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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/30/2025 has been entered.
Status of Claims
This action is in reply to an amendment filed on 06/30/2025. Claims 1, 8, 11-13, 16, 19, and 20 have been amended. Claims 4, 5, and 15 have been cancelled. No claims have been added. Therefore, claims 1-3, 6-14, and 16-22 are currently pending and have been examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 8 and 12 recite the limitation “the one or more manually input CPT codes". There is insufficient antecedent basis for this limitation in the claim.
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, 6-14, and 16-22 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:
performing a clinical procedure on a patient that records clinical activity information associated with the clinical procedure;
automatically detecting, based on the recorded clinical activity information, patient specific attributes of the clinical procedure that has been performed on the patient;
determining, based on a plurality of discrete data about the clinical procedure received, whether all appropriate clinical and treatment documentation for the clinical procedure has been recorded into a patient specific medical record, the clinical and treatment documentation not including billing codes;
generating and sending a request to one or more end-users to supply any missing clinical and treatment documentation when all appropriate clinical and treatment documentation for the clinical procedure has not been recorded;
updating the patient specific medical record with the missing clinical and treatment documentation associated with the clinical procedure;
determining, by correlating discrete data corresponding to the clinical and treatment documentation for the clinical procedure to Current Procedural Terminology (CPT) codes and CPT code families, one or more codes appropriate to the clinical procedure when all appropriate clinical and treatment documentation for the clinical procedure has been recorded;
comparing the determined one or more CPT codes against one or more pre-registered CPT codes for the clinical procedure to determine CPT code completeness;
displaying information regarding the CPT code completeness;
wherein, when the determined one or more CPT codes do not match the one or more pre-registered CPT codes, 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.
The dependent claims 2, 3, 6-12, 14, and 16-22 recite further abstract concepts that involve organizing human activity such as 2/14 the clinical procedure is a radiation therapy procedure; 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; 6/17 the request further includes information pertaining to the clinical procedure; 7/18 the information pertaining to the procedure is selected from the group consisting of: patient name; date of the clinical procedure; and type of the clinical procedure; 8/16 when the determined one or more CPT codes do not match the one or more pre-registered CPT codes, notifying an end-user that the determined one or more CPT codes do not match the one or more manually input CPT codes; 9 the notification includes information pertaining to the clinical procedure and the determined CPT codes; 10 the information pertaining to the procedure is selected from the group consisting of: patient name; date of the clinical procedure; and type of the clinical procedure; 11/19 when the determined one or more CPT codes do not match the one or more pre-registered CPT codes, automatically generating one or more CPT codes; 12/20 when the determined one or more CPT codes match the one or more pre-registered CPT codes, marking the one or more pre-registered input 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; 22 the plurality of discrete data including at least one of the following: a prescription relating to the clinical procedure, a physician order, clinical documentation, physician notes, planning and delivery techniques relating to the clinical procedure, diagnosis codes, medications, equipment used, imaging methods, time spent in performance of the clinical procedure, quantity of certain items used in performance of the clinical procedure, complexity of activities performed during the clinical procedure, and modality of 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
using a clinical procedure delivery device
the clinical procedure delivery device
from a clinical device or a data store via a communications network
via the communications network
system
on a graphical user interface
Dependent claim 8:
via the communications network
Dependent claim 11:
using the processor
Independent claim 13:
a billing validation and creation system, including:
a transceiver configured to access one or more databases and to receive information from the one or more databases;
a memory, configured to store information sent from the one or more databases;
a graphical user interface; and
a processor, configured to:
of a clinical procedure delivery device
using the clinical procedure delivery device
from a clinical device or the memory via a communications network
using the transceiver, via the communications network
Dependent claim 16:
the processor is further configured
using the transceiver
Dependent claim 19:
the processor is further configured
Dependent claim 20:
the processor is further configured
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, delivery device, clinical device, communications network, medical records 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, delivery device, clinical device, communications network, medical records 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: 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; when the determined one or more CPT codes do not match the one or more pre-registered input CPT codes, notifying an end-user that the determined one or more CPT codes do not match the one or more pre-registered input CPT codes; when the determined one or more CPT codes do not match the one or more pre-registered input CPT codes, automatically generating one or more CPT codes; 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; 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: the clinical procedure is a radiation therapy procedure; the request further includes information pertaining to the clinical procedure; the information pertaining to the procedure is selected from the group consisting of: patient name; date of the clinical procedure; and type of the clinical procedure; the notification includes information pertaining to the clinical procedure and the determined CPT codes; the information pertaining to the procedure is selected from the group consisting of: patient name; date of the clinical procedure; and type of the clinical procedure; the plurality of discrete data including at least one of the following: a prescription relating to the clinical procedure, a physician order, clinical documentation, physician notes, planning and delivery techniques relating to the clinical procedure, diagnosis codes, medications, equipment used, imaging methods, time spent in performance of the clinical procedure, quantity of certain items used in performance of the clinical procedure, complexity of activities performed during the clinical procedure, and modality of the clinical 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, 6-14, and 16-22 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).
