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 .
Priority
Applicant’s claim of benefit of the instant application as a National Stage entry under 35 USC 371 to PCT/US2022/018158 (28 February 2022), which claims benefit to US Provisional 63/154977 (1 March 2021) is acknowledged.
Formal Matters
Applicant’s preliminary amendment to the claims filed 15 November 2022 is acknowledged. Claim 6 is cancelled claims 1-5 and 7-20 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 15 November 2022 has been considered by the examiner. A signed copy is attached.
Specification - Objection
The abstract of the disclosure is objected to because it contains more than 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 17 is objected to because of the following informalities: line 18 recite “wherein the arch is fix to the upper plate”. It is believed that the word “fix” should be “fixed”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) Indefiniteness
Lack of Antecedent Basis
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 14 is 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 14 recites the limitation "the first radio-opacity” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. “A first radio-opacity” is first mentioned in claim 13, but Applicant amended the dependency of claim 14 from claim 13 to claim 1 in a preliminary amendment filed 15 November 2022.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7, 8, 10, 15, 16, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piferi et al., US 20090112084 (30 April 2009).
Regarding independent claim 1, Piferi teaches a medical device introducer guide (MRI-guided interventional system 50) comprising:
a guide assembly (FIGs 3A, 30, trajectory frame 100) comprising:
a base (110) adapted to be affixed to an organism relative to an insertion point (FIG 3A; ¶141);
an arch (FIG 3A, yoke 120) connected with the base (110),
the arch (FIG 3A, yoke 120) having a semicircular curvature (FIG 3A),
the curvature (arcuate arms 116) having a radius of curvature centered on the insertion point (FIG 12),
wherein the insertion point is co-planar with an outer surface of the organism (FIGs 2S shows burr hole 10 coplanar with skull S of the patient); and
a guide body (FIG 3A, platform 130) slidably disposed on the arch (FIG 12, yoke 120 comprising arcuate arms 122; ¶155, platform 130 engages and moves along the yoke arcuate arms),
the guide body (platform 130) including a bore (FIG 3A, the hole defined by tubular member 204 extending from platform 130 through base 110 as patient access aperture 112, ¶¶145, 178),
wherein an axis of the bore defines an insertion path (FIG 3A, the insertion path axis defined by tubular member 204 expending from platform 130 through base 110 and patient access aperture 112, overlying burr hole 10 in the patient skull, ¶¶145, 178),
wherein the insertion path has a trajectory (¶134; FIG 3A, roll axis RA, ¶154), and
wherein the insertion path intersects the insertion point (¶134; FIG 3A, ¶178);
a remote operator (FIGs 1A, 9, 30; remote control unit 400); and
a linkage (FIGs 3A, actuators 140a-d linked through cables 150a-d; 158) connected with the remote operator (400) and the guide assembly (100),
wherein a motion of the remote operator (400) is communicated by the linkage (¶17) to one or more of the arch (120) and the guide body (130) to vary the trajectory of the insertion path (FIGS 9, 10A-10C; ¶159),
where the linkage comprises a first cable (FIG 30, cables 150a-d, ¶151),
wherein the first cable comprises a first shaft (flexible drive shafts or control cables 150a-d; ¶151) and a first sheath surrounding the first shaft (FIG 15, collars 154a-d ¶165),
wherein a distal end of the first sheath (FIG 15, collars 154 a-d; ¶165) is fixed to the arch (FIG 8A, yoke 120),
wherein a distal end of the first shaft (flexible drive shafts or control cables 150a-d; ¶151) is fixed to the guide body (FIGs 3A, 14, platform 130, ¶158), and
wherein the motion is communicated (¶142) by movement of the first shaft (flexible drive shafts or control cables 150a-d; ¶151) relative to the first sheath (FIG 15, collars 154a-d ¶165) to move the guide body (130) along the arch to vary the trajectory of the insertion path through a first angle (FIGs 9, 10A-10C 30, 31; pitch axis rotation, roll axis rotation, X-Y translation; ¶¶142, 159).
