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 .
Application Status
This is the first non-final action on the merits. Claims 1-20 as originally filed on September 24, 2025 are currently pending and considered below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 24, 2025 is being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2 and 5-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,2, 4-6, 8-16, 18 and 19 of U.S. Patent No. 12,451,247 B2.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,451,247 B2 in view in view of Mishima (US 2006/0259265 A1).
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over of Booker (US 2017/0177724 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other as shown below.
Instant Application
U.S. Patent No. 12,451,247 B2
1. A point of care system comprising: a plurality of diagnostic engines, each diagnostic engine being configured to perform a test on a sample and to generate a measured result based on the test on the sample; and an instrument data manager (IDM) in electronic communication with each of the plurality of diagnostic engines, the IDM being configured to:
1. A method performed by an instrument data manager (IDM) in electronic communication with a first diagnostic engine and a second diagnostic engine, the first diagnostic engine and the second diagnostic engine each including a processor configured to adjust one or more characteristics of the first diagnostic engine and the second diagnostic engine to keep the first diagnostic engine and the second diagnostic engine within operating conditions to obtain measured results of corresponding tests, and a memory that stores one or more values representing the measured result of the corresponding tests, the first diagnostic engine and the second diagnostic engine having no user interface display, the method comprising:
communicate with each of the plurality of diagnostic engines to enable a plurality of tests to be performed on a plurality of samples by a plurality of users using the plurality of diagnostic engines, wherein times of each of the tests of the plurality of tests at least partially overlap;
receiving, via a single user interface displayed on a display screen and from a first user, a first request to perform a first test on a first fluid sample associated with the first diagnostic engine;
sending, to the first diagnostic engine and in response to the first request, a first instruction to perform the first test on the first fluid sample associated with the first diagnostic engine;
receiving, via the single user interface displayed on the display screen and from a second user, a second request to perform a second test on a second sample associated with the second diagnostic engine;
sending, to the second diagnostic engine and in response to the second request, a second instruction to perform the second test associated with the second diagnostic engine… wherein the first test and the second test are performed simultaneously.
receive one or more measured results from one or more of the diagnostic engines;
receiving from the first diagnostic engine, one or more first measured result of the first test, wherein the first diagnostic engine, without control from the IDM, carries out the first test to obtain the one or more first measured result of the first test, by:
mixing the first fluid sample a first time;
heating, using a heating element, the first fluid sample;
mixing the first fluid sample a second time, subsequent to heating the first fluid sample; and
taking, using an optical scanner, an optical reading of the first fluid sample;
receiving from the second diagnostic engine, one or more second measured result of the second test, wherein the second diagnostic engine, without control from the IDM, carries out the second test to obtain the one or more second measured result; and
determine one or more calculated results based on the one or more measured results and at least one other parameter; and
processing one or more of the one or more first measured result and the one or more second measured result to determine a calculated result;
present a single user interface for managing testing by the plurality of diagnostic engines and for displaying the one or more calculated results.
presenting, on the single user interface for managing testing of the first diagnostic engine and the second diagnostic engine, the calculated result,
2. The point of care system recited in claim 1, wherein the user interface requires entry of a patient identifier associated with a given one of the samples prior to displaying a calculated result associated with the given sample.
2. The method of claim 1, further comprising:
prompting, via the single user interface, the first user to enter information corresponding to the first fluid sample associated with the first diagnostic engine; and
prompting, via the single user interface, the second user to enter information corresponding to the second sample associated with the second diagnostic engine,
wherein the information includes one or more of a patient identifier, a patient demographic, a sample demographic, and order information.
3. The point of care system recited in claim 1, wherein the IDM is configured to communicate with each of the plurality of diagnostic engines via wireless communications.
1. A method performed by an instrument data manager (IDM) in electronic communication with a first diagnostic engine and a second diagnostic engine…
4. The point of care system recited in claim 1, wherein each diagnostic engine is the same type of diagnostic engine.
5. The point of care system recited in claim 1, wherein one or more of the plurality of diagnostic engines are different types of diagnostic engines.
6. The method of claim 5, wherein the first diagnostic engine and the second diagnostic engine are different types of diagnostic engines.
6. The point of care system recited in claim 1, wherein the plurality of diagnostic engines comprise at least one of a blood gas diagnostic engine, a cardiac diagnostic engine, a coagulation diagnostic engine, a diabetes diagnostic engine, and a urinalysis diagnostic engine.
