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 .
Response to Amendment
In light of the amendments, the previous claim objections have been withdrawn.
In light of the amendments, the claims are rejected under 35 U.S.C. 101.
In light of the amendments, the claims are rejected under 35 U.S.C. 103.
Notice to Applicant
In the amendment dated 08/18/2025, the following has occurred: claims 3, 8, and 12-13 have been amended; claims 1-2, 4-7, 9-11, and 15-18 remain unchanged; and claims 19-21 have been added.
Claims 1-13 and 15-21 are pending.
Effective Filing Date: 08/11/2021
Response to Arguments
Claim Objections:
Examiner withdraws the previous claim objections in view of the amendments to the claims.
35 U.S.C. 101 Rejections:
Applicant argues that the 101 rejections were flawed. Applicant states that the claims are directed to an improvement to a problem with a particular technology – i.e., automated sample analysis. The present invention and specification supposedly outline issues with automated instruments such as lacking ranges of motion and providing incorrect test results based on this, and not being able to handle certain containers. Examiner however respectfully disagrees that the claims reflect a technical improvement to these problems. For example, the solution to the problem with generating and providing sample-collecting involving physical limitations of some machines is to generate and provide data in another way. The abstract idea of generating and providing this data is being improved as opposed to an improvement to how some machines, which cannot capture this data, would capture this data.
Additionally, Applicant cites DDR Holdings and states that the present claims are similar. Examiner however respectfully disagrees. The present claims, minus the computing components, can exist in the context of being an abstract idea.
Lastly, Applicant states that claim 13 recites limitations what outline a particular machine that might include an abstract idea. Applicant states that pipettes and laboratory instruments are not generic computer components. These instruments are however considered as part of the abstract idea and not being considered as generic computer components.
35 U.S.C. 103 Rejections:
Applicant argues that the previous references do not teach claims 1, 6, amended claim 13, and newly added claims 19-21. Examiner however respectfully disagrees and directs Applicant towards the 35 U.S.C. 103 rejection section for a complete analysis of these rejections.
Applicant specifically argues that Godshall does not teach the generating step of claim 1. Applicant says that there is no teaching of using instrument data to generate sample-collecting data. Examiner however respectfully disagrees. The test data and instrument data in the context of the Godshall reference is related to the test results of a collection (test data) and the instrument data (data related to aspects of the instruments such as accelerated clotting, etc.). The instrument data comprising information specifying a state was taught in the Maetzler et al. reference.
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 1-13 and 15-21 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 1-13 and 15-18 are drawn to methods, each of which is within the four statutory categories. Claims 1-13 and 15-21 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 1 recites a computer-implemented method comprising:
1) accessing, by a) a first computing device, test data and instrument data, wherein:
1a) the test data comprise information specifying at least one clinical test to be carried out on a biological sample of a subject,
1b) the instrument data comprise information specifying a state and/or a configuration of a set of laboratory instruments, and
1c) at least one laboratory instrument of the set of laboratory instruments is configured to carry out the at least one clinical test,
2) generating, by the first computing device, sample-collecting data by using at least the test data and the instrument data, wherein:
2a) the sample-collecting data comprise at least one of a sample volume requirement and a sample container requirement,
2b) the sample volume requirement comprises one or more suitability constraints on a volume of the biological sample, and
2c) the sample container requirement comprises one or more constraints on a container in which the biological sample is to be held,
3) providing, by the first computing device, the sample-collecting data to a phlebotomy agent.
Claim 1 recites, in part, performing the steps of 1) accessing test data and instrument data, wherein: 1a) the test data comprise information specifying at least one clinical test to be carried out on a biological sample of a subject, 1b) the instrument data comprise information specifying a state and/or a configuration of a set of laboratory instruments, and 1c) at least one laboratory instrument of the set of laboratory instruments is configured to carry out the at least one clinical test, 2) generating sample-collecting data by using at least the test data and the instrument data, wherein: 2a) the sample-collecting data comprise at least one of a sample volume requirement and a sample container requirement, 2b) the sample volume requirement comprises one or more suitability constraints on a volume of the biological sample, and 2c) the sample container requirement comprises one or more constraints on a container in which the biological sample is to be held, 3) providing the sample-collecting data to a phlebotomy agent. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claim describes how a person might decide what tests to run and what equipment is necessary for a phlebotomist.