Regarding claim 2, Piferi teaches the introducer guide of claim 1, as set forth above, further comprising one or more hinges (FIG 11, pivot points 113; ¶154) connecting the arch with the base, wherein the one or more hinges (113) allow the arch to rotate about an axis of rotation parallel with the base (FIG 3A, roll axis; ¶154), and wherein the axis of rotation intersects the insertion point (FIGs 3A, 4, 5; ¶154).
Regarding claim 3, Piferi teaches the introducer guide of claim 2, as set forth above, wherein the one or more hinges comprise two sliding hinges (first and second pivot pins are slid down the guide slots, ¶44; claim 17), the sliding hinges each comprising: a semicircular support surface fixed to the base and having a hinge radius of curvature (FIG 11, base arcuate arms 116 comprising arm surfaces 116a), wherein the hinge radius of curvature is centered on the axis of rotation (FIGs 3A, 11, radius of curvature of arm surface 116 centered on roll axis RA); and a slider having a sliding surface in sliding contact with the support surface (FIG 12, rotatable worm 142; ¶154), wherein the arch is fixed with the slider and extends from the slider in a direction radially away from the support surface (FIGs 11, 12; yoke 120 comprising fixed rotatable worm 142, extending from worm 142 radially upward and away from surface 116a; ¶154), and wherein rotation of the arch about the axis of rotation slides the slider along the support surface (FIGs 11, 12; ¶154).
Regarding claim 4, Piferi teaches the introducer guide of claim 3, as set forth above, wherein a curvature of the sliding surface conforms with the curvature of the support surface (FIGs 11, 12; yoke 120 comprising fixed rotatable worm 142, extending from worm 142 radially upward and away from surface 116a; ¶154).
Regarding claim 5, Piferi teaches the introducer guide of claim 4, as set forth above, further comprising a retainer (FIGs 2A, 27; burr hole ring 12; ¶90) fixed with the base (110), wherein the retainer (12) has a semicircular inner surface that is concentric with the support surface (FIGs 2A, 27), wherein an upper surface of the slider is in sliding contact with the retainer (FIGs 3B, 3C), and wherein the retainer holds the slider against the support surface (FIGs 3B, 3C; ¶43).
Regarding independent claim 7, Piferi teaches a medical device introducer guide (MRI-guided interventional system 50) comprising:
a guide assembly (FIGs 3A, 30, trajectory frame 100) comprising:
a base (110) adapted to be affixed to an organism relative to an insertion point (FIG 3A; ¶141);
an arch (FIG 3A, yolk 120) connected with the base (110),
the arch (FIG 3A, yolk 120) having a semicircular curvature (FIG 3A),
the curvature (arcuate arms 116) having a radius of curvature centered on the insertion point (FIG 12),
wherein the insertion point is co-planar with an outer surface of the organism (FIGs 2S shows burr hole 10 coplanar with skull S of the patient); and
a guide body (FIG 3A, platform 130) slidably disposed on the arch (FIG 12, yoke 120 comprising arcuate arms 122; ¶155, platform 130 engages and moves along the yoke arcuate arms),
the guide body (platform 130) including a bore (FIG 3A, patient access aperture 112, ¶145),
wherein an axis of the bore defines an insertion path (FIG 3A, patient access aperture 112 in platform 130 overlies burr hole 10 in the patient skull, ¶145),
wherein the insertion path has a trajectory (¶134; FIG 3A, roll axis RA, ¶154), and
wherein the insertion path intersects the insertion point (¶134; FIG 3A, ¶178);
a remote operator (FIGs 1A, 9, 30; remote control unit 400); and
a linkage (FIGs 3A, actuators 140a-d linked through cables 150a-d; 158) connected with the remote operator (400) and the guide assembly (100),
wherein a motion of the remote operator (400) is communicated by the linkage (¶17) to one or more of the arch (120) and the guide body (130) to vary the trajectory of the insertion path (FIGS 9, 10A-10C; ¶159),
where the linkage comprises a second cable (FIG 30, cables 150a-d, ¶151),
wherein the first cable comprises a second shaft (flexible drive shafts or control cables 150a-d; ¶151) and a second sheath surrounding the first shaft (FIG 15, collars 154a-d; ¶165),
wherein a distal end of the second sheath (FIG 15, collars 154 a-d) is fixed to the arch (FIG 8A),
wherein a distal end of the first shaft (flexible drive shafts or control cables 150a-d; ¶151) is fixed to the guide body (FIGs 3A, 14, platform 130, ¶158), and
wherein the motion is communicated (¶142) by movement of the second shaft (flexible drive shafts or control cables 150a-d; ¶151) relative to the second sheath (FIG 15, collars 154a-d ¶165) to move the guide body (130) along the arch to vary the trajectory of the insertion path through a second angle (FIGs 9, 10A-10C 30, 31; pitch axis rotation, roll axis rotation, X-Y translation; ¶¶142, 159).
