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 .
Claim Amendment Notes
It is noted that some amendments to Claim 28 are not properly identified by strikethroughs/brackets. In particular, the deletion of “applying a machine learning algorithm to the plurality of features to perform a seizure binary classification to classify” is not shown in the current claim set.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 28, 30, 31, 33, 35-40, 55-57, 59, and 72-77 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 28 recites that one or more notifications is indicative of a different “type” of seizure. The phrase “is indicative of a different type of seizure” renders the claim indefinite in that it is unclear what different types of seizures the one or more notifications are indicative of. The term “type” could be referring to different categorizations of seizures such as focal, generalized, tonic, clonic, tonic-clonic, etc., or it could be referring to varying levels of severity of a seizure. As the specification fails to discuss different categorizations of seizures, the claims are being interpreted such that each of the one or more notifications is indicative of a different level of severity of seizure. Claims 30, 31, 33, 35-40, 55-57, 59, and 72-77 are rejected due to their dependence on claim 28.
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 28, 30, 31, 33, 35-40, 55-57, 59, and 72-77 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 28 follows.
Regarding claim 28, the claim recites a series of steps or acts, including determining a seizure burden and generating one or more notifications indicative of different types of seizures based on the determined seizure burden. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of classifying each temporal data segment as seizure-positive or seizure-negative using machine learning, and determining a seizure burden based on the temporal data segments classified as seizure-positive set forth a judicial exception. These steps describe concepts performed in the human mind (including an observation, evaluation, judgment, opinion). It is noted that while the claim recites using machine learning to classify each temporal data segment, this is a step that is capable of being performed in the human mind. Thus, the claim is drawn to both a Mental Process and a Mathematical Concept, which are both Abstract Ideas.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 28 recites displaying a seizure burden plot and generating one or more notifications when the seizure burden plot is equal to or exceeds one or more threshold values, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The display of the seizure burden plot and generation of one or more notifications do not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the display or generated notification(s), nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Ideas, the claim recites additional steps of receiving at least one EEG signal, segmenting the at least one EEG signal into a plurality of temporal data segments within a moving time window, extracting features from each temporal data segment, and applying machine learning to the temporal data segments to perform a binary seizure classification. The receiving, segmenting, extracting, and applying steps are each recited at a high level of generality such that they amount to insignificant presolution activity, e.g., mere data gathering steps necessary to perform the Abstract Ideas, and the applying step recites an Abstract Idea in that it is drawn to the use of mathematical calculations (the broadly claimed machine learning algorithm). When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and processing activity engaged in by medical professionals prior to Applicant's invention.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and the display of data. The receiving, segmenting, extracting, and applying steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
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 28, 30, 31, 33, 35-39, 55-57, 72, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Faul et al.’401 (US Pub No. 2012/0101401 – previously cited) in view of Nelson et al.’347 (US Pub No. 2014/0081347 – previously cited) further in view of Osorio’246 (US Pub No. 2015/0196246 – previously cited) further in view of Jain et al.’382 (US Pub No. 2016/0000382 – previously cited) further in view of Ahmed et al.’988 (US Pub No. 2019/0320988).
Regarding claims 28, 30, 31, 36, and 56, Figure 2 of Faul et al.’401 teaches a method for seizure detection (see TITLE), the method comprising: receiving a plurality of electroencephalography (EEG) signals over a plurality of channels from a subject (step 200, page 9, section [0170]); segmenting the plurality of EEG signals for each channel into a plurality of temporal data segments within a moving time window (steps 204 and 206, page 5, sections [0067-0068], page 10, sections [0172-0173]); extracting a plurality of features from each temporal data segment for each channel (step 208, page 10, sections [0174] and [0177]); applying a machine learning algorithm to the plurality of features to perform a seizure binary classification of each temporal data segment for each channel, thereby generating a plurality of classifications for the plurality of temporal data segments, wherein the seizure binary classification for each temporal data segment comprises classifying each temporal data segment for each channel as (1) seizure-positive or (2) seizure-negative (step 210, page 10, section [0178]), and wherein the machine learning algorithm is individually applied to the plurality of features extracted for each channel, such that each channel has a separate iteration of the machine learning algorithm (page 10, section [0179]); and aggregating the seizure binary classifications for the plurality of temporal data segments for the plurality of channels over a moving time window (page 5, sections [0067-0068]).
