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 .
Response to Amendment
The amendment filed April 14, 2026 has been entered. Claims 1-29 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112 and 101 rejection previously set forth in the Non- Final Office Action mailed January 14, 2026. Applicant’s amendments to the claims necessitate new grounds of rejection, as described in the Response to Arguments and 102/103 Rejections below.
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, 4-5, 8-12, 17, 20-21, and 24-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “A New Apparatus for Recording Evoked Responses to Painful and Non-painful Sensory Stimulation in Freely Moving Mice” (Zhang et al, 2021) (hereinafter referred to as “Zhang”).
Regarding claim 1, Zhang teaches an apparatus for automated measurement of pain and responses to various somatosensory stimuli in laboratory rodents, comprising:
one or more enclosures for one or more rodents, each enclosure configured to house one rodent (Fig. 1A – “chamber”);
a platform on which said one or more enclosures are positioned (Figs. 1-2 – Fig. 2A “upper platform”);
a moveable device positioned underneath said platform and enclosures (Fig. 1A – “stimulator”) and configured to:
aim at a target paw of at least one of the one or more rodents (Page 5, Col. 1: Control Unit - “targeting the stimulator to the mouse paw”),
deliver one or more different stimulus modalities, alone or in combination, to the target paw (Page 5, Col. 1: Tactile Stimulator – ‘tactile stimulator was constructed in-house to be interchangeable with the laser stimulator”),
measure one or more signals associated with an interaction between the target paw and the moveable device during delivery of the one or more different stimulus modalities (Pages 2-3: Custom Made Apparatus for Sensory Testing: “The camera also recorded a red indicator-LED light on top of the mouse platform indicating when the laser or the mechanical stimulation had been triggered. This signal facilitates synchronization of stimulation and recording, measuring paw withdrawal latency and aligning evoked potentials.”; Page 5, Col. 2: Tactile Stimulator: “Tests were performed to measure the time taken between the TTL signal input and the physical stimulation of the paw.”; Page 9, Col. 1: Results: “Electrophysiological recordings and the stimulation signals were synchronized by a trigger signal from a custom-made control unit”);
detect changes in position of the target paw with millisecond precision based on changes in the measured one or more signals (Page 9, Col. 2: Results: “There was a significant increase of hind paw guarding time after 10 ms laser stimulation compared to 3 or 5 ms”; 13, Col. 1: Discussion – “In addition to paw withdrawal, we also measured other pain-induced behaviors like guarding, flinching and freezing”; Page 4, Col. 2: Control Unit: “Trigger two was set to 100 ms and is used to drive the red LED in view of the lateral camera (100 ms is sufficient time to produce a reliable video signal when the laser is triggered), and this trigger was also fed into the electrophysiological recording system for synchronization with the LED-on period in the video”), and
collect video of rodent activity (Page 4, Col. 2 – Control Unit: “the video would start recording 3 s before the stimulation and continue recording 30 s after the stimulation.”; Page 9, Col. 1: Results – “to facilitate the alignment of the stimulation and the behaviors via video”); and
a controller operably connected to the moveable device (Page 2, Col. 2: Custom Made Apparatus for Sensory Testing – “The horizontal position of the stimulator could be freely determined by manually moving the connected control stick (Figure 1A).”) and configured to:
coordinate all aspects of stimulation using programmed instructions (Page 4, Col. 1: Control Unit - “separate control unit (Figures 2D, 3) was designed to handle the following functions: i. Triggering of the laser/tactile stimulator either manually or automatically; ii. Triggering the red LED indicator (in view of the lateral camera); iii. Controlling recording intervals of the lateral camera as required by the experiment; iv. Initiate trials with random timing within a pre-set minimum and maximum time interval.”),
synchronize recorded data with stimulus timing and calculate withdrawal latency therefrom (Page 3, Col. 1: Custom Made Apparatus for Sensory Testing - “This signal facilitates synchronization of stimulation and recording, measuring paw withdrawal latency”), and
automatically record all data, metadata, and calculations to electronic files (Page 5, Col. 1: Control Unit – “All electrophysiological and video data was recorded on a PC for later offline analysis”).
Regarding claim 4, Zhang teaches the apparatus according to claim 1, wherein the platform is made of an optically clear material, and wherein the moveable device is adapted to provide infrared (IR) light for thermal stimulation via radiant heating (Page 2, Col. 2: Custom Made Apparatus for Sensory Testing – “We used an infrared laser stimulator (MRC Systems GmbH, Germany) of 1470 nm and with pulse durations from 1 – 100 ms (pulse energy 1.2 – 306 mJ) (Figure 1B). A pilot laser of 650 nm (red light, visible to naked eye) indicted the position of the laser beam.”, “A circular grid plate (100 mm in diameter) was produced by a 3D printer (Formlabs Form2, United States) and inserted in the hole in the top plate to create a floor for the animal that allows laser/tactile stimulation to be conducted without obstruction (Figures 2A,B). A transparent plexiglass cylinder (120 mm in diameter) was then placed vertically on top of the circular grid, bordering the experimental arena of the mouse (Figure 1A).”).
Regarding claim 5, Zhang teaches the apparatus according to claim 1, wherein the platform is metal grating, and wherein the moveable device includes a mechanostimulator which is adapted to stimulate by physical contact with the target paw (Page 2, Col. 2: Custom Made Apparatus for Sensory Testing – “We used an infrared laser stimulator (MRC Systems GmbH, Germany) of 1470 nm and with pulse durations from 1 – 100 ms (pulse energy 1.2 – 306 mJ) (Figure 1B). A pilot laser of 650 nm (red light, visible to naked eye) indicted the position of the laser beam.”, “A circular grid plate (100 mm in diameter) was produced by a 3D printer (Formlabs Form2, United States) and inserted in the hole in the top plate to create a floor for the animal that allows laser/tactile stimulation to be conducted without obstruction (Figures 2A,B). A transparent plexiglass cylinder (120 mm in diameter) was then placed vertically on top of the circular grid, bordering the experimental arena of the mouse (Figure 1A).”; (Fig. 4 – “Electronic design of the tactile stimulator. The 27 V signal is reduced to 5 V to power the NE555 chip which is responsible for the duration of the pulse sent to the actuator. U5 regulates the output voltage to 24 V when the input voltage is equal to, or more than 27 V: Using an input voltage of less than 27 V reduces the force applied to the actuator and increases the actuation time.”; Fig. 5F - “View of the lateral camera showing the moment of paw withdrawal following laser stimulation.”).