Regarding claim 8, Piferi teaches the introducer guide of claim 1, as set forth above, wherein the remote operator (400) comprises an operator having a housing (FIGs 9, 10A-C) and a sliding actuator (remotely translate, ¶17) positioned in the housing (400) and adapted to slide in a distal and a proximal direction (translate in an X-direction or Y-direction; ¶18) relative to the housing to generate the motion communicated by the linkage to vary the trajectory of the insertion path (¶18).
Regarding claim 10, Piferi teaches the introducer guide of claim 1, as set forth above. wherein the first cable has a length between about 30 cm and 250 cm (¶151, “cables 150a-d may extend a suitable distance, e.g. between about 1-4 feet”). A length of 1-4 feet translates to about 30cm to 121cm.
Regarding claim 15, Piferi teaches the introducer guide of claim 1, as set forth above, wherein one or more of the base (110) and the guide body (130) comprise optical alignment features (¶35) arranged to reflect light emitted by a laser alignment system (¶211) of an imaging system and to provide a visual indication of the position of the base (110) or the guide body (130) with respect to the imaging system (¶¶35, 211). See also, claim 6.
Regarding claim 16, Piferi teaches the introducer guide of claim 15, as set forth above, wherein the optical alignment features comprise one or more holes, extensions (bracket 1502; ¶202), or grooves on the guide body (130) (claim 6).
Regarding claim 19, Piferi teaches the introducer guide of claim 1, as set forth above, wherein the linkage (FIGs 3A, actuators 140a-d linked through cables 150a-d; 158) further comprises one or more of a Bowden cable (flexible drive shafts or control cables 150a-d; ¶151), a rotary control cable, a hydraulic cylinder, and a pneumatic cylinder.
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Piferi et al., US 20090112084 (30 April 2009) in view of Chen et al., US 20180214177 (2 August 2018).
Regarding claim 11, Piferi teaches the introducer guide of claim 1, as set forth above.
Piferi does not teach wherein the guide body further comprises a plurality of membranes arranged along the bore, wherein the membranes include openings arranged colinearly and aligned with the insertion path. Chen teaches a fully separable piercer comprising a trocar and a cannula comprising a primary sealing seat with an axial through home and a primary sealing membrane (32) fixedly connected to an external edge (¶¶18-20). Chen also teaches a plurality of guide sealing plates (34) arranged uniformly along the periphery of the round hole with one being fixedly connected to the primary sealing membrane (32) (FIGs 3, 4; ¶67).
Piferi and Chen teach in the same field of endeavor, devices related to introducer guides. Piferi disclosed the claimed base device, but does not teach where the guide body further comprises a plurality of membranes. Chen teaches a plurality of membranes arranged along the bore to form an airtight structure (¶18). Chen explains that a plurality of sealing plates are connected to the primary sealing membrane where neighboring plates are overlapped to form a lens-type leaf structure that forms an airtight structure whether a device is inserted or removed (¶18). Chen discloses that the sealing plates are arranged at either side of the round hole to enable the device to keep sealing in the process of inserting in and pulling out (¶18). The addition of a membrane or a plurality of membranes around the bore is a mechanically simple solution to providing an air tight structure for the introducer device. A person of ordinary skill in the art seeking to provide a similar mechanism for advancing the position of a stereotactic probe could readily incorporate the plural membrane system of Chen using known assembly methods without redesigning Piferi’s core device. Because Piferi and Chen address the same engineering problem (positioning stereotactic probes) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a plurality of membranes at the bore to effect an airtight structure whether a device is being inserted or being pulled out), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining the teachings.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Piferi et al., US 20090112084 (30 April 2009) in view of Peshkin et al., US RE40176 E (25 March 2008).
