length, wherein the longitudinal notch is sized to fit the peg on the tool support of the surgical instrument, the peg adapted and sized to permit the tool support to slide along the longitudinal axis defined by the tubular structure, and prevent rotational movement relative to the tubular structure), and wherein the safety structure and the guiding structure are embodied by at least one projection stationary to one of the housing tip or the plurality of sensors (figs. 7A-8, col. 15 line 2, force sensor 604; peg 808) and at least one corresponding recess stationary to the other one of the housing tip and the plurality of sensors, the at last one recess receiving the at least one projection (figs. 7A-8, col. 15 lines 1-2, force sensor 604; tool holder 802 has a longitudinal notch 806 which is interfaced with peg 808).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher, Akata, and Romoscanu hereinabove, such that the force sensing device further comprises a guiding structure, wherein the guiding structure is configured to prevent rotational movements of the housing tip and the plurality of sensors about a longitudinal axis of the force sensing device relative to each other, and wherein the safety structure and the guiding structure are embodied by at least one projection stationary to one of the housing tip or the plurality of sensors and at least one corresponding recess stationary to the other one of the housing tip and the plurality of sensors, the at last one recess receiving the at least one projection, in view of the teachings of Kostrzewski, in order to prevent rotational movement relative to the tubular structure (Kostrzewski, claim 13).
Lupotti, as modified by Heimbecher, Akata, Romoscanu, and Kostrzewski hereinabove, does not disclose the guiding structure predefining possible movements of the housing tip and the plurality of sensors relative to each other.
However, Barrish discloses an articulation system 10 for a catheter 12 predefining possible movements of the housing tip and the plurality of sensors relative to each other (para. [0067], embodiments of articulation system 10 may allow, for example, distal end 24 to be moved with 5 degrees of freedom … resulting catheter tip and/or tool position and orientation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lupotti, as modified by Heimbecher, Akata, Romoscanu, and Kostrzewski hereinabove, such that the force sensing device further comprises the guiding structure predefining possible movements of the housing tip and the plurality of sensors relative to each other, in view of the teachings of Barrish, to enable movement of the distal end in 5 degrees of freedom for positioning and orienting the catheter tip (Barrish, para. [0067]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Juravic (US 20170056069 A1) discloses a spring 332 and a force adjustment mechanism 334 (wheel or knob) configured to change the amount of force that the constant force mechanism applies (para. [0121]); Lavergne (US 20160107712 A1) directed to a device for measuring the force present in the drive chain of an electric bicycle having a force sensor 4 and an adjusting screw 5 to adjust said force sensor and transmit a force to the input of the force sensor (para. [0045, 0048]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at
http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHARLES A MARMOR II/ Supervisory Patent Examiner, Art Unit 3791
/A.E.H./Examiner, Art Unit 3791