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 .
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Response to Arguments
Applicant’s arguments with respect to the rejection under 35 U.S.C. 101 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103.
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 (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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 5-11, and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gokcebay et al. (US 2020/0349796 A1) in view of Tu et al. (US 2021/0285977 A1).
Regarding claim 1, Gokcebay discloses a biologic test system (BTS), comprising:
a kiosk (Paragraph [0032]), comprising:
a user interface (Paragraph [0033]);
a locker (Paragraph [0032]);
wherein at least one of (1) the locker comprises a lock configured to selectively remain locked for a predetermined period of time, (2) the locker comprises a power source configured to provide power, and (3) the locker comprises a disinfecting light configured to emit light into the locker (Paragraphs [0075]: each locker 18 can further include a UV lamp [0076]: the UV lamp 246 emits UV-C light waves and is a sterilizing lamp. This form of lamp is useful for destroying the ability of bacteria, viruses, and other pathogens to reproduce).
Gokcebay discloses the limitations above. Gokcebay does not explicitly disclose:
a dispensing system.
Tu teaches:
a dispensing system (Paragraph [0188]: Based upon the test order number/reservation number, the kiosk may dispense the appropriate self-testing kit(s) 301 to the patient through the self-testing kit dispensing port).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gokcebay to disclose a dispensing system as taught by Tu. Gokcebay discloses a modular system of locker banks for receipt and delivery where each locker includes a lock and a light (Gokcebay Abstract). Using the automated medical diagnostic system and method of Tu would facilitate testing of samples for biomarkers indicative of a medical condition (Tu Paragraph [0011]).
Regarding claim 5, Gokcebay does not explicitly disclose the BTS of claim 1, wherein the dispensing system is configured to accommodate a vertical stack of test kits and wherein the dispensing system is configured to dispense a lowest located test kit within the vertical stack of test kits.
Tu teaches:
wherein the dispensing system is configured to accommodate a vertical stack of test kits and wherein the dispensing system is configured to dispense a lowest located test kit within the vertical stack of test kits (Figure 15B; Paragraph [0188]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gokcebay to disclose the dispensing system is configured to accommodate a vertical stack of test kits and wherein the dispensing system is configured to dispense a lowest located test kit within the vertical stack of test kits as taught by Tu. Gokcebay discloses a modular system of locker banks for receipt and delivery where each locker includes a lock and a light (Gokcebay Abstract). Using the automated medical diagnostic system and method of Tu would facilitate testing of samples for biomarkers indicative of a medical condition (Tu Paragraph [0011]).
Regarding claim 6, Gokcebay does not explicitly disclose the BTS of claim 1, wherein the dispensing system comprises an actuator arm configured to move to allow dispensing of a test kit.
Tu teaches:
wherein the dispensing system comprises an actuator arm configured to move to allow dispensing of a test kit (Paragraph [0144]: the motion system can be comprised of a linear actuator 7 for vertical linear motion and a servo motor 8 for horizontal rotational/polar motion ).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gokcebay to disclose the dispensing system comprises an actuator arm configured to move to allow dispensing of a test kit as taught by Tu. Gokcebay discloses a modular system of locker banks for receipt and delivery where each locker includes a lock and a light (Gokcebay Abstract). Using the automated medical diagnostic system and method of Tu would facilitate testing of samples for biomarkers indicative of a medical condition (Tu Paragraph [0011]).
Regarding claim 7, Gokcebay discloses the BTS of claim 1, wherein the kiosk comprises a plurality of lockers and a plurality of power supplies associated with the plurality of lockers (Paragraphs [0032]: As will be described below, each kiosk 20 can control each and every locker and [0047]: Disposed on the lock board 140 is a first connector 144a that receives power and control signals regarding the lock status.)
Regarding claim 8, Gokcebay discloses the BTS of claim 1, wherein at least one of the plurality of lockers is addressable to be associated with patient information entered via the user interface (Paragraph [0058]: The touchscreen display 22 can further be used to provide further validation of the recipient by requiring a signature before opening of the locker door).
Regarding claim 9, Gokcebay discloses the BTS of claim 1, further comprising: a frame that vertically supports the user interface, and the locker, wherein the user interface face forward while the locker faces backward (Fig. 2; Paragraphs [0032] and [0033].