Claim 6 recites a computer-implemented method comprising:
4) accessing, by b) a second computing device, sample-collecting data generated based on at least test data and instrument data, wherein:
4a) the test data comprise information specifying at least one clinical test to be carried out on a biological sample of a subject,
4b) the instrument data comprise information specifying a state and/or a configuration of a set of laboratory instruments, and at least one laboratory instrument of the set of laboratory instruments is configured to carry out the at least one clinical test,
4c) the sample-collecting data comprise at least one of a sample volume requirement and a sample container requirement,
4d) the sample volume requirement comprises one or more suitability constraints on a volume of the biological sample, and
4e) the sample container requirement comprises one or more constraints on a container in which the biological sample is to be held, and
5) providing, by the second computing device, the sample-collecting data to a phlebotomy agent.
Claim 6 recites, in part, performing the steps of a computer-implemented method comprising: 4) accessing sample-collecting data generated based on at least test data and instrument data, wherein: 4a) the test data comprise information specifying at least one clinical test to be carried out on a biological sample of a subject, 4b) the instrument data comprise information specifying a state and/or a configuration of a set of laboratory instruments, and at least one laboratory instrument of the set of laboratory instruments is configured to carry out the at least one clinical test, 4c) the sample-collecting data comprise at least one of a sample volume requirement and a sample container requirement, 4d) the sample volume requirement comprises one or more suitability constraints on a volume of the biological sample, and 4e) the sample container requirement comprises one or more constraints on a container in which the biological sample is to be held, and 5) providing the sample-collecting data to a phlebotomy agent. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claim describes how a person might decide what tests to run and what equipment is necessary for a phlebotomist.
Depending claims 2-5, 7-13, and 15-21 include all of the limitations of claims 1 and 6, and therefore likewise incorporate the above described abstract idea. Depending claim 2 adds the additional step of “providing the sample-collecting data to a second computing device, the second computing device being configured to provide the sample-collecting data to the phlebotomy agent”; claim 4 adds the additional step of “accessing, by the first computing device, subject data, wherein the subject data comprise information about at least the identity of the subject, wherein the subject data are encoded in an indicium and the indicium is comprised in or arranged on the container”; claim 5 adds the additional step of “decrypting the encrypted subject data”; claim 7 adds the additional step of “retrieving and/or receiving the sample-collecting data from a first computing device”; claim 9 adds the additional step of “encoding, by the second computing device, subject data in an indicium, wherein the subject data comprise information about at least the identity of the subject”; claims 13 and 20 add the additional steps of “control each instrument of the set of laboratory instruments”, “receive the test data from the portable computing device”, “generate the sample-collecting data using at least the test data and the instrument data”, and “upload, to a laboratory information system (LIS), dates and times of receipt of sample containers received at a laboratory associated with the laboratory computing device”; and claims 19 and 21 add the additional step of “generating the sample-collecting data using at least the test data and the instrument data comprises determining a route plan for the biological sample based on the instrument data and information comprising the state and/or a configuration of the transporting means and the set of pre-analytic devices”. Additionally, the limitations of depending claims 3, 8, 10-13, and 15-18 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2-5, 7-13, and 15-21 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1 and 6 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using a) a first computing device and b) a second computing device to perform the claimed steps.
The a) first computing device and b) second computing device in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification for a lack of description of anything but generic components, see MPEP 2106.05(f)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
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 a) a first computing device and b) a second computing device to perform the claimed steps amounts to no more than mere instructions to apply the exception using a generic computer component that does not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity. Specifically, MPEP 2106.05(f) recites that the following limitations are not significantly more:
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)).
The current invention provides data to an agent utilizing a) a first computing device and b) a second computing device, thus these computing devices are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 1-13 and 15-21 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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.
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.
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, 11-13, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2009/0048870 to Godshall et al. in view of U.S. 2018/0340949 to Maetzler et al.
