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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/13/2026 has been entered.
Priority
This application makes reference to or appears to claim subject matter disclosed in Application No. PCT/CN2020/078752, filed 03/11/2020. However, the corrected continuation number is still not found. The Examiner request the Applicant’s provide the documents for priority to be considered.
Response to Amendment
The amendments and remarks, filed on 4/13/2026, have been entered. The claim amendments overcome the previous prior art rejection, and a new prior art rejection is applied to address the claim amendments.
Claim Status
Claims 76-80 and 82-115 are pending and being examined.
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 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.
Claim(s) 76-79, 97-99, 101-103, 108-109, 111-115 are rejected under 35 U.S.C. 103 as being unpatentable over Lemme et al (US 20070086917 A1; hereinafter “Lemme”; already of record) in view of Ochranek et al (US 20140273245 A1; hereinafter “Ochranek”; already of record) in view of Clarke et al (US 20020142470 A1; hereinafter “Clarke”).
Regarding claim 76, Lemme teaches a tissue staining device (Lemme; Fig. 12; apparatus 1000) comprising:
(a) a microscope slide carousel having an outer perimeter (Lemme; Fig. 14; para [72]; a slide support assembly 1099 which is comprised of a slide support 1033 which in turn supports a circular pan 1035 having a peripheral wall 1036; the Examiner interprets the peripheral wall as the outer perimeter)1,
wherein the microscope slide carousel is configured to rotate on a first axis of rotation controlled by a first rotary control mechanism (Lemme; para [5]; A stepper motor rotates the slide carousel), and
wherein the microscope slide carousel comprises at least one microscope slide cartridge stall configured to hold a microscope slide cartridge assembly (Lemme; Fig. 15; para [70, 73]; plurality of slide platforms 1050 are mounted radially about a center point 1032 of slide support assembly 1099 upon which standard microscope glass slides 1060 with tissue samples may be placed…thirty of the pie-shaped sections 1070 are occupied by slide platforms 1050), and
(b) a reagent assembly (Lemme; Fig. 14, 17a; examiner interprets the structure above the slide support assembly 1099 to be the reagent assembly) comprising:
(i) a reagent carousel (Lemme; Fig. 17a; para [79]; reagent support 1300),
wherein the reagent carousel is configured to rotate on a second axis of rotation (Lemme; Fig. 14; para [79]; reagent support 1300 is fixedly mounted to a cage 1110 vertically above nozzle support 1100, which cage in turn is rotatably mounted for rotation on a shaft 1113) and wherein the second axis of rotation is located outside the outer perimeter of the microscope slide carousel (Lemme; Fig. 18; The examiner interest the outer perimeter of the microscope slide carousel to be the peripheral wall, and the reagent carousel interpreted as the reagent support 1300 is positioned above and not integrated with the peripheral wall), and
wherein the reagent carousel comprises at least one reagent holder (Lemme; Fig.17a; examiner interprets the holder as the bottles/containers seen in Fig. 17a),
(ii) a dispensing actuator (Lemme; para [79, 84]; Fig. 14, 17a; A plurality of reagent dispensers 1302…hammer or piston 1400 comprises a servo or piston 1404 for moving vertically into engagement with the top of a selected reagent dispenser), and
wherein the reagent carousel is positioned above the microscope slide carousel (Lemme; Fig. 14), and
wherein the reagent carousel and the microscope slide carousel are positioned such that when a reagent is placed in the reagent carousel the reagent can flow from the reagent carousel to the microscope slide carousel (Lemme; Fig. 14; para [84]; Thus, in order to dispense a selected reagent on a selected slide, the nozzle support 1100 is rotatably moved to a dispense position vertically over the selected slide which had been previously prepared, e.g. washed, etc., by the treatment stations carried on the nozzle support 1100)2, wherein the reagent assembly further comprises a second rotary control mechanism comprising a stationary actuator positioned relative to the second axis of rotation (Lemme; para [75]; Nozzle support 1100 is mounted on a shaft 1113 which in turn is rotatably mounted on a bridge 1112, and driven by a computer controlled stepping motor and drive belt; the examiner interprets the shaft that is rotatably mounted and driven by the stepping motor). Lemme teaches that the secondary rotary control mechanism, interpreted as the stepping motor, is different from the motor driving the slide carousel (Lemme; para [16]; a plurality of slides are mounted in a circular array on a carousel which rotates, as directed by the computer, to a dispensing location placing each slide under one of a series of reagent dispensers on a second rotating carousel positioned above the slides).
1 Examiner interprets the structures supported on the slide support assembly as the microscope slide carousel. As seen in the exploded view of the slide plate portion in Fig. 15, examiner notes the carousel is supported on the slide support tray.
2 The limitation “when a reagent is placed…the reagent can flow” is directed to the function of the reagent carousel and/or the manner of operating the reagent carousel, all the structural limitations of the claim has been disclosed by Lemme and the reagent carousel of Lemme is capable of “placing reagent in the reagent carousel” and “flowing the reagent from the reagent carousel”. As such, it is deemed that the claimed apparatus is not differentiated from the reagent carousel of Lemme (see MPEP §2114).
Lemme does not teach wherein the reagent carousel is configured to rotate on the second axis of rotation that is not coaxial with the first axis of rotation.
