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 .
DETAILED ACTION
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.
Claims 1-13, 15, 24-27 and 29-30 are 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. Limitation “manually operable by a user to deform the one or more shape sensing optical fibers at the trigger location into a previously determined known shape” is not in the specification.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13, 15, 24-27 and 29-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Limitation “manually operable by a user to deform the one or more shape sensing optical fibers at the trigger location into a previously determined known shape” is unclear. How can one manually deform the one or more shape sensing optical fibers at the trigger location into a previously determined known shape? According to specification paragraph [0020], “the hub or trigger mechanism may include a shape profile that deflects the fiber passing through it into a known shape”. It is not possible for manual operation with a shape profile. The shape profile is instruction store in computer to bend the device to certain shape or move device a certain way. The input device includes a known shape profile to deform shape sensing optical fibers into a known shape is done by computer/device and not manual hand operation. Therefore, examiner interpreted the claim limitation as a hand-operated controller input that bend/twist the fiber at the trigger location to the left or right, etc. as determine by feedback signal. Feedback signal help guide instrument/fiber to the target and input device bend/twist fiber to the previously determine known shape provided by feedback signal to have the instrument/fiber position at the target.
Claim Rejections - 35 USC § 103
1. 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.
2. Claims 1-2, 6, 8-10 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Larkin et al. (US 2007/0156019).
3. Addressing claims 1 and 10, Larkin discloses a system for generating a manual input on a shape sensing fiber, comprising (see Figs. 4, 6, 8):
a shape sensing enabled device insertable in a volume including: one or more shape sensing optical fibers configured to provide optical shape sensing data (see [0042], Figs. 2, 4 and 10; the fiber optic 220);
an input device comprised a hub or a trigger mechanism in direct contact with a portion of the one or more shape sensing optical fibers at a previously designated trigger location outside the volume, wherein the input device is manually operable by a user to deform the one or more shape sensing optical fibers at the trigger location into a previously determined known shape, wherein detection of the known shape of the one or more shape sensing optical fibers at the trigger location is automatically associated with the input device and causes an input signal to be generated for triggering an action previously associated with the known shape, wherein the input signal is distinguishable from other optical shape sensing data used for sensing a shape of the shape sensing enabled device inside the volume based on at least one of the trigger location or the known shape (see Figs. 1-4, 8, abstract, [0035-0036], [0038], [0043], [0045], [0051], [0102] and [0111], the hand-operated controller 12 is the input device comprising hub or trigger mechanism (manipulator assembly 4, control system 250 which include servo controller, detection system and imaging system) use to steer/bend/twist the fiber optic (220) and the medical device (212) to make change to the optical shape sensing data; examiner interprets limitation “the input signal is distinguishable from other shape sensing data used for sensing a shape of the shape sensing enabled device” as the change in fiber optic light reflection and Bragg refraction index when the fiber optic is bend or twist by the servo controller cause strain in the fiber optic; each bend and twist cause a different strain which cause a different distinguishable light reflection and Bragg refraction index detect by the sensor and the sensor output signal; the sensor output signal by Larkin is the generated input signal; Larkin’s sensors sense the change in reflection and Bragg refraction index cause by the strain to the optical fiber result of bend and twist of optical fiber; different strain, different reflection and refraction index is the distinguishable change of data; also see [0048-0058]; especially [0054]); the 808 bend sensor feedback and position loop 802 are triggering an action; basically the sensor sense the bending and twisting of the fiber at each segment of body segment or joint region (see [0045] and abstract); it provides a feedback that trigger the user to change the position of the device; as see in applicant’s specification paragraphs [0037-0038], [0052-0053] and Fig. 4, sensing the change of geometry of the shape sensing device by the input device (bend and twist of the device), produce input signal and perform action responsive to input signal; the feedback is perform action responsive to input signal; examiner interprets the claim limitation according to applicant’s specification paragraphs [0037-0038], [0052-0053] and Fig. 4; the input device is direct contact with a portion of the one or more shape sensing optical fibers outside the volume as see in Figs. 1-2 and 4; fiber 220 is in direct contact with 260 which is part of input device outside the volume; see Figs. 1-2, instrument 20/200 include fiber 220 connect to trigger mechanism and part of the instrument is outside the body; the input device 12 is manually operated to band instrument include fiber at the trigger location into a previously determined known shape; the trigger location is the location connect the shape sensing fiber to 220 to control system 250; at this connection the control system can bend/twist/move the instrument into previously determined known shape; previously determined known shape is not disclose by the specification therefore examiner interpret previously determined known shape as a shape determine by user/system based on feedback to guide instrument to the target; obvious to one of ordinary skill in the art at the time of the invention that detection of the known shape of the one or more shape sensing optical fibers at the trigger location is automatically associated with the input device because the bending/twisting of the fiber at the trigger location is being sensed by sensor of the change in Bragg refraction index and the bend/twist is caused by the hand-operated control device);