5. The method of claim 1, wherein the second diagnostic engine comprises at least one of a blood gas diagnostic engine, a cardiac diagnostic engine, a coagulation diagnostic engine, a diabetes diagnostic engine, and a urinalysis diagnostic engine.
7. The point of care system recited in claim 1, wherein the user interface displays, for each diagnostic engine, an icon representing that diagnostic engine.
4. The method of claim 1, further comprising:
displaying, via the single user interface and after initiating the first test associated with the first diagnostic engine, a first icon representing the first diagnostic engine; and
displaying, via the single user interface and after initiating the second test associated with the second diagnostic engine, a second icon representing the second diagnostic engine.
8. The point of care system recited in claim 7, wherein the icon for each diagnostic engine indicates a status of the diagnostic engine.
4. The method of claim 1, further comprising:
displaying, via the single user interface and after initiating the first test associated with the first diagnostic engine, a first icon representing the first diagnostic engine; and
displaying, via the single user interface and after initiating the second test associated with the second diagnostic engine, a second icon representing the second diagnostic engine.
10. The method of claim 1, further comprising:
receiving from the first diagnostic engine a first status of the first test and from the second diagnostic engine a second status of the second test, each of the first status and the second status being one or more of: a percentage complete, a time remaining, and a time elapsed; and
presenting on the single user interface for managing testing of the first diagnostic engine and the second diagnostic engine, the first status of the first diagnostic engine the second status of the second diagnostic engine.
9. The point of care system recited in claim 1, wherein the IDM receives the measured results from one or more of the plurality of diagnostic engines in non-real time.
8. The method of claim 1, wherein the IDM receives measured results from the first diagnostic engine in non-real time.
10. The point of care system recited in The point of care system recited in wherein the at least one other parameter comprises one or more of demographic information associated a patient and a time of day at which the measured result was determined.
9. The method of claim 8, wherein processing one or more of the one or more first measured result and the one or more second measured result to determine the calculated result includes generating the calculated result based on the measured result and at least one other parameter, wherein the at least one other parameter comprises demographic information associated with a patient and a time of day at which the measured result was determined.
Claims 1,2, 4-6, 8-16, 18 and 19 of U.S. Patent No. 12,451,247 B2 include the limitations of claims 1-20 of the instant application except:
each diagnostic engine is the same type of diagnostic engine
communicate via wireless communications
However, Mishima teaches each diagnostic engine is the same type of diagnostic engine
(e.g. see [0052]-[0053]). It would have been obvious to one of ordinary skill in the art to have each diagnostic engine as the same type of diagnostic engine as taught by Mishima for the purposes of use in a medical institution (Mishima [0052]).
However, Booker teaches each communicate via wireless communications (e.g. see [0054]). It would have been obvious to one of ordinary skill in the art to communicate via wireless communications as taught by Booker of transmitting results with minimal human intervention (Booker [0006]).
Claims 11-20 of the instant application recite substantially similar limitations as claims 1-10 of the instant application, and, as such are rejected for similar reasons as given above. See also claims 11-16, 18 and 19 of the ‘247 patent.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-10 recite a point of care system, which is within the statutory category of an article of manufacture. Claims 11-20 recite an instrument data manager (IDM) for controlling a plurality of diagnostic engines, which is within the statutory category of an article of manufacture.
Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they "recite" a judicial exception or in other words whether a judicial exception is "set forth" or "described" in the claims. An "abstract idea" judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes. Representative independent claim 1 includes limitations that recite at least one abstract idea.
Specifically, independent claim 1 recites: A point of care system comprising:
a plurality of diagnostic engines, each diagnostic engine being configured to perform a test on a sample and to generate a measured result based on the test on the sample; and
an instrument data manager (IDM) in electronic communication with each of the plurality of diagnostic engines, the IDM being configured to:
communicate with each of the plurality of diagnostic engines to enable a plurality of tests to be performed on a plurality of samples by a plurality of users using the plurality of diagnostic engines, wherein times of each of the tests of the plurality of tests at least partially overlap;
receive one or more measured results from one or more of the diagnostic engines;
determine one or more calculated results based on the one or more measured results and at least one other parameter; and
present a single user interface for managing testing by the plurality of diagnostic engines and for displaying the one or more calculated results.
