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 an amendment filed on 11/06/2025. Claims 1, 11, 13, 16, and 20 have been amended. Claims 4-10, 12, 15-18, and 22 have been cancelled. No claims have been added. Therefore, claims 1-3, 11, 13, 14, and 19-21 are currently pending and have been examined.
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 1-3, 11, 13, 14, and 19-21 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. element 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.
STEP 1
The claims are directed to a method and system which are included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims recite the abstract idea of:
A method for validating medical coding, comprising:
correlating specific pieces of discrete electronic information that accurately represent that a clinical treatment procedure was performed and storing corresponding Current Procedural Terminology (CPT) codes:
generating discrete data from imaging, treatment, planning, and examinations procedures related to a current clinical practice:
storing the generated discrete data, wherein the discrete data includes radiation prescriptions prepared by a medical professional, physician orders, clinical documentation, notes, planning and delivery techniques, diagnosis codes, medications, equipment used, imaging methods, and modality;
performing a clinical procedure on patients that apply a medical treatment to patients and records clinical activity information associated with performing the clinical procedure on patients;
on a set schedule, automatically searching, automatically detecting which patients had clinical activity on a particular day and automatically collecting treatment related discrete data for each detected patient from store the generated discrete data relating to the current clinical practice;
automatically determining, by matching the discrete data to the specific pieces of discrete electronic information and using the matching to correlate discrete data to a corresponding one of the CPT codes and CPT code families
displaying information regarding the CPT code;
automatically entering the determined one or more CPT codes into the patient specific medical record; and
using the determined one or more CPT codes for generating an accurate patient specific bill based on the detected clinical procedure.
The claims, as illustrated by Claim 1, 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 claims recite determining received clinical procedure data and coding for the clinical procedure data is complete and correct for billing purposes. Determining received clinical procedure data and coding for the clinical procedure data is complete and correct for billing purposes using a computer is a process that merely organizes human activity, as it involves following rules and instructions to identify whether clinical procedure data and it’s coding are complete and correct, and then using the complete and correct coding data for billing purposes. It also involves an interaction between a person and a computer. Interaction between a person and computer qualifies as interaction under certain methods of organizing human activity. See MPEP 2106.04(a)(2)(II). As such, the claims recite an abstract idea within the category of certain methods of organizing human activity.
Dependent claims 3, 11, and 19-21 recite further abstract concepts that involve organizing human activity such as 3 the clinical procedure is a clinical procedure that requires billing, and wherein the detecting a clinical procedure that has been performed on the patient further includes determining whether a clinical procedure requires billing; 11/19 when the determined one or more CPT codes do not match the one or more manually input CPT codes, automatically using the determined one or more CPT codes; 20 when the determined one or more CPT codes match the one or more pre-registered CPT codes, mark as reviewed the one or more pre-registered CPT codes; 21 repeating the steps of claim 1 upon occurrence of an event, the event comprising at least one of the following: expiration of a threshold time period, periodic polling event, or a request for a bill for the clinical procedure.
STEP 2A PRONG TWO
The claims recite additional elements beyond those that encompass the abstract idea above including:
Independent claim 1:
computer-implemented
by a processor
providing clinical procedure delivery devices, electronic medical records storage, and record and verify system, which are connected over a communication network of a treatment facility;
in associated clinical procedure delivery devices, electronic medical records storage, and record and verify system
using the clinical procedure delivery devices
the clinical procedure delivery devices, electronic medical records storage, and record and verify system
the clinical procedure delivery devices, electronic medical records storage, and record and verify system that
system
on a graphical user interface
Independent claim 13:
clinical procedure delivery devices, electronic medical records storage, and record and verify system, which are connected over a communication network of a treatment facility;
clinical procedure delivery devices configured to
a billing validation and creation system, including:
a transceiver configured to access databases of clinical procedure delivery devices, electronic medical records storage, and record and verify system and to receive information from the databases;
a memory, configured to store information sent from the one or more databases
in associated clinical procedure delivery devices, electronic medical records storage, and record and verify system
a graphical user interface; and
a processor, configured to:
Dependent claim 19:
the processor is further configured to
Dependent claim 20:
the processor is further configured to
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with considerations laid out by the Supreme Court or the Federal Circuit. (see MPEP 2106.05 a-c and e). The additional elements integrate the abstract idea into a practical application when they: improve the functioning of a computer or improving any other technology, apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, apply the judicial exception with, or by use of, a particular machine, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. The additional limitations do not integrate the abstract idea into a practical application when they merely serve to link the use of the abstract idea to a particular technological environment or field of use — i.e. merely uses the computer as a tool to perform the abstract idea; or recite insignificant extra-solution activity (see MPEP 2106.05 f - h).
