DETAILED ACTION
Applicant's response filed 20 October 2025 has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Claim Status
Claims 1-8, 11-18 and 20 are currently pending and under exam herein.
Claims 9-10 and 19 are cancelled.
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 1-8, 11-18 and 20 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Any newly recited portions herein are necessitated by claim amendment.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With respect to step (1): yes, the claims are directed to a method and system of determining an erroneous code in a medical report.
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas).
Claim Interpretation: Under the Broadest Reasonable Interpretation (BRI) the claims herein are presumed to have their plain meaning as consistent with the Specification and understood by one of ordinary skill in the art (MPEP2111).
Claim 1: generating a respective vector representation for each of a plurality codes in the medical report, wherein values of a vector representation for a code of the plurality of codes are generated based on relation of the code in a set of reference medical reports to other codes in the set of reference medical reports, wherein relative values of a pair of vector wherein relative values of any pair of vector representations are correlated with a co-occurrence of corresponding codes in the set of reference medical reports; identifying at least one of the generated vector representations as an outlying vector representation relative to other vector representations for the plurality of codes in the medical report, wherein said identifying comprises determining that the at least one generated vector representations is separated by more than a threshold separation from the other vector representations and determining, based on the identification of the at least one generated vector representation as being an outlier, that the code represented by the at least one generated vector is an erroneous code in the medical report” wherein the claim steps are directed to “generating” and “identifying”. Under the plain meaning of “generating” such steps can be performed mentally, as there are no details about how the “generating” is performed, other than by being “based on” relation of code to other codes using correlation, as claimed. As such, making said operations are fairly interpreted as mental
process. Further with respect to “vectorization” said steps are also performed mathematically wherein words, for example, may be converted to numbers and wherein said numbers can represent a position. Vector mathematics includes assignment of direction and magnitude to a quantity and is thus abstract.
Claim 2: “determining a respective vector representation for each of the plurality of codes comprises: for each code: determining a plurality of word vector representations, the plurality of word vector representations comprising a vector representation for each word in the comment represented by the code, wherein relative values of any selected pair of vector representations in the plurality of word vector representations are correlated with a co-occurrence of the corresponding words in the set of reference medical reports” wherein the further steps limited in claim 2 are directed to also further defining the steps of making a determination. Under the plain meaning of “determining” such steps can be performed mentally, as there are no details about how the “determining” is performed, other than by “correlation” of data, as claimed. Further with respect to “vectorization” said steps are also performed mathematically wherein words, for example, may be converted to numbers and wherein said numbers can represent a position.
Claim 3: “concatenating the plurality of word vector representations to obtain a concatenated word vector representation for the code” wherein said step is directed to concatenation, which is a process that can be performed mentally or by mathematical operation.
Claim 4: “concatenated word vector representation is used as the vector representation for the code” wherein words may be truncated an joined to form representation and can be performed mentally, for example, with pen and paper.
Claim 5: “concatenating the concatenated word vector representation with the vector representation for the code to create a combined vector representation for the code” wherein words may be truncated an joined to form representation and can be performed mentally, for example, with pen and paper.
Claim 6: “weighting each vector representation in the plurality of word-vector representations using the vector representation for the code; determining an average of the weighted word-vector representations to create a weighted- average vector representation for the code” wherein the process of “weighting” and determining averages are mathematically performed operations.
Claim 7: “determining a respective vector representation for each of the plurality of codes comprises: using a machine learning process to determine each vector representation, based on a co- occurrence of the corresponding codes in the set of reference medical reports” wherein the step is directed to making determinations of vector representations by using the tool that is machine learning, wherein the machine learning employed is by way of known models for predicting words from a set of words or other to create vector representations of a word (e.g., CBOW, Word2Vec etc…-page 5 of the Specification as filed).
Claim 8: “machine learning process comprises a Word2Vec, process” wherein said operation uses a tool to predict the “word” vector
Claim 11: “determining: an average separation of the vector representations in the vector space; or an average separation of a predetermined number of the most separated vector representations in the vector space”---wherein said operations are steps that also require mental operation as one can “determine” representations by merely making visual assessments give the proper data (vectors).
Claim 12: “determining a probability that each code comprises an outlying code, based on a normalized measure of separation of the plurality of codes in a vector space”---wherein probability determinations are mathematical operations.
Claim 13: “predicting at least one additional code that could be missing from the medical report, based on the vector representations” wherein predictions are preformed mathematically given observations of data.