Other than the steps performed by the generic computer components, the underlined limitations are directed to methods of organizing human activity. The claim recites steps of enabling a plurality of tests to be performed on a plurality of samples and managing testing. These steps, under its broadest reasonable interpretation, are categorized as methods of organizing human activity, specifically associated with managing personal behavior or relationships or interactions between people (e.g. managing testing of a plurality of samples). In addition, the claim encompasses an abstract idea that falls under the mathematical concepts grouping because determining one or more calculated results based on the one or more measured results and at least one other parameter under its broadest reasonable interpretation, represents mathematical calculations and relationships (see MPEP 2106.04(a)(2)). The abstract idea for Claims 11 are identical as the abstract idea for Claim 1, because the only difference between Claim 1 and 11 is that Claim 1 recites a system, whereas Claim 11 recites an IDM. Any limitations not identified above as part of methods of organizing human activity or mathematical concepts, are deemed “additional elements” and will be discussed further in detail below. Accordingly, claims 1 and 11 recite at least one abstract idea.
Similarly, dependent claims 10 and 20 recite at least one abstract idea. Claims 10 and 20 describe the inputs used in the calculation. These limitations only serve to further limit the abstract idea and hence, are directed toward fundamentally the same abstract ideas as independent claims 1 and 11, even when considered individually and as an ordered combination.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. More specifically, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a "practical application."
In the present case, claims 1-20 as a whole do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea. The additional elements or combination of additional elements, beyond the above-noted at least one abstract idea will be described as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the “abstract idea(s)”).
Specifically, independent claim 1 recites: A point of care system comprising:
a plurality of diagnostic engines, each diagnostic engine being configured to perform a test on a sample and to generate a measured result based on the test on the sample; and
an instrument data manager (IDM) in electronic communication with each of the plurality of diagnostic engines, the IDM being configured to:
communicate with each of the plurality of diagnostic engines to enable a plurality of tests to be performed on a plurality of samples by a plurality of users using the plurality of diagnostic engines, wherein times of each of the tests of the plurality of tests at least partially overlap;
receive one or more measured results from one or more of the diagnostic engines;
determine one or more calculated results based on the one or more measured results and at least one other parameter; and
present a single user interface for managing testing by the plurality of diagnostic engines and for displaying the one or more calculated results.
The claim recites the additional elements of an IDM, diagnostic engines and user interface that implement the identified abstract idea. The IDM, diagnostic engines and user interface are not described by the applicant and are recited at a high-level of generality such that they amount to no more than mere instructions to apply the exception using a generic computer component. Limiting the analysis to point of care and diagnostic engines generally links the use of a judicial exception to a particular technological environment or field of use, and thus, does not integrate a judicial exception into a practical application.
Claim 1 further recites the additional elements of performing a test on a sample, generating a measured result, electronic communication, receiving measured results and displaying calculated results. The dependent claims 2, 7-9, 12 and 17-19 recite entry of a patient identifier, displaying an icon, the icon indicating status and receiving results in non-real time. Under practical application, performing a test on a sample, generating a measured result, electronic communication, receiving measured results, displaying calculated results, entry of a patient identifier, displaying an icon, the icon indicating status and receiving results in non-real time are forms of extra-solution activity. MPEP 2106.5(g) indicates the term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Therefore, even in combination, these additional elements do not integrate the abstract idea into a practical application.
The dependent claims 3-6 and 13-16 recite additional element(s) beyond those already recited in the independent claims that implement the identified abstract idea. Claims 3 and 13 recite wireless communications. Claims 4-6 and 14-16 describe the diagnostic engines. However, these functions do not integrate a practical application more than the abstract idea because:
the diagnostic engines represent mere instructions to apply the abstract idea on a computer (i.e., merely invoking the computer structure as a tool used to execute the limitations); and,
the wireless communication generally links the use of a judicial exception to a particular technological environment or field of use.
Accordingly, the claims as a whole do not integrate the abstract idea into a practical application as they do not impose any meaningful limits on practicing the abstract idea.
Step 2B
Regarding Step 2B, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
When viewed as a whole, claims 1-20 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite processes that are routine and well-known in the art and simply implements the process on a computer(s) is not enough to qualify as "significantly more."
