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 .
Status of Claims
This action is in reply to the application filed on 06/24/2025.
Claims 1-20 are currently pending and have been examined.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because FIG. 13-19 of the drawings are illegible and do not comply with line uniformity, density definition requirement and the use of shading standards put forth in 37 CFR 1.84 (l) and (m):
l) All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning.
(m) Shading. The use of shading in views is encouraged if it aids in understanding the invention and if it does not reduce legibility. Shading is used to indicate the surface or shape of spherical, cylindrical, and conical elements of an object. Flat parts may also be lightly shaded. Such shading is preferred in the case of parts shown in perspective, but not for cross sections. See paragraph (h)(3) of this section. Spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings. As a substitute for shading, heavy lines on the shade side of objects can be used except where they superimpose on each other or obscure reference characters. Light should come from the upper left corner at an angle of 45°. Surface delineations should preferably be shown by proper shading. Solid black shading areas are not permitted, except when used to represent bar graphs or color.
The Examiner further notes that due the grayscale conversion process inherent in the Office's electronic application filing system, elements of FIG. 13-19 are rendered partially illegible which interferes with providing a clear disclosure of the invention to the public.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as "amended." If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either "Replacement Sheet" or "New Sheet" pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings.
Thus, new corrected drawings in compliance with 37 CFR 1.121(d) are required in this application for FIG. 13-19.
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 non-statutory subject matter. The claimed invention is directed to an abstract idea without significantly more. Claims 1-20 are directed to a method which is one of the statutory categories of invention. (Step 1: YES).
Independent Claim 1 discloses a method for managing a cardiac monitoring device, the method comprising: accessing, from a rules database, a patient care modality rule; generating a monitoring interval associated with the cardiac monitoring device, the monitoring interval having an end date based at least partly on the patient care modality rule; accessing transmission data having a received date and originating from the cardiac monitoring device; calculating whether the received date is later than the end date; generating a docket report for the transmission data; receiving an approval timestamp corresponding to the docket report; calculating whether the approval timestamp indicates an approval date later than the end date; accessing, from a rules database, an interval extension rule; generating, according to the interval extension rule, a monitoring interval extension having an extended end date based at least partly on whether the received date is later than the end date or whether the approval date is later than the end date; and generating a date of service (DOS) for the transmission data, the DOS being the extended end date of the monitoring interval extension.
Independent Claim 8 discloses a method for managing a cardiac monitoring device, the method comprising: accessing, from a rules database, a plurality of patient care modality rules; generating a first monitoring interval associated with the cardiac monitoring device, the first monitoring interval having a first end date based at least partly on a first patient care modality rule of the plurality of patient care modality rules; generating a second monitoring interval associated with the cardiac monitoring device, the second monitoring interval having a second end date based at least partly on a second patient care modality rule of the plurality of patient care modality rules, the second end date being different than the first end date; accessing transmission data having a received date and originating from the cardiac monitoring device; generating, for the transmission data, a first docket report associated with the first patient care modality rule; generating, for the transmission data, a second docket report associated with the second patient care modality rule; receiving an approval timestamp after the received date and indicating an approval date corresponding to only one the first docket report or the second docket report; calculating whether the approval date is later than the first end date; accessing, from the rules database, an interval extension rule; determining, according to the interval extension rule, whether to generate a monitoring interval extension having an extended end date based at least partly on whether the approval date is later than the first end date; and generating a date of service (DOS) for the transmission data, the DOS being the approval date.
Independent claim 15 discloses a method for managing a cardiac monitoring device, the method comprising: accessing, from a rules database, a plurality of patient care modality rules; generating, based at least partly on the plurality of patient care modality rules, a plurality of monitoring intervals, running concurrently, and associated with the cardiac monitoring device, a first monitoring interval of the plurality of monitoring intervals having a first end date and a second monitoring interval of the plurality of monitoring intervals having a second end date that is different than the first end date; accessing transmission data having a received date prior to the first end date and originating from the cardiac monitoring device; generating, for the transmission data, a docket report associated with the first monitoring interval or the second monitoring interval; receiving an approval timestamp indicating an approval date later than the received date and corresponding to the docket report; calculating that the approval date is later than the first end date; accessing, from the rules database, an interval extension rule; generating, according to the interval extension rule, a monitoring interval extension having an extended end date based at least partly on the approval date being later than the received date and later than the first end date; and generating a date of service (DOS) for the transmission data, the DOS being the approval date.
The examiner is interpreting the above bolded limitations as additional elements as further discussed below. The remaining un-bolded limitations merely recite steps that which could be performed by the human mind and/or a human with a physical aid as with a pen and paper which is an abstract idea. (Step 2A- Prong 1: YES. The claims are abstract).
