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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on 11/11/2015. Claims 1, 3, 4 and 6-20 are pending. Claims 2 and 5 are canceled.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 1, 3, 4, 6, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Testa et al. in view of Fukushima et al. and U.S. Patent No. 6,288,369 to Sherman.
Regarding applicant’s claim 1, Testa et al. teaches an apparatus 10 in which tissue samples are processed that reads on applicant’s claimed tissue processor. The apparatus of Testa et al. is heated and includes a lid 14 to which a heating means 16a can be coupled. (column 17, lines 3-5).
The lid of Testa et al. does not include an outer cover and an inner plate, and a heater that is disposed within a chamber defined by the outer cover and the inner plate.
Fukushima et al. teaches a sample processing apparatus in which biological tissue can be processed. (Page 1, last full paragraph of English translation)
Fukushima et al. teaches a lid 26 that include an outer layer (“cover”) 104a and an inner case (“plate”) 106 “disposed on the bottom portion of the lid portion 26.” [0060], [0062]
Fukushima et al. further teaches a heater 62 that is disclosed as being “disposed inside the lid portion 26” [0020] and “provided inside the lid portion 26” [0056] and “disposed on the upper surface of the inner case 106.”[0062]
It would have been obvious to one of ordinary skill in the art to modify Testa et al. to include a lid that includes an outer cover and an inner plate, and a heater that is disposed within a chamber defined by the outer cover and the inner plate and an insulating layer disposed on the heater between the outer cover and inner plate as taught by Fukushima et al. for purposes of temperature control.
Testa et al. in view of Fukushima et al. does not teach that the insulation layer is spaced away from the outer cover.
Sherman teaches an apparatus that includes heaters 5 and closed and empty spaces 11 above the heaters that “are much cooler than the space directly above the heaters.” (column 3, lines 12-14)
It would have been obvious to modify Testa et al. in view of Fukushima et al. to include a closed, empty space between the insulation layer and the outer cover, to provide a cooler space adjacent the outer cover as taught by Sherman for purposes of keeping the outer cover cool.
I.) As noted above, Testa et al. in view of Fukushima et al. and Sherman teaches all the elements of claim 1.
Therefore, Testa et al. in view of Fukushima et al. and Sherman renders claim 1 obvious.
II.) Regarding applicant’s claim 3, as noted above Testa et al. in view of Fukushima et al. and Sherman renders claim 1 obvious from which claim 3 depends.
Claim 3 recites that the heater is a heating pad.
While Testa et al. in view of Fukushima et al. and Sherman includes a heater within a chamber defined by the outer cover and the inner plate and an insulating layer disposed on the heater between the outer and inner plate for purposes of temperature control, Testa et al. in view of Fukushima et al. and Sherman does not teach the type of heater used.
It would have been obvious to one of ordinary skill in the art to use any conventional type of heater, including one having a pad shape.
Therefore, Testa et al. in view of Fukushima et al. and Sherman renders claim 3 obvious.
III.) Regarding applicant’s claim 4, as noted above Testa et al. in view of Fukushima et al. and Sherman renders claim 1 obvious from which claim 4 depends.
Claim 4 recites that the inner plate is a heat-conducting plate.
Fukushima et al. teaches that the inner plate is made from a heat transfer material. (paragraph bridging pages 12-13 of English translation)
Therefore, Testa et al. in view of Fukushima et al. and Sherman renders claim 4 obvious.
IV.) Regarding applicant’s claim 6, as noted above Testa et al. in view of Fukushima et al. and Sherman renders claim 1 obvious from which claim 6 depends.
Claim 6 recites that the retort lid is pivotally connected to the retort.
As shown in Fig. 1 the lid 14 of Testa et al. is pivotally connected to the apparatus 10.
Therefore, Testa et al. in view of Fukushima et al. and Sherman renders claim 6 obvious.
V.) Regarding applicant’s claim 9, as noted above Testa et al. in view of Fukushima et al. and Sherman renders claim 1 obvious from which claim 9 depends.
Claim 9 recites a conduit fluidly connected to the retort to introduce a fluid into the retort or discharge the fluid from the retort.
Fukushima et al. teaches nozzle holes 38 that are provided to introduce fluid into the apparatus which are interpreted as providing a conduit that is fluidly connected to the apparatus. (page 13, second full paragraph of English translation).
In Testa et al. in view of Fukushima et al. and Sherman it would have been obvious to include the nozzle holes of Fukushima et al. for purposes of providing processing fluids into the apparatus.
Therefore, Testa et al. in view of Fukushima et al. and Sherman renders claim 9 obvious.