However, Ochranek teaches an analogous art of an automated diagnostic analyzer (Ochranek; Abstract) comprising a microscope slide carousel, wherein the microscope slide carousel is configured to rotate on a first axis of rotation controlled by a first rotary control mechanism (Ochranek; para [81]; t The example analyzer 100 disclosed above includes a reaction carousel (e.g., the second carousel 104) having a plurality of reaction vessels. In some examples, the reaction carousel has 187 reaction vessels (e.g., glass cuvettes) spaced around the outer circumference of the second carousel); and a reagent carousel, wherein the reagent carousel is configured to rotate on the second axis of rotation that is not coaxial with the first axis of rotation (Ochranek; para [29, 39]; a reagent carousel rotatably coupled to a base about a first axis of rotation…the first carousel 102 and the second carousel 104 are rotatably coupled to a base station 106 independent of each other). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the reagent carousel of Lemme to be independent/separate from the slide carousel cartridge as taught by Ochranek as this is a known and suitable substitution for the reagent carousel in the art. One would have a reasonable expectation of success by substituting the reagent carousel of Lemme to the claimed limitation as Ochranek teaches this arrangement is a known and suitable substitution in the art. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Modified Lemme does not teach fluid is removed from a chamber of the microscope slide cartridge assembly by centrifugal force.
However, Clarke teaches an analogous art of a centrifugal analyzer and method for staining biological or non-biological samples (Clarke; Abstract) comprising a microscope slide carousel (Clarke; para [25]; the spinning disc centrifuge), wherein the microscope slide carousel comprises at least one microscope slide cartridge stall configured to hold a microscope slide cartridge assembly (Clarke; para [15] ; The sample, e.g. isolated cells, blood smear or tissue section, is first attached onto one surface of a standard 22 mm square glass cover-slip 66 which is then placed sample side down over the staining chamber), wherein fluid is removed from a chamber of the microscope slide cartridge assembly by centrifugal force (Clarke; para [10,19]; sequential filling and emptying of a staining chamber, is achieved using a network of reservoirs and connecting tubes created on a single slide; Examiner notes emptying is achieved through rotating the slide). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the microscope slide cartridge assembly of modified Lemme to comprise the chamber as taught by Clarke as this is a known and suitable substitution for slides in the art. Further, it is a matter of engineering design to arrange the ----slides in different ways, where the change in form or shape, without any new or unexpected result, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Regarding claim 77, modified Lemme teaches the tissue staining device of claim 76, wherein the directionality of the flow of the reagent is based on that of the gravitational force (Lemme; Fig. 14). Examiner notes that the reagent carousel is positioned over the slide support assembly as seen in Fig. 14, thus the reagent flows down due to gravity as there is no force applied in an opposing direction.
Regarding claim 78, modified Lemme teaches the tissue staining device of claim 76, wherein the reagent flow represents an imaginary reagent dispensing axis, and wherein the reagent dispensing axis, the first axis of rotation, and the second axis of rotation are substantially parallel (Lemme; Fig. 14). Examiner notes that the reagent carousel is positioned over the slide support assembly as seen in Fig. 14, thus the axis of the first axis of rotation and the second axis of rotation is parallel to each other.
Regarding claim 79, modified Lemme teaches the tissue staining device of claim 76, with the first axis and the second axis are parallel and with distance larger than the diameter of the slide carousel to allow direct access to slide cartridge assemblies on the slide carousel (Lemme; Fig. 14; para [16]; a plurality of slides are mounted in a circular array on a carousel which rotates, as directed by the computer, to a dispensing location placing each slide under one of a series of reagent dispensers on a second rotating carousel positioned above the slides). The examiner notes that the distance between the two axis would allow access to the slide cartridge assembly as the slides can be added/removed from the platform (Lemme; para [43]).
Regarding claim 97, modified Lemme teaches the tissue staining device of claim 76, wherein the microscope slide carousel further comprises a first rotary control mechanism comprising a first rotary actuator which is driven by a rotary stepper motor (Lemme; para [31]; stepping motors, etc. for locating and positioning a rotating slide carousel), wherein the first rotary control mechanism is configured to rotate the microscope slide carousel 360° on the first axis of rotation (Lemme; Fig. 1).
Regarding claim 98, modified Lemme teaches the tissue staining device of claim 76, wherein the microscope slide carousel further comprises a heating element, and wherein the heating element is positioned in proximity to the microscope slide of the microscope slide cartridge assembly (Lemme; para [42]; a plurality of slots or channels are formed on the top surface of each of the slide heaters, i.e. the interface surface between the slide heater and the slide).
Regarding claim 99, modified Lemme teaches the tissue staining device of claim 76, wherein the microscope slide carousel further comprises a temperature sensing element (Lemme; para [70]; the temperature of each slide may be individually controlled by means of temperature sensors and a microprocessor), and wherein the temperature sensing element is positioned in proximity to the microscope slide of the microscope slide cartridge assembly (Lemme; para [31]; the slide platforms in drawer 34 is that each of the heaters and thermal sensors).
Regarding claim 101, modified Lemme teaches the tissue staining device of claim 76, wherein each reagent holder is configured to hold a reagent bottle in a pre-specified orientation (Lemme; Fig. 7; para [40]; A plurality of reagent bottles 302 are removably mounted within recesses 304).
Regarding claim 102, modified Lemme teaches the tissue staining device of claim 101, wherein each reagent holder comprises a depression to accept the reagent bottle in the pre-specified orientation (Lemme; Fig. 7; para [40]; A plurality of reagent bottles 302 are removably mounted within recesses 304).
Regarding claim 103, modified Lemme teaches the tissue staining device of claim 101, further comprising the reagent bottle (Lemme; Fig. 7; para [40]; A plurality of reagent bottles 302 are removably mounted within recesses 304).