Regarding claim 8, Zhang teaches the apparatus according to claim 1, wherein said one or more stimulus modalities include light, heat, mechanical, chemical agents, and any combination thereof (Page 9, Col. 1: Results - “The apparatus was tested for painful heat stimuli, using a laser beam, and for tactile stimulation with an electrically driven mechanical actuator (Figure 2E).”; Page 3, Col. 2: Custom Made Apparatus for Sensory Testing “different responses to laser- and mechanical stimuli which both activated the LED in the same manner”).
Regarding claim 9, Zhang teaches the apparatus according to claim 1, wherein said moveable device is configured to provide different stimulus modalities sequentially to test different stimulus modalities on separate trials (Page 7, Col. 2: Stimulation, Electrophysiology, and Behavior – “Tactile stimulations were applied 3–6 times onto the right hind paw of the mouse while it was awake and immobile. Then, the tactile stimulator was replaced by the laser which was used to stimulate the right hind paw for 3–6 times.”).
Regarding claim 10, Zhang teaches the apparatus according to claim 1, wherein said moveable device is configured to provide two or more different stimulus modalities together on a given trial (Page 10, Col. 2: Discussion – “The trigger signal of the stimulus is synchronized with LFP recordings by a custom made control unit, while behavioral reactions are recorded by a lateral camera which is synchronized with the stimulus by an indicator-LED light.”; Page 7, Col. 2: Stimulation, Electrophysiology, and Behavior – “Experimental trials were conducted after habituation. The indicator LED was turned toward the lateral camera for video recording. Before the real stimulation, both mechanical and laser stimuli were tested without targeting on the mouse (targeting the empty space of the grid plate), to make sure that the stimulation worked and that the red light of the indicator LED did not evoke any paw withdrawal or other pain-like behaviors.”).
Regarding claim 11, Zhang teaches the apparatus according to claim 1, wherein said moveable device includes a source of red light configured to be aimed at said target paw in order to assist aiming by identifying a photostimulation zone prior to initiating photostimulation with other wavelengths of light (Page 9, Col. 1: Results – “The indicator LED beside the chamber shined red light toward the lateral camera when stimulation was triggered, to facilitate the alignment of the stimulation and the behaviors via video.”; Page 2, Col. 2: Custom Made Apparatus for Sensory Testing – “We used an infrared laser stimulator (MRC Systems GmbH, Germany) of 1470 nm and with pulse durations from 1 – 100 ms (pulse energy 1.2 – 306 mJ) (Figure 1B). A pilot laser of 650 nm (red light, visible to naked eye) indicted the position of the laser beam.”).
Regarding claim 12, Zhang teaches the apparatus according to claim 1, wherein the moveable device is mounted on a set of motorized actuators and is configured to be aimed at the target paw under user control from a human operator via computer using a joystick or keypad (Page 9, Col. 1: Results - “The apparatus was tested for painful heat stimuli, using a laser beam, and for tactile stimulation with an electrically driven mechanical actuator (Figure 2E). The position of the laser beam and the actuator can be manually controlled by a control stick under guidance by a video-image from underneath the animal (Figures 1A, 2C).”).
Regarding claim 17, Zhang teaches a method for automated measurement of pain and responses to various somatosensory stimuli in laboratory rodents, comprising:
confining one or more rodents individually in one or more enclosures (Fig. 1A – “chamber”) in which said one or more enclosures are located on a platform (Figs. 1-2 – Fig. 2A “upper platform”);
directing a moveable device positioned underneath said platform and enclosures (Fig. 1A – “stimulator”) for:
aiming one or more different sources of stimulation, alone or in combination, at a target paw at least one of the one or more rodents (Page 5, Col. 1: Control Unit - “targeting the stimulator to the mouse paw”),
delivering one or more different stimulus modalities, alone or in combination, to the target paw (Page 5, Col. 1: Tactile Stimulator – ‘tactile stimulator was constructed in-house to be interchangeable with the laser stimulator”),
measuring one or more signals associated with an interaction between the target paw and the moveable device during delivery of the one or more different stimulus modalities (Pages 2-3: Custom Made Apparatus for Sensory Testing: “The camera also recorded a red indicator-LED light on top of the mouse platform indicating when the laser or the mechanical stimulation had been triggered. This signal facilitates synchronization of stimulation and recording, measuring paw withdrawal latency and aligning evoked potentials.”; Page 5, Col. 2: Tactile Stimulator: “Tests were performed to measure the time taken between the TTL signal input and the physical stimulation of the paw.”; Page 9, Col. 1: Results: “Electrophysiological recordings and the stimulation signals were synchronized by a trigger signal from a custom-made control unit”);
detecting changes in position of the target paw with millisecond precision based on changes in the measured one or more signals (Page 9, Col. 2: Results: “There was a significant increase of hind paw guarding time after 10 ms laser stimulation compared to 3 or 5 ms”; 13, Col. 1: Discussion – “In addition to paw withdrawal, we also measured other pain-induced behaviors like guarding, flinching and freezing”; Page 4, Col. 2: Control Unit: “Trigger two was set to 100 ms and is used to drive the red LED in view of the lateral camera (100 ms is sufficient time to produce a reliable video signal when the laser is triggered), and this trigger was also fed into the electrophysiological recording system for synchronization with the LED-on period in the video”), and
collect video of rodent activity (Page 4, Col. 2 – Control Unit: “the video would start recording 3 s before the stimulation and continue recording 30 s after the stimulation.”; Page 9, Col. 1: Results – “to facilitate the alignment of the stimulation and the behaviors via video”); and
using a controller operably connected to the moveable device (Page 2, Col. 2: Custom Made Apparatus for Sensory Testing – “The horizontal position of the stimulator could be freely determined by manually moving the connected control stick (Figure 1A).”) for:
coordinating all aspects of stimulation using programmed instructions (Page 4, Col. 1: Control Unit - “separate control unit (Figures 2D, 3) was designed to handle the following functions: i. Triggering of the laser/tactile stimulator either manually or automatically; ii. Triggering the red LED indicator (in view of the lateral camera); iii. Controlling recording intervals of the lateral camera as required by the experiment; iv. Initiate trials with random timing within a pre-set minimum and maximum time interval.”),
synchronizing recording of data with stimulus timing and calculate withdrawal latency therefrom (Page 3, Col. 1: Custom Made Apparatus for Sensory Testing - “This signal facilitates synchronization of stimulation and recording, measuring paw withdrawal latency”), and
automatically recording all data, metadata, and calculations to electronic files (Page 5, Col. 1: Control Unit – “All electrophysiological and video data was recorded on a PC for later offline analysis”).