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: performing a clinical procedure on a patient using a clinical procedure delivery device that records clinical activity information associated with the clinical procedure (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 detecting, based the recorded clinical activity information, patient specific attributes of the clinical procedure that has been performed on the patient using the clinical procedure delivery device (see at least page 5, line 29 – page 6, line 15, information related to physician-patient encounter [clinical procedure] is entered into a template on a computer screen of a computer [clinical procedure device] by a physician, the computer receives the information and uses the information to determine CPT coding levels [automatically detecting a clinical procedure that has been performed on a patient]; at least page 10, lines 9-16, page 13, line 26 – page 14, line 2, patient specific information is input into computer and coding software determines whether the patient specific information is correct according to the input; 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]); determining, based on a plurality of discrete data about the clinical procedure received from a clinical procedure delivery device or a data store via a communications network, whether all appropriate clinical and treatment documentation for the clinical procedure has been recorded into a patient specific medical record system (see at least figure 3 (304), page 10, lines 1-23, a medical feedback application determines whether a physician potentially missed or misdiagnosed information or services provided, or whether information was left undocumented because that procedure is often performed with the documented procedures regarding the physician-patient encounter information received), the clinical and treatment documentation not including billing codes (see at least figure 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 [information not including billing codes]); generating and sending, via the communications network, a request to one or more end-users to supply any missing clinical and treatment documentation when all appropriate clinical and treatment documentation for the clinical procedure has not been recorded into the medical record system (see at least figure 3 (306, 308), page 10, lines 6-23, When it is determined the physician has missed or misdiagnosed information or services provided, or whether information was left undocumented, the medical feedback application automatically generates and electronically sends a query to the physician to correct the missing, misdiagnosed, or undocumented information, which allow the physician to add any missing information or fix any misdiagnosed information); updating the patient specific medical record system with the missing clinical and treatment documentation associated with the clinical procedure (see at least figure 3 (310), page 10, lines 27-31, physician amends missing or misdiagnosed information to the record); determining, by correlating discrete data corresponding to the clinical and treatment documentation for the clinical procedure to Current Procedural Terminology (CPT) codes and CPT code families, one or more CPT codes appropriate to the clinical procedure when all appropriate clinical and treatment documentation for the clinical procedure has been recorded (see at least figure 3 (312), page 11, lines 1-2, CPT coding determined for received corrected encounter information); …displaying information on a graphical user interface regarding the CPT code completeness (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 …comparing the determined one or more CPT codes against one or more pre-registered CPT codes for the clinical procedure to determine CPT code completeness; …and wherein when the determined one or more CPT codes do not match the one or more pre-registered input CPT codes, automatically entering the determined one or more CPT codes into the patient specific medical record system. Rao teaches ……comparing the determined one or more CPT codes against one or more pre-registered CPT codes for the clinical procedure to determine CPT code completeness (see at least paragraph 0055, comparing extracted billing codes with actually recorded billing codes [pre-registered]); and wherein when the determined one or more CPT codes do not match the one or more pre-registered input CPT codes, 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).
