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 .
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 103-105 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 103 recites “the base” in line 4. There is insufficient antecedent basis for this limitation in the claim.
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.
1. Claims 14, 15, 17, 19-28, 33, 106 and 107 are rejected under 35 USC 103 as being unpatentable over International Patent Application Publication No. WO2020047004 to Schnall-Levin et al. (cited by applicant) in view of U.S. Patent Application Publication No. 2018/0080876 to Rockel et al. (cited by applicant).
Schnall-Levin et al. teaches a sample handling apparatus that includes a first holder 2704 that holds a first substrate 2706 on which a sample 2708 is positioned, a second holder 2710 that holds a second substrate 2712 with an array of features 2714 and reagents (reagents are delivered before any interaction between the sample and the array of features takes place, p. 239, lines 26-30), an alignment subsystem 2730 including an imaging unit, which can be electrically connected to a control unit 2728, and which functions to ensure that sample 2708 and feature array 2714 are optically aligned in the x-y plane prior to translating second substrate 2712 in the z-direction so that sample 2708 contacts, or nearly contacts, feature array 2714; and an adjustment mechanism configured to translate the second substrate 2712 in any of the x-, y-, and z-coordinate directions.
Schnall-Levin et al. teaches that the sample handling apparatus further includes a control unit 2728 having an electronic processor 2780, a memory unit 2782, a storage device 2784, and an input/output interface 2786. Processor 2780 is capable of processing instructions stored in memory unit 2782 or in storage device 2784, and to display information on input/output interface 2786 (Fig. 27C, p. 243, lines 16-30)
Schnall-Levin et al. teaches that a variety of different imaging elements can be used in detection sub-system 2764, including CCD detectors and other image capture devices to generate one or more images of sample 2708 or feature array 2714 by detecting light from the sample or feature array. (page 242, lines 22-25)
Schnall-Levin et al. does not teach a shuttle to which the image capture device is mounted, wherein the shuttle is configured to move the image capture device.
Rockel et al. teaches an automated analysis system for biological samples, that as shown in Fig. 3 include optical systems 30 and 40 that may be moved relative to the samples. [0044]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Schnall-Levin et al. to provide for the image capturing device to move as taught by Rockel et al to adjust alignment with the sample or feature assay.
I.) Regarding applicant’s claim 14, as noted above Schnall-Levin et al. in view of Rockel et al. renders all the limitations of claim 14 obvious.
Therefore, Schnall-Levine et al. in view of Rockel et al. renders claim 14 obvious.
II.) Regarding applicant’s claim 15, as noted above Schnall-Levine et al. in view Rockel et al. renders claim 14 obvious from which claim 15 depends.
Claim 15 recites that the image capture device is positioned inferior to below the second member.
Schnall-Levine et al. teaches that the light is received by light delivery optics 2756 and directed onto sample 2708 or feature array 2714, either of which is positioned on a mount 2758. (page 242, lines 11-130
As shown in Fig. 27B of Schnall-Levine et al. the elements of the image capture system are located below the mount 2758.
Therefore, Schnall-Levine et al. in view of Rockel et al. renders claim 15 obvious.
III.) Regarding applicant’s claim 17, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 14 obvious from which claim 17 depends.
Claim 17 recites first member is further configured to retain a third substrate disposed in the first plane, the third substrate comprising a second sample disposed in a third region of the third substrate.
Schnall-Levine et al. in view of Rockel et al. does not teach that the first member is further configured to retain a third substrate disposed in the first plane, the third substrate comprising a second sample disposed in a third region of the third substrate.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Schnall-Levine et al. in view of Rockel et al, to modify the first member to retain a third substrate disposed in the first plane, the third substrate comprising a second sample disposed in a third region of the third substrate. Note, duplication of parts has no patentable significance unless a new and unexpected result is produced. (MPEP 2144.04(VI)(B))
Therefore, Schnall-Levine et al. in view of Rockel et al. renders claim 17 obvious.
IV.) Regarding applicant’s claim 19, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 17 obvious from which claim 19 depends.