Regarding claim 20, Zhang teaches the method according to claim 17, wherein the platform is made of an optically clear material, and wherein the moveable device is adapted to provide infrared (IR) light for thermal stimulation via radiant heating (Page 2, Col. 2: Custom Made Apparatus for Sensory Testing – “We used an infrared laser stimulator (MRC Systems GmbH, Germany) of 1470 nm and with pulse durations from 1 – 100 ms (pulse energy 1.2 – 306 mJ) (Figure 1B). A pilot laser of 650 nm (red light, visible to naked eye) indicted the position of the laser beam.”, “A circular grid plate (100 mm in diameter) was produced by a 3D printer (Formlabs Form2, United States) and inserted in the hole in the top plate to create a floor for the animal that allows laser/tactile stimulation to be conducted without obstruction (Figures 2A,B). A transparent plexiglass cylinder (120 mm in diameter) was then placed vertically on top of the circular grid, bordering the experimental arena of the mouse (Figure 1A).”).
Regarding claim 21, Zhang teaches the method according to claim 17, wherein the platform is metal grating, and wherein the moveable device includes a mechanostimulator which is adapted to stimulate by physical contact with the target paw (Page 2, Col. 2: Custom Made Apparatus for Sensory Testing – “We used an infrared laser stimulator (MRC Systems GmbH, Germany) of 1470 nm and with pulse durations from 1 – 100 ms (pulse energy 1.2 – 306 mJ) (Figure 1B). A pilot laser of 650 nm (red light, visible to naked eye) indicted the position of the laser beam.”, “A circular grid plate (100 mm in diameter) was produced by a 3D printer (Formlabs Form2, United States) and inserted in the hole in the top plate to create a floor for the animal that allows laser/tactile stimulation to be conducted without obstruction (Figures 2A,B). A transparent plexiglass cylinder (120 mm in diameter) was then placed vertically on top of the circular grid, bordering the experimental arena of the mouse (Figure 1A).”; (Fig. 4 – “Electronic design of the tactile stimulator. The 27 V signal is reduced to 5 V to power the NE555 chip which is responsible for the duration of the pulse sent to the actuator. U5 regulates the output voltage to 24 V when the input voltage is equal to, or more than 27 V: Using an input voltage of less than 27 V reduces the force applied to the actuator and increases the actuation time.”; Fig. 5F - “View of the lateral camera showing the moment of paw withdrawal following laser stimulation.”).
Regarding claim 24, Zhang teaches the method according to claim 17, wherein said moveable device includes a source of red light configured to be aimed at said target paw in order to assist aiming by identifying a photostimulation zone prior to initiating photostimulation with other wavelengths of light (Page 9, Col. 1: Results – “The indicator LED beside the chamber shined red light toward the lateral camera when stimulation was triggered, to facilitate the alignment of the stimulation and the behaviors via video.”; Page 2, Col. 2: Custom Made Apparatus for Sensory Testing – “We used an infrared laser stimulator (MRC Systems GmbH, Germany) of 1470 nm and with pulse durations from 1 – 100 ms (pulse energy 1.2 – 306 mJ) (Figure 1B). A pilot laser of 650 nm (red light, visible to naked eye) indicted the position of the laser beam.”).
Regarding claim 25, Zhang teaches the method according to claim 17, wherein the moveable device is mounted on a set of motorized actuators and is configured to be aimed at the target paw under user control from a human operator via computer using a joystick or keypad (Page 9, Col. 1: Results - “The apparatus was tested for painful heat stimuli, using a laser beam, and for tactile stimulation with an electrically driven mechanical actuator (Figure 2E). The position of the laser beam and the actuator can be manually controlled by a control stick under guidance by a video-image from underneath the animal (Figures 1A, 2C).”).
Claim Rejections - 35 USC § 103
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.
Claims 2 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over “A New Apparatus for Recording Evoked Responses to Painful and Non-painful Sensory Stimulation in Freely Moving Mice” (Zhang et al, 2021) in view of US 20160150758 A1 (Salem et al.).
