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 112(f) claim interpretation and 112(a) and 112(b) rejections given based on this interpretation remain and now also apply to claims 16-17.
In light of the amendments, the claims are rejected under 35 U.S.C. 112(b).
In light of the amendments, claims 3, 6, 10, 16, and 19 are rejected under 35 U.S.C. 112(d).
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 09/05/2025, the following has occurred: claims 1-6, 9-13, and 15 have been amended; claims 7-8 and 14 were canceled; and claims 16-23 have been added.
Claims 1-6, 9-13, and 15-23 are pending.
Effective Filing Date: 05/05/2023
Response to Arguments
Claim Interpretation:
The previous claim interpretation remains as the structure of the module is still unknown. For example, the claims state that the analytical testing management system is comprising of a processor and a memory storing program data. Thus the analytical system has both a processor and memory but the system is not limited to those. The modules being part of the system still leave open the possibility for these modules to be something other than what Examiner is assuming as program data on the memory.
35 U.S.C. 112(a) and 112(b) Rejections:
The previous 112(a) and 112(b) rejections have been maintained in view of Examiner’s statement above for the claim interpretation.
35 U.S.C. 101 Rejections:
Applicant states that the claims do not include an abstract idea. Applicant further categorizes certain limitations as being categorized as additional elements. Examiner however respectfully disagrees. The amended claims, as a whole, are directed to an abstract idea categorized under certain methods of organizing human activity. To elaborate, people can perform the abstract concept in the claims as the claims recite a process of determining what to do with samples. The elements of “a remote agent device” and “sensors” are still considered as part of the abstract idea as the usage of these elements in the claims is merely descriptive in nature to obtain data. The functions which recite these elements in the claims can be performed by humans. For example, a person can determine sample data based on sensor data. The sensor data being from the remote agent device is descriptive, and distinct from an active step of receiving sensor data from a remote agent device.
Applicant also states that the claims are integrated into a practical application using the additional elements and that there is an improvement to previous technological systems. Examiner however respectfully disagrees. The claims recite additional elements in an “apply it” manner. Furthermore, the improvement to performing test on bad samples in the form of assessing the samples before testing those samples is moreover an improvement directed towards the abstract idea of how to process samples.
Applicant additionally argues in view of the August 2025 USPTO Memorandum and states that the computers are not being used as a tool to perform an existing process as there is no indication that an existing manual process involves “sensor data captured, during transportation of the medical sample, by the one or more sensors of a remote agent device used to transport the medical sample”. Examiner however respectfully disagrees as the recitation of these elements in the claims in a manner indicative of a mere application of computing elements to perform the abstract idea as previously stated.
Lastly, Applicant states that the claims include significantly more and recite a particular machine. Examiner however respectfully disagrees for the reasons stated above.
35 U.S.C. 103 Rejections:
Applicant argues that the amended claims are not taught by the previous combination of references. These arguments are deemed moot in view of the updated art rejections which now require a different combination of references to teach.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “an optimisation module” and “a compliance module” in claim 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The limitations “an optimisation module” and “a compliance module” in claim 15 do not have structure in the specification leading to Examiner to question whether Applicant had possession over the claimed invention at the time of filing.
Claims 16-17 are rejected based on their dependency on claim 15.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6, 9-13, and 15-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitation “an optimisation module” and “a compliance module” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that perform the functions in the claim Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 16-17 are rejected based on their dependency on claim 15.
Additionally, claims 1, 15, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: a step involving the determination of the status of the second medical sample. There is a performing of a mitigation action step which involves the usage of a second medical sample which already has a determined compliance status. The claims appear to be missing how this sample has its status already determined.
