DETAILED ACTION
Status of Claims
This action is in reply to the communication filed on 11 December, 2025.
Claims 1, 7, 13 and 14 have been amended.
Claim 21 has been added.
Claims 1, 2 and 5 - 21 are currently pending and have been examined.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11 December, 2025 has been entered.
Notice of Supervisory Review
This application has been pending five years or more. Consistent with MPEP 707.02, it has been considered “special” by the Examiner, and, in an effort to terminate prosecution, it has been reviewed by the Supervisory Patent Examiner as indicated by signature below.
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683
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, 2 and 5 - 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea), and does not include additional elements that either: 1) integrate the abstract idea into a practical application, or 2) that provide an inventive concept – i.e. elements that amount to significantly more than the abstract idea. The Claims are directed to an abstract idea because, when considered as a whole, the plain focus of the claims is on an abstract idea.
Claim 7 is representative. Claim 7 recites:
A method for automating the designation of a disease classification code using a rules engine:
providing a rules engine to execute on one or more processors, wherein the rules engine implements a clinical diagnosis decision tree;
providing a differential diagnosis program configured to account for uncertain diagnosis and reduce re-entry of patient-specific metadata, the differential diagnosis program in communication with the rules engine;
providing a database in communication with the rules engine, the database comprising a plurality of rules for providing a disease classification code in response to the input of patient information;
wherein the database comprises a set of anatomical zones,
wherein one or more of the plurality of rules comprises a query, wherein the query is configured to search for a location on the body corresponding to one or more of the anatomical zones of the set of anatomical zones,
wherein the differential diagnosis program automates the ICD designation based on anatomical locations using the one or more of the anatomical zones,
wherein the plurality of rules comprises a set of dynamic embeddable ICD-10 rules,
wherein one or more of the plurality of rules are a search type rule, a render type rule, or an automated type rule,
wherein each rule is executed independent from an antecedent and a resultant rule implemented in the clinical diagnosis decision tree;
wherein with each rule one or more intelligence flags can be applied, wherein the use of intelligence flags ensure correct ICD-10 codes are calculated;
entering, by a user, patient information for use by the rules engine, using an interface;
entering, by a user, one or more differential diagnoses for use by the rules engine using an interface;
displaying using an interface, an anatomical atlas, the anatomical atlas configured to display one or more diagnoses at one or more locations on the anatomical atlas in response to placement of the one or more diagnoses at one or more locations by the user;
automatically outputting at least one designation of disease classification from the rules engine; and
wherein the rules comprise the clinical diagnosis decision tree which is traversed by the rules engine to determine the next rule and disease classification code;
wherein each of the plurality of rules provides at least one alpha-numeric character corresponding to a digit in the disease classification code; and
wherein at least one of the plurality of rules comprises at least one rule that provides at least a second alpha-numeric character corresponding to a second digit in the disease classification code,
wherein each rules may use a plurality of algorithms to determine a placeholder value, wherein the plurality of algorithms is selected from three types, wherein the three types are render, search and automated,
wherein a search type rules searches body locations from the anatomical atlas;
wherein an automated type rule comprises rules that are based on whether a patient visit is an initial visit or a follow up visit,
wherein a render rule type requires metadata response.
Claim 14 recites a system that executes the steps of the method recited in Claim 7. Claim 1 recites a system that performs similar limitations.
STEP 1
The claims are directed to a system and a method which are included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims, as illustrated by Claim 7, recite limitations that encompass an abstract idea including:
entering, by a user, patient information;
entering, by a user, one or more differential diagnoses;
outputting at least one designation of disease classification; and
a plurality of rules for providing a disease classification code in response to the input of patient information,
wherein one or more of the plurality of rules comprises a query, wherein the query is configured to search for a location on the body corresponding to one or more of the anatomical zones of the set of anatomical zones,
wherein the ICD designation [is] based on anatomical locations using the one or more of the anatomical zones,
wherein each rule is executed independent from an antecedent and a resultant rule implemented in the clinical diagnosis decision tree;
wherein with each rule one or more intelligence flags can be applied, wherein the use of intelligence flags ensure correct ICD-10 codes are calculated;
wherein the rules comprise the clinical diagnosis decision tree which is traversed to determine the next rule and disease classification code;
wherein each of the plurality of rules provides at least one alpha-numeric character corresponding to a digit in the disease classification code; and
wherein at least one of the plurality of rules comprises at least one rule that provides at least a second alpha-numeric character corresponding to a second digit in the disease classification code;
wherein each rules may use a plurality of algorithms to determine a placeholder value.
