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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/08/2026 has been entered.
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.
1. Claims 1-5 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0052082 to Groll et al. in view of U.S. Patent Application Publication No. 2018/0252623 to Dyson-Holland et al., U.S. Patent No. 6,207,408 to Essenfeld et al. and U.S. Patent Application Publication No. 2018/0306686 to Poulsen et al.
Groll et al. teaches devices and methods for the deposition of reagents onto cells or tissue samples. (Abstract).
Groll et al. teaches “a computer system for staining a tissue sample comprising one or more processors and at least one memory, the at least one memory storing non-transitory computer-readable instructions for execution by the one or more processors to cause a staining apparatus, having a droplet-on-demand dispensing mechanism, in communication with the computer system to dispense a predetermined quantity of a primary staining reagent composition or a large molecule reagent composition onto at least a portion of a biological sample.” [0032].
Groll et al. teaches wax removal or deparaffinization of samples and applying a staining reagent to samples, which would necessarily be exposed. [0065] and [0031]
Essenfeld et al. teaches dewaxing by submerging slides in a xylene bath. (column 18, lines 37-38).
Groll et al. does not teach separate modules for the wax removal or staining.
Dyson-Holland et al. teaches a specimen processing system that includes a staining module, baking module and label reading module. [0049], [0222].
It would have been obvious to modify Groll et al. to include a staining module as taught by Dyson-Holland et al. for purposes of being able to control the staining process variables within a module.
Groll et al. teaches a relative motion system 904 which moves target samples into and out of alignment with an inkjet printer.
Groll et al. does not teach a robotic transfer mechanism to transfer slides to different processing locations.
Dyson-Holland et al. teaches a transfer mechanism that can include, without limitation, one or more robotic handlers or arms, X-Y-Z transport systems, conveyors, or other automated mechanisms capable of carrying items between locations. [0258]
Dyson-Holland et al. also teaches transferring slides in slide carriers, such as racks, baskets, trays, or other types of carriers suitable for carrying slides before, during, or after specimen processing. [0216]
It would have been obvious to modify Groll et al to use a robotic transfer mechanism to transfer slides in baskets from an area or module (“core module) where samples are exposed to an area or module where staining reagent is applied to samples as taught by Dyson-Holland et al. base on using a known transfer mechanism for transferring the slides in Groll et al.
Groll et al. teaches a control module containing a processor. [0030].
Groll et al. further teaches a computer system for staining a tissue sample comprising one or more processors and at least one memory, the at least one memory storing non-transitory computer-readable instructions. [0032]
Dyson-Holland et al. teaches one or more memories and a programmable processor and teaches processors that execute instructions. [0056]
It would have been obvious to one of ordinary skill in the art to modify Groll et al. in view of Dyson-Holland et al. to include a processor with a memory including non-transitory machine-readable instructions that when executed cause the processor to: direct performance of a baking process and a dewaxing process to expose the sample on the slide, wherein the dewaxing process comprises submerging the sample portion of the slide in at least one volume of a dewaxing; direct transfer of the slide basket from the core module to the staining module; direct removal of the slide from the slide basket; and direct application of the reagent on to the removed slide in a staining area in the staining module, in view of Groll et al. and Dyson-Holland teaching baking, dewaxing, staining and applying reagents are known process and the use of processors programmed with instructions is known and Essenfeld et al. teaching submersion in xylene for dewaxing with Dyson-Holland teaching transferring slides in slide carriers, such as racks, baskets, trays, or other types of carriers suitable for carrying slides before, during, or after specimen processing.
Regarding the newly added limitations to claim 1 directed to the staining module comprising a humidor operable to accept at least one slide therein; and direct transfer of the removed slide into the humidor at least one of prior to the direct application of the reagent on to the removed slide and after the direct application of the reagent on to the removed slide, Poulsen et al. teaches a tissue processing apparatus that involves “processing steps, such as baking, target retrieval, deparaffination, stringency wash, cover slipping, staining, enzymatic treatment, etc.” [0046]
Further Poulsen et al. teaches “control of the humidity and temperature during the processing and/or treating and/or staining.” [0014]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Groll et al. in view of Dyson-Holland et al. and Essenfeld et al. to provide the staining module with a controlled humidity areas (“humidor”) operable to accept at least one slide therein, and direct transfer of the removed slide into the humidor at least one of prior to the direct application of the reagent on to the removed slide and after the direct application of the reagent on to the removed slide in view of Poulsen et al. teaching controlling humidity during the processing and/or treating and/or staining.