Claim 18 recites that the alignment mechanism is further configured to optically align the third region with a fourth region of the second substrate along the first plane and/or the second plane such that the second sample contacts at least a portion of the reagent medium when the third region and the fourth region are aligned and when the third substrate and the second substrate are separated by the threshold distance.
As noted above, Schnall-Levine et al. teaches an alignment subsystem 2730 including an imaging unit, which can be electrically connected to a control unit 2728, and which functions to ensure that sample 2708 and feature array 2714 are optically aligned in the x-y plane.
Also as noted above, it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Schnall-Levine et al. in view of Rockel et al, to modify the first member to retain a third substrate disposed in the first plane, the third substrate comprising a second sample disposed in a third region of the third substrate.
It would have further been obvious to one of ordinary skill in the art before applicant’s effective filing date to optically align the third region with a fourth region of the second substrate along the first plane and/or the second plane such that the second sample contacts at least a portion of the reagent medium when the third region and the fourth region are aligned and when the third substrate and the second substrate are separated by the threshold distance, for purposes of imaging the samples and feature arrays.
Therefore, Schnall-Levine et al. in view of Rockel et al. renders claim 19 obvious.
V.) Regarding applicant’s claim 20, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 19 obvious from which claim 20 depends.
Claim 20 recites that the alignment mechanism is further configured to optically align, responsive to optically aligning the first region with the second region, the third region with the fourth region along the first plane and/or the second plane.
As noted above, Schnall-Levine et al. teaches an alignment subsystem 2730 including an imaging unit, which can be electrically connected to a control unit 2728, and which functions to ensure that sample 2708 and feature array 2714 are optically aligned in the x-y plane.
It would have further been obvious to one of ordinary skill in the art before applicant’s effective filing date to optically aligning the first region with the second region, the third region with the fourth region along the first plane and/or the second plane for purposes of imaging the samples and feature arrays.
Therefore, Schnall-Levine et al. in view of Rockel et al. renders claim 20 obvious.
VI.) Regarding applicant’s claim 21, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 19 obvious from which claim 21 depends.
Claim 21 recites that the alignment mechanism comprises a sensor configure to determine a threshold alignment of the first region with the second region and a threshold alignment of the third region with the fourth region.
Applicant discloses that the “The computing device can be further communicatively coupled image capture device 2120, such as a microscope, a camera, an optical sensor, an imaging device, or the like configured to acquire and provide an image of the sample to the computing device.” [0252] Applicant’s sensor is an image capture device.
Therefore, the CCD taught by Schnall-Levine et al. reads on the “sensor” recited in claim 21.
As noted above, Schnall-Levine et al. teaches an alignment subsystem 2730 including an imaging unit, which can be electrically connected to a control unit 2728, and which functions to ensure that sample 2708 and feature array 2714 are optically aligned in the x-y plane. Therefore, the CCD (or other image capturing device taught by Schnall-Levine et al.) is “configured” to determine a threshold alignment of the first region with the second region and a threshold alignment of the third region with the fourth region.
Therefore, Schnall-Levine et al. in view of Rockel et al. renders claim 21 obvious.
VII.) Regarding applicant’s claim 22, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 19 obvious from which claim 22 depends.
Claim 22 recites that the image capture device is further configured to capture, responsive to the alignment of the third region with the fourth region and during a time when the second sample is in contact with at least a portion of the reagent medium, an image of the third region and the fourth region.
As noted above, Schnall-Levine et al. teaches an alignment subsystem 2730 including an imaging unit, which can be electrically connected to a control unit 2728, and which functions to ensure that sample 2708 and feature array 2714 are optically aligned in the x-y plane.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Schnall-Levine et al. in view Rockel et al. to use the imaging unit to capture, responsive to the alignment of the third region with the fourth region and during a time when the second sample is in contact with at least a portion of the reagent medium, an image of the third region and the fourth region.
Therefore Schnall-Levine et al. in view of Rockel et al. renders claim 22 obvious.
VIII.) Regarding applicant’s claim 23, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 14 obvious from which claim 23 depends.
Claim 23 recites a computing device configured to control the alignment mechanism, the adjustment mechanism, and/or the image capture device.