The processor, clinical procedure delivery device, electronic medical records storage, record and verify system, communications network, billing validation and creation system, transceiver, database, memory, and graphical user interface are recited at a high level of generality such that it amounts to no more than instructions to apply the abstract idea using generic computer components. These elements merely add instructions to implement the abstract idea on a computer, and generally link the abstract idea to a particular technological environment. Nothing in the claim recites specific limitations directed to an improved processor, clinical procedure delivery device, electronic medical records storage, record and verify system, communications network, billing validation and creation system, transceiver, database, memory, and graphical user interface. Similarly, the specification is silent with respect to these kinds of improvements. A general purpose computer that applies a judicial exception to computer functions, as is the case here, does not qualify as a particular machine, nor does the recitation of a basic 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 claims do not integrate the abstract clinical documentation correctness process into a practical application of that process.
STEP 2B
The additional elements identified above do not amount to significantly more than the abstract clinical documentation correction process. The additional structural 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. Because the specification describes these additional elements in general terms, without describing particulars, Examiner concludes that the claim limitations may be broadly, but reasonably construed, as reciting basic computer components and techniques. The specification describes the elements in a manner that indicates that they are sufficiently straightforward such that the specification does not need to describe the particulars in order to satisfy U.S.C. 112. Thus, as outlined above, the additional elements are merely used as a tool to perform the abstract idea. Considered as an ordered combination, the limitations recited in the claims add nothing that is not already present when the steps are considered individually.
The limitations recited in the dependent claims, in combination with those recited in the independent claims add nothing that integrates the abstract idea into a practical application, or that amounts to significantly more. For example, dependent claim limitations: 3 the clinical procedure is a clinical procedure that requires billing, and wherein the detecting a clinical procedure that has been performed on the patient further includes determining whether a clinical procedure requires billing; 11/19 when the determined one or more CPT codes do not match the one or more manually input CPT codes, automatically using the determined one or more CPT codes; 20 when the determined one or more CPT codes match the one or more pre-registered CPT codes, marking the one or more pre-registered CPT codes as reviewed; 21 repeating the steps of claim 1 upon occurrence of an event, the event comprising at least one of the following: expiration of a threshold time period, periodic polling event, or a request for a bill for the clinical procedure are directed to the abstract idea of organizing human activity where the additional elements are merely used as a tool to perform the abstract idea. Limitations such as: 2/14 the clinical procedure is a radiation therapy procedure merely serve to further narrow the abstract idea above. The limitations recited in the dependent claims, in combination with those recited in the independent claims add nothing that integrates the abstract idea into a practical application, or that amounts to significantly more. As such, the additional elements do not integrate the abstract idea into a practical application, or provide an inventive concept that transforms the claims into a patent eligible invention. Therefore, the claims are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 11, 13, 14, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Holland (CA 2,357,415 A1) in view of Rao, et al. (US 2005/0137910 A1) in further view of Kos, et al. (US 2013/0151265 A1).