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using an IDM, diagnostic engines and user interface to perform the noted steps amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). In addition, limiting the analysis to point of care and diagnostic engines generally links the use of a judicial exception to a particular technological environment or field of use, and thus, does not amount to significantly more than the judicial exception.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of performing a test on a sample, generating a measured result, electronic communication, receiving measured results, displaying calculated results, entry of a patient identifier, displaying an icon, the icon indicating status and receiving results in non-real time were considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. MPEP 2106.05(d)(II) indicates that receiving and/or transmitting data over a network has been held by the courts to be well-understood, routine, conventional activity (citing Symantec, TLI Communications, OIP Techs., and buySAFE). In addition, MPEP indicates that displaying results of a rudimentary analysis (TLI Communications, 823 F.3d at 612-13,118 USPQ2d at 1747-48) (MPEP 2106.05(a)) and/or mere data gathering (MPEP 2106.05(g)) has been held by the courts to be insignificant extra-solution activity. Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such, the claims also do not recite significantly more than the abstract idea and are not patent eligible.
The dependent claims 3-6 and 13-16 recite additional element(s) beyond those already recited in the independent claims that implement the identified abstract idea. Claims 3 and 13 recite wireless communications. Claims 4-6 and 14-16 describe the diagnostic engines. However, these functions are not deemed significantly more than the abstract idea because:
the diagnostic engines represent mere instructions to apply the abstract idea on a computer (i.e., merely invoking the computer structure as a tool used to execute the limitations); and,
the wireless communication generally links the use of a judicial exception to a particular technological environment or field of use.
Therefore, claims 1-20 are rejected under 35 USC §101 as being directed to non-statutory subject matter.
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 1, 4-6, 9, 11, 14-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mishima (US 2006/0259265 A1) in further view of Pollack (US 2015/0338427 A1) and Margery (US Patent No. 6,055,487).
Regarding claim 1, Mishima teaches: A point of care system comprising: (e.g. see [0052]-[0053])
a plurality of diagnostic engines, each diagnostic engine being configured to perform a test on a sample and to generate a measured result based on the test on the sample; and (the system includes “hemocyte analyzers 2a and 2b” and “blood coagulation measuring apparatuses
4a and 4b”, e.g. see [0052]; hemocyte analyzers test blood specimens and generate measurement data, e.g. see [0053]-[0062], [0120]-[0129]; blood coagulation measuring apparatuses/analyzers test specimens and generate measurement values, e.g. see [0084]-[0087], [0147]-[0154])
an instrument data manager (IDM) in electronic communication with each of the plurality of diagnostic engines, the IDM being configured to: (“data processing apparatus 6” communicates over “communication network NW” with hemolytic analyzers and coagulation analyzers, e.g. see [0052], [0108])
communicate with each of the plurality of diagnostic engines to enable a plurality of tests to be performed on a plurality of samples by a plurality of users using the plurality of diagnostic engines, […]; (“data processing apparatus 6” sends measurement item instructions to the respective hemocyte and coagulation analyzers, which then perform the requested measurements and return measurement values; the “data processing apparatus 6” allows tests to be run on various samples by a plurality of users such as operators, technicians, clinicians and supervisors across the network, e.g. see [0108], [0166]-[0173])
receive one or more measured results from one or more of the diagnostic engines; (the data processing apparatus receives the measurement data from hemocyte analyzers and coagulation analyzers and records the data in “database DB21” and “database DB41”, e.g. see [0169]-[0173])
determine one or more calculated results based on the one or more measured results […]; and (“analysis processing means for performing analysis of measurement results”, e.g. see [0008]; processing the “measurement value data” such as with “unit conversion” before display, e.g. see [0129])
present a single user interface for managing testing by the plurality of diagnostic engines and for displaying the one or more calculated results. (the data processing apparatus provides operation settings and operation start instructions for all hemocyte and coagulation analyzers; its application uses a “unified user interface” that permits switching among analyzer/test types through the same interface, e.g. see [0108], [0163]-[0173]; “the measurement result display window 284 of the data processing apparatus 6” acts as a single interface with switchable tabs “CBC tab 284s, DIFF tab 284t, and RET tab 284u” for displaying measurements/analysis results from the hemocyte and coagulation analyzers, e.g. see [0176], [0180], Fig. 33)
Mishima does not teach:
wherein times of each of the tests of the plurality of tests at least partially overlap
However, Pollack in the analogous art of managing tests across multiple diagnostic analyzers (e.g. see [0006-[0008]) teaches:
wherein times of each of the tests of the plurality of tests at least partially overlap (“plurality of analyzer modules” and “scheduling a plurality of samples to undergo tests at the plurality of analyzer modules”; distributing/scheduling testing across analyzers to increase throughput; analyzer modules operate concurrently to improve system throughput and reduce turnaround, including dividing test panels across different analyzers, e.g. see [0006]-[0014], [0045]-[0048], [0060]-[0065])
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 the teachings of Mishima to include times of each of the tests of the plurality of tests at least partially overlap as taught by Pollack, for the purposes of minimizing incompatibilities, increasing throughput and reducing overall turnaround time (Pollack [0046], [0060]-[0065]).
