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 .
Application Status
The present communication is in response to the Amendments to the Claims and Remarks filed on 05/12/2026. Claims 1-20 are pending and addressed below. Claims 1, 10, and 16 are currently amended.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 10, and 16 recite determining an amount of information entered into the EMR system and number and type of interruptions during entry of the information into the EMR system during the first monitoring period. However, there is not sufficient support for determining number and type of interruptions during entry of information into the EMR. The specification describes number and type of user interruptions during the data entry as a characteristic that can be considered (Page 16, line 22-24). However, the determination of the number and type of interruptions is not described or disclosed. The values of the characteristics are merely considered for calculating input features to calculate a reliability measure (Page 15, lines 20-25).
Claims 1, 10, and 16 recite estimating, based on the amount comparison result, the number and type of interruptions during the entry of the information, and the determined method of entering the information into the EMR system, a likelihood of error for the information entered. However, there is not sufficient support for the concept of estimating a likelihood error based on the number and type of interruptions during entry of information. The specification describes the comparison being used for estimating a likelihood of error (Pages 3, 5, and 10). The specification also describes the method of entry contributing to the likelihood of error (Page 9, line 29-31). Additionally, the specification describes the number and type of interruptions being a characteristic which is considered and also the value of characteristics are considered for calculating input features to calculate a reliability measure, as described above. However, there is no description or disclosure of the number and type of interruptions being used for estimating a likelihood of error. Although the likelihood of error may be related to the reliability measure, they are not the same and the specification does not disclose the use of the number and type of interruptions for estimating the likelihood error.
As per Claims 2-9, 11-15, and 17-20, the claims depend on Claims 1, 10, and 16 and do not remedy the written description requirement issues of Claims 1, 10, and 16. As dependent claims inherit the deficiencies of the claims they depend on, they are also rejected.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-20 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.
Claims 1, 10, and 16 recite determining further comprises determining a time of entry of the information into the EMR system. However, there is no determining step prior to this in the claim. Therefore, it is indefinite what determining this step is further limiting. Therefore, the metes and bounds of the claims are indefinite.
Claim 1 recites the limitations:
“the information” in line 5.
Claim 10 recites the limitations:
“the information entered” in lines 11-12 (Claim 10). The claim previously recites the amount of information, but “information” is not recited.
"the patient monitor" in lines 12 (Claim 10).
“the monitoring device” in line 13 (Claim 10).
“the determined amount of information entered into the EMR system” in line 17 (Claim 10). The claim does not recite determining an amount of information.
Claim 1 recites the limitations:
“the patient monitor” in line 7.
“the information” in line 9.
There is insufficient antecedent basis for these limitations in the claims.
As per Claims 2-9, 11-15, and 17-20, the claims depend on Claims 1, 10, and 16 and do not remedy the indefiniteness issues of Claims 1, 10, and 16. As dependent claims inherit the deficiencies of the claims they depend on, they are also rejected.
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 an abstract idea without significantly more.
Step 1: Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter). (MPEP 2106.03)
Claims 1-9 recite a series of steps, thus falling within one of the four statutory classes; i.e., a process. Claims 10-20 describe tangible system components, thus falling within one of the four statutory classes; i.e., machine or manufacture.
Step 2A, Prong One: Evaluating whether the claim(s) recite(s) a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. (MPEP 2106.04).
Representative claim 10 recites:
A system for monitoring electronic medical records (EMR) data entered into an EMR system, comprising:
a monitor device configured to measure an amount of information entered into the EMR system and a number and type of interruptions during entry of the information into the EMR system;
a user interface configured to provide output to a healthcare professional and/or to receive input from the healthcare professional; and
a processor configured to:
(i) estimate an amount of information to be entered into the EMR system during a first monitoring period, wherein the estimated amount of information to be entered into the EMR system during the first monitoring period is based at least in part on the information measured by the patient monitor;
(ii) obtain, from the monitor device, the amount of information entered into the EMR system and the number and type of interruptions during entry of the information into the EMR system during the first monitoring period, wherein determining further comprises determining a time of entry of the information into the EMR system;
(iii) compare the determined amount of information entered into the EMR system during the first monitoring period to the estimated amount of information to be entered into the EMR system to determine an amount comparison result;
(iv) determine a method of entering the information into the EMR system;
(v) estimate, based on the amount comparison result, the number and type of interruptions during entry of the information into the EMR system, and the determined method of entering the information into the EMR system, a likelihood of error for the information entered into the EMR system during the first monitoring period; and
(vi) assign, based on the estimated likelihood of error, a reliability measure to the information entered into the EMR system or to information missing from the EMR system;
(vii) if the assigned reliability measure exceeds a threshold, automatically generate an alert indicating the likelihood of error for the information entered into the EMR system.