With regards to claim 1, Holland teaches a computer-implemented method (see at least figure 3) and claim 13 recites a system comprising: a billing validation and creation system (see at least figure 1), including: a transceiver configured to access one or more databases and to receive information from the one or more databases (see at least figure 1); a memory, configured to store information sent from the one or more databases (see at least figure 1); a graphical user interface (see at least page 6, lines 14-15, electronic form on a computer screen); and a processor (see at least figure 1) for validating medical coding, comprising: correlating specific pieces of discrete electronic information that accurately represent that a clinical treatment procedure was performed and storing corresponding Current Procedural Terminology (CPT) codes (see at least page 8, lines 18-28, page 13, line 24 – page 14, line 7, page 29 “Example Lists”, reference information that includes procedures and their correlated CPT codes as well tables of related procedures and diagnosis that are often performed in conjunction with each other as are stored in electronic memory); providing clinical procedure delivery devices, electronic medical records storage, and record and verify system, which are connected over a communication network of a treatment facility (see at least figures 1-2, pages 5-8, computer 102 is used for receiving information during a physician-patient encounter [clinical procedure delivery device], storing information in either the memory 204 or storage area 206 [electronic medical records storage], and use reference information [record and verify system] to verify information entered by the physician during the patient encounter is correct for CPT coding purposes, where the whole system is connected by a communication network in a hospital or other medical facility); generating discrete data from imaging, treatment, planning, and examinations procedures related to a current clinical practice (see at least pages 17-18, Table 1: Example Template, page 5 – page 9, information from physician-patient encounter is received, information includes history of present illness, review of bodily systems, past medical, family, and social history of a patient, types of examinations performed on patient, procedures and treatments performed on patient, diagnoses specified, X-Ray/Ultrasound/CT information, etc.); storing the generated discrete data in associated clinical procedure delivery devices, electronic medical records storage, and record and verify system (see at least pages 5-8, computer 102 is used for receiving information during a physician-patient encounter [clinical procedure delivery device], storing information in either the memory 204 or storage area 206 [electronic medical records storage], and use reference information [record and verify system] to verify information entered by the physician during the patient encounter is correct for CPT coding purposes, where all the received information is stored in the computer, computer storage and reference information tables), wherein the discrete data includes radiation prescriptions prepared by a medical professional (see at least page 18, Table 1: Example Template – Page 2, upper right, radiation prescriptions), physician orders (see at least pages 17-18, Table 1: Example Template, various physician orders), clinical documentation, notes, planning and delivery techniques (see at least pages 17-18, Table 1: Example Template, various clinical documentation, notes, planning and delivery techniques), …medications (see at least page 17, Table 1: Example Template – Page 1, middle right, medications), equipment used (see at least page 18, Table 1: Example Template – Page 2, various equipment used), imaging methods (see at least page 18, Table 1: Example Template – Page 2, upper right, imaging methods), and modality (see at least page 18, Table 1: Example Template – Page 2, upper right, modality); performing a clinical procedure on patients using the clinical procedure delivery devices …and that record clinical activity information associated with performing the clinical procedure on patients (see at least page 11, lines 24-27, computer [clinical procedure delivery device] receives information [records clinical activity information associated with clinical procedure] about physician-patient encounter [performing clinical procedure on a patient]); automatically determining, by matching the discrete data to the specific pieces of discrete electronic information and using the matching to correlate discrete data to a corresponding one of the CPT codes and CPT code families (see at least page 5, line 29 – page 6, line 15, information related to physician-patient encounter is entered into a template on a computer screen of a computer by a physician, the computer receives the information and uses the information to determine CPT coding levels; at least page 10, lines 9-16, page 13, line 26 – page 14, line 7, patient specific information is input into computer and coding software determines whether the patient specific information is correct by matching input information to look up tables with each typical individual procedure performed in a procedure category and corresponding CPT codes for the typical individual procedures under the procedure category tables; at least figure 3 (300, 302), page 9, lines 22-31, computer electronically receives physician-patient encounter information and then compares it reference information [automatically detecting]; displaying information on a graphical user interface regarding the CPT code (see at least page 5, line 29 – page 6, line 2, page 10, lines 1-23, physician uses computer during physician-patient encounter, computer checks physician coding and provides documentation feedback to physician in real-time regarding potential mistakes [displaying information on graphical user interface]); …using the determined one or more CPT codes for generating an accurate patient specific bill based on the detected clinical procedure (see at least page 6, lines 29-31, page 11, lines 2-3, final coding sent to user so physician or medical facility bills for services rendered and billing information is printed).
Holland does not explicitly teach …diagnosis codes; …that apply a medical treatment to patients; …on a set schedule, automatically searching the clinical procedure delivery devices, electronic medical records storage, and record and verify system, automatically detecting which patients had clinical activity on a particular day and automatically collecting treatment related discrete data for each detected patient from the clinical procedure delivery devices, electronic medical records storage, and record and verify system that store the generated discrete data relating to the current clinical practice; …automatically entering the determined one or more CPT codes into the patient specific medical record system.
