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 14-15 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.
Claim 14 recites the limitations "a first region of the cam path and a second region of the cam path" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 13 previously introduced first and second regions of the cam path, and the claims are unclear as to whether these are the same regions or different regions. For the purposes of examination, the regions will be considered the same. Claim 15 is rejected for their dependency on claim 14.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Grace et al. (Pub. No. 2023/0346418).
Regarding claim 1, Grace et al. discloses an intraluminal cutting device (100; FIG. 1; [0163]), comprising:
a flexible elongate member (106) configured to be positioned within a body lumen of a patient (FIG. 1: 106 is inserted into the body of a subject S), wherein the flexible elongate member comprises a proximal portion (FIG. 2: the connection to handle assembly 104) and a distal portion (554; FIGs. 5A-5D; [0181]);
a cutting tip assembly (528) positioned at the distal portion of the flexible elongate member (FIG. 5A: the cutting tip assembly is at the distal end of 106), wherein the cutting tip assembly comprises a cam pin (558), a cam slot (556), and a blade (534) configured to cut tissue associated with the body lumen ([0185] 534 is used to cut tissue),
wherein the cam pin is configured to move within the cam slot along a cam path ([0181] 558 moves within 556; FIGs. 5B-5D), and
wherein the cam pin is configured to oscillate along only a portion of the cam path ([0173] 534 can assume a partially extended first extended configuration where 558 has only moved part of the way through 556; FIG. 5C).
Regarding claim 2, Grace et al. further discloses, in a first mode of operation, the cam pin is configured to move along an entirety of the cam path ([0173] fully extended configuration; FIG. 5D), and wherein the cam pin oscillating along only the portion of the cam path is associated with a second mode of operation ([0173] partially extended configuration; FIG. 5C).
Regarding claim 3, Grace et al. further discloses, in the first mode of operation, the blade is configured to provide a first type of cutting of the tissue ([0173] and FIG. 5C: when 534 cuts tissue while fully extended out of the distal end, 534 will cut in a first method), and wherein, in the second mode of operation, the blade is configured to provide a second type of cutting of the tissue ([0173] and FIG. 5C: when 534 cuts tissue while partially extended out of the distal end, 534 will cut in a second method).
Regarding claim 4, Grace et al. further discloses the first type of cutting of the tissue is associated with rotational movement of the blade ([0185] 534 rotates to cut tissue), and wherein the second type of cutting of the tissue is associated with longitudinal movement of the blade ([0185] 534 is moved longitudinally into position to cut the tissue).
Regarding claim 5, Grace et al. further discloses the cutting tip assembly is coupled to the flexible elongate member (FIG. 5A: 528 is coupled to 106), wherein, in the second mode of operation, the cam pin oscillating along only the portion of the cam path is associated with the flexible elongate member oscillating (FIG. 5C: 106 moves partially longitudinally for 558 to move partially within 556).
Regarding claim 6, Grace et al. further discloses the second mode of operation is associated with rotational movement of the flexible elongate member (FIG. 5C: 106 partially rotates relative to 534 to partially move 558 within 556).
Regarding claim 7, Grace et al. further discloses the cam pin reciprocating along only the portion of the cam path is associated with a third mode of operation ([0182] 556 can have a combination of profiles that would allow for additional positions that correspond to other methods of cutting).
Regarding claim 8, Grace et al. further discloses a handle (104) positioned at the proximal portion of the flexible elongate member (FIG. 2); and a motor (314; [0169]; FIG. 3A) positioned within the handle (FIG. 3A: the electric motor of 314 is within housing 308), wherein the motor is configured to control the cam pin to oscillate along only a portion of the cam path ([0184] 314 controls the path of 534, including how 558 moves within 556).
Regarding claim 9, Grace et al. further discloses a processor circuit ([0209] controller 2404 has processors) positioned within the handle (FIG. 17: 2348, which includes 2404, is within the handle), wherein the processor circuit is configured to control the motor ([0078] the processors control the device functions).
Regarding claim 10, Grace et al. further discloses a battery ([0169] a battery can be the power supply for the motor) positioned within the handle ([0169] the battery is within 308), wherein the battery is configured to power the motor and the processor circuit ([0169] the battery powers the device, including the motor and processor).
Regarding claim 11, Grace et al. further discloses the cam pin oscillating along only the portion of the cam path is associated with a mode of operation ([0173] partially extended configuration; FIG. 5C), wherein the processor circuit is configured to receive a user input associated with the mode of operation ([0209] when the clinician activates the trigger, the processor receives the signal), and wherein the processor circuit is configured to control the motor in response to the user input ([0209] when the processor receives the signal, the motor is activated).
Regarding claim 12, Grace et al. further discloses the cam pin oscillating along only the portion of the cam path is associated with a mode of operation ([0173] partially extended configuration; FIG. 5C), wherein the processor circuit is configured to determine a duration for the mode of operation ([0243] 2404 determines the duration of usage of the motor), and wherein the processor circuit is configured to control the motor in response to determining the duration ([0243] 2402 controls the motor to ensure the motor only goes for the predetermined threshold).
Regarding claim 13, Grace et al. further discloses the portion of the cam path is associated with a first region of the cam path (FIG. 5B: the initial region where 558 is in the unexpanded state) and a second region of the cam path (FIG. 5D: the final region where 558 is in the fully expanded state).
Regarding claim 14, Grace et al. further discloses the first region of the cam path and the second region of the cam path are opposite to one another along the cam path (FIGs. 5B and 5D: the initial and final positions of 558 are on opposite sides of 556).
Regarding claim 15, Grace et al. further discloses the processor circuit is configured to control the motor such that the cam pin alternates between oscillating along the first region of the cam path; and oscillating along the second region of the cam path ([0078] the processors control the device functions, including the change in regions between the unexpanded, partially expanded, and fully expanded configurations).
Regarding claim 16, Grace et al. discloses an intraluminal cutting device (100; FIG. 1; [0163]), comprising:
a flexible elongate member (106) configured to be positioned within a body lumen of a patient (FIG. 1: 106 is inserted into the body of a subject S), wherein the flexible elongate member comprises a proximal portion (FIG. 2: the connection to handle assembly 104), a distal portion (554; FIGs. 5A-5D; [0181]), and a lumen configured to receive a medical device (FIG. 5A: 106 has a longitudinal lumen along axis 326);
a handle (104) positioned at the proximal portion of the flexible elongate member (FIG. 2), wherein the handle comprises a motor (314; [0169]; FIG. 3A), a processor circuit ([0209] controller 2404 has processors), and a battery ([0169] a battery can be the power supply for the motor); and
a cutting tip assembly (528) positioned at the distal portion of the flexible elongate member (FIG. 5A: the cutting tip assembly is at the distal end of 106), wherein the cutting tip assembly comprises a cam pin (558), a cam slot (556), and a blade (534) configured to cut tissue associated with the body lumen ([0185] 534 is used to cut tissue),
wherein processor is configured to control the motor to cause the cam pin to move within the cam slot along a cam path (([0078] the processors control the device functions, including [0181] 558 moves within 556; FIGs. 5B-5D), and
wherein the cam pin is configured to oscillate along only a portion of the cam path ([0173] 534 can assume a partially extended first extended configuration where 558 has only moved part of the way through 556; FIG. 5C) such that the blade is configured to provide repeated longitudinal contact with the tissue ([0181] 534 is capable of being advanced and retracted multiple times).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES R MCGINNITY/Examiner, Art Unit 3771
