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 .
Response to Amendment
Applicant’s “Response to Amendment and Reconsideration” filed on 2/2/2026 has been considered.
Claims 34-37 are added. Claims 1-13 are cancelled. Claims 14-37 are pending in this application and an action on the merits follows.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 14, 21 and 28 recite “communicatively isolated” and “the second communication pathway not in communication with the first communication pathway”.
The scope and meaning of these limitations are unclear. It is unclear whether “isolated” requires physical or logical separation or merely different interfaces and protocols.
Further the claims simultaneously recited retrieval of consumables information across instruments, updating consumables based on information received from another instrument and synchronization o consumables between systems. The claims now recite pathways not in communication with one another.
Claim Rejections - 35 USC § 103
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.
Claims 14-37 are rejected under 35 U.S.C. 103 unpatentable over Mattingly et al. (WO 2008156566), in view of Carroll et. al. (U.S. Patent Publication No. 2020/0090808) and further in view of Scott et al. (U.S. Patent Publication No. 2018/0226139).
Regarding claims 14, 21, 24-28, Mattingly teaches a consumables database, instructions and processor to
access, from a first instrument via a first interface, instrument status information about the first instrument, the first instrument communicatively coupled to the first interface associated with a first communication protocol between the first instrument and one or more of the at least one processor circuit;
access, from the first instrument via a second interface, consumables information about a consumable item, associated with a second communication protocol between the first instrument and one or more of the at least one processor circuit,
the consumable item removably installed in the first instrument, the first instrument to use the consumable item to form a partially depleted consumable item; cause, via a first communication pathway, the instrument status to be stored in a second database, the second database different than the consumables database; and cause, via a second communication pathway, the consumables information to be stored in the consumables database,
a second instrument to access the consumables information for the consumable item from the consumables database responsive to the partially depleted consumable item being removably installed in the second instrument.
(IPS 102 includes Interface Software B (referred to herein synonymously as "ISB" or "Ventana Lab Manager" or "VLM" software), that allows for the performance of automatic functions related to the management of data between network of host computers 106, such as the sharing of data elements between the first host computer 108 and second host computer 112 without difficulty or undesired data transmittal even if the first host computer 108 is one type of host computer and second host computer 112 is a different type of host computer, pg 11, ln 9-25
The IPS 102 implements data element storage and sharing of data that as delivered from a LIS, in the illustrative embodiment described herein, conforms to an adaptation of the Health Level Seven (HL7) standard for information exchange between medical applications.. Standard TCP/IP protocols are used to connect with the LIS and VLM, pg. 13 ln 13-25,
. There is a software messaging system that permits one host to request a transfer of ownership from another host, thereby ensuring that reagent data elements get properly and safely changed (i.e. dispensed amount does not exceed container limits)… Another function of the VLM is to provide a web interface to a remote operator that can be used for reporting and status updates for the host systems and the instruments to which the hosts are connected, pg.12 ln 20-30,
A host having ownership of the data element associated with one or more reagents may update the recorded amounts of each of the reagents as may be included in an attribute or other field of the reagent data element. In other words, in order to write or update a data element of a reagent, the host has ownership of this data element. One method for acquiring ownership that may be performed in an embodiment is described, for example, in Figure 8, pg 64-66, ln 30-35, 1-5,
the reagents may physically be moved to the second host and the second host may request and obtain ownership of the new set of reagents. While in use by the first instrument, the first host accordingly updates any associated amounts of the associated data element for the new set of reagents. While in use by the second instrument, the second host similarly updates any amounts for the new set of reagents in the associated data element. In another example, the first instrument may be processing a set of slides using the new set of reagents. While the first instrument is working, a request for ownership of the new reagents is made by a second host so that the new set of reagents can be moved for use in a second instrument associated with the second host. The ownership request by the second host will be denied while the first instrument is still using the new set of reagents. While the first instrument is using the reagent, the first host updates amounts of the new set of reagents in the associated data element. When the second host acquired ownership of the reagents, the second host updates the amounts to reflect consumption by the second instrument), pg. 66 ln 15-33).
Mattingly substantially discloses the claimed invention, however, does not explicitly disclose the consumable information and instrument status information are transmitted via different communication interfaces using with different communication protocols, the second database communicatively isolated from the consumables database and the second communication pathway different than not in communication with the first communication pathway.
However, Carroll teaches a first control circuit configure to communicate with an energy module using at least a first protocol over a first communication line and a second control circuit configured to communicate with another surgical instrument using at least a second protocol over a second communication line, see abstract.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the invention to implement the system of Mattingly using Carroll’s architecture, in order to segregate different communication domains. Doing so yields predictable benefits in modularity and data segregation, consistent with routing laboratory software design.
Mattingly does not explicitly teach different interfaces; however, Scott teaches CCU 102 connected to LIS via network connection which can use a variety of protocols including HL& based interface or ASTM, [61]. The CCU system may provide integration with a variety of Laboratory Information Systems (LIS's) which may be installed at a customer's facility. Two exemplary LIS communication protocols that may be supported are ASTM 1381/1394 and HL7. ASTM 1394 and HL7 are data format standards, while ASTM 1381 is a low-level transport protocol standard that is used by ASTM 1394. The communication transport used for the HL7 protocol may be TCP/IP. While the protocols, transports, and command set for communicating between instruments and an LIS may be standardized flexibility may be built into an LIS, [97]. Providing utility interfaces for data archiving and purging for use in GUI or console applications; [0133] Providing utility interfaces for data backup and restore for use in GUI or console applications; and [0134] Providing utility classes for data serialization and mapping for class libraries and service programs, (separate communication pathways corresponding to those different protocols)
Scott’s reference provides the separation of data by communication protocol was well-known and obvious to incorporate into Mattingly system.