The limitations of measure amount of information entered into the EMR system and a number and type of interruptions during entry of the information into the EMR system; (i) estimate an amount of information to be entered into the EMR system during a first monitoring period, wherein the estimated amount of information to be entered into the EMR system during the first monitoring period is based at least in part on the information measured; (iii) compare the determined amount of information entered into the EMR system during the first monitoring period to the estimated amount of information to be entered into the EMR system to determine an amount comparison result; (iv) determining a method of entering the data into the EMR system; (v) estimate, based on the amount comparison result, the number and type of interruptions during entry of the information into the EMR system, and the determined method of entering data into the EMR system, a likelihood of error for the information entered into the EMR system during the first monitoring period; and (vi) assign, based on the estimated likelihood of error, a reliability measure to the information entered into the EMR system or to information missing from the EMR system, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting a “monitor device”, a “user interface” and a “processor”, nothing in the claim elements precludes the steps from practically being performed in the mind.
For example, but for the a “monitor device”, a “user interface” and a “processor” language, the functions of measure, (i) estimate (iii) compare (iv) determine (v) estimate and (vi) assign, in the context of this claim encompasses a person measuring an amount of information entered into the EMR system and interruptions during the entry; (i) estimating an amount of information to be entered into the medical record (EMR) system during a first monitoring period, wherein the estimated amount of information to be entered into the EMR system during the first monitoring period is based at least in part on the information measured; (iii) comparing the determined amount of information entered into the EMR system during the first monitoring period to the estimated amount of information to be entered into the EMR system; (iv) determining a method of entering the data into the EMR system; (v) estimating, based on said comparison, number and type of interruptions, and determined method of entering data into the EMR, a likelihood of error for the information entered into the EMR system during the first monitoring period; and (vi) assigning, based on the estimated likelihood of error, a reliability measure to the information entered into the EMR system or to information missing from the EMR system. These steps can be performed using human mental observation, evaluation, judgment, and opinion. For example, measuring an amount of information entered into the EMR system and a number and type of interruptions during entry of the information into the EMR system can be performed by a person using human observation of the data entry process. Human mental processing can measure “amount of information” and number and type of interruptions, as these are all information types that can be processed in the human mind or with the aid of pencil and paper. Additionally, the steps of estimating amount of information to be entered, comparing amount of information with estimated amount of information, determining a method of entering information, estimating a likelihood of error, and assigning a reliability measure can all be performed using human mental processing including observation, evaluation, judgment, and opinion.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas (Mental Processes. •concepts performed in the human mind (including an observation, evaluation, judgment, opinion)). Accordingly, the claim recites an abstract idea.
In addition, the limitations of measure an amount of information entered into the EMR system and a number and type of interruptions during entry of the information into the EMR system and generate an alert indicating the likelihood of error for the information entered into the EMR system if the assigned reliability measure exceeds a threshold, as drafted, is a process that, under its broadest reasonable interpretations, exemplify relationships or interactions between people (including social activities, teaching, and following rules or instructions), but for the recitation of generic computer components.
That is, other than reciting a “monitor device”, nothing in the claim element disqualifies the step from being managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)) or between a person and a computer. For example, but for the “monitor device” language, the steps of measure, in the context of this claim encompasses steps of a person evaluating what is entered into a device, which can be performed by human observation of actions of a person. The step of generate an alert, in the context of this claim encompasses steps of a person sending a notification to another person when the likelihood of error exceeds a threshold.
If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions), then it falls within the “Certain methods of organizing human activity” grouping of abstract ideas (Certain Methods Of Organizing Human Activity. •fundamental economic principles or practices (including hedging, insurance, mitigating risk); •commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); and •managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)). Accordingly, the claim recites an abstract idea.
Independent claims 1 and 16 recite the same abstract idea as identified above and dependent claims 2-9, 11-15, 17-20 further narrow it.
Step 2A, Prong Two: Identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and then evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application. Prong Two distinguishes claims that are "directed to" the recited judicial exception from claims that are not "directed to" the recited judicial exception. (MPEP 2106.04).
This judicial exception is not integrated into a practical application. In particular, the claims recite the following additional elements:
electronic medical records;
a monitor device;
a user interface;
a processor;
non-transitory computer-readable medium
obtain, from the monitoring device, the amount of information entered into the EMR system and the number and type of interruptions during entry of the information into the EMR system during the first monitoring period
The limitations of a monitor device, a user interface, a processor and a non-transitory computer-readable medium are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function) such that it amounts no more than mere instructions to apply the exception using generic computer components. 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. (MPEP 2106.05(f) Mere Instructions To Apply An Exception).
