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 .
DETAILED ACTION
Status of Claims
The original claims 1-8 filed 03/24/2025 are pending and have been examined.
Priority
Acknowledgement is made of applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has NOT been filed or received. An attempt was made by the Office to electronically retrieve the priority document, but the attempt failed. The effective filing date appears to be 03/24/2025 as the priority document has not been received and 35 U.S.C. 119(a)-(d) conditions have NOT been met.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 03/24/2025 follows the provisions of 37 CFR 1.97 and has been fully considered by the Examiner.
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 1-8 are rejected under 35 U.S.C. §101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 8 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 (YES)
Claims 1 and 8 fall into at least one of the statutory categories (i.e., machine or process).
Step 2A1 (YES)
The limitations of a testing information obtaining step of obtaining testing information, which is used to order testing; a displaying step of causing to display the obtained testing information; a testing information editing step of editing the obtained testing information; and a storing step of storing the edited testing information, which has been edited in the testing information editing step, as drafted (claim 8 being representative), is a process that under the broadest reasonable interpretation (BRI) covers a method of organizing human activity (i.e., managing personal behavior or relationships or interactions between people including following rules or instructions) but for the recitation of generic computer component language (discussed below in 2A2). The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to manage a medical testing workflow including the management of testing information (see, e.g., Spec. Para. 0004, 0024, 0026, 0028-0029, 0031-0032 describing test order information management as a human activity) in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “a testing information obtaining step… a displaying step… a testing information editing step… and a storing step…” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a system implemented by a data processor (computer), the claimed invention amounts to managing personal behavior or interaction between people. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2 (NO)
The judicial exception, the above-identified abstract idea, is not integrated into a practical application. In particular, the claims recite the additional elements of a medical testing apparatus (claim 8) comprising a communication unit (claim 1), one or more processors (claim 1) executing various modules, a display unit, and a storage unit that implement the identified abstract idea represented by claim 8. The additional elements aforementioned are not described by the applicant and are recited at a high-level of generality (i.e., a generic computer or computer component performing a generic computer or computer component function that facilitates the identified abstract idea) such that these amount no more than mere instructions to apply the exception using a generic computer component (see Specification, e.g., at para. 0014-0016). See MPEP § 2106.04(d)(I). Accordingly, alone or in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
The claims further recite the additional element of a server communicably connected via a network as collecting, transmitting or outputting data. The additional element is recited at a high-level of generality (i.e., as a general means of collecting, transmitting or outputting data) and amounts to a location from which data is received or to which data is transmitted or outputted, each of which represents an extra-solution activity (e.g., mere data gathering or data output). MPEP § 2106.04(d)(I) indicates that extra-solution data gathering and data output activity cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application. The claims are directed to an abstract idea.
Step 2B (NO)
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a medical testing apparatus (claim 8) comprising a communication unit (claim 1), one or more processors (claim 1) executing various modules, a display unit, and a storage unit to perform the method (represented by claim 8) amount no more than mere instructions to apply the exception using a generic computer or generic computer component. Mere instructions to apply an exception using generic computer(s) and/or generic computer component(s) cannot provide an inventive concept (“significantly more”). See MPEP § 2106.05(f).
Also discussed above with respect to integration of the abstract idea into a practical application, the additional element of the server communicably connected via a network (i.e., a device that collects, transmits or outputs data) is considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. MPEP 2106.05(d)(II) indicates that receiving, transmitting or outputting data over a network has been held by the courts to be well-understood, routine, conventional activity (citing TLI Communications, Symantec, OIP Techs., and buySAFE). See also MPEP 2106.05(g) (citing Cybersource, Mayo, OIP Techs.) Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such, the claims are not patent eligible.
Dependent claims 2-7, when analyzed as a whole, are similarly rejected under 35 U.S.C. §101 because the additional limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. The claims, when considered alone or as an ordered combination, either (1) merely further define the abstract idea, (2) do not further limit the claim to a practical application, or (3) do not provide an inventive concept such that the claims are subject matter eligible.
Claim 2 merely further describes the abstract idea (e.g., the testing information includes patient information). See analysis, supra.
Claim 3 merely further describes the additional element(s) of the storage unit as a volatile storage unit, which is a generic computer component performing generic computer component functions; the one or more processors (e.g., executing functions including causing the display unit to display a confirmation screen); and the display unit (e.g., displaying data). See analysis, supra.
Claim 4 merely further describes the additional element of the communication unit (e.g., transmitting data); and the server (e.g., receiving data). See analysis, supra.
Claim 5 merely further describes the additional elements of the one or more processors (e.g., executing functions of searching for edited testing information, selecting testing information in search results, and causing the display unit to display select data); and the display unit (e.g., displaying data). See analysis, supra.
