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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-26 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.
In re claim 1, the limitation, “displays presence of the condition” is unclear, specifically because there is no recited step of determining the presence of a condition. Additionally, the limitation “wherein the microprocessor is in electronic communication with a computing device that displays presence of the condition” is unclear in regards to whether the microprocessor or the computing device performs the detection of the condition. For examination purposes, the microprocessor is interpreted as performing the detection of the condition.
In re claim 10, see in re claim 1 above.
In re claim 11, the limitation “the audio tone” lacks antecedent basis.
In re claim 25, see in re claim 1 above.
In re claim 26, see in re claim 1 above.
Appropriate correction is required.
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 1-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1:
Independent claims 1, 10, 25, and 26 are directed to a system, method, kit, and system for detecting the presence of a condition in a subject, respectively. Thus, they are directed to statutory categories of invention.
Step 2A, Prong 1:
Claims 1, 10, 25, and 26 recite the following claim limitations which are directed to abstract ideas, specifically mental processes (see MPEP § 2106.04(a)(2)):
In re claim 1: “detecting a condition in a subject” (mental process – person must detect condition in a subject)
In re claim 10, see above and the following limitations:
“detecting presence of at least one biomarker” (mental process – doctor can detect the presence of a biomarker)
“monitoring the at least one biomarker” (mental process – doctor can monitor the biomarker)
“predicting an onset of a condition based on the at least one biomarker” (mental process – doctor can predict the onset of a condition based on the biomarker)
In re claim 25, see above.
In re claim 26, see above and the following limitations:
“knowledge of the at least one factor is used to recommend a course of action” (mental process – doctor may verbally or via pen and paper recommend a course of action such as a treatment)
“The at least one neural network accepts the data, and a collection of output data of the at least one neural network is used to predict the condition” (mental process – neural network is known to mimic human behavior such as organizing and analyzing data, which in this case, would be used to predict the condition).
These limitations, under their broadest reasonable interpretation, cover concepts that can be practically performed in the human mind, i.e., using pen and paper.
Therefore, the claim limitations fall within the 'mental processes' grouping of abstract ideas.
Step 2A, Prong 2:
Claims 1, 10, and 25-26 recite the following additional elements:
In re claim 1, “a patch further comprising:
at least one hollow microneedle;
an assay compartment in fluid communication with the at least one hollow microneedle;
a microprocessor that controls collection rate of a fluid from the subject via the at least one hollow microneedle,
wherein the microprocessor is in electronic communication with a computing device that displays presence of the condition”.
In re claim 10, see above and the following limitations:
“affixing the patch to the subject so that the at least one hollow microneedle accesses a fluid;
drawing the fluid through the at least one hollow microneedle”.
In re claim 25, see above and the following limitation, “instructions for use”.
In re claim 26, see above and the following limitations:
“circuitry that creates an audio tone based on assay data and a cap that ensures integrity of the system…,
with the condition being at least one of acute myocardial infarction, infectious diseases, biological poisons, radiation, tropical diseases, and COVID-19;
wherein the at least one hollow microneedle draws fluid from the subject to … by way of at least one of an osmotic gradient, a pumping mechanism, vacuum, capillary action, surface tension, microfluidics, nanofluidics, and tubing;
the at least one hollow microneedle draws fluid from the subject at least one of continuously and intermittently; data associated with the fluid is transferred from the microprocessor to the computing device;
the at least one hollow microneedle gains access to the fluid by at least one of subcutaneously, percutaneously, dermally, sub- dermally, intra-peritoneally, and peritoneally;
the at least one biomarker is detected at least one of before the condition, during the condition, and after the condition;
the assay compartment prevents backflow into the subject;
the assay compartment comprises at least one reagent chamber, at least one detection chamber and at least one waste chamber; and
an adhesive affixes the patch to the subject”.