Regarding claim 13, Piferi teaches the introducer guide of claim 1, as set forth above.
wherein the guide assembly (100) comprises a material with a first radio-opacity (fiducial markers 117) and wherein the base (110) further comprises one or more center alignment indicators (117) shaped to indicate a direction relative to the insertion point (¶153).
Piferi does not teach wherein the center alignment indicators have a radio-opacity greater than the first radio-opacity, and wherein, when viewed under x-ray radiation, the center alignment indicators show the position of the insertion point.
Peshkin teaches apparatus for stereotactic surgical procedures using coordinated fluoroscopy (Abstract). Peshkin teaches artifact 24 that is visually transparent with the exception of 8 opaque spheres and fiducials 26 and an aperture 30 to hold tool guide 28 (FIGs 2, 3A; ¶26).
Piferi and Peshkin teach in the same field of endeavor, devices related to introducer guides. Piferi disclosed the claimed base device, but does not teach where the center alignment indicators have a radio-opacity greater than the first radio-opacity, and wherein, when viewed under x-ray radiation, the center alignment indicators show the position of the insertion point. Peshkin teaches apparatus for stereotactic surgical procedures using coordinated fluoroscopy (Abstract). Peshkin teaches artifact 24 that is visually transparent with the exception of 8 opaque spheres and fiducials 26 and an aperture 30 to hold tool guide 28 (FIGs 2, 3A; ¶26).
The addition of a radio-opaque fiducial using coordinated fluoroscopy is a mechanically simple solution to providing an additional imaging mechanism to Piferi’s radio-opaque fiducial markers 117. A person of ordinary skill in the art seeking to provide a similar coordinated fluoroscopy mechanism imaging visualization could readily incorporate the coordinated fiducial marker solution of Peshkin using known assembly methods without redesigning Piferi’s core device comprising MRI-based fiducials. Because Piferi and Peshkin address the same engineering problem (positioning stereotactic probes) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a plurality of coordinated fiducials that are radio-opaque to multiple imaging methodologies), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining the teachings.
Regarding claim 14, Piferi teaches the introducer guide of claim 1, as set forth above, wherein the guide body (130) comprises a plurality of path alignment indicators arranged co-linearly with the bore (¶¶53, 146, 153).
Piferi does not teach wherein the path alignment indicators have a radio-opacity different from the first radio-opacity, and wherein, when viewed under x-ray radiation, the path alignment indicators show the trajectory of the insertion path.
Peshkin teaches apparatus for stereotactic surgical procedures using coordinated fluoroscopy (Abstract). Peshkin teaches artifact 24 that is visually transparent with the exception of 8 opaque spheres and fiducials 26 and an aperture 30 to hold tool guide 28 (FIGs 2, 3A; ¶26).
Piferi and Peshkin teach in the same field of endeavor, devices related to introducer guides. Piferi disclosed the claimed base device, but does not teach where the path alignment indicators have a radio-opacity greater than the first radio-opacity, and wherein, when viewed under x-ray radiation, the path alignment indicators show the position of the insertion point. Peshkin teaches apparatus for stereotactic surgical procedures using coordinated fluoroscopy (Abstract). Peshkin teaches artifact 24 that is visually transparent with the exception of 8 opaque spheres and fiducials 26 and an aperture 30 to hold tool guide 28 (FIGs 2, 3A; ¶26).
The addition of a radio-opaque fiducial using coordinated fluoroscopy is a mechanically simple solution to providing an additional imaging mechanism to Piferi’s radio-opaque fiducial markers 117. A person of ordinary skill in the art seeking to provide a similar coordinated fluoroscopy mechanism and imaging visualization for path alignment could readily incorporate the coordinated fiducial marker solution of Peshkin using known assembly methods without redesigning Piferi’s core device comprising MRI-based path alignment fiducials. Because Piferi and Peshkin address the same engineering problem (positioning stereotactic probes) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a plurality of coordinated fiducials that are radio-opaque to multiple imaging methodologies), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining the teachings.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Piferi et al., US 20090112084 (30 April 2009) in view of Kynast et al., US 6,416,520 (9 July 2002).