Rao teaches …diagnosis codes (see at least ¶ 0041); …that apply a medical treatment to patients (see at least figure 2, X-Ray, PET); …automatically entering the determined one or more CPT codes into the patient specific medical record system (see at least paragraph 0055, extracted billing codes are compared to actual billing codes to determine if they match, actual billing code will be deemed incorrect and rejected if there is an extracted billing code that is contrary to actual billing code; at least paragraphs 0058-0059, system automatically removes actual billing codes deemed incorrect and replaces them with extracted billing codes that reflect the patient record). It would have been obvious to one of ordinary skill in the art to combine the medical code validation system of Rao with the medical documentation feedback method of Holland with the motivation of ensuring the proper codification and classification of medical diagnoses and procedures (Rao, ¶ 0004).
Kos teaches …on a set schedule, automatically searching the clinical procedure delivery devices, electronic medical records storage, and record and verify system, automatically detecting which patients had clinical activity on a particular day and automatically collecting treatment related discrete data for each detected patient from the clinical procedure delivery devices, electronic medical records storage, and record and verify system that store the generated discrete data relating to the current clinical practice (see at least figure 7 [date interpreted as clinical activity on a particular day], ¶ 0086, treatment phase of the workflow then commences, step 70. Every time a treatment occurs [set schedule], the DICOM treatment data for that treatment is relayed to the DICOM Code Interpreter (DCI). The patient is automatically identified with the previously linked DICOM identifiers. The DICOM treatment data is associated with the previously recorded DICOM plan and supplemental data. The DCI generates treatment codes, step 72. The DCI leverages the old plan data recorded along with the new data in order to generate treatment codes. The user approves those treatment billing codes, step 74. The approved billing codes are again sent directly to the billing system or sent via HL7. They are recorded in the patient's account and are ready to be invoiced. This cycle, starting with the treatments, step 70, repeats until the treatment regime is complete. At that point, the Follow Up phase commences, step 78. This phase is again more similar to that practiced by most physicians, and is recorded and billed separately). It would have been obvious to one of ordinary skill in the art to combine the medical coding system of Kos with the medical documentation feedback method of Holland with the motivation of reducing errors and providing accurate and efficient billing (Kos, ¶ 0037).
Claim 13 recites similar limitations and is rejected for the same reasons.
With regards to claim 2, Rao teaches the method as recited in claim 1, wherein the clinical procedure is a radiation therapy procedure (see at least paragraph 0058). It would have been obvious to one of ordinary skill in the art to combine the medical code validation system of Rao with the medical documentation feedback method of Holland with the motivation of ensuring the proper codification and classification of medical diagnoses and procedures (Rao, ¶ 0004).
Claim 14 recites similar limitations and is rejected for the same reasons.
With regards to claim 3, Holland teaches the method as recited in claim 1, wherein the clinical procedure is a clinical procedure that requires billing, and wherein the detecting a clinical procedure that has been performed on the patient further includes determining whether a clinical procedure requires billing (see at least page 14, lines 8-13).
With regards to claim 11, Rao teaches the method as recited in claim 1, further comprising: when the determined one or more CPT codes do not match the one or more manually input CPT codes, automatically, using the determined one or more CPT codes (see at least ¶ 0005, doctors record codes for patient records [manually input]; ¶ 0055, 0058-0059, system automatically determines billing codes for a patient record and codes extracts previously recorded billing codes from the patient record, deems previously recorded billing code as incorrect, removes recorded billing codes deemed incorrect and replaces them with automatically determined billing codes that reflect the patient record). It would have been obvious to one of ordinary skill in the art to combine the medical code validation system of Rao with the medical documentation feedback method of Holland with the motivation of ensuring the proper codification and classification of medical diagnoses and procedures (Rao, ¶ 0004).
Claim 19 recites similar limitations and is rejected for the same reasons.
With regards to claim 20, Rao teaches the system as recited in claim 13, wherein, when the determined one or more CPT codes match the one or more pre-registered CPT codes, the processor is further configured to mark as reviewed the one or more pre-registered CPT codes (see at least paragraph 0055, a comparison between a recorded billing and an extracted billing code deems the recorded billing code as correct; at least paragraph 0056, an explanation for extracted billing code including comparison results is stored, interpreted as marking codes reviewed). It would have been obvious to one of ordinary skill in the art to combine the medical code validation system of Rao with the medical documentation feedback method of Holland with the motivation of ensuring the proper codification and classification of medical diagnoses and procedures (Rao, ¶ 0004).
