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 .
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 e-Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about e-Terminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 8, and 15 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 11, and 17 of U.S. Patent No. 12,148,512 in view of U.S. 2015/0363567 to Pettus. The present invention claims less of that of the patent, but now changes the intervening action to that of a particular treatment procedure.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claims 1 and 8 recite an administration of a particular treatment to the patient but this step involves the usage of technology/a processor. The specification appears to lack support of this administration step being performed by a computer. Additionally, the specification appears to lack support for the administration step entirely for claims 1, 8, and 15.
Claims 2-7, 9-14, and 16-20 are rejected based on their dependency on claims 1, 8, and 15.
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 1-20 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 1-7 are drawn to a system, claims 8-14 are drawn to a non-transitory media, and claims 15-20 are drawn to a method, each of which is within the four statutory categories. Claims 1-20 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 1 recites a system having a) one or more hardware processors configured to facilitate a plurality of operations, the operations comprising:
1) determining that a falls risk assessment is to be presented (a) on b) a clinician device, (b) for clinical input comprising falls-risk assessment information (c) in order to include the falls-risk assessment information as an update in c) an electronic health record (EHR) of a patient;
2) after determining that the falls risk assessment is to be presented on the clinician device, causing presentation of a prompt at the clinician device for the clinical input comprising the falls-risk assessment information;
3) based on the clinical input: (i) storing the falls-risk assessment information for the patient to the EHR and (ii) initiating generation of an order to assign d) processor based virtual sitter technology; and
4) subsequent to assigning the virtual sitter technology, e) electronically receiving an update for the patient, the update corresponding to data associated with operation of the virtual sitter technology, wherein:
4a) in response at least to receiving the update for the patient, an intervening action comprising a particular treatment procedure is administered to the patient in connection with treating a particular condition associated with at least one of the clinical input, the falls-risk assessment information, the update, or the data.
Claim 1 recites, in part, performing the steps of 1) determining that a falls risk assessment is to be presented (b) for clinical input comprising falls-risk assessment information (c) in order to include the falls-risk assessment information as an update in a health record (HR) of a patient, 2) after determining that the falls risk assessment is to be presented, causing presentation of a prompt for the clinical input comprising the falls-risk assessment information, 3) based on the clinical input: (i) storing the falls-risk assessment information for the patient to the HR and (ii) initiating generation of an order to assign a sitter, and 4) subsequent to assigning the sitter, receiving an update for the patient, the update corresponding to data associated with operation of the sitter, wherein: 4a) in response at least to receiving the update for the patient, an intervening action comprising a particular treatment procedure is administered to the patient in connection with treating a particular condition associated with at least one of the clinical input, the falls-risk assessment information, the update, or the data. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, one can determine if a patient needs monitoring and assign a sitter to them. Independent claims 8 and 15 recite similar limitations and are also directed to an abstract idea under the same analysis.
Depending claims 2-7, 9-14, and 16-20 include all of the limitations of claims 1, 8, and 15, and therefore likewise incorporate the above described abstract idea. Depending claims 2-7, 9-14, and 16-20 further specify elements from the claims which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2-7, 9-14, and 16-20 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 8, and 15 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using a) one or more hardware processors, b) a clinician device, c) an electronic health record (EHR), d) processor based virtual sitter technology, e) electronically receiving, f) electronically monitoring (from claims 2-5, 9-12, and 16-19), and g) a processor coupled camera (from claims 2-4, 6, 9-11, 13, 16-18, and 20) to perform the claimed steps.
The a) one or more hardware processors, b) a clinician device, c) an electronic health record (EHR), d) processor based virtual sitter technology, e) electronically receiving, f) electronically monitoring, and g) a processor coupled camera in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification for a lack of description of anything non-generic for these components, see MPEP 2106.05(f)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, 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 (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, the additional elements of using a) one or more hardware processors, b) a clinician device, c) an electronic health record (EHR), d) processor based virtual sitter technology, e) electronically receiving, f) electronically monitoring, and g) a processor coupled camera to perform the claimed steps amounts to no more than mere instructions to apply the exception using generic computer components that do not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity. Specifically, MPEP 2106.05(f) recite that the following limitations are not significantly more:
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)).
The current invention administers a treatment utilizing a) one or more hardware processors, b) a clinician device, c) an electronic health record (EHR), d) processor based virtual sitter technology, e) electronically receiving, f) electronically monitoring, and g) a processor coupled camera, thus these computing components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 1-20 are therefore 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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, 6-9, 13-16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2017/0147770 to Xu et al. in view of U.S. Patent No. 9,368,014 to Bittman and further in view of U.S. 2015/0363567 to Pettus.