The claims, as illustrated by Claim 7, recite an abstract idea within the mental process grouping – concepts performed in the human mind including observation, evaluation, judgment and opinion. The claims as illustrated by Claim 7 recite entering patient information and a differential diagnosis; analyzing the information using rules comprising rules organized as a decision tree, and output a designation of disease classification that, under its broadest reasonable interpretation, covers performance of the steps in the human mind.
Collecting information is within the realm of abstract ideas; that analyzing information by steps that people go through in their minds, or by mathematical algorithms are essentially mental processes within the abstract idea category; and merely presenting the results of abstract processes is abstract as an ancillary part of such collection and analysis. (Electric Power Group).
Patient information includes selections made by the user via a user interface. Selections may be made the diagnosis and exam findings for a particular location on the body of the patient. The recited rules for designation an ICD-10 code based on the patient information and diagnosis, including a location on the body, and other characteristics as described in the ICD-10 code definitions. Selecting characters for a 3 – 7 digit code that designates the category of diagnosis, etiology, anatomic site, severity or other clinical detail, as well as an extension character that designates the encounter type, is a process that can be performed mentally.
The specification discloses that, while difficult, a physician can memorize the codes (0020). ICD-10 codes are calculated using rules that use algorithms to determine the value of the code for its placeholder. Further, the specification discloses that the number of available ICD-10 codes make it difficult to memorize them, and that conventional mapping from ICD-9 to ICD-10 is time consuming because the physician may still have to select from among hundreds of codes. As such, the claims recite an abstract idea within the mental process grouping.
The claims, as illustrated by Claim 7, also recite an abstract idea within the “certain methods of organizing human activity” grouping –
managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions.
The specification discloses that a physician in the U.S. is mandated to use ICD-10 codes. Further, the specification discloses that the number of available ICD-10 codes make it difficult to memorize them, and that conventional mapping from ICD-9 to ICD-10 is time consuming because the physician may still have to select from among hundreds of codes. Designating a disease classification code based on patient information is process that merely organizes this human activity.
Claim 1 recites the abstract idea of designating ICD codes for a patient. This idea is described by the steps of implementing a clinical diagnosis decision tree/rules, entering patient information, providing a disease classification code in response to the input of patient information, using rules to determine the next rule and disease classification code, provide at least one alpha-numeric character corresponding to a digit in the disease classification code, and provide at least a second alpha-numeric character corresponding to a second digit in the disease classification code.
These steps fall into the method of organizing human activity grouping of abstract ideas as they are directed towards managing personal behavior including following rules or instructions (i.e. to determine a proper disease classification). Note that the above steps are similar to that described in In re Meyer describing a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, (In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)). See MPEP 2106. 04(a)(2).II.C.
Claim 7 recites the abstract idea of designating ICD codes for a patient. This idea is described by the steps of entering patient information, entering or more differential diagnoses, implementing a clinical diagnosis decision tree/rules, providing a disease classification code in response to the input of patient information, outputting at least one designation of disease classification from the rules engine, and using rules to determine the next rule and disease classification code, provide at least one alpha-numeric character corresponding to a digit in the disease classification code, provides at least a second alpha-numeric corresponding to a second digit in the disease classification code, and use a plurality of algorithms to determine a placeholder value.
These steps also fall into the method of organizing human activity grouping of abstract ideas as they are directed towards managing personal behavior including following rules or instructions (i.e. to determine a proper disease classification). Note that the above steps are similar to that described in In re Meyer describing a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, (In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)). See MPEP 2106. 04(a)(2).II.C.
Claim 14 recites the abstract idea of designating ICD codes for a patient. This idea is described by the steps of entering one or more ICD-10 codes and patient information, providing a disease classification code in response to the input of patient information, and using rules comprising a clinical diagnosis decision tree to determine the next rule and disease classification code and use a plurality of algorithms to determine a placeholder value.
These steps also fall into the method of organizing human activity grouping of abstract ideas as they are directed towards managing personal behavior including following rules or instructions (i.e. to determine a proper disease classification). Note that the above steps are similar to that described in In re Meyer describing a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, (In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)). See MPEP 2106. 04(a)(2).II.C.
As such, the claims recite an abstract idea within the certain methods of organizing human activity grouping.