This judicial exception is not integrated into a practical application. Limitations that are not indicative of integration into a practical application include: (1) Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (MPEP 2106.05.f), (2) Adding insignificant extra- solution activity to the judicial exception (MPEP 2106.05.g), (3) Generally linking the use of the judicial exception to a particular technological environment or field of use (MPEP 2106.05.h).
Independent claims 1 disclose the following additional elements:
A cardiac monitoring device
A rules database (containing patient care modality rules)
Accessing transmission data having a received date and originating from the cardiac monitoring device
Receiving an approval timestamp corresponding to the docket report
A rules database (containing interval extension rules)
Independent claims 8 disclose the following additional elements:
A cardiac monitoring device
A rules database (containing patient care modality rules)
Accessing transmission data having a received date and originating from the cardiac monitoring device
Receiving an approval timestamp after the received date and indicating an approval date corresponding to only one the first docket report or the second docket report
A rules database (containing interval extension rules)
Independent claims 15 disclose the following additional elements:
A cardiac monitoring device
A rules database (containing patient care modality rules)
Accessing transmission data having a received date prior to the first end date and originating from the cardiac monitoring device
Receiving an approval timestamp indicating an approval date later than the received date and corresponding to the docket report
A rules database (containing interval extension rules)
In particular, the cardiac monitoring device, the rules database (containing patient care modality rules), and the rules database (containing interval extension rules) are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception.
Additionally, the following limitations amount to insignificant extra solution activity:
accessing transmission data having a received date and originating from the cardiac monitoring device (of claims 1 and 8)
accessing transmission data having a received date prior to the first end date and originating from the cardiac monitoring device (claim 15)
receiving an approval timestamp corresponding to the docket report (of claim 1)
receiving an approval timestamp after the received date and indicating an approval date corresponding to only one the first docket report or the second docket report (of claim 8)
receiving an approval timestamp indicating an approval date later than the received date and corresponding to the docket report (of claim 15)
Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Further, Applicant’s specification para 3-4 discloses tracking every transmission of every cardiac monitoring device, generating docketing reports for the transmissions, approving the docketing reports, and establishing dates of service for the transmissions as a human task. MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicates that a practical application may be present where the claimed invention provides a technical solution to a technical problem. See, e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1259 (Fed. Cir. 2014) (finding that claiming a website that retained the “look and feel” of a host webpage provided a technological solution to the problem of retention of website visitors by utilizing a website descriptor that emulated the “look and feel” of the host webpage, where the problem arose out of the internet and was thus a technical problem). The problem of healthcare providers not being able to track every transmission of every cardiac monitoring device, generate docketing reports for the transmissions, approve the docketing reports, and establish dates of service for the transmissions is not a technical problem. The Examiner notes that the Applicant does not claim any hardware in a system claim or a computer implemented method. Thus, further indicating that this is a mental process for managing a cardiac monitoring device. The Applicant’s specification at para 36 discloses the network environment 100 includes at least one server 112 hosting a website or an application that the user may visit to access the medical device manager 102. Even if this server hosting a website or application was claimed, the problem of healthcare providers not being able to track every transmission of every cardiac monitoring device, generate docketing reports for the transmissions, approve the docketing reports, and establish dates of service for the transmissions is not a problem that is caused by the server itself (further indicating that this is not a technical problem). At best, Applicant’s identified problem is a business or management problem. Because no technological problem is present, the claims do not provide a practical application.
Accordingly, claim(s) 1, 8, and 15 are directed to an abstract idea(s) without a practical application. (Step 2A-Prong 2: NO: the additional claimed elements are not integrated into a practical application).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim does 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 the cardiac monitoring device, the rules database (containing patient care modality rules), and the rules database (containing interval extension rules) amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more’). MPEP2106.05(I)(A) indicates that merely saying "apply it” or equivalent to the abstract idea cannot provide an inventive concept ("significantly more").
Further, accessing transmission data having a received date and originating from the cardiac monitoring device (of claims 1 and 8), accessing transmission data having a received date prior to the first end date and originating from the cardiac monitoring device (claim 15), receiving an approval timestamp corresponding to the docket report (of claim 1), receiving an approval timestamp after the received date and indicating an approval date corresponding to only one the first docket report or the second docket report (of claim 8), receiving an approval timestamp indicating an approval date later than the received date and corresponding to the docket report (of claim 15) was considered insignificant extra-solution activity in Step 2A, Prong 2. Re-evaluating here in step 2B, this is also determined to be well-understood, routine, conventional activity in the field. The Mayo and OIP Techs court decisions cited in MPEP 2106.05(g) indicate that mere data gathering is well-understood, routine, conventional activity in the field.