As per claim 1, Xu et al. teaches a system having one or more hardware processors configured to facilitate a plurality of operations, the operations comprising:
--based on the clinical input: (i) storing the assessment information for the patient to the EHR (see: paragraph [0026] where based on the spot check data and EMR data (clinical input), certain things occur. Patients are monitored continuously. Thus, there is generation of information which is used for assessment of the patient here and it is at least stored in memory temporarily) and (ii) initiating generation of an order to assign processor based virtual sitter technology; (see: paragraph [0026] where based on the spot check data and EMR data (clinical input), certain things occur. A continuous monitoring assignment (order) using monitoring devices (virtual sitter technology) is determined) and
--subsequent to assigning the virtual sitter technology, electronically receiving an update for the patient, the update corresponding to data associated with operation of the virtual sitter technology (see: paragraphs [0016] and [0026] where there is continuous monitoring of or updates of a patient’s condition. Thus, after it is determined that continuous monitoring is to remain assigned, an update is being received via the monitoring device (virtual sitter technology)).
Xu et al. may not further, specifically teach:
1) --assessment as falls-risk assessment;
2) --determining that a assessment is to be presented (a) on a clinician device, (b) for clinical input comprising assessment information (c) in order to include the assessment information as an update in an electronic health record (EHR) of a patient;
3) --after determining that the assessment is to be presented on the clinician device, causing presentation of a prompt at the clinician device for the clinical input comprising the assessment information; and
4) --wherein:
--in response at least to receiving the update for the patient, an intervening action comprising a particular treatment procedure is administered to the patient in connection with treating a particular condition associated with at least one of the clinical input, the assessment information, the update, or the data.
Bittman et al. teaches:
1) --assessment as falls-risk assessment; (see: column 1, lines 37-50 where falls is an issue, and column 5, lines 53-56 where issue is being assessed)
2) --determining that a assessment is to be presented (a) on a clinician device, (b) for clinical input comprising assessment information (c) in order to include the assessment information as an update in an electronic health record (EHR) of a patient; (see: column 4, line 56 to column 5, line 7 where there is a determination to send an alert to a clinician. The alert is for the clinician to update the patient’s info using the documentation notes) and
3) --after determining that the assessment is to be presented on the clinician device, causing presentation of a prompt at the clinician device for the clinical input comprising the assessment information (see: column 5, lines 3-15 where a second window/prompt is sent to the clinician to input information. This is sent after it is determined that an assessment needs to be sent to the clinician).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a falls-risk assessment as taught by Bittman for the assessment as disclosed by Xu et al. since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Xu et al. already teaches of using an assessment thus one could substitute another assessment to obtain predictable results of using an assessment information. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute 2) determine that an assessment is to be presented (a) on a clinician device, (b) for clinical input comprising assessment information (c) in order to include the assessment information as an update in an electronic health record (EHR) of a patient and 3) after determining that the assessment is to be presented on the clinician device, causing presentation of a prompt at the clinician device for the clinical input comprising the assessment information as taught by Bittman for how the information is being collected as disclosed by Xu et al. since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, Xu et al. already teaches of collecting information thus one could substitute another way to collect information to obtain predictable results of obtaining information. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
Pettus teaches:
4) --wherein:
--in response at least to receiving the update for the patient, an intervening action comprising a particular treatment procedure is administered to the patient in connection with treating a particular condition associated with at least one of the clinical input, the assessment information, the update, or the data (see: paragraph [0062] where there is an assessment to a falls risk. Also see: paragraphs [0066] and [0067] where there is treatment in response to the updated patient information).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have 4) wherein: in response at least to receiving the update for the patient, an intervening action comprising a particular treatment procedure is administered to the patient in connection with treating a particular condition associated with at least one of the clinical input, the assessment information, the update, or the data as taught by Pettus in the system as taught by Xu et al. and Bittman in combination with the motivation(s) of improving the patient’s overall health (see: paragraph [0048] of Pettus).
As per claim 2, Xu et al., Bittman, and Pettus in combination teaches the system of claim 1, see discussion of claim 1. Xu et al. further teaches wherein the order is associated with activation of a processor coupled device in a patient room, and wherein the operations further comprise: electronically monitoring electronic-signal information associated with the device to generate the update (see: paragraph [0026] where the determination here is associated with using monitoring devices to monitor patients. Thus the order there to monitor the patient is associated with the activation of a monitoring device in the patient’s room).
Pettus et al. further teaches a device as a camera (see: paragraph [0102] where there is a camera as a device).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 6, Xu et al., Bittman, and Pettus in combination teaches the system of claim 1, see discussion of claim 1. Xu et al. further teaches wherein generating the order corresponds to information associated with the EHR being determined as similar to information associated with other assignments of virtual sitter technology, (see: paragraph [0018] and [0026] where a continuous monitoring assignment (order) is based on a comparison of current EMR information and retrospective data which define thresholds. The retrospective data includes other patients/recipients of the monitoring technology. Thus the patient’s info is being deemed similar to other recipients’ information when comparing the patient with the thresholds) and wherein the update corresponds to: data associated with operation of a processor coupled device in a patient room after the assignment of the virtual sitter technology (see: paragraphs [0016] and [0026] where there is continuous monitoring of or updates of a patient’s condition. Thus, after it is determined that continuous monitoring is to remain assigned, an update is being received via the monitoring device (virtual sitter technology)).
