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 .
Response to Amendment
The previous double patenting rejections remain.
The IDSes have been considered.
In light of the amendments, the previous 112(b) rejections are withdrawn.
In light of the amendments, the claims are rejected under 35 U.S.C. 101.
In light of the amendments, the claims are rejected under 35 U.S.C. 103.
Notice to Applicant
In the amendment dated 11/12/2025, the following has occurred: claims 1 and 17 have been amended; claims 2-16 and 18-20 remain unchanged; and no new claims have been added.
Claims 1-20 are pending.
Effective Filing Date: 06/20/2017
Response to Arguments
Double Patenting:
Applicant requests the double-patenting rejections be held in abeyance until the claims are otherwise in condition for allowance. Accordingly, the previous double patenting rejections remain.
35 U.S.C. 112(b) Rejections:
Applicant has overcome the previous 112(b) rejections. Examiner withdraws these rejections.
35 U.S.C. 101 Rejections:
Applicant argues that the claims recite limitations which are additional elements. The limitations which Applicant are referring to are in fact actually part of the abstract idea.
Applicant further states that a technical problem in the field of providing neurostimulation via implantable neurostimulators by allowing physicians to monitor the status of multiple patients without having to re-interrogate each patient’s implantable device. This is comparable to having information about a patient without having to connect with the neurostimulator, and having a person review this information for multiple patients.
35 U.S.C. 103 Rejections:
Applicant argues that Kamen does not teach Examiners rejection and citations. Applicant further states that Kamen does not teach determining a status of a progression of a treatment based on treatment parameters that were received during an initial interrogation of a device of a patient. Specifically, Applicant states that the Kamen reference fails to teach “receiving…titration parameters for a plurality of patient…the titration parameters being received for each patient during an initial interrogation of an implantable neurostimulator of the patient” and “determining…a status of a progression off the titration of the neurostimulator for each patient based on the titration parameters, the status of the progression of the titration for each patient including a current stimulation parameter for the patient”. These limitations however are taught using the Kamen, Libbus et al., and Suneja et al. references. Kamen teaches that the parameters are received during an initial interrogation, as when the information is being received from the device and used one can say that is the initial interrogation. Libbus et al. teaches both treatment as titration of neurostimulation and devices as implantable neurostimulators, while Suneja et al. teaches of determining a priority of each patient based on the progress of a treatment in the form of a procedure. Separately these references do not teach the entirety of the claim limitations, but together they do.
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 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.
Claims 1-20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,029,591. Although the claims at issue are not identical, they are not patentably distinct from each other because the present application uses less limitations of from the patent, but these present limitations are the same ones used in the patent without any additional functionalities.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/12/2025, 11/20/2025, and 12/31/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 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 1-8 are drawn to a method, claims 9-16 are drawn to a device, and claims 17-20 are drawn to a medium, 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 method of managing a plurality of patients using a management device, comprising:
1) receiving, via a) a processor, titration parameters for a plurality of patients undergoing titration of neurostimulation delivered via implantable neurostimulators, the titration parameters being received for each patient during an initial interrogation of an implantable neurostimulator of the patient,
2) determining, via the processor, a status of a progression of the titration of the neurostimulation for each patient based on the titration parameters, the status of the progression of the titration for each patient including a current stimulation parameter for the patient,
3) determining, via the processor, a priority of each patient based on the status of the progression of the titration for the patient,
4) generating, via the processor, a user interface visually indicating the priority and the current stimulation parameter of each patient,
5) receiving, via the processor, an update of a selected stimulation parameter for a selected patient via an input received on the user interface, and
6) transmitting, via the processor, the update of the selected stimulation parameter to the implantable neurostimulator of the selected patient.
Claim 1 recites, in part, performing the steps of 1) receiving titration parameters for a plurality of patients undergoing titration of neurostimulation delivered via implantable neurostimulators, the titration parameters being received for each patient during an initial interrogation of an implantable neurostimulator of the patient prior to the patient (the interrogation can be part of the abstract idea as claimed), 2) determining a status of a progression of the titration of the neurostimulation for each patient based on the titration parameters, the status of the progression of the titration for each patient including a current stimulation parameter for the patient, 3) determining a priority of each patient based on the status of the progression of the titration for the patient, 4) generating a user interface (can be constructed with a pen and paper) visually indicating the priority and the current stimulation parameter of each patient, and 5) receiving an update of a selected stimulation parameter for a selected patient via an input received on the user interface. 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, the claim describes how a person could update parameters on a device. Independent claims 9 and 17 recite similar limitations and is/are also directed to an abstract idea under the same analysis.
Depending claims 2-8, 10-16, and 18-20 include all of the limitations of claims 1, 9, and 17, and therefore likewise incorporate the above described abstract idea. Depending claims 2-8, 10-16, and 18-20 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2-8, 10-16, and 18-20 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 9, and 17 (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) management device comprising a1) a processor and a2) a circuitry (from claim 9) to perform the claimed steps.