Although the monitor device and user interface have been interpreted as “apply it”, a monitor device and a user interface configured to provide output to a healthcare professional and/or to receive input from the healthcare professional could reasonably be alternatively or additionally interpreted as a field of use limitations. The claimed limitation of electronic medical records, is also interpreted as field of use limitation. Assuming the monitor device is electronic, describing the monitor and the medical records as electronic, and describing the type of users of the interface, describe the environment in which the activities occur. As such, these limitations alone and in combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. (MPEP 2106.05(h) Field of Use and Technological Environment).
The limitation of obtaining, from the monitoring device, the amount of information entered into the EMR system and the number and type of interruptions during entry of the information into the EMR system during the first monitoring period is insignificant extra-solution activity, as in MPEP 2106.05(g), because the step of obtaining amount of information and interruptions from the monitoring device is mere data gathering in conjunction with the abstract idea where the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). 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. (MPEP 2106.05(g) Insignificant Extra-Solution Activity)
Therefore, under Step 2A, Prong Two, the claims are directed to an abstract idea.
Step 2B: Identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s)). (MPEP 2106.05)
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 a monitor device, a user interface, a processor and a non-transitory computer-readable medium alone and in combination amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Similarly, the additional elements of monitor device and user interface and electronic, are merely field of use limitations which neither alone nor in combination provide an inventive concept.
The additional element of obtaining, from the monitoring device, the amount of information entered into the EMR system and the number and type of interruptions during entry of the information into the EMR system during the first monitoring period are insignificant extra-solution activity. However, obtaining information from a device is well-understood, routine, and conventional activity in the field of data management because they are claimed at a high level of generality and include receiving or transmitting data, which have been found to be a well-understood, routine and conventional computer function by the Court (MPEP 2106.05(d)(II)(i) Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)). Therefore, this does not amount to significantly more than the underlying abstract idea.
Independent claims 1 and 16 recite the same abstract idea as identified above and dependent claims 2-9, 11-15, 17-20 further narrow it.
Therefore, claims 1-20 are not patent eligible.
Response to Applicant’s Arguments
Applicant’s arguments with respect to the 35 USC § 101 rejection have been considered but are not persuasive.
35 USC § 101
Applicant' s arguments, see Pages 11-16, “Claim Rejections under 35 U.S.C. §101”, filed 05/12/2026 with respect to claims 1-20 have been fully considered but they are not persuasive.
Applicant argues that the claim 1 does not constitute a mental process or certain methods of organizing human activity because activities such as monitoring interaction with an electronic medical records across a medical facility cannot practically be performed in the human mind nor do they involve interactions between people. Examiner respectfully disagrees. Examiner notes that the claims do not limit the claims to monitoring interaction with electronic medical records across a medical facility. The claims recite estimating an amount of information to be entered into the EMR during a first period, determining an amount of information entered into the EMR and interruptions during entry during a first period, comparing the estimated to the entered information and estimating a likelihood of error from the comparison. This is only limited to data entry into an EMR system, which under BRI can be one person entering information at one location. Therefore, the argument regarding monitoring interaction with an EMR across a medical facility is moot and is not persuasive. Additionally, Examiner notes that although the data is entered into an EMR, the steps of measuring the amount of information entered into the EMR and interruptions during entry into the EMR, estimating amount of information to be entered into the EMR, comparing the amount entered to the estimated amount to be entered, estimating a likelihood of error, and assigning a reliability measure can be performed using human mental observation, evaluation, judgment, and opinion. A person can observe the entry of information into an EMR system and mentally measure the amount of information entered and also can mentally measure the number and type of interruptions. The amount of information is recited at a very high-level of generality, such that it can be processed by the human mind. The information which is measured can be compared to the data which is obtained from the monitoring device using human mental processing. And the remaining steps are all data analysis which can be performed using human mental processing. Therefore, the claims recite a mental process. The use of the EMR and the monitor device amount to mere instructions to apply the exception.
Applicant also argues that the step of generating an alert indicating the likelihood of error or the information entered into the EMR system is not a method of organizing human activity because this is not performed by interaction between human. Examiner respectfully disagrees. A person can generate an alert to another person when a condition arises. An alert can be as simple as a notification to another person or entity. The monitoring system is recited as generating this alert, but since the monitoring system is a general purpose computing component carrying out the abstract idea, this amounts to mere instructions to apply the exception and does not preclude the step from falling into the abstract grouping of certain methods of organizing human activity.
