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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/14/2023 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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.
Claim 19 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 19 requires specific steps of controlling the linear actuator, a heating unit, a thermocouple, aCO2 sensor solenoid valve, and cameras, the program executable instructions comprising instructions to: create markers on the images acquired from the camera to allow a user to set the linear actuator to the engineered tissue strips at an unstretched length, calculate tissue length and percentage stretch based on the linear actuator position, and save and convert the images acquired from the camera into a video file using a semi-automated file naming scheme. However, the instant specification fails to teach or suggest computer readable medium, an algorithm that achieves the claimed function in sufficient detail; a computer or microprocessor configured to carry out the algorithm. Therefore, the claims are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
Claim 19 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 pre-AIA the applicant regards as the invention.
Claim 19 is indefinite under § 112(b) because the specification fails to adequately disclose structure (e.g., computer readable medium, an algorithm that achieves the claimed function in sufficient detail; a computer or microprocessor configured to carry out the algorithm) to perform the claimed function.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 5-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Costa et al. (hereinafter Costa) US 2017/0260488 cited in the IDS filed 03/14/2023.
Regarding claim 1, Costa discloses a multi-sample system for engineered tissue strip assay comprising: an engineered tissue strip module (bioreactor system 100) enabled with a set of channels (wells 520 at the bottom of the culture well 130), wherein each channel is configured to house one or more engineered tissue strips from a set of engineered tissue strips [0052-0053], wherein each engineered tissue strip is in contact with a sensor (sensors component 350) at one end and a tissue lengthening mechanism (fiber optic tissue post 340/movable tissue post 400) at the other end, wherein the tissue lengthening mechanism is configured to lengthen or contract at least one of the engineered tissue strips, wherein the sensor is displaced or deformed when the engineered tissue strip exerts force against the sensor during the lengthening or contraction of each of the engineered tissue strips [0043-0044, 0051 and 0059]; and a detection system (force sensor assembly 300/photodetector) configured to capture change in the sensor in contact with the engineered tissue strip, during lengthening or contraction of at least one of the engineered tissue strips [0034-0035 and 0109-0110].
Regarding claim 5, Costa discloses wherein the tissue lengthening mechanism is configured to control linear displacement (The movable tissue posts 400 are operatively coupled to a mechanism 410 which controllably moves the tissue posts 400 and more particularly, moves the tissue posts 400 in a controlled linear manner. [0045]).
Regarding claim 6, Costa discloses wherein the tissue lengthening mechanism comprises a linear actuator integrated into the bioreactor (The mechanism 410 can be in the form of an actuator, such as a linear actuator, that controllably moves the tissue posts 400 in a linear direction. The linear actuator includes a motor, such a stepper motor, which allows for precise control over the movable tissue posts 400. [0045]).
Regarding claim 7, Costa discloses engineered tissue strip module enables formation, culturing, and controlling of at least one of the engineered tissue strips, and wherein each channel is enabled with an inlet port and an outlet port, wherein a perfusion system is configured for fluid circulation in each channel through the inlet port and the outlet port, and wherein each channel is recessed to allow for the fluid to flow around the engineered tissue strips wherein volume of the fluid is limited and contained in specific part of the set of channels with the sensor, wherein at least one of the set of channels are connected upstream and downstream to common areas for inlet and outlet of fluid, and wherein the common areas are connected to the perfusion system through a common inlet port and common outlet port (A perfusion system can be implemented using ports in the sides of the culture well 130 and out the sides of the bioreactor system 100. This allows for a press-fit stopcock or similar coupling device to be connected along with tubing to circulate or exchange culture media. [0009, 0054 and 0106]).
Regarding claim 8, Costa discloses wherein the set of channels is isolated from each other with a dedicated inlet and outlet for each channel, and wherein the dedicated inlet and outlet of each of the channel connects to a same or different perfusion system as shown in at least Fig. 5.
