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 § 102
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 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)(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 128-133, 137-146, 150-157, and 159-161 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by SHANKAR et al. (US Pub. 2020/0075130 A1, hereinafter “Shankar”).
Claim 128: Shankar teaches A method executed by at least one processor for providing guidance through a graphical user interface (GUI) to assist with completion of one or more steps of a process (“Shankar”, Abstract, [0034], [0047]), the method comprising:
receiving, by the at least one processor, a first command to select an experiment comprising one or more steps to be performed on an instrument or other equipment (“Shankar”, Figs. 22-24, [0079], receives a user selection of a sequencing run plan; [0041], [0044], a run plan includes an identification of one or more tests and associated parameters and is implemented by the instrument);
providing, by the at least one processor, a second command to display assistance information corresponding to a user-selectable experiment characteristic (“Shankar”, Figs. 22-93, [0078]-[0079], graphical displays guide the user through a series of steps to prepare the instrument, for example, for a sequencing run), the assistance information comprising:
one or more images corresponding to one or more components of the experiment (“Shankar”, [0034], the display screen present graphical representation of the instrument components); or
instructions to prepare the one or more components of the experiment including a description and/or an image (“Shankar”, [0084]-[0087], provides stepwise graphical instructions); and
providing, by the at least one processor, a third command, to instruct the instrument or the other equipment to at least partially carry out the one or more steps of the experiment in response to receiving an input from the GUI, the input indicative of the one or more components are prepared (“Shankar”, Figs. 79-80, [0093]-[0095], sequence establishes that the start-run input indicates that component preparation is complete).
Claim 129: Shankar teaches the method according to claim 128, wherein the instrument includes an assay-based reader and the other equipment includes one or more of a shaker, washer, and incubator (“Shankar”, [0102]-[0103], sequencing instrument and biosensor constitute an assay-based reader because they detect and measure the results of a chemical or biological sequencing assay).
Claim 130: Shankar teaches the method according to claim 128, wherein the at least one processor provides the assistance information for the completion of one or more steps of the experiment without further human interaction after the at least one processor receives the first command (“Shankar”, Figs. 79-84, [0093]-[0095], the GUI automatically provides information that all reagents are installed and displays progress and that sequencing run is complete).
Claim 131: Shankar teaches the method according to claim 128, wherein the preparation of the one or more components of the experiment include one or more of washing an assay plate, shaking an assay plate, incubating an assay plate, and reading an assay plate (“Shankar”, Fig. 94, [0103]-[0105]).
Claim 132: Shankar teaches the method according to claim 128 further comprising the step of receiving, by the at least one processor, a fourth command for providing a status indicator to be associated with at least one step of the experiment (“Shankar”, [0034], [0095]).
Claim 133: Shankar teaches the method according to claim 132, wherein the status indicator can include an indication through the GUI of one or more of the following statuses: In Progress, Completed, Paused, and Error (“Shankar”, Figs. 81-83, [0095]).
Claim 137: Shankar teaches the method according to claim 128, wherein the user-selectable component characteristic comprises a kit temperature and/or assay type (“Shankar”, Figs. 22-24, [0079], the selected sequencing run type corresponds to the claimed user-selectable assay type).
Claim 138: Shankar teaches the method of claim 137, further comprising, in response to a user selection of the component characteristic, displaying components that correspond to the user-selected component characteristic (“Shankar”, Figs. 27-40, [0082], [0085], [0091], displays and highlights the particular components that must be removed or installed for the selected run).
Claim 139: Shankar teaches the method according to claim 128, wherein the GUI includes a first sub- section and a second sub-section and the assistance information is displayed in the second sub- section (“Shankar”, [0080], [0082], Fig. 25 depicts an upper title subsection and a lower assistance subsection).
Claim 140: claim 140 is directed to a system for implementing the method steps of claim 128. Therefore, claim 140 is rejected under similar rationale.
