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 .
Status of Claims
Claim 1-20 are pending with claims 1-12 under examination and claims 13-20 withdrawn from consideration.
Information Disclosure Statement
The information disclosure statement (IDS) document(s) submitted on 11/26/2025 is/are compliant with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group 1, claims 1-12, in the reply filed on 07/10/2026 is acknowledged. The traversal is on the ground(s) that it would not place an undue burden on the Examiner to search the subject matter of the claims of Groups I and II as a search directed to one Group would likely yield results applicable to the other Group, and that Applicant should not be required to incur the additional costs associated with the filing of multiple divisional applications in order to obtain protection for the claimed subject matter. This is not found persuasive because:
Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination (Group II) requires a cassette comprising one or more patient specimens or quality control specimens, but does not specifically require the cassette to be a mixed cassette as claimed in the subcombination (Group I). The subcombination (Group I) has separate utility such as in a laboratory instrument that performs quality control and specimen testing sequentially on a cassette, or separate utility such as ejecting a mixed cassette.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
a. The inventions have acquired a separate status in the art in view of their different classification; and/or
b. The inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
c. The inventions require a different field of search (e.g., searching different class/subclasses or electronic resources, or employing different search strategies or search queries).
The requirement is still deemed proper and is therefore made FINAL.
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 1-12 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 pre-AIA the applicant regards as the invention.
Claim 1 line 6 refers to “the ejection of the cassette”. There is insufficient antecedent basis for this term in the claims and it is unclear what applicant is referring to as “the ejection”. What ejection is being described? Claims 2-12 are also rejected based on their dependency from claim 1.
Claim 5 recites “a quality control specimen”. Claim 1 line 5 previously refers to “a quality control specimen”. It is unclear if applicant is referring to the previously recited quality control specimen or if applicant attempting to introduce a second quality control specimen.
Claim 6 recites “the tests in progress” and “the additional patient specimens”. There is insufficient antecedent basis for these terms in the claims and it is unclear what applicant is referring to by “the test in progress” and “the additional patient specimens”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Claim 1 is directed toward a system.
Step 2A, Prong One: Claim 1 recites the abstract idea, “determining whether a cassette received from the input buffer is a mixed cassette that comprises both a quality control specimen and a patient specimen”.
These abstract ideas are mental processes that could be performed by a human person by pen and paper or by a black box computer. The computing system comprising a process to perform the recited steps/processes is simply a general-purpose computer for which to apply the abstract ideas, but does not preclude the steps from being considered an abstract idea. See MPEP 2106.04(a)(2)(III).
Step 2A, Prong Two: Has the abstract idea been integrated into a particular practical application?
No. These judicial exceptions are not integrated into a practical application.
The abstract idea is performed by a computing system comprising a process which are just a general-purpose computer. However, use of conventional computer functions to apply the judicial exception does not qualify as a particular machine (MPEP § 2106.05(b)(I), MPEP § 2106.05(b)(II) and MPEP § 2106.05(b)(III)).
The laboratory instrument having an input buffer are interpreted as generally linking the abstract idea to the field of endeavor and insignificant extra-solution activity, which do not amount to significantly more than the exception itself and cannot integrate the judicial exception into a practical application (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity, and MPEP § 2106.05(h), Field of Use and Technological Environment).
Claim limitation “causing the ejection of the cassette responsive to the determination that the cassette is the mixed cassette, and send an alert responsive to the determination that the cassette is the mixed cassette” are interpreted as mere instructions to implement the abstract idea to the field of use and insignificant extra-solution activity incidental to the primary process as mere data gathering which is not considered significantly more than the abstract idea (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity, MPEP § 2106.05(h), Field of Use and Technological Environment and § 2106.05(f), Mere Instructions To Apply an Exception).
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
Claim 1 recite the additional elements of a laboratory instrument having an input buffer, a computing system comprising a processor, and causing the ejection of the cassette responsive the determination that the cassette is the mixed cassette, and send an alert responsive to the determination that the cassette is the mixed cassette.