Regarding claim 108, modified Lemme teaches the tissue staining device of claim 76 (the reagent carousel of Lemme is modified to be independent from the slide cartridge carousel as taught by Ochranek discussed above in claim 76), wherein the second rotary control mechanism is a rotary stepper motor (Ochranek; para [47]; The second carousel 104 is rotated via a second motor 127 (e.g., a stepper motor or a servo motor).
Regarding claim 109, modified Lemme teaches the tissue staining device of claim 76, wherein the dispensing actuator comprises:
a) a central body coupled to a dispensing arm (Lemme; para [47]; automatic pipette metering/dispensing pick-up devices), and wherein the dispensing actuator comprises an arm movement mechanism configured to move the dispensing arm in a direction substantially parallel with the reagent dispensing axis (Lemme; para [46]; Arm 400 is rotatably driven by a computer driven stepping motor (not shown), and rotates plus or minus 185.degree. in either direction from a home position 410);
b) a dispensing arm extends from the central body of the dispensing actuator to over at least a portion of the reagent carousel (Lemme; Fig. 1; para [47]; Reagent transfer probes 402 and 404); and
c) the dispensing arm extends from the central body of the dispensing actuator to over at least a portion of each reagent holder (Lemme; para [47]; Reagent transfer probes 402 and 404, which are identical to one another, preferably comprise automatic pipette metering/dispensing pick-up devices designed to aspirate or "sip" reagent from a reagent bottle, move to a slide, and then "spit" or deposit the reagent onto the slide).
Regarding claim 111, modified Lemme teaches the tissue staining device of claim 76, further comprising one or more cameras or detectors configured to image and read a barcode label (Lemme; para [76]; preparing a slide for staining, stain reagent removal, and the like, and to clear the bar codes (not shown) carried on the slides, and a bar code reader 1109).
Regarding claim 112, modified Lemme teaches the tissue staining device of claim 76, further comprising a control unit (Lemme; para [70]; a microprocessor).
Regarding claim 113, modified Lemme teaches the tissue staining device of claim 112, wherein the control unit comprises one or more processors and memory storing one or more programs, the one or more programs configured to be executed by the one or more processors, the one or more programs including instructions for:
(i) positioning the reagent carousel and/or positioning the microscope slide carousel (Lemme; para [16]; the computer, to a dispensing location placing each slide under one of a series of reagent dispensers on a second rotating carousel positioned above the slides);
(ii) enacting the dispensing actuator (Lemme; para [47]; reagent transfer probes 402 and 404 are carried on the distal end of arm 400 and are spaced from one another so that when one of the probes, e.g. probe 402 is located centrally over a slide 60, the other reagent transfer probe 404 may be centrally positioned); and
(iii) performing a tissue staining protocol and/or performing a tissue dehydration protocol (Lemme; para [49]; the computer than downloads the run steps for the entire run, the nozzle plate 100 is indexed to the first slide, and the slide is washed and prepared for staining).
Regarding claim 114, modified Lemme teaches the tissue staining device of claim 76, further comprising a user interface component, wherein the said interface is graphical with touch sensitive functions (Lemme; para [69]; apparatus 1000 (FIG. 12) functions as one component or module of a system which also comprises a host computer 1014 preferably a personal computer).
Regarding claim 115, modified Lemme teaches the tissue staining device of claim 76, wherein the microscope slide carousel is configured to control the rotary motions back and forth to agitate fluid in microscope slide cartridges to achieve mixing reagents and thoroughly wash clean the tissues on the slides (Lemme; para [5]; A stepper motor rotates the slide carousel placing each slide under one of a series of reagent dispensers positioned above the slides). The limitation is directed to the function and/or the manner of operating the microscope slide carousel, all the structural limitations of the claim has been disclosed Lemme and the microscope slide carousel of Lemme is capable of “control[ing] the rotary motions back and forth to agitate fluid in microscope slide cartridges to achieve mixing reagents and thoroughly wash clean the tissues on the slides”. As such, it is deemed that the claimed microscope slide carousel is not differentiated from the microscope slide carousel of Lemme (see MPEP §2114).
Claims 104-105 and 110 are rejected under 35 U.S.C. 103 as being unpatentable over Lemme in view of Ochranek in view of Clarke, and in further view of Copeland et al (US 5595707 A; hereinafter “Copeland”; already of record).
Regarding claim 104, modified Lemme teaches the tissue staining device of claim 103, with the reagent bottle.
Modified Lemme does not teach wherein the reagent bottle comprises: (a) a reagent reservoir; (b) a mounting element; and (c) a dispensing element, wherein the dispensing element comprises a press-to-dispense assembly and a reagent outlet.
