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 claims filled on 12/10/2024 for application 18/975592.
Claim 1 has been canceled.
Claims 2-21 have been added new and 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 2-21 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 2-21 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 recite generating a static diagnosing web; generating a treatment plan; and associating timestamps with the response information and completed care steps associated with the order of the one or more care steps.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity by identifying and reporting events preceding a pattern in a set of user data. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. 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 engine (as seen in claim 9) and a non-transitory computer readable media (as seen claim 16), which are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The claims recite the additional element of obtaining a working diagnosis and receiving response information of a patient, which are considered limitations directed to insignificant extra-solution activity that does not amount to an inventive concept because the limitations do not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. In the claimed context, the claimed receiving limitations are incidental to the performance of the recited abstract idea of identifying and reporting events preceding a pattern in a set of user data. See: MPEP 2106.05(g).
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
Paragraph 7 wherein “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.”
Paragraph 73 wherein “Fig. 5, the physical hardware that makes up the system will now be discussed. The system 500 comprising an exemplary hardware platform that can form one element of certain embodiments of the invention is depicted. Computer 502 can be a desktop computer, a laptop computer, a server computer, a mobile device such as a smartphone or tablet, or any other form factor of general- or special-purpose computing device. Depicted with computer 502 are several components, for illustrative purposes. In some embodiments, certain components may be arranged differently or absent. Additional components may also be present. Included in computer 502 is system bus 504, whereby other components of computer 502 can communicate with each other. In certain embodiments, there may be multiple busses or components may communicate with each other directly. Connected to system bus 504 is central processing unit (CPU) 506. Also attached to system bus 504 are one or more random-access memory (RAM) modules 508.”
Paragraph 78, where “The memory elements may be capable of storing or retaining the computer program and may also store data, typically binary data, including text, databases, graphics, audio, video, combinations thereof, and the like. The memory elements may also be known as a “computer- readable storage medium” and may include random access memory (RAM), read only memory (ROM), flash drive memory, floppy disks, hard disk drives, optical storage media such as compact discs (CDs or CDROMs), digital video disc (DVD), and the like, or combinations thereof. In addition to these memory elements, the server devices may further include file stores comprising a plurality of hard disk drives, network attached storage, or a separate storage network.”
The claims recite the additional element of obtaining a working diagnosis and receiving response information of a patient associated with the patient, which amounts to extra-solution activity concerning mere data gathering. 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) 3-8, 10-15, and 17-21 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. For instance claim 3 further defines the extra solution activity of what data is being displayed; Claim 4 further defines what the extra solution activity of receiving data; Claim 5 defines the extra solution activity of displaying information; Claim 6 further defines the extra solution activity of administering medication; and claims 7-8 further define the extra solution of receiving information. 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 2-21 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2-21 of U.S. Patent No 12191039, 1-20 of US Patent No. 11769593, and claims 1-20 of U.S. Patent No. 15/017072 . Although the claims at issue are not identical, they are not patentably distinct from each other because for the reasons set forth below. Although the conflicting claims are not identical, they are not patentably distinct from each other because the differences between the steps recited in the claims of ’039, ‘593, and ‘072 and the system of the instant application would have been deemed obvious by one skilled in the art.
For example, with respect to claim 1 of ‘039 teaches “presenting a plurality of data queries of a patient's health to a user including patient history, symptoms, and events; receiving a plurality of data query responses, the plurality of data query responses comprising at least one of prepopulated responses, natural language text strings generated from voice recognition, or user selections; traversing a static node graph by following a route through the static node graph with a dynamic analyzer, the route based on the plurality of data query responses; analyzing the plurality of data query responses through the dynamic analyzer; generating a first working etiology and a second working etiology based on the route through the static node graph; generating a first diagnosis and a second diagnosis based on at least one of the first working etiology, the second working etiology or the plurality of data query responses, the first diagnosis and the second diagnosis determined by the dynamic analyzer; and presenting the first diagnosis, the second diagnosis, the first working etiology, and the second working etiology to the user.” Accordingly, while the language varies slightly as between the two claims, the language in each of these claims is describing a feature that is the same or a mere obvious variation of that recited in the other claim. The remaining claims of the instant application similarly encompass features that one skilled in the art would recognize as the same or obvious variants of features recited in claims 1-19 of ‘039.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2-6, 9-16, and 18-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lynn et al (US 2009/0281839 A1).