Claims 1-6, 9-13, and 15-23 are rejected based on their dependency on claims 1, 15, and 18.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3, 6, 10, 16, and 19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claims from which these claims depend on state that there is a singular mitigating action which is then defined in those preceding claims. Claims 3, 6, 10, 16, and 19 however elaborate upon the mitigating action by adding an additional action which is occurring, to make it in fact not a singular mitigating action. Two mitigating actions being used where only one is claimed is broadening the scope of the independent claims. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-6, 9-13, and 15-23 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 1-6, 9-13, and 21-23 are drawn to a method, claims 15-17 is drawn to a system, and claims 18-20 are drawn to a media, each of which is within the four statutory categories. Claims 1-6, 9-13, and 15-23 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 for optimizing an assignment of a medical sample to an analytical test, prior to processing of the medical sample in an analytical laboratory using the analytical test, the method comprising:
1) accessing scheduling data indicating an initial assignment of the medical sample to a first analytical test;
2) determining sample data, associated with the medical sample, based at least in part on:
sensor data captured, during transportation of the medical sample, by one or more sensors of a remote agent device used to transport the medical sample;
3) determining, based on the sample data, a compliance status indicating that the medical sample is non-compliant with the first analytical test, by determining at least one of:
3a) that a sample quality metric of the medical sample, indicated by the sample data, violates an analytical test specification of the first analytical test, or
3b) that the medical sample is unprocessable using the first analytical test; and
4) performing prior to the processing of the medical sample in the analytical laboratory, a mitigation action in response to determining the compliance status, wherein:
4a) the mitigation action comprises modifying the scheduling data to reassign a second medical sample, compliant with the first analytical test, to the first analytical test.
Claim 1 recites, in part, performing the steps of 1) accessing scheduling data indicating an initial assignment of the medical sample to a first analytical test, 2) determining sample data, associated with the medical sample, based at least in part on: sensor data captured, during transportation of the medical sample, by one or more sensors of a remote agent device used to transport the medical sample, 3) determining, based on the sample data, a compliance status indicating that the medical sample is non-compliant with the first analytical test, by determining at least one of: 3a) that a sample quality metric of the medical sample, indicated by the sample data, violates an analytical test specification of the first analytical test, or 3b) that the medical sample is unprocessable using the first analytical test, and 4) performing prior to the processing of the medical sample in the analytical laboratory, a mitigation action in response to determining the compliance status, wherein: 4a) the mitigation action comprises modifying the scheduling data to reassign a second medical sample, compliant with the first analytical test, to the first analytical test. 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 recites a process of determining what to do with samples. Independent claims 15 and 18 recite similar limitations and are also directed to an abstract idea under the same analysis.
Depending claims 2-6, 9-13, 16-17, and 19-23 include all of the limitations of claims 1, 15, and 18, and therefore likewise incorporate the above described abstract idea. Depending claim 2 adds the additional step of “following modification of the scheduling data, forwarding instructions to a laboratory scheduling system to use the first analytical test to process the second medical sample, according to the modification of the scheduled data, to generate a test result”; claim 10 adds the additional step of “determining, based on the sample data, that the medical sample violates analytical test specifications of all of a plurality of analytical tests available to be performed in the analytical laboratory, wherein the mitigation action comprises modifying the scheduling data to avoid using any of the plurality of analytical tests to process the medical sample in the analytical laboratory”; claim 11 adds the additional step of “requesting a new medical sample to replace the medical sample”; and claim 12 adds the additional step of “modifying the assignment is based in part on the priority ranking”. Additionally, the limitations of depending claims 3-6, 9-10, 13, 16-17, and 19-23 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 2-6, 9-13, 16-17, and 19-23 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 15, and 18 (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 processor (from claim 15), b) memory storing program data that, when executed by the processor, causes the analytical testing management system to perform functions (from claim 15), c) an optimisation module (from claim 15), and d) a compliance module (from claim 15) to perform the claimed steps.
The a) processor, b) memory storing program data that, when executed by the processor, causes the analytical testing management system to perform functions, c) optimisation module, and d) compliance module 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, where the modules are not anything but what may be considered as generic computer 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 processor, b) memory storing program data that, when executed by the processor, causes the analytical testing management system to perform functions, c) an optimisation module, and d) a compliance module to perform the claimed steps amounts to no more than mere instructions to apply the exception using generic computer components 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 determines a compliance status utilizing a) a processor, b) memory storing program data that, when executed by the processor, causes the analytical testing management system to perform functions, c) an optimisation module, and d) a compliance module, thus these computing device 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 1-6, 9-13, and 15-23 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 1-5, 9, 11-12, 15, 18, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0324047 to Depraetere et al. in view of G.B. 2597686 to Yannick.