Regarding claim 2, Zhang teaches the apparatus according to claim 1, wherein said enclosures each comprise a separate clear tube and opaque cubicle, wherein the clear tube is used to transfer each rodent from its home cage to the testing platform and to house the rodent during testing on the platform (Page 7, Col. 1: Surgery for Electrode Implantation - “After surgery, the animals were placed into their cage and the environment was maintained at 28C until the animals woke up. Immediately after waking, the animals were transferred to the housing scantainer for 1 week of recovery before recording.”; Page 2, Col. 2: Custom Made Apparatus for Sensory Testing – “A transparent plexiglass cylinder (120 mm in diameter) was then placed vertically on top of the circular grid, bordering the experimental arena of the mouse (Figure 1A)”; Page 7, Col. 1-2- Stimulation, Electrophysiology, and Behavior – “A cardboard partition was placed between the apparatus and the experimenter to prevent visual contact”).
Zhang does not explicitly teach wherein the opaque, magnetically connectable cubicles separate the rodents and position them at a desired spacing and alignment on the platform.
However,
Salem teaches wherein the opaque, magnetically connectable cubicles separate the rodents and position them at a desired spacing and alignment on the platform ([0046] “the door assembly 160 of the SCORHE enclosure 100 includes a hinged door 102 with a magnetic latch 104 to allow for insertion and removal of the home cage 20 from the rack 300 without removing the enclosure from the rack system … the bottom surface 141 may include combinations of transparent, translucent, or opaque portions”; [0040] “a ventilated cage rack system 300 that is compatible with the SCORHE 10 to increase the functionality of the rack system while also while maintaining the efficiency of using a readily-available multi-cage ventilated rack”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus taught by Zhang to include a magnetically connectable cubicle. One would have been motivated to make this modification because the magnetic component allows the cage (cubicle) to be removed easily without the entire enclosure being moved for testing, as suggested by Salem ([0046]).
Regarding claim 18, Zhang teaches the method according to claim 17, wherein said enclosures each comprise a separate clear tube and opaque cubicle, wherein the clear tube is used to transfer each rodent from its home cage to the testing platform and to house the rodent during testing on the platform (Page 7, Col. 1: Surgery for Electrode Implantation - “After surgery, the animals were placed into their cage and the environment was maintained at 28C until the animals woke up. Immediately after waking, the animals were transferred to the housing scantainer for 1 week of recovery before recording.”; Page 2, Col. 2: Custom Made Apparatus for Sensory Testing – “A transparent plexiglass cylinder (120 mm in diameter) was then placed vertically on top of the circular grid, bordering the experimental arena of the mouse (Figure 1A)”; Page 7, Col. 1-2- Stimulation, Electrophysiology, and Behavior – “A cardboard partition was placed between the apparatus and the experimenter to prevent visual contact”).
Zhang does not explicitly teach wherein the opaque, magnetically connectable cubicles separate the rodents and position them at a desired spacing and alignment on the platform.
However,
Salem teaches wherein the opaque, magnetically connectable cubicles separate the rodents and position them at a desired spacing and alignment on the platform ([0046] “the door assembly 160 of the SCORHE enclosure 100 includes a hinged door 102 with a magnetic latch 104 to allow for insertion and removal of the home cage 20 from the rack 300 without removing the enclosure from the rack system … the bottom surface 141 may include combinations of transparent, translucent, or opaque portions”; [0040] “a ventilated cage rack system 300 that is compatible with the SCORHE 10 to increase the functionality of the rack system while also while maintaining the efficiency of using a readily-available multi-cage ventilated rack”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Zhang to include a magnetically connectable cubicle. One would have been motivated to make this modification because the magnetic component allows the cage (cubicle) to be removed easily without the entire enclosure being moved for testing, as suggested by Salem ([0046]).
Claims 3, 16, 19, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over “A New Apparatus for Recording Evoked Responses to Painful and Non-painful Sensory Stimulation in Freely Moving Mice” (Zhang et al, 2021) in view of US 20190261596 A1 (Woolf et al.)
Regarding claim 3, Zhang teaches the apparatus according to claim 1, wherein the platform is made of an optically clear material, and wherein the moveable device includes a light source to provide optogenetic stimulation (Page 2, Col. 2: Custom Made Apparatus for Sensory Testing – “We used an infrared laser stimulator (MRC Systems GmbH, Germany) of 1470 nm and with pulse durations from 1 – 100 ms (pulse energy 1.2 – 306 mJ) (Figure 1B). A pilot laser of 650 nm (red light, visible to naked eye) indicted the position of the laser beam.”, “A circular grid plate (100 mm in diameter) was produced by a 3D printer (Formlabs Form2, United States) and inserted in the hole in the top plate to create a floor for the animal that allows laser/tactile stimulation to be conducted without obstruction (Figures 2A,B). A transparent plexiglass cylinder (120 mm in diameter) was then placed vertically on top of the circular grid, bordering the experimental arena of the mouse (Figure 1A).”; Page 7, Col. 2: Stimulation, Electrophysiology, and Behavior – “In order to apply different energies we applied laser pulse durations of different durations: 3 ms (2.3 mJ), 5 ms (5 mJ), and 10 ms (11.7 mJ). These pulses are far shorter than the subsequent activation of central neuronal networks or behavioral reactions, allowing for appropriate alignment of evoked potentials. Stimulations were done when the animal was immobile such that the paw could be targeted.”; Page 2, Col. 1: Introduction - “brief infrared laser pulses are widely used as nociceptive stimuli”).
Zhang does not explicitly teach a light source having at least one selectable wavelength.
However,
Woolf teaches a light source having at least one selectable wavelength ([0027] “light stimulus may be applied by directing specific wavelengths of laser generated light at points on the animal body (e.g., the footpads) using a scanning mirror galvanometer or other laser pointing devices, or via LED arrays positioned below the sensor and generating specific light wavelengths directed through the sensor to the entire inferior surface of the animal body”; [0055]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus taught by Zhang to include a light source with at least one selectable wavelength. One would have been motivated to make this modification because directing multiple wavelengths of light to the foot of a rodent allows internal reflection of different bands of light to be assessed and rodent behavior to be analyzed, as suggested by Woolf [0023-0027].
