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 .
Claims 1-10, 12, 14-15 have been amended. Claims 11 and 13 have been cancelled. Claims 1-10, 12 and 14-15 are pending.
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 1-10, 12 and 14-15 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 1-10 are drawn to a method for a patient monitoring device which is within the four statutory categories (i.e. process). Claims 12 and 14 are drawn to a system for a patient monitoring device which is within the four statutory categories (i.e. machine). Claim 15 is drawn to a non-transitory medium for executing a method for a patient monitoring device which is within the four statutory categories (i.e. manufacture).
Claims 1-10 (Group I) recite a computer implemented method performed by a patient monitoring device, the method comprising:
using a patient monitoring model to determine a health parameter for a subject;
and using one or more outputs of the patient monitoring model to determine a search query with which to query a database of medical images in order to retrieve a matching medical image relevant to the determined health parameter,
obtaining the matching medical image from the database of medical images; and
sending an instruction to a display to make the matching medical image available for rendering on the display.
Claim 12 further includes the limitations of:
a memory comprising instruction data representing a set of instructions (MPEP § 2106.05(f), apply it); and a processor configured to communicate with the memory and to execute the set of instructions, wherein the set of instructions, when executed by the processor, cause the processor to… (MPEP § 2106.05(f), apply it).
Claim 15 further recites:
a computer program product comprising a non-transitory computer readable medium, the computer readable medium having computer readable code embodied therein, the computer readable code being configured such that, on execution by a suitable computer or processor…(MPEP § 2106.05(f), apply it).
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity because it recites fundamental economic practices, commercial or legal interactions, and/or managing personal behavior or relationships or interactions between people. Any limitations not identified above as part of the abstract idea are underlined and deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claims 12 and 14 and Claim 15 is identical as the abstract idea for Claims 1-10 (Group I), because the only difference is they are directed towards different statutory categories.
Dependent Claims 2-10 and 14 include other limitations, for example Claim 2 recites wherein the step of using one or more outputs of the patient monitoring model to determine a search query, is performed responsive: to the determined health parameter triggering an alert on the patient monitoring device; and/or to the determined health parameter being indicative of a deterioration of the patient, Claim 3 recites wherein medical images in the database of medical images are associated with accompanying structured reports comprising measurements and/or annotations of a feature in the associated medical image; and wherein the search query is formatted to search said measurements and/or annotations, Claim 4 recites wherein at least one of the one or more outputs of the patient monitoring model is formatted as a string or image; and wherein the string or image is used in the search query, Claim 5 recites wherein at least one of the one or more outputs of the patient monitoring model is formatted in a manner for use directly as a Digital Imaging and Communications in Medicine, DICOM, search query, Claim 6 recites wherein the step of using one or more outputs of the patient monitoring model to determine the search query comprises: converting the one or more outputs of the patient monitoring model into the search query using: a look-up table, a machine learning model or a mapping procedure, Claim 7 recites wherein the determined health parameter is a score derived from patient data available to the patient monitoring device, Claim 8 recites wherein the score is: a Hemodynamic Stability Index score; a Hypotensive Predictive Index score; an acute heart failure prediction index; or a score linked to a patient monitoring alarm or patient monitoring trend, Claim 9 recites wherein the medical images contain meta information, Claim 10 recites wherein the medical images are in the DICOM image format, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1, 12 and 15.
Furthermore, Claims 1-10, 12 and 14-15 are not integrated into a practical application because the additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of a memory, a processor, and a computer program product comprising a non-transitory computer readable medium, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see pages 2 and 4 of the present Specification, see MPEP 2106.05(f).
Furthermore, the Claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e. the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
Pages 2 and 4 of the Specification discloses that the additional elements (i.e. memory, processor, computer readable medium) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare)
Dependent Claims 2-10 and 14 include other limitations, but they merely further limit the abstract idea and do not contain any additional elements beyond those recited in the independent claims.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above-identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-10, 12 and 14-15 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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.