These additional elements do not amount to significantly more as they are well-understood, routine, and conventional (WURC) in the art as evidenced by Vansickler et al. (US 2020/0319219 – hereinafter “Vansickler”), Fujita (US 2013/0316461 – hereinafter “Fujita”), and Glavina et al. (US 2016/0356800; – hereinafter “Glavina”).
Vansickler, Fujita, and Glavina disclose:
A laboratory instrument having an input buffer (Vansickler; figs. 1A-3 & 7, #120, [0096, 0125], Fujita; fig. 1, #1, [0028-0030], and Glavina; fig. 1, #100, [0037]), a computing system comprising a processor (Vansickler; fig. 20, #802, #804, [0183], Fujita; fig. 1, #4, [0039], and Glavina; [0037]), and causing the ejection of the cassette responsive the determination that the cassette is the mixed cassette (Vansickler; [0236]), and send an alert responsive to the determination that the cassette is the mixed cassette (Vansickler; [0236], Fujita; fig. 11, S22, [0096], and Glavina; [0079, 0089]).
Claim 2 further limits the alert to being displayed on a display device. However, displaying is not considered a practical application, such as improving the functioning of a computer, effecting a transformation, effecting a particular treatment, or applying the judicial exception in some other meaningful way. Indeed, the Court did not find that displaying information on a computer display without any limitations specifying how to achieve the desired result (information display) was not sufficient to show patent eligibility. Nor did the court find that arranging information on a graphical user interface in a manner that assists in processing information more quickly was sufficient to show patent eligibility. MPEP 2106.05(a)(I).
Claim 3 further limits the alert to be activated on the laboratory instrument. This is interpreted as insignificant post-solution activity and cannot integrate the judicial exception into a practical application (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity).
Claim 4 limits the computing system as being connected to the laboratory instrument via a wired connection. However, receiving and transmitting data over a network has been recognized as a generic computer function and is interpreted as insignificant extra-solution activity (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity).
Claim 5 limits the abstract idea by “determining that the cassette includes a quality control specimen comprises reading a bar code or other identifying indicia on the quality control specimen”, but does not integrate the exception under 2A prong 2 because reading a barcode or other indicia is interpreted as generally linking the abstract idea to the field of endeavor and as extra-solution activity incidental to the primary process as mere data gathering which is not considered significantly more than the abstract idea (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity, and MPEP § 2106.05(h), Field of Use and Technological Environment).
Claim 6 limits the abstract idea by “determining that the cassette includes the quality control specimen comprises allowing the tests in progress on the additional patient specimens to continue”, but does not integrate the exception under 2A prong 2 because continuing a test on a sample is interpreted as mere instructions to implement the abstract idea to the field of use and insignificant extra-solution activity incidental to the primary process as mere data gathering which is not considered significantly more than the abstract idea (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity, MPEP § 2106.05(h), Field of Use and Technological Environment and § 2106.05(f), Mere Instructions To Apply an Exception)
Claim 7 limits the computing system as being internal to the laboratory instrument. However, having a computing system internal to the laboratory instrument does not particularly transform the system to a different state or thing (see MPEP§ 2106.05(g), Particular Transformation).
Claim 8 limits the computing system as being external to the laboratory instrument. However, having a computing system external to the laboratory instrument does not particularly transform the system to a different state or thing (see MPEP§ 2106.05(g), Particular Transformation).
Claim 9 limits the computing system as being connected to the laboratory instrument via a wireless connection. However, receiving and transmitting data over a network has been recognized as a generic computer function and is interpreted as insignificant extra-solution activity (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity).
Claim 10 recites the abstract idea “determine whether the cassette includes the quality control specimen”, but does not integrate the abstract idea under step 2A prong 2 because the processor configured to perform the determination in a case where the cassette is not ejected and in response to the determination, testing the quality control to obtain a first measurement of a parameter are interpreted as mere instructions to implement the abstract idea to the field of use and insignificant extra-solution activity incidental to the primary process as mere data gathering which is not considered significantly more than the abstract idea (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity, MPEP § 2106.05(h), Field of Use and Technological Environment and § 2106.05(f), Mere Instructions To Apply an Exception).
