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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 16, 2026 has been entered.
Status of Claims / Response to Amendment
This office action is in response to an amendment filed on March 16, 2026.
Claims 1, 4-19, 22-23 and 31-33 were previously pending. Applicant Amended claims 1 and 32; cancelled claim 11.
Claims 1, 4-10, 12-19, 22-23 and 31-33 are currently pending, with claims 6, 8-9, 12, 16-19, 22 withdrawn.
Claims 1, 4-5, 7, 10, 13-15, 23 and 31-33 are under consideration.
All of the previously presented rejections have been withdrawn as being obviated by the amendment of the claims, which added new limitations to the claims, that were not considered in the previous rejections.
Applicant' s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
This office action contains new grounds for rejection necessitated by amendment.
Priority
The priority date of the instant claims 1, 4-5, 7, 10, 13-15, 23 and 31-33 is 11/20/2020, filling date of the US provisional application NO. 63/116,725.
Claim Objections
Claim 31 is objected to because of the following informalities:
In claim 31, "a physician" should read "the physician" to properly refer back to the earlier recitation of "a physician" in base claim 1.
Claim Interpretation
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP§ 2111.
For the purpose of applying prior art, claim 1 recites the term "unmanned autonomous vehicle," which is described by the application's disclosure as follows:
"[0083] The term “unmanned autonomous vehicle” (or “UAV”) is used herein to refer to one of various types of autonomous vehicles (e.g., autonomous aircraft, land vehicles, waterborne vehicles, or a combination thereof) that may not utilize onboard, human pilots. "
"[0219] An individual is interested in learning if he or she has the presence of blood in their stool. From their home, they access a website or use an application on their smart device to request an iFOB test kit to be delivered to their home. The test kit is delivered via an unmanned aerial vehicle (UAV) colloquially referred to as a drone, for example an FAA certified drone to handle medical tissue, such as those described by Matternet, Amazon, or the UPS Flight Forward™ programs."
Therefore, under BRI the term "unmanned autonomous vehicle" is interpreted to encompass any autonomous vehicle, such as a drone.
For the purpose of applying prior art, claim 1 recites "generating a report." The application's disclosure does not define the term "report." The specification provides the following relevant description regarding "report":
"[0157] In some embodiments, the method further includes providing a report to the subject, a healthy agency, a physician, or other health care professional, wherein the report includes the results from examining the sample."
Therefore, under BRI and in light of the specification, the term "report" is interpreted to encompass any format capable of including results, such as a paper report, an electronic message, an oral report, or a voice recording.
For the purpose of applying priori art, claim 1 recites "identifying whether a disease is present in the biological sample."
Under BRI, a skilled artisan would naturally understand that a biological sample itself cannot be sick or have a disease. Therefore, this limitation is interpreted as identifying whether the biological sample is obtained from an individual having a disease, encompassing identifying disease-related biomarkers in the biological sample and determining the risk or likelihood of the individual having a disease.
Claim Rejections - 35 USC § 103 -- New
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1, 4-5, 7, 10, 13-15, 23 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over P23Labs (P23 LABs COVID-19 SELF-COLLECTION KIT INSTRUCTIONS FOR PATIENTS; Archived June 15, 2020 on WaybackMachine), as evidenced by P23Labs EUA (EMERGENCY USE AUTHORIZATION (EUA) SUMMARY P23 LABS TAQPATH SARS-COV-2 ASSAY(P23 Labs); Archived June 13, 2020 on WaybackMachine);
in view of
Alabama (ADOR, MorphoTrust® USA Launch First eID in Alabama; www.revenue.alabama.gov; April 11, 2017);
Cho (Why AAMVA Verification is not a foolproof ID Authentication method; October 20, 2015;blog.fraudfighter.com );
Plebani (Plebani et al., The Brain-to-Brain Loop Concept for Laboratory Testing 40 Years After Its Introduction, American Journal of Clinical Pathology, Volume 136, Issue 6, December 2011, Pages 829–833, https://doi.org/10.1309/AJCPR28HWHSSDNON);
Balogh (Balogh EP, Miller BT, Ball JR, editors. Improving Diagnosis in Health Care. Washington (DC): National Academies Press (US); 2015 Dec 29. 2, The Diagnostic Process. Available from: https://www.ncbi.nlm.nih.gov/books/NBK338593/);
Sampsel (WO2021247734A1 - Care delivery telehealth drone; effective filing date June 02, 2020);
Patel (US20160144358A1 - Dynamic Lab on a Chip Based Point-Of-Care Device For Analysis of Pluripotent Stem Cells, Tumor Cells, Drug Metabolites, Immunological Response, Glucose Monitoring, Hospital Based Infectious Diseases, and Drone Delivery Point-of-Care Systems ; Published on: 2016-05-26); and
Werobotics ("How Delivery Drones Are Being Used to Tackle COVID-19 (Updated)"; werobotics.org; Published April 25th, 2020; werobotics.org/blog/cargo-drones-covid-19).