However, Copeland teaches an analogous art of an automated immunostaining apparatus (Copeland; Abstract) comprising a reagent bottle (Copeland; Fig. 1; col 6, line 42; Reagent bottles 12), wherein the reagent bottle comprises: (a) a reagent reservoir (Copeland; Fig. 1; col 6, line 42; Reagent bottles 12; examiner notes that the bottles comprise an interior); (b) a mounting element (Copeland; Fig. 1; col 6, line 45; reagent bottle receptors 11); and (c) a dispensing element, wherein the dispensing element comprises a press-to-dispense assembly and a reagent outlet (Copeland; col 15, lines 35-39; solenoid valve 424 permits pressurized air to pass from line 422 to air cylinder input line 300, causing rod 302 and foot 306 (FIG. 15) to press the reagent dispenser bottle 12 downward, emitting a precise volume of reagent liquid). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the reagent bottle of Lemme with the reagent bottle comprising the dispensing element as taught by Copeland as this is a known and suitable substitution for the reagent bottle in the art. Further, one would have a reasonable expectation of success by substituting the reagent bottle of Lemme to the claimed limitation as taught by Copeland, because Copeland teaches this arrangement is a known and suitable arrangement in the art. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Regarding claim 105, modified Lemme teaches the tissue staining device of claim 104, wherein the press-to-dispense assembly is configured to dispense about 50 µL to about 200 µL per press (Lemme; Fig. 7; para [40]; A plurality of reagent bottles 302 are removably mounted within recesses 304). The limitation is directed to the function and/or the manner of operating the press-to-dispense assembly, all the structural limitations of the press-to-dispense assembly has been disclosed by Lemme and the press-to-dispense assembly of Lemme is capable of “to dispense about 50 µL to about 200 µL per press”. As such, it is deemed that the claimed apparatus is not differentiated from the press-to-dispense assembly of Lemme (see MPEP §2114).
Regarding claim 110, modified Lemme teaches the tissue staining device of claim 76, with the reagent assembly.
Modified Lemme does not teach wherein the reagent assembly comprises at least one common liquid dispenser comprising a liquid dispenser output port and at least one liquid pump, wherein the liquid dispenser output port is positioned such that when a liquid is dispensed from the liquid dispenser output port the liquid can flow from the liquid dispenser output port to the input port of the microscope slide cartridge assembly on the microscope slide carousel (Lemme; Fig. 14; para [84]; Thus, in order to dispense a selected reagent on a selected slide, the nozzle support 1100 is rotatably moved to a dispense position vertically over the selected slide which had been previously prepared, e.g. washed, etc., by the treatment stations carried on the nozzle support 1100), wherein the directionality of the flow of the liquid is based on that of gravitational force (Lemme; Fig. 14; Examiner notes that the reagent carousel is positioned over the slide support assembly as seen in Fig. 14, thus the reagent flows down due to gravity as there is no force applied in an opposing direction), wherein the liquid flow represents an imaginary liquid dispensing axis, and wherein the liquid dispensing axis, the first axis of rotation, and the second axis of rotation are substantially parallel (Lemme; Fig. 1).
However, Copeland teaches an analogous art of an automated immunostaining apparatus (Copeland; Abstract) comprising a reagent carousel (Copeland; col 11, line 50; the reagent bottle carousel 10) comprises at least one common liquid dispenser (Copeland; col 15, lines 35-39; solenoid valve 424 permits pressurized air to pass from line 422 to air cylinder input line 300, causing rod 302 and foot 306 (FIG. 15) to press the reagent dispenser bottle 12 downward, emitting a precise volume of reagent liquid) comprising a liquid dispenser output port (Copeland; col 15, lines 35-39; solenoid valve 424) and at least one liquid pump (Copeland; col 3, line 55; delivery of reagent from a reagent container by the volumetric pump). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the liquid dispenser of Lemme with the liquid dispense comprising the outport port and the liquid pump as taught by Copeland as this is a known and suitable substitution for the liquid dispenser in the art. Further, one would have a reasonable expectation of success by substituting the liquid dispenser of Lemme to the claimed limitation as taught by Copeland, because Copeland teaches this arrangement is a known and suitable arrangement in the art. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Thus, modified Lemme teaches wherein the liquid dispenser output port is positioned such that when a liquid is dispensed from the liquid dispenser output port the liquid can flow from the liquid dispenser output port to the input port of the microscope slide cartridge assembly on the microscope slide carousel, wherein the directionality of the flow of the liquid is based on that of gravitational force, wherein the liquid flow represents an imaginary liquid dispensing axis, and wherein the liquid dispensing axis, the first axis of rotation, and the second axis of rotation are substantially parallel.
Claim 76, 80, 82-83, 85-86, 95, and 100-103 are rejected under 35 U.S.C. 103 as being unpatentable over Oei et al (US 20210318341 A1; hereinafter “Oei”; priority filed 8/7/2019; already of record) in view of Lemme, and in further view of Ochranek. Examiner relies on Oei as the primary reference to address the claim limitations of the microscope slide cartridge in the dependent claim.
Regarding claim 76, Oei teaches a tissue staining device (Oei; Abstract; para [113]) comprising:
(a) a microscope slide carousel having an outer perimeter (Oei; Fig. 13; para [116]; Referring to FIG. 13, in one preferred embodiment of the invention a cartridge processing system 400 may be designed as a carousel 401; the Examiner interprets the outer perimeter as the outer wall of the carousel), and
wherein the microscope slide carousel comprises at least one microscope slide cartridge stall configured to hold a microscope slide cartridge assembly (Oei; Fig. 13; para [116]; the slide with biopsy tissue 402 may be placed directly into one of the eight, for example, basses 403 that are fixed to the carousal 401),
wherein fluid is removed from a chamber of the microscope slide cartridge assembly by centrifugal force (Oei; Fig. 1B; para [9, 24]; The lid creates a sealed chamber around the gasket that encloses the slide). The Examiner notes that Oei teaches the slide assembly comprising the chamber, thus fluid is capable of being removed from the chamber through rotation of the carousel. The limitation is directed to the function and/or the manner of operating the microscope slide cartridge assembly, all the structural limitations of the claim has been disclosed by Oei. As such, it is deemed that the claimed microscope slide cartridge assembly is not differentiated from the microscope slide cartridge assembly of Oei (see MPEP §2114).