Accordingly, even in combination, this additional element does not provide significantly more. As such the independent claims 1, 8, and 15 are not patent eligible. (Step 2B: NO. The claims do not provide significantly more).
Dependent claim(s) 2-7, 9-14, and 16-20 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Dependent claims 2-7, 9-14, and 16-20 do not further disclose any additional elements. As such, no further additional hardware components other than those found in the respective independent claims are recited, thus it is presumed that the claims are further utilizing the same generic systemization as presented above. The dependent claims do not include any additional elements that integrate the abstract idea into a practical application of the exception or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination.
Therefore, the dependent claims are also directed to an abstract idea.
Thus, Claims 1-20 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Subject Matter Free of Prior Art
Claims 1-20 contain subject matter free of prior art. The following references are relevant to the subject matter in claims 1-20, however, there is no obvious combination of prior references that disclose the claimed invention as described in further detail below.
Wadhwa (US 2018/0151255 A1) discloses generating a monitoring interval… accessing transmission data having a received date and originating from a cardiac monitoring device; calculating whether the received date is later than the end date…; generating… a monitoring interval extension having an extended end date based at least partly on whether the received date is later than the end date (See para 6 which discloses adjusting a billing cycle end date after the interrogation data is received (broadly an extension). See further para 35 discloses implantable cardiac devices and interrogation data as the transmission data).
However, Wadhwa does not disclose accessing, from a rules database, a patient care modality rule; generating a monitoring interval associated with the cardiac monitoring device, the monitoring interval having an end date based at least partly on the patient care modality rule…generating a docket report for the transmission data; receiving an approval timestamp corresponding to the docket report; calculating whether the approval timestamp indicates an approval date later than the end date; accessing, from a rules database, an interval extension rule; generating, according to the interval extension rule, a monitoring interval extension having an extended end date based at least partly on whether the approval date is later than the end date; and generating a date of service (DOS) for the transmission data, the DOS being the extended end date of the monitoring interval extension.
Zaidi (US 2017/0225001 A1) discloses generating a monitoring interval associated with the cardiac monitoring device, the monitoring interval having an end time (see abstract, para 165, Fig. 3, and para 78), and extending the time period if no high accuracy clauses are encountered wherein clauses that exhibit a high predictive certainty, e.g. accuracy, based on PPV and/or NPV may be categorized as high accuracy clauses (see para 33).
However, Zaidi does not explicitly discloses accessing, from a rules database, a patient care modality rule; the monitoring interval having an end date based at least partly on the patient care modality rule; accessing transmission data having a received date, calculating whether the received date is later than the end date; generating a docket report for the transmission data; receiving an approval timestamp corresponding to the docket report; calculating whether the approval timestamp indicates an approval date later than the end date; accessing, from a rules database, an interval extension rule; generating, according to the interval extension rule, a monitoring interval extension having an extended end date based at least partly on whether the received date is later than the end date or whether the approval date is later than the end date; and generating a date of service “DOS” for the transmission data, the DOS being the extended end date of the monitoring interval extension.
Brown (US 2002/0019748 A1) discloses a method for managing a cardiac monitoring device (a method for managing a plurality of remote monitoring devices, such as devices for cardiovascular disease; para 21, 68), the method comprising: generating a monitoring interval associated with the cardiac monitoring device (measurements from the monitoring device are collected over a predetermined period of time; para 47); accessing transmission data having a received date and originating from the cardiac monitoring device (collection date 64 is the date the corresponding set of measurements are received by clinic server 12; para 41).
However, Brown does not explicitly disclose accessing, from a rules database, a patient care modality rule; the monitoring interval having an end date based at least partly on the patient care modality rule; calculating whether the received data is later than the end date; generating a docket report for the transmission data; receiving an approval timestamp corresponding to the docket report; calculating whether the approval timestamp indicates an approval date later than the end date; accessing, from a rules database, an interval extension rule; generating, according to the interval extension rule, a monitoring interval extension having an extended end date based at least partly on whether the received date is later than the end date or whether the approval date is later than the end date; and generating a date of service “DOS” for the transmission data, the DOS being the extended end date of the monitoring interval extension.
Karz (US 4,173,971 A) discloses a method for managing a cardiac monitoring device (a method of continuously monitoring an ECG device; abstract), the method comprising: generating a monitoring interval associated with the cardiac monitoring device (predetermined time period during which recording occurs; column 6, lines 44-47).