Gokcebay discloses the limitations above. Gokcebay does not explicitly disclose:
the dispensing system.
Tu teaches:
the dispensing system (Paragraph [0188]: Based upon the test order number/reservation number, the kiosk may dispense the appropriate self-testing kit(s) 301 to the patient through the self-testing kit dispensing port).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gokcebay to disclose the dispensing system as taught by Tu. Gokcebay discloses a modular system of locker banks for receipt and delivery where each locker includes a lock and a light (Gokcebay Abstract). Using the automated medical diagnostic system and method of Tu would facilitate testing of samples for biomarkers indicative of a medical condition (Tu Paragraph [0011]).
Regarding claim 10, Gokcebay does not explicitly disclose the BTS of claim 9, further comprising: a biohazard trash bin carried by the frame and disposed below at least one of the dispensing system and the locker.
Tu teaches:
a biohazard trash bin carried by the frame and disposed below at least one of the dispensing system and the locker (Fig. 14A; Paragraph [0193]: The patient may throw away any trash from the self-testing kit into the external waste receptacle 111 of the kiosk).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gokcebay to disclose a biohazard trash bin carried by the frame and disposed below at least one of the dispensing system and the locker as taught by Tu. Gokcebay discloses a modular system of locker banks for receipt and delivery where each locker includes a lock and a light (Gokcebay Abstract). Using the automated medical diagnostic system and method of Tu would facilitate testing of samples for biomarkers indicative of a medical condition (Tu Paragraph [0011]).
Regarding claim 11, Gokcebay discloses a method of conducting a biologic test, comprising:
providing a kiosk comprising a locker wherein at least one of (1) the locker is configured to selectively remain locked for a predetermined period of time, (2) the locker comprises a power source and the power source provides power, and (3) the locker comprises a disinfecting light and the disinfecting light selectively emits light into the locker (Paragraphs [0075]: each locker 18 can further include a UV lamp [0076]: the UV lamp 246 emits UV-C light waves and is a sterilizing lamp. This form of lamp is useful for destroying the ability of bacteria, viruses, and other pathogens to reproduce).
Gokcebay discloses the limitations above. Gokcebay does not explicitly disclose:
providing a medical professional computer system;
dispensing a biologic test kit from the locker.
Tu teaches:
providing a medical professional computer system (Paragraph [0087]: The device may be configured to…store and display results in a spreadsheet in a file like a CSV file that can be transferred to and displayed on a separate computer (e.g., a physician computing device));
dispensing a biologic test kit from the locker (Paragraph [0188]: Based upon the test order number/reservation number, the kiosk may dispense the appropriate self-testing kit(s) 301 to the patient through the self-testing kit dispensing port).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gokcebay to disclose providing a medical professional computer system; and dispensing a biologic test kit from the locker as taught by Tu. Gokcebay discloses a modular system of locker banks for receipt and delivery where each locker includes a lock and a light (Gokcebay Abstract). Using the automated medical diagnostic system and method of Tu would facilitate testing of samples for biomarkers indicative of a medical condition (Tu Paragraph [0011]).
Regarding claim 13, Gokcebay discloses the method of claim 11, further comprising: operating the kiosk to receive patient information (Paragraph [0032]: Each of the control modules 14 includes a kiosk 20 designed to allow…recipients to input information).
Regarding claim 14, Gokcebay does not explicitly disclose the method of claim 11, further comprising: operating the medical professional computer system to provide telehealth services.
Tu teaches:
operating the medical professional computer system to provide telehealth services (Paragraph [0124]: Patients or caregivers may be directed to use the self-service kiosk device by remote clinician via telehealth ).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gokcebay to disclose operating the medical professional computer system to provide telehealth services as taught by Tu. Gokcebay discloses a modular system of locker banks for receipt and delivery where each locker includes a lock and a light (Gokcebay Abstract). Using the automated medical diagnostic system and method of Tu would facilitate testing of samples for biomarkers indicative of a medical condition (Tu Paragraph [0011]).