Regarding claim 16, Zhang teaches the apparatus according to claim 1, wherein the one or more signals comprises reflectance of red light off the target paw, and a photodetector is used to measure changes in the reflectance of red light off the target paw before, during and after stimulation in order to detect withdrawal of the target paw with millisecond precision (Pages 2-3: Custom Made Apparatus for Sensory Testing – “The camera also recorded a red indicator-LED light on top of the mouse platform indicating when the laser or the mechanical stimulation had been triggered. This signal facilitates synchronization of stimulation and recording, measuring paw withdrawal latency and aligning evoked potentials. The LED light was directed toward the lateral camera and was not visible to the animal to be sure not to trigger any behavioral reaction, confirming that the LED and the laser light themselves provided no relevant cues.”; Page 4, Col. 2: Control Unit – “Trigger two was set to 100 ms and is used to drive the red LED in view of the lateral camera (100 ms is sufficient time to produce a reliable video signal when the laser is triggered), and this trigger was also fed into the electrophysiological recording system for synchronization with the LED-on period in the video.”; Page 13, Col. 1: Discussion – “Time of stimulation was indicated by a LED, allowing accurately measurement of paw withdraw latency and further behavioral responses.”).
Zhang does not explicitly teach wherein the one or more signals comprises reflectance of red light off the target paw, and a photodetector is used to measure changes in the reflectance of red light off the target paw before, during and after stimulation in order to detect withdrawal of the target paw.
However,
Woolf teaches wherein the one or more signals comprises reflectance of red light off the target paw, and a photodetector is used to measure changes in the reflectance of red light off the target paw before, during and after stimulation in order to detect withdrawal of the target paw ([0036-0037] “the light emitted by the lights 114 is totally internally reflected (see e.g. at 116). When a rodent's 104 footprint, toe print, or other inferior surface comes into contact with the upper base surface 110, e.g. at 118, the internally reflected light becomes frustrated and is refracted out of the base surface 108 via the bottom base surface 112.”; [0038] “rodents (e.g., mice) are more active when the corral 102 is illuminated with a red or infrared lights”; [0057] “The image is generated as a result of contact between the footprint or toe print, or other inferior surface of the rodent, and the base surface 108, which frustrates the band light and causes the light to be reflected and to exit the base surface 108 for detecting by the capturing device 120. The capturing device 120 captures the illuminated areas on the base surface 108 and these images are collected and analyzed.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Zhang to include the one or more signals comprising a reflectance of red light that is applied to the target paw. One would have been motivated to make this modification because reflectance measures the response of the red light stimulus to the rodent, which allows their behavior to be measured before and after the stimulus and how their response changes over time, as suggested by Woolf [0057].
Regarding claim 19, Zhang teaches the method according to claim 17, wherein the platform is made of an optically clear material, and wherein the moveable device includes a light source to provide optogenetic stimulation (Page 2, Col. 2: Custom Made Apparatus for Sensory Testing – “We used an infrared laser stimulator (MRC Systems GmbH, Germany) of 1470 nm and with pulse durations from 1 – 100 ms (pulse energy 1.2 – 306 mJ) (Figure 1B). A pilot laser of 650 nm (red light, visible to naked eye) indicted the position of the laser beam.”, “A circular grid plate (100 mm in diameter) was produced by a 3D printer (Formlabs Form2, United States) and inserted in the hole in the top plate to create a floor for the animal that allows laser/tactile stimulation to be conducted without obstruction (Figures 2A,B). A transparent plexiglass cylinder (120 mm in diameter) was then placed vertically on top of the circular grid, bordering the experimental arena of the mouse (Figure 1A).”; Page 7, Col. 2: Stimulation, Electrophysiology, and Behavior – “In order to apply different energies we applied laser pulse durations of different durations: 3 ms (2.3 mJ), 5 ms (5 mJ), and 10 ms (11.7 mJ). These pulses are far shorter than the subsequent activation of central neuronal networks or behavioral reactions, allowing for appropriate alignment of evoked potentials. Stimulations were done when the animal was immobile such that the paw could be targeted.”; Page 2, Col. 1: Introduction - “brief infrared laser pulses are widely used as nociceptive stimuli”).
Zhang does not explicitly teach a light source having at least one selectable wavelength.
However,
Woolf teaches a light source having at least one selectable wavelength ([0027] “light stimulus may be applied by directing specific wavelengths of laser generated light at points on the animal body (e.g., the footpads) using a scanning mirror galvanometer or other laser pointing devices, or via LED arrays positioned below the sensor and generating specific light wavelengths directed through the sensor to the entire inferior surface of the animal body”; [0055]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Zhang to include a light source with at least one selectable wavelength. One would have been motivated to make this modification because directing multiple wavelengths of light to the foot of a rodent allows internal reflection of different bands of light to be assessed and rodent behavior to be analyzed, as suggested by Woolf [0023-0027].
Regarding claim 29, Zhang teaches the method according to claim 1, wherein the one or more signals detect withdrawal of the target paw with millisecond precision (Pages 2-3: Custom Made Apparatus for Sensory Testing – “The camera also recorded a red indicator-LED light on top of the mouse platform indicating when the laser or the mechanical stimulation had been triggered. This signal facilitates synchronization of stimulation and recording, measuring paw withdrawal latency and aligning evoked potentials. The LED light was directed toward the lateral camera and was not visible to the animal to be sure not to trigger any behavioral reaction, confirming that the LED and the laser light themselves provided no relevant cues.”; Page 4, Col. 2: Control Unit – “Trigger two was set to 100 ms and is used to drive the red LED in view of the lateral camera (100 ms is sufficient time to produce a reliable video signal when the laser is triggered), and this trigger was also fed into the electrophysiological recording system for synchronization with the LED-on period in the video.”; Page 13, Col. 1: Discussion – “Time of stimulation was indicated by a LED, allowing accurately measurement of paw withdraw latency and further behavioral responses.”).