Oei does not teach a reagent assembly comprising (i) a reagent carousel, wherein the reagent carousel is configured to rotate on a second axis of rotation and wherein the second axis of rotation is located outside the perimeter of the microscope slide carousel, and wherein the reagent carousel comprises at least one reagent holder, wherein the reagent carousel is positioned above the microscope slide carousel, and a dispensing actuator, and wherein the reagent carousel and the microscope slide carousel are positioned such that when a reagent is placed in the reagent carousel the reagent can flow from the reagent carousel to the microscope slide carousel, and wherein the first rotary control mechanism is configured to rotate the microscope slide carousel on the first axis of rotation at a speed sufficient to remove a fluid from a chamber of the microscope slide cartridge assembly.
However, Lemme teaches an analogous art of a staining apparatus (Lemme; Abstract) comprising (b) a reagent assembly (Lemme; Fig. 14, 17a; examiner interprets the structure above the slide support assembly 1099 to be the reagent assembly) comprising: (i) a reagent carousel (Lemme; Fig. 17a; para [79]; reagent support 1300), wherein the reagent carousel is configured to rotate on a second axis of rotation (Lemme; Fig. 14; para [79]; reagent support 1300 is fixedly mounted to a cage 1110 vertically above nozzle support 1100, which cage in turn is rotatably mounted for rotation on a shaft 1113) and wherein the second axis of rotation is located outside the outer perimeter of the microscope slide carousel (Lemme; Fig. 18; The examiner interest the outer perimeter of the microscope slide carousel to be the peripheral wall, and the reagent carousel interpreted as the reagent support 1300 is positioned above and not integrated with the peripheral wall), and wherein the reagent carousel comprises at least one reagent holder (Lemme; Fig.17a; examiner interprets the holder as the bottles/containers seen in Fig. 17a), (ii) a dispensing actuator (Lemme; para [79, 84]; Fig. 14, 17a; A plurality of reagent dispensers 1302…hammer or piston 1400 comprises a servo or piston 1404 for moving vertically into engagement with the top of a selected reagent dispenser), and wherein the reagent carousel is positioned above the microscope slide carousel (Lemme; Fig. 14), and wherein the reagent carousel and the microscope slide carousel are positioned such that when a reagent is placed in the reagent carousel the reagent can flow from the reagent carousel to the microscope slide carousel (Lemme; Fig. 14; para [84]; Thus, in order to dispense a selected reagent on a selected slide, the nozzle support 1100 is rotatably moved to a dispense position vertically over the selected slide which had been previously prepared, e.g. washed, etc., by the treatment stations carried on the nozzle support 1100)4, wherein the reagent assembly further comprises a second rotary control mechanism comprising a stationary actuator positioned relative to the second axis of rotation (Lemme; para [75]; Nozzle support 1100 is mounted on a shaft 1113 which in turn is rotatably mounted on a bridge 1112, and driven by a computer controlled stepping motor and drive belt; the examiner interprets the shaft that is rotably mounted and driven by the stepping motor) and wherein the first rotary control mechanism is configured to rotate the microscope slide carousel on the first axis of rotation at a speed sufficient to remove a fluid from a chamber of the microscope slide cartridge assembly5 (Lemme; para [5]; A stepper motor rotates the slide carousel). Lemme teaches that the secondary rotary control mechanism, interpreted as the stepping motor, is different from the motor driving the slide carousel (Lemme; para [16]; a plurality of slides are mounted in a circular array on a carousel which rotates, as directed by the computer, to a dispensing location placing each slide under one of a series of reagent dispensers on a second rotating carousel positioned above the slides). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the tissue staining device of Oei to comprise the reagent assembly as taught by Lemme, because Lemme teaches that the reagent assembly dispenses the active reagent on the slide for processing (Lemme; para [60]).
4 The limitation “when a reagent is placed…the reagent can flow” is directed to the function of the reagent carousel and/or the manner of operating the reagent carousel, all the structural limitations of the claim has been disclosed by Lemme and the reagent carousel of Lemme is capable of “placing reagent in the reagent carousel” and “flowing the reagent from the reagent carousel”. As such, it is deemed that the claimed apparatus is not differentiated from the reagent carousel of Lemme (see MPEP §2114).
5 The limitation is directed to the function and/or the manner of operating the first rotary control mechanism, all the structural limitations of the claim has been disclosed by Lemme and the first rotary control mechanism of Lemme is capable of “rotat[ing] the microscope slide carousel on the first axis of rotation at a speed sufficient to remove a fluid from a chamber of the microscope slide cartridge assembly". As such, it is deemed that the claimed first rotary control mechanism is not differentiated from the first rotary control mechanism of Lemme.
Modified Oei does not teach wherein the reagent carousel is configured to rotate on the second axis of rotation that is not coaxial with the first axis of rotation.
However, Ochranek teaches an analogous art of an automated diagnostic analyzer (Ochranek; Abstract) comprising a microscope slide carousel, wherein the microscope slide carousel is configured to rotate on a first axis of rotation controlled by a first rotary control mechanism (Ochranek; para [81]; t The example analyzer 100 disclosed above includes a reaction carousel (e.g., the second carousel 104) having a plurality of reaction vessels. In some examples, the reaction carousel has 187 reaction vessels (e.g., glass cuvettes) spaced around the outer circumference of the second carousel); and a reagent carousel, wherein the reagent carousel is configured to rotate on the second axis of rotation that is not coaxial with the first axis of rotation (Ochranek; para [29, 39]; a reagent carousel rotatably coupled to a base about a first axis of rotation…the first carousel 102 and the second carousel 104 are rotatably coupled to a base station 106 independent of each other). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the reagent carousel of modified Oei to be independent/separate from the slide carousel cartridge as taught by Ochranek as this is a known and suitable substitution for the reagent carousel in the art. One would have a reasonable expectation of success by substituting the reagent carousel of modified Oei to the claimed limitation as Ochranek teaches this arrangement is a known and suitable substitution in the art. The simple substitution of one known element for another is obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Regarding claim 80, modified Oei teaches the tissue staining device of claim 76, wherein the microscope slide carousel comprises 4 to 20 microscope slide cartridge stalls (Oei; para [116]; the slide with biopsy tissue 402 may be placed directly into one of the eight, for example, basses 403 that are fixed to the carousal 401).