The following limitations:
a patch further comprising:
at least one hollow microneedle;
an assay compartment in fluid communication with the at least one hollow microneedle;
a microprocessor that controls collection rate of a fluid from the subject via the at least one hollow microneedle;
affixing the patch to the subject so that the at least one hollow microneedle accesses a fluid;
drawing the fluid through the at least one hollow microneedle;
circuitry that creates an audio tone based on assay data and a cap that ensures integrity of the system…, with the condition being at least one of acute myocardial infarction, infectious diseases, biological poisons, radiation, tropical diseases, and COVID-19;
wherein the at least one hollow microneedle draws fluid from the subject to … by way of at least one of an osmotic gradient, a pumping mechanism, vacuum, capillary action, surface tension, microfluidics, nanofluidics, and tubing;
the at least one hollow microneedle draws fluid from the subject at least one of continuously and intermittently; data associated with the fluid is transferred from the microprocessor to the computing device;
the at least one hollow microneedle gains access to the fluid by at least one of subcutaneously, percutaneously, dermally, sub- dermally, intra-peritoneally, and peritoneally;
the at least one biomarker is detected at least one of before the condition, during the condition, and after the condition;
the assay compartment prevents backflow into the subject;
the assay compartment comprises at least one reagent chamber, at least one detection chamber and at least one waste chamber; and
an adhesive affixes the patch to the subject,
are pre-solution activities (see MPEP 2106.05(g)), because they’re used to obtain additional information used to detect or predict a condition in a subject.
Additionally, regarding the limitations “wherein the microprocessor is in electronic communication with a computing device that displays presence of the condition”, Examiner asserts that these limitations are directed to additional elements, specifically insignificant post solution activity (see MPEP 2106.05(g)).
The above recited limitations merely process information and then output the results of the above identified abstract ideas. Additionally, the recited “display” is neither particular enough to meaningfully limit the recited exception nor does it have more than a nominal relationship to the exception. In other words, the breadth of the recited “display” is such that it substantially encompasses all applications of the recited exception (such as moving information around to display presence of the condition).
There is nothing in the claims which show how displaying the above recited limitations integrates the judicial exception into a practical application.
Further, there is no evidence of record that would support the assertion that this step is an improvement to a computer or a technological solution to a technological problem.
Additionally, the above recited claims’ recitation of a microprocessor and a computing device as well as instructions for use are merely reciting the computer components at a high-level of generality. In other words, the computer components are being used as a tool to carry out the system’s functions (See MPEP 2106.05(f)).
Thus, the abstract idea is not integrated into a practical application. The combination of these additional elements is no more than insignificant extra solution activity, and generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than insignificant extra solution activity and generic computer components.
The same analysis applies here in 2B and does not provide an inventive concept.
Therefore, none of the claims 1-26 amount to significantly more than the abstract idea itself. Accordingly, claims 1-26 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 8-10, 12-14, 18-20, 23, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Delamarche et al. (US 2018/0103884).
In re claim 1, Delamarche discloses a system [0007-0009] for detecting a condition in a subject [0006], the system comprising:
a patch (fig. 3: 300) further comprising:
at least one hollow microneedle (314; [0058]: sample pump 318 forces sample fluid through microneedle 314, which means microneedle 314 must be hollow at one point to allow the sample fluid to enter);
an assay compartment (combination of analysis module 304 and fluid conduit 342; [0083]) in fluid communication with the at least one hollow microneedle ([0083]: analysis module 304, which includes fluid conduit 342, is in fluid communication with sample chamber 322 and a plurality of sensors 340, which may include an electrochemical assay sensor);
a microprocessor (376; [0085]) that controls collection rate of a fluid from the subject via the at least one hollow microneedle ([0072]: 376 regulates flow of the sample fluid from the microneedles 314 to the sensors 340; [0088]: microprocessor comprises of instructions for use);
wherein the microprocessor is in electronic communication with a computing device ([0072]: 376 is in wireless communication with cloud computing node 10, which may be a smart phone) that displays presence of the condition ([0079]: cloud computing node 10 displays a diagnostic alert; [0087-0088]: communicating sensor readings to the cloud computing node would display the presence of the condition).
In re claim 2, Delamarche discloses wherein the at least one hollow microneedle draws fluid from the subject ([0058]: 314 obtains sample fluid) to monitor the at least one biomarker ([0016]: biomarkers in sample fluid are used for disease diagnosis; [0068, 0088]) by way of at least one of
an osmotic gradient,
a pumping mechanism ([0058-0059]: sample pump 318 consists of a pumping mechanism ),
vacuum ([0058]: 318 may be a vacuum),
capillary action,
surface tension,
microfluidics,
nanofluidics, and
tubing.
In re claim 3, Delamarche discloses wherein the at least one hollow microneedle draws fluid from a subject (see above) at least one of continuously [0077] and intermittently ([0077]: 300 may be for discrete monitoring or single use).
In re claim 4, Delamarche discloses wherein data associated with the fluid is transferred from the microprocessor to the computing device ([0088]: data from sample fluid is communicated to the cloud computing node).
In re claim 8, Delamarche discloses wherein the at least one hollow microneedle gains access to the fluid by at least one of
subcutaneously ([0005]: beneath the skin),
percutaneously ([0005]: penetrating into the skin; [0008, 0057]),
dermally,
sub-dermally,
intra-peritoneally, and
peritoneally.