I.) Regarding applicant’s claim 1, as noted above Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders all the limitations of claim 1 obvious.
Therefore, Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 1 obvious from which claim 2 depends.
Claim 2 recites that the staining module comprises: a reagent cartridge comprising a reagent and a thermal inkjet print head; and a processor including non-transitory machine-readable instructions that when executed cause the processor to direct application of the reagent from the thermal inkjet print head of the reagent cartridge.
Groll et al. teaches a droplet-on-demand reagent dispensing system is an inkjet dispensing system which would include a reagent cartridge for providing reagent for inkjet printing and teaches one or more processor having a memory storing non-transitory computer-readable instructions for operating the inkjet printer. [0010], [0032]
Therefore, Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 2 obvious.
III.) Regarding applicant’s claim 3, as noted above Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 2 obvious from which claim 3 depends.
Claim 3 recites that the core module or the staining module comprises an imager operable to capture an image of the sample and the processor includes non-transitory machine-readable instructions that when executed cause the processor to determine a target location on the sample based on the captured image for application of the reagent from the thermal inkjet printhead of the cartridge.
Groll et al. teaches “to create a “staining job,” the target sample 908, in some embodiments, may be analyzed by a target imaging system 901 to determine the spatial position of the target sample.” [0070]
Therefore, Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 3 obvious.
IV.) Regarding applicant’s claim 4, as noted above Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 2 obvious from which claim 4 depends.
Claim 4 recites that the cartridge is positioned in a staining area and the staining module comprises a storage station operable to store a plurality of cartridges, wherein prior to directing application of the reagent from the thermal inkjet print head, the instructions cause the cartridge to be retrieved from the storage station and coupled to a printing assembly.
Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. does not teach that the cartridge is positioned in a staining area and the staining module comprises a storage station operable to store a plurality of cartridges, wherein prior to directing application of the reagent from the thermal inkjet print head, the instructions cause the cartridge to be retrieved from the storage station and coupled to a printing assembly.
It would have been obvious to one of ordinary skill in the art to modify Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. so that to provide the staining module with a storage station operable to store a plurality of cartridges purposes of providing different reagents in different reagent cartridges for different processes retrieve reagent cartridges from the storage station and couple them to a printing assembly as they are needed.
Therefore, Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 4 obvious.
V.) Regarding applicant’s claim 5, as noted above Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 2 obvious from which claim 5 depends.
Claim 5 recites that the processor includes non-transitory machine-readable instructions that when executed caused the slide to be removed from the humidor and aligned with the thermal inkjet print head of the cartridge.
Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. does not teach that the processor includes non-transitory machine-readable instructions that when executed caused the slide to be removed from the humidor and aligned with the thermal inkjet print head of the cartridge.
It would have been obvious to one of ordinary skill in the art to modify Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. to include a processor that includes non-transitory machine-readable instructions that when executed caused the slide to be removed from and area in which humidity is controlled (humidor) and aligned with the thermal inkjet print head of the cartridge, for purposes of automating the overall system.
Therefore, Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 5 obvious.
VI.) Regarding applicant’s claim 7, as noted above Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 2 obvious from which claim 7 depends.
Claim 7 recites that the core module comprises a dehydration station, wherein, after staining, the processor includes non-transitory machine-readable instructions that when executed caused the slide to be transported to the dehydration station.
Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. does not teach a dehydration station, wherein, after staining, the processor includes non-transitory machine-readable instructions that when executed caused the slide to be transported to the dehydration station.
Dyson-Holland et al. teaches a processing station that can include a dehydration unit. [0222].
It would have been obvious to one of ordinary skill in the art to modify Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. to includes a dehydration unit (“station”) to perform dehydration in view of Dyson-Holland et al. teaching that dehydration is a conventional step in tissue slide processing. It would have been obvious to include machine readable instructions for the controller to move the slides to the dehydration unit after staining, in order to dry the stained sample.
Therefore, Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 7 obvious.
VII.) Regarding applicant’s claim 8, as noted above Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 1 obvious from which claim 8 depends.
Claim 8 recites that the core module comprises a baking station and a dewaxing station.
Groll et al. teaches wax removal. [0065]
Groll does not teach a baking station.
Dyson-Holland et al. teaches a baking a baking module. [0222]
Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. does not teach a baking station and a dewaxing station.
It would have been obvious to one of ordinary skill in the art to modify Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. to include a baking and a dewaxing area or station to perform baking and dewaxing in view of Groll et al. and Dyson-Holland et al. teaching that baking and dewaxing are conventional steps in tissue slide processing.