As noted above, Schnall-Levine et al. teaches an electronic processor 2780 which is interpreted as being a computing device that controls the alignment mechanism and/or the imaging capturing device of Schnall-Levine et al.
Therefore, Schnall-Levine et al. in view of Rockel et al renders claim 23 obvious.
IX.) Regarding applicant’s claim 24, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 23 obvious from which claim 24 depends.
Claim 24 recite that the computing device is configured to communicate with a user interface, the user interface configured to display information about the sample holder.
As noted above, Schnall-Levine et al. teaches a control unit 2728 having an electronic processor 2780, a memory unit 2782, a storage device 2784, and an input/output interface 2786.
Therefore, Schnall-Levine et al. in view of Rockel et al renders claim 24 obvious.
X.) Regarding applicant’s claim 25, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 24 obvious from which claim 25 depends.
Claim 25 recites that the computing device is configured to receive a user input from the user interface.
As noted above, Schnall-Levine et al. teaches a control unit 2728 having an electronic processor 2780, a memory unit 2782, a storage device 2784, and an input/output interface 2786.
Therefore, Schnall-Levine et al. in view of Rockel et al renders claim 25 obvious.
XI.) Regarding applicant’s claim 26, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 25 obvious from which claim 26 depends.
Claim 26 recites that the computing device is configured to control the alignment mechanism, the adjustment mechanism, and/or the image capture device responsive to the user input.
As noted above, Schnall-Levine et al. teaches a control unit 2728 having an electronic processor 2780, a memory unit 2782, a storage device 2784, and an input/output interface 2786. The input/output interface would at least allow a user to turn on and off the adjustment mechanism and/or image capturing device or overall system.
Therefore, Schnall-Levine et al. in view of Rockel et al renders claim 26 obvious.
XII.) Regarding applicant’s claim 27, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 26 obvious from which claim 27 depends.
Claim 27 recite that the computing device is further configured to control, based on the sensor, the alignment mechanism, the adjustment mechanism, and/or the image capture device.
As noted above, the CCD or other image capturing device taught by Schnall-Levine et al. reads on applicant’s disclosed sensor. Further as noted above, Schnall-Levine et al. teaches an electronic processor and an alignment subsystem 2730 including an imaging unit, which can be electrically connected to a control unit 2728, and which functions to ensure that sample 2708 and feature array 2714 are optically aligned in the x-y plane.
Therefore, Schnall-Levine et al. in view of Rockel et al. renders claim 27 obvious.
XIII.) Regarding applicant’s claim 28, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 14 obvious from which claim 28 depends.
Claim 28 recites that the first retaining mechanism is configured to retain the first substrate in a fixed position with respect to the first plane.
As noted above, Schnall-Levine et al. teaches a first holder 2704 holds a first substrate 2706 and an adjustment mechanism configured to translate the second substrate 2712 in any of the x-, y-, and z-coordinate directions, thus teaching that the first substrate is retained in a fixed position with respect to the first plane.
Therefore, Schnall-Levine et al. in view of Rockel et al. renders claim 28 obvious.
XIV.) Regarding applicant’s claim 33, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 14 obvious from which claim 33 depends.
Claim 33 recites that the adjustment mechanism is configured to move the second member toward the first member.
As noted above, Schnall-Levine et al. teaches that the adjustment mechanism configured to translate the second substrate 2712 in any of the x-, y-, and z-coordinate directions.
Therefore, Schnall-Levine et al. in view of Rockel et al. renders claim 33 obvious.
XV.) Regarding applicant’s claim 106, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 14 obvious from which claim 106 depends.
Claim 106 recites that the adjustment mechanism is configured to move the second member toward the first member such that the first substrate contacts at least a portion of the reagent medium.
As noted above, Schnall-Levine et al. teaches that the adjustment mechanism is configured to move the second member toward the first member.
The recitation that the first substrate contacts at least a portion of the reagent medium does not incorporate a structural limitation into the sample holder of claim 14.
Nevertheless it is noted that when a sufficient amount of the reagent is present, the first substrate will contact at least a portion of the reagent medium.
Therefore, Schnall-Levine in view of Rockel et al. renders claim 106 obvious.