Claim 11 recites the abstract idea(s) “determining that the first measurement is outside an expected tolerance”, “determining the second measurement is within the expected tolerance”, and “determining the second measurement is outside the expected tolerance”, but does not integrate the abstract ideas under step 2A prong 2 because the processing functions including ceasing performing tests, obtaining a second measurement are interpreted as mere instructions to implement the abstract idea to the field of use and insignificant extra-solution activity incidental to the primary process as mere data gathering which is not considered significantly more than the abstract idea (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity, MPEP § 2106.05(h), Field of Use and Technological Environment and § 2106.05(f), Mere Instructions To Apply an Exception).
Claim 12 recites the process is configured to transfer the additional cassettes to be transferred to a second laboratory instrument and performing the tests on the additional patient specimens on the second laboratory instrument. However, these limitations are interpreted as mere instructions to implement the abstract idea to the field of use and insignificant extra-solution activity incidental to the primary process as mere data gathering which is not considered significantly more than the abstract idea (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity, MPEP § 2106.05(h), Field of Use and Technological Environment and § 2106.05(f), Mere Instructions To Apply an Exception).
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4 and 6-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Vansickler et al. (US 2020/0319219 – hereinafter “Vansickler”).
Regarding claim 1, Vansickler disclose a system (Vansickler; figs. 1A-3, [0096]) comprising:
a laboratory instrument having an input buffer (Vansickler; figs. 1A-3 & 7, #120, [0096, 0125]); and
a computing system comprising a processor (Vansickler; fig. 20, #802, #804, [0183]) configured to:
determine whether a cassette received from the input buffer is a mixed cassette that comprises both a quality control specimen and a patient specimen (Vansickler disclose the system comprise a vision system that acquires an image of the racks. The image is evaluated to identify errors in the way the racks were loaded including racks with mixed container types. If the rack is determined to have an error, it is associated with an error in the system software and routed to rack storage 22. The system 10 notifies the operator via a graphical user interface 820, audio/visual, text message, email, etc., and advises that the rack with the associated error should be removed from the system; [0236]. The sample rack may compris one or more controls mixed with samples as desired; [0310, 0312]),
cause the ejection of the cassette responsive to the determination that the cassette is the mixed cassette (Vansickler disclose if the rack is determined to have an error, it is associated with an error in the system software and routed to rack storage 22; [0236]), and
send an alert responsive to the determination that the cassette is the mixed cassette (Vansickler disclose the system 10 notifies the operator via a graphical user interface 820, audio/visual, text message, email, etc., and advises that the rack with the associated error should be removed from the system; [0236]).
Regarding claim 2, Vansickler disclose the system of claim 1 above, wherein the sending of the alert comprises causing the alert to be displayed on a display device (The system 10 notifies the operator via a graphical user interface 820, audio/visual, text message, email, etc., and advises that the rack with the associated error should be removed from the system; [0236]).
Regarding claim 3, Vansickler disclose the system of claim 1 above, wherein the sending of the alert comprises causing the alert to be activated on the laboratory instrument (The system 10 notifies the operator via a graphical user interface 820, audio/visual, text message, email, etc., and advises that the rack with the associated error should be removed from the system; [0236]).
Regarding claim 4, Vansickler disclose the system of claim 1 above, wherein the computing system is connected to the laboratory instrument via a wired connection (Vansickler disclose computer system 802 connected to the laboratory instrument via bus 810; fig. 20, [0317, 0330]).
Regarding claim 6, Vansickler disclose the system of claim 1 above, wherein determining that the cassette includes the quality control specimen comprises allowing the tests in progress on the additional patient specimens to continue (Vansickler disclose when a rack is determined to be mixed, the system notifies the operator and advises that the rack be removed from the system through input/ouput 120; [0236]. Accordingly, tests in progress are not interrupted and are allowed to continue).
