DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicant
2. This communication is in response to the communication filed 11/4/2024. Claims 1-20 are currently pending.
Double Patenting
3. 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).
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3.1. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 9, 11, 13-19 of U.S. Patent No. 12,167,945, as indicated in the chart below. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined application claim(s) is/are either anticipated by, or would have been obvious over, the reference claim(s) because all of the limitations of claims 1-20 of instant pending patent application 18/935821 correspond to limitations recited in claims 1-3, 5, 9, 11, 13-19 of U.S. Patent 12,167,945. Any claim limitation differences are not substantively significant and/or are obvious under a broad and reasonable interpretation, as detailed in the comparison chart below.
PENDING CLAIMS (18/935821)
US PATENT 12,167,945
CLAIM 1
A method of providing point of care diagnostic testing using a diagnostic engine, comprising:
scanning, via a scanner at the diagnostic engine, diagnostic consumable information of a diagnostic consumable received at the diagnostic engine, the diagnostic consumable containing a patient sample to be tested at the diagnostic engine;
determining via a processor whether the diagnostic consumable information is linked via a data structure in a memory with patient information;
if the diagnostic consumable information is determined to be not linked with the patient information, transmitting instructions via the processor to the diagnostic engine to prevent the
diagnostic engine from performing a test on the patient sample contained in the diagnostic consumable; and
if the diagnostic consumable information is determined to be linked with the patient information, allowing, via the processor, the diagnostic engine to perform a test on the patient
sample contained in the diagnostic consumable.
CLAIM 17 + CLAIM 18
[CLAIM 17: A method of providing point of care diagnostic testing using a diagnostic engine, comprising:
receiving via a user interface or a camera identification (ID) information of a patient for which a test is to be performed using the diagnostic engine;
receiving via a user interface or a camera ID information of a diagnostic consumable to be used to collect a sample from the patient;
linking via a data structure stored in a memory the patient ID information with the diagnostic consumable ID information; and
prior to performing a test on a sample collected with the diagnostic consumable with the diagnostic engine:
scanning via a scanner at the diagnostic engine ID information of the diagnostic consumable received at the diagnostic engine;
determining via a processor whether the diagnostic consumable is linked via the data structure with the patient ID information; and
if the diagnostic consumable is not linked with the patient ID information, transmitting instructions to the diagnostic engine to prevent the diagnostic engine from performing a test on the sample collected with the diagnostic consumable.]
[CLAIM 18: The method of claim 17, further comprising: if the diagnostic consumable is linked with patient ID information, transmitting instructions to the diagnostic engine to perform a test on the sample collected with the diagnostic consumable.]
CLAIM 2
The method of claim 1 further comprising:
performing, via the diagnostic engine, the test on the patient sample at the diagnostic engine; and
generating, via the diagnostic engine, a measured result based on the test on the patient sample.
CLAIM 2 + CLAIM 5
[CLAIM 2: The point of care system of claim 1, wherein the IDM is further configured to: if the diagnostic consumable is linked with patient ID information within the IDM, transmit instructions to the diagnostic engine to perform a test on the sample collected with the diagnostic consumable.]
[CLAIM 5: The point of care system of claim 1, further comprising the diagnostic engine, wherein the diagnostic engine is configured to perform a test on a sample and to generate a measured result based on the test on the sample.]
CLAIM 3
The method of claim 1 further comprising prior to the scanning:
obtaining the patient information via the processor;
obtaining the diagnostic consumable information via the processor; and
linking the obtained patient information with the obtained diagnostic consumable information via the data structure in the memory.
CLAIM 17
receiving via a user interface or a camera identification (ID) information of a patient for which a test is to be performed using the diagnostic engine;
receiving via a user interface or a camera ID information of a diagnostic consumable to be used to collect a sample from the patient;
linking via a data structure stored in a memory the patient ID information with the diagnostic consumable ID information; and
determining via a processor whether the diagnostic consumable is linked via the data structure with the patient ID information
CLAIM 4
The method of claim 3 wherein at least one of the obtaining the patient information and the obtaining the diagnostic consumable information comprises scanning a barcode.