Faul et al.’401 discloses all of the elements of the current invention, as discussed above, except for determining a seizure burden for the moving time window based on the aggregated seizure binary classifications, wherein the seizure burden is based on a total duration of the temporal data segments that are classified as seizure-positive. Nelson et al.’347 teaches determining a seizure burden (total number of data segments classified as seizure-positive within a given time period) based on seizure binary classifications, wherein the seizure burden is compared to a threshold value in order to determine whether or not a subject has a seizure disorder (page 6, section [0049]). Nelson et al.’347 further teaches that the seizure burden is based on a total duration of the temporal data segments within the moving time window that are classified as seizure-positive (page 5, sections [0040-0042] – these sections describe using “the relative amount of time episodes are occurring (e.g., number of minutes per hour or day during which episodes occur” as a metric to compare to a threshold value)). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Faul et al.’401 to include determining a seizure burden for the moving time window based on the aggregated seizure binary classifications, wherein the seizure burden is based on the total duration of the temporal data segments within the moving time window that are classified as seizure-positive, as taught by Nelson et al.’347, since it would provide an indication of whether or not the subject has a seizure disorder. The seizure burden that is determined by Nelson et al.’347 is a metric that provides an assessment of whether the subject is at risk of having a seizure of a degree of severity or likelihood of a seizure. The longer the occurrences of seizure-positive temporal data segments within a given time period, the more severe the seizure.
Faul et al.’401 in view of Nelson et al.’347 discloses all of the elements of the current invention, as discussed above, except for the method comprising assessing whether the subject is at risk of having a seizure based on the seizure burden. Osorio’246 teaches assessing whether a subject is at risk of having a seizure based on output classifications of seizure activity (section [0104]). The “Time of Occurrence Unit” of Osorio’246 assesses periods of increased or decreased risk of seizures based on the time at which a seizure determination unit identifies the occurrence of a seizure. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Faul et al.’401 in view of Nelson et al.’347 to include using the seizure burden data (which identifies the occurrence of a seizure) to assess whether the subject is at risk of having a seizure, as this would allow a subject to take preventative measures when a period of risk of having a seizure is identified.
Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 discloses all of the elements of the current invention, as discussed above, except for the method comprising displaying the seizure burden at each instance of the moving time window as a times-series plot. Jain et al.’382 teaches that outputting a seizure detection parameter as a time-series plot along with a threshold corresponding to the seizure detection parameter facilitates a physician’s interpretation of the seizure detection parameter and provides the physician with a quick visual alert that indicates whether or not the parameter is exceeding the set threshold (page 4, section [0041]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 to output the seizure burden as a time-series plot on the display, along with one or more thresholds, as taught by Jain et al.’382, since it would facilitate a physician’s interpretation of the seizure burden, and provide the physician with a quick visual alert when the seizure burden exceeds an established threshold. The graphical visual element taught by Jain et al.’382 is updated dynamically in real-time as the seizure detection parameter is being determined for a moving time window (see Figure 1, time-series plot 118, and page 4, section [0041] – “running trend” indicates that the time-series plot is updated dynamically in real time). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed for the time-series plot of Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 to update dynamically as it would merely be combining prior art elements according to known methods to yield predictable results.
Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 discloses all of the elements of the current invention, as discussed above, except for generating one or more notifications when the seizure burden plot is equal to or exceeds the one or more threshold values, wherein each of the one or more notifications is indicative of a different type of seizure. Osorio’246 teaches generating one or more notifications when a medical condition is detected, the one or more notifications enabling a subject or caregiver to monitor whether a patient’s condition is deteriorating, improving, or remaining stable (page 14, section [0141]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 to include generating a notification when the seizure burden is equal to or exceeds one or more thresholds since Osorio’246 teaches that generating a notification would enable the subject or their caregiver to monitor the subject’s seizure disorder (as taught by Nelson et al.’347 in section [0049], a seizure burden equal to or exceeding one or more thresholds is indicative of a seizure disorder).