Therefore, Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 8 obvious.
VIII.) Regarding applicant’s claim 9, as noted above Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 1 obvious from which claim 9 depends.
Claim 9 recites that the core module comprises an identification station comprising an identifier operable to identify label information on the slide.
Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. does not teach an identification station comprising an identifier operable to identify label information on the slide.
Dyson-Holland et al. teaches that slide carriers can be transferred to a reader (e.g., a label reader, a barcode reader, etc.), not shown that reads labels, if any, on the slides. [0222]
It would have been obvious to one of ordinary skill in the art to provide the slides of Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. with labels to provide for identifying information associated with the slides.
Therefore, Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 9 obvious.
IX.) Regarding applicant’s claim 10, as noted above Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 1 obvious from which claim 10 depends.
Claim 10 recites that in the core module, the slide is in a basket operable to contain a plurality of slides and the robotic transfer mechanism is operable to transfer the basket from the core module to the staining module and the processor assembly further comprises a processor including non-transitory machine-readable instructions that when executed cause the slide to be removed from the basket for a printing operation in the staining.
Dyson-Holland et al. teaches “other types of slide carriers, such as racks, baskets, trays, or other types of carriers suitable for carrying slides before, during, or after specimen processing.” [0216] Dyson-Holland also teach that the slides are removed from the carrier by an ejector [0257]
It would have been obvious to modify Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. to include baskets as taught by Dyson-Holland et al. to transfer slides as taught by Dyson-Holland et al. and to remove the slides from the basket for individual processing.
Therefore, Groll et al. in view of Dyson-Holland et al. Essenfeld et al. and Poulsen et al. renders claim 10 obvious.
X.) Regarding applicant’s claim 11, as noted above Groll et al. in view of Dyson-Holland et al. Essenfeld et al. and Poulsen et al. renders claim 2 obvious from which claim 11 depends.
Claim 11 recites that the cartridge is a single use cartridge.
Any cartridge can be used once and discarded. Claim 11 does not recite any structure that renders the single use cartridge distinguishable over any other cartridge.
Therefore, Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 11 obvious.
2. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. as applied to claim 2 above and further in view of U.S. Patent Application Publication No. 2010/0304989 to Von Hoff et al.
I.) Regarding applicant’s claim 6, as noted above Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 2 obvious from which claim 6 depends.
Claim 6 recites an antigen retrieval station in the staining module operable to expose antigenic sites on the sample utilizing pressure, wherein the processor includes non-transitory machine-readable instructions that when executed caused the slide to be transported to the antigen retrieval station and, after an antigen retrieval process, transported to the staining area.
Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. does not teach an antigen retrieval station in the staining module operable to expose antigenic sites on the sample utilizing pressure, wherein the processor includes non-transitory machine-readable instructions that when executed caused the slide to be transported to the antigen retrieval station and, after an antigen retrieval process, transported to the staining area.
Von Hoff et al. teaches processing and analyzing tissue samples mounted on slides including “After deparaffination and rehydration through a series of graded alcohols, pretreatment was performed as required to expose the targeted antigen.” [0307]
It would have been obvious to one of ordinary skill in the art to modify Groll et al. in view of Dyson et al., Essenfeld et al. and Poulsen et al. to expose antigenic sites on the slides as taught by Von Hoff et al. using fluid or gaseous pressure as necessary to expose the antigenic sites.
Therefore, Groll et al. in view of Dyson-Holland et al., Essenfeld et al., Poulsen at el. and Von Hoff et al. renders claim 6 obvious.
3. Claims 15 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al.
I) Regarding applicant’s claim 15, claim 15 recites a method comprising: exposing a sample on a slide in a core module of a processor assembly; robotically transferring the slide from the core module of the processor assembly to a staining module of the processor assembly; applying a reagent to the exposed sample in the staining module by a thermal inkjet printing process; and after applying the reagent, robotically transferring the slide back to the core module.
As noted above, Groll et al. teaches devices and methods for the deposition of reagents onto cells or tissue samples. (Abstract).
Groll et al. teaches “a computer system for staining a tissue sample comprising one or more processors and at least one memory, the at least one memory storing non-transitory computer-readable instructions for execution by the one or more processors to cause a staining apparatus, having a droplet-on-demand dispensing mechanism, in communication with the computer system to dispense a predetermined quantity of a primary staining reagent composition or a large molecule reagent composition onto at least a portion of a biological sample.” [0032].