CLAIM 16
The method of claim 14, wherein at least one of the receiving ID information of a patient and the receiving ID information of a diagnostic consumable includes using the IDM to scan a barcode.
CLAIM 5
The method of claim 3 wherein at least one of the obtaining the patient information and the obtaining the diagnostic consumable comprises using a camera.
CLAIM 17
receiving via a user interface or a camera identification (ID) information of a patient for which a test is to be performed using the diagnostic engine;
receiving via a user interface or a camera ID information of a diagnostic consumable to be used to collect a sample from the patient;
CLAIM 6
The method of claim 1 wherein the scanning, via the scanner at the diagnostic engine, comprises scanning a barcode of the diagnostic consumable received at the diagnostic engine to obtain the diagnostic consumable information.
CLAIM 19
The method of claim 17, wherein at least one of the receiving ID information of a patient and the receiving ID information of a diagnostic consumable includes scanning a barcode.
CLAIM 7
The method of claim 6 further comprising communicating the diagnostic consumable information to an instrument data manager comprising the processor and the memory and
configured to determine whether the diagnostic engine performs the test on the patient sample.
CLAIM 14 + CLAIM 15
A method of providing point of care diagnostic testing using a diagnostic engine and employing an instrument data manager (IDM) comprising a user interface, a camera, a processor, and a memory having computer executable instructions stored therein, the IDM configured via the computer executable instructions to perform the method comprising
and if the diagnostic consumable is not linked with patient ID information stored in the memory, transmitting instructions to the diagnostic engine to prevent the diagnostic engine from performing a test on the sample collected with the diagnostic consumable
[CLAIM 15: The method of claim 14, further comprising: if the diagnostic consumable is linked with patient ID information stored in the memory, transmitting instructions to the diagnostic engine to perform a test on the sample collected with the diagnostic consumable]
CLAIM 8
The method of claim 1 further comprising:
determining, via the processor, whether the diagnostic consumable received at the diagnostic engine is valid based on the diagnostic consumable information; and
if the diagnostic consumable received at the diagnostic engine is determined to be not valid, transmitting instructions via the processor to the diagnostic engine to prevent the diagnostic engine from performing the test on the patient sample contained in the diagnostic consumable.
CLAIM 17 + CLAIM 18
determining via a processor whether the diagnostic consumable is linked via the data structure with the patient ID information; and
if the diagnostic consumable is not linked with the patient ID information, transmitting instructions to the diagnostic engine to prevent the diagnostic engine from performing a test on the sample collected with the diagnostic consumable.
[CLAIM 18: The method of claim 17, further comprising: if the diagnostic consumable is linked with patient ID information, transmitting instructions to the diagnostic engine to perform a test on the sample collected with the diagnostic consumable.]
CLAIM 9
The method of claim 1 wherein the transmitting instructions comprises transmitting instructions via the processor to the diagnostic engine to eject the diagnostic consumable from the diagnostic engine prior to the diagnostic engine performing any test on the patient sample contained in the diagnostic consumable.
CLAIM 14
A method of providing point of care diagnostic testing using a diagnostic engine and employing an instrument data manager (IDM) comprising a
user interface, a camera, a processor, and a memory having computer executable instructions stored therein, the IDM configured via the computer executable instructions to perform the method comprising:
if the diagnostic consumable is not linked with patient ID information stored in the memory, transmitting instructions to the diagnostic engine to perform prevent the diagnostic engine from performing a test on the sample collected with the diagnostic consumable.
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CLAIM 14 teaches preventing performing a test but does not appear to explicitly teach “eject the diagnostic consumable from the diagnostic engine” prior to the diagnostic engine performing any test.