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 6, Holland teaches the method as recited in claim 3, wherein the request further includes information pertaining to the clinical procedure (see at least page 12, lines 27-28, pages 19-28, query examples are in “Example Documentation Dialogs” and include information pertaining to clinical procedure).
With regards to claim 7, Holland teaches the method as recited in claim 6, wherein the information pertaining to the procedure is selected from the group consisting of: patient name; date of the clinical procedure; and type of the clinical procedure (see at least pages 19-28, query examples are in “Example Documentation Dialogs” and include information pertaining to type of clinical procedure).
With regards to claim 8, Rao teaches the method as recited in claim 1, further comprising: if the determined one or more CPT codes do not match the one or more pre-registered input CPT codes, notifying, via the communications network, an end-user that the determined one or more CPT codes do not match the one or more manually input CPT codes (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 16 recites similar limitations and is rejected for the same reasons.
With regards to claim 9, Rao teaches the method as recited in claim 8, wherein the notification includes information pertaining to the clinical procedure and the determined CPT codes (see at least paragraph 0030, code used to identify treatments; at least paragraph 0058, notification of comparison of code results). 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 17 recites similar limitations and is rejected for the same reasons.
With regards to claim 10, Holland teaches the method as recited in claim 9, wherein the information pertaining to the procedure is selected from the group consisting of: patient name; date of the clinical procedure; and type of the clinical procedure (see at least pages 19-28, query examples are in “Example Documentation Dialogs” and include information pertaining to type of clinical procedure).
Claim 18 recites similar limitations and is rejected for the same reasons.
With regards to claim 11, Rao teaches the method as recited in claim 8, further comprising: when the determined one or more CPT codes do not match the one or more pre-registered CPT codes, automatically, using the processor, generating one or more CPT codes (see at least paragraphs 0055, 0058-0059, system automatically generates, or extracts billing codes from patient record, deems actual billing code as incorrect, 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).
Claim 19 recites similar limitations and is rejected for the same reasons.
With regards to claim 12, Rao teaches the method as recited in claim 1, further comprising: 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 (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).
Claim 20 recites similar limitations and is rejected for the same reasons.
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).
With regards to claim 22, Holland teaches the method as recited in claim 1, wherein the plurality of discrete data including at least one of the following: a prescription relating to the clinical procedure, a physician order, clinical documentation, physician notes, planning and delivery techniques relating to the clinical procedure, diagnosis codes, medications, equipment used, imaging methods, time spent in performance of the clinical procedure, quantity of certain items used in performance of the clinical procedure, complexity of activities performed during the clinical procedure, and modality of the clinical procedure (see at least table 1 [physician notes]).
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 “performing a clinical procedure on a patient using a clinical procedure delivery device that records clinical activity information associated with the clinical procedure; automatically detecting, based on the recorded clinical activity information, patient specific attributes of the clinical procedure that has been performed on the patient using the clinical procedure delivery device; comparing the determined one or more CPT codes against one or more pre-registered CPT codes for the clinical procedure to determine CPT code completeness; displaying information on a graphical user interface regarding the CPT code completeness; and using the determined one or more CPT codes for generating an accurate patient specific bill based on the detected clinical procedure” do not involve an abstract idea.
Applicant’s limitations are subject matter eligible because they integrate any abstract idea into a practical application through improving the technology by “reducing errors, beyond those capable of humans, and increasing the speed of the system, automation, redundancy, etc.” and “determining missing data points and facilitating completion of records across multiple computing media prior to the determination of billing codes”.