As per claim 1, Depraetere et al. teaches a computer-implemented method for optimizing an assignment of a medical sample to an analytical test, prior to processing of the medical sample in an analytical laboratory using the analytical test, the method comprising:
--accessing scheduling data indicating an initial assignment of the medical sample to a first analytical test; (see: paragraph [0081] where schedule data is being accessed in the form of assigned test orders) and
--determining, based on the sample data, a compliance status indicating that the medical sample is non-compliant with the first analytical test, (see: paragraphs [0045] and [0114] where there is a determination of a compliance status for a sample based on the sample’s quality) by determining at least one of:
--that a sample quality metric of the medical sample, indicated by the sample data, violates an analytical test specification of the first analytical test, (see: paragraphs [0053] and [0114] where there is a determination that the sample quality is low and violates a test specification of the minimum quality in order to run that first test) or
--that the medical sample is unprocessable using the first analytical test; (see: paragraphs [0053] and [0114] where there is a determination that the sample quality is low and is unprocessable in order to run that first test) and
--performing prior to the processing of the medical sample in the analytical laboratory, a mitigation action in response to determining the compliance status, (see: paragraph [0053] where prior to processing the sample there is the performance of a mitigating action of changing the priority level of a test order in response to determining that the quality is low) wherein:
--the mitigation action comprises modifying the scheduling data to reassign a second medical sample, compliant with the first analytical test, to the first analytical test (see: paragraph [0114] where there is a mitigating action of modifying the data to reassign the low quality sample and then requiring a further sample. The further sample can be a compliant sample if sample quality is not low).
Depraetere et al. may not further, specifically teach:
1) --determining sample data, associated with the medical sample, based at least in part on:
--sensor data captured, during transportation of the medical sample, by one or more sensors of a remote agent device used to transport the medical sample.
Yannick teaches:
1) --determining sample data, associated with the medical sample, (see: paragraph [0010] where there is a determination of sample data) based at least in part on:
--sensor data captured, during transportation of the medical sample, by one or more sensors of a remote agent device used to transport the medical sample (see: paragraph [0010] where there is a determination using sensor data captured during transportation of a sample by a sensor of a remote agent device (the device with the sensor)).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to 1) determine sample data, associated with the medical sample, based at least in part on: sensor data captured, during transportation of the medical sample, by one or more sensors of a remote agent device used to transport the medical sample as taught by Yannick in the method as taught by Depraetere et al. with the motivation(s) of improving medical quality (see: paragraph [0007] of Yannick).
As per claim 2, Depraetere et al. and Yannick in combination teaches the method of claim 1, see discussion of claim 1. Depraetere et al. further teaches following modification of the scheduling data, forwarding instructions to a laboratory scheduling system to use the first analytical test to process the second medical sample, according to the modification of the scheduling data to generate a test result (see: paragraph [0053] where prior to processing the sample there is the performance of a mitigating action of changing the priority level of a test order in response to determining that the quality is low. The modification here involves a forwarding of instructions to a scheduling system where the lower quality ones are being scheduled/prioritized for a later time slot).
As per claim 3, Depraetere et al. and Yannick in combination teaches the method of claim 1, see discussion of claim 1. Depraetere et al. further teaches wherein the mitigation action further comprises at least one of flagging or invalidating a test order that had indicated that the first analytical test was to be used to process the medical sample according to the initial assignment (see: paragraphs [0053] and [0114] where the modification involves removing the assignment of the test with the low quality sample based on the compliance (the quality not meeting a certain level). The mitigation here comprises invalidating a test order via removing it).
As per claim 4, Depraetere et al. and Yannick in combination teaches the method of claim 1, see discussion of claim 1. Yannick further teaches wherein the sensor data, captured by the one or more sensors of the remote agent device, indicates one or more of:
--transport information associated with the transportation of the medical sample within the remote agent device, or
--storage condition information associated with storage of the medical sample within the remote agent device during transportation of the medical sample (see: paragraph [0010] where there is temperature and humidity being tracked during transportation).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 5, Depraetere et al. and Yannick in combination teaches the method of claim 1, see discussion of claim 1. Depraetere et al. further teaches wherein determining the compliance status comprises:
--determining, based on the sample data, the sample quality metric for the medical sample; (see: paragraphs [0045] and [0114] where there is a determination of a compliance status for a sample based on the sample’s quality)
--identifying the analytical test specification for the first analytical test; (does not need to be met as the above limitation was met) and
--performing a compliance process by assessing, for the medical sample, whether the sample quality metric violates the analytical test specification of the first analytical test (does not need to be met as the first limitation was met).
As per claim 9, Depraetere et al. and Yannick in combination teaches the method of claim 1, see discussion of claim 1. Depraetere et al. further teaches determining that the sample quality metric of the medical sample, indicated by the sample data, does not violate a second analytical test specification of the second analytical test (see: paragraphs [0053] and [0114] where there is a determination that the sample quality is low and violates a test specification of the minimum quality in order to run that test/second test. Thus, there is also a determination that the sample quality is not low and does not violate a test).