Regarding claim 7, Vansickler disclose the system of claim 1 above, wherein the computing system is internal to the laboratory instrument (Vansickler; fig. 20, [0183]).
Regarding claim 8, Vansickler disclose the system of claim 1 above, wherein the computing system is external to the laboratory instrument (Vansickler; fig. 20, devices connected to Bus, [0317]).
Regarding claim 9, Vansickler disclose the system of claim 1 above, wherein the computing system is connected to the laboratory instrument via a wireless connection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Vansickler in view of Fujita (US 2013/0316461 – hereinafter “Fujita”).
Regarding claim 5, Vansickler disclose the system of claim 1 above, wherein determining that the cassette includes a quality control specimen (Vansickler; [0236])
Vansickler does not teach the determining comprises reading a bar code or other identifying indicia on the quality control specimen.
However, Fujita disclose the analogous art of a cassette comprising a quality control specimen and a patient specimen (Fujita; figs. 2A-C, [0033-0035, 0037]), wherein a barcode reader determines the cassette includes a quality control specimen by reading a barcode or other identifying indicia on the quality control specimen (Fujita; figs. 2A-C & 3, [0043-0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the determination of the quality control specimen of Vansickler to comprise reading a barcode or other identifying indicia on the quality control specimen, as taught by Fujita, because Fujita teach the determination by reading a barcode allows a network of analyzers to jointly use the analysis results for determining whether the result is within a predetermined threshold value (Fujita; figs. 8 & 10-12, [0081, 0089-0101]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Vansickler and Fujita both teach an analysis instrument for measuring specimen samples and performing quality inspection with QC samples.
Regarding claim 10, Vansickler disclose the system of claim 1 above, wherein the processor is further configured to, in a case wherein the cassette is not ejected: determine whether the cassette includes the quality control specimen (Vansickler disclose determining whether the cassette includes the quality control specimen based on a type of container; [0127, 0236]).
Vansickler does not teach responsive to the determination that the cassette includes the quality control specimen, cause the laboratory instrument to test the quality control specimen to obtain a first measurement of a parameter.
However, Fujita disclose the analogous art of a cassette comprising a quality control specimen and a patient specimen (Fujita; figs. 2A-C, [0033-0035, 0037]), wherein a barcode reader determines the cassette includes a quality control specimen by reading a barcode or other identifying indicia on the quality control specimen (Fujita; figs. 2A-C & 3, [0043-0044]), and responsive to the determination that the cassette includes the quality control specimen, cause the laboratory instrument to test the quality control specimen to obtain a first measurement of a parameter (Fujita; fig. 3, [0046, 0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the determination of the quality control specimen of Vansickler to comprise reading a barcode to determine the cassette includes a quality control specimen and responsive to the determination that the cassette includes the quality control specimen, cause the laboratory instrument to test the quality control specimen to obtain a first measurement of a parameter, as taught by Fujita, because Fujita teach the determination by reading a barcode allows a network of analyzers to jointly use the analysis results for determining whether the result is within a predetermined threshold value (Fujita; figs. 8 & 10-12, [0081, 0089-0101]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Vansickler and Fujita both teach an analysis instrument for measuring specimen samples and performing quality inspection with QC samples.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Vansickler in view of Glavina et al. (US 2016/0356800; already of record – hereinafter “Glavina”).
Regarding claim 9, Vansickler disclose the system of claim 1 above, wherein the computing system is connected to the laboratory instrument (Vansickler; fig. 20, [0183, 0317]).
Vansickler does not teach the connection is a wireless connection.
However, Glavina the analogous art of a system comprising a laboratory instrument (Glavina; fig. 1, #100, [0037]), and a computing system comprising a processor (Glavina; fig. 1, #104, [0037]), wherein the computing system is connected to the laboratory instrument via a wireless connection (Glavina; [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the connection of the laboratory instrument and computing system of Vansickler, to be a wireless connection, as in Glavina, because Glavina teach the wireless connection allows a plurality of analyzers to be in communication with one another via the wireless network (Glavina; [0020]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Vansickler and Glavina both teach a plurality of analysis devices configured with a central computing system.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Vansickler in view of Fujita, and further in view of Glavina.