Groll et al. teaches wax removal or deparaffinization of samples and applying a staining reagent to samples, which would necessarily be exposed. [0065] and [0031]
Essenfeld et al. teaches dewaxing by submerging slides in a xylene bath. (column 18, lines 37-38).
Groll et al. does not teach separate modules for the wax removal or staining.
Dyson-Holland et al. teaches a specimen processing system that includes a staining module, baking module and label reading module. [0049], [0222].
It would have been obvious to modify Groll et al. to include a staining module as taught by Dyson-Holland et al. for purposes of being able to control the staining process variables within a module.
Groll et al. teaches a relative motion system 904 which moves target samples into and out of alignment with an inkjet printer.
Groll et al. does not teach a robotic transfer mechanism to transfer slides to different processing locations.
Dyson-Holland et al. teaches a transfer mechanism that can include, without limitation, one or more robotic handlers or arms, X-Y-Z transport systems, conveyors, or other automated mechanisms capable of carrying items between locations. [0258]
Dyson-Holland et al. also teaches transferring slides in ide carriers, such as racks, baskets, trays, or other types of carriers suitable for carrying slides before, during, or after specimen processing. [0216]
It would have been obvious to modify Groll et al to use a robotic transfer mechanism to transfer slides in baskets from an area or module (“core module) where samples are exposed to an area or module where staining reagent is applied to samples as taught by Dyson-Holland et al. base on using a known transfer mechanism for transferring the slides in Groll et al.
Groll et al. teaches a control module containing a processor. [0030].
Groll et al. further teaches a computer system for staining a tissue sample comprising one or more processors and at least one memory, the at least one memory storing non-transitory computer-readable instructions. [0032]
Dyson-Holland et al. teaches one or more memories and a programmable processor and teaches processors that execute instructions. [0056]
It would have been obvious to one of ordinary skill in the art to modify Groll et al. in view of Dyson-Holland et al. to include a processor with a memory including non-transitory machine-readable instructions that when executed cause the processor to: direct performance of a baking process and a dewaxing process to expose the sample on the slide, wherein the dewaxing process comprises submerging the sample portion of the slide in at least one volume of a dewaxing; direct transfer of the slide basket from the core module to the staining module; direct removal of the slide from the slide basket; and direct application of the reagent on to the removed slide in a staining led e in the staining module, in view of Groll et al. and Dyson-Holland teaching baking, dewaxing, staining and applying reagents are known process and the use of processors programmed with instructions is known and Essenfeld teaching submersion in xylene for dewaxing. Removing the slides from baskets for applying reagents would have been obvious for applying reagents to individual slides.
Therefore, Groll et al. in view of Dyson-Holland and Essenfeld et al. renders claim 15 obvious.
Regarding the newly added limitations to claim 15 directed to the staining module comprising a humidor operable to accept at least one slide therein; and placing the slide in the humidor at least one of prior to applying the reagent and after applying the reagent, Poulsen et al. teaches a tissue processing apparatus that involves “processing steps, such as baking, target retrieval, deparaffination, stringency wash, cover slipping, staining, enzymatic treatment, etc.” [0046]
Further Poulsen et al. teaches “control of the humidity and temperature during the processing and/or treating and/or staining.” [0014]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Groll et al. in view of Dyson-Holland et al. and Essenfeld et al. to provide the staining module with a controlled humidity areas (“humidor”) operable to accept at least one slide therein, and placing the slide in the humidor at least one of prior to applying the reagent and after applying the reagent in view of Poulsen et al. teaching controlling humidity during the processing and/or treating and/or staining.
II.) Regarding applicant’s claim 21, as noted above, Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 15 obvious from which claim 21 depends.
Claim 21 recites that the slide if placed in a humidor prior to applying reagent to the exposed sample.
As noted above, Poulsen et al. teaches controlling of the humidity and temperature during the processing and/or treating and/or staining.
It would have been obvious to one of ordinary skill in the art to modify Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. to provide the staining area or module with a humidified atmosphere (a humidor) in view of Poulsen et al. teaching controlling humidify during staining.
Therefore, Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 21 obvious.
III.) Regarding applicant’s claim 22, as noted above Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 15 obvious from which claim 22 depends.
Claim 22 recites that after robotically transferring the slide back to the core module, the method further comprises dehydrating the sample.
Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. does not teach a dehydration station, wherein, after staining, the processor includes non-transitory machine-readable instructions that when executed caused the slide to be transported to the dehydration station.