Regarding independent claim 17, Piferi teaches a medical device introducer guide (MRI-guided interventional system 50) comprising:
a guide assembly (FIGs 3A, 30, trajectory frame 100) comprising:
a base (110) adapted to be affixed to an organism relative to an insertion point (FIG 3A; ¶141);
an arch (FIG 3A, yolk 120) connected with the base (110),
the arch (FIG 3A, yolk 120) having a semicircular curvature (FIG 3A),
the curvature (arcuate arms 116) having a radius of curvature centered on the insertion point (FIG 12),
wherein the insertion point is co-planar with an outer surface of the organism (FIGs 2S shows burr hole 10 coplanar with skull S of the patient); and
a guide body (FIG 3A, platform 130) slidably disposed on the arch (FIG 12, yoke 120 comprising arcuate arms 122; ¶155, platform 130 engages and moves along the yoke arcuate arms),
the guide body (platform 130) including a bore (FIG 3A, the hole defined by tubular member 204 extending from platform 130 through base 110 as patient access aperture 112, ¶¶145, 178),
wherein an axis of the bore defines an insertion path (FIG 3A, patient access aperture 112 in platform 130 overlies burr hole 10 in the patient skull, ¶145),
wherein the insertion path has a trajectory (¶134; FIG 3A, roll axis RA, ¶154), and
wherein the insertion path intersects the insertion point (¶134; FIG 3A, ¶178);
a remote operator (FIGs 1A, 9, 30; remote control unit 400); and
a linkage (FIGs 3A, actuators 140a-d linked through cables 150a-d; 158) connected with the remote operator (400) and the guide assembly (100),
wherein a motion of the remote operator (400) is communicated by the linkage (¶17) to one or more of the arch (120) and the guide body (130) to vary the trajectory of the insertion path (FIGS 9, 10A-10C; ¶159),
wherein the base (110) comprises a lower plate (patient access aperture 112) and an upper plate (platform 130),
wherein a bottom surface of the lower plate adapted to be fix to the organism (¶147),
wherein the upper plate (platform 130) is rotatably connected with the lower plate (yoke 120; ¶147),
wherein the arch (FIG 3A, 120) is fix [sic] to the upper plate (platform 130) and extends upward in a plane normal to the upper plate (FIG 3A).
Piferi does not teach wherein an upper surface of the lower plate comprises a rack gear disposed along at least part of a circular path centered on the insertion point, wherein a pinion gear is rotatably mounted to the upper plate, wherein the pinion gear engages the rack gear, and wherein rotation of the pinion gear causes the upper plate and the arch to rotate relative to the lower plate. Instead of a rack and pinion gear system, Piferi teaches a worm gear (142) with teeth that are configured to engage thread pattern (118) as shown in FIG 5 (¶154). “Because the base is fixed to a patient’s skull, rotation of the roll actuator worm 142 causes the yoke 120 to rotate about roll axis RA relative to fixed base 100” (¶154). Piferi also teaches that “drive belts, linkages, gears, or worm drives may be utilized, as would be understood by one skilled in the art of X-Y tables” (¶157).
Kynast teaches a microdrive for probes in the field of neurosurgical sterotaxy, wherein advancement of the probe into the patient’s brain can be done while visually reading a mechanical scale or digital readout and can involve turning a mechanical screw or a rack-and-pinion to advance the position of the electrode mechanically.
Piferi and Kynast teach in the same field of endeavor, devices related to stereotactic introducer guides. Piferi disclosed the claimed base device, but does not teach rack and pinion gears.
However, Piferi teaches a similar mechanism using worm gears with teeth (142) configured to engage a thread pattern (118) that is strikingly similar to the manner in which rack and pinion systems work (FIGs 11, 12; yoke 120 comprising fixed rotatable worm 142, extending from worm 142 radially upward and away from surface 116a; ¶154). Piferi also teaches the configuration wherein the base (110) comprises a lower plate (patient access aperture 112) and an upper plate (platform 130), wherein a bottom surface of the lower plate adapted to be fix to the organism (¶147), wherein the upper plate (platform 130) is rotatably connected with the lower plate (yoke 120; ¶147), wherein the arch (FIG 3A, 120) is fix [sic] to the upper plate (platform 130) and extends upward in a plane normal to the upper plate (FIG 3A). The only difference between the disclosure of Piferi and the instant claim is the rack and pinion gear.