Claims 21:
Further Mattingly does not explicitly disclose retrieve, via the first interface, first consumables information for the consumable item from the first database using the first communication protocol; transmit, via the second interface, instrument status information for the first instrument to the second database using the second communication protocol, and transmit, updated information for partial usage of the consumable item using the first communication protocol;
However, Caroll teaches a first control circuit configure to communicate with an energy module using at least a first protocol over a first communication line and a second control circuit configured to communicate with another surgical instrument using at least a second protocol over a second communication line, see abstract. Caroll further teaches isolated Comms.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the invention to implement the sequential method by applying the modular teachings of Caroll to the reagent ownership of Mattingly because both references address laboratory data integration and the combination merely arranges known steps in a predictable matter.
Mattingly does not explicitly disclose, however, Scott teaches:
Regarding claims 15, Scott teaches instrument status information includes one or more of an operational state of the first instrument, a workload of the first instrument, quality control information generated by the first instrument for samples, or sample analysis results generated by the first instrument, [64].
Regarding claims 16, Scott teaches the consumables information includes one or more of a number of tests conducted using the consumable item, a number of tests remaining for the consumable item, shelf-life expiration data for the consumable item, quality control information for the consumable item, or calibration information for the consumable item, [71-72].
Regarding claims 17, Scott teaches first communication protocol includes an HL7 communication protocol or an ASTM communication protocol and the second communication protocol is different than the HL7 communication protocol and the ASTM communication protocol, [61, 97, 138, 172].
Regarding claims 18, Scott teaches the consumables information includes (a) first consumables information corresponding to a number of tests before depletion of the consumable item, the first consumables information associated with a first time, and (b) second consumables information corresponding to the number of tests before depletion of the consumable item, the second consumables information associated with a second time, the second time after the first time, [173].
Regarding claims 19, Scott teaches the processor circuitry is to update the first consumables information in the consumables database based on the second consumables information, [60].
Regarding claims 20, Scott teaches the processor circuitry is to update the consumables information in the consumables database responsive to an indication that the consumable item has been removed from the first instrument, [93].
Regarding claims 22, Scott teaches the first consumables information includes a first number of tests remaining for use with the consumable item and the second consumable information includes a second number of tests remaining for use with the partially used consumable item, [71, 207].
Regarding claims 23, Scott teaches the first number of tests corresponds to a maximum number of tests remaining for use with the consumable item, [207].
Regarding claims 29, Scott teaches transmit the first consumables information to the second instrument via the first interface responsive to a request from the second instrument, the request indicative of a receipt of the reagent at the second instrument, [79, 135, 152].
Regarding claims 30, Scott teaches the first communication protocol is different than an HL7 communication protocol or an ASTM communication protocol, [171].
Regarding claims 31, Scott teaches update the third consumables information based on fourth consumables information for the reagent received from the second instrument, the fourth consumables information received from the second instrument after the second consumables information, [62-63]).
Regarding claims 32, Scott teaches the first consumables information includes a first test count associated with the reagent and the second consumables information includes a second test count associated with the reagent, [175].
Regarding claims 33, Scott teaches the instrument status information includes one or more of an operational state of the first instrument, a workload of the first instrument, or test results generated by the first instrument, [40, 59, 61].
Regarding claims 34-37, Scott teaches the first and second interface is implemented by a middleware software component; the first and second database is remote to the middleware software component, (instrument communication service 706…LIS interface service 708, [135, 138].
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that Mattingly does not disclose a second database communicatively isolated from a consumables database and a second communication pathway not in communication with a first communication pathway. Applicant further argues that the communication architecture of Mattingly is integrated because Fig. 3A illustrates communication between instruments, hosts, VLM software, VIP software and LIS systems.
Examiner does not agree. The rejection now relies on the combined teachings of Mattingly, Carroll and Scott. Mattingly teaches distributed reagent information management, consumable tracking, communication between instruments, host systems, LIS and in particular sharing data elements between host systems and transfer reagent ownership between systems. Carroll teaches isolated communication architecture utilizing different communication protocols over separate communication pathways. See rejection above.
Applicant argues that the references do not teach communication pathways “not in communication with one another”. However, Applicant’s arguments improperly require complete physical disconnection or absolute absence of coordination between communication domains. The claims do not require absolute inability or indirect communication or physical separation. Instead, the claims broadly recite communication pathways and databases that are isolated from one another. Carroll expressly teaches isolated communications implemented through separate communication pathways and separate protocols. Applicant’s own specification supports such interpretation, “the custom protocol may not be compatible with the HL-7 and ASTM protocol”, which is understood as communication isolation may be implemented through separate and incompatible protocols rather than complete physical communication prohibition. One of ordinary skilled in the art would have found it obvious to modify the distributed reagent management architecture of Mattingly using architecture of Carroll in order to improve communication reliability.
Scott further discloses that it was known in the art to utilize separate communications services, interfaces for different laboratory communications including instruments and LIS. Accordingly, when considered as a whole the combined teachings of Mattingly, Carroll and Scott teach the limitations of claims 14, 21 and 28.
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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/MILENA RACIC/Patent Examiner, Art Unit 3627
/FLORIAN M ZEENDER/Supervisory Patent Examiner, Art Unit 3627
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