Dyson-Holland et al. teaches a processing station that can include a dehydration unit. [0222].
It would have been obvious to one of ordinary skill in the art to modify Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. to includes a dehydration area or station to perform dehydration in view of Dyson-Holland et al. teaching that dehydration is a conventional step in tissue slide processing.
Therefore, Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 22 obvious.
V.) Regarding applicant’s claim 23, as noted above Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 15 obvious from which claim 23 depends.
Claim 23 recites that prior to robotically transferring the slide to the staining module, the method comprises capturing identification information from the slide in the core module.
As noted above, Dyson-Holland et al. teaches that slide carriers can be transferred to a reader (e.g., a label reader, a barcode reader, etc.), not shown that reads labels, if any, on the slides. [0222]
It would have been obvious to one of ordinary skill in the art to provide the slides of Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. with labels to provide for identifying information associated with the slides.
Therefore, Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. renders claim 23 obvious.
4. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Groll et al. in view of Dyson-Holland et al., Essenfeld et al, and Poulsen et al. as applied to claim 15 and further in view of Von Hoff.
I.) Regarding applicant’s claim 16, as noted above Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen renders claim 15 obvious from which claim 16 depends.
Claim 16 recites that prior to applying the reagent, the method comprises exposing antigenic sites of the exposed sample in the staining module.
Groll et al. in view of Dyson-Holland et al., Essenfeld et al. and Poulsen et al. does not teach an antigen retrieval station in the staining module operable to expose antigenic sites on the sample utilizing pressure, wherein the processor includes non-transitory machine-readable instructions that when executed caused the slide to be transported to the antigen retrieval station and, after an antigen retrieval process, transported to the staining area.
As noted above, Von Hoff et al. teaches processing and analyzing tissue samples mounted on slides including “After deparaffination and rehydration through a series of graded alcohols, pretreatment was performed as required to expose the targeted antigen.” [0307]
It would have been obvious to one of ordinary skill in the art to modify Groll et al. in view of Dyson et al., Essenfeld et al. and Poulsen et al. to expose antigenic sites on the slides as taught by Von Hoff et al. using fluid or gaseous pressure as necessary to expose the antigenic sites.
Therefore, Groll et al. in view of Dyson-Holland et al., Poulsen et al. and Von Hoff et al. renders claim 16 obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-5 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7 of copending Application No. 17/790,040 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5 and 7 of the reference application recite limitations that encompass limitations of the correspondingly numbered claims 1-5 and 7 of the present application recite limitations that are the same and/or interpreted as reading on the limitations of claims 1-5 and 7 of the present application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to claims 1-11, 15, 16 and 20-23 have been considered but are moot because the new ground of rejection that relies upon Poulsen et al. as teaching a tissue processing apparatus that involves “processing steps, such as baking, target retrieval, deparaffination, stringency wash, cover slipping, staining, enzymatic treatment, etc.,” and “control of the humidity and temperature during the processing and/or treating and/or staining.” [0046], [0014]
On pages 8-9 applicant argues that Groll does not teach processing slides in a basket and that Dyson-Holland teaches slides can be individually processed.
As noted above, Essenfeld et al. teaches submerging slides in a xylene bath. Essenfeld et al, further teaches the use of a “rack” to hold slides during processing. (column 18, lines 60-66)
Further as noted in the Advisory Action of 04/20/2026, Dyson-Holland teaches "slide carriers such as baskets are suitable for carrying slides "before, during, or after specimen processing," but argues that this is not how the slide carriers are used in Dyson-Holland. The examiner notes that obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so (MPEP 2143.01). Dyson-Holland's teaching that baskets can be suitable for carrying slides "during processing" (and Essenfeld et al teaching processing slides by submerging slides in racks in processing fluids) would motivate one skilled in the art to modify Groll to process slides in baskets to avoid the complexity of removing and processing the slides individually, thereby providing for processing of multiple slides at the same time.
Allowable Subject Matter
Claim 20 would be allowable if rewritten to include all of the limitations of the base claim and any intervening claims.
The prior art of record does not teach removing a slide from a basket by placing a cap on the slide and removing the slide by the cap in a method as recited in claim 20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent No. 6,218,191 to Palander teaches that “Too little humidity can result in the sample drying out and excess humidity can result in condensation forming on the glass slides.” (column 2, lines 49-51.
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/MICHAEL STANLEY GZYBOWSKI/ Examiner, Art Unit 1798
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