The claims also include the additional element step of 6) “transmitting, via the processor, the update of the selected stimulation parameter to the implantable neurostimulator of the selected patient”.
The a) management device comprising a1) a processor and a2) a circuitry 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, paragraph [0042] where there is a general-purpose computer, see MPEP 2106.05(f)).
The additional element step of 6) “transmitting, via the processor, the update of the selected stimulation parameter to the implantable neurostimulator of the selected patient” in these steps adds insignificant extra-solution activity to the abstract idea which amounts to insignificant application, see MPEP 2106.05(g).
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) management device comprising a1) a processor and a2) a circuitry to perform the claimed steps and the additional element step of 6) “transmitting, via the processor, the update of the selected stimulation parameter to the implantable neurostimulator of the selected patient” amounts to no more than insignificant extra-solution activity in the form of WURC activity (well-understood, routine, and conventional activity) and mere instructions to apply the exception using a generic computer component that does 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(d) and MPEP 2106.05(f) recite that the following limitations are not significantly more:
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)); and
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 determines and transmits stimulation parameters utilizing a) management device comprising a1) a processor and a2) a circuitry, thus these components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Additionally, the additional element step of 6) “transmitting, via the processor, the update of the selected stimulation parameter to the implantable neurostimulator of the selected patient” in these steps add insignificant extra-solution activity/pre-solution activity in the form of WURC activity to the abstract idea. The following is an example of a court decision demonstrating computer functions as well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II): Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives stimulation parameter data, and transmits the data to an implantable neurostimulator over a network, for example the Internet.
Mere instructions to apply an exception using generic computer components or insignificant extra-solution activity in the form of WURC activity 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, 7-10, 15-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 10,380,321 to Kamen et al. in view of U.S. 2013/0158617 to Libbus et al. and further in view of U.S. 2016/0239778 to Suneja et al.
As per claim 1, Kamen et al. teaches a method of managing a plurality of patients using a management device, comprising:
--receiving, via a processor, treatment parameters for a plurality of patients undergoing treatment delivered via devices, (see: column 13, lines 17-23 and column 16, lines 57-67 where there is reception of data from a plurality of patient devices from various patients. Also see: column 44, lines 9-41 where there is reception of treatment parameters for patients and displaying of that data) the treatment parameters being received for each patient during an initial interrogation of a device of the patient; (see: column 12, lines 44-46 where there is interrogation of a monitor device. There is an initial interrogation of an infusion pump which is the monitoring device as explained in column 50, lines 13-21)
--determining, via the processor, a status of a progression of the treatment for each patient based on the treatment parameters, (see: column 12, lines 31-40 where there is a determination of a status of treatment progress of an infusion pump) the status of the progression of the treatment for each patient including a current parameter for the patient; (see: column 12, lines 31-40 and column 44, lines 9-41 where there is a current parameter for the patient in the form of operating parameters)
--generating, via the processor, a user interface visually indicating the current parameter of each patient; (see: column 122, lines 7-30 where there is displaying of a user interface which has been generated and visually indicates the current parameter/data of each patient)
--receiving, via the processor, an update of a selected parameter for a selected patient via an input received on the user interface; (see: column 73, lines 54-67 where there is receiving of an update to a parameter for a patient. Also see: column 70, lines 32-46 where there is an interface for a hub which accepts changes to settings) and
--transmitting, via the processor, the update of the selected parameter to the device of the selected patient (see: column 75, lines 1-21 where there is transmission of settings to a device to update that device. Also see: column 50, lines 12-48 where the settings here are infusion pump settings. This would include for an updated setting/parameter for a device which was selected by an individual).
Kamen et al. may not further, specifically teach:
1) --treatment as titration of the neurostimulation;
2) --parameter as stimulation parameter;
3) --determining, via the processor, a priority of each patient based on the status of the progression of the treatment for the patient;
4) --generating, via the processor, a user interface visually indicating the priority of each patient; and
5) --device(s) as implantable neurostimulator(s).
Libbus et al. teaches:
1) --treatment as titration of the neurostimulation; (see: paragraph [0020] where there is titration of the neurostimulation as a treatment)
2) --parameter as stimulation parameter; (see: paragraph [0019] where there are stimulation parameters) and
5) --device(s) as implantable neurostimulator(s) (see: paragraph [0020] where there is an implantable neurostimulator).
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 titration of the neurostimulation as taught by Libbus et al. for treatment as disclosed by Kamen 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, Kamen et al. already teaches of using a treatment thus one could substitute that treatment for another treatment and obtain predictable results of using a treatment. 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).