VI.) Regarding applicant’s claim 10, as noted above Testa et al. in view of Fukushima et al. and Sherman renders claim 1 obvious from which claim 10 depends.
Claim 10 recites a controller electrically coupled to the heater and configured to control the heater to heat the retort lid.
Testa et al. teaches a programmable temperature controlling means. (column 7, lines 53-55)
It would have been obvious to control the heater in the lid of Testa et al. in view of Fukushima et al. and Sherman for purposes of controlling the temperature in the apparatus.
Therefore, Testa et al. in view of Fukshima et al. and Sherman renders claim 10 obvious.
2. Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Testa et al. in view of Fukushima et al. as applied to claim 1 and further in view of Williamson.
I.) Regarding applicant’s claim 7, as noted above Testa et al. in view of Fukushima et al. and Sherman renders claim 1 obvious from which claim 7 depends.
Claim 7 recites that a periphery of the retort lid exceeds a periphery of the opening when the retort lid is closed.
Testa et al. in view of Fukushima et al. and Sherman does not teach that a periphery of the retort lid exceeds a periphery of the opening when the retort lid is closed.
Williamson teaches a cassette for processing tissue samples under heating conditions.
The cassettes include a lower frame 14 having side and bottom walls and a pivoting lid 18 as shown in Fig. 1.
The lid 18 includes peripheral portions 16 that extend beyond the opening of the frame as shown in Fig. 1.
When the lid 18 is closed the peripheral portion 16 in the front includes a latch (lock) 28 that locks the lid 18 in the closed position.
It would have been obvious to one of ordinary skill in the art to modify Testa et al. in view of Fukushima et al. and Sherman to include peripheral portions of the lid that extend beyond the opening and include a latch (lock) as taught by Williamson for purposes of preventing inadvertent opening of the apparatus during a processing operation.
Therefore, Testa et al. in view of Fukushima et al., Sherman and Williamson renders 7 obvious.
II.) Regarding applicant’s claim 8, as noted above Testa et al. in view of Fukushima et al. and Sherman renders claim 1 obvious from which claim 8 depends.
Claim 8 recites that the retort has a flange at the opening, and the retort lid has a lock engaged with the flange when the retort lid is closed.
Testa et al. in view of Fukushima et al. and Sherman does not teach that the apparatus has a lock engaged with the flange when the retort lid is closed.
As noted above, Williamson teaches a cassette for processing tissue samples under heating conditions.
The cassettes include a lower frame 14 having side and bottom walls and a pivoting lid 18 as shown in Fig. 1.
The lid 18 includes peripheral portions 16 that extend beyond the opening of the frame as shown in Fig. 1.
When the lid 18 is closed the peripheral portion 16 in the front includes a latch (lock) 28 that locks the lid 18 in the closed position.
It would have been obvious to one of ordinary skill in the art to modify Testa et al. in view of Fukushima et al. and Sherman to include peripheral portions of the lid that extend beyond the opening and include a latch (lock) as taught by Williamson for purposes of preventing inadvertent opening of the apparatus during a processing operation.
Therefore, Testa et al. in view of Fukushima et al., Sherman and Williamson renders 8 obvious.
3. Claims 11, 13-16, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Testa et al. in view of Fukushima et al. and Sherman as applied to claim 10 above and further in view of Applicant’s Admitted Prior Art.
I.) Regarding applicant’s claim 11, as noted above Testa et al. in view of Fukushima et al. and Sherman renders claim 10 obvious from which claim 11 depends.
Claim 11 recites that the temperature controller comprises: a memory device having instructions stored therein, and a processor configured to execute the instructions to implement any of the following operations of: processing the tissue sample with formalin, processing the tissue sample with alcohol, processing the tissue sample with xylene, processing the tissue sample with paraffin, cleaning the retort with xylene, cleaning the retort with alcohol, and drying the retort.
Testa et al. in view of Fukushima et al. and Sherman does not teach the temperature controller comprises: a memory device having instructions stored therein, and a processor configured to execute the instructions to implement any of the following operations of: processing the tissue sample with formalin, processing the tissue sample with alcohol, processing the tissue sample with xylene, processing the tissue sample with paraffin, cleaning the retort with xylene, cleaning the retort with alcohol, and drying the retort.
Testa et al. teaches a programmable temperature controlling means. (column 7, lines 53-55)
Applicant’s Admitted Prior Art as found on page 1, lines 8-12 includes processing tissue samples using formalin, alcohol and xylene, and embedding the tissue samples in paraffin. After that, the tissue may be stabilized, and further sectioned by a microtome. The tissue processor may also perform a cleaning protocol to clean the retort so as to process other tissues.
