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 .
Claim Status
Claims 1-20 are cancelled.
Claims 21-35 are new.
Claims 21-35 are pending.
Information Disclosure Statement
The information disclosure statement filed 8/5/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-24, 26-28, 30-35 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Favaloro (WO 2013071357 A2).
Regarding Claim 21 Favaloro teaches “A system comprising:” (Title, Page 3 and 5, automated system and method for treating tissue samples on slides, the application using reagents to stain the samples and some of the reagents being haematoxylin (British spelling of hematoxylin);
“a tray configured to receive a hematoxylin waste solution; a hematoxylin waste system in fluidic communication with the tray” (Pages 5, 21, Figures 1 1 to 13 show different configurations of a waste treatment module (hematoxylin waste system) deployed by the apparatus 10 to treat waste arising from treating the tissue samples using one or more of the reagents. In these figures, waste from the slide treatment modules 12, shown as slide processing modules, is collected in a hazardous waste tank (tray) for processing. In another embodiment, the BFR and/or the FTP robot are configured to dispense said reagents to otherwise treat the samples and/or the slides by washing, dehydrating, etc. Thus, for example, the system can be used with respect to immunohistochemistry (IHC), in-situ hybridization (ISH), fluorescent in-situ hybridization, staining, microarray, and other chemical and biological applications. Also, the system can be used with respect to in-situ polymerase chain reaction (PCR).
In an example, the reagents dispensed by the BFR are bulk fluid reagents such as oxalic acid, sulphuric acid, potassium permanganate, alcohol, dewaxing agent, haematoxylin, peroxide, citric acid, EDTA, blueing agents, Dl water, and Bond™ wash. The high value reagents comprise, for example, chromagens, ISH probes, fluorescents, IHC probes, antibodies, PCR reagents);
“and a cleaning system configured to introduce a volume of a cleaning composition to the hematoxylin waste solution in the tray and/or in the hematoxylin waste system” (Pages 5, 6, and 23, Figures 1 1 to 13 show different configurations of a waste treatment module deployed by the apparatus 10 to treat waste arising from treating the tissue samples using one or more of the reagent. Page 5 and 23, The BFR and/or the FTP robot are configured to dispense said reagents to otherwise treat the samples and/or the slides by washing, dehydrating, etc. Also to wash the lines from the FTP nozzle 28 to the pumps, a wash block is deployed in association with Bond™ wash and DI water pumps. In an embodiment, the same Bond™ wash pump and DI water pump are used as for the BFR with further reagents line to deliver these reagents to the FTP robot 18. In another embodiment, high speed diaphragm wash pumps are used by the apparatus 10 in association with a solenoid selector valve to enable selection of Bond™ wash and DI water for washing the fluid delivering lines of the FTP robot 18. In an alternative embodiment, the FTP robot 18 comprises a single gear pump rather than the syringe pumps to pump the high level reagents to the FTP robot as shown in Figure 10. In an example, the reagents dispensed by the BFR are bulk fluid reagents such as oxalic acid, sulphuric acid, potassium permanganate, alcohol, dewaxing agent, haematoxylin, peroxide, citric acid, EDTA, blueing agents, Dl water, and Bond™ wash. The high value reagents comprise, for example, chromagens, ISH probes, fluorescents, IHC probes, antibodies, PCR reagents.). Therefore, as stated within the present specification “the cleaning composition may be dispensed into the staining system via the hematoxylin dispenser before and/or after the relevant staining cycle.” The cleaning composition can be delivered through the same lines as the stain this is disclosed within the BFR and/or the FTP robot dispensing the cleaning reagent which as seen in Figs. 11-13 are then pumped to the waste tank.
Further taught “wherein the cleaning composition is selected from the group consisting of (a) one or more of aluminum chelators or complexing agents, (b) an acid, and (c) an oxidizing agent and an optional base;” (Page 5, 6, and 21: The reagents dispensed by the BFR are bulk fluid reagents such as oxalic acid, sulphuric acid, potassium permanganate, alcohol, dewaxing agent, haematoxylin, peroxide, citric acid, EDTA, blueing agents, DI water, and Bond TM wash. It can be seen from this figure that each bulk fluid reagent has a dedicated reagent line extending from respective containers (not shown) via respective pumps), Therefore the EDTA is an aluminum chelator, the oxalic acid is the acid, and Potassium permanganate is an oxidizing agent.