With regards to claim 21, Holland teaches the method as recited in claim 1, further comprising repeating the steps of claim 1 upon occurrence of an event (see at least figure 3, “YES” branch), the event comprising at least one of the following: expiration of a threshold time period, periodic polling event, or a request for a bill for the clinical procedure (see at least page 1, lines 23-24, physician desires highest coding level for encounter to provide largest amount of compensation [request for bill for clinical procedure]).
Furthermore, Rao teaches repeating the steps of claim 1 upon occurrence of an event (see at least figure 5, paragraph 0059, repeating process for all patient records in given database). It would have been obvious to one of ordinary skill in the art to combine the medical code validation system of Rao with the medical documentation feedback method of Holland with the motivation of ensuring the proper codification and classification of medical diagnoses and procedures (Rao, ¶ 0004).
Response to Arguments
Applicant's arguments with respect to the 35 USC § 101 rejections set forth in the previous office action have been considered, but are not persuasive. In an effort to advance prosecution, the Examiner has provided a response to applicant's arguments. Applicant argues:
Applicant’s amended limitations do not involve an abstract idea.
Applicant’s limitations are subject matter eligible because they are significantly more than any abstract idea.
Applicant’s limitations are subject matter eligible similar to USPTO Example 42.
Applicant’s limitations are subject matter eligible in view of Director Squires’ recently issued decision on In re Desjardins.
With regards to Applicant’s argument that the amended limitations do not involve an abstract idea, the Examiner respectfully disagrees. The claims limitations “storing corresponding Current Procedural Terminology (CPT) codes”, “storing the generated discrete data in associated clinical procedure delivery devices, electronic medical records storage, and record and verify system, wherein the discrete data includes radiation prescriptions prepared by a medical professional, physician orders, clinical documentation, notes, planning and delivery techniques, diagnosis codes, medications, equipment used, imaging methods, and modality”, “performing a clinical procedure on patients using the clinical procedure delivery devices that apply a medical treatment to patients and that records clinical activity information associated with performing the clinical procedure on patients”, “on a set schedule, automatically searching the clinical procedure delivery devices, electronic medical records storage, and record and verify system, automatically detecting which patients had clinical activity on a particular day and automatically collecting treatment related discrete data for each detected patient from the clinical procedure delivery devices, electronic medical records storage, and record and verify system that store the generated discrete data relating to the current clinical practice”, and ”automatically entering the determined one or more CPT codes into the patient specific medical record system” involve collecting information. Collecting information has been treated as within the realm of abstract ideas. See, e.g., Internet Patents, 790 F.3d at 1349; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015); Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat’l Ass’n, 776 F.3d 1343, 1347 (Fed. Cir. 2014); Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014); CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1370 (Fed. Cir. 2011); Electric Power, LLC v. Alstom S.A., (Fed. Cir. 2016). The claims limitations “correlating specific pieces of discrete electronic information that accurately represent that a clinical treatment procedure was performed”, “generating discrete data from imaging, treatment, planning, and examinations procedures related to a current clinical practice Analyzing information has been treated as within the abstract-idea category”, “automatically determining, by matching the discrete data to the specific pieces of discrete electronic information and using the matching to correlate discrete data to a corresponding one of the CPT codes and CPT code families”, and “using the determined one or more CPT codes for generating an accurate patient specific bill based on the detected clinical procedure” involve analyzing information. Analyzing information has been treated as within the realm of abstract ideas. See, e.g., TLI Commc’ns, 823 F.3d at 613; Digitech, 758 F.3d at 1351; SmartGene, Inc. v. Advanced Biological Labs., SA, 555 F. App’x 950, 955 (Fed. Cir. 2014); Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012); CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372 (Fed. Cir. 2011); SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 1333 (Fed. Cir. 2010); Electric Power, LLC v. Alstom S.A., (Fed. Cir. 2016); see also Mayo, 132 S. Ct. at 1301; Parker v. Flook, 437 U.S. 584, 589–90 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972). Claim limitation “displaying information on a graphical user interface regarding the CPT code” involves displaying results of an analysis. Merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis. See, e.g., Content Extraction, 776 F.3d at 1347; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014); Electric Power, LLC v. Alstom S.A., (Fed. Cir. 2016). As such, the claims recite an abstract idea.