Regarding claim 11, modified Vansickler disclose the system of claim 10 above, wherein the processor is further configured to: responsive to determining that the first measurement is outside an expected tolerance (The modification of the determination of the quality control specimen of Vansickler to comprise reading a barcode to determine the cassette includes a quality control specimen and responsive to the determination that the cassette includes the quality control specimen, cause the laboratory instrument to test the quality control specimen to obtain a first measurement of a parameter, as taught by Fujita, has previously been discussed in claim 10 above. Fujita additionally teach determining that the first measurement is outside an expected tolerance; fig. 11, S21, [0096]).
Modified Vansickler does not teach responsive to determining that the first measurement is outside the expected tolerance: cause the laboratory instrument to cease performing tests on additional patient specimens from one or more additional cassettes, and cause the laboratory instrument to test the quality control specimen to obtain a second measurement; responsive to determining the second measurement is within the expected tolerance: restart the ceased tests on the additional patient specimens; and responsive to determining the second measurement is outside the expected tolerance: continue to cause the laboratory instrument to cease performing the tests on the additional patient specimens.
However, Glavina teach the analogous art of a system comprising a laboratory instrument (Glavina; fig. 1, #100, [0037]), and a computing system comprising a processor (Glavina; fig. 1, #104, [0037]), wherein the computing system is connected to the laboratory instrument via a wireless connection (Glavina; [0037]) wherein the system is configured to determine that the cassette includes the quality control specimen (Glavina discloses a quality control system 300 comprising a data manger 315 that communicates with one or more test devices 305 to initiate a quality control check using one or more cassettes 310; figs. 4 & 5, #305, #310, #505, [0072, 0096]. The data manager 315 is configured with a scheduler that accommodates lot based scheduling of performance of quality control with requirements for recording selected or predetermined lot-acceptance information; [0018, 0083]. The requirements for recording selected or predetermined lot-acceptance information of the quality control therefore being a determination that the cassette includes the quality control specimen), testing the quality control specimen to obtain a first measurement of a parameter (Glavina discloses the method of fig. 5 comprises performing the quality control tests by running on or more quality control samples on a first test apparatus; fig. 5, #515, [0069, 0098], and that the quality control data is evaluated by comparing the quality control test results with a threshold or target value for the control samples; fig. 5, #525, [0101]); and responsive to determining that the first measurement is outside an expected tolerance: causing the laboratory apparatus to cease performing tests on additional patient specimens from one or more additional cassettes (Glavina discloses thresholds or target values for the control samples are used to determine if an instrument 305 is in compliance or non-compliance, and in cases of non-compliance, that is, when the control samples are outside the target values or thresholds, the instrument 305 is automatically locked out of use; fig. 5, #560, [0092, 0117]), and cause the laboratory instrument to test the quality control specimen to obtain a second measurement (Glavina discloses that upon determining the quality control test results are non-compliant, the data manager 315 may request the quality control test(s) be repeated; [0104, 0109]); responsive to determining the second measurement is within the expected tolerance (Glavina; fig. 5, #555, “Compliant”): restart the ceased tests on the additional patient specimens (Glavina discloses that upon determining the quality control test is compliant, the instrument is configured to operate under normal operating procedures to perform the analytical test and/or another quality control test; fig. 5, #565, [0116]); and responsive to determining the second measurement is outside the expected tolerance: continue to cause the laboratory instrument to cease performing the tests on the additional patient specimens (Glavina discloses that upon determining the quality control test is non-compliant, the instrument is configured to be at least partially disabled from performing the analytical test and/or another quality control test; fig. 5, #560, [0117]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the computing system and process or modified Vansickler to be configured to cause the laboratory instrument to cease performing tests on additional patient specimens from one or more additional cassettes, and cause the laboratory instrument to test the quality control specimen to obtain a second measurement; responsive to determining the second measurement is within the expected tolerance: restart the ceased tests on the additional patient specimens; and responsive to determining the second measurement is outside the expected tolerance: continue to cause the laboratory instrument to cease performing the tests on the additional patient specimens, as taught by Glavina, because Glavina teach the configuration ensures that test devices and/or test instruments of a biological sample testing system that are non-compliant with a quality control program are locked out from use on patent samples (Glavina; fig. 4, [0072]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Vansickler and Glavina both teach methods for validating measurement results with a quality control sample.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Vansickler in view of Fujita and Glavina, and further in view of Yano et al. (US 2012/0179405 – hereinafter “Yano”).