STEP 2A PRONG TWO
The claims recite additional elements beyond that abstract idea that include:
providing a rules engine to execute on one or more processors, wherein the rules engine implements a clinical diagnosis decision tree;
providing a differential diagnosis program configured to account for uncertain diagnosis and reduce re-entry of patient-specific metadata, the differential diagnosis program in communication with the rules engine;
providing a database in communication with the rules engine, the database comprising a plurality of rules for providing a disease classification code in response to the input of patient information;
wherein the database comprises a set of anatomical zones,
wherein the plurality of rules comprises a set of dynamic embeddable ICD-10 rules,
wherein one or more of the plurality of rules are a search type rule, a render type rule, or an automated type rule,
entering, by a user, patient information for use by the rules engine, using an interface;
entering, by a user, one or more differential diagnoses for use by the rules engine using an interface;
displaying using an interface, an anatomical atlas, the anatomical atlas configured to display one or more diagnoses at one or more locations on the anatomical atlas in response to placement of the one or more diagnoses at one or more locations by the user.
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with the MPEP. (see MPEP 2106.05).
The rules engine/one or more processors and database are recited at a high level of generality such that it amounts to no more than instructions to apply the abstract idea using a generic computer component. These elements merely add instructions to implement the abstract idea on a computer, and generally link the abstract idea to a particular technological environment.
The functions performed by the rule and algorithm types recited in the claims – i.e. dynamic rules such as a search type rule, a render rule or an automated rule, is described in the specification. For example, a render rule is a rule that requires a response from the user specifying the severity of the disease (0028); a search rule searches for body locations and present results; and an automated rule determines the encounter type. Each of these rules select the appropriate value for the relevant digit in the code scheme. This is an insignificant extra-solution activity – i.e. a data gathering process. Similarly, entering patient information for use by the rules engine is an insignificant extra-solution activity – i.e. a data gathering step. Displaying an interface for entering information is an extra-solution data gathering step.
Claim 1 recites a computer system comprising a processor and computer memory, rules engine (software) configured to execute on the processor, input device, output device, and database. However, the computer system comprising a processor and computer memory, rules engine configured to execute on the processor, input device, output device, database are generic computing components recited at a high level of generality (see pg. 20, lines 14-20) that are simply used as tools to perform the abstract idea. Claim 1 also recites a differential diagnosis program in communication with the rules engine, the differential diagnosis program configured to reduce re-entry of patient information when a primary diagnosis is uncertain. The differential diagnosis program, however, simply uses the rules engine to traverse a clinical diagnosis decision tree in such a way that it amounts to no more than a generic computing component utilized to perform a process that would otherwise be abstract. This allows the physician to save time and reduces documentation burden for billing in addition to reducing the re-entry of metadata, i.e. by the physician or other user (see at least pg. 9, line 25-pg. 10, line 7). Therefore, the differential diagnosis program more quickly performs a process traditionally performed by a physician and serves to reduce the burden on the physician by simplifying the process of determining the clinical diagnoses. Implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application (See MPEP 2106.05(f)). To the extent that the limitations involving entering data could be considered additional elements, these elements would be considered insignificant extra-solution activity and do not integrate the abstract idea into a practical application as they only amount to necessary data gathering wherein all uses of the recited abstract idea would require such data gathering/data output (See MPEP 2106.05(g)). Furthermore, the storage of data/rules by the database also amounts to necessary data gathering and would similarly be considered insignificant extra solution activity.
Claim 7 recites a rules engine to execute on one or more processors, a database in communication with the rules engine, the database comprising a plurality of rules for providing a disease classification code in response to the input of patient information. However, the rules engine to execute on one or more processors, a database in communication with the rules engine, the database comprising a plurality of rules for providing a disease classification code in response to the input of patient information are generic computing components recited at a high level of generality (see pg. 20, lines 14-20) that are simply used as tools to perform the abstract idea. Implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application (See MPEP 2106.05(f)). To the extent that the limitations involving entering and outputting data could be considered additional elements, these elements would be considered insignificant extra-solution activity and do not integrate the abstract idea into a practical application as they only amount to necessary data gathering wherein all uses of the recited abstract idea would require such data gathering/data output (See MPEP 2106.05(g)). Furthermore, the storage of data/rules by the database also amounts to necessary data gathering and would similarly be considered insignificant extra solution activity.