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute stimulation parameters as taught by Libbus et al. for parameters as disclosed by Kamen 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, Kamen et al. already teaches of using a parameter thus one could substitute that parameter for another parameter and obtain predictable results of using a treatment parameter. 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).
Lastly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute implantable neurostimulator(s) as taught by Libbus et al. for the device(s) as disclosed by Kamen 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, Kamen et al. already teaches of using treatment device thus one could substitute that stimulator for another treatment device and obtain predictable results of using a treatment device. 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).
Suneja et al. teaches:
3) --determining, via the processor, a priority of each patient based on the status of the progression of the treatment for the patient; (see: paragraph [0030] and [0061] and claim 2 where there is determining of a priority of each patient based on the progress status of the procedure) and
4) --generating, via the processor, a user interface visually indicating the priority of each patient (see: paragraph [0053] where there is color coding to show patient priority).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to 3) determine, via the processor, a priority of each patient based on the status of the progression of the treatment for the patient and 4) generate, via the processor, a user interface visually indicating the priority of each patient as taught by Suneja et al. in the method as taught by Kamen et al. and Libbus et al. in combination with the motivation(s) of enabling a care team to operate efficiently (see: paragraph [0021] of Suneja et al.).
As per claim 7, Kamen et al., Libbus et al., and Suneja et al. in combination teaches the method of claim 1, see discussion of claim 1. Kamen et al. further teaches wherein the update of the selected stimulation parameter is transmitted, by the processor, to the implantable neurostimulator of the selected patient from a remote location (see: column 37, lines 6-24 where there is updating of a device from a remote location. The device being an implantable neurostimulator was taught in the claim from which this claim depends on).
As per claim 8, Kamen et al., Libbus et al., and Suneja et al. in combination teaches the method of claim 7, see discussion of claim 7. Kamen et al. further teaches wherein the selected stimulation parameter is transmitted, by the processor, to the implantable neurostimulator of the selected patient from the remote location via one of cellular or internet communication (see: column 48, lines 37-62 where there is internet communications between devices which can be used to transmit information).
As per claim 9, claim 9 is similar to claim 1 and is therefore rejected in a similar manner to claim 1 using the Kamen et al., Libbus et al. and Suneja et al. references. Kamen et al. further teaches a management device for managing a plurality of patients, the management device comprising:
--circuitry (see: column 41, lines 20-31 where there is circuitry).
As per claim 10, Kamen et al., Libbus et al. and Suneja et al. in combination teaches the device of claim 9, see discussion of claim 9. Suneja et al. further teaches wherein the titration parameters are received via remote communication with at least one of a programming device, an implantable medical device, or a home management device (see: paragraph [0025] where there are devices in communication. There is a programming device here in the form of a mobile device for inputting information. Thus the received information here is done using a programming device).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 9, and incorporated herein.
As per claim 15, Kamen et al., Libbus et al., and Suneja et al. in combination teaches the device of claim 9, see discussion of claim 9. Kamen et al. further teaches wherein the update of the selected stimulation parameter is transmitted to the implantable neurostimulator of the selected patient when the implantable neurostimulator is located remotely from the management device (see: column 37, lines 6-24 where there is updating of a device from a remote location. The device being an implantable neurostimulator was taught in the claim from which this claim depends on).
As per claim 16, Kamen et al., Libbus et al., and Suneja et al. in combination teaches the device of claim 15, see discussion of claim 15. Kamen et al. further teaches wherein the selected stimulation parameter is transmitted to the implantable neurostimulator of the selected patient via one of cellular or internet communication (see: column 48, lines 37-62 where there is internet communications between devices which can be used to transmit information).
As per claim 17, claim 17 is similar to claim 1 and is therefore rejected in a similar manner to claim 1 using the Kamen et al., Libbus et al. and Suneja et al. references.
As per claim 19, Kamen et al., Libbus et al., and Suneja et al. in combination teaches the medium of claim 17, see discussion of claim 17. Kamen et al. further teaches wherein the update of the selected stimulation parameter is transmitted to the implantable neurostimulator of the selected patient from a remote location (see: column 37, lines 6-24 where there is updating of a device from a remote location. The device being an implantable neurostimulator was taught in the claim from which this claim depends on).
As per claim 20, Kamen et al., Libbus et al., and Suneja et al. in combination teaches the medium of claim 19, see discussion of claim 19. Kamen et al. further teaches wherein the selected stimulation parameter is transmitted to the implantable neurostimulator via one of cellular or internet communication (see: column 48, lines 37-62 where there is internet communications between devices which can be used to transmit information).
Claims 2-3, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 10,380,321 to Kamen et al. in view of U.S. 2013/0158617 to Libbus et al. and further in view of U.S. 2016/0239778 to Suneja et al. as applied to claims 1 and 9, and further in view of U.S. 2017/0007126 to Shahar.