Claims 1-2, 4, 6-8, 12 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tremper (U.S. Pub. No. 2013/0245481 A1) in view of Morris (U.S. Pub. No. 2017/286601 A1).
Regarding claim 1, Tremper teaches a computer implemented method performed by a patient monitoring device, the method comprising:
using a patient monitoring model to determine a health parameter for a subject (Paragraphs [0005], [0039-0040] and [0074] discuss using patient data which in inputted into a clinical decision support system to determine health and health needs of a patient.);
and using one or more outputs of the patient monitoring model to determine a search query with which to query a database of medical data in order to retrieve a matching medical data relevant to the determined health parameter (Paragraphs [0075-0078] discusses that once a risk factor has been detected, determined or calculated, a risk factor alert can be displayed, and that the alert display system can automatically query a database or other repository of references to link to clinical documentation, which can change depending on the current status of the patient.),
obtaining the matching medical data from the database of medical data (Paragraphs [0075-0078] discusses that once a risk factor has been detected, determined or calculated, a risk factor alert can be displayed, and that the alert display system can automatically query a database or other repository of references to link to clinical documentation, which can change depending on the current status of the patient.); and
sending an instruction to a display to make the matching medical data available for rendering on the display (Paragraphs [0077-0079] discuss an icon that be clicked to cause the clinical documentation to be displayed, construed as an instruction.),
but Tremper does not explicitly disclose wherein the medical data is a medical image data.
However, Morris teaches wherein the medical data is a medical image data (Paragraph [0066-0067] discusses the data including medical image data, such as a CT scan.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the medical data of Tremper to include medical image data, as taught by Morris, so if “a medical event in the EMR is found to be matching a medical event in the predefined list of medical events, such medical event in the EMR can be identified, and an executive summary/explanation for the medical event can be automatically constructed/extracted (Morris, Paragraph [0006]).”
Regarding claim 2, Tremper discloses wherein the step of using one or more outputs of the patient monitoring model to determine a search query, is performed responsive: to the determined health parameter triggering an alert on the patient monitoring device (Paragraphs [0075-0078] discusses that once a risk factor has been detected, determined or calculated, a risk factor alert can be displayed, and that the alert display system can automatically query a database or other repository of references to link to clinical documentation, which can change depending on the current status of the patient.).
Regarding claim 4, Tremper discloses wherein at least one of the one or more outputs of the patient monitoring model is formatted as an image; and wherein the image is used in the search query (Paragraph [0044] discusses the output of the model including an image of the at risk area, such as the brain.).
Regarding claim 6, Tremper discloses wherein the step of using one or more outputs of the patient monitoring model to determine the search query comprises: converting the one or more outputs of the patient monitoring model into the search query using a mapping procedure (Paragraph [0076] discusses using a particular term to search for the query to find relevant clinical documentation.).
Regarding claim 7, Tremper discloses wherein the determined health parameter is a score derived from patient data available to the patient monitoring device (Paragraphs [0075-0078] discusses that once a risk factor has been detected, determined or calculated, a risk factor alert can be displayed).
Regarding claim 8, Tremper discloses wherein the score is a score linked to a patient monitoring alarm or patient monitoring trend (Paragraphs [0075-0078] discusses that once a risk factor has been detected, determined or calculated, a risk factor alert can be displayed.).
2025Attorney Docket No. 317EP.001US01
Claim 12 recites substantially similar limitations as those already addressed in claim 1, and, as such, is rejected for similar reasons as given above.
Claim 12 further recites:
a memory comprising instruction data representing a set of instructions; and
a processor configured to communicate with the memory and to execute the set of instructions, wherein the set of instructions, when executed by the processor, cause the processor to....
Examiner notes that while Tremper is a computer-based system and method, the computer itself is not explicitly disclosed.