Zhang does not explicitly teach wherein the one or more signals comprises reflectance of red light off the target paw, and a photodetector is used to measure changes in the reflectance of red light off the target paw before, during and after stimulation in order to detect withdrawal of the target paw.
However,
Bonin teaches wherein the one or more signals comprises reflectance of red light off the target paw, and a photodetector is used to measure changes in the reflectance of red light off the target paw before, during and after stimulation in order to detect withdrawal of the target paw ([0036-0037] “the light emitted by the lights 114 is totally internally reflected (see e.g. at 116). When a rodent's 104 footprint, toe print, or other inferior surface comes into contact with the upper base surface 110, e.g. at 118, the internally reflected light becomes frustrated and is refracted out of the base surface 108 via the bottom base surface 112.”; [0038] “rodents (e.g., mice) are more active when the corral 102 is illuminated with a red or infrared lights”; [0057] “The image is generated as a result of contact between the footprint or toe print, or other inferior surface of the rodent, and the base surface 108, which frustrates the band light and causes the light to be reflected and to exit the base surface 108 for detecting by the capturing device 120. The capturing device 120 captures the illuminated areas on the base surface 108 and these images are collected and analyzed.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Zhang to include the one or more signals comprising a reflectance of red light that is applied to the target paw. One would have been motivated to make this modification because reflectance measures the response of the red light stimulus to the rodent, which allows their behavior to be measured before and after the stimulus and how their response changes over time, as suggested by Woolf [0057].
Claims 6 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over “A New Apparatus for Recording Evoked Responses to Painful and Non-painful Sensory Stimulation in Freely Moving Mice” (Zhang et al, 2021) in view of US 20120255500 A1 (Dixon et al.).
Regarding claim 6, Zhang teaches the apparatus according to claim 5.
Zhang does not explicitly teach wherein the one or more signals comprises a force that is applied to the target paw, and the mechanostimulator is configured to measure the force applied to the target paw and to detect withdrawal based on changes in the force applied to the target paw as the target paw is withdrawn from a probe of the mechanostimulator.
However,
Dixon teaches wherein the one or more signals comprises a force that is applied to the target paw, and the mechanostimulator is configured to measure the force applied to the target paw and to detect withdrawal based on changes in the force applied to the target paw as the target paw is withdrawn from a probe of the mechanostimulator ([0065] “a force measurement of a rodent comprising: [0066] (a) providing an operator with a force measurement device as described above connected to a data acquisition system as described above; [0067] (b) placing the rodent in a rodent enclosure as described above to allow access for the force sensor's probe filament from below; [0068] (c) the operator placing the tip of the probe filament in contact with a paw pad of the rodent and then actuating the force measurement device by gradually increasing the amount of relative rotation between the fixed and rotatable body parts so as to increase gradually the force applied to the rodent's paw pad until such time as the rodent withdraws its paw as a result of a tactile response”; [0127] “the force increases gradually from around zero to 3 gf whereupon a reaction is solicited and the force rapidly drops back to zero as the mouse's paw is withdrawn. It will be seen also that the peak force is maintained for approximately 0.4 seconds, which is considered to be a valid application of force.”)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus taught by Zhang to include the one or more signals comprising a force that is applied to the target paw. One would have been motivated to make this modification because the filament probe functions as a mechanostimulator, which is analogous to the tactile stimulator taught by Zhang, and measuring the gradual change in force from the probe allows the time of withdrawal to be measured as a result of tactile response to assess pain threshold, as suggested by Dixon [0002, 0044, 0065].
Regarding claim 22, Zhang teaches the method according to claim 21.
Zhang does not explicitly teach wherein the one or more signals comprises a force that is applied to the target paw, and the mechanostimulator is configured to measure the force applied to the target paw and to detect withdrawal based on changes in the force applied to the target paw as the target paw is withdrawn from a probe of the mechanostimulator.
However,
Dixon teaches wherein the one or more signals comprises a force that is applied to the target paw, and the mechanostimulator is configured to measure the force applied to the target paw and to detect withdrawal based on changes in the force applied to the target paw as the target paw is withdrawn from a probe of the mechanostimulator ([0065] “a force measurement of a rodent comprising: [0066] (a) providing an operator with a force measurement device as described above connected to a data acquisition system as described above; [0067] (b) placing the rodent in a rodent enclosure as described above to allow access for the force sensor's probe filament from below; [0068] (c) the operator placing the tip of the probe filament in contact with a paw pad of the rodent and then actuating the force measurement device by gradually increasing the amount of relative rotation between the fixed and rotatable body parts so as to increase gradually the force applied to the rodent's paw pad until such time as the rodent withdraws its paw as a result of a tactile response”; [0127] “the force increases gradually from around zero to 3 gf whereupon a reaction is solicited and the force rapidly drops back to zero as the mouse's paw is withdrawn. It will be seen also that the peak force is maintained for approximately 0.4 seconds, which is considered to be a valid application of force.”)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Zhang to include the one or more signals comprising a force that is applied to the target paw. One would have been motivated to make this modification because the filament probe functions as a mechanostimulator, which is analogous to the tactile stimulator taught by Zhang, and measuring the gradual change in force from the probe allows the time of withdrawal to be measured as a result of tactile response to assess pain threshold, as suggested by Dixon [0002, 0044, 0065].
Claims 7 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over “A New Apparatus for Recording Evoked Responses to Painful and Non-painful Sensory Stimulation in Freely Moving Mice” (Zhang et al, 2021) in view of US 20090270757 A1 (Backonja, Miroslav).
Regarding claim 7, Zhang teaches the apparatus according to claim 5, wherein the mechanostimulator is adapted to provide other somatosensory modalities requiring contact with the paw (Page 11, Col. 1: Discussion - “Furthermore, the apparatus is able to carry other types of stimulators, as demonstrated with the tactile stimulation”), including:
needle prick using a sharp-tipped probe (Page 5, Col. 1: Tactile Stimulator – “At this position, any standard hyperdermic needle is easily mounted, allowing to use a wide range of different thicknesses and lengths as well as sharp or blunt tips.”).