Applicant argues that the generation of an alert indicating the likelihood of error in the present claims is not part of the abstract idea similar to Example 42 which recites automatically generating a message whenever updated information is stored (see page 12). Examiner respectfully disagrees. Each application is analyzed separately and the all claim elements are considered individually and as a whole. Similar claim language does not equate to the same overall analysis of claims. Examiner, respectfully, notes that the instant claims have been fully and properly rejected as above. Examiner notes that Example 42, Claim 1 is analyzed as reciting a method of organizing human activity including allowing users to access patients’ medical records and receive updated patient information in real time from other users. Receiving updated patient information from other users is similar to generating an alert indicating the likelihood of error for information entered into the EMR system. Both of these steps is a communication of information to a user based on the analysis of the information. In Example 42, the updated information is communicated and in the present claims, the indication of likelihood of error is communicated as an alert. The analysis of Example 42 continues on to include automatically generating a message whenever updated information has been stored as an additional element, which when considered with the other elements of the claims as a whole is distinguishable from the instant claims. Example 42's abridged background provides the technical problem of latency and incompatibility between remote devices stating "medical providers must continually monitor a patient’s medical records for updated information, which is often-times incomplete since records in separate locations are not timely or readily-shared or cannot be consolidated due to format inconsistencies as well as physicians who are unaware that other physicians are also seeing the patient for varying reasons" wherein the technical solution is reflected in the claim language. The instant application, however, present a non-technical problem – monitoring data entered into electronic medical records. The solution to the problem is rooted in an improvement to the abstract idea itself and not a technical failure of a computer system. Even if the generation of an alert were to be considered an additional element, it would not integrate the abstract idea into a practical application because it would best be characterized as mere data outputting. This would be insignificant extra-solution activity similar to presenting offers (MPEP § 2106.05(g)).
Applicant argues (Page 14) that the claimed invention integrates the abstract idea into a practical application by improving the technical field of medical record systems because the invention addresses the issue of problematic data by automatically generating an alert indicating the likelihood of error for the information entered into the EMR. Examiner respectfully disagrees. The claims do not provide for any improvement or change to medical record systems. The claim, instead, merely monitor the input to the EMR. The EMR system functionality is not changed, impacted, or improved in any way. Generating an indication of the likelihood of an error is a communication of information from one party to another, which does not provide an improvement to the EMR system. It merely provides information based on the analysis of data which is measured or observed during data entry.
Applicant also argues that the generating of an alert integrates the abstract idea into a practical application for reasons similar to Example 42. Examiner respectfully disagrees. As described above, Example 42 provides an improvement to the technical problem of latency and incompatibility between remote devices, which is specifically described in the specification. The real-time sharing of information in a standardized format regardless of format input by the user provides the technical improvement. The instant claims do not provide a similar technical improvement to a technical problem. As stated above, even if the generation of an alert were to be considered an additional element, it would not integrate the abstract idea into a practical application because it would best be characterized as mere data outputting.
Applicant argues that the claims provide significantly more than the abstract idea because automatically alerting a user to problematic data entered into electronic medical records provides an inventive concept because it is not well-understood, routine, and conventional activity in the technical field. Examiner respectfully disagrees. Examiner maintains that generating an alert indicating the likelihood of error for the information entered into the EMR system is part of the abstract idea and falls into the grouping of certain methods of organizing human activity. A person can generate an alert, which is not limited beyond a notification of any sort, and can be verbal, to give an indication of likelihood of error. However, even if the generation of an alert were to be considered an additional element, it is mere data outputting that would be well-understood, routine, and conventional activity such as presenting offers and gathering statistics, as per MPEP 2106.05(d)(II).
35 USC § 103
Applicant' s arguments, see Pages 16-18, “Claim Rejections under 35 U.S.C. §103”, filed 05/12/2026 with respect to claims 1-20 have been fully considered and they are persuasive. Therefore, the rejection of 03/26/2026 has been withdrawn. The prior art does not teach the combination of determining an amount of information entered into the EMR system and number and type of interruptions during entry of the information into the EMR system; estimating, based on the amount comparison result, the number and type of interruptions during the entry of the information, and the determined method of entering the information into the EMR system, a likelihood of error for the information entered into the EMR system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Anderson (US 2010/0106724 A1) teaches interruptions in completing entry of information into a form are results in errors or missing information ([0085]). However, the measuring of the number and type of interruptions and use of the number and type of interruptions to estimate a likelihood of error is not taught.
Dela Cruz et al. (Dela Cruz JE, Shabosky JC, Albrecht M, Clark TR, Milbrandt JC, Markwell SJ, Kegg JA. Typed versus voice recognition for data entry in electronic health records: emergen):541-7.) teaches measuring the numb cy physician time use and interruptions. West J Emerg Med. 2014 Jul;15(4er of interruptions in entering data into an EMR (Page 542 Col. 2) and the high level concept of high number of interruptions leads to increased risk of errors (Page 542, Col. 1). However, determining type of interruption and estimating a likelihood of error based on the number and type of interruption is not taught.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evangeline Barr whose telephone number is (571)272-0369. The examiner can normally be reached Monday to Friday 8:00 am to 4:00 pm.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682
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