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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/28/2023, 05/01/2023, 07/25/2023, 03/15/2024, 11/27/2024, 04/10/2025, 07/29/2025, 11/30/2025 was filed before the mailing date of the FAOM. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-4, 7, 9-18, 24, and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rhodes et al (US20200041387A1 published 02/06/2020; hereinafter Rhodes).
Regarding claim 1, Rhodes teaches a microtomy system comprising:
a tissue chuck configured to accept a tissue block (a moving platform of a positioner 402 holding a tissues block 401 – Figs. 4A-C);
a microtome blade (a knife 408 – Figs. 4A-C) configured to remove one or more tissue sections from the tissue block (the knife 408 slices the tissue block 401 – Figs. 4A-C and paragraph 50), the microtome blade being axially offset from the tissue chuck along a horizontal axis (the knife 408 and the tissue block 401 are offset on a horizontal axis – Figs. 4A-C and paragraph 50), wherein the microtome blade and the tissue chuck are axially displaceable relative to one another along the horizontal axis (the knife 408 and the tissue block 401 movable relative to the horizontal axis – Figs. 4A-C and paragraph 50); and
a control system (central computer or cluster of computers – paragraph 39) configured to receive information indicative of a relative axial location of the microtome blade to the tissue chuck along the horizontal axis (Each positioner receives a signal from a driver and controller, which receive their signals from a central computer or cluster of computers – paragraphs 37 and 39), and to use a control loop to control the relative axial location of the microtome blade to the tissue chuck such that the one or more tissue sections have a desired thickness (One or more electronic controllers may coordinate the movement of actuators necessary to carry out this sequence of steps, in an open-loop manner, or closed-loop with the help of encoders, speed, or position sensors – paragraph 56).
Regarding claim 2, Rhodes teaches the microtomy system of claim 1 further comprising:
one or more position sensors configured to collect information indicative of the relative axial location of the microtome blade to the tissue chuck (encoders, speed, or position sensors – paragraph 56) and to communicate the relative axial location to the control system (One or more electronic controllers may coordinate the movement of actuators necessary to carry out this sequence of steps, in an open-loop manner, or closed-loop with the help of encoders, speed, or position sensors – paragraph 56); and
an actuator (a positioner 402 comprising linear actuators such as linear motors, rotary motors – paragraph 51), in communication with the control system, configured to displace the tissue chuck along the horizontal axis (using one positioner to move multiple components in the same direction, or in different directions by way of a multi-axis positioning stage – paragraph 51, 56 and Figs. 4A-D).
Regarding claim 3, Rhodes teaches the microtomy system of claim 1, wherein the control system further includes one or more position sensors (encoders, speed, or position sensors – paragraph 56) to measure an axial location of the tissue chuck and an axial location of the microtome blade along the horizontal axis (One or more electronic controllers may coordinate the movement of actuators necessary to carry out this sequence of steps, in an open-loop manner, or closed-loop with the help of encoders, speed, or position sensors – paragraph 56).
Regarding claim 4, Rhodes teaches the microtomy system of claim 1 further comprising:
an axial actuator (a positioner 402 comprising linear actuators such as linear motors, rotary motors – paragraph 51 and Figs. 4A-D) coupled the tissue chuck to axially displace the tissue chuck (the positioner 402 moves the tissue block 401 and moving platform – paragraph 51 and Figs. 4A-D),
wherein the control system is configured to actuate the axial actuator to displace the tissue chuck as a function of the relative axial location of the microtome blade to the tissue chuck (One or more electronic controllers may coordinate the movement of actuators necessary to carry out this sequence of steps, in an open-loop manner, or closed-loop with the help of encoders, speed, or position sensors – paragraph 56).
Regarding claim 7, Rhodes teaches the microtomy system of claim 1 further comprising one or more force sensors positioned on the tissue chuck (Application force may be varied by means of voltage, current, pulse cycle to electric actuators – paragraph 85) and configured to determine a force applied to the tissue block from the microtome blade (the electric actuators is deemed capable of being used to determine a force applied between the tissue block from the microtome blade – paragraph 85).
Regarding claim 9, Rhodes teaches the microtomy system of claim 1, further comprising an actuator (a positioner 402 comprising linear actuators such as linear motors, rotary motors – paragraph 39 and Figs. 4A-D), in communication with the control system, configured to displace the tissue chuck along a vertical axis (the positioner 402 which may be called a sample block holder 402 – paragraph 51, 56 and Figs. 4A-D).