Furthermore, Ahmed et al.’988 teaches generating different notifications, wherein each notification is indicative of a different severity of an alarm, each notification being based on a degree to which a patient’s physiological parameter has deviated from a threshold (section [0123]). The severity of an alarm is indicated by color-coded or glowing indicators (section [0216]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 to include generating color-coded indicators indicative of different types of seizures (different levels of severity) based on a degree to which the seizure burden plot exceeds the threshold value, as this would provide a visual indication of the severity of the patient’s detected seizure.
Regarding the limitations in claims 30, 36, and 56 with respect to the duration of the moving time window, Faul et al.’401 discloses using time windows of varying lengths. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As such, it would have been obvious, through routine experimentation, to realize the appropriate amount of time for the moving time windows.
Regarding claim 33, the plurality of channels comprises eight channels (page 9, section [0170] of Faul et al.’401).
Regarding claim 35, each temporal data segment has a duration ranging from about one second to twenty seconds (page 6, section [0070] of Faul et al.’401).
Regarding claim 37, the plurality of features comprises time and/or frequency domain features that are intrinsic in the at least one EEG signal (page 6, sections [0076-0078], and page 10, section [0177] of Faul et al.’401).
Regarding claim 38, the plurality of features comprises at least twenty different time and/or frequency features (page 6, section [0085] – page 7, section [0087] of Faul et al.’401).
Regarding claim 39, the plurality of features comprises a plurality of discrete values associated with the time and/or frequency domain features (page 8, section [0126] – page 9, section [0135] of Faul et al.’401).
Regarding claims 55 and 57, Osorio’246 teaches that the one or more notifications include different characteristics based on the type and severity of the detected event (this is also taught by Ahmed et al.’988). Based on this teaching by Osorio’246, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 to include providing a first notification indicative of one type of seizure activity, a second notification indicative of another type of seizure activity, and a third notification indicative of yet another type of seizure activity, wherein each type of seizure activity is indicative of a different severity of seizure activity. Furthermore, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As such, it would have been obvious, through routine experimentation, to realize the appropriate threshold levels (or degree of deviation from a single threshold level) for the varying levels of seizure severity by which to generate the different types of notifications.
Regarding claim 72, Nelson et al.’347 teaches that the seizure burden is based on a total duration of the temporal data segments within the moving time window that are classified as seizure-positive (page 5, sections [0040-0042] – these sections describe using “the relative amount of time episodes are occurring (e.g., number of minutes per hour or day during which episodes occur” as a metric to compare to a threshold value)).
Regarding claim 74, the one or more notifications comprises a visual alert (either section [0041] of Jain et al.’382 or section [0216] of Ahmed et al.’988).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988, as applied to claim 28, further in view of Bosl’436 (US Pub No. 2015/0216436 – previously cited).
Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for the machine learning comprising an algorithm including one or more of a random forest, a boosted decision tree, a classification tree, a regression tree, a bagging tree, a neural network, or a rotation forest. Faul et al.’401 teaches the use of a support vector machine. Bosl et al.’436 teaches that several different machine learning algorithms may be used to classify a subject’s neural signals, including decision trees, random forests, and support vector machines (page 10, section [0107]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 to use machine learning comprising an algorithm including a random forest, as taught by Bosl et al.’436, since it would merely be the substitution of one known element (a random forest machine learning algorithm) for another (a support vector machine learning algorithm) to yield predictable results (binary classification of the subject’s neural signals).
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988, as applied to claim 28, further in view of Giftakis et al.’877 (US Pub No. 2006/0135877 – previously cited).
Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for the method comprising detecting status epilepticus. Giftakis et al.’877 teaches notifying a patient/caregiver of a prolonged neurological event (such as status epilepticus – section [0095]). Official notice is being taken that it is well known in the art that status epilepticus is determined when seizure activity occurs for a prolonged amount of time, or when two or more sequential seizures without full recovery of consciousness between the seizures occurs within a set amount of time. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 to include detecting status epilepticus and notifying a caregiver of the detected status epilepticus, as taught by Giftakis et al.’877, as it would allow the caregiver to provide medical treatment to the subject when the subject is experiencing status epilepticus. The modification to Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 would be applying a known technique (alerting a caregiver when a subject is experiencing status epilepticus) to a known method ready for improvement to yield predictable results (quickly attending to a subject experiencing status epilepticus).