In claim 2, a method for managing a code blue medical event associated with a patient instance, the method comprising:
Lynn 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 (Para. 415 wherein interactive environment nodes may be collapsed or expanded);
obtaining a working diagnosis based at least in part on utilizing a dynamic diagnosing analyzer to perform a step of (Para. 94 wherein building a dynamic real-time image of disease, injury, and/or drug reactions, the care provided, and the expense associated with the care is taught):
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 (Para. 94 wherein “The measurements of various mediators, ions, biologic profiles, as well as standard blood tests, and the outputs of vital sign monitors may begin to vary as a function of these early physiologic perturbations and responses”);
generating a treatment plan based on the working diagnosis, the treatment plan comprising an order of one or more care steps (Para. 107 wherein many patient data is analyzed to produce a treatment)
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. 131 wherein “the processor will automatically consider alternate pyramids under certain conditions--such as the existence of perturbation for which no precursors may be identified. The sudden existence of perturbation or of divergence may, by considering the range of possible precursors, suggest anomalous conditions: inaccurate diagnosis, faulty monitoring equipment, labeling mistakes, the failure of a patient to take medication as prescribed, to name a few. According to one aspect, the values and/or patterns of the blood tests such as the inflammatory mediators is/are compared to the image(s) of physiologic perturbation or to the pattern(s) or values of at least one physiologic parameter, such as the pulse rate, respiration rate, and/or ventilation oximetry index to name a few. Upon the detection of an apparent relationship, the processor may automatically order a sufficing number of sequential blood tests to confirm that the pattern of the parameter is convergent with the pattern of the blood test thereby providing strong supporting evidence, reinforcing redundant evidence, that the physiologic parameter and the mediator have a common physiologic failure based linkage, such as the failure of sepsis for example”); and
automatically associating timestamps with the response information and completed care steps associated with the order of the one or more care steps (Para. 132).
As per claim 3, Lynn teaches the method of claim 2, further comprising: causing display of, based on the response information, a list of selectable events associated with the patient instance (Para. 149 wherein “the processor may be programmed such that the user may select each alpha event and allow the processor to detect, offer, and/or derive events and relational binaries, which have specified temporal, frequency, or spatial relationships with the selected event object”).
As per claim 4, Lynn 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. 152).
As per claim 5, Lynn teaches the method of claim 2, 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).
As per claim 6, Lynn teaches the method of The method of 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 and 380); wherein the response information is indicative of the administration of the medication (Para. 311 and 380).
As per claim 15, 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).
As per claim 18, Lynn teaches the one or more non-transitory computer-readable media of The one or more non-transitory computer-readable media of wherein the treatment plan is revisable by the user (Para. 103).
As per claim 20, Lynn teaches the one or more non-transitory computer-readable media of 16, 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).
As per claim 21, Lynn teaches the one or more non-transitory computer-readable media of claim 20, 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).
Claims 9-14, 16, 19 recite substantially similar limitations as seen in the claims above and hence are rejected for similar rationale as noted above.
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) 7, 8, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lynn et al. (US 2009/0281839 A1) in view of Choubey (US 2010/0274588 A1)
As per claim 7, Lynn teaches the method of claim 2. Lynn does not explicitly teach however Choubey 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, wherein the category is for the code blue medical event (abstract and Para. 6 wherein diagnosis events can be classified in different categories is taught). It would have been obvious to one of ordinary skill at the time of invention to combine the dynamic analysis of physiological data of patient using with the management of billing workflow as taught in Choubey. The well-known elements described are merely a combination of old elements, and in combination, each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
As per claim 8, Lynn teaches the method of claim 2. Lynn does not explicitly teach however Choubey teaches, further comprising:
receiving information indicative of an end to the code blue medical event (Para. 6 wherein emergency code events can be classified); 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 (Para. 6 and 31). The motivation to combine references is the same as seen in claim 7.
As per claim 17, Lynn teaches the method of claim 2. Lynn does not explicitly teach however Choubey 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. 6). The motivation to combine references is the same as seen in claim 7.
Conclusion
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.
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MAROUN P. KANAAN
Primary Examiner
Art Unit 3687
/MAROUN P KANAAN/ Primary Examiner, Art Unit 3687