In re claim 9, Delamarche discloses wherein the at least one biomarker is detected at least one of
before the condition,
during the condition ([0078]: cancer biomarkers are used for cancer diagnostic i.e. during the condition; [0076]: biomarkers of infection would be during the condition), and
after the condition [0091].
In re claim 10, Delamarche discloses a method [0006] of predicting a condition in a subject ([0076]: sensor readings used to predict presence of synovial cavity infection),
Regarding the limitations, “the method comprising:
providing a system for detecting a condition in a subject, the system comprising a patch further comprising:
at least one hollow microneedle;
an assay compartment in fluid communication with the at least one hollow microneedle;
a microprocessor that controls collection rate of a fluid from the subject via the at least one hollow microneedle;
wherein the microprocessor is in electronic communication with a computing device that displays presence of the condition”,
see in re claim 1 above.
Regarding the limitations,
“affixing the patch to the subject so that the at least one hollow microneedle accesses a fluid;
drawing the fluid through the at least one hollow microneedle;
detecting presence of at least one biomarker;
monitoring the at least one biomarker; and
predicting an onset of a condition based on the at least one biomarker”,
Delamarche discloses
affixing the patch to the subject so that the at least one hollow microneedle accesses a fluid ([0057]: layer 310 provides adhesion to affix the patch to the patient and would allow the microneedle to access fluid);
drawing the fluid through the at least one hollow microneedle ([0058]: sample pump 318 forces sample fluid through microneedle 314);
detecting presence of at least one biomarker ([0068]: sensors detect biomarkers);
monitoring the at least one biomarker ([0071]: sensor data used for real-time monitoring; [0068]: sensing biomarkers means they’re being monitored); and
predicting an onset of a condition based on the at least one biomarker ([0076]: biomarker of infection are used to generate a diagnostic alert for presence of synovial cavity infection).
In re claim 12, regarding the limitation, “wherein at least one hollow microneedle draws fluid from the subject to detect the presence of at least one biomarker by way of at least one of
an osmotic gradient,
a pumping mechanism,
vacuum, capillary action,
surface tension,
microfluidics,
nanofluidics, and
tubing”,
see in re claim 2 above.
In re claim 13, regarding the limitation, “wherein the at least one hollow microneedle draws fluid from the subject at least one of continuously and intermittently”, see in re claim 3 above.
In re claim 14, regarding the limitation, “wherein data associated with the fluid is transferred from the microprocessor to the computing device”, see in re claim 4 above.
In re claim 18, regarding the limitation, “wherein the at least one hollow microneedle gains access to the fluid by at least one of percutaneously, dermally, sub-dermally, intra-peritoneally, and peritoneally”, see in re claim 8 above.
In re claim 19, regarding the limitation, “wherein the at least one biomarker is detected at least one of before the condition, during the condition, and after the condition”, see in re claim 9 above.
In re claim 20, Delamarche discloses wherein a threshold [0071] associated with the at least one biomarker ([0071]: threshold values of sensor data; [0068]: sensors detect biomarkers) determines whether treatment is necessary ([0071]: threshold used to indicate risk, indicating that some treatment is necessary by triggering an alert to a caregiver).
In re claim 23, Delamarche discloses wherein an adhesive (310; [0057]) affixes the patch to the subject ([0057]: layer 310 would affix the patch to the patient).
In re claim 25, Delamarche discloses a kit ([0077-0079]: combination of 300 and computing node 10 is a kit; [0080]: 10 may be a smart phone) comprising at least one patch (300).
Regarding the limitations,
“the at least one patch comprising at least one hollow microneedle;
an assay compartment in fluid communication with the at least one hollow microneedle;
a microprocessor that controls collection rate of a fluid from the subject via the at least one hollow microneedle;
wherein the microprocessor is in electronic communication with a computing device that displays presence of a condition; and
instructions for use”,
see in re claim 1 above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-7 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Delamarche et al. (US 2018/0103884) in view of Gumbo et al. (WO 2020/167899).
In re claim 5, Delamarche discloses wherein at least one factor ([0076]: sensor readings) is used to predict an onset of the condition ([0076]: sensor readings used to predict presence of synovial cavity infection).
Delamarche fails to disclose with the at least one factor being time to peak of biomarker levels.