Regarding claim 12, modified Vansickler teach the system of claim 11 above.
Modified Vansickler does not disclose wherein the processor is further configured to: cause the additional one or more cassettes comprising the additional patient specimens to be transferred from the input buffer to a second laboratory instrument; and cause the second laboratory instrument to perform the tests to be performed on the additional patient specimens from the input buffer.
However, Yano teaches the analogous art of a system comprising a laboratory instrument (Yano; fig. 3, [0001]), wherein the system comprises causing the testing apparatus to cease performing tests on additional patient specimens (Yano teaches if the analyzing system is under calibration, the apparatus management unit 02 can notify to the conveyance management unit 01 that the analysis with the particular analyzing system cannot be continued; [0021]), and transferring a cassette to a second testing apparatus and performing tests on the performing tests on the patient specimens using the second testing apparatus (Yano teaches that under a situation that information on the operational status of the analyzing system is unobtainable therefrom, while automatic retest request occurring in each analyzing system, any analyzing system capable of obtaining test results within a shorter time can be determined as the apparatus to which the sample is to be conveyed; [0024]. Accordingly, the retest of the patient specimen in an analyzing system that is unobtainable being transferred to a second testing apparatus where testing is performed on the patient specimen. The examiner notes that a cassette to hold the samples would be required to perform the function of conveying each sample).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system configured to cease performing tests on an additional patient specimens of modified Vansickler, to further comprise transferring the cassette to a second testing apparatus and performing tests on the patient specimens using the second testing apparatus, as taught by Yana, because Yano teaches the method comprising ceasing performing tests on additional patient specimens and transferring the cassette to a second testing apparatus where testing is performed on the patient specimens using the second test apparatus allows test results to be obtained on the patient specimen within a short time; [0024]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Vansickler and Yano both teach testing systems configured to transport sample, and to cease performing tests on additional patient specimens.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,867,708. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 11,867,708 disclose:
A system (11,867,708 – Claim 1, “hematology laboratory instrument”) comprising: a laboratory instrument having an input buffer (11,867,708 – Claim 1, “hematology laboratory instrument … input buffer”); and a computing system comprising a processor (11,867,708 – Claim 1, “a processor”) configured to: determine whether a cassette received from the input buffer is a mixed cassette that comprises both a quality control specimen and a patient specimen, cause the ejection of the cassette responsive to the determination that the cassette is the mixed cassette (11,867,708 – Claim 1, “determines that the cassette is a mixed cassette that comprises both a quality control specimen and a patient specimen, wherein the processor is configured to cause the ejection of the cassette responsive to the determination that the cassette is the mixed cassette”), and send an alert responsive to the determination that the cassette is the mixed cassette (11,867,708 – Claim 2, “sending an alert”).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to Applicant’s disclosure include:
Tamura et al. (US 2003/0049171) disclose a rack storage portion having racks for storing general specimen racks, quality control racks, measurement line racks, emergency measurement racks, and reinspection racks.
Yamakawa et al. (US 2005/0036913) disclose a barcode reader and an error message on an LCD or audio notification.
McKeen et al. (US 2013/0019697) disclose a system for processing samples that determines the presence or absence of a tube on a rack and alerts an operator.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
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E-mail communication Authorization
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Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
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/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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