Mishima and Pollack do not teach:
at least one other parameter
However, Margery in the analogous art of networked point of care specimen analysis systems (e.g. see col. 4 lines 38-64) teaches:
at least one other parameter (calculating test results using patient related parameters, “patient temperature and hemoglobin which influence the calculation of the results of the analysis”, e.g. see col. 7 lines 14-19)
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 the teachings of Mishima and Pollack to include at least one other parameter as taught by Margery, for the purposes of accounting for factors that “influence the calculation of the results of the analysis” (Margery col. 7 lines 14-19).
Regarding claim 4, Mishima, Pollack and Margery teach the system of claim 1 as described above.
Mishima further teaches:
wherein each diagnostic engine is the same type of diagnostic engine (hemocyte analyzers 2a and 2b both have identical structures, e.g. see [0052]-[0053])
Regarding claim 5, Mishima, Pollack and Margery teach the system of claim 1 as described above.
Mishima further teaches:
wherein one or more of the plurality of diagnostic engines are different types of diagnostic engines (the system includes “hemocyte analyzers 2a and 2b” and “blood coagulation measuring apparatuses 4a and 4b”, e.g. see [0052]-[0053])
Regarding claim 6, Mishima, Pollack and Margery teach the system of claim 1 as described above.
Mishima further teaches:
wherein the plurality of diagnostic engines comprise at least one of a blood gas diagnostic engine, a cardiac diagnostic engine, a coagulation diagnostic engine, a diabetes diagnostic engine, and a urinalysis diagnostic engine (the system includes “hemocyte analyzers 2a and 2b” and “blood coagulation measuring apparatuses 4a and 4b”, e.g. see [0052]; coagulation measurements includes “prothrombin time (PT), active part thromboplastin time (APTT), fibrinogen (Fbg)”, e.g. see [0140])
Regarding claim 9, Mishima, Pollack and Margery teach the system of claim 1 as described above.
Mishima does not teach:
wherein the IDM receives the measured results from one or more of the plurality of diagnostic engines in non-real time
However, Pollack in the analogous art teaches:
wherein the IDM receives the measured results from one or more of the plurality of diagnostic engines in non-real time (samples may be schedules in a first-in first-out manner and samples with STAT priority may be scheduled to be handled by a single analyzer, i.e. see [0075])
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 the teachings of Mishima to include the IDM receives the measured results from one or more of the plurality of diagnostic engines in non-real time as taught by Pollack, for the purposes of minimizing incompatibilities, increasing throughput and reducing overall turnaround time (Pollack [0046], [0060]-[0065]).
Claim 11 recites substantially similar limitations as those already addressed in claim 1, and, as such is rejected for similar reasons as given above.
Claim 14 recites substantially similar limitations as those already addressed in claim 4, and, as such is rejected for similar reasons as given above.
Claim 15 recites substantially similar limitations as those already addressed in claim 5, and, as such is rejected for similar reasons as given above.
Claim 16 recites substantially similar limitations as those already addressed in claim 6, and, as such is rejected for similar reasons as given above.
Claim 19 recites substantially similar limitations as those already addressed in claim 9, and, as such is rejected for similar reasons as given above.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Mishima, Pollack and Margery in further view of Darmstadt (US 2014/0100791 A1).
Regarding claim 2, Mishima, Pollack and Margery teach the system of claim 1 as described above.
Mishima teaches displaying a calculated result associated with the given sample as described above.
Mishima, Pollack and Margery do not teach:
wherein the user interface requires entry of a patient identifier associated with a given one of the samples prior to displaying a result
However, Darmstadt in the analogous art of computerized medical diagnostic testing (e.g. see [0004]) teaches:
wherein the user interface requires entry of a patient identifier associated with a given one of the samples prior to displaying a result (the UI allows retrieval by patient identifier, the user enters a “patient ID number”, actuates “Apply Filter”, and only then is a second screen displayed containing the patient’s test results, e.g. see [0039]-[0041] )
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 the teachings of Mishima, Pollack and Margery to include at least one other parameter as taught by Darmstadt, for the purposes of enabling a “a user to conveniently and quickly produce reports” (Darmstadt [0038]).