As per claim 1, Godshall et al. teaches a computer-implemented method comprising:
--accessing, by a first computing device, test data and instrument data, (see: paragraph [0041] where test data is being accessed using the LIS/HIS (first computing device) in the form of specific medical tests called for by medical professionals. Also see: paragraphs [0180] and [0181] where there is an accessing of instrument data in the form of collection tubes) wherein:
--the test data comprise information specifying at least one clinical test to be carried out on a biological sample of a subject, (see: paragraph [0041] where the test data comprises information specifying at least one clinical test to be carried out on a biological/patient sample of a subject)
--generating, by the first computing device, sample-collecting data by using at least the test data and the instrument data, (see: paragraph [0041] where a sample-collecting data is being generated using the test data where a determination is being made to determine how many containers are needed and at what volume. Also see: paragraph [0182] where an order to draw is being determined for a certain test. Also see: paragraphs [0180] and [0181] where there are a myriad of different collection tubes. This would be factored in by the LIS (first computing device) when making the determination of what instructions to display on the handheld) wherein:
--the sample-collecting data comprise at least one of a sample volume requirement and a sample container requirement, (see: paragraphs [0041] and [0182] where a sample container requirement exists in the form of the number of containers. Additionally, there is a volume requirement for the sample(s) here)
--the sample volume requirement comprises one or more suitability constraints on a volume of the biological sample, (see: paragraphs [0041] and [0187] where there is a correct order of containers which involve the correct volumes, thus there is a sample volume constraint for the samples to be collected where volume is accounted for) and
--the sample container requirement comprises one or more constraints on a container in which the biological sample is to be held; (see: paragraphs [0041] and [0182] where a sample container requirement exists in the form of the number of containers)
--providing, by the first computing device, the sample-collecting data to a phlebotomy agent (see: paragraph [0184] where the invention can be implemented via a server that bridges the LIS (first computing device) to a handheld device (second computing device). Also see: paragraph [0056] where there is a handheld which is displaying instructions for an order. These instructions are the sample-collecting data and the user of the device is a phlebotomy agent as shown in paragraph [0043]).
Godshall et al. may not further, specifically teach:
1) --the instrument data comprise information specifying a state and/or a configuration of a set of laboratory instruments, and
2) --at least one laboratory instrument of the set of laboratory instruments is configured to carry out the at least one clinical test.
Maetzler et al. teaches:
1) --the instrument data comprise information specifying a state and/or a configuration of a set of laboratory instruments, (see: paragraphs [0019], [0047], and [0055] where there are instruments and there are instructions comprising these instruments and how to carry out the tests on the samples. There is a configuration present for the lab instruments here) and
2) --at least one laboratory instrument of the set of laboratory instruments is configured to carry out the at least one clinical test (see: paragraph [0055] where at least one instrument is configured to carry out the test on the sample).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have 1) the instrument data comprise information specifying a state and/or a configuration of a set of laboratory instruments and have 2) at least one laboratory instrument of the set of laboratory instruments is configured to carry out the at least one clinical test as taught by Maetzler et al. in the method as taught by Godshall et al. with the motivation(s) of enabling the automated handling of biological samples (see: paragraph [0008] of Maetzler et al.).
As per claim 2, Godshall et al. and Maetzler et al. in combination teaches the method of claim 1, see discussion of claim 1. Godshall et al. further teaches wherein providing the sample-collecting data to a phlebotomy agent comprises:
--providing the sample-collecting data to a second computing device, the second computing device being configured to provide the sample-collecting data to the phlebotomy agent (see: paragraph [0184] where the invention can be implemented via a server that bridges the LIS (first computing device) to a handheld device (second computing device). Also see: paragraph [0056] where there is a handheld which is displaying instructions for an order. These instructions are the sample-collecting data and the user of the device is a phlebotomy agent as shown in paragraph [0043]).
As per claim 3, Godshall et al. and Maetzler et al. in combination teaches the method of claim 2, see discussion of claim 2. Godshall et al. further teaches wherein the step of providing the sample-collecting data to the second computing device is carried out by using at least a computer network, wherein the computer network comprises the first computing device and the second computing device (see: paragraph [0023] where there is a computer network which is connected to both the first computing device (LIS) and the second computing device (handheld)).
As per claim 4, Godshall et al. and Maetzler et al. in combination teaches the method of claim 1, see discussion of claim 1. Godshall et al. further teaches:
--accessing, by the first computing device, subject data, wherein the subject data comprise information about at least the identity of the subject; (see: paragraph [0026] where patient data is being a accessed and associated with the specimen tube)
--wherein the subject data are encoded in an indicium and the indicium is comprised in or arranged on the container (see: paragraph [0026] where there is an RFID/barcode (indicium) on the tube. The subject/patient data is associated with the barcode here).