Given that Piferi teaches that “drive belts, linkages, gears, or worm drives may be utilized, as would be understood by one skilled in the art of X-Y tables” (¶157) and given the similarity of configurations to the worm with teeth (142) and thread (118) system as shown in FIG 5 of Piferi and a rack and pinion system, which is a mechanically simple solution, as taught by Kynast, a person of ordinary skill in the art seeking to provide a similar mechanism for advancing the position of a stereotactic probe could readily incorporate the rack and pinon gear of Kynast using known assembly methods without redesigning Piferi’s core device. Because Piferi and Kynast address the same engineering problem (positioning stereotactic probes) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting the worm/teeth 142 and thread 118 system of Piferi with a rack and pinon gear system of Kynast), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining the teachings.
Regarding claim 18, Piferi modified by Kynast teaches the introducer of claim 17, as set forth above.
Piferi does not clearly teach wherein the linkage comprises a rotary cable, wherein a distal end of the rotary cable is connected with the pinion gear, wherein the remote operator comprises a knob connected with a proximal end of the rotary cable, and wherein rotation of the knob causes the upper plate and arch to rotate relative to the lower plate.
Piferi teaches linkage comprising flexible drive shafts or cables (FIG 30, cables 150a-d, ¶151). Rotation of actuators is taught by Piferi at ¶156. In another embodiment of comprising remote control unit 800 (FIGs 32A-32C), Piferi teaches that a knob or other device that facilitates rotation may be secure to the proximal end of rod 804 (¶174). In another embodiment of device 100, related to remote control unit 800, Piferi teaches a multi-rod control device 802a-d for each respective actuator 140a-140d (¶171; FIGs 32A-32C). Piferi teaches that a knob or other device that facilitates rotation may be secure to the proximal end of rods 804 that are linked to control devices 802a-d (¶¶172, 174). In operation, a user rotates the proximal end 804a of rod 804 in a clockwise or counterclockwise direction to correspondingly rotate actuator 140a (¶174). Piferi also teaches that “drive belts, linkages, gears, or worm drives may be utilized, as would be understood by one skilled in the art of X-Y tables” (¶157).
Kynast teaches drive shaft elements comprising rotational-type wires (col 4, lines 7-8). Rotational knobs 92 are taught at FIG 1 (col 2, line 58). Kynast teaches rack and pinon gears as set forth above in claim 17, which is similar to the mechanism using worm gears with teeth (142) configured to engage a thread pattern (118) taught by Piferi (FIGs 11, 12; yoke 120 comprising fixed rotatable worm 142, extending from worm 142 radially upward and away from surface 116a; ¶154).
Piferi and Kynast teach in the same field of endeavor, devices related to stereotactic introducer guides. Piferi disclosed the claimed base device, but does not teach rack and pinion gears.
However, Piferi teaches a similar mechanism using worm gears with teeth (142) configured to engage a thread pattern (118) that is strikingly similar to the manner in which rack and pinion systems work (FIGs 11, 12; yoke 120 comprising fixed rotatable worm 142, extending from worm 142 radially upward and away from surface 116a; ¶154). Piferi also teaches the configuration wherein the base (110) comprises a lower plate (patient access aperture 112) and an upper plate (platform 130), wherein a bottom surface of the lower plate adapted to be fix to the organism (¶147), wherein the upper plate (platform 130) is rotatably connected with the lower plate (yoke 120; ¶147), wherein the arch (FIG 3A, 120) is fix [sic] to the upper plate (platform 130) and extends upward in a plane normal to the upper plate (FIG 3A). The only difference between the disclosure of Piferi and the instant claim is the rack and pinion gear.