Regarding claim 9, Costa discloses wherein one end of each of the engineered tissue strips is anchored to a rigid body that the engineered tissue strips cannot displace or deform [0063 and 0102], wherein the rigid body is selected from a shape comprising needle, rod, pin, post, or anchor (a rigid tungsten wire (post 400)), and wherein the rigid body is connected to a movable block of a rail system to enable lengthening of the engineered tissue strips (The tissue post assembly 401 also includes a post holder 420 which is coupled to linear slides 430 and carries the tissue posts 400 such that movement of the post holder 420 is directly translated into movement of the tissue posts 400. The linear slides 430 are frictionless slides that permit the post holder 420 to be moved in a controlled manner in a linear direction. A linkage 425 couples the drive shaft 416 to the post holder 420 and translates the motion of the drive shaft 416 to the post holder 420 which carries the tissue posts 400. [0047])
Regarding claim 10, Costa discloses wherein the rigid body is enabled with an electrode component configured to electrically pace the set of engineered tissue strips or the subset of engineered tissue strips, wherein the electrode component is composed of a conductive material or an array of electrodes positioned on each side of the engineered tissue strips to apply voltage/current for electrically pacing the engineered tissue strips, and wherein the rigid body is enabled to aid in the anchoring of the engineered tissue strips [0045, 0102 and 0112].
Regarding claim 11, the sensor of Costa appears to be geometrically defined material that displaces and/or deforms when the engineered tissue strip exerts force on the sensor, and wherein the displacement and/or deformation of the sensor is monitored by the detection system to measure the lengthening or contraction of the engineered tissue strip, wherein the sensor is a passive sensor or an active sensor [0059].
Regarding claim 12, Costa discloses an alignment component to align each of the sensors in the channels of the engineered tissue strip module, wherein the alignment component comprises a top frame and a bottom frame configured to accommodate the sensors in between the top frame and bottom frame, wherein the top frame, bottom frame and sensors have corresponding holes or registration mechanisms or markers that are used for alignment of the sensor in between the top frame and the bottom frame within the same plane (Any number of different locating, coupling and/or locking mechanisms can be used to securely attach the lid 140 to the base 120. [0033]), wherein a dowel pin is press-fitted into each of the holes to align the sensors, wherein the top frame of the alignment component have additional holes (ports) between every two sensors, wherein the additional holes act as inlet for tubes of the perfusion system, and wherein the additional holes directly feed into the channels of the engineered tissue strip module (A perfusion system can be implemented using ports in the sides of the culture well 130 and out the sides of the bioreactor system 100. This allows for a press-fit stopcock or similar coupling device to be connected along with tubing to circulate or exchange culture media. [0054 and 0106]).
Regarding claim 13, Costa discloses wherein the sensors [350] are directly embedded into the wall of the engineered tissue strip module when at least one region of the sensors is to be isolated from a fluid reservoir (The second sensor component 350 can be in the form of a sensor (e.g., a position sensitive detector (PSD)) that is disposed below the transparent floor 135 (glass slide) of the culture well 130 and is configured to detect movement of the first sensor component 310 (posts 340).).
Regarding claim 14, Costa discloses wherein the tissue lengthening mechanism is configured to displace the movable block forward and backward to allow lengthening and shortening of the engineered tissue strip, wherein the rail system comprises one or more rods restricting movement of the movable block to one axis [0047, 0063 and 102].
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.
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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Costa US 2017/0260488 as applied to claims 1 and 5-14 above.
Regarding claim 16, Costa discloses wherein a multi-channel peristaltic pump is used to drive fluid flow into and suction out of the engineered tissue strip module (Tubing is routed from the ports to a peristaltic pump to exchange media in the culture well with fresh media (or media containing a soluble biochemical compound or pharmaceutical agent for measuring dose response) at an appropriate rate. [0106]).