As per claim 6, Godshall et al. teaches a computer-implemented method comprising:
--accessing, by a second computing device, sample-collecting data generated based on at least test data and instrument data, (see: paragraph [0041] where a sample-collecting data is being generated using the test data where a determination is being made to determine how many containers are needed and at what volume. Also see: paragraph [0182] where an order to draw is being determined for a certain test. Also see: paragraphs [0180] and [0181] where there are a myriad of different collection tubes. This would be factored in by the LIS when making the determination of what instructions to display on the handheld (second computing device). The handheld device is accessing this instruction information from the LIS) wherein:
--the test data comprise information specifying at least one clinical test to be carried out on a biological sample of a subject, (see: paragraph [0041] where the test data comprises information specifying at least one clinical test to be carried out on a biological/patient sample of a subject)
--the sample-collecting data comprise at least one of a sample volume requirement and a sample container requirement, (see: paragraphs [0041] and [0182] where a sample container requirement exists in the form of the number of containers. Additionally, there is a volume requirement for the sample(s) here)
--the sample volume requirement comprises one or more suitability constraints on a volume of the biological sample, (see: paragraphs [0041] and [0187] where there is a correct order of containers which involve the correct volumes, thus there is a sample volume constraint for the samples to be collected where volume is accounted for) and
--the sample container requirement comprises one or more constraints on a container in which the biological sample is to be held; (see: paragraphs [0041] and [0182] where a sample container requirement exists in the form of the number of containers)
--providing, by the second computing device, the sample-collecting data to a phlebotomy agent (see: paragraph [0184] where the invention can be implemented via a server that bridges the LIS (first computing device) to a handheld device (second computing device). Also see: paragraph [0056] where there is a handheld which is displaying instructions for an order. These instructions are the sample-collecting data and the user of the device is a phlebotomy agent as shown in paragraph [0043]).
Godshall et al. may not further, specifically teach:
1) --the instrument data comprise information specifying a state and/or a configuration of a set of laboratory instruments, and at least one laboratory instrument of the set of laboratory instruments is configured to carry out the at least one clinical test.
Maetzler et al. teaches:
1) --the instrument data comprise information specifying a state and/or a configuration of a set of laboratory instruments, (see: paragraphs [0019], [0047], and [0055] where there are instruments and there are instructions comprising these instruments and how to carry out the tests on the samples. There is a configuration present for the lab instruments here) and at least one laboratory instrument of the set of laboratory instruments is configured to carry out the at least one clinical test (see: paragraph [0055] where at least one instrument is configured to carry out the test on the sample).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have 1) the instrument data comprise information specifying a state and/or a configuration of a set of laboratory instruments and at least one laboratory instrument of the set of laboratory instruments is configured to carry out the at least one clinical test as taught by Maetzler et al. in the method as taught by Godshall et al. with the motivation(s) of enabling the automated handling of biological samples (see: paragraph [0008] of Maetzler et al.).
As per claim 7, Godshall et al. and Maetzler et al. in combination teaches the method of claim 6, see discussion of claim 6. Godshall et al. further teaches wherein accessing the sample-collecting data comprises retrieving and/or receiving the sample-collecting data from a first computing device (see: paragraph [0184] where the invention can be implemented via a server that bridges the LIS (first computing device) to a handheld device (second computing device). Also see: paragraph [0056] where there is a handheld which is displaying instructions for an order. These instructions are the sample-collecting data and the user of the device is a phlebotomy agent as shown in paragraph [0043]).
As per claim 8, Godshall et al. and Maetzler et al. in combination teaches the method of claim 7, see discussion of claim 7. Godshall et al. further teaches wherein the step of accessing the sample-collecting data is carried out by using at least a computer network, wherein the computer network comprises the first computing device and the second computing device (see: paragraph [0023] where there is a computer network which is connected to both the first computing device (LIS) and the second computing device (handheld)).
As per claim 9, Godshall et al. and Maetzler et al. in combination teaches the method of claim 6, see discussion of claim 6. Godshall et al. further teaches further comprising:
--encoding, by the second computing device, subject data in an indicium, wherein the subject data comprise information about at least the identity of the subject (see: paragraph [0026] where patient data is being a accessed and associated with the specimen tube. There is an RFID/barcode (indicium) on the tube. The subject/patient data is being encoded into an indicium (RDIF) and the data here comprises the identity of the patient).