As per claim 2, Kamen et al., Libbus et al. and Suneja et al. in combination teaches the method of claim 1, see discussion of claim 1. Suneja et al. further teaches the status as the status of the progression of the titration for the patient (see: FIG. 4 and paragraph [0061] where priorities for patient are being determined based on any or all of the real-time information. Also see: claim 2 where there is prioritizing of patients based on the procedural status (progression of treatment). Furthermore, the Libbus et al. reference discusses a procedure in the form of neurostimulation and could be combined with Suneja et al.).
Kamen et al., Libbus et al. and Suneja et al. in combination may not further, specifically teach wherein the priority for each patient is determined using a weighted combination of the status and side effects of the patient.
Shahar teaches:
--wherein the priority for each patient is determined using a weighted combination of the status and side effects of the patient (see: paragraph [0142] where a patient is being ranked and prioritized based on at least a group of symptoms (side effects) and health or medical condition (status). Also see: paragraph [0144]. Prioritizing using multiple aspects indicates a weighted combination).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein the priority for each patient is determined using a weighted combination of the status and side effects of the patient as taught by Shahar in the method as taught by Kamen et al., Libbus et al. and Suneja et al. in combination with the motivation(s) of improving the quality of care by assessing and improving a broader range of aspects of care (see: paragraph [0144] of Shahar).
As per claim 3, Kamen et al., Libbus et al., Suneja et al., and Shahar in combination teaches the method of claim 2, see discussion of claim 2. Libbus et al. further teaches wherein the side effects are individually weighted (see: paragraph [0067] where these quantified physiological effects can be combined in any manner to express the relative level of extent of potential side effects 74, including weighting particular effects more heavily than others or applying statistical or numeric functions based directly on or derived from observed physiological changes. The physiological side effects here can be individually weighted).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 11, claim 11 is similar to claim 2 and is rejected in a similar manner to claim 2 using the Kamen et al., Libbus et al., Suneja et al., and Shahar references.
As per claim 13, Kamen et al., Libbus et al., Suneja et al., and Shahar in combination teaches the device of claim 11, see discussion of claim 11. Suneja et al. further teaches wherein the circuitry is further configured to determine an updated status of the progression of the titration and an updated priority for each patient one of daily, weekly, or when a stimulation parameter is incrementally increased during the titration (see: paragraph [0075] where there is daily collection of data).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 9, and incorporated herein.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 10,380,321 to Kamen et al. in view of U.S. 2013/0158617 to Libbus et al. and further in view of U.S. 2016/0239778 to Suneja et al. as applied to claim 1, and further in view of U.S. 2015/0213205 to Van De Sluis et al.
As per claim 5, Kamen et al., Libbus et al., and Suneja et al. in combination teaches the method of claim 1, see discussion of claim 1. The combination may not further, specifically teach wherein the plurality of patients are sorted on the user interface based on the priority of each patient.
Van De Sluis et al. teaches:
--wherein the plurality of patients are sorted on the user interface based on the priority of each patient (see: paragraphs [0035] and [0038] where there is updating of a nurses station based on changes in patient status. Also see: paragraph [0004] where the invention outputs a prioritized list of patients based on patients’ data).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein the plurality of patients are sorted on the user interface based on the priority of each patient as taught by Van De Sluis et al. in the method as taught by Kamen et al., Libbus et al., and Suneja et al. in combination with the motivation(s) of providing better care to patients (see: paragraph [0039] of Van De Sluis et al.).
Claims 6, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 10,380,321 to Kamen et al. in view of U.S. 2013/0158617 to Libbus et al. and further in view of U.S. 2016/0239778 to Suneja et al. as applied to claim 1, and further in view of U.S. 2012/0143286 to Hahn et al.
As per claim 6, Kamen et al., Libbus et al., and Suneja et al. in combination teaches the method of claim 1, see discussion of claim 1. The combination may not further, specifically teach wherein the selected stimulation parameter is a titration hold.
Hahn et al. teaches:
--wherein the selected stimulation parameter is a titration hold (see: FIGS. 6-9 where there is a stimulation parameter of a titration hold).
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 titration hold as taught by Hahn et al. for the stimulation parameters as disclosed by Kamen et al., Libbus et al., and Suneja et al. in combination 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, the combination of Kamen et al., Libbus et al., and Suneja et al. teaches of using stimulation parameters and one could replace the parameters and obtain predictable results of using stimulation parameters. 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).
As per claim 14, claim 14 is similar to claim 6 and is rejected in a similar manner to claim 6 using the Kamen et al., Libbus et al., Suneja et al., and Hahn et al. references.
As per claim 18, claim 18 is similar to claim 6 and is rejected in a similar manner to claim 6 using the Kamen et al., Libbus et al., Suneja et al., and Hahn et al. references.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684