Claim 141: claim 141 is directed to the system according to claim 140 for implementing the method steps of claim 129. Therefore, claim 141 is rejected under similar rationale.
Claim 142: claim 142 is directed to the system according to claim 140 for implementing the method steps of claim 130. Therefore, claim 142 is rejected under similar rationale.
Claim 143: Shankar teaches the system according to claim 140, wherein the at least one processor provides assistance information for displaying to a user via the GUI for the completion of one or more steps of the experiment after the at least one processor receives the first command, wherein the assistance information includes one or more of:
displaying one or more images of components of the experiment; or displaying a description of the one or more components of the experiment (“Shankar”, Figs. 26-27, [0081], [0082], [0085], display images of the instrument components).
Claim 144: claim 144 is directed to the system according to claim 140 for implementing the method steps of claim 131. Therefore, claim 144 is rejected under similar rationale.
Claim 145: claim 145 is directed to the system according to claim 140 for implementing the method steps of claim 132. Therefore, claim 145 is rejected under similar rationale.
Claim 146: claim 146 is directed to the system according to claim 145 for implementing the method steps of claim 133. Therefore, claim 146 is rejected under similar rationale.
Claim 150: Shankar teaches the system according to claim 140, wherein the one or more steps of the experiment including collecting and preparing one or more components of a kit and/or an assay for the experiment (“Shankar”, Fig. 5, [0050]-[0051], blocks 512-514, “locate” corresponds to collecting the component, while apply or install corresponds to preparing it for the sequencing test/assay) and the assistance information includes instructions for preparing the kit and/or assay for the experiment (“Shankar”, Figs. 45-62, [0085], graphical displays and instructions for installing component), wherein the GUI includes a first sub-section and a second sub- section and the assistance information is displayed in the second sub-section (“Shankar”, [0080], [0082], Fig. 25 depicts an upper title subsection and a lower assistance subsection).
Claim 151: claim 151 is directed to a non-transitory computer readable storage medium for implementing the method steps of claim 128. Therefore, claim 151 is rejected under similar rationale.
Claim 152: claim 152 is directed to the non-transitory computer readable storage medium according to claim 151 for implementing the method steps of claim 129. Therefore, claim 152 is rejected under similar rationale.
Claim 153: claim 153 is directed to the non-transitory computer readable storage medium according to claim 151 for implementing the method steps of claim 130. Therefore, claim 153 is rejected under similar rationale.
Claim 154: claim 154 is directed to the non-transitory computer readable storage medium according to claim 151 for implementing the method steps of claim 143. Therefore, claim 154 is rejected under similar rationale.
Claim 155: claim 155 is directed to the non-transitory computer readable storage medium according to claim 151 for implementing the method steps of claim 131. Therefore, claim 155 is rejected under similar rationale.
Claim 156: claim 156 is directed to the non-transitory computer readable storage medium according to claim 151 for implementing the method steps of claim 132. Therefore, claim 156 is rejected under similar rationale.
Claim 157: claim 157 is directed to the non-transitory computer readable storage medium according to claim 156 for implementing the method steps of claim 133. Therefore, claim 157 is rejected under similar rationale.
Claim 159: claim 159 is directed to the non-transitory computer readable storage medium according to claim 151 for implementing the method steps of claim 135. Therefore, claim 159 is rejected under similar rationale.
Claim 160: claim 160 is directed to the non-transitory computer readable storage medium according to claim 159 for implementing the method steps of claim 136. Therefore, claim 160 is rejected under similar rationale.
Claim 161: claim 161 is directed to the non-transitory computer readable storage medium according to claim 151 for implementing the method steps of claim 150. Therefore, claim 151 is rejected under similar rationale.
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.
Claims 134, 147, and 158 are rejected under 35 U.S.C. 103 as being unpatentable over SHANKAR et al. (US Pub. 2020/0075130 A1, hereinafter “Shankar”) in view of Haas et al. (US 2009/0247417 A1, hereinafter "Haas").