In response to Applicant’s argument the limitations are subject matter eligible because they are significantly more than any abstract idea, the Examiner respectfully disagrees. Applicant’s specification states “[t]he current state of the art requires a significant amount of human interaction in performing assigning billing codes and in determining the accuracy of billing codes… [which] increases the time and cost of billing and increases the risk of human error. The present disclosure, however, provides a system 100 and method 200 that significantly reduces the amount of human interaction required by using server hardware to execute specific services that perform the coding functions …By reducing the human interactions required to perform these functions, the systems and methods of the present disclosure reduce the timeframe needed to perform these functions and reduce the costs associated with these functions, thus improving upon the existing technologies in the art. Additionally, the system 100 and method 200 of the present disclosure uses automation to decrease common errors made in this field.” See specification ¶ 0040-0041.
The instant application is merely applying generic computer components such as a processor, clinical procedure delivery device, electronic medical records storage, record and verify system, communications network, billing validation and creation system, transceiver, database, memory, and graphical user interface to perform coding functions that were previously performed by humans. In order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it". Thus claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. Furthermore, having the ability for processing large amounts of data in a manner more efficient than a human could do to save time, money, and errors does not amount to significantly more as “the inability for the human mind to perform each claim step does not alone confer patentability. As we have explained, ‘the fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter.’ Bancorp Servs., 687 F.3d at 1278.” FairWarning IP, LLC v. Iatric Systems, _ F.3d _, 120 U.S.P.Q.2d 1293 (Fed. Cir. 2016).
In response to Applicant’s argument the limitations are subject matter eligible similar to USPTO Example 42, the Examiner respectfully disagrees. Claim 1 of Example 42 was ruled eligible because “the additional elements recite a specific improvement over prior art systems by allowing remote users to share information in real time in a standardized format regardless of the format in which the information was input by the user”. The instant invention is not involved with converting information from non-standardized formats into a standard format. It is involved with determining medical data is coded correctly for billing. In fact, the Applicant argues that the instant invention involves something different “than reformatting or converting source files or formats to a common format.” See 11/06/2025 Remarks, pages 9-10. Therefore the instant limitations are not subject matter eligible for similar reasons to Example 42.
In response to Applicant’s argument the limitations are subject matter eligible in view of Director Squires’ recently issued decision on In re Desjardins, the Examiner respectfully disagrees. Desjardins involved an improvement to a method of training a machine learning model on a series of tasks because the specification identified the improvement to machine learning technology by explaining how the machine learning model is trained to learn new tasks while protecting knowledge about previous tasks to overcome the problem of “catastrophic forgetting,” and that the claims reflected the improvement identified in the specification. Indeed, enumerated improvements identified in the Desjardins specification included disclosures of the effective learning of new tasks in succession in connection with specifically protecting knowledge concerning previously accomplished tasks; allowing the system to reduce use of storage capacity; and the enablement of reduced complexity in the system. Such improvements were tantamount to how the machine learning model itself would function in operation and therefore not subsumed in the identified mathematical calculation. The memo further states that decisions like Enfish should be considered when evaluating the claims of applications.
As stated above, the instant specification merely purports to solve the problem of human inefficiency by applying conventional computer components to the judicial exception of coding medical records for billing. The Examiner has not found any evidence in the specification that would allow the instant application to be considered an improvement in the technology similar to Desjardins. “The claims here are unlike the claims in Enfish. There, we relied on the distinction…between, on one hand, computer-functionality improvements and, on the other, uses of existing computers as tools in aid of processes focused on ‘abstract ideas’ Enfish, 822 F.3d at 1335–36; see Alice, 134 S. Ct. at 2358–59. That distinction, the Supreme Court recognized, has common-sense force even if it may present line-drawing challenges because of the programmable nature of ordinary existing computers. In Enfish…the claims at issue focused not on asserted advances in uses to which existing computer capabilities could be put, but on a specific improvement—a particular database technique—in how computers could carry out one of their basic functions of storage and retrieval of data. Enfish, 822 F.3d at 1335–36; see Bascom, 2016 WL 3514158, at *5; cf. Alice, 134 S. Ct. at 2360 (noting basic storage function of generic computer). The present case is different: the focus of the claims is not on such an improvement in computers as tools, but on certain independently abstract ideas that use computers as tools...Inquiry therefore must turn to any requirements for how the desired result is achieved…The claims at issue do not require any nonconventional computer, network, or display components, or even a ‘non-conventional and non-generic arrangement of known, conventional pieces,’ but merely call for performance [of the invention] ‘on a set of generic computer components’ and display devices. Bascom, 2016 WL 3514158, at *6–7.” Electric Power Group v Alstom S.A. (Fed Cir, 2015-1778, 8/1/2016).