The prior art, however, teaches this limitation. For example, Voneiff et al. (US 7374907) teaches “eject the diagnostic consumable from the diagnostic engine” (See, for example, Voneiff: col.6, ln. 65-col. 7, ln. 7; FIGS. 1-A-1C).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the aforementioned features, as taught by Voneiff, with Claim 14 of US Patent 12,167,945 with the motivation of stopping sample processing upon detection of an invalid code (Voneiff: col.6, ln. 65-col. 7, ln. 7; FIGS. 1-A-1C).
CLAIM 10
The method of claim 1 wherein the diagnostic engine comprises a blood gas diagnostic engine, a cardiac diagnostic engine, a coagulation diagnostic engine, a diabetes diagnostic engine, or a urinalysis diagnostic engine.
CLAIM 13
The point of care system of claim 12, wherein the plurality of diagnostic engines 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.
CLAIM 11
A point of care system comprising:
one or more diagnostic engines each configured to perform one or more tests on one or more patient samples;
a memory having stored therein computer executable instructions; and
a processor coupled to the memory and to each of the one or more diagnostic engines and configured via the computer executable instructions to:
receive from one of the one or more diagnostic engines, prior to performing a test on a patient sample contained in a diagnostic consumable, diagnostic consumable information of the diagnostic consumable received at the one of the one or more diagnostic engines;
determine via the processor whether the diagnostic consumable information is linked via a data structure in a memory with patient information;
if the diagnostic consumable information is determined to be not linked with the patient information, transmit instructions via the processor to the one of the one or more diagnostic engines to prevent the one of the one or more diagnostic engines from performing a test on the patient sample contained in the diagnostic consumable; and
if the diagnostic consumable information is determined to be linked with the patient information, allow, via the processor, the one of the one or more diagnostic engines to perform a test on the patient sample contained in the diagnostic consumable.
CLAIM 1 + CLAIM 2
A point of care system comprising:
an instrument data manager (IDM) configured to
communicate with a diagnostic engine, the IDM comprising a user interface, a camera, a processor, and a memory having computer executable instructions stored therein, the IDM configured via the computer executable instructions to:
receive via the user interface or the camera identification (ID) information of a patient for which a test is to be performed using the diagnostic engine;
receive via the user interface or the camera ID
information of a diagnostic consumable to be used to collect a sample from the patient;
link via a data structure stored in the memory the received patient ID information with the received diagnostic consumable ID information;
receive from the diagnostic engine, prior to performing a test on a sample collected with a diagnostic consumable received at the diagnostic engine, ID information of the diagnostic consumable received at the diagnostic engine;
determine via the processor whether the diagnostic consumable received at the diagnostic engine is linked with patient ID information stored in the memory; and
if the diagnostic consumable received at the diagnostic engine is not linked with patient ID information stored in the memory, transmit instructions to the diagnostic engine to prevent the diagnostic engine from performing a test on the sample collected with the diagnostic consumable received at the diagnostic engine.
[CLAIM 2: The point of care system of claim 1, wherein the IDM is further configured to: if the diagnostic consumable is linked with patient ID information within the IDM, transmit instructions to the diagnostic engine to perform a test on the sample collected with the diagnostic consumable.]
CLAIM 12
The point of care system of claim 11 further comprising:
an instrument data manager (IDM) configured to communicate with the one or more diagnostic engines, the IDM comprising the processor and the memory and configured to:
obtain the patient information;
obtain the diagnostic consumable information; and
link the obtained patient information with the obtained diagnostic consumable information via the data structure in the memory.
CLAIM 1
A point of care system comprising:
an instrument data manager (IDM) configured to
communicate with a diagnostic engine, the IDM comprising a user interface, a camera, a processor, and a memory having computer executable instructions stored therein, the IDM configured via the computer executable instructions to:
receive via the user interface or the camera identification (ID) information of a patient for which a test is to be performed using the diagnostic engine;
receive via the user interface or the camera ID
information of a diagnostic consumable to be used to collect a sample from the patient;
link via a data structure stored in the memory the received patient ID information with the received diagnostic consumable ID information;
CLAIM 13
The point of care system of claim 12 wherein the IDM is configured to scan a barcode to determine at least one of the patient information and the diagnostic consumable information.