Regarding claim 82, modified Oei teaches the tissue staining device of claim 81, wherein the microscope slide cartridge stall is configured to hold the microscope slide cartridge assembly such that a face of a microscope slide in the microscope slide cartridge assembly is in a substantially horizontal position (Oei; Fig. 13).
Regarding claim 83, modified Oei teaches the tissue staining device of claim 82, wherein the microscope slide cartridge stall comprises an opening having a size that is based on the dimensions of the microscope slide (Oei; Fig. 14; para [116]; the base 403 with a window and gasket may be fixed to the carousal 401).
Regarding claim 85, modified Oei teaches the tissue staining device of claim 76, wherein a distal portion of the microscope slide cartridge stall is configured to interface with a locking clip on the microscope slide cartridge assembly (Oei; para [74]; the parent cartridge-processing system could be designed as a carousel where slides with tissue are entered into slots).
Regarding claim 86, modified Oei teaches the tissue staining device of claim 76, further comprising the microscope slide cartridge assembly (Oei; Fig. 13; para [116]; Cartridges or base containing biological samples may be placed on a carousel designed to convey cartridges in series).
Regarding claim 95, modified Oei teaches the tissue staining device of claim 87, wherein the sealed perimeter formed on the microscope slide by the gasket has an area of 1 cm2 to 10 cm2 (Oei; para [107]). Examiner notes that Oei teaches the slide having a dimension of 75mmx26mm, thus the area of the slide is 19.5 cm2. examiner notes that the gasket is sized to provide a vacuum seal in the glass slide, thus is dependent on the size of the slide. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of an area is a result effective variable that gives the well-known and expected results of the sealing the slide, in the absence of a showing of unexpected results, the Office maintains the area of 1 cm2 to 10 cm2 would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 100, modified Oei teaches the tissue staining device of claim 76, wherein the reagent carousel comprises between about 5 and about 20 reagent holders (Oei; para [116]; the slide with biopsy tissue 402 may be placed directly into one of the eight, for example, basses 403 that are fixed to the carousal 401).
Regarding claim 101, modified Oei teaches the tissue staining device of claim 76 (the tissue staining device of Oei to comprise the reagent assembly as taught by Lemme as discussed above in para 46), wherein each reagent holder is configured to hold a reagent bottle in a pre-specified orientation (Lemme; Fig. 7; para [40]; A plurality of reagent bottles 302 are removably mounted within recesses 304).
Regarding claim 102, modified Oei teaches the tissue staining device of claim 101 (the tissue staining device of Oei to comprise the reagent assembly as taught by Lemme as discussed above in para 46), wherein each reagent holder comprises a depression to accept the reagent bottle in the pre-specified orientation (Lemme; Fig. 7; para [40]; A plurality of reagent bottles 302 are removably mounted within recesses 304).
Regarding claim 103, modified Oei teaches the tissue staining device of claim 101 (the tissue staining device of Oei to comprise the reagent assembly as taught by Lemme as discussed above in para 46), further comprising the reagent bottle (Lemme; Fig. 7; para [40]; A plurality of reagent bottles 302 are removably mounted within recesses 304).
Claims 84, 104, and 106 rejected under 35 U.S.C. 103 as being unpatentable over Oei in view of Lemme in view of Ochranek, and in further view of Copeland.
Regarding claim 84, modified Oei teaches the tissue staining device of claim 76, with the microscope slide cartridge stall.
Modified Oei does not teach wherein a proximal portion of the microscope slide cartridge stall comprises a loading spring.
However, Copeland teaches an analogous art of an automated immunostaining apparatus (Copeland; Abstract) comprising microscope slide carousel, wherein the microscope slide carousel further comprises a microscope slide cartridge stall (Copeland; col 21, line 50), wherein a proximal portion of the microscope slide cartridge stall comprises a loading spring (Copeland; col 21, lines 47-49; Spring 121A biases the slide engaging member 120A to firmly hold the slide 234). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the microscope slide cartridge stall of modified Oei to comprise the loading spring as taught by Copeland, because Copeland teaches that the clamp pivotally secures the slide (Copeland; col 21, lines 46-49).
Regarding claim 104, modified Oei teaches the tissue staining device of claim 103, with the reagent bottle.
Modified Lemme does not teach wherein the reagent bottle comprises: (a) a reagent reservoir; (b) a mounting element; and (c) a dispensing element, wherein the dispensing element comprises a press-to-dispense assembly and a reagent outlet.