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988, as applied to claim 28, further in view of Osorio’963 (US Pub No. 2017/0143963).
Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for the method including monitoring the effectiveness of a treatment for seizure based on the seizure burden plot. Osorio’963 teaches determining whether a treatment for seizure has provided an adequate beneficial effect by monitoring the effectiveness of the treatment for seizure based on the treatment’s effects on seizure severity (section [0088]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 to include monitoring the effectiveness of a treatment for seizure (Official notice is being taken that it is well known in the art to provide treatment to subject’s who experience seizures) based on the seizure burden plot (the seizure burden plot provides an indication of seizure severity), as this would provide an indication as to whether the treatment is providing an adequate beneficial effect.
Claims 75 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988, as applied to claim 74, further in view of Harper et al.’704 (US Pub No. 2011/0193704).
Regarding claim 75, Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for the visual alert comprising a change in color of the seizure burden plot when the seizure burden is equal to or exceeds the one or more threshold values. Harper et al.’704 teaches providing a visual alert wherein a color of a plotline changes color when a parameter exceeds a threshold value (section [0086]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 to include changing the color of the seizure burden plot when it is equal to or exceeds the one or more threshold values, as it would merely be combining prior art elements according to known methods to yield predictable results. The modification to Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 would help provide a visual alert by changing the color of the seizure burden plot when an alarm condition is met.
Regarding claim 77, Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for the visual alert comprising a change in color of one or more words on a user interface. Harper et al.’704 also teaches changing the color of text indicative of an alarm condition (section [0098]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 to include changing the color of text indicative of an alarm condition (i.e., the seizure burden plot exceeding a threshold value), as it would merely be combining prior art elements according to known methods to yield predictable results. The modification to Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 would help provide a visual alert by changing the color of text that is indicative of an alarm condition.
Claim 76 is rejected under 35 U.S.C. 103 as being unpatentable over Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988, as applied to claim 74, further in view of Jansen et al.’006 (US Pub No. 2012/0179006).
Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for the visual alert comprising a change in color of a screen of a user interface. Jansen et al.’006 teaches that visual alerts on a user interface may include flashing screens (section [0116]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Faul et al.’401 in view of Nelson et al.’347 further in view of Osorio’246 further in view of Jain et al.’382 further in view of Ahmed et al.’988 to include a visual alert that changes the color of a screen of a user interface (e.g., a flashing screen), as this would provide an additional means by which to alert a caregiver of an alarm condition.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 28, 30, 31, 33, 35-40, 55, and 57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 8, 9, 11-16, 24, and 25 of U.S. Patent No. 10,743,809. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the US Patent are narrower in scope than the current claims and encompass the subject matter of the current claims. Any reference meeting the limitations set forth in claims 1, 2, 4, 8, 9, 11-16, 24, and 25 of the US Patent would also meet the requirements set forth in claims 28, 30, 31, 33, 35-40, 55, and 57 of the current invention.
Response to Arguments
Applicant's arguments filed 29 October 2025 have been fully considered. Applicant’s arguments are moot as the amendments to the claims have warranted new grounds of rejections. It is also noted that contrary to Applicant’s assertion on page 7 of the Remarks filed 29 October 2025, sections [0031] and [0108] of the application as originally filed do not provide support for “wherein each of the one or more notifications is indicative of a different type of seizure”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Osorio’701 (US Pub No. 2012/0083701) teaches generating one or more notifications wherein each of the one or more notifications is indicative of a different type of seizure (section [0170]). Chaudhari et al.’653 (US Pub No. 2010/0156653) teaches changing a color of a screen of a user interface to provide a visual alert (section [0075]). Kassem et al.’818 (US Pub No. 2014/0275818) teaches different ways to provide an alert to a user, including changing the color of a screen of a user interface and changing the color of one or more words on the user interface (sections [0040], [0068-0069], [0076]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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