Applicant's arguments with respect to the 35 USC § 103 rejections set forth in the previous office action have been considered, but are not persuasive. In an effort to advance prosecution, the Examiner has provided a response to applicant's arguments. Applicant argues:
The desktop computer/personal computer relied on by the Office is not a clinical treatment device.
In response to Applicant’s argument that the desktop computer/personal computer relied on by the Office is not a clinical treatment device, the Examiner respectfully disagrees. Holland teaches information related to physician-patient encounter is entered into a template on a computer screen of a computer by a physician, the computer receives the information and uses the information to determine CPT coding levels. It provides feedback to the physician in real-time during the patient encounter to ensure that the physician is entering the correct series of procedures corresponding to a specific type of treatment based on procedures the physician has entered compared to look up tables and corresponding CPT codes for specific types of treatments. If a particular procedure of a specific type of treatment is not documented by the physician, the computer provides a query to the physician so they can quickly determine during the encounter whether any services provided were missed. Therefore, under broadest reasonable interpretation standard, the computer is a “clinical treatment device” because it provides feedback if a service is missed. Rao is cited for clinical procedure delivery devices that “apply a medical treatment to patients” because it involves X-Ray and PET machines.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Krishnan, et al. (US 2005/0234740 A1) which discloses business methods and systems that are provided use knowledge-based expert systems for mining (extracting) highly structured clinical information from various structured and unstructured sources of healthcare provider data. In one business method for on-line healthcare management and decision support, a service provider maintaining a collection of structured clinical data, the structured clinical data comprising information automatically mined from various structured and unstructured sources of healthcare provider data from one or more different healthcare providers. The service provider provides a customer on-line access to structured clinical data in the collection, or providing an on-line service to the customer using structured clinical data in the collection, based on a service agreement between the customer and the service provider.
Kelley (US 2003/0154085 A1) which discloses systems and methods for automatically recognizing and processing verbal data associated with medical treatment diagnosis and related billing, compliance and reporting procedures in the healthcare industry are provided. A method for completing and generating a claim form comprises providing an interactive voice interface for receiving and analyzing one or more verbal inputs to a computing system. The system interprets the one or more verbal inputs to fill one or more corresponding fields in an electronic form. The system continues to receive and analyze verbal inputs until the electronic form is completed. The system associates the content of the electronic form with one or more industry codes. The industry codes identify at least the nature of one or more services associated with the one or more verbal inputs. The system then arranges the codes in a predetermined manner to generate a claim for reimbursement that can be processed by a medical claims processing facility
C. Clinkingbeard, A. Froehlich, C. Smith, J. F. Calland and S. Guerlain, "Designing a physician's daily note template to support higher quality documentation of patient information," 2009 Systems and Information Engineering Design Symposium, 2009, pp. 208-212, doi: 10.1109/SIEDS.2009.5166185 which discloses computerized medical records are continuing to be adopted in hospitals nationwide, but the vast majority of health care systems rely on paper records as well. Physician documentation of patient conditions must support a variety of functions, which often conflict with each other. The goal of this project was to redesign the daily note template for a Trauma Center to encourage higher quality documentation of patient information. This, in turn, supports patient care, physicians' training, standardization of information, the hospital's billing, and legal records. The authors' methodology was to assess the residents' current routine and conduct focus groups with Trauma residents and attendings to shape the design of the new note to encourage higher quality documentation that follows a systems-based approach to evaluating the patient.
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
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/JOSEPH D BURGESS/Primary Examiner, Art Unit 3681
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