Claim 6 merely further describes the additional elements of the one or more processors (e.g., executing functions of searching pieces of testing information for testing information of the same patient, determining whether or not the stored patient information has been edited, and causing the display of the edited patient information after determining that the patient information has been edited); and the display unit (e.g., displaying the data). See analysis, supra.
Claim 7 merely further recites the additional elements of the one or more processor modules causing both the information obtained and the stored information to be displayed after determining that the patient information has been edited and allowing for selecting one or two pieces of the displayed information to take. See analysis, supra.
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.
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 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0156307 A1 to Masuda in view of US 2009/0054755 A1 to Shiibashi.
Re. Claim 1, Masuda teaches a medical testing apparatus comprising:
a communication unit (44) communicably connected to a server (2) via a network (N) (Figs. 1, 5 and [0069] teach a client terminal wireless communication unit 44 carries out sending/receiving of data with the medical image management apparatus 2 through a communication network N.);
one or more processors (41) configured to execute functions (Fig. 5 and [0066] teach the client terminal control unit 41 is configured with a CPU… The control unit 41 reads out various programs such as a system program and processing programs which are stored in the storage unit 46, opens the programs in the RAM 45 and executes various processes according to the programs that are opened.) of:
a testing information obtainer to obtain testing information, which is used to order testing, from the server (Fig. 8 and [0087] teach the control unit 41 sends the patient ID of the patient C1… to the medical image management apparatus 2… then the control unit 41 obtains the information relating to the medical image of the selected patient C1…);
a display controller to cause a display unit (43) to display the obtained testing information ([0068] teaches display unit 43 displays various types of screens according to the instructions of display signals which are input from the control unit 41. [0087] teaches the image display screen 433 of the selected patient C1… is displayed as shown in Fig. 9.); and
[…]; and
a storage unit (45) to store […] ([0070] teaches the RAM 45 functions as a work area for temporarily storing various types of programs read from the storage unit 46 that can be executed by the control unit 41, input and output data and the like in various processing which are executed and controlled by the control unit 41.)
Masuda may not teach
a testing information editor to edit the obtained testing information; or
a storage unit to store the edited testing information edited by the testing information editor.
Shiibashi teaches
a testing information editor to edit the obtained testing information; and a storage unit to store the edited testing information edited by the testing information editor (abstract teaches receiving the image data or examination data (also obtaining testing information) when a screen showing information on the specified patient is displayed, the received data is automatically associated with the designated patient information (editing the obtained testing information) and stored in an image DB (storage unit)… and the received data is temporarily stored in a temporary storage section for storing data waiting for association with the patient information. See also [0172], [0180].)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the medical imaging system of Masuda to perform additional data processing and storage operations and to use this information as part of a medical imaging system as taught by Shiibashi, with the motivation of improving medical imaging systems, diagnostic efficiency, operating costs, and patient data management (see Shiibashi at para. 0011-0012, 0023 and 0026-0027).
Re. Claim 2, Masuda/Shiibashi teaches the medical testing apparatus according to claim 1, wherein the testing information includes patient information (Masuda Fig. 8 and [0087] teaches… obtaining the information relating to the medical image of the selected patient C1. Masuda Fig. 4, [0044], [0049] teaches table T2 for managing information regarding medical images wherein a row of data, including patient ID and patient name, is stored as one record by being associated to one another.)
Re. Claim 3, Masuda/Shiibashi teaches the medical testing apparatus according to claim 1, wherein the storage unit is a volatile storage unit (45) (Masuda [0070] teaches the RAM 45 functions as a work area for temporarily storing various types of programs read from the storage unit 46 that can be executed by the control unit 41, input and output data and the like in various processing which are executed and controlled by the control unit 41.), and the display controller causes the display unit (43) (see again Masuda [0068]) to display a confirmation screen to confirm whether or not to record the edited testing information in a non-volatile storage unit (Shiibashi Figs. 10-11, [0205]-[0206] teaches an association verification screen 355 showing the patient information of the currently designated patient, a message asking for verifying the suitability of association of the data with the displayed patient, OK button 355a (a confirmation screen)… when the received data is an image data, the image data is associated with the patient information designated in Step S22 and is stored in the image DB 38 (see [0150])… When the received data is an examination data, the examination data is associated with the patient information designated in Step S22 and is stored in the image DB 39 (see [0151]). Masuda [0044] also teaches an HDD / non-volatile memory.)
Re. Claim 4, Masuda/Shiibashi teaches the medical testing apparatus according to claim 1, wherein the communication unit (44) transmits the edited testing information to the server (2) to feed back the edited testing information (Shiibashi Figs. 1, 3, abstract and [0153] teaches the received image data or examination data is automatically associated with the designated patient information (editing the obtained testing information) and stored in the server image DB 70. Also, Masuda Figs. 2, 5 and [0062] teaches the client terminal 4 control unit 21 stores (necessarily transmits) the medical image(s) in the storage unit 26 of element 2 with the information indicating that the medical image(s) is approved ("0: OK" in the field of "NG flag" in table T2) associated thereto; and Masuda Fig. 12 and [0114] teach updating… table T2 stored in storage unit 26.)