a processor system configured to receive the input signal and initiate the action responsive to the input signal (see Fig. 8, abstract and [0017]; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the control system has a processor);
a system comprising: a shape sensing enabled device insertable in a volume including: one or more shape sensing optical fibers configured to provide optical shape sensing data (see [0042], Figs. 2, 4 and 10; the fiber optic 220);
an input device comprised a hub or a trigger mechanism in direct contact with a portion of the one or more shape sensing optical fibers at a previously designated trigger location outside the volume, wherein the input device is manually operable by a user to deform the one or more shape sensing optical fibers at the trigger location into a previously determined known shape, wherein detection of the known shape of the one or more shape sensing optical fibers at the trigger location is automatically associated with the input device and causes an input signal to be generated for triggering an action previously associated with the known shape, wherein the input signal is distinguishable from other optical shape sensing data used for sensing a shape of the shape sensing enabled device inside the volume based on at least one of the trigger location or the known shape (see Figs. 1-4, 8, abstract, [0035-0036], [0038], [0043], [0045], [0051], [0102] and [0111], the hand-operated controller 12 is the input device comprising hub or trigger mechanism (manipulator assembly 4, control system 250 which include servo controller, detection system and imaging system) use to steer/bend/twist the fiber optic (220) and the medical device (212) to make change to the optical shape sensing data; examiner interprets limitation “the input signal is distinguishable from other shape sensing data used for sensing a shape of the shape sensing enabled device” as the change in fiber optic light reflection and Bragg refraction index when the fiber optic is bend or twist by the servo controller cause strain in the fiber optic; each bend and twist cause a different strain which cause a different distinguishable light reflection and Bragg refraction index detect by the sensor and the sensor output signal; the sensor output signal by Larkin is the generated input signal; Larkin’s sensors sense the change in reflection and Bragg refraction index cause by the strain to the optical fiber result of bend and twist of optical fiber; different strain, different reflection and refraction index is the distinguishable change of data; also see [0048-0058]; especially [0054]); the 808 bend sensor feedback and position loop 802 are triggering an action; basically the sensor sense the bending and twisting of the fiber at each segment of body segment or joint region (see [0045] and abstract); it provides a feedback that trigger the user to change the position of the device; as see in applicant’s specification paragraphs [0037-0038], [0052-0053] and Fig. 4, sensing the change of geometry of the shape sensing device by the input device (bend and twist of the device), produce input signal and perform action responsive to input signal; the feedback is perform action responsive to input signal; examiner interprets the claim limitation according to applicant’s specification paragraphs [0037-0038], [0052-0053] and Fig. 4; the input device is direct contact with a portion of the one or more shape sensing optical fibers outside the volume as see in Figs. 1-2 and 4; fiber 220 is in direct contact with 260 which is part of input device outside the volume; see Figs. 1-2, instrument 20/200 include fiber 220 connect to trigger mechanism and part of the instrument is outside the body; the input device 12 is manually operated to band instrument include fiber at the trigger location into a previously determined known shape; the trigger location is the location connect the shape sensing fiber to 220 to control system 250; at this connection the control system can bend/twist/move the instrument into previously determined known shape; previously determined known shape is not disclose by the specification therefore examiner interpret previously determined known shape as a shape determine by user/system based on feedback to guide instrument to the target; obvious to one of ordinary skill in the art at the time of the invention that detection of the known shape of the one or more shape sensing optical fibers at the trigger location is automatically associated with the input device because the bending/twisting of the fiber at the trigger location is being sensed by sensor of the change in Bragg refraction index and the bend/twist is caused by the hand-operated control device);
a processor (see Fig. 8, abstract and [0017]; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the control system has a processor);
non-transitory memory coupled to the processor, the memory storing instructions, which when executed by the processor, cause the processor to interpret optical signals from the one or more shape sensing optical fibers, wherein the optical signals include the input signal generated by the change in the optical shape sensing data (see Figs. 2-4, [0102], [0106] and [0111], the servo controller is the input device use to steer/bend/twist the fiber optic and the medical device; the sensors 1 and 2 output shape sensing data; basically the input to bend the fiber; the sensors sensing the fiber is bend at a certain position and output feedback);
wherein the processor and memory are configured to receive the input signal and initiate the action responsive to the input signal (see Fig. 8, abstract, [0017] [0106]; sense position and provide feedback to the control system (processor and memory) for adjust the medical device and shape sensing device position).