Additionally, these claim limitations recite limitations similar to claim limitations already stated within claim 1 without adding any other functionalities. Repeating steps that do not add a new and unexpected result has no patentable significance (see: MPEP 2144.04 (VI)(B), Duplication of Parts). Simply repeating steps that were applied to one set of questions and applying those steps to another set of questions produces expected results, and as such, amounts to a mere duplication of parts conferring to no additional patentable weight.
As per claim 11, Depraetere et al. and Yannick in combination teaches the method of claim 1, see discussion of claim 1. Depraetere et al. further teaches requesting a new medical sample to replace the medical sample (see: paragraph [0114] where an alert is generated for a new sample).
As per claim 12, Depraetere et al. and Yannick in combination teaches the method of claim 1, see discussion of claim 1. Depraetere et al. further teaches wherein:
--the scheduling data comprises a priority ranking of analytical tests to be performed on medical samples, (see: paragraphs [0093] – [0094] where there is a priority ranking of the tests) and
--modifying the scheduling data comprises modifying the priority ranking based on reassignment of the second medical sample to the first analytical test (see: paragraphs [0092] – [0093] where there is updating of priority level. Also see: paragraphs [0053] and [0114] where the modification involves removing the assignment of the test with the low quality sample based on the compliance. The modification here is based on the priority levels).
As per claim 15, claim 15 is similar to claim 1 and is rejected in a similar manner to claim 1 using the Depraetere et al. and Yannick references in combination. Depraetere et al. further teaches:
--a processor, (see: paragraph [0132] where there is a processor) and
--memory storing program data that, when executed by the processor, causes the analytical testing management system to perform operations (see: paragraph [0127] where there is a memory).
As per claim 18, claim 18 is similar to claim 1 and is rejected in a similar manner to claim 1 using the Depraetere et al. and Yannick references in combination.
As per claim 21, Depraetere et al. and Yannick in combination teaches the method of claim 1, see discussion of claim 1. Yannick further teaches wherein the sample data is determined based on:
--the sensor data captured by the one or more sensors of the remote agent device, (see: paragraph [0010] where there is a determination using sensor data captured during transportation of a sample by a sensor of a remote agent device (the device with the sensor)) and
--additional data indicating at least one of:
--collection information associated with collection of the medical sample from a patient, or
--centrifugation information associated with centrifugation of the medical sample after the collection of the medical sample and prior to arrival of the medical sample at the analytical laboratory (see: paragraph [0012] where there is such centrifugal information).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 22, Depraetere et al. and Yannick in combination teaches the method of claim 1, see discussion of claim 1. Depraetere et al. further teaches wherein the first analytical test is performed via an in-vitro diagnostic instrument in the analytical laboratory (see: paragraph [0003] where there is in-vitro test, which would include in-vitro test equipment).
As per claim 23, Depraetere et al. and Yannick in combination teaches the method of claim 4, see discussion of claim 4. Yannick further teaches wherein the one or more of the transport information or the storage condition information, indicated by the sensor data captured by the one or more sensors during the transportation of the medical sample within the remote agent device, comprises one or more of a temperature measurement, a humidity measurement, a light exposure measurement, a shock exposure measurement, or a storage duration measurement (see: paragraph [0076] where there is temperature and humidity information inside the package during transport of the sample).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0324047 to Depraetere et al. in view of G.B. 2597686 to Yannick as applied to claim 1, and further in view of U.S. 2014/0122106 to Malven et al.
As per claim 13, Depraetere et al. and Yannick in combination teaches the method of claim 1, see discussion of claim 1. The combination may not further, specifically teach wherein:
--modifying the scheduling data comprises assigning the second medical sample to the first analytical test and at least one additional analytical test.
Malven et al. teaches:
--modifying the scheduling data comprises assigning the second medical sample to the first analytical test and at least one additional analytical test (see: claims 3 and 4 where there is modification of a test panel to add one or more tests).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to modify the scheduling data comprises assigning the second medical sample to the first analytical test and at least one additional analytical test as taught by Malven et al. in the method as taught by Depraetere et al. and Yannick in combination with the motivation(s) of improving the healthcare decision making process (see: paragraph [0108] of Malven et al.).
No Art Rejections
Claims 6, 10, 16, and 19 do not have art in view of the above 112 rejections. Claims 17 and 20 also do not have
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