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 .
Claim Rejections - 35 USC § 112
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 10-26 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.
The term “most probable” in claim 19 is a relative term which renders the claim indefinite. The term “most probable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “particular neurological approach” in claim 21 is a relative term which renders the claim indefinite. The term “particular neurological approach” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 22-26 are rejected for the same reasons because they depend on claim 21.
The term “major portion” in claim 23 is a relative term which renders the claim indefinite. The term “major portion” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 102
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 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) 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leimbach et al (Pub. No.: US 2015/0272575)
Regarding claim 13, Leimbach et al disclose a surgical apparatus or assembly for use in
cooperation with a surgical navigation system, said apparatus or assembly comprising:
at least one surgical instrument having an operative tip or end effector [see 0175, 0260];
a plurality of sensor devices optionally of a non-optical active tracking device each disposed in a predetermined fixed position and predetermined fixed orientation on said instrument, each sensor device including a plurality of motion sensors [see 0372, 0376, 0417, 0431] by disclosing more than two sensors and each such sensor can comprise an accelerometer and/or a gyroscope [see 0372];
a microprocessor disposed on or mounted to said surgical instrument and operatively connected to said sensor devices [see 0360, 0373, 0436] by disclosing a surgical instrument, such as a surgical stapling instrument, for example, can include a processor, computer, and/or controller, for example, (herein collectively referred to as a “processor”) and one or more sensors in signal communication with the processor, computer, and/or controller [see 0360];
a power source disposed on or mounted to said surgical instrument and
operatively connected to said sensor devices [see 0034, 0041, 0234] by disclosing a surgical instrument comprising a power assembly [see 0034];
a wireless signal transmitter (electrical contacts 3410 transmit wireless to the microprocessor from the jaw; therefore, it behaves as a wireless signal transmitter) disposed on or mounted to said surgical instrument (in the jaw 3402 since it is part of the surgical instrument, emphasis added) and operatively connected to said microprocessor and said power source [see 0347, 0362] by disclosing the electrical contacts 3410 in the jaw 3402 can be in signal communication with the microcontroller of the surgical system. The electrical contacts 3410 can be wired to a power source, for example, and/or can communicate with the microcontroller via a wired and/or wireless connection [see 0347].
Alternatively, Leimbach et al also disclose the first sensor and/or the second sensor can communicate wirelessly with the processor. In at least one such instance, the first sensor can include a first wireless transmitter and the second sensor can include a second wireless transmitter, wherein the processor can include and/or can be in communication with at least one wireless signal receiver configured to receive the first signal and/or the second signal and transmit the signals to the processor [see 0363]
Since the first/second sensors are disposed on or mounted to said surgical instrument; therefore, the first wireless transmitter and the second wireless transmitter are also disposed on or mounted to said surgical instrument (emphasis added).
Regarding claim 14, Leimbach et al disclose wherein each of said sensor devices includes a motion sensor that is a gyroscopic element [see 0372, 0417], a motion sensor that is an accelerometer [see 0372], and a motion sensor that is a Hall Effect magnetic sensor [see 0205-0206, 0431] or magnetometer [see 0417].
Regarding claim 15, Leimbach et al disclose wherein said sensor devices are fixed to said surgical instrument at predetermined mutually spaced locations thereon [see 0372] by disclosing a first sensor can comprise a first accelerometer arranged along a first axis and a second sensor can comprise a second accelerometer arranged along a second axis which is different than the first axis. In at least one such instance, the first axis can be transverse to the second axis [see 0372].
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.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Leimbach et al (Pub. No.: US 2015/0272575) in view of Gettman (Pub. No.: US 2011/02822144).
Regarding claim 16, Leimbach et al don’t disclose wherein said surgical instrument includes a polymer core and a sturdy external layer on or over said core to provide structural integrity necessary for operative strain, said polymer core having a hollow cavity housing a capsule containing said sensor devices.
Nonetheless, Gettman discloses a polymer core (housing 402) and a sturdy external layer on or over said core to provide structural integrity necessary for operative strain, said polymer core having a hollow cavity housing a capsule containing said sensor devices (imaging devices) [see 0099, fig 4].