The recitation “wherein after the introducing of the cleaning composition to the hematoxylin waste solution in the tray and/or in the hematoxylin waste system:(i) if the cleaning composition introduced included the one or more of aluminum chelators or complexing agents, when the one or more aluminum chelators or complexing agents are mixed with the hematoxylin waste solution the cleaning composition alters a pH of the hematoxylin waste solution to 2 or above;(ii) if the cleaning composition introduced included the acid, when the acid is mixed with the hematoxylin waste solution the cleaning composition alters a pH of the hematoxylin waste solution to from 2 to 3.5; or (iii) if the cleaning composition introduced included the oxidizing agent and the optional base, when the oxidizing agent and the optional base are mixed with the hematoxylin waste solution the cleaning composition alters a pH of the hematoxylin waste solution to 9 or above;” is considered an intended use limitation, which do not further delineate the system from that of the prior art. See MPEP 2114.
Further the recitation “wherein the introduced volume of the cleaning composition comprises a concentration of (i) the one or more aluminum chelators or complexing agents, (ii) the acid, or (iii) the oxidizing agent and the optional base sufficient to (a) inhibit formation of a hematoxylin precipitate, and/or (b) dissolve the hematoxylin precipitate in the hematoxylin waste solution.” is capability of the cleaning composition however taught within (Page 11 and 12, For example, potassium permanganate, sulphuric acid, ascorbic acid, H2O2, peroxidase and oxalic acid can be used to treat waste from the staining of tissue samples.). Therefore, the waste is the hematoxyline precipitate and ascorbic acid is known in the art to inhibit hematoxylin precipitate and H2O2 is known in the art to inhibit unwanted resin precipitates.
Regarding claim 22, Favaloro teaches all of claim 21 as above in addition to “wherein the hematoxylin waste system comprises a waste/vacuum reservoir in fluidic communication with the tray. (Page 21, The waste can be forced into the tank using a vacuum pump or fan as shown in Figures 1 1 and 13, with Figure 13 additionally having a sump.)
Regarding claim 23, Favaloro teaches all of claim 22 as above in addition to “wherein the hematoxylin waste system comprises a vacuum blower configured to provide waste vacuum to the waste/vacuum reservoir.” (Page 21, The waste can be forced into the tank using a vacuum pump or fan as shown in Figures 1 1 and 13, with Figure 13 additionally having a sump.)
Regarding claim 24, Favaloro teaches all of claim 21 as above in addition to “wherein the hematoxylin waste system comprises a gear pump.” (Page 5 and 23, In an alternative embodiment, the FTP robot 18 comprises a single gear pump rather than the syringe pumps to pump the high level reagents to the FTP robot as shown in Figure 10.)
Regarding claim 26, Favaloro teaches all of claim 21 as above in addition to “wherein the hematoxylin waste system comprises a strainer.” (Page 14 and 16: plurality of slide treatment modules 12 arranged to receive ones of the slides. The high value reagent containers 20 and the bulk fluid reagent containers comprise a variety of sizes, shapes and configurations necessary to facilitate adequate supply of reagent for a single reaction or multiple reactions without requiring replacement and adequately reside within the architecture of the apparatus 10.).
Regarding claim 27, Favaloro teaches all of claim 21 as above in addition to “wherein the hematoxylin waste system comprises a waste manifold.” (Fig. 12, where all of the lines from the slide processing modules combine before entering the waste tank).
Regarding claim 28, Favaloro teaches all of claim 21 as above in addition to “wherein the hematoxylin waste system comprises a waste valve.” (Pages 21 and 22, Also, for the two syringe pumps to be operable independently, syringe pump bypass valves are deployed by the apparatus 10. Further, to wash the lines from the FTP nozzle 28 to the pumps, a wash block is deployed in association with Bond™ wash and Dl water pumps. In an embodiment, the same Bond™ wash pump and Dl water pump are used as for the BFR with further reagents line to deliver these reagents to the FTP robot 18. In another embodiment, high speed diaphragm wash pumps are used by the apparatus 10 in association with a solenoid selector valve to enable selection of Bond™ wash and Dl water for washing the fluid delivering lines of the FTP robot 18.).
Regarding claim 30, Favaloro teaches all of claim 21 as above in addition to “further comprising a fluid off nozzle fluidly coupled to the hematoxylin waste system.” (Fig. 13, dispense hose).
Regarding claim 31, Favaloro teaches all of claim 21. The recitation “wherein the system is configured to introduce the cleaning composition into the hematoxylin waste system via the same path as the hematoxylin waste solution is introduced into the hematoxylin waste system.” is capability of the system however already disclosed within claim 21.