XVI.) Regarding applicant’s claim 107, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 14 obvious from which claim 107 depends.
Claim 107 recites that the adjustment mechanism is configured to move the second member toward the first member such that the first substrate contacting the at least a portion of the reagent medium urges the reagent medium in an opposite direction such that the reagent medium is displaced over the second substrate and/or the first substrate as the second member moves toward the first member and the second substrate and the first substrate become substantially parallel.
As noted above, Schnall-Levine et al. teaches that the adjustment mechanism is configured to move the second member toward the first member.
The recitation that at least a portion of the reagent medium urges the reagent medium in an opposite direction such that the reagent medium is displaced over the second substrate and/or the first substrate as the second member moves toward the first member and the second substrate and the first substrate become substantially parallel does not incorporate any structural limitations into the sample holder of claim 14.
Nevertheless it is noted that when a sufficient amount of the reagent is present, the reagent medium will be displaced over the second substrate and/or the first substrate as the second member moves toward the first member and the second substrate and the first substrate become substantially parallel does not incorporate any structural limitations into the sample holder
Therefore, Schnall-Levine et al. in view of Rockel et al. renders claim 107 obvious.
2. Claim 108 is rejected under 35 USC 103 as being unpatentable in view of Schnall-Levine et al. in view of Rockel et al.
I.) Claim 108 recites a the system comprising:
the sample holder of claim 14; and
a computing device communicatively coupled to the image capture device and to the sample holder, the computing device comprising a display, a data processor, and a non-transitory computer readable storage medium storing computer readable and executable instructions, which when executed cause the data processor to adjust a location of the first substrate relative to the second substrate to cause all or the portion of the first region to be aligned with the second region.
As noted above, Schnall-Levine et al. in view of Rockel et al. renders that sample holder of claim 1 obvious.
Further as noted above, Schnall-Levine et al. teaches that the sample handling apparatus further includes a control unit 2728 having an electronic processor 2780, a memory unit 2782, a storage device 2784, and an input/output interface 2786. Processor 2780 is capable of processing instructions stored in memory unit 2782 or in storage device 2784, and to display information on input/output interface 2786 (Fig. 27C, p. 243, lines 16-30).
Schnall-Levine et al.’s control unit, electronic processor, memory unit, storage device, and input/output interface reads on or renders obvious computing device comprising a display, a data processor, and a non-transitory computer readable storage medium storing computer readable and executable instructions.
As also noted above, Schnall-Levine et al. teaches an alignment subsystem 2730 including an imaging unit, which can be electrically connected to a control unit 2728, and which functions to ensure that sample 2708 and feature array 2714 are optically aligned in the x-y plane prior to translating second substrate 2712 in the z-direction so that sample 2708 contacts, or nearly contacts, feature array 2714; and an adjustment mechanism configured to translate the second substrate 2712 in any of the x-, y-, and z-coordinate directions. Adjusting the position of the first substrate as opposed to the second substrate would have been an obvious modification to achieve the same result of aligning the substrates in a desired alignment.
Therefore, Schnall-Levine et al. in view of Rockel et al. renders claim 108 obvious.
3. Claims 30 and 32 are rejected under 35 USC 103 as being unpatentable over Schnall-Levine et al. in view of Rockel et al. as applied to claim 14 above and further in view of U.S. Patent No. 7,220,573 to Shea et al. (cited by applicant).
I.) Regarding applicant’s claim 30, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 14 obvious from which claim 30 depends.
Claim 30 recites that the second member further comprises a base configured to couple to a bottom surface of the second substrate and retain the second substrate on the second member.
Schnall-Levine et al. in view of Rockel et al. does not teach that the second member further comprises a base configured to couple to a bottom surface of the second substrate and retain the second substrate on the second member.
Shea et al. teaches the use of a base 1 for supporting a substrate as shown in Fig. 4. (column 12, lines 25-41)
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Schnall-Levine et al. in view of Rockel et al. to use a base to support the second substrate as taught by Shea et al. as a simple substitution of one known element for another to obtain predictable results. (MEPE 2143 (I)(B))
Therefore, Schnall-Levine et al. in view of Rockel et al. and Shea et al. renders claim 30 obvious.