As well known in the art, polymeric material lightweight yet strong, making them ideal for applications requiring both strength and reduced weight; therefore, Polymer is inherently sturdy which will provide structural integrity necessary for operative strain (emphasis added).
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Leimbach et al and Gettman by using a polymer core and a sturdy external layer on or over said core to provide structural integrity necessary for operative strain, said polymer core having a hollow cavity housing a capsule containing said sensor devices; because Polymers are generally cheaper to produce than metals, leading to reduced manufacturing costs and more affordable products and they are lightweight yet strong, making them ideal for applications requiring both strength and reduced weight
Allowable Subject Matter
Claims 17-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance: No prior arts of record alone or in combination discloses the following:
Claim 17,
“operating said computer to calculate at least one relative vector between two of said inertial measurement units from the transmitted position and orientation data;
operating said computer to determine a difference between the calculated relative vector and a reference constraint determined by said predetermined fixed distances and said fixed orientations;
operating said computer to determine position and orientation of said object with
a correction or compensation owing to the difference between said calculated relative
vector and said reference constraint”
Claims 21-26 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 21.
“fastening component which is a device for fixating fixing a patient's head for a neurosurgical procedure, comprising a substantially rigid frame including a plurality of arcuate arms arranged in a predetermined configuration adapted to a particular neurosurgical approach,
said arms being connected to one another at a hub region, each of said arms being curved as to fit around a superior half of a-the patient's head, each of said arms being provided, at a free end, with a respective head contact member, wherein said arms optionally each include a central body portion having longitudinal edges and further include at least two flanges extending from said longitudinal edges perpendicularly to said central body portion or each include a superstructure made of hard and sturdy polymeric material, each of said arms being each coated on an interior or concave side with a layer of resilient material”
Claim 29 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim 29
“providing a tracking sensor assembly including a plurality of first tracking devices each having a
casing and a plurality of motion or inertial measurement sensors, said tracking sensor assembly including at least one first power source, at least one first signal transmitter,
and at least one first microprocessor operatively connected to one or more of said tracking devices;
disposing said first tracking devices at predetermined locations in a surgical operating room;
providing at least one surgical instrument carrying at least one second tracking device including a plurality of motion or inertial measurement sensors,
said at least one surgical instrument carrying at least one second power source, at least one second signal transmitter, and at least one second microprocessor all operatively connected to at least one of said motion or inertial measurement sensors;
operating the first tracking devices and the at least one second tracking device to transmit motion-encoding signals to a computer;
operating said computer to register and periodically or continuously update a location and orientation of said at least one surgical instrument relative to the patient, said computer being connected to a display device”
Claims 34-36 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 34.
“operating said calibration apparatus in a static calibration process to confirm that a local
magnetic field in said spatial region is static;
while maintaining said calibration magnetometer in a stationary position, determining a direction of a strongest magnetic field in said spatial region;
determining from measurements of said calibration apparatus a position of a source of a strongest magnetic field;
upon determining the direction of a strongest magnetic field in said spatial region, operating said calibration apparatus in a mobile calibration process to determine a 3D vector field map describing a magnetic vector as a function of position within at least a portion of said spatial region,
the operating said calibration apparatus in a mobile calibration process comprising moving said calibration sensor along a predetermined path within said spatial region at a controlled rate while tracking acceleration and position of said calibration sensor as a function of time”
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Prior Arts:
Claims 17 and 29,
Leimbach et al (Pub. No.: US 2015/0272575)
Leimbach et al disclose more than two sensors and each such sensor can comprise an accelerometer and/or a gyroscope [see 0372];
disclosing a surgical instrument, such as a surgical stapling instrument, for example, can include a processor, computer, and/or controller, for example, (herein collectively referred to as a “processor”) and one or more sensors in signal communication with the processor, computer, and/or controller [see 0360];
disclosing the electrical contacts 3410 in the jaw 3402 can be in signal communication with the microcontroller of the surgical system. The electrical contacts 3410 can be wired to a power source, for example, and/or can communicate with the microcontroller via a wired and/or wireless connection [see 0347].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3798