Claim 14 recites a computer system comprising a processor and computer memory, rules engine (software) configured to execute on the processor, input device, output device, and database. However, the computer system comprising a processor and computer memory, rules engine configured to execute on the processor, input device, output device, database are generic computing components recited at a high level of generality (see pg. 20, lines 14-20) that are simply used as tools to perform the abstract idea. Claim 14 also recites a differential diagnosis program configured to account for uncertain diagnoses and reduce re-entry of patient-specific metadata. The differential diagnosis program, however, simply uses the rules engine to traverse a clinical diagnosis decision tree in such a way that it amounts to no more than a generic computing component utilized to perform a process that would otherwise be abstract. This allows the physician to save time and reduces documentation burden for billing in addition to reducing the re-entry of metadata, i.e. by the physician or other user (see at least pg. 9, line 25-pg. 10, line 7). Therefore, the differential diagnosis program more quickly performs a process traditionally performed by a physician and serves to reduce the burden on the physician by simplifying the process of determining the clinical diagnoses. Implementing an abstract idea on a generic computer, does not integrate the abstract idea into a practical application (See MPEP 2106.05(f)). To the extent that the limitations involving entering data could be considered additional elements, these elements would be considered insignificant extra-solution activity and do not integrate the abstract idea into a practical application as they only amount to necessary data gathering wherein all uses of the recited abstract idea would require such data gathering/data output (See MPEP 2106.05(g)). Furthermore, the storage of data/rules by the database also amounts to necessary data gathering and would similarly be considered insignificant extra solution activity.
Nothing in the claim recites specific limitations directed to an improvement to in technology, or a technological process. Similarly, the specification is silent with respect to these kinds of improvements. For example, the specification discloses that current approaches to determining the correct ICD-10 code uses a cross walk technique that is “time consuming for the physician” because they need to select between many codes. The present system is purported to create precise ICD-10 codes without the physician having to use cross walks or narrow the list of codes manually. “This saves the physician time and reduces documentation burden for billing” (0024, 0035, 0055). A general purpose computer that applies a judicial exception by use of conventional computer functions, as is the case here, does not qualify as a particular machine, nor does the recitation of a generic computer impose meaningful limits in the claimed process. (see Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17 (Fed. Cir. 2014)). As such, the additional elements recited in the claim do not integrate the abstract code identification process into a practical application of that process.
STEP 2B
The additional elements identified above do not amount to significantly more than the abstract identification process. The additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generic computer structure (i.e. a rules engine, a database). Each of the above components are disclosed as being purely conventional and/or known in the industry. For example, the specification discloses that the rules engine may be a general purpose computer (published specification paragraph 0058). Similarly, the database is disclosed at a high level of generality and is construed as a conventional storage element.
The rule types recited in the claims – i.e. dynamic rules such as a search type rule, a render rule or an automated rule. The specification describes the function of these rule types. For example a render rule is a rule that requires a response form the user specifying the severity of the disease (0028); a search rule searches for body locations and present results; and an automated rule determines the encounter type. Each of these rules select the appropriate value for the relevant digit in the code scheme and are construed as conventional computer functions such as requesting and receiving information over a network. Requesting information, for example over a network, is a well-understood, routine and conventional computer function – i.e. receiving or transmitting data over a network as in Symantec, TLI, OIP and buySAFE. Similarly, a user interface for entering data is a conventional computer element (Fairwarnings). Considered as an ordered combination the limitations recited in the claims add nothing that is not already present when the steps are considered individually. Entering information using an unspecified input device is a well-understood, routine and convention computer function – i.e. electronic recordkeeping as in Alice and Ultramercial.
Claims 1, 7 and 14 further recite: “a differential diagnosis program configured to account for uncertain diagnosis and reduce re-entry of patient-specific metadata”. The differential diagnosis program, however, simply uses the rules engine to traverse a clinical diagnosis decision tree in such a way that it amounts to no more than a generic computing component utilized to perform a process that would otherwise be abstract. This allows the physician to save time and reduces documentation burden for billing in addition to reducing the re-entry of metadata, i.e. by the physician or other user (see at least pg. 9, line 25-pg. 10, line 7). Therefore, the differential diagnosis program more quickly performs a process traditionally performed by a physician and serves to reduce the burden on the physician by simplifying the process of determining the clinical diagnoses. However, as addressed in the above rejection, these limitations are not a practical application since the differential diagnosis program only serves to automate and thereby simplify a process normally performed by a physician/human user. Therefore, utilizing the differential diagnosis program in claims 1 and 14 improves the abstract idea of designating ICD codes for a patient and does not offer a technical solution to a technical problem.