With regards to Applicant’s argument that the amended limitations “performing a clinical procedure on a patient using a clinical procedure delivery device that records clinical activity information associated with the clinical procedure; automatically detecting, based on the recorded clinical activity information, patient specific attributes of the clinical procedure that has been performed on the patient using the clinical procedure delivery device; comparing the determined one or more CPT codes against one or more pre-registered CPT codes for the clinical procedure to determine CPT code completeness; displaying information on a graphical user interface regarding the CPT code completeness; and using the determined one or more CPT codes for generating an accurate patient specific bill based on the detected clinical procedure” do not involve an abstract idea, the Examiner respectfully disagrees. The claims collecting data in steps ”performing a clinical procedure on a patient using a clinical procedure delivery device that records clinical activity information associated with the clinical procedure; updating the patient specific medical record system with the missing clinical and treatment documentation associated with the clinical procedure. 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 further recite various steps used to analyze the collected data such as: “automatically detecting, based on the recorded clinical activity information, patient specific attributes of the clinical procedure that has been performed on the patient using the clinical procedure delivery device; determining, based on a plurality of discrete data about the clinical procedure received from the clinical procedure delivery device or a data store via a communications network, whether all appropriate clinical and treatment documentation for the clinical procedure has been recorded into a patient specific medical record system, the clinical and treatment documentation not including billing codes; generating and sending, via the communications network, a request to one or more end- users to supply any missing clinical and treatment documentation when all appropriate clinical and treatment documentation for the clinical procedure has not been recorded into the medical record system; determining, by correlating discrete data corresponding to the clinical and treatment documentation for the clinical procedure to Current Procedural Terminology (CPT) codes and CPT code families, one or more CPT codes appropriate to the clinical procedure when all appropriate clinical and treatment documentation for the clinical procedure has been recorded; comparing the determined one or more CPT codes against one or more pre-registered CPT codes for the clinical procedure to determine CPT code completeness; wherein, when the determined one or more CPT codes do not match the one or more pre-registered CPT codes, automatically entering the determined one or more CPT codes into the patient specific medical record system.” Analyzing information has been treated as within the abstract-idea category. 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). The claims additionally recite presenting data based on the analysis in steps: “displaying information on a graphical user interface regarding the CPT code completeness; using the determined one or more CPT codes for generating an accurate patient specific bill based on the detected clinical procedure.” 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 integrate any abstract idea into a practical application through improving the technology by “reducing errors, beyond those capable of humans, and increasing the speed of the system, automation, redundancy, etc.” and “determining missing data points and facilitating completion of records across multiple computing media prior to the determination of billing codes”, 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, graphical user interface, memory, transceiver, database, data store, and clinical procedure device 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).
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:
Holland does not teach “performing a clinical procedure on a patient using a clinical procedure delivery device that records clinical activity information associated with the clinical procedure; automatically detecting, based on the recorded clinical activity information, patient specific attributes of the clinical procedure that has been performed on the patient using the clinical procedure delivery device”.
In response to Applicant’s argument Holland does not teach “performing a clinical procedure on a patient using a clinical procedure delivery device that records clinical activity information associated with the clinical procedure; automatically detecting, based on the recorded clinical activity information, patient specific attributes of the clinical procedure that has been performed on the patient using the clinical procedure delivery device”, the Examiner respectfully disagrees. Holland teaches information related to physician-patient encounter [performing a clinical procedure on a patient] is entered into a template on a computer screen of a computer [clinical procedure delivery device] by a physician, the computer receives the information and uses the information to determine CPT coding levels [automatic detection] (page 5, line 29 – page 6, line 15). Therefore, Holland teaches “performing a clinical procedure on a patient using a clinical procedure delivery device that records clinical activity information associated with the clinical procedure; automatically detecting, based on the recorded clinical activity information, patient specific attributes of the clinical procedure that has been performed on the patient using the clinical procedure delivery device”.
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.
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/JOSEPH D BURGESS/Primary Examiner, Art Unit 3681