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 .
Status of Claims
This action is in response to applicant arguments filled on 06/22/2026 for application 18/975592.
Claim 1, 3, 10, and 11 have been canceled.
Claims 22-24 have been added new.
Claims 2, 4-9, and 12-24 are currently pending.
Detailed Action
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 2, 4-9, and 12-24 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.
Step 1:
Claims 2, 4-9, and 12-24 are drawn to a method and system, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One:
Independent claims 2, 9, and 16 r recite evaluating response to diagnostic inquires to select subsequent inquiries, determining a working diagnosis based on the resulting sequence of inquiries, and developing a treatment plan. These limitations constitute evaluations and judgments that can practically be performed in the human mind, with the aid of a paper diagnostic flowchart and therefore fall within the mental processes grouping of abstract idea. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including an artificial intelligence event management, which is additional element that is recited at a high level of generality such that it amounts to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The claims recite the additional elements of obtaining a working diagnosis, navigating the user through nodes, generating a treatment plan, receiving patient response information, and automatically associating timestamps with patient response. These limitation constitutes data gathering or a mechanism for carrying out the diagnostic evaluation. As recited, these elements organize diagnostic inquiries and implement response dependent selection of subsequent inquiries, without specifying an improvement to computer operation beyond performing that diagnostic process.
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even 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.
Hence, the 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. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B:
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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See: MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, and
Para. 54 wherein “This artificial intelligence may also allow the dynamic diagnosing analyzer to predict the outcomes of various diagnostic tests. For example, say that a certain diagnosis has five known etiologies. Based upon historical iterations involving similar patients and known medical frequencies, the dynamic diagnosing analyzer may determine the relative likelihood of each etiology. The dynamic diagnosing analyzer may then select or eliminate etiologies in the most efficient manner. The selection may be based upon the likelihood of the etiology, the time and expense of the diagnostic test, etiological overlap of the tests, the likelihood of a false positive or a false negative for the diagnostic test, and other considerations.Paragraph 84, where “Figure 5 is the portion of a Patient Results Report displaying summary eGFR, blood pressure, and proteinuria according to one embodiment. The summary eGFR, blood pressure, and proteinuria depicted in figures 5 and 10 may graphically present one or more eGFR test results over time, (e.g., from the oldest recorded test to the most recent test). The Summary eGFR may present the eGFR test results in a format that also shows the stage of CKD disease for the patient over time. In one embodiment, the 10 most recent tests are highlighted in brackets.”
Para. 7-8 wherein “ Embodiments of the invention are directed to a diagnostic care coordination system for assisting with treating a patient, the system comprising a diagnostic engine and a care engine. The diagnostic engine is configured to generate a working diagnosis of the patient. The diagnostic engine includes a static diagnosing web containing a plurality of information nodes and a dynamic diagnosing analyzer for presenting to a user a plurality of information requests. The dynamic diagnosing analyzer navigates a user through the plurality of information nodes of the static diagnosing web based upon received responses to said plurality of information requests. Based upon a route through the static diagnosing web as taken by the dynamic diagnosing analyzer, the diagnostic engine generates the working diagnosis. The care engine determines a treatment plan based upon said working diagnosis. The treatment plan includes a set of care steps. The care engine oversees administration of the set of care steps to determine whether a patient response to the treatment plan is consistent with the working diagnosis.
[0008] Embodiments of the invention are directed to a diagnostic engine for assisting with treating a patient, the diagnostic engine comprising a static diagnosing web and a dynamic diagnosing analyzer. The static diagnosing web contains a plurality of information nodes. The dynamic diagnosing analyzer presents to a user a plurality of information requests based upon the information nodes. The dynamic diagnosing analyzer navigates a user through the information nodes of the static diagnosing web based upon received responses from said plurality of information requests. Based upon a route through the static diagnosing web as taken by the dynamic diagnosing analyzer, the diagnostic engine generates a working diagnosis, which includes a working etiology indicative of a cause or source of the working diagnosis.
Para. 74 wherein “ Also attached to system bus 504 is graphics card 510. In some embodiments, graphics card 510 may not be a physically separate card, but rather may be integrated into the motherboard or the CPU 506. In some embodiments, graphics card 510 has a separate graphics-processing unit (GPU) 512, which can be used for graphics processing or for general purpose computing (GPGPU). Also on graphics card 510 is GPU memory 514. Connected (directly or indirectly) to graphics card 510 is display 516 for user interaction. In some embodiments no display is present, while in others it is integrated into computer 502. Similarly, peripherals such as keyboard 518 and mouse 520 are connected to system bus 504. Like display 516, these peripherals may be integrated into computer 502 or absent. Also connected to system bus 504 is local storage 522, which may be any form of computer-readable media, and may be internally installed in computer 502 or externally and removably attached.”