Claim 12 recites substantially similar limitations as those already addressed in claim 2, and, as such is rejected for similar reasons as given above.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mishima, Pollack and Margery in further view of Booker (US 2017/0177724 A1).
Regarding claim 3, Mishima, Pollack and Margery teach the system of claim 1 as described above.
Mishima teaches IDM is configured to communicate with each of the plurality of diagnostic engines as described above.
Mishima, Pollack and Margery do not teach:
communicate via wireless communications
However, Booker in the analogous art of diagnostic testing (i.e. see [0008]) teaches:
communicate via wireless communications (multiple diagnostic instruments connected to a central network, with the “connection between each diagnostic instrument l00a-b and hub or switch 110 can be a cable connection or a wireless connection”, e.g. see [0054], [0085])
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 the teachings of Mishima, Pollack and Margery to include communicate via wireless communications as taught by Booker, for the purposes of transmitting results with minimal human intervention (Booker [0006]).
Claim 13 recites substantially similar limitations as those already addressed in claim 3, and, as such is rejected for similar reasons as given above.
Claims 7, 8, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mishima, Pollack and Margery in further view of Bosko (US 2016/0020986 A1).
Regarding claim 7, Mishima, Pollack and Margery teach the system of claim 1 as described above.
Mishima, Pollack and Margery do not teach:
wherein the user interface displays, for each diagnostic engine, an icon representing that diagnostic engine
However, Bosko in the analogous art of diagnostic testing (i.e. see [0008]) teaches:
wherein the user interface displays, for each diagnostic engine, an icon representing that diagnostic engine (the analyzer page lists the various analyzers and provides an image/widget associated with each analyzer; it also provides an analyzer specific “connected icon” and permits multiple analyzers to be selected with corresponding analyzer information sections, e.g. see [0081]-[0083]; a user interface to present the first and second diagnostic analyzer information to the user, e.g. see [0012])
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 the teachings of Mishima, Pollack and Margery to include the user interface displays, for each diagnostic engine, an icon representing that diagnostic engine as taught by Bosko, for the purposes of purposes of facilitating accessing education and/or service information associated with the selected analyzer (Bosko [0084]).
Regarding claim 8, Mishima, Pollack, Margery and Bosco teach the system of claim 7 as described above.
Mishima does not teach:
wherein the icon for each diagnostic engine indicates a status of the diagnostic engine
However, Bosko in the analogous art teaches:
wherein the icon for each diagnostic engine indicates a status of the diagnostic engine (analyzer status is obtained and displayed, e.g. see [0077]-[0079]; the analyzer specific “connected icon 612” represents connection status, e.g. see [0082])
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 the teachings of Mishima, Pollack and Margery to include the icon for each diagnostic engine indicates a status of the diagnostic engine as taught by Bosko, for the purposes of purposes of facilitating accessing education and/or service information associated with the selected analyzer (Bosko [0084]).
Claim 17 recites substantially similar limitations as those already addressed in claim 7, and, as such is rejected for similar reasons as given above.
Claim 18 recites substantially similar limitations as those already addressed in claim 8, and, as such is rejected for similar reasons as given above.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mishima, Pollack and Margery in further view of Varsavsky (US 2017/0049964 A1).
Regarding claim 10, Mishima, Pollack and Margery teach the system of claim 1 as described above.
Mishima, Pollack and Margery do not teach:
wherein the at least one other parameter comprises one or more of demographic information associated a patient and a time of day at which the measured result was determined
However, Varsavsky in the analogous art of diagnostic testing (Varsavsky [0041], [0093]) teaches:
wherein the at least one other parameter comprises one or more of demographic information associated a patient and a time of day at which the measured result was determined (a calibrated sensor glucose measurement value is determined for a glucose measurement of the patient based on factors including the patient’s current body mass index, gender and the current time of day of the glucose measurement, e.g. see [0059], [0031])
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 the teachings of Mishima, Pollack and Margery to include the at least one other parameter comprises one or more of demographic information associated a patient and a time of day at which the measured result was determined as taught by Varsavsky. It is advantageous to adjust a user’s blood glucose levels and account for the many variables that influence glucose regulation and control as it leads to improved patient outcomes (Varsavsky [0004]).
Claim 20 recites substantially similar limitations as those already addressed in claim 10, and, as such is rejected for similar reasons as given above.
Conclusion
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/A.A./
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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