As per claim 11, Godshall et al. and Maetzler et al. in combination teaches the method of claim 6, see discussion of claim 6. Godshall et al. further teaches wherein:
--the one or more suitability constraints of the sample volume requirement comprise a volume value and/or a volume range; (see: paragraph [0180] where there are specific blood volumes (volume value) for specific containers) and/or,
--wherein the one or more constraints of the sample container requirement comprise at least one of: a type of container, a type of reagent which is to be present in the container, and a volume of reagent which is to be present in the container (This limitation is an alternative and does not need to be met because a citation for the first limitation was provided for. However, see: paragraph [0180] where there are specific blood volumes for specific containers (a type of container)).
As per claim 12, Godshall et al. and Maetzler et al. in combination teaches the method of claim 6, see discussion of claim 6. Godshall et al. further teaches a portable computing device comprising a processor and programmed as the second computing device of the method of claim 6 to access the sample-collecting data and provide the sample-collecting data to the phlebotomy agent (see: paragraph [0023] where the LIS is a computer system and the handheld is a computing device. These both have processors. The limitation “to access…” is merely intended use).
As per claim 15, Godshall et al. and Maetzler et al. in combination teaches the method of claim 1, see discussion of claim 1. Godshall et al. further teaches a non-transitory computer-readable medium comprising instructions which, when executed by a computer, cause the computer to carry out the method according to claim 1 (see: paragraph [0023] where the LIS is a computer system and the handheld is a computing device. These both have memories and instructions in memory. Also see: claim 15 where there is such a medium with instructions).
As per claim 16, Godshall et al. and Maetzler et al. in combination teaches the method of claim 1, see discussion of claim 1. Godshall et al. further teaches wherein:
--the one or more suitability constraints of the sample volume requirement comprise a volume value and/or a volume range; (see: paragraph [0180] where there are specific blood volumes (volume value) for specific containers) and/or,
--wherein the one or more constraints of the sample container requirement comprise at least one of: a type of container, a type of reagent which is to be present in the container, and a volume of reagent which is to be present in the container (This limitation is an alternative and does not need to be met because a citation for the first limitation was provided for. However, see: paragraph [0180] where there are specific blood volumes for specific containers (a type of container)).
As per claim 17, Godshall et al. and Maetzler et al. in combination teaches the method of claim 3, see discussion of claim 3. Godshall et al. further teaches wherein the first computing device and the second computing device are in remote data communication with one another (see: paragraph [0057] where there handheld (second device) is remote from the LIS (first device)).
As per claim 18, Godshall et al. and Maetzler et al. in combination teaches the method of claim 8, see discussion of claim 8. Godshall et al. further teaches herein the first computing device and the second computing device are in remote data communication with one another (see: paragraph [0057] where there handheld (second device) is remote from the LIS (first device)).
Claims 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2009/0048870 to Godshall et al. in view of U.S. 2018/0340949 to Maetzler et al. as applied to claims 4 and 9, and further in view of U.S. 2016/0321480 to Hamlin et al.
As per claim 5, Godshall et al. and Maetzler et al. in combination teaches the method of claim 4, see discussion of claim 4. The combination may not further, specifically teach wherein the subject data is encoded in the indicium in an encrypted form and accessing the subject data comprises decrypting the encrypted subject data.
Hamlin et al. teaches:
--wherein the subject data is encoded in the indicium in an encrypted form and accessing the subject data comprises decrypting the encrypted subject data (see: paragraph [0123] where there is a process of encrypting information and decrypting information during a process of encoding and decoding information).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein the subject data is encoded in the indicium in an encrypted form and accessing the subject data comprises decrypting the encrypted subject data as taught by Hamlin et al. in the method as taught by Godshall et al. and Maetzler et al. in combination with the motivation(s) of removing human error from the blood storage process (see: paragraph [0007] of Hamlin et al.).
As per claim 10, Godshall et al. and Maetzler et al. in combination teaches the method of claim 9, see discussion of claim 9. The combination may not further, specifically teach teaches wherein encoding the subject data comprises encrypting the subject data.