The dependent claims add additional features including those that merely serve to further narrow the abstract idea above including:
further limiting the types of rules (2, 8);
further limiting the types of diagnoses (6, 12);
those that recite additional abstract ideas including:
generating a disease code in response to selecting a diagnosis and location (5, 11);
determining if the code is multiple, bilateral or split; (Claims 18 – 20);
determining if ICD-10 codes should be based on anatomical locations in a diagnosis; (Claim 13, 21);
or those that recite well-understood, routine and conventional activity or computer functions including:
using intelligence flags; (Claim 13);
searching for anatomical locations using a search rule (10);
inputting metadata responses (9);
using placement at a location to create the ICD-10 code; (Claims 15 – 17).
The limitations recited in the dependent claims, in combination with those recited in the independent claims merely serve to further narrow the abstract idea above, and add nothing that amounts to significantly more.
The apparatus claims are no different from the method claims in substance. “The equivalence of the method, system and media claims is readily apparent.” “The only difference between the claims is the form in which they were drafted.” (Bancorp). The method claims recite the abstract idea implemented on a generic computer, while the apparatus claims recite generic computer components configured to implement the same idea. Specifically, Claims 1, 2, 5, 6, 14, 15, 17, 18, 20 and 21 merely add the generic hardware noted above that nearly every computer will include. The apparatus claim’s requirement that the same method be performed with a programmed computer does not alter the method’s patentability under U.S.C. 101 (In re Grams). Therefore, the claims are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
The Prior Art
Claims 1, 7 and 14 recite a differential program configured to reduce re-entry of patient information when a primary diagnosis is uncertain. The prior art does not disclose this feature. As such, these claims, and those that depend therefrom, are non-obvious over the prior art.
Response to Arguments
Applicant's arguments filed 11 December, 2025 have been fully considered but they are not persuasive.
The U.S.C. 101 Rejection
Applicant disagrees that the claims are directed to an abstract idea, without more. Applicant notes the recitation of “features such as intelligence flags that ensure that the calculation of the ICD-10 codes is correct”. In particular, Applicant asserts “practical benefits and advantages of the interplay of the rules engine, diagnosis, metadata, and other claimed features.”
However, the “practical benefits and advantages” appear to be limited to provider time savings; and Examiner disagrees that providing a time savings to physicians is a technological improvement. The purported improvement in time savings, accuracy and efficiency is not relative to a prior art technological process, but a manual one. The specification is explicit in describing the improvement provided by the claimed invention – i.e. that of saving a doctor’s time.
With respect to the recited “intelligence flag”; Examiner initially notes that the claims recite that the flag “can be applied”; but does not positively recite applying any such flag. The specification discloses that intelligence flags may be applied to rules; as either a “smartGuess” flag or a “full-stop” flag. “Smartguess” is a default setting indicating that the rule should be executed against the patient information and diagnosis; however, once a code is determined for a rule, by body location or metadata, the flag is set to “full-stop”. A rule designated with a “full-stop” flag may also truncate downstream rule if they have no further specificity. (@ 0031, 0032) Applicant does not explain how such flags provide a technological improvement.
CONCLUSION
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US PGPUB 2004/0172297 A1 to Rao et al. discloses a system and method for extracting a diagnosis code based on patient information.
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to John A. Pauls whose telephone number is (571) 270-5557. The Examiner can normally be reached on Mon. - Fri. 8:00 - 5:00 Eastern. If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773.
Official replies to this Office action may now be submitted electronically by registered users of the EFS-Web system. Information on EFS-Web tools is available on the Internet at: http://www.uspto.gov/patents/process/file/efs/guidance/index.jsp. An EFS-Web Quick-Start Guide is available at: http://www.uspto.gov/ebc/portal/efs/quick-start.pdf.
Alternatively, official replies to this Office action may still be submitted by any one of fax, mail, or hand delivery. Faxed replies should be directed to the central fax at (571) 273-8300. Mailed replies should be addressed to “Commissioner for Patents, PO Box 1450, Alexandria, VA 22313-1450.” Hand delivered replies should be delivered to the “Customer Service Window, Randolph Building, 401 Dulany Street, Alexandria, VA 22314.”
/JOHN A PAULS/Primary Examiner, Art Unit 3683
Date: 9 February, 2025