II.) Regarding applicant’s claim 32, as noted above Schnall-Levine et al. in view of Rockel et al. and Shea et al. renders claim 30 obvious from which claim 32 depends.
Claim 32 recites that the first member is configured to dispose the first substrate along the first plane such that the first substrate is parallel with a surface on which the base is located.
As shown in Fig. 27A of Schnall-Levine et al. the first member is configured to dispose the first substrate along the first plane such that the first substrate is parallel with a surface of second substrate that would be on the base incorporated from Shea et al. above.
Therefore, Schnall-Levine et al. in view of Rockel et al. and Shea et al. renders claim 32 obvious.
4. Claims 102, 103 and 105 are rejected under 35 USC 103 as being un patentable over Schnall-Levine et al. in view of Rockel et al. as applied to claim 14 and further in view of U.S. Patent Application Publication No. 2016/0003718 to Ikushima et al.
I.) Regarding applicant’s claim 102, as noted above Schnall-Levine et al. in view of Rockel et al. renders claim 14 obvious from which claim 102 depends.
Claim 102 recites that the second member further comprises a spring mechanism configured to couple to at least a portion of a bottom surface of the second substrate.
Schnall-Levine et al. in view of Rockel et al. does not teach that the second member further comprises a spring mechanism configured to couple to at least a portion of a bottom surface of the second substrate.
Ikushima et al. teaches the use of springs 64 that support a slide 16 on a palette 57, which springs contract under pressure. (Fig. 6; [0081])
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Schnall-Levine et al. in view of Rockel et al. to provide the second holder (member) with a spring mechanism configured to couple to at least a portion of a bottom surface of the second substrate as taught by Ikushima et al. to absorb pressure when the second substrate contacts the first substrate.
Therefore, Schnall-Levine et al. in view of Rockel et al. and Ikushima et al. renders claim 102 obvious.
II.) Regarding applicant’s claim 103, as noted above Schnall-Levine et al. in view of Rockel et al. and Ikushima et al. renders claim 102 obvious from which claim 103 depends.
Claim 103 recites that second member further comprises a base configured to couple to the bottom surface of the second substrate and retain the second substrate on the second member, wherein the spring mechanism extends in a superior direction from the base.
Schnall-Levine et al. in view of Rockel et al. does not teach that second member further comprises a base configured to couple to the bottom surface of the second substrate and retain the second substrate on the second member, wherein the spring mechanism extends in a superior direction from the base.
As noted above, Ikushima et al. teaches the use of springs 64 that support a slide 16 on a palette 57, which springs contract under pressure.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Schnall-Levine et al. in view of Rockel et al. to provide the second holder (member) with a base for additional support and a spring mechanism configured to couple to at least a portion of a bottom surface of the second substrate as taught by Ikushima et al. to absorb pressure when the second substrate contacts the first substrate.
As shown in Fig. 6 of Ikushima et al. the spring mechanism extends upward.
Therefore, Schnall-Levine et al. in view of Rockel et al. and Ikushima et al. renders claim 102 obvious.
III.) Regarding applicant’s claim 105, as noted above Schnall-Levine et al. in view of Rockel et al. and Ikushima et al. renders claim 103 obvious from which claim 103 depends.
Claim 105 recites that the adjustment mechanism configured to move the second member toward the first member such that the spring mechanism compresses so that the first substrate, the second substrate, and the base are substantially parallel.
As shown in Fig. 27A of Schnall-Levine et al. the first member is configured to dispose the first substrate along the first plane such that the first substrate is parallel with a surface of second substrate.
Therefore, Schnall-Levine et al. in view of Rockel et al. and Ikushima et al. renders claim 105 obvious.
Allowable Subject Matter
Claim 104 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art or record does not teach a spring mechanism as recited in claim 104 in combination with the sample holder of claim 14 wherein the spring member is configured to dispose the second substrate along a plane at an angle different than the base that is coupled to bottom of the second substrate as shown in Fig. 18A.
Conclusion
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/MICHAEL STANLEY GZYBOWSKI/Examiner, Art Unit 1798
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