Costa does not explicitly disclose wherein fluid is pumped into the engineered tissue strip module at flow rates ranging from 0.001 to 10 mL/min per channel, wherein liquid height in each channel is set by adjusting the position of an outlet tubing and wherein the outlet flow is recycled back to an inlet of the fluid reservoir, collected for analysis, redirected for collection or disposed of.
However, it would have been prima facie obvious to one of ordinary skill in the art to pump fluid at flow rates ranging from 0.001 to 10 mL/min per channel, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP §2144.05 (II-A).
Further, since wherein liquid height in each channel is set by adjusting the position of an outlet tubing would only require a mere change in the size (or dimension) of a component which is generally recognized as being within the level of ordinary skill in the art, a mere change in size or dimension of the device, i.e. height, would have been prima facie obvious to one of ordinary skill in the art. Furthermore, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP §2144.04 (IV)(A).
Lastly, wherein the outlet flow is recycled back to an inlet of the fluid reservoir, collected for analysis, redirected for collection or disposed of, the device disclosed by Costa is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Costa is capable of providing the operating conditions as listed in the intended use section of the claim in view of [0054, 0106 and 0114] .
Claims 2, 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Costa US 2017/0260488 as applied to claims 1, 5-14 and 16 above, and further in view of Tanaka et al. (hereinafter Tanaka) US 2017/0045824 cited in the IDS filed 03/14/2023.
Regarding claim 2, Costa discloses wherein the detection system comprises a mirror system comprising an imaging platform with a camera and a mirrors, wherein the camera is configured to capture a video of at least one of the engineered tissue strips and the sensor in contact with the engineered tissue strip, through the mirrors, during the lengthening or contraction of at least one of the engineered tissue strips (Because optical visualization of the tissues, for intermittent inspection without removal from the incubator, remains of practical necessity, the bioreactor system is mounted on legs with an angled mirror underneath. Thereby a camera can be placed beside the bioreactor and focused on the mirror, which provides a live image of the engineered tissues. [0110]).
Costa does not disclose a mirror array/a set of mirrors.
Tanaka discloses an illumination optical system comprising a mirror array (mirror elements 5a) [0079 and 0085].
Absent unexpected results, it would have been obvious to one of ordinary skill in the art to modify Costa with a mirror array/a set of mirrors as taught by Tanaka in order to provide a means to view a plurality of discrete samples simultaneously.
Regarding claim 3, the device disclosed by the combination of Costa and Tanaka is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Costa is capable of providing the operating conditions (i.e., processing the video using an image-processing based kymograph for determining characteristic properties of each of the engineered tissue strips from the set of engineered tissue strips or the subset of engineered tissue strips) as listed in the intended use section of the claim in view of [0055-00577 of Costa].
Additionally, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 15, Costa discloses the bioreactor system is mounted on legs with an angled mirror underneath. Thereby a camera can be placed beside the bioreactor and focused on the mirror, which provides a live image of the engineered tissues [0110]. Costa also discloses wherein the twitch force id measure [0007 and 0111].
Tanaka discloses wherein the at least one camera is enabled with microscopic lenses oriented horizontally towards the set of mirrors that direct toward the engineered tissue strips, wherein the set of mirrors are arranged to enable the camera to capture multiple engineered tissue strips simultaneously, wherein the mirror arrangement enables capturing separate views of the engineered tissue strips located apart and combine the views together into a single image captured by the camera, wherein the set of mirrors are positioned to have equal focal distance for all of the engineered tissue strips to ensure all engineered tissue strips are in the same focal plane, wherein the set of mirrors are mounted over sliding elements that adjust the distance between the camera and the engineered tissue strip, and wherein the sliding elements enable a focusing mechanism to ensure that the engineered tissue strips are in focus with the camera [0085, 0087, 0091, 0099, 0102, 0104-0105, 0130, 0199, 0206 and 0219]. Also see whole document.
Absent unexpected results, it would have been obvious to one of ordinary skill in the art to modify Costa with the teachings of Tanaka in order to provide a means to view a plurality of discrete samples simultaneously.