CLAIM 3
The point of care system of claim 1, wherein the IDM is configured via the camera to scan a barcode to determine at least one of the patient ID information and the diagnostic consumable ID information.
CLAIM 14
The point of care system of claim 12 wherein the IDM comprises a camera to scan at least one of the patient information and the diagnostic consumable information.
CLAIM 1
an instrument data manager (IDM) configured to
communicate with a diagnostic engine, the IDM comprising a user interface, a camera, a processor, and a memory having computer executable instructions stored therein, the IDM configured via the computer executable instructions to:
receive via the user interface or the camera identification (ID) information of a patient for which a test is to be performed using the diagnostic engine;
receive via the user interface or the camera ID information of a diagnostic consumable to be used to collect a sample from the patient;
CLAIM 15
The point of care system of claim 12 wherein at least one of the one or more diagnostic engines is configured to scan barcodes of diagnostic consumables to determine diagnostic consumable information for each diagnostic consumable and communicate diagnostic consumable information to the IDM.
CLAIM 3
The point of care system of claim 1, wherein the IDM is configured via the camera to scan a barcode to determine at least one of the patient ID information and the diagnostic consumable ID information.
CLAIM 16
The point of care system of claim 12 wherein the IDM is further configured to communicate with the one or more diagnostic engines via wireless communications.
CLAIM 11
The point of care system of claim 1, wherein the IDM is configured to communicate with the diagnostic engine via wireless communications.
CLAIM 17
The point of care system of claim 12 wherein the IDM is further configured to:
determine, via the processor, whether a diagnostic consumable received at one of the one or more diagnostic engines is valid based on the diagnostic consumable information; and
if the diagnostic consumable received at the one of the one or more diagnostic engines is determined to be not valid, transmit instructions via the processor to the one of the one or more diagnostic engines to prevent the one of the one or more diagnostic engines from performing the test on the patient sample contained in the diagnostic consumable.
CLAIM 1
A point of care system comprising:
an instrument data manager (IDM) configured to
communicate with a diagnostic engine, the IDM comprising a user interface, a camera, a processor, and a memory having computer executable instructions stored therein, the IDM configured via the computer executable instructions to:
determine via the processor whether the diagnostic consumable received at the diagnostic engine is linked with patient ID information stored in the memory; and
if the diagnostic consumable received at the diagnostic engine is not linked with patient ID information stored in the memory, transmit instructions to the diagnostic engine to prevent the diagnostic engine from performing a test on the sample collected with the diagnostic consumable received at the diagnostic engine.
CLAIM 18
The point of care system of claim 11 wherein at least one of the one or more diagnostic engines is configured to scan a barcode of a diagnostic consumable when the diagnostic consumable is inserted into the diagnostic engine.
CLAIM 3
The point of care system of claim 1, wherein the IDM is configured via the camera to scan a barcode to determine at least one of the patient ID information and the diagnostic consumable ID information.
CLAIM 19
The point of care system of claim 11 wherein the diagnostic consumable comprises a urine sample cup or a sample cartridge.
CLAIM 9
The point of care system of claim 5, wherein the diagnostic engine is configured to analyze samples collected with diagnostic consumables that include a urine sample cup or a sample cartridge.
CLAIM 20
The point of care system of claim 11 wherein the one or more diagnostic engines comprises a blood gas diagnostic engine, a cardiac diagnostic engine, a coagulation diagnostic engine, a diabetes diagnostic engine, or a urinalysis diagnostic engine.
CLAIM 13
The point of care system of claim 12, wherein the plurality of diagnostic engines 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.
Conclusion
4. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Tomaszewski whose telephone number is (313)446-4863. The examiner can normally be reached M-F 5:30 am - 2:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H Choi can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL TOMASZEWSKI/Primary Examiner, Art Unit 3681
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