Regarding claim 15, Gokcebay discloses the method of claim 11, further comprising: opening a locker of the kiosk to receive the test kit (Paragraph [0046]: When the actuator 150 is actuated, the actuator 150 pulls the latch 172 downwardly, which thereby releases the latch 172 from the latch hook 162, allowing the latch hook 162 to rotate under the force of the torsion spring 170, and thereby automatically opening the locker door ).
Regarding claim 16, Gokcebay discloses the method of claim 15, further comprising: connecting the test kit to a power supply of the locker (Paragraph [0049]: The control module 14 includes a kiosk 20 as described above which is connected to a main circuit board 62, and each output device and input device of the kiosk 20 is operatively connected to the main board 62. The main board 62 receives power from a power supply).
Regarding claim 17, Gokcebay discloses the method of claim 16, further comprising: locking the locker for a predetermined period of time (Paragraph [0077]: The lock board 140 then causes the illumination of the UV lamp 246 for a specified period of time effective to help eliminate pathogens…. During this period of time that the UV lamp is illuminated, the lock board 140 prevents the lock 46 from opening).
Regarding claim 18, Gokcebay does not explicitly disclose the method of claim 17, further comprising: transmitting visual information about the test kit to the medical professional computer system.
Tu teaches:
transmitting visual information about the test kit to the medical professional computer system (Paragraph [0194]: The results may be electronically sent to the patient's phone, a physician of the patient, and/or a remote provider).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gokcebay to disclose transmitting visual information about the test kit to the medical professional computer system as taught by Tu. Gokcebay discloses a modular system of locker banks for receipt and delivery where each locker includes a lock and a light (Gokcebay Abstract). Using the automated medical diagnostic system and method of Tu would facilitate testing of samples for biomarkers indicative of a medical condition (Tu Paragraph [0011]).
Regarding claim 19, Gokcebay does not explicitly disclose the method of claim 18, further comprising: receiving test result information from the medical professional computer system.
Tu teaches:
receiving test result information from the medical professional computer system (Paragraph [0087]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gokcebay to disclose receiving test result information from the medical professional computer system as taught by Tu. Gokcebay discloses a modular system of locker banks for receipt and delivery where each locker includes a lock and a light (Gokcebay Abstract). Using the automated medical diagnostic system and method of Tu would facilitate testing of samples for biomarkers indicative of a medical condition (Tu Paragraph [0011]).
Regarding claim 20, Gokcebay does not explicitly disclose the method of claim 19, further comprising: associating the test result information with patient information.
Tu teaches:
associating the test result information with patient information (Paragraph [0087]: The test results (e.g., an indication of the presence of one or more patient conditions) will be sent with the unique test ID to an LIS, EHR system, or another HIPAA-compliant database on a cloud server, where it will be matched to the patient ID using the corresponding unique test ID).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gokcebay to disclose associating the test result information with patient information as taught by Tu. Gokcebay discloses a modular system of locker banks for receipt and delivery where each locker includes a lock and a light (Gokcebay Abstract). Using the automated medical diagnostic system and method of Tu would facilitate testing of samples for biomarkers indicative of a medical condition (Tu Paragraph [0011]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gokcebay et al. (US 2020/0349796 A1) in view of Tu et al. (US 2021/0285977 A1) in further view of Bluth (US 2009/0240528 A1).
Regarding claim 12, Gokcebay, in view of Tu, does not explicitly disclose the method of claim 11, further comprising: operating the kiosk to receive payment for the biologic test prior to dispensing the biologic test.
Bluth teaches:
operating the kiosk to receive payment for the biologic test prior to dispensing the biologic test (Paragraph [0055]: attach a payment system to the managed health kiosk and prescription dispensement system. Such a payment system may be capable of receiving payment by cash or by credit or debit card).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gokcebay, in view of Tu, to disclose operating the kiosk to receive payment for the biologic test prior to dispensing the biologic test as taught by Bluth. Gokcebay, in view of Tu, discloses a modular system of locker banks for receipt and delivery where each locker includes a lock and a light (Gokcebay Abstract). Using the community based managed health kiosk and prescription dispensement system of Bluth would facilitating automated drug dispensement by a kiosk system (Bluth Abstract).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHINYERE MPAMUGO whose telephone number is (571)272-8853. The examiner can normally be reached Monday-Friday, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at (571) 272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHINYERE MPAMUGO/ Primary Examiner, Art Unit 3685