However, Copeland teaches an analogous art of an automated immunostaining apparatus (Copeland; Abstract) comprising a reagent bottle (Copeland; Fig. 1; col 6, line 42; Reagent bottles 12), wherein the reagent bottle comprises: (a) a reagent reservoir (Copeland; Fig. 1; col 6, line 42; Reagent bottles 12; examiner notes that the bottles comprise an interior); (b) a mounting element (Copeland; Fig. 1; col 6, line 45; reagent bottle receptors 11); and (c) a dispensing element, wherein the dispensing element comprises a press-to-dispense assembly and a reagent outlet (Copeland; col 15, lines 35-39; solenoid valve 424 permits pressurized air to pass from line 422 to air cylinder input line 300, causing rod 302 and foot 306 (FIG. 15) to press the reagent dispenser bottle 12 downward, emitting a precise volume of reagent liquid). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the reagent bottle of Lemme with the reagent bottle comprising the dispensing element as taught by Copeland as this is a known and suitable substitution for the reagent bottle in the art. Further, one would have a reasonable expectation of success by substituting the reagent bottle of Lemme to the claimed limitation as taught by Copeland, because Copeland teaches this arrangement is a known and suitable arrangement in the art. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Regarding claim 106, modified Oei teaches the tissue staining device of claim 104, wherein the reagent reservoir has a volume of about 5 mL to about 50 mL (Lemme; Fig. 7; para [40]; A plurality of reagent bottles 302 are removably mounted within recesses 304). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum volume to a range about 5 mL to about 50 mL which would allow the bottles to dispense the reagent (MPEP § 2144.05 (II)).
Claims 87, 92-94, and 96 are rejected under 35 U.S.C. 103 as being unpatentable over Oei in view of Lemme in view of Ochranek, and in further view of Ng (US 20200319067 A1; hereinafter “Ng”; filed on 1/24/2020; already of record).
Regarding claim 87, modified Oei teaches the tissue staining device of claim 86, wherein the microscope slide cartridge assembly comprises: a gasket positioned on a bottom side of the microscope slide cartridge assembly (Oei; para [11, 111]; a gasket in the base), wherein the gasket is configured to form a sealed perimeter on a face of a microscope slide (Oei; para [11, 111]; The gasket in the base surrounds the slide. The lid creates a sealed chamber around the gasket that encloses the slide); one or more walls, wherein the one or more walls are configured to connect, at least in part, the top side and the gasket thereby forming a chamber over a face of the microscope slide (Oei; Fig. 8; examiner interprets the side surfaces as the wall); and a microscope slide (Oei; para [108]; each cartridge may accept one glass slide with tissue).
Modified Oei does not teach the microscope slide cartridge comprising a fluid input port positioned on a top side of the microscope slide cartridge assembly; an inclined waste flow pathway configured to direct fluid flow from the chamber to a waste output element; one or more clips configured to hold the face of the microscope slide against the gasket; a portion of a locking clip.
However, Ng teaches an analogous art of a sample processing assembly (Ng; Abstract) further comprising a fluid input port positioned on a top side of the microscope slide cartridge assembly (Ng; Fig. 15; para [71]; on cover member 2000 which opens into inlet port 2450); an inclined waste flow pathway configured to direct fluid flow from the chamber to a waste output element (Ng; Fig. 16, 17; para [72]; First fluid path 1500 is also configured for coupling with a fluid flow port 2500 in a cover member 2000; examiner notes that the waste flow pathway is inclined because the port is positioned in the cover member which would have to flow up/at an incline); one or more clips configured to hold the face of the microscope slide against the gasket (Ng; Fig. 16; para [74]; coupling means in the form of coupling surface 1160 and projections 2160 are provided on the closure body 1100 and cover member 2000); a portion of a locking clip (Ng; Fig. 1; para [59, 65]; spring clip 1350). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the microscope slide cartridge to comprise the fluid input port and the inclined waste flow pathway as taught by Ng, because Ng teaches that the ports apply/clear the reagent within the reaction chamber and washes/cleans the reaction chamber (Ng; para [78]). Additionally, it would it would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the microscope slide cartridge of modified Oei to comprise the one or more clips as taught by Ng, because Ng teaches that the coupling means releasably attaches the cover to the body and seals the reaction chamber (Ng; para [17, 21]; examiner notes that the reaction chamber is formed by the gasket, cover, and the slide see para [64]). Further, it would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the microscope slide cartridge of modified Oei to comprise the locking clip as taught by Ng, because Ng teaches that the spring clip engages with the mounting surface which is mounted on to an assembly for processing (Ng; para [59]).
Regarding claim 92, modified Oei teaches the tissue staining device of claim 87 (the microscope slide cartridge of modified Oei is modified to comprise the input port, the outlet, the one or more clips, and the locking clip as taught by Ng discussed above in claim 86), wherein the portion of the locking clip of the microscope slide cartridge assembly is configured to interface with another portion of the locking clip located on a microscope slide cartridge stall (Ng; para [59, 65]; mounting surface 1200 is provided to support a substrate, not shown, such as a slide onto which a sample has been mounted for processing… spring clip 1350 is engaged with lip 1280 on mounting surface 1200). Examiner notes that the spring clip engages with the mounting surface which can be provided on a processing assembly. Additionally, the limitation is directed to the function and/or the manner of operating the locking clip, all the structural limitations of the claim has been disclosed by modified Oei and the locking clip of modified Oei is capable “to interface with another portion of the locking clip located on a microscope slide cartridge stall”. As such, it is deemed that the claimed locking clip is not differentiated from the locking clip of modified Oei (see MPEP §2114).
Regarding claim 93, modified Oei teaches the tissue staining device of claim 87 (the microscope slide cartridge of modified Oei is modified to comprise the input port, the outlet, the one or more clips, and the locking clip as taught by Ng discussed above in claim 86), wherein the fluid input port is on a proximal portion of the microscope slide cartridge assembly (Ng; Fig. 16), and the portion of the locking clip is on a distal portion of the microscope slide cartridge assembly (Ng; Fig. 3).
