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 .
Status of Claims
Claims 1-20 are pending, claims 2, 6, and 8-20 have been withdrawn from consideration, and claims 1, 3-5, and 7 are currently under consideration for patentability under 37 CFR 1.104.
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, 5, 7, and all dependent claims thereof 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.
Claim 1 recites inter alia, “[a] method for navigating an endoscopic device through an anatomical luminal network of a patient, the method comprising: (a) commanding a distal top of an articulating elongate member to move along a pre-determined path.” Based on the preamble of the claim, the predetermined path is within an anatomical luminal network of a patient.
Applicant has amended claim 1 to further recited, “collecting real-time positional sensor data and real-time kinematics data, wherein the real-time positional sensor data is captured by an electromagnetic sensor and provides a rotation of an EM sensor frame with respect to a static EM field generator frame, wherein the real-time kinematics data provides a rotation of the distal tip with respect to a base of the articulating elongate member and wherein a registration result comprises a relative rotation between the base of the articulating elongate member and the static EM field generator frame.”
Applicant broadly points to paragraphs [0043]-[0059] as providing support for the above amended language. However, it appears that within this section of the specification, the amended language is described as being performed during a calibration procedure and not while the elongate member is being navigated along a pre-determined path. As such the claims are rejected for reciting new matter.
MPEP 2161.01 6th paragraph states, “the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed.” Claim 1 has been amended to recite inter alia “collecting real-time positional sensor data and real-time kinematics data, wherein the real-time positional sensor data is captured by an electromagnetic sensor and provides a rotation of an EM sensor frame with respect to a static EM field generator frame.” Claim 5 depends from claim 1 and recites inter alia, “wherein the EM sensor does not measure a roll orientation.” There is no disclosure in the specification of the algorithm or steps necessary for providing a rotation of an EM sensor frame with respect to a static EM field generator frame without the EM sensor measuring a roll orientation. Therefore claim 5 is rejected for lacking written description.
Claim 7 has been amended to recite inter alia, “i) synchronizing the real-time positional sensor data and the real-time kinematics data and ii) applying a registration algorithm to obtain the registration result comprising the relative rotation between the base of the articulating elongate member and the static EM field generator frame.”
There is no support in the specification for synchronizing the real time positional sensor data and the real-time kinematics data. The synchronization language is used with respect to a calibration procedure performed before the elongate member is inserted into a patient. Therefore claim 7 is rejected for new matter.
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.
Claim(s) 1, 3, and 4 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramamurthy et al. (U.S. 2009/0137952).
Ramamurthy incorporates U.S. application 11/637,951 at least at paragraph [0113] for example. This corresponds to U.S. 2007/0197896 to Moll et al.
With respect to claim 1, Ramamurthy et al. teaches a method for navigating an endoscopic device through an anatomical luminal network of a patient, the method comprising:
(a) commanding a distal tip of an articulating elongate member to move along a pre- determined path (1705 for example);
(b) concurrent with (a), collecting real-time positional sensor data and real-time kinematics data (1710 for example), wherein the real-time positional sensor data is captured by an electromagnetic (EM) sensor and provides a rotation of an EM sensor frame with respect to a static EM field generator frame (para [0217] of Moll et al. for example) wherein the real-time kinematics data provides a rotation of the distal tip with respect to a base of the articulating elongate member (para [0210], FIG. 32 for example); and
(c) computing an estimated roll angle of the distal tip based at least in part on registration result and positional sensor data as input (para [0212], FIG. 32, 34 for example).
That is, Ramamurthy et al. does not explicitly teach the real-time kinematics is collected with real-time positional sensor data from an EM sensor. However, Ramamurthy et al. teaches the kinematics data utilizes “localization XYZ position of the distal tip of the instrument as measured by the localization system” in paragraph [0202] and “other localization technologies, such as electromagnetic and potential-difference based localization technologies, may also be used, depending upon the capabilities of the particular system employed” at paragraph [0126]. Therefore it would be obvious to one of ordinary skill in the art that the kinematics disclosed at FIG. 32 of Ramamurthy could be performed using an EM sensor.
With respect to claim 3, Ramamurthy et al. teaches the pre-determined path comprises a non- straight trajectory (see FIG. 2a for example).
With respect to claim 4, Ramamurthy et al. teaches the EM sensor is located at the distal tip of the articulating elongate member (FIG. 112b of Moll et al.).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALEXANDRA L NEWTON/Primary Examiner, Art Unit 3799