Gumbo teaches an analogous method of diagnoses and treatment [0002], and teaches
wherein at least one factor ([0075]: factor is treatment response prediction result based on a kill rate) is used to predict an onset of the condition ([0085]: methods use biomarkers for early decision-making during TB treatment, therefore, the kill rate and biomarkers will be used to predict the onset of the condition [0075]),
with the at least one factor being time to peak of biomarker levels ([0085]: the peak of biomarker levels is when the biomarkers are enough to detect tuberculosis), and
wherein knowledge of the at least one factor is used to recommend a course of action ([0075]: treatment recommendation is made based on the treatment prediction result).
Gumbo further teaches that different treatment response prediction results may be used to select a specific treatment regimen [0075], which is useful in cases where a relapse is expected [0075] and also for early decision-making [0085].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system for detecting a condition in a subject taught by Delamarche, to provide at least one factor being time to peak of biomarker levels, as taught by Gumbo, because a factor may be used to select a specific treatment regimen which is useful in cases where a relapse is expected and also for early decision-making.
In re claim 6, regarding the limitation, “wherein knowledge of the at least one factor is used to recommend a course of action”, see the proposed combination yielded in re claim 5 above.
In re claim 7, Delamarche fails to disclose wherein
at least one neural network accepts the data, and
a collection of output data of the at least one neural network is used to predict the condition.
Gumbo teaches wherein
at least one neural network ([0101]: classification regression trees is a neural network) accepts the data ([0101]: data is used as input to make predictions of outcomes), and
a collection of output data of the at least one neural network is used to predict the condition ([0101]: output data used to predict the outcomes of tuberculosis).
Gumbo further teaches that the machine learning method is used to make predictions of the disease outcome [0101], such as a successful therapy outcome [0101] or a failure of treatment [0101].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system for detecting a condition in a subject taught by Delamarche, to provide wherein at least one neural network accepts the data, and a collection of output data of the at least one neural network is used to predict the condition, as taught by Gumbo, because the neural network may be used to make predictions of the disease outcome, such as a successful therapy outcome or a failure of the treatment.
In re claim 15, regarding the limitation, “wherein at least one factor is used to predict an onset of the condition, with the at least one factor being time to peak of biomarker levels”, see in re claim 5 above.
In re claim 16, regarding the limitation, “wherein knowledge of the at least one factor is used to recommend a course of action”, see the proposed combination yielded in re claim 5 above.
In re claim 17, regarding the limitation, “wherein at least one neural network accepts the data, and a collection of output data of the at least one neural network is used to predict the condition”, see in re claim 7 above.
Claims 11 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Delamarche et al. (US 2018/0103884) in view of Fu et al. (US 2017/0311807).
In re claim 11, Delamarche fails to disclose wherein the audio tone serves to indicate at least one of
an initiation of an assay,
a completion of an assay,
results of the assay being sent to the computing device, and
a warning for the presence of a condition.
Fu teaches detecting biomarkers [0002] comprising of an assay ([0034]: biomarker detection material 130 includes an assay for detection of biomarkers), wherein an audio tone ([0059]: audible indication; [0074]) serves to indicate at least one of
an initiation of an assay,
a completion of the assay,
results of the assay being sent to a computing device, and
a warning for a presence of a condition ([0106]: audible warning when biomarker detection signal is indicative of a development of a pressure ulcer).
Fu further teaches that the notification of a characteristic of the detected biomarker [0074] may be provided as either a visual or an audible output [0074], and is used to indicate the development of a condition [0106].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for detecting a condition in a subject taught by Delamarche, to provide wherein the audio tone serves to indicate at least one of an initiation of an assay, a completion of an assay, results of the assay being sent to the computing device, and a warning for the presence of a condition, as taught by Fu, because the audio tone serves a characteristic of the detected biomarker and is used to indicate the development of a condition.
In re claim 24, regarding the limitation, “further comprising circuitry that creates an audio tone based on assay data and a cap that ensures integrity of the system”, see the proposed combination yielded in re claim 11 above.
Regarding the limitations, “optionally at least one neural network that trains the system to better predict the condition, with the condition being at least one of acute myocardial infarction, infectious diseases, biological poisons, radiation, tropical diseases, and COVID-19”, Examiner notes that these limitations are directed toward optional limitations.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Delamarche et al. (US 2018/0103884) in view of Bernstein et al. (US 2015/0313522).
In re claim 21, Delamarche fails to disclose wherein the assay compartment prevents backflow into the subject.
Bernstein teaches a method of sensing [0003] and responding to conditions [0003], and teaches wherein an assay compartment prevents backflow into a subject ([0112]: check valve 88 is used to prevent backflow from one compartment to another; [0004]: fluid withdrawn from a subject).