Regarding claim 94, modified Oei teaches the tissue staining device of claim 87 (the microscope slide cartridge of modified Oei is modified to comprise the input port, the outlet, the one or more clips, and the locking clip as taught by Ng discussed above in claim 86), wherein the chamber has a volume of about 300 µL or more (Ng; para [77]; a reaction chamber of 20 μl to 500 μl in volume).
Regarding claim 96, modified Oei teaches the tissue staining device of claim 87 (the microscope slide cartridge of modified Oei is modified to comprise the input port, the outlet, the one or more clips, and the locking clip as taught by Ng discussed above in claim 86), wherein the microscope slide cartridge assembly comprises a fluid input port position on a top side of the microscope slide cartridge assembly (Ng; Fig. 15; para [71]; on cover member 2000 which opens into inlet port 2450), and wherein when the microscope slide cartridge assembly is loaded in the microscope slide cartridge stall the reagent flow from the reagent carousel to the microscope slide carousel is directed to the fluid input port (Lemme; Fig. 14; para [84]; Thus, in order to dispense a selected reagent on a selected slide, the nozzle support 1100 is rotatably moved to a dispense position vertically over the selected slide which had been previously prepared, e.g. washed, etc., by the treatment stations carried on the nozzle support 1100).
Claims 88-91 are rejected under 35 U.S.C. 103 as being unpatentable over Oei in view of Lemme in view Ochranek in view of Ng, and in further view of Lin et al (US 20060218994 A1; hereinafter “Lin”; already of record).
Regarding claim 88, modified Oei teaches the tissue staining device of claim 87, with the microscope slide cartridge assembly.
Modified Oei does not teach wherein the microscope slide cartridge assembly further comprises a microscope slide covertile configured to be positioned on the microscope slide.
However, Lin teaches an analogous art of a substrate holder (Lin; Fig. 16a, b; para [178]; holder 148) comprising a microscope slide covertile configured to be positioned on the microscope slide (Lin; Fig. 16a, b; para [180]; The spacers 144). It would it would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the microscope slide cartridge of modified Oei to comprise the covertile as taught by Lin, because Lin teaches that the spacers form a gap for the sample (Lin; para [180; Fig. 16a).
Regarding claim 89, modified Oei teaches the tissue staining device of claim 88 (the microscope slide cartridge of modified Oei is modified to comprise the covertile as taught by Lin), wherein the microscope slide covertile comprises one or more downward protruding spacers (Lin; Fig. 16a, b; para [180]; The spacers 144).
Regarding claim 90, modified Oei teaches the tissue staining device of claim 89 (the microscope slide cartridge of modified Oei is modified to comprise the covertile as taught by Lin), wherein each of the one or more downward protruding spacers has a height of about 0.05 mm to about 0.5 mm (Lin; Fig. 16a, b; para [180]; spacers 144 have a thickness of about 0.05 mm).
Regarding claim 91, modified Oei teaches the tissue staining device of claim 88 (the microscope slide cartridge of modified Oei is modified to comprise the covertile as taught by Lin), wherein the microscope slide covertile, when positioned on the microscope slide, forms a space configured to hold about 40 µL to 200 µL of a fluid (Lin; Fig. 16a, b; para [180]; Oei; para [107]). Examiner notes that Oei teaches the slide having a dimensions of 75mmx26mm, the spacers have a height of 0.05mm, thus the space formed equals 97.5 mm3 which is equal to 97.5 µL.
Response to Arguments
Applicant’s arguments filed, 4/13/2026, have been considered and some of the arguments are found to be persuasive. However, those arguments are directed towards the claim amendments. The examiner notes that the previous prior art rejection is withdrawn and a new prior art rejection is applied to address the claim amendments. The non-persuasive arguments are addressed below.
In the Applicant’s arguments, on pages 12-13, the Applicant argues that Lemme fails to teach wherein the reagent carousel is configured to rotate on a second axis of rotation and wherein the second axis of rotation is located outside the outer perimeter of the microscope slide carousel. The Examiner respectfully disagrees. Lemme teaches wherein the reagent carousel is configured to rotate on a second axis of rotation (Lemme; Fig. 14; para [79]; reagent support 1300 is fixedly mounted to a cage 1110 vertically above nozzle support 1100, which cage in turn is rotatably mounted for rotation on a shaft 1113) and wherein the second axis of rotation is located outside the outer perimeter of the microscope slide carousel (Lemme; Fig. 18; The examiner interest the outer perimeter of the microscope slide carousel to be the peripheral wall, and the reagent carousel interpreted as the reagent support 1300 is positioned above and not integrated with the peripheral wall). Specifically, the broadest reasonable interpretation of the limitation would be met if the second axis of rotation is outside of the same plane as the first axis of rotation. Lemme teaches that the axis of rotations are on different planes as depicted in Fig. 18.
In the Applicant’s arguments, on pages 12-13, the Applicant argues that Lemme fails to teach fluid is removed from a chamber of the microscope slide cartridge assembly by centrifugal force. The Examiner respectfully agrees. However, a new prior art rejection is applied to address the claim amendments.
In the Applicant’s arguments, on pages 14-15, the Applicant argues that the secondary references Ochranek, Copeland, and Oei fails to disclose the claim amendments. However, the Examiner does not rely on the secondary references to teach new limitations. The Examiner notes that Lemme teaches the limitations as discussed above or was modified in view of Clarke.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/A.Q.L./Examiner, Art Unit 1796
/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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