Zhang does not explicitly teach heating or cooling using a Peltier device, application of chemicals including for cooling or for heating, and dynamic touch using a rotary brush.
However,
Bakconja teaches heating or cooling using a Peltier device ([0005] “contacting the skin with a water circulating thermode, an ohmic heating element, or a Peltier device.”; [0028] “Any other device capable of producing heat, such as wire coil, Peltier element, semiconductor crystal, etc., may be used as well.”),
application of chemicals including for cooling or for heating ([0046] “chemical (capsaicin, menthol, histamine)”), and/or
dynamic touch using a rotary brush ([0046] “mechanical (brush, pressure, pinprick and punctate)”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus taught by Zhang to include other stimulation devices including a Peltier device, capsaicin for colling, and a rotary brush. One would have been motivated to make this modification because subjects may have different reactions to different types of stimuli which can illicit positive and negative sensory reactions from the subject, as suggested by Backonja ([0045-0046]).
Regarding claim 23, Zhang teaches the method according to claim 21, wherein the mechanical indenter is adapted to provide other somatosensory modalities requiring contact with the paw (Page 11, Col. 1: Discussion - “Furthermore, the apparatus is able to carry other types of stimulators, as demonstrated with the tactile stimulation”), including:
needle prick using a sharp-tipped probe (Page 5, Col. 1: Tactile Stimulator – “At this position, any standard hyperdermic needle is easily mounted, allowing to use a wide range of different thicknesses and lengths as well as sharp or blunt tips.”).
Zhang does not explicitly teach heating or cooling using a Peltier device, application of chemicals including for cooling or for heating, and dynamic touch using a rotary brush.
However,
Backonja teaches heating or cooling using a Peltier device ([0005] “contacting the skin with a water circulating thermode, an ohmic heating element, or a Peltier device.”; [0028] “Any other device capable of producing heat, such as wire coil, Peltier element, semiconductor crystal, etc., may be used as well.”),
application of chemicals like acetone for cooling or for capsaicin for heating ([0046] “chemical (capsaicin, menthol, histamine)”),
and dynamic touch using a rotary brush ([0046] “mechanical (brush, pressure, pinprick and punctate)”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Zhang to include other stimulation devices including a Peltier device, capsaicin for colling, and a rotary brush. One would have been motivated to make this modification because subjects may have different reactions to different types of stimuli which can illicit positive and negative sensory reactions from the subject, as suggested by Backonja ([0045-0046]).
Claims 13-15 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over “A New Apparatus for Recording Evoked Responses to Painful and Non-painful Sensory Stimulation in Freely Moving Mice” (Zhang et al, 2021) in view of US 20150146939 A1 (Datta et al.).
Regarding claim 13, Zhang teaches the apparatus according to claim 1, wherein the moveable device is mounted on a set of motorized actuators (Page 9, Col. 1: Results - “The apparatus was tested for painful heat stimuli, using a laser beam, and for tactile stimulation with an electrically driven mechanical actuator (Figure 2E).”).
Zhang does not teach the stimulus is configured to be aimed at the target paw automatically by a neural network pre-trained to recognize and track the target paw.
However,
Datta teaches the stimulus is configured to be aimed at the target paw automatically by a neural network pre-trained to recognize and track the target paw ([0176]; [0100] “An investigation can then be conducted into how the overall behavioral state of the animal changes (these changes are measured as alterations in the density and distribution of the animal's postural clusters) when the animal is offered a particular stimulus (including but not limited to odors, tastes, tactile stimuli, auditory stimuli, visual stimuli, stimuli designed to cause the animal pain or itch),”; [0127] “Mice can be videotaped walking in a straight line on glass, and their paws can be detected using computer vision algorithms”; [0032] “a system for studying the behavior of an animal in an experimental area, comprising: a stimulus device for stimulating the animal”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus taught by Zhang to include a neural network recognizing and tracking the target paw to aim the stimulus. One would have motivated to make this modification because Zhang describes in the Discussion on Page 10 that “The device allows for manual or automatic triggering of laser- or other kinds of stimulations (for example tactile)”. Datta describes that using video images of the mice, computer vision and neural networks may be implemented in the software to recognize the anatomy and behavior of the mice, which allows the tracking to be automated and the rodent to be continuously monitored, as suggested in [0127] and [0176] of Datta.
Regarding claim 14, Zhang teaches the apparatus according to claim 13, wherein initiation of stimulation is made contingent on various factors ascertained from video, the various factors comprising whether the rodent is stationary, has assumed a certain posture, and/or is engaged in a certain behavior Page 7, Col. 2: Stimulation, Electrophysiology, and Behavior – “Stimulations were done when the animal was immobile such that the paw could be targeted. The interval between two stimuli was dependent on the behavior of the animal. Only when the mouse was awake and resting quiescently on its four paws, the stimulation was applied.”).
Zhang does not teach assessed by artificial intelligence.
However,
Datta teaches assessed by artificial intelligence ([0122] “machine learning algorithm”; [0176] “convolution neural networks and deep belief network … characterize how alterations in genotype or stimulus might alter behaviors as they evolve over time.).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus taught by Zhang to include assessing rodent behavior using artificial intelligence. One would have motivated to make this modification because machine learning and neural network artificial intelligence can analyze and classify behavior of the mice in an automated way without significant human intervention, as suggested by Datta ([0096-0098]).