A) The subject matter of claim 1 reflects an obvious combination of two known concepts: at-home sample collection for laboratory testing with identity verification, and transportation by a delivery drone.
P23Labs teaches instructions for use of a COVID-19 self-collection kit for an in vitro diagnostic(IVD) test (see P23Labs EUA, describing the same assay in more detail) performed in a CLIA lab. The collection kit is delivered to the patient with an identity verification step, the patient performs sample collection and sends the specimen to P23 Labs for testing.
Regarding claim 1, P23Labs as evidenced by P23Labs EUA teaches the limitations comprising:
(i) requesting delivery of a collection device using a computing device (page 1, step 1b);
(ii) providing the collection device to the subject and verifying the identity of the subject (Step 2, Authenticate your order; Step 3),
(iii) obtaining the biological sample from the subject and depositing the biological sample in the collection device (page 2, specimen collection);
(iv) delivering the collection device to an examination center (page 2, Step 4, Specimen shipping);
(v) examining the biological sample and generating a report (P23Labs EUA, page 1, para 5, “Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities”; Table 4); and
(vi) identifying whether a disease is present in the biological sample (P23Labs EUA, page 1, para 5; page 15, test is used for in vitro diagnostics for diagnosis of COVID-19) ; and
(vii) detecting a disease in the subject when a biomarker associated with the disease is identified in the biological sample (Table 4; page 1, para 5, “Results are for the detection and identification of SARS-CoV-2 RNA.”).
Regarding "verifying the identity of the subject," P23Labs teaches identity verification step that requires the subject's driver license photo. While P23Labs does not teach the details on how the driver license photo is used for identity verification, identity verification process including comparing driver license information to a trusted database with pre-collected information is well-known in the art.
Alabama (page 2, lines 3-7) teaches verifying users' identity by comparing a photo of driver license and compare it against the data and photo on record in the driver’s license database to ensure only the rightful identity holder is able to obtain an eID.
Cho (page 2, para 2, "What is AAMVA verification?") teaches a method verifying an individual’s identity in which the individual’s data from driver’s license is compared with known data in a database in order to ensure that the identity as depicted on the card/license is real.
Accordingly, a person of ordinary skill in the art would have found it obvious to compare the driver license information provided by the subject with an existing database in order to authenticate the subject's identity and ensure that the only rightful identity holder is able to access a test prescribed to that identity holder. Thus, the limitations "wherein verifying comprises receiving, from the computing device, authenticating information and comparing the authenticating information to pre-collected authenticating information, wherein a match between the authenticating information and the pre-collected authenticating information verifies the identity of the subject" are met. This comparing step would have been obvious as it represents the KSR principle of predictable use of prior art elements (i.e. identity verification by comparing driver license information to a pre-existing database) according to a known method (i.e., identity verification in P23Labs's COVID IVD method) to yield predictable results. (See MPEP §2143).
Regarding the limitation "wherein identifying comprises reviewing the report by a physician," although not explicitly taught by P23Labs, this limitation is obvious within the context of clinical lab testing, because having a physician reviewing clinical lab testing report is well-known, common practice in the field of laboratory testing, as supported by the common knowledge in the prior art.
Plebani (see Figure 1) provides a review for the "brain-to-brain loop" concept for Laboratory testing, in which the physician who orders the test is also responsible for reviewing and interpretating the test result, prior to communicating to the patient.
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Balogh is a diagnosis textbook that highlights the general usefulness of the brain-to-brain loop model for diagnostic testing (page 40, para 1).
Accordingly, a skilled artisan would have readily understood that having a physician review a laboratory test report is an obvious step in the clinical laboratory testing, as disclosed in P23Labs. Incorporating this step into P23Labs's IVD method merely applies a known approach to a known method to yield predictable results.
Regarding the limitations reciting "an unmanned autonomous vehicle," although P23Labs does not explicitly teach transporting sample collection kit using an unmanned autonomous vehicle, this feature is obvious as using unmanned autonomous vehicle, such as drones for the transport of medical supplies and biosamples is well-known in the art.
Sampsel teaches there is a need for a remote device that allows health care providers to assess patients and collect samples for evaluation ([0005]) and specifically teaches using drone to transport specimen collection devices (Abstract), such as covid-19 test kit (page 9, line 4).
Patel teaches drone delivery embodiment in which the device navigates to a remote location, then collect the necessary sample, and navigate to a nearby hospital for analysis ([0137]).
As reported by Werobotics, delivery drones were being used to tackle COVID-19 all around the globe before the effective filling date of this present application. Specifically in Ghana, Werobotics teaches delivery drones are used for sample collection and delivery, which is “shaving hours and even days off the time it takes to get a COVID-19 test from suspected rural victim to urban laboratory with the help of delivery drones ." (page 5-6).