Pettus et al. further teaches a device as a camera (see: paragraph [0102] where there is a camera as a device. Russell et al. also teaches of remote monitoring using a camera).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 7, Xu et al., Bittman, and Pettus in combination teaches the system of claim 6, see discussion of claim 6. Xu et al. further teaches wherein a determination to continue the virtual sitter technology indicates that information associated with the update is determined to be similar to information associated with EHRs of other virtual sitter technology continuances (see: paragraph [0018] and [0026] where a continuous monitoring assignment (order) is based on a comparison of current EMR information and retrospective data which define thresholds. The retrospective data includes other patients/recipients of the monitoring technology. Thus the patient’s info is being deemed similar to other recipients’ information when comparing the patient with the thresholds).
As per claim 8, claim 8 is similar to claim 1 and is therefore rejected in a similar manner to claim 1.
As per claim 9, claim 9 is similar to claim 2 and is therefore rejected in a similar manner to claim 2.
As per claim 13, claim 13 is similar to claim 6 and is therefore rejected in a similar manner to claim 6.
As per claim 14, claim 14 is similar to claim 7 and is therefore rejected in a similar manner to claim 7.
As per claim 15, claim 15 is similar to claim 1 and is therefore rejected in a similar manner to claim 1.
As per claim 16, claim 16 is similar to claim 2 and is therefore rejected in a similar manner to claim 2.
As per claim 20, claim 20 is similar to claim 6 and is therefore rejected in a similar manner to claim 6.
Claims 3-5, 10-12, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2017/0147770 to Xu et al. in view of U.S. Patent No. 9,368,014 to Bittman and further in view of U.S. 2015/0363567 to Pettus as applied to claims 2, 9, and 16, and further in view of U.S. 2015/0221202 to Russell et al.
As per claim 3, Xu et al., Bittman, and Pettus in combination teaches the system of claim 2, see discussion of claim 2. The combination may not further, specifically teach wherein the electronic-signal information associated with the camera is electronically monitored via a processor based virtual sitter device to generate the update.
Russell et al. teaches:
--wherein the electronic-signal information associated with the camera is electronically monitored via a processor based virtual sitter device to generate the update (see: paragraphs [0020], [0025], and [0027] where there is remote monitoring using sensors and that there is camera movement detectors are sensors).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein the electronic-signal information associated with the camera is electronically monitored via a processor based virtual sitter device to generate the update as taught by Russell et al. in the system as taught by Xu et al., Bittman, and Pettus in combination with the motivation(s) of monitoring bed-ridden patients (see: paragraph [0006] of Russell et al.).
As per claim 4, Xu et al., Bittman, Pettus, and Russell et al. in combination teaches the system of claim 3, see discussion of claim 3. Xu et al. further teaches wherein the virtual sitter device is configured to electronically monitor, from a location remote to the device, the electronic-signal information (see: paragraph [0017] where continued monitoring is occurring for the patient’s condition. Also see: FIG. 2 where there is a diagram of what happens with the monitored information. Thus the continuous monitoring here is communicating updated assessment information about the patient’s condition here. Also see: paragraph [0015] where remote telehealth solutions may be applied).
Pettus et al. further teaches a device as a camera (see: paragraph [0102] where there is a camera as a device. Russell et al. also teaches of remote monitoring using a camera).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 5, Xu et al., Bittman, Pettus, and Russell et al. in combination teaches the system of claim 4, see discussion of claim 4. Xu et al. further teaches wherein the virtual sitter device is further configured to electronically communicate a particular update associated with assessment information corresponding to the patient based on the electronic monitoring (see: paragraphs [0016] and [0026] where there is continuous monitoring of or updates of a patient’s condition. Thus, after it is determined that continuous monitoring is to remain assigned, an update is being received via the monitoring device (virtual sitter technology)).
Bittman et al. further teaches assessment as falls-risk assessment (see: column 1, lines 37-50 where falls is an issue, and column 5, lines 53-56 where issue is being assessed).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 10, claim 10 is similar to claim 3 and is therefore rejected in a similar manner to claim 3.
As per claim 11, claim 11 is similar to claim 4 and is therefore rejected in a similar manner to claim 4.
As per claim 12, claim 12 is similar to claim 5 and is therefore rejected in a similar manner to claim 5.
As per claim 17, claim 17 is similar to claim 3 and is therefore rejected in a similar manner to claim 3.
As per claim 18, claim 18 is similar to claim 4 and is therefore rejected in a similar manner to claim 4.
As per claim 19, claim 19 is similar to claim 5 and is therefore rejected in a similar manner to claim 5.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri).
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684