Regarding claim 15, Zhang teaches the apparatus according to claim 13, wherein software coordinates interleaved testing of a cohort of rodents positioned on the platform so that many rodents can be rapidly tested sequentially, but where each rodent is not re-tested before a minimum acceptable period has elapsed, thus enabling high-throughput testing of the cohort (Page 7, Col. 2: Stimulation, Electrophysiology, and Behavior – “Stimulations were done when the animal was immobile such that the paw could be targeted. The interval between two stimuli was dependent on the behavior of the animal. Only when the mouse was awake and resting quiescently on its four paws, the stimulation was applied. In many cases the mouse was actively exploring the chamber, such that intervals between stimuli lasted as long as half an hour or longer. The shortest interval between stimuli was set at 30 s”).
Regarding claim 26, Zhang teaches the method according to claim 17, wherein the moveable device is mounted on a set of actuators (Page 9, Col. 1: Results - “The apparatus was tested for painful heat stimuli, using a laser beam, and for tactile stimulation with an electrically driven mechanical actuator (Figure 2E).”).
Zhang does not teach is configured to be aimed at the target paw automatically by a neural network pre-trained to recognize and track the target paw.
However,
Datta teaches is configured to be aimed at the target paw automatically by a neural network pre-trained to recognize and track the target paw ([0176]; [0100] “An investigation can then be conducted into how the overall behavioral state of the animal changes (these changes are measured as alterations in the density and distribution of the animal's postural clusters) when the animal is offered a particular stimulus (including but not limited to odors, tastes, tactile stimuli, auditory stimuli, visual stimuli, stimuli designed to cause the animal pain or itch)”; [0127] “Mice can be videotaped walking in a straight line on glass, and their paws can be detected using computer vision algorithms”; [0032] “a system for studying the behavior of an animal in an experimental area, comprising: a stimulus device for stimulating the animal”.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Zhang to include a neural network recognizing and tracking the target paw to aim the stimulus. One would have motivated to make this modification because Zhang describes in the Discussion on Page 10 that “The device allows for manual or automatic triggering of laser- or other kinds of stimulations (for example tactile)”. Datta describes that using video images of the mice, computer vision and neural networks may be implemented in the software to recognize the anatomy and behavior of the mice, which allows the tracking to be automated and the rodent to be continuously monitored, as suggested in [0127] and [0176] of Datta.
Regarding claim 27, Zhang teaches the method according to claim 26, wherein initiation of stimulation is made contingent on various factors ascertained from video, the various factors comprising whether the rodent is stationary, has assumed a certain posture, and/or is engaged in a certain behavior Page 7, Col. 2: Stimulation, Electrophysiology, and Behavior – “Stimulations were done when the animal was immobile such that the paw could be targeted. The interval between two stimuli was dependent on the behavior of the animal. Only when the mouse was awake and resting quiescently on its four paws, the stimulation was applied”).
Zhang does not teach assessed by artificial intelligence.
However,
Datta teaches assessed by artificial intelligence ([0122] “machine learning algorithm”; [0176] “convolution neural networks and deep belief network … characterize how alterations in genotype or stimulus might alter behaviors as they evolve over time”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Zhang to include assessing rodent behavior using artificial intelligence. One would have motivated to make this modification because machine learning and neural network artificial intelligence can analyze and classify behavior of the mice in an automated way without significant human intervention, as suggested by Datta ([0096-0098]).
Regarding claim 28, Zhang teaches the method according to claim 26, wherein software coordinates interleaved testing of a cohort of rodents positioned on the platform so that many rodents can be rapidly tested sequentially, but where each rodent is not re-tested before a minimum acceptable period has elapsed, thus enabling high-throughput testing of the cohort (Page 7, Col. 2: Stimulation, Electrophysiology, and Behavior – “Stimulations were done when the animal was immobile such that the paw could be targeted. The interval between two stimuli was dependent on the behavior of the animal. Only when the mouse was awake and resting quiescently on its four paws, the stimulation was applied. In many cases the mouse was actively exploring the chamber, such that intervals between stimuli lasted as long as half an hour or longer. The shortest interval between stimuli was set at 30 s”).
Response to Arguments
Applicant's arguments filed April 14, 2026 have been fully considered but they are not persuasive. With respect to the 102 and 103 Rejections in the Non-Final Office Action (See Pages 15-18 of Applicant’s Response “Claim Rejections – 35 USC § 102 and 35 USC § 103”), Applicant argues that Zhang fails to describe detecting paw withdrawal by measuring changes in a measured signal associated with an interaction between a stimulation device and the target paw during delivery of the stimulus. Applicant also states that Datta, Backonja, and Salem fail to cure the deficiencies of Zhang.
MPEP § 2111 discusses proper claim interpretation, including giving claims their broadest reasonable interpretation in light of the specification during examination. Under broadest reasonable interpretation (BRI), the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim.
Under BRI, the claim language “measure one or more signals associated with an interaction between the target paw and the moveable device during delivery of the one or more different stimulus modalities” in claims 1 and 17 may be interpreted to be any type of signal that is related to the target paw and moveable device. This is taught by Zhang, as the video signals from the camera read on the “signal” language in claim 1. As described in “Materials and Equipment” on Pages 2-4 of Zhang, video signals and an indicator LED signal are collected, which facilitate synchronization of stimulation and recording, measuring paw withdrawal latency and aligning evoked potentials. Applicant’s arguments describe examples of force and reflectance being measured, which are described in dependent claims 6, 16, 22, and 29, however these signals are not disclosed in independent claims 1 and 17.
There are new grounds of claim rejections that were necessitated by the claim amendments. Claims 3, 16, 19, and 29 have been rejected under U.S.C. 103, as described above as being unpatentable over Zhang in view of Woolf. Claims 6 and 22 have been rejected under U.S.C. 103, as described above as being unpatentable over Zhang in view of Dixon.
Claims 2-16 and 18-29 are rejected because the rejection of claims 1 and 17 are proper and the prior art teaches or suggests all the features of these claims for the reasons described in the 102 and 103 Rejections.
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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/EVELYN GRACE PARK/Examiner, Art Unit 3791
/TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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