Regarding claim 10, Rhodes teaches the microtomy system of claim 9, wherein the actuator is coupled to a leadscrew (rotary motors coupled to transmission screws – paragraph 51) via a non-rigid system configured to decouple the leadscrew from the actuator (a rotary solenoids, a cam, or a linkage transmission capable of decoupling the rotary motor – paragraph 51) .
Regarding claim 11, Rhodes teaches the microtomy system of claim 1, further comprising an actuator (a positioner 402 comprising linear actuators such as linear motors, rotary motors – paragraph 39 and Figs. 4A-D), in communication with the control system, configured to displace the tissue chuck along the horizontal axis (the positioner 402 which may be called a sample block holder 402 – paragraph 51, 56 and Figs. 4A-D), wherein the control loop controls the actuator to displace the tissue chuck along the horizontal axis such that the one or more tissue sections have a desired thickness (One or more electronic controllers may coordinate the movement of actuators necessary to carry out this sequence of steps, in an open-loop manner, or closed-loop with the help of encoders, speed, or position sensors – paragraph 56).
Regarding claim 12, Rhodes teaches the microtomy system of claim 1, further comprising an actuator (a positioner 402 comprising linear actuators such as linear motors, rotary motors capable of moving the tissue block 401 vertically – paragraph 39 and Figs. 4A-D), in communication with the control system, configured to displace the tissue chuck along a vertical axis (the positioner 402 which may be called a sample block holder 402 – paragraph 51, 56 and Figs. 4A-D), wherein the control loop controls the actuator to displace the tissue chuck along the vertical axis such that the one or more tissue sections have a desired thickness (One or more electronic controllers may coordinate the movement of actuators necessary to carry out this sequence of steps, in an open-loop manner, or closed-loop with the help of encoders, speed, or position sensors – paragraph 56).
Regarding claim 13, Rhodes teaches the microtomy system of claim 1, further comprising:
a first actuator (linear actuators such as linear motors, rotary motors of the positioner 402 – paragraph 51), in communication with the control system, configured to displace the tissue chuck along the horizontal axis (Two or more positioners may be combined, for example by using one positioner to move multiple components in the same direction, or in different directions by way of a multi-axis positioning stage – paragraph 51); and
a second actuator (a moving platform of the positioner 402 – paragraph 39 and Figs. 4A-D), in communication with the control system, configured to displace the tissue chuck along a vertical axis (the sample block 401 moves vertically – Figs. 4A-D), wherein the control loop controls the first actuator to displace the tissue chuck along the horizontal axis and the second actuator to displace the tissue chuck along the vertical axis such that the one or more tissue sections have a desired thickness (Each positioner receives a signal from a driver and controller, which receive their signals from a central computer or cluster of computers – paragraph 39).
Regarding claim 14, Rhodes teaches the microtomy system of claim 1 further comprising:
a first actuator (a moving platform of the positioner 402 – paragraph 39 and Figs. 4A-D), in communication with the control system (Each positioner receives a signal from a driver and controller – paragraph 39), configured to displace the tissue chuck along a vertical axis (the sample block 401 moves vertically – Figs. 4A-D); and
a second actuator (linear actuators such as linear motors, rotary motors of the positioner 402 – paragraph 51), in communication with the control system (Each positioner receives a signal from a driver and controller – paragraph 39), configured to displace the tissue chuck along the horizontal axis (Two or more positioners may be combined, for example by using one positioner to move multiple components in the same direction, or in different directions by way of a multi-axis positioning stage – paragraph 51).
Regarding claim 15, Rhodes teaches a control system, comprising:
at least one non-transitory computer-readable storage medium (central computer or cluster of computers – paragraph 39) having encoded thereon executable instructions that (a signal from a driver and controller, which receive their signals from a central computer or cluster of computers – paragraph 39), when executed by at least one processor, cause the at least one processor to carry out a method comprising:
receiving information indicative of a relative axial location of a microtome blade (knife 408 – Fig. 4A-D) to a tissue chuck (moving platform – Fig. 4A-D and paragraph 51) along a horizontal axis (return the applicator 406 and knife 408 to their initial positions – paragraph 55 and Fig. 4D) (the computer moves the knife 408 an initial position and is deemed to read on “a relative axial location” between the knife 408 and based 403), wherein:
the microtome blade is configured to remove one or more tissue sections from a tissue block accepted in the tissue chuck (Each positioner receives a signal from a driver and controller, which receive their signals from a central computer or cluster of computers – paragraphs 37 and 39); and
the microtome blade and the tissue chuck are axially displaceable relative to one another along the horizontal axis (the knife 408 and the tissue block 401 displaceable relative to each other along the horizontal axis – Figs. 4A-D and paragraph 50); and
using a control loop to control the relative axial location of the microtome blade to the tissue chuck such that the one or more tissue sections have a desired thickness (One or more electronic controllers may coordinate the movement of actuators necessary to carry out this sequence of steps, in an open-loop manner, or closed-loop with the help of encoders, speed, or position sensors – paragraph 56).