Piferi also teaches that “drive belts, linkages, gears, or worm drives may be utilized, as would be understood by one skilled in the art of X-Y tables” (¶157). In light of the multiple embodiments of Piferi teaching rotational cables with rods and rotational knobs, one of ordinary skill in the art would be motivated to find the best solution for the particular introducer guide based on the specific stereotactic surgical use case and need. The overlap in teachings between Piferi and Kynast results in a mechanically simple solution. A person of ordinary skill in the art seeking to provide a similar mechanism for advancing the position of a stereotactic probe could readily incorporate the rack and pinon gear of Kynast using known assembly methods without redesigning Piferi’s core device. One would also be able to select the most effective actuator for the use case, whether that is a flexible cable or a rotary cable connected to the gear mechanism. Because Piferi and Kynast address the same engineering problem (positioning stereotactic probes) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting the worm/teeth 142 and thread 118 system of Piferi with a rack and pinon gear system of Kynast and substituting a flexible cable system for a rod or a rotary cable system), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining the teachings.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Piferi et al., US 20090112084 (30 April 2009) in view of Viswanathan et al., US 20060009735 (12 January 2006).
Regarding claim 20, Piferi teaches the introducer guide of claim 1, as set forth above. Piferi teaches actuators 140a-d (¶151).
Piferi does not teach wherein the linkage comprises a fluid-driven actuator, wherein, when fluid is moved into or out from the actuator, the actuator exerts force on the guide body to move the guide body to the selected location.
Viswanathan teaches hydraulically navigated medical devices (¶21) wherein the linkage comprises a fluid-driven actuator (¶21), wherein, when fluid is moved into or out from the actuator, the actuator exerts force on the guide body to move the guide body to the selected location (¶21).
Piferi and Viswanathan teach in the same field of endeavor using remotely actuatable medical devices. Although Piferi teaches the claimed base introducer guide, Piferi does not teach where the linkage comprises a fluid-driven actuator, wherein, when fluid is moved into or out from the actuator, the actuator exerts force on the guide body to move the guide body to the selected location.
Viswanathan specifically addresses hydraulically navigated medical devices (¶21) wherein the linkage comprises a fluid-driven actuator (¶21), wherein, when fluid is moved into or out from the actuator, the actuator exerts force on the guide body to move the guide body to the selected location (¶21). Because Piferi teaches that the actuators may be manually-operated devices (¶151) a person of ordinary skill in the art would reasonably consult Viswanathan’s mechanically navigated medical devices (¶19), including hydraulically navigated medical devices and pneumatically controlled medical devices (¶19) in addition to electrorestrictive medical devices and magneorestrictive medical devices (¶19), according to the suitability of use, using known assembly methods without redesigning Piferi’s base device controls.
Because Piferi and Viswanathan address the same engineering problem (remote actuator control of medical devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting a hydraulic control for a manual cable-defined actuator), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Allowable Subject Matter
Claims 9 and 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 9, Piferi teaches the introducer guide of claim 8, as set forth above. Neither Piferi nor any other prior art reasonably teaches or suggests wherein the remote operator further comprises a toothed rail fixed to the first housing, wherein the first sliding actuator comprises a ridged surface shaped to engage the toothed rail and a spring between the housing and the first sliding actuator, wherein resiliency of the spring holds the ridged surface of the actuator in engagement with the toothed rail to fix a position of the first sliding actuator relative to the housing, and wherein pressure applied to the first sliding actuator disengages the ridged surface from the toothed rail to allow the first sliding actuator to move in the proximal and distal directions.
Regarding claim 12, Piferi modified by Chen teaches the introducer guide of claim 11, as set forth above. Neither Piferi modified by Chen nor any other prior art reasonably teaches or suggests wherein one or more of the membranes comprise a plurality of resilient tines extending into the bore, wherein, when the tines are flexed by an instrument inserted along the bore, the tines are adapted to apply resilient force on the instrument toward the insertion path.
Conclusion
Claims 1-5, 7, 8, 10, 11, and 13-20 are rejected. Claims 9 and 12 are objected to.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Fichtinger et al., 20060241368 (26 October 2026) teaches apparatus for insertion of a medical device during a medical imaging procedure comprising flexible shafts 570a,b for controlling translation motion of the needle.
Mills et al., US 7,366,561 (29 April 2008) teaches a robotic trajectory guide comprising a remote control with cables or hydraulics (col 2, lines 25-35).
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771