However, Karz does not explicitly disclose accessing, from a rules database, a patient care modality rule; the monitoring interval having an end date based at least partly on the patient care modality rule; calculating whether the received data is later than the end date; generating a docket report for the transmission data; receiving an approval timestamp corresponding to the docket report; calculating whether the approval timestamp indicates an approval date later than the end date; accessing, from a rules database, an interval extension rule; generating, according to the interval extension rule, a monitoring interval extension having an extended end date based at least partly on whether the received date is later than the end date or whether the approval date is later than the end date; and generating a date of service “DOS” for the transmission data, the DOS being the extended end date of the monitoring interval extension.
Mayou (US 2013/0035871 A1) discloses generating a monitoring interval associated with the cardiac monitoring device, the monitoring interval having an end date, accessing transmission data having a received date and originating from the cardiac monitoring device (abstract, para 18, 106,and 159), generating a report from the transmitted data signal (see para 185), and changing or modifying the start and end dates and times for the collected data to obtain more accurate pattern data (See para 321-329).
However, Mayou does not explicitly disclose accessing, from a rules database, a patient care modality rule; the monitoring interval having an end date based at least partly on the patient care modality rule; calculating whether the received data is later than the end date; receiving an approval timestamp corresponding to the docket report; calculating whether the approval timestamp indicates an approval date later than the end date; accessing, from a rules database, an interval extension rule; generating, according to the interval extension rule, a monitoring interval extension having an extended end date based at least partly on whether the received date is later than the end date or whether the approval date is later than the end date; and generating a date of service “DOS” for the transmission data, the DOS being the extended end date of the monitoring interval extension.
Reasons why the subject matter of the instant application contains subject matter free of prior art:
In conclusion, while the above listed references list some of the limitations as claimed in the independent claims (such as a method for managing a cardiac monitoring device, the method comprising: generating a monitoring interval associated with the cardiac monitoring device; accessing transmission data having a received date and originating from the cardiac monitoring device), there is no obvious combination of references that also discloses the following: accessing, from a rules database, a patient care modality rule; generating a monitoring interval… having an end date based at least partly on the patient care modality rule; receiving an approval timestamp corresponding to the docket report; calculating whether the approval timestamp indicates an approval date later than the end date; accessing, from a rules database, an interval extension rule; generating, according to the interval extension rule, a monitoring interval extension having an extended end date based at least partly on whether the received date is later than the end date or whether the approval date is later than the end date; and generating a date of service (DOS) for the transmission data, the DOS being the extended end date of the monitoring interval extension.
Claim 8 contains subject matter free of prior art for the same reasons as claim 1, and further because there is no obvious combination of prior art that discloses generating a first monitoring interval associated with the cardiac monitoring device, the first monitoring interval having a first end date based at least partly on a first patient care modality rule of the plurality of patient care modality rules; generating a second monitoring interval associated with the cardiac monitoring device, the second monitoring interval having a second end date based at least partly on a second patient care modality rule of the plurality of patient care modality rules, the second end date being different than the first end date; accessing transmission data having a received date and originating from the cardiac monitoring device; generating, for the transmission data, a first docket report associated with the first patient care modality rule; generating, for the transmission data, a second docket report associated with the second patient care modality rule; receiving an approval timestamp after the received date and indicating an approval date corresponding to only one the first docket report or the second docket report; calculating whether the approval date is later than the first end date; accessing, from the rules database, an interval extension rule; determining, according to the interval extension rule, whether to generate a monitoring interval extension having an extended end date based at least partly on whether the approval date is later than the first end date; and generating a date of service (DOS) for the transmission data, the DOS being the approval date.
Claim 15 contains subject matter free of prior art for the same reasons as claim 1, and further because there is no obvious combination of prior art that discloses accessing, from a rules database, a plurality of patient care modality rules; generating, based at least partly on the plurality of patient care modality rules, a plurality of monitoring intervals, running concurrently, and associated with the cardiac monitoring device, a first monitoring interval of the plurality of monitoring intervals having a first end date and a second monitoring interval of the plurality of monitoring intervals having a second end date that is different than the first end date; accessing transmission data having a received date prior to the first end date and originating from the cardiac monitoring device; generating, for the transmission data, a docket report associated with the first monitoring interval or the second monitoring interval; receiving an approval timestamp indicating an approval date later than the received date and corresponding to the docket report; calculating that the approval date is later than the first end date; accessing, from the rules database, an interval extension rule; generating, according to the interval extension rule, a monitoring interval extension having an extended end date based at least partly on the approval date being later than the received date and later than the first end date; and generating a date of service (DOS) for the transmission data, the DOS being the approval date.
Therefore, claims 1-20 contain subject matter free of prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA J MORICE DE VARGAS whose telephone number is (703)756-4608. The examiner can normally be reached M-F 8:30-5:30 pm.
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/SARA JESSICA MORICE DE VARGAS/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681