The claims recite the additional element of obtaining a working diagnosis, navigating the user through nodes, generating a treatment plan, receiving patient response information, and automatically associating timestamps with patient response which amounts to extra-solution activity concerning mere data displaying or provide the mechanism or steps for carrying out the diagnostic evaluation. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 4-8, 12-15, and 17-24 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 2, 4-6, 9, 12-16, and 18-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. (US 2009/0062623 A1) in view of Lynn et al. (US 2009/0281839 A1).
In claim 2, a method for artificial intelligence-based rapid response event management associated with a patient instance, the method comprising:
Cohen 3333 teaches:
generating a static diagnosing web comprising a plurality of information nodes, wherein one or more information requests are associated with the plurality of information nodes, wherein each information node of at least a subset of the plurality of information nodes comprises an inquiry, question, or information field, and wherein at least some information nodes of the plurality of information nodes are connected to other information nodes of the plurality of information nodes (Fig. 4 wherein decision tree nodes correspond to medical questions Is taught. In addition, Fig. 4 teaches wherein questions are conditionally linked to other questions);
obtaining a working diagnosis based at least in part on utilizing a dynamic diagnosing analyzer to perform a step of (Para. 22, 25, and 27 wherein ):
navigating, by the dynamic diagnosing analyzer, a user through the plurality of information nodes based on received responses to the one or more information requests, comprising: (Para. 20 and 22-23 wherein subsequent questions are selected based on responses”);
prompting the user with the one or more information requests by generating a first prompt based on a first information request associated with a first node of the plurality of information nodes (Para. 4 and 23); and
navigating from a first node to a second node based on a received response from the received responses to an information request from the one or more information requests by traversing, by the dynamic diagnosing analyzer, a connection between the first node and the second node based on the received response, wherein the working diagnosis is generated based on a route through the static diagnosing web including the first node and the second node (Para. 23 and Fig. 4 wherein the response determines the branch on a decision tree);
generating a treatment plan based on the working diagnosis, the treatment plan comprising an order of one or more care steps (Para. 34, 37, and 38 wherein medication recommendation associated with a medical condition is taught))
receiving response information of a patient associated with the patient instance to the treatment plan, wherein the response information comprises at least one of signs, symptoms, or events associated with the patient instance (Para. 38); and
Cohen does not explicitly teach however Lynn teaches
automatically associating timestamps with the response information and completed care steps associated with the order of the one or more care steps (Para. 199 and 201).
It would have been obvious to one of ordinary skill at the time of invention to modify Cohen’s diagnostic and treatment support system to incorporate Lynn’s processor-based association of time information with treatment events and physiological response. This modification would allow Cohen’s system to track when treatments were administered and when patient response occurred facilitating evaluation of treatment effectiveness and timely follow up care.
As per claim 4, Cohen teaches the method of claim 2, further comprising: receiving one or more physiological readings from a patient monitoring device, wherein the working diagnosis is based at least in part on the one or more physiological readings from the patient monitoring device (Para. 28).
As per claim 5, Cohen in view of Lynn teach the method of claim 2. Cohen does not explicitly teach however Lynn teaches, further comprising: generating a timing recommendation for at least one care step from the order of the one or more care steps (Para. 288); and
causing display of, via a visual interface, the timing recommendation for the at least one care step from the order of the one or more care steps (Para. 288). The motivation to combine references is the same as seen in claim 2.
As per claim 6, Cohen in view of Lynn teach the method of claim 5. Cohen does not explicitly teach however Lynn teaches wherein the at least one care step from the order of the one or more care steps comprises an administration of a medication (Para. 311, 325, and 380); wherein the response information is indicative of the administration of the medication (Para. 311, 325 and 380). The motivation to combine references is the same as seen in claim 2.
As per claim 15, Cohen in view of Lynn teach the system of claim 14. Cohen does not explicitly teach however Lynn teaches the system of The system of wherein the records engine exports the received responses and the timestamps to an external electronic health record system (Para. 140 and 201). The motivation to combine references is the same as seen in claim 2.
As per claim 18, Cohen teaches the one or more non-transitory computer-readable media of claim 16 wherein the treatment plan is revisable by the user (Para. 37-38).