Claim 134: Shankar teaches the method according to claim 128, however, Shankar does not teach the following feature, taught by Haas who teaches the step of receiving, by the at least one processor, a fourth command for assigning one or more users to the one or more steps of the experiment (“Haas”, [0073], [0076]-[0077], programing a laboratory workflow that assigns particular experimental responsibilities and work times to laboratory technicians and sending the resulting schedule to one or more users who perform the experiments).
It would have been obvious to one having the ordinary skill in the art before the effective filing date of the claimed invention to modify Shankar’s laboratory guidance system to incorporate Haas’s technician assignment functionality so that particular preparation or testing steps are assigned to appropriate laboratory personnel. A person of ordinary skill would have been motivated to combine these references to coordinate personnel and equipment, allocate laboratory resources efficiently, and ensure that each experimental step is performed by the responsible technician.
Claim 147: claim 147 is directed to the system according to claim 140 for implementing the method steps of claim 134. Therefore, claim 147 is rejected under similar rationale.
Claim 158: claim 158 is directed to the non-transitory computer readable storage medium according to claim 151 for implementing the method steps of claim 134. Therefore, claim 158 is rejected under similar rationale.
Claims 135-136 and 148-149 are rejected under 35 U.S.C. 103 as being unpatentable over SHANKAR et al. (US Pub. 2020/0075130 A1, hereinafter “Shankar”) in view of Zaworski et al. (US 2014/0367278 A1, hereinafter "Zaworski").
Claim 135: Shankar teaches the method according to claim 128, however, Shankar does not teach the following feature, taught by Zaworski who teaches wherein the experiment includes an electrochemiluminescence (ECL) assay (“Zaworski”, [0066], [0094]-[0096], provides an ECL reader that electrochemically stimulates a ruthenium based Sulfo-tag and detects the resulting ECL signal).
It would have been obvious to one having the ordinary skill in the art before the effective filing date of the claimed invention to modify Shankar’s computer guided system to incorporate Zaworski’s known ECL assay. A person of ordinary skill would have been motivated to combine these references to use ECL detection because Zaworski teaches that it provides sensitive, precise, and controllable measurement of analyte concentration.
Claim 136: Shankar and Zaworski teach the method according to claim 135, Shankar further teaches comprising the step of receiving, by the at least one processor, a sixth command for exporting data (“Shankar”, Fig. 4, [0041], [0046], receiving user input through interface 414 to provide the processed report outside the data processing module constitutes receiving a command to export the experimental data).
However, Shanka does not explicitly teach that the reported data originates from an ECL assay. Zaworski explicitly teaches the reported data originates from an ECl assay (“Zaworski”, [0068], [0091], [0100]-[0101]).
It would have been obvious to one having the ordinary skill in the art before the effective filing date of the claimed invention to modify Shankar’s computer guided system to incorporate Zaworski’s known ECL assay. A person of ordinary skill would have been motivated to combine these references to use ECL detection because Zaworski teaches that it provides sensitive, precise, and controllable measurement of analyte concentration.
Claim 148: claim 148 is directed to the system according to claim 140 for implementing the method steps of claim 135. Therefore, claim 148 is rejected under similar rationale.
Claim 149: claim 149 is directed to the system according to claim 140 for implementing the method steps of claim 136. Therefore, claim 149 is rejected under similar rationale.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Magnant et al. (US 2008/0031774 A1) discloses apparatus for guiding sample and reagent manipulations and receptacles for holding same.
KOCHAR et al. (US 2019/0391170 A1) discloses integrated consumable data management system and platform.
WOHLSTADTER et al. (US 2020/0026397 A1) discloses graphical user interface system.
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
Point of Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG H NGUYEN whose telephone number is (571)270-1300. The examiner can normally be reached M-F 9:30-4:00 PM.
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, William Bashore can be reached at 571-272-4088. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHUONG H NGUYEN/Primary Examiner, Art Unit 2174
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