Hamlin et al. teaches:
--wherein encoding the subject data comprises encrypting the subject data (see: paragraph [0123] where there is a process of encrypting information and decrypting information during a process of encoding and decoding information).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein encoding the subject data comprises encrypting the subject data as taught by Hamlin et al. in the method as taught by Godshall et al. and Maetzler et al. in combination with the motivation(s) of removing human error from the blood storage process (see: paragraph [0007] of Hamlin et al.).
Claims 13 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2009/0048870 to Godshall et al. in view of U.S. 2018/0340949 to Maetzler et al. as applied to claims 12 and 1, and further in view of U.S. 2022/0011330 to Yamada.
As per claim 13, Godshall et al. and Maetzler et al. in combination teaches the method of claim 12, see discussion of claim 12. Maetzler et al. further teaches a laboratory system comprising:
--the portable computing device according to claim 12, (see: 22 of FIG. 1)
--a laboratory computing device; (see: 28 of FIG. 1) and
--the set of laboratory instruments, (see: paragraph [0112] where there is a set of instruments) wherein:
--the laboratory computing device is operatively connected to the set of laboratory instruments and is configured to:
--control each instrument of the set of laboratory instruments, (see: paragraph [0112] where there is a computing device (which comprises the control unit 12) connected to the set of instruments to control each instrument)
--receive the test data from the portable computing device, (see: paragraph [0049] where there is reception of test data from the portable/handheld device)
--generate the sample-collecting data using at least the test data and the instrument data, (see: paragraph [0041] where a sample-collecting data is being generated using the test data where a determination is being made to determine how many containers are needed and at what volume. Also see: paragraph [0182] where an order to draw is being determined for a certain test. Also see: paragraphs [0180] and [0181] where there are a myriad of different collection tubes. This would be factored in by the LIS (first computing device) when making the determination of what instructions to display on the handheld) and
--upload, to a laboratory information system (LIS), dates and times of receipt of sample containers received at a laboratory associated with the laboratory computing device (see: paragraph [0184] where the invention can be implemented via a server that bridges the LIS (first computing device) to a handheld device (second computing device). Also see: paragraph [0056] where there is a handheld which is displaying instructions for an order. These instructions are the sample-collecting data and the user of the device is a phlebotomy agent as shown in paragraph [0043]. Also see: paragraph [0049] where there are the dates and times which are included with the collected data).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 6, and incorporated herein.
Godshall et al. and Maetzler et al. in combination may not further, specifically teach:
--each laboratory instrument from the set of laboratory instrument comprises a pipette and is configured to aspirate sample material from a container which is compatible with that laboratory instrument using the pipette.
Yamada teaches:
--each laboratory instrument from the set of laboratory instrument comprises a pipette and is configured to aspirate sample material from a container which is compatible with that laboratory instrument using the pipette (see: paragraph [0032] where there are laboratory instruments and aspirating samples using pipettes).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have each laboratory instrument from the set of laboratory instrument comprises a pipette and is configured to aspirate sample material from a container which is compatible with that laboratory instrument using the pipette as taught by Yamada in the method as taught by Godshall et al. and Maetzler et al. in combination with the motivation(s) of being a type of automated analysis device (see: paragraph [0010] of Yamada).
As per claim 19, Godshall et al. and Maetzler et al. in combination teaches the method of claim 13, see discussion of claim 13. Maetzler et al. further teaches wherein:
--the laboratory system comprises:
--a transporting means for transporting containers comprising biological samples; (see: paragraph [0020] where there are transportation means) and
--a set of pre-analytic devices, (see: paragraph [0047] where there is a set of pre-analytical devices) and
--generating the sample-collecting data using at least the test data and the instrument data comprises determining a route plan for the biological sample based on the instrument data and information comprising the state and/or a configuration of the transporting means and the set of pre-analytic devices (see: paragraph [0127] where there is a determination of a route based on the instrument data and the state of the pre-analytic devices).
As per claim 20, claim 20 is similar to claim 13 and is rejected in a similar manner to claim 13 using the Godshall et al., Maetzler et al., and Yamada references in combination.
As per claim 21, claim 21 is similar to claim 19 and is rejected in a similar manner to claim 19 using the Godshall et al., Maetzler et al., and Yamada references in combination.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684