However, Morris teaches a memory and processor that is used to implement the claimed steps (Paragraph [0069] discusses a memory and processor used to implement the invention.).
2025Attorney Docket No. 317EP.001US01
Claim 14 recites substantially similar limitations as those already addressed in claim 2, and, as such, is rejected for similar reasons as given above.
2025Attorney Docket No. 317EP.001US01
Claim 15 recites substantially similar limitations as those already addressed in claim 1, and, as such, is rejected for similar reasons as given above.
Claim 15 further recites a computer program product comprising a non-transitory computer readable medium, the computer readable medium having computer readable code embodied therein, the computer readable code being configured such that, on execution by a suitable computer or processor, the computer or processor is caused to perform the method….
Examiner notes that while Tremper is a computer-based system and method, the computer or non-transitory computer readable medium itself is not explicitly disclosed.
However, Morris teaches a non-transitory computer readable medium that is used to implement the claimed steps (Paragraph [0069] discusses a non-transitory medium used to store instructions and being used implement the invention.).
Claims 3, 5 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Tremper in view of Morris, and in further view of Paik (U.S. Pub. No. 2024/0177836 A1).
Regarding claim 3, Tremper does not appear to explicitly disclose wherein medical images in the database of medical images are associated with accompanying structured reports comprising measurements and/or annotations of a feature in the associated medical image; and wherein the search query is formatted to search said measurements and/or annotations.
Paik teaches wherein medical images in the database of medical images are associated with accompanying structured reports comprising measurements and/or annotations of a feature in the associated medical image; and wherein the search query is formatted to search said measurements and/or annotations (Paragraphs [0010-0011] and [0151] discuss the query including measurements and specific text label for images to find similar images.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the query of Tremper to include measurements of the medical image data, as taught by Paik, in order to “assist human readers in the task of image interpretation, which can incorporate one or more of artificial intelligence (AI), deep learning (DL), machine learning (ML), computer-aided detection/diagnosis (CADe/CADx), and other algorithms (Paik, Paragraph [0005]).”
Regarding claim 5, Tremper does not appear to disclose where wherein at least one of the one or more outputs of the patient monitoring model is formatted in a manner for use directly as a Digital Imaging and Communications in Medicine, DICOM, search query.
Paik teaches wherein at least one of the one or more outputs of the patient monitoring model is formatted in a manner for use directly as a Digital Imaging and Communications in Medicine, DICOM, search query (Paragraphs [0229] and [0235-0236] discuss the output including hanging protocol for DICOM images.)
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the output of Tremper to be in DICOM format, as taught by Paik, in order to “assist human readers in the task of image interpretation, which can incorporate one or more of artificial intelligence (AI), deep learning (DL), machine learning (ML), computer-aided detection/diagnosis (CADe/CADx), and other algorithms (Paik, Paragraph [0005]).”
Regarding claim 9, Tremper does not appear to explicitly disclose wherein the medical images contain meta information.
Paik teaches wherein the medical images contain meta information (Paragraph [0020] discusses the images including metadata.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the data of Tremper to include medical image data that includes meta information, as taught by Paik, in order to “assist human readers in the task of image interpretation, which can incorporate one or more of artificial intelligence (AI), deep learning (DL), machine learning (ML), computer-aided detection/diagnosis (CADe/CADx), and other algorithms (Paik, Paragraph [0005]).”
Regarding claim 10, Tremper does not appear to explicitly disclose wherein the medical images are in the DICOM image format.
Paik teaches wherein the medical images are in the DICOM image format (Paragraphs [0020] and [0231] discusses the images being in DICOM format.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the medical data Tremper to include medical images in DICOM format, as taught by Paik, in order to “assist human readers in the task of image interpretation, which can incorporate one or more of artificial intelligence (AI), deep learning (DL), machine learning (ML), computer-aided detection/diagnosis (CADe/CADx), and other algorithms (Morris, Paragraph [0005]).”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686