Regarding claim 16, Rhodes teaches the control system of claim 15, wherein the method further comprises: receiving the relative axial location of the microtome blade to the tissue chuck from one or more position sensors (encoders, speed, or position sensors – paragraph 56) configure to collect information indicative of the relative axial location (One or more electronic controllers may coordinate the movement of actuators necessary to carry out this sequence of steps, in an open-loop manner, or closed-loop with the help of encoders, speed, or position sensors – paragraph 56); and controlling an actuator to displace the tissue chuck along the horizontal axis (Each positioner receives a signal from a driver and controller, which receive their signals from a central computer – paragraph 39).
Regarding claim 17, Rhodes teaches the control system of claim 16, wherein the one or more position sensors (position sensors – paragraph 56) are configured to measure (sensors for other aspects of method automation also connect, optionally via drivers and controllers, to a computer or cluster – paragraph 39) an axial location of the tissue chuck and an axial location of the microtome blade along the horizontal axis (position sensors, controlled by the computer, is capable of measuring locations and is deemed to read on “configured to measure axial location” of the knife and moving platform – Fig. 4A-D).
Regarding claim 18, Rhodes teaches the control system of claim 15, wherein the method further comprises actuating an axial actuator (a positioner 402 comprising linear actuators such as linear motors, rotary motors – paragraph 51 and Figs. 4A-D) coupled to the tissue chuck to displace the tissue chuck as a function of the relative axial location of the microtome blade to the tissue chuck (the motion of one or more positioners may be nonlinear, such as rotary solenoids, or indirectly linked to an actuator, such as by a cam or linkage transmission – Figs. 4A-D and paragraph 51).
Regarding claim 24, Rhodes teaches a microtomy system, comprising:
one or more position sensors (encoders, speed, or position sensors – paragraph 56) configured to collect information indicative of a relative axial location along a horizontal axis of a microtome blade to a tissue chuck (Similarly, valves and sensors for other aspects of method automation also connect, optionally via drivers and controllers, to a computer or cluster – paragraph 39), wherein:
the microtome blade is configured to remove one or more tissue sections from a tissue block (a knife 408 cuts a tissue block 401 – Figs. 4A-D), the microtome blade being axially offset from the tissue chuck along the horizontal axis (the knife 408 is horizontally offset from the tissue block 401 – Figs. 4A-D); and
the microtome blade and the tissue chuck are axially displaceable relative to one another along the horizontal axis (the knife 408 and the tissue block 401 move relative to each other horizontally – Figs. 4A-D); and
a control system configured to receive information indicative of a relative axial location of the microtome blade to the tissue chuck along the horizontal axis (Each positioner receives a signal from a driver and controller, which receive their signals from a central computer or cluster of computers – paragraphs 37 and 39), and to use a control loop to control the relative axial location of the microtome blade to the tissue chuck such that the one or more tissue sections have a desired thickness (One or more electronic controllers may coordinate the movement of actuators necessary to carry out this sequence of steps, in an open-loop manner, or closed-loop with the help of encoders, speed, or position sensors – paragraph 56).