Regarding claim 32, Favaloro teaches all of claim 21. The recitation “wherein the system is configured to introduce the cleaning composition periodically.” is considered an intended use limitation, which do not further delineate the system from that of the prior art. Claims 21-35 are drawn to a system which lists active steps without requiring the supporting structural features to perform the active steps. Further the system lacks a processor and memory which would be needed to perform the active steps. The prior art is capable of performing the intended use.
Regarding claim 33, Favaloro teaches all of claim 21. The recitation “wherein the system is configured to introduce the cleaning composition continuously.” is considered an intended use limitation, which do not further delineate the system from that of the prior art. Claims 21-35 are drawn to a system which lists active steps without requiring the supporting structural features to perform the active steps. Further the system lacks a processor and memory which would be needed to perform the active steps. The prior art is capable of performing the intended use.
Regarding claim 34, Favaloro teaches all of claim 21. The recitation “wherein the cleaning composition comprises the acid, and wherein after the introducing of the cleaning composition the pH of the hematoxylin waste solution is altered to between 2.8 to 3.5.” is considered a capability and intended use limitation, which do not further delineate the system from that of the prior art. The system is capable of holding the acid which the acid is disclosed within the Favaloro and the acid is intended to alter the pH.
Regarding claim 35, Favaloro teaches all of claim 34 in addition to “wherein the acid is selected from hydrochloric acid, sulfuric acid, nitric acid, phosphoric acid, formic acid, fumaric acid, malonic acid, acetic acid, oxalic acid, perchloric acid, hydrobromic acid, hydroiodic acid, citric acid, tartaric acid, sulfamic acid, succinic acid, glutaric acid, maleic acid, malic acid, or a combination thereof.” (Page 11 and 12, For example, potassium permanganate, sulphuric acid, ascorbic acid, H2O2, peroxidase and oxalic acid can be used to treat waste from the staining of tissue samples.).
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.
Claim 25 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Favaloro (WO 2013071357 A2) as applied to claim 21, and further in view of Reinhardt et. al. (US 7468161 B2).
Regarding Claim 25, Favaloro teaches all of claim 21 but does not teach “wherein the hematoxylin waste system comprises a check valve.”.
Reinhardt teaches an automated high volume slide processing system in addition to “wherein the hematoxylin waste system comprises a check valve.” (Para 186, Fluid leaves the diluted reagent dispense chamber through outlet check valve 1128 to prevent drain back from the system. The constant pressure maintained in the diluted reagent dispense chamber makes it possible to deliver reagent on demand without any interruptions while it is being filled from the dilution chamber (diluted reagent dispense chamber can be simultaneously recharged while dispensing). Delivery of reagents to the system is not typically interrupted unless the reagent supply (or supplies) is exhausted, and a low level switch event in the dispense chamber serves as a warning that the dispense chamber has not been recharged. To guard the fluidics module in the event of a failure in the system, distribution chambers for pressure, liquid and vacuum can be employed, and sensors can be used to signal an overflow event by detecting the overflow. Valves can be used to purge overflow to waste during an overflow condition.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Favaloro to incorporate the teachings of Reinhardt wherein the hematoxylin waste system has a check valve. Doing so would prevent drain back from the system as taught by Reinhardt.
Regarding claim 29, Favaloro teaches all of claim 21 but does not teach “wherein the hematoxylin waste system is configured to deliver the hematoxylin waste solution to a waste carboy.”
Reinhardt teaches “wherein the hematoxylin waste system is configured to deliver the hematoxylin waste solution to a waste carboy.” (Para [226], A diverter valve 1404 can either send the emulsified waste to the sewer or into waste container 1406. Cycling of a fluid a few times through the restrictor improves emulsification, so typically, waste is continuously cycled into the waste container 1406 until the waste container is full as indicated by float switch 1408.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Favaloro to incorporate the teachings of Reinhardt wherein the hematoxylin waste system has a waste carboy (waste container). Doing so allows waste to be collected and further diluted prior to placing in water system i.e. sink as taught within Reinhardt.
Response to Amendments/ Arguments
Applicant's arguments filed 2/18/ 2026 have been fully considered.
The claim amendments have overcome the previous 112(b) rejections and drawing objections.
Applicant’s amendments to the claims have changed the scope of the claims and, as a result, new rejections under 35 USC 102 and 35 USC 103 are applied.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is (571)272-1557. The examiner can normally be reached M-F.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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