Claims 4, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Costa US 2017/0260488 in view of Tanaka US 2017/0045824 as applied to claims 2-3 and 15 above, and further in view of Parker et al. (hereinafter Parker) US 2018/0357927 cited in the IDS filed 03/14/2023.
Regarding claim 4, Costa discloses a bioreactor [100] for housing the engineered tissue strip module and the mirror array system. See whole document.
However, neither Costa nor Tanaka disclose wherein the bioreactor provides environmental control and monitoring of one or more environmental conditions of interest comprising temperature, carbon dioxide (CO2), relative humidity and oxygen (02) concentration in the bioreactor.
Parker discloses a temperature and carbon dioxide (CO2) control system [0167 and 0180].
Absent unexpected results, it would have been obvious to one of ordinary skill in the art to modify Costa and Tanaka with a temperature and carbon dioxide (CO2) control system as taught by Parker in order regulate the environmental conditions of interest based on the desired testing parameters.
Regarding claim 17, neither Costa nor Tanaka disclose wherein the imaging platform is enabled with an optical mapping system, wherein the optical mapping system comprises an excitation source, filter cubes, mirrors, camera, and lens, wherein the optical mapping system is configured to measure tissue properties including conduction velocity of the engineered tissue strips, wherein the engineered tissue strips exhibit fluorescence or bioluminescence.
Parker discloses an optical mapping system, wherein the optical mapping system comprises an excitation source, filter cubes, mirrors, camera, and lens, wherein the optical mapping system is configured to measure tissue properties including conduction velocity of the engineered tissue strips, wherein the engineered tissue strips exhibit fluorescence or bioluminescence [0041, 0143, 0152, 0154, 0157, 0163 0168-01714]. Also see whole document.
Absent unexpected results, it would have been obvious to one of ordinary skill in the art to modify Costa and Tanaka with the teachings of Parker in order to provide a monitoring means that is capable of providing high temporal resolution.
Regarding claim 18, neither Costa nor Tanaka disclose wherein each of the sensors is marked with a marker, wherein the marker is detectable when excited by fluorescent light source, wherein the marker is trackable during measurements, and wherein the marker is tracked simultaneously to capture sensor movement, wherein the sensor movement is used for computing applied force by the tissue.
Parker discloses wherein each of the sensors is marked with a marker, wherein the marker is detectable when excited by fluorescent light source, wherein the marker is trackable during measurements, and wherein the marker is tracked simultaneously to capture sensor movement, wherein the sensor movement is used for computing applied force by the tissue [0152 and 0230].
Claims 3 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Costa US 2017/0260488 in view of Tanaka US 2017/0045824 as applied to claims 2-3 and 15 above, and further in view of Lu et al. (hereinafter Lu) WO 2019/073252 cited in the IDS filed 03/14/2023.
Regarding claim 3, the device disclosed by the combination of Costa and does not explicitly disclose processing the video using an image-processing based kymograph for determining characteristic properties of each of the engineered tissue strips from the set of engineered tissue strips or the subset of engineered tissue strips.
Lu discloses processing the video using an image-processing based kymograph for determining characteristic properties of each of the engineered tissue strips from the set of engineered tissue strips or the subset of engineered tissue strips on at least page 12, lines 27-28, page 44, lines 17-22. Also see Fig. 17.
Absent unexpected results, it would have been obvious to one of ordinary skill in the art to modify Costa and Tanaka with the teachings of Lu in order to provide a summary of the video in a single image.
Additionally, it is noted that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See MPEP § 2113.
Further, apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Regarding claim 20, it is noted that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See MPEP § 2113.
Further, apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114.
Therefore, the device disclosed by the combination of Costa, Tanaka and Lu is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of the combination of Costa, Tanaka and Lu is capable of providing the operating conditions as listed in the claim.
Conclusion
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796