Therefore, It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply delivery drones as means for transportation, for delivering P23Labs’ sample collection kit to the subject and then transporting the collected sample to a testing lab.
A skilled artisan would have been motivated to perform this modification, because the advantages of drone delivery especially in the context of providing timely testing access to those who are in remote area is clear, as discussed in the prior art above.
There is reasonable expectation of success because using delivery drones to deliver medical supplies and biosamples for lab testing is a well-known practice, as supported by Sampsel, Patel and Werobotics. Thus a skilled artisan would have sufficient knowledge and skill to apply this modification.
B) Regarding claim 4, P23Labs as evidenced by P23Labs EUA teaches COVID-19 ( P23Labs EUA, page 1, intended use), which is an infectious disease.
Regarding claim 5, P23Labs teaches wherein providing the collection device to a subject is responsive to a request for delivery from a physician (page 1, step 1).
Regarding claim 7, P23Labs as evidenced by P23Labs EUA teaches detecting a biomarker in the biological sample (P23Labs EUA, page 2, para 2, RNA from SARS-CoV-2).
Regarding claim 10, P23Labs as evidenced by P23Labs EUA teaches performing a nucleic acid assay, wherein the nucleic acid assay comprises contacting at least one primer complementary to a portion of a nucleic acid within the biological sample (P23Labs EUA, page 6, 2 Analytical Specificity: “the primers and probes were mapped to 185 complete SARS-CoV-2 genomes that were available in the GenBank and GISAID (Global Initiative on Sharing All Influenza Data) databases as of March 5, 2020. For all primers and probes, there was 100% homology to each of the SARS-CoV-2 sequences analyzed”).
Regarding claim 13, P23Labs EUA teaches CLIA-certified laboratory (page 1, para 1).
Regarding claim 14, P23Labs teaches saliva (page 1, saliva collection tube; page 2, species collection).
Regarding claim 15, P23Labs teaches a device configured to collect and store a bodily fluid (page 1, saliva collection tube).
Regarding claim 23, Werobotics teaches unmanned aerial vehicle (see picture in page 1, for example).
Regarding claim 31, Balogh teaches providing report to physician and the subject (page 40, para 2, lines 12-14: “The post-analytic phase includes the generation of results, reporting, interpretation, and follow-up. Ensuring accurate and timely reporting from the laboratory to the ordering clinician and patient is central to this phase.”)
Regarding claim 32, Balogh teaches communicating a therapy or treatment option to the subject based on the identification of the disease in the biological sample in response to the detecting of the disease in the subject (page 40, para 1, line 6, clinical action; para 2, lines 14-24, as Balogh discusses a failure by the clinician is not providing treatment consistent with the test result, a skilled artisan would have readily understood that in a successful post-post-analytic phase, the clinician provides appropriate treatment options to patients, essentially by communicating such treatment options to patients first).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over P23Labs as evidenced by P23Labs EUA, in view of Alabama, Cho, Plebani, Balogh, Sampsel, Patel, with Werobotics, as applied to claims 32 and 1 above and further in view of FDA (Coronavirus (COVID-19) Update: FDA Issues EmergencyUse Authorization for Potential COVID-19 Treatment; May 01, 2020)
The teachings of P23Labs, in view of Alabama, Cho, Plebani, Balogh, Sampsel, Patel, with Werobotics are recited above and applied as for base claims 1 and 32.
Regarding claim 33, P23Labs teaches a COVID-19 in vitro diagnostic test (see P23Labs EUA, page 1). And Balogh teaches that a physician considers a subject's diagnosis and potential treatment in view of the test results (page 40, para 1, line 6, clinical action; para 2, lines 14-2). A skilled artisan would have readily understood that communicating treatment options to the subject is an obvious, and necessary step before providing treatment.
Although the combined teachings do not expressly identify a specific treatment option, such as a drug, this feature would have been obvious in view of the context of the combined references and the knowledge in the art. A skilled artisan would have understood that, when a subject is diagnosed with a disease, the physician would discuss available treatment options with the subject. In many cases, such treatment options include a drug.
In the specific context of COVID-19 diagnosis, drug products for treating laboratory confirmed COVID-19 were available, as disclosed in FDA (page 1, para 1). Accordingly, a skilled artisan would have found it obvious that the treatment option for COVID-19 include a drug.
This combination would have been obvious as it represents the KSR principle of predictable use of prior art element according to a known method to yield predictable results. (See MPEP §2143).
Prior Art
Below are relevant prior art not used in rejection but pertinent to the claims or disclosure.
LIEPOLD (US20190015031A1 - Fluid sampling apparatus and method; published 2019-01-17) teaches identity verification in at-home blood sample collection ([0017]; [0102];[0106]).
Conclusion
Claim 31 is objected to; claims 1, 4-5, 7, 10, 13-15, 23 and 31-33 are rejected. No claims are allowed.
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/TIAN NMN YU/Examiner , Art Unit 1681
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