As per claim 20, Cohen in view of Lynn teach the one or more non-transitory computer-readable media of 16. Cohen does not explicitly teach however Lynn teaches wherein the method further comprises:
transferring the patient instance, including the working diagnosis, the treatment plan, and the timestamps, to a second user device of a second user associated with a different specialty or care facility (Para. 181 wherein treatment plans can be shared with other users),
wherein the user is a first user, the first user being associate with a first user device (Para. 20). The motivation to combine references is the same as seen in claim 2.
As per claim 21, Cohen in view of Lynn teach the one or more non-transitory computer-readable media of claim 20, Cohen does not explicitly teach however Lynn teaches wherein the treatment plan is adapted to the second user such that at least one information request for the one or more information requests is changed (Para. 181 wherein the information can be shared to other users that do not have access to patient safety image database). The motivation to combine references is the same as seen in claim 2.
As per claim 22, Cohen in view of Lynn teach the method of claim 2. Cohen does not explicitly teach however Lynn teaches, further comprising: determining an etiology of the working diagnosis utilizing the dynamic diagnosing analyzer, comprising:
predicting an outcome of at least one diagnostic test from one or more diagnostic tests, wherein the etiology is determined by analyzing at least the one or more diagnostic tests (Para. 287 and 342-344). The motivation to combine references is the same as seen in claim 2.
As per claim 23, Cohen in view of Lynn teach the system of claim 9. Cohen does not explicitly teach however Lynn teaches
wherein the dynamic diagnosing analyzer is further operable to generate one or more etiologies of the working diagnosis; wherein the dynamic diagnosing analyzer is further operable to recognize, based on the patient instance and at least one historical patient instance, a likelihood of each etiology from the one or more etiologies (Para. 342-356). The motivation to combine references is the same as seen in claim 2.
Claims 9, 12-14, 16, 19, and 24 recite substantially similar limitations as seen in the claims above and hence are rejected for similar rationale as noted above.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. (US 2009/0062623 A1) in view of Lynn et al. (US 2009/0281839 A1)as applied to claims above, and further in view of Freeman et al. (US 2014/0201627 A1).
As per claim 7, Cohen teaches the method of claim 2, further comprising: receiving a category selection of a category from a plurality of initial diagnosis based on an initial diagnosis specified by the user (Para. 19 and 22 wherein the patient selects a health topic from the displayed categories and then uses the selection to choose the corresponding diagnostic tree). Cohen does not explicitly teach however Freeman teaches:
wherein the category is for the code blue medical event (Para. 115, 119-121 wherein caregiver can select cardiac arrest diagnostic protocol is taught).
It would have been obvious to one of ordinary skill at the time of invention to modify the diagnostic system of Cohen and Lynn to incorporate Freeman selectable emergency diagnosis and treatment pathways and protocols. This modification would enable a caregiver to select a pathway relevant to the patient’s presenting condition or confirmed diagnosis and receive corresponding diagnostic and treatment guidance during an emergency. Incorporating Freeman’s emergency pathways would predictably direct the caregiver to questions and care steps appropriate to the selected clinical condition.
As per claim 8, Cohen in view of Lynn teaches the method of claim 2. Cohen and Lynn do not explicitly teach however Freeman teaches, further comprising:
receiving information indicative of an end to the code blue medical event (115, 119-121); and
in response to the end of the code blue medical event, generating a record of the completed care steps of the code blue medical event (115, 119-121). The motivation to combine references is the same as seen in claim 7.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. (US 2009/0062623 A1) in view of Lynn et al. (US 2009/0281839 A1) as applied to claims above, and further in view of Dew (US 2003/0033169 A1).
As per claim 17, Cohen in view of Lynn teach the method of claim 2. Cohen and Lynn do not explicitly teach however Dew teaches one or more non-transitory computer-readable media of wherein each node from the plurality of information nodes is associated with at least one billing code (Para. 21, 27, 33, and 38 wherein medical codes are used to generate an invoice containing billing codes ). It would have been ordinary skill at the time of filling to modify Cohen and Lynn diagnostic system to incorporate Dew’s automatic assignment of diagnosis and procedure codes as clinical decision tree branches with the generating of billing codes. This would allow information collected during diagnostic navigation to support billing without requiring staff to separately reconstruct and code the medical encounter, thereby reducing duplicate data entry.
Response to Arguments
Applicant arguments with respect to the 101 and art rejection are moot in view of new grounds of rejections necessitated by claim amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MAROUN P KANAAN whose telephone number is (571)270-1497. The examiner can normally be reached Monday-Friday 8:00-5:00.
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, Mamon Obeid can be reached at (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
MAROUN P. KANAAN
Primary Examiner
Art Unit 3687
/MAROUN P KANAAN/ Primary Examiner, Art Unit 3687