It would have been obvious to one of ordinary skill in the art to modify Testa et al. in view of Fukushima et al. and Sherman to process tissue samples in formalin, alcohol and xylene, and embedding the tissue samples in paraffin according to Applicant’s Admitted Prior Art and include a memory coupled to temperature controller to automate temperature control during the processing. It would further have been obvious to modify Testa et al. in view of Fukushima et al. and Sherman to perform a cleaning protocol after tissue processing for purpose of cleaning the apparatus so as to process other tissues as taught by Applicant’s Admitted Prior art. Providing Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art with a memory device having instructions stored therein to process tissue samples would have been obvious to provide for automation of tissue processing.
Therefore, Testa et al, in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 11 obvious
II.) Regarding applicant’s claim 13, as noted above Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 11 obvious from which claim 13 depends.
Claim 13 recites that the heater is controlled to heat the retort lid when the tissue sample is processed with alcohol.
As noted above, Applicant’s Admitted Prior Art teaches using alcohol as a processing component.
It would have been obvious to one of ordinary skill in the art to modify Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art to process tissue samples with known processing components including alcohol while controlling the temperature of heater in lid as necessary to perform processing with alcohol.
Therefore, Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 13 obvious.
IV.) Regarding applicant’s claim 14, as noted above Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 11 obvious from which claim 14 depends.
Claim 14 recites that the heater is controlled to heat the retort lid when the tissue sample is processed with xylene.
As noted above, Applicant’s Admitted Prior Art teaches using xylene as a processing component.
It would have been obvious to one of ordinary skill in the art to modify Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art to process tissue samples with known processing components including xylene while controlling the temperature of heater in lid as necessary to perform processing with xylene.
Therefore, Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 14 obvious.
V.) Regarding applicant’s claim 15, as noted above Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 11 obvious from which claim 15 depends.
Claim 15 recites that the heater is controlled to heat the retort lid when the tissue sample is processed with paraffin.
As noted above, Applicant’s Admitted Prior Art teaches using paraffin as a processing component.
It would have been obvious to one of ordinary skill in the art to modify Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art to process tissue samples with known processing components including paraffin while controlling the temperature of heater in lid as necessary to perform processing with paraffin.
Therefore, Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 15 obvious.
VI.) Regarding applicant’s claim 16, as noted above Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 11 obvious from which claim 16 depends.
Claim 16 recites that the heater is controlled to heat the retort lid when the retort is cleaned with xylene.
Testa et al. teaches that xylene can remove paraffin. (column 4, line 37)
It would have been obvious to one of ordinary skill in the art to modify Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art to clean the apparatus of any excess paraffin using xylene while controlling the temperature of heater in lid as necessary to perform the cleaning.
Therefore, Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 16 obvious.
VII.) Regarding applicant’s claim 18, as noted above Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 11 obvious from which claim 18 depends.
Claim 18 recites that the heater is controlled to heat the retort lid when the retort is dried.
It would have been obvious to one of ordinary skill in the art to modify Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art to dry the apparatus of after processing while controlling the temperature of heater in lid as necessary to perform the drying.
Therefore, Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 18 obvious.
VIII.) Regarding applicant’s claim 19, as noted above Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 11 obvious from which claim 19 depends.
Claim 19 recites that the operations are programmable to set a predetermined temperature of each of the operations independently.
It would have been obvious to one of ordinary skill in the art to modify Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art to program the temperature controller to control the temperature of heater in lid as necessary to perform the processing steps of tissue samples, for purposes of automating processing.
Therefore, Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 19 obvious.
4. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art as applied to claim 11 above and further in view of Xylene Program (Office of Research Services, 2019)
I.) Regarding applicant’s claim 17, as noted above Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 11 obvious from which claim 17 depends.
Claim 17 recites that the heater is controlled to heat the retort lid when the retort is cleaned with alcohol.
Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art does not teach controlling the heater to heat the apparatus when cleaning the apparatus with alcohol.
As noted above, it would have been obvious to one of ordinary skill in the art to modify Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art to clean the apparatus of any excess paraffin using xylene while controlling the temperature of heater in lid as necessary to perform the cleaning.
Xylene Program teaches that xylene is soluble in alcohol.
It would have been obvious to one of ordinary skill in the art to modify Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art to clean the apparatus of any excess xylene using alcohol while controlling the temperature of heater in lid as necessary to perform the cleaning in view of Xylene Program teaching that xylene is soluble in alcohol.
Therefore, Testa et al. in view of Fukushima et al., Sherman, Applicant’s Admitted Prior Art and Xylene Program renders claim 17 obvious.
5. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Testa et al. in view of Fukushima et al. Sherman and Applicant’s Admitted Prior Art as applied to claim 11 above and further in view of Chafin et al.
I.) Regarding applicant’s claim 12, as noted above Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 11 obvious from which claim 12 depends.
Claim 12 recites that the heater is controlled so as not to heat the retort lid when the tissue sample is processed with formalin.
Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art does not teach controlling the heater to not heat the apparatus lid when tissue in the apparatus is processed with formalin.
As noted above, Applicant’s Admitted Prior Art as found on page 1, lines 8-12 includes processing tissue samples using formalin, alcohol and xylene, and embedding the tissue samples in paraffin. After that, the tissue may be stabilized, and further sectioned by a microtome. The tissue processor may also perform a cleaning protocol to clean the retort so as to process other tissues.
Chafin et al. teaches that tissue samples can be processed in formalin at room temperature.
It would have been obvious to one of ordinary skill in the art to modify Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art to process tissue samples with known processing components including formalin while keeping the heater in the lid off so as to allow processing with formalin to proceed at room temperature as taught by Chafin et al.
Therefore Testa et al. in view of Fukushima et al, Sherman, Applicant’s Admitted Prior Art and Chafin et al. renders claim 12 obvious.
6. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art and Xylene Program.
I.) Regarding applicant’s claim 20, claim 20 recites a method of processing a tissue sample by a tissue processor according to claim 1.
As noted above, Testa et al. in view of Fukushima et al. and Sherman renders claim 1 obvious.
As further noted above, Applicant’s Admitted Prior Art as found on page 1, lines 8-12 includes processing tissue samples using formalin, alcohol and xylene, and embedding the tissue samples in paraffin. After that, the tissue may be stabilized, and further sectioned by a microtome. The tissue processor may also perform a cleaning protocol to clean the retort so as to process other tissues.
It would have been obvious to one of ordinary skill in the art to use the apparatus of Testa et al. in view of Fukushima at al. and Sherman to perform tissue processing as disclosed in Applicant’s Admitted Prior Art.
As noted above, Xylene Program teaches that xylene is soluble in alcohol.
It would have been obvious to one of ordinary skill in the art to modify Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art to clean the apparatus of any excess xylene using alcohol while controlling the temperature of heater in lid as necessary to perform the cleaning in view of Xylene Program teaching that xylene is soluble in alcohol
Therefore, Testa et al. in view of Fukushima et al., Sherman and Applicant’s Admitted Prior Art renders claim 20 obvious.
Response to Arguments
Applicant’s arguments with respect to claims 1, 3, 4 and 6-20 have been considered but are moot because the new ground of rejection relies upon Sherman as new prior art necessitated by applicant’s amendments to the claims.
Applicant argues that Fukushima '791 does not teach, suggest, or disclose that a heat insulation layer is disposed on the heater within the chamber and positioned between the outer cover of the retort lid and the heater such that the heat insulation layer is spaced away from the outer cover.
As noted above, Fukushima et al. teaches a lid 26 that include an outer layer (“cover”) 104a and an inner case (“plate”) 106 “disposed on the bottom portion of the lid portion 26.” [0060], [0062]
Further, Fukushima et al. further teaches a heater 62 that is disclosed as being “disposed inside the lid portion 26” [0020] and “provided inside the lid portion 26” [0056] and “disposed on the upper surface of the inner case 106.”[0062]
Further, Fukushima et al. teaches a layer of heat insulating material that, as shown in Fig. 1 is disposed on the heater 62 within a chamber between the outer cover 104a and inner plate 106.
It would have been obvious to one of ordinary skill in the art to modify Testa et al. to include a lid that includes an outer cover and an inner plate, and a heater that is disposed within a chamber defined by the outer cover and the inner plate and an insulating layer disposed on the heater between the outer cover and inner plate as taught by Fukushima et al. for purposes of temperature control.
As noted above, Sherman teaches an apparatus that includes heaters 5 and closed and empty spaces 11 above the heaters that “are much cooler than the space directly above the heaters.” (column 3, lines 12-14)
It would have been obvious to modify Testa et al. in view of Fukushima et al. to include a closed, empty space between the insulation layer and the outer cover, to provide a cooler space adjacent the outer cover as taught by Sherman for purposes of keeping the outer cover cool.
Therefore, Testa et al. in view of Fukushima et al. renders obvious a lid that includes an outer cover and an inner plate, and a heater that is disposed within a chamber defined by the outer cover and the inner plate and an insulating layer disposed on the heater between the outer cover and inner plate, with the insulating layer be spaced away from the outer cover.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798