Also see the prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
4. Addressing claims 2, 6 and 8-9, Larkin discloses:
wherein the shape sensing enabled device includes a medical device (see Fig. 2 and [0043]; instrument 200);
wherein the hub comprises spring-loaded button configured to bend the portion of the one or more shape sensing optical fibers at the trigger location into the known shape (see Figs. 2-6; the servo controller; control system change the shape of the shape sensing optical fibers and the sensors detect the change/bend; spring-loaded button is a designer choice that equivalent to servo control; it only require routine skill in the art to use similar device to perform the same function (see applicant’s specification [0045]; could use any device known to those skill in the art to bend a fiber/instrument);
a feedback device to indicate to the user when the input signal has been received (see Fig. 8);
wherein the feedback device generates one or more of acoustic, vibratory, visual and temperature feedback (see [0004] and [0036]; haptic/tactile feedback is vibratory);
Addressing claim 26, the device of claims 1-2, 6 and 8-10 perform the method of claim 26 therefore claim 26 are being rejected for the same reason as claims 1-2, 6 and 8-10.
5. Claims 3-5, 7, 11-13, 15, 24-25, 27 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Larkin et al. (US 2007/0156019), in view of Swann et al. (US 2007/0227544) and further in view of Hoffart et al. (US 5,796,905).
6. Addressing claims 3-5, 11-13 and 24-25, Larkin does not disclose feedback device as color band diodes, or texture bands or stiffness bands are designer choices as seen in applicant’s specification paragraphs [0018], [0036] and [0039] (designer can choose color diodes bands, or passive color bands or stiffness bands or texture bands, designer could choose numerous type of feedback bands). Swann discloses feedback device as color bands or other markings on the instrument (other markings are texture bands) (see [0121]). Hoffart discloses feedback device as color marking (see abstract and Fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Larkin to have feedback device as color bands or other markings on the instrument as taught by Swann and Hoffart because help provide visual feedback to aid the physician (see Swann’s paragraph [0121]; see Hoffart’s col. 1, lines 34-51; use color for identification of the optical fibers when using many optical fibers).
7. Regarding claims 7, 15 and 30, Larkin in view of Swann and Hoffart discloses a display for rendering a representation of each shape sensing enabled device thereon, such that activating the input device of the shape sensing enabled device causes an effect to distinguish the shape sensing enabled device from the another shape enabled device on the display and wherein the command or the action comprises identifying the shape sensing enabled device from among a plurality of shape sensing enabled devices (see Larkins’s Fig. 1, [0035], [0037], [0042], [0076]; using another shape sensing devices/fibers; Larkins discloses using control servo bend/twist shape sensing devices and this is display on the monitor/display 10 at the surgical site; Swann and Hoffart discloses color/texture bands/rings for identification of each fibers or wire; therefore Larkin in view of Swann and Hoffart discloses rendering a representation of each shape sensing enabled device thereon, such that activating the input device of an active shape sensing enabled device causes an effect to distinguish the active shape sensing enabled device from other shape enabled device on the display; color on each fiber allow user or system to identifying the shape sensing enabled device from among a plurality of shape sensing enabled devices).
8. Addressing claims 27 and 29, the device of claims 3-5, 7, 11-13 and 15 perform the method of claims 27 and 29 therefore claims 27 and 29 are being rejected for the same reason as claims 3-5, 7, 11-13 and 15.
Response to Arguments
Applicant’s arguments with respect to claims 1-13, 15, 24-27 and 29-30 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2017/0325896 (see [0029], [0043-0044], [0052] and Figs. 1-3; input device 106 directly connect to instrument body 204 and fiber 222 outside the body; input device 106 can be manually operated (manual actuator) to grip/twist/bend/pull instrument 202 at trigger location outside the body; this is the catheter system insert into lung etc. therefore part of the catheter is outside the body and connected to manually input to allow user to manipulate the catheter with fiber).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HIEN NGOC NGUYEN whose telephone number is (571)270-7031. The examiner can normally be reached Monday-Thursday 8:30am-6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3793
Prosecution Insights