Regarding claim 37, Rhodes teaches a microtomy system for controlling tissue section thickness, the microtomy system comprising:
a tissue chuck configured to accept a tissue block (a moving platform of a positioner 402 holding a tissues block 401 – Figs. 4A-C);
a microtome blade (a knife 408 – Figs. 4A-D) configured to remove one or more tissue sections from the tissue block (the knife 408 slices the tissue block 401 – Figs. 4A-D), the microtome blade being axially offset from the tissue chuck along a horizontal axis (the knife 408 is offset from the tissue block 401 – Figs. 4A-D), wherein the microtome blade and the tissue chuck are axially displaceable relative to one another along the horizontal axis (the knife 408 moves towards the tissue block 401 – Figs. 4A-D);
one or more sensors (encoders, speed, or position sensors – paragraph 56) configured to collect information indicative of a relative axial location along the horizontal axis of the microtome blade to the tissue chuck (One or more electronic controllers may coordinate the movement of actuators necessary to carry out this sequence of steps, in an open-loop manner, or closed-loop with the help of encoders, speed, or position sensors – paragraph 56);
an actuator (a positioner 402 – Figs. 4A-D) configured to displace the tissue chuck along the horizontal axis (using one positioner to move multiple components in the same direction, or in different directions by way of a multi-axis positioning stage – paragraph 51, 56 and Figs. 4A-D); and
a control system (central computer or cluster of computers – paragraph 39) configured to receive information indicative of a relative axial location of the microtome blade to the tissue chuck along the horizontal axis (Each positioner receives a signal from a driver and controller, which receive their signals from a central computer or cluster of computers – paragraphs 37 and 39, and to use a control loop to control the relative axial location of the microtome blade to the tissue chuck such that the one or more tissue sections have a desired thickness (One or more electronic controllers may coordinate the movement of actuators necessary to carry out this sequence of steps, in an open-loop manner, or closed-loop with the help of encoders, speed, or position sensors – paragraph 56).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-6 is rejected under 35 U.S.C. 103 as being unpatentable over Rhodes in view of Chen et al (US20170122844A1 published 05/04/2017; hereinafter Chen).
Regarding claim 5, Rhodes teaches the microtomy system of claim 1.
However, Rhodes does not teach a series of elastic actuators for clamping the microtome blade that has an anisotropic structure so that it can provide high clamping forces on the microtome blade and conform to an opposing clamping plate - blade system in another direction, while dissipating energy to passively control vibrations of the microtome blade.
Chen teaches a microtome with a flexure drive comprising a series of elastic actuators (flexure F2 and flexure F1 – Fig. 3A) for clamping the microtome blade that has an anisotropic structure (flexure F2 and flexure F1 have different stiffnesses in difference directions – Fig. 3A and paragraph 12) so that it can provide high clamping forces on the microtome blade and conform to an opposing clamping plate - blade system in another direction (first flexure configured to be compliant in the transverse direction while being stiff in the cut direction – paragraph 12), while dissipating energy to passively control vibrations of the microtome blade (oscillates the blade in the transverse direction while effectively isolating non-transverse motion from the blade – paragraph 12). Chen teaches to use a flexure drive to gain the advantage of an oscillating microtome for cutting thick sections from non-embedded or fresh tissue samples (paragraph 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the knife 408, as taught by Rhodes, with the flexure drive microtome, taught by Chen, to gain the oscillating microtome superior for cutting thick sections from non-embedded or fresh tissue samples. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Rhodes and Chen teach microtome systems from cutting tissue samples.
Regarding claim 6, Rhodes, modified by Chen, teaches the microtomy system of claim 5 further comprising:
one or more force sensors (encoders, speed, or position sensors – Rhodes paragraph 56) configured to collect information indicative of the relative axial location of the microtome blade to the tissue chuck and to communicate the relative axial location to the control system (One or more electronic controllers may coordinate the movement of actuators necessary to carry out this sequence of steps, in an open-loop manner, or closed-loop with the help of encoders, speed, or position sensors – Rhodes paragraph 56); and
an actuator (a positioner 402 comprising linear actuators such as linear motors, rotary motors – Rhodes paragraph 51 and Figs. 4A-D), in communication with the control system, configured to displace the tissue chuck along the horizontal axis (the positioner 402 moves the tissue block 401 – Rhodes paragraph 51 and Figs. 4A-D).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Rhodes in view of Chen (US20220120641A1 filed 10/16/2020; hereinafter Chen’641).
Regarding claim 8, Rhodes teaches the microtomy system of claim 1.
However, Rhodes does not teach wherein the information indicative of the relative axial location is a force applied to the tissue block from the microtome blade.
Chen’641 teaches an oscillating microtome with a flexure drive wherein the information indicative of the relative axial location is a force applied to the tissue block from the microtome blade (active vibration control comprising a sensor 16, measuring motions and forces, generating a signal about the motions and the forces; a vibration controller 17, receiving the signal from the sensor 16 – paragraph 42). Chen’641 also teaches to use the active vibration control and oscillating blade to reduce parasitic blade motions (paragraph 25) and improve sectioning results (paragraph 26).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the knife 408, as taught by Rhodes, with oscillating microtome and controller, taught by Chen’641, to reduce parasitic blade motions and improve sectioning results. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Rhodes and Chen’641 teach microtome systems from cutting tissue samples.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20140026683A1 – a microtome system comprising a non-transitory computer-readable storage medium having computer-executable instructions
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/T.C.S./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796