Bernstein further teaches that preventing backflow allows the fluid to flow in one direction [0112].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system for detecting a condition in a subject taught by Delamarche, to provide wherein the assay compartment prevents backflow into the subject, as taught by Bernstein, because preventing backflow allows the fluid to flow in one direction.
In re claim 22, the proposed combination (all mapping directed to Delamarche unless otherwise stated) yields wherein the assay compartment comprises
at least one reagent chamber (324; [0059]),
at least one detection chamber ([0066]: each fluid conduit 342 may include a sample sub-chamber 346 which is connected to at least one sensor 340 which are used for detection [0068]), and
at least one waste chamber ([0077]: microfluidic channels may be flushed and are therefore considered as waste chambers).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Delamarche et al. (US 2018/0103884) in view of Fu et al. (US 2017/0311807) in view of Gumbo et al. (WO 2020/167899) in view of Bernstein et al. (US 2015/0313522).
In re claim 26, regarding the limitation, “a system for detecting a condition in a subject,
the system comprising a patch further comprising:
at least one hollow microneedle;
an assay compartment in fluid communication with the at least one hollow microneedle;
a microprocessor that controls collection rate of a fluid from the subject via the at least one hollow microneedle;
wherein the microprocessor is in electronic communication with a computing device that displays presence of the condition”, see in re claim 1 above.
Regarding the limitation, “instructions for use”, see in re claim 25 above.
Regarding the limitation,
“circuitry that creates an audio tone based on assay data and a cap that ensures integrity of the system; and
optionally at least one neural network that trains the system to better predict the condition, with the condition being at least one of
acute myocardial infarction,
infectious diseases,
biological poisons,
radiation,
tropical diseases, and
COVID-19”,
see in re claim 24 above, where it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system for detecting a condition in a subject taught by Delamarche, to provide circuitry that creates an audio tone based on assay data and a cap that ensures integrity of the system, as taught by Fu, for substantially the same reasons as discussed above.
Regarding the limitation, “wherein the at least one hollow microneedle draws fluid from the subject to monitor presence of at least one biomarker by way of at least one of an
osmotic gradient,
a pumping mechanism,
vacuum,
capillary action,
surface tension,
microfluidics,
nanofluidics, and
tubing”,
see in re claim 2 above.
Regarding the limitation, “the at least one hollow microneedle draws fluid from the subject at least one of continuously and intermittently”, see in re claim 3 above.
Regarding the limitation, “data associated with the fluid is transferred from the microprocessor to the computing device”, see in re claim 4 above.
Regarding the limitation, “at least one factor is used to predict an onset of the condition, with the at least one factor being time to peak of biomarker levels”, see in re claim 5 above, where it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system for detecting a condition in a subject yielded by the proposed combination, to provide at least one factor is used to predict an onset of the condition, with the at least one factor being time to peak of biomarker levels, as taught by Gumbo, for substantially the same reasons as discussed above.
Regarding the limitation, “knowledge of the at least one factor is used to recommend a course of action”, see in re claim 6 above.
Regarding the limitation, “the at least one neural network accepts the data, and a collection of output data of the at least one neural network is used to predict the condition”, see in re claim 7 above, where it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system for detecting a condition in a subject yielded by the proposed combination, to provide wherein the at least one neural network accepts the data, and a collection of output data of the at least one neural network is used to predict the condition, as taught by Gumbo, for substantially the same reasons as discussed above.
Regarding the limitation, “the at least one hollow microneedle gains access to the fluid by at least one of
subcutaneously,
percutaneously,
dermally,
sub- dermally,
intra-peritoneally, and
peritoneally”,
see in re claim 8 above.
Regarding the limitation, “the at least one biomarker is detected at least one of
before the condition,
during the condition, and
after the condition”,
see in re claim 9 above.
Regarding the limitation, “the assay compartment prevents backflow into the subject”, see in re claim 21 above, where it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system for detecting a condition in a subject yielded by the proposed combination, to provide wherein the assay compartment prevents backflow into the subject, as taught by Bernstein, for substantially the same reasons as discussed above.
Regarding the limitation, “the assay compartment comprises
at least one reagent chamber,
at least one detection chamber and
at least one waste chamber”,
see in re claim 22 above.
Regarding the limitation, “an adhesive affixes the patch to the subject”, see in re claim 23 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Giusti (US 2019/0147989) discloses using biomarkers [0012] to detect disease initiation [0012] and treatment progression [0012] through fine needle aspiration [0099].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796