Re. Claim 5, Masuda/Shiibashi teaches the medical testing apparatus according to claim 1, wherein the one or more processors are further configured to execute functions of:
a searcher to search for edited testing information (Shiibashi Figs. 1, 3 and [0153] teaches the associated image data and supplementary information (patient information and information including the UID) are stored in the server image DB 70… At the same time, the server searches the image DB 70 in response to the request from the control apparatus 3 (Masuda’s CPU 41) and reads out the image data and its supplementary information meeting the request. See also Masuda [0084].); and
a selector to select testing information in search results (Masuda Fig. 8 and [0085] teaches a display button B2 (selector functionality) is a button for instructing to display the image display screen of the patient (testing information) who is selected in the patient list (search results).), wherein the display controller causes the display unit to display the testing information selected by the selector (Masuda Fig. 5 and [0086]-[0087] teaches the client terminal 4 control unit 41 displays the image display screen for displaying an image of the patient who is the target for image capturing in the display unit 43; and the image display screen 433 is displayed as shown in FIG. 9 including an examination list display section A4, etc.)
Re. Claim 6, Masuda/Shiibashi teaches the medical testing apparatus according to claim 1, wherein the one or more processors are further configured to execute functions of:
a same-patient searcher to search pieces of testing information, which have been obtained from the server, for testing information of the same patient (Shiibashi Fig. 13 and [0153] teaches the associated image data and supplementary information (patient information and information including the UID) are stored in the server image DB 70… At the same time, the server searches the image DB 70 (pieces of testing information) in response to the request (to search) from the control apparatus 3 and reads out the image data and its supplementary information (testing information) meeting the request. Shiibashi [0130] teaches the search may use a search ID which is set associated with the patient (the same patient).); and
an editing determiner to determine whether or not the stored patient information has been edited, wherein the display controller causes the display unit to display the edited patient information when the editing determiner has determined that the patient information has been edited (Shiibashi Fig. 13 and [0153] teaches the server sends the extracted image data and its supplementary information (the stored patient information) to the control apparatus 3. Masuda [0114] teaches with updating of data in the image management table T2, the control unit re-extracts the information (the edited patient information)… from the image management table T2 stored in the storage unit… (updating necessarily determined) and the updated information is reflected in the information on the screen (step S41). Shiibashi Fig. 7a-7b and [0188] teaches a captured image display screen 352 gives a list display by thumbnail representation of the image data and examination information among other information related to patient “Taro Yamada”.)
Re. Claim 7, Masuda/Shiibashi teaches the medical testing apparatus according to claim 6, wherein
the display controller causes both the information obtained from the server and the stored information (Shiibashi’s extracted image data and its supplementary information and/or Masuda’s re-extracted information from table T2 and/or re-extracted image data and its supplementary information) to be displayed, when the editing determiner has determined that the patient information has been edited (see claim 6 prior art rejection), and
the one or more processors are further configured to execute a function of: a selector to allow for selecting one of two pieces of the displayed information to take (Shiibashi Fig. 7a and [0188] teaches a screen 352 with a list of thumbnail images and examination information and an “image comparison screen” button B24… When the "image comparison screen" button B24 (selector) has been pressed… the display… is switched over to the image comparison screen 354 (allowing). Masuda Fig. 9 and [0087] teaches a screen 433… displaying two thumbnail images for an examination selected from a list. Shiibashi Fig. 14a-14b and [0238] teaches the area for setting the number of the images (pieces… to take) to be compared (necessitates selecting) with the reference image pops up, and the comparison images in the number set from this area, e.g., three comparison images including the one reference image (see Fig. 14b), can be displayed in the comparative screen display area 354a. The Examiner notes that Fig. 14a shows two comparison images including the one reference image, such that one of the two captured images is compared to the reference image.)
Re. Claim 8, the subject matter of claim 8 is essentially defined in terms of a process, which is technically corresponding to machine claim 1. Since claim 8 is analogous to claim 1, it is similarly analyzed and rejected in a manner consistent with the rejection of claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 8,229,761 B2 to Backhaus et al. for teaching enhanced multiple resource planning and forecasting including an order server processing a doctor work list (see Fig. 2) and a sequence of operations for assigning medical requests to doctor systems (see Fig. 6 and associated text).
US 2021/0074410 A1 to Tsunamoto for teaching medical image management apparatus, medical image management method, and recording medium including normal image processing (see Fig. 1), patient image associating processing (see e.g. Fig. 6), and associated GUI with patient work/order list that has an update functionality icon and filtering options (see e.g. Fig. 12).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica M Webb whose telephone number is (469)295-9173. The examiner can normally be reached Mon-Thurs 9:30am-3:30pm CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.M.W./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683