Claim 14: performs the method of claim 1 using a non-transitory computer-readable medium---see above.
Claim 15: a system with memory to execute instructions for the processor to: “generate a respective vector representation for each of the plurality of codes in the medical report, wherein relative values of any pair of vector representations are correlated with a co-occurrence of the corresponding codes of the pair of vector representations in a set of reference medical reports; identify at least one of the generated vector representations as an outlying vector representation relative to other vector representations for the plurality of codes in the medical report, wherein said identifying comprises determining that the at least one generated vector representations is separated by more than a threshold separation from the other vector representations and generate an erroneous code in the medical report, based on comparison of the pair of vector representations; determine, based on the identification of the at least one generated vector representation as being an outlier, that the code represented by the at least one generated vector is an erroneous code in the medical report ” ---see above.
Claim 16: determining a plurality of word vector representations, the plurality of word vector representations comprising a vector representation for each word in the comment represented by the code, wherein relative values of any selected pair of vector representations in the plurality of word vector representations are correlated with a co-occurrence of the corresponding words in the set of reference medical reports” wherein the further steps limited in claim 2 are directed to also further defining the steps of making a determination. Under the plain meaning of “determining” such steps can be performed mentally, as there are no details about how the “determining” is performed, other than by “correlation” of data, as claimed. Further with respect to “vectorization” said steps are also performed mathematically wherein words, for example, may be converted to numbers and wherein said numbers can represent a position.
Claim 17: concatenating the concatenated word vector representation with the vector representation for the code to create a combined vector representation for the code” wherein words may be truncated an joined to form representation and can be performed mentally, for example, with pen and paper.
Claim 18: “weight each vector representation in the plurality of word-vector representations using the vector representation for the code, and determine an average of the weighted word-vector representations to create a weighted-average vector representation for the code” wherein the process of weighting is a mathematical operation of assigning different importance to components within a calculation (weighted averages; weighted sums).
Claim 20: “determine an average separation of the vector representations in the vector space, or an average separation of a predetermined number of the most separated vector representations in the vector space” wherein steps of determining an average are mathematical calculations.
As such, under the BRI each of said limitations above are determined herein to each cover performance either in the mind and/or performance by mathematical operation. There are no specifics as to the methodology involved in “generating”, as an example, and thus, under the BRI, one could simply perform the steps by using pen and paper. Other steps, recited in dependent claims encompass mathematical concepts as they require operations such as “concatenating” and “probability”. With respect to the recitation of a processor to perform the steps, said processor is a tool by which said judicial exceptions operate.
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements:
Claim 1: computer; obtaining the medical report comprising a plurality of codes each code representing a comment comprising clinical information;
Claim 2: codes
Claim 7: using a machine learning process
Claim 8: wherein the machine learning process comprises a Word2Vec process
Claim 14: computer program product comprising a non-transitory computer readable medium…code embodied there…configured…execution by a suitable computer or processor
Claims 15-18 and 20: system; memory; processor
With respect to the steps herein directed to additional non-abstract elements of “computer; storage medium etc…” do not describe any specific steps by which the “computer parts” perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. In addition the “use” of machine learning also provides nothing more to the claim except instructions to operate the claimed method on a generic computing system, which generally applies the judicial exceptions without limitations on the machine learning functions themselves and operate to instruct the environment (field of use) for which the judicial exceptions are to operate. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer. (see MPEP 2106.05(f)). Finally, the steps directed to “obtaining a medical report comprising a plurality of codes…representing a comment comprising clinical information” are steps directed to insignificant extra-solution activity that is data gathering, i.e. get the information (a report with codes) needed for the steps directed to vectorization. See, for example Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). See also, selecting information, based on types of information and
availability of information in a power-grid environment, for collection, analysis and display, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016);
As such, the claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to claims 1-8, 11-18 and 20, the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. The specification includes that computer processors and systems, such as described at pages 14-15 and the machine learning programs are readily known (page 5). The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III).
With respect to claims 1-8, 11-18 and 20 and “codes” therein, the Specification indicates that defining codes based on comments in medical reports is well-established in the art (page 1, background). Further, the art of Sun et al. (previously cited) demonstrates that a well-established practice in medical record keeping is that of coding for documentation and billing purposes [col. 1, lines 62-67]-[col. 2, line 1-51]. Thus getting coding data is well-known and conventional in the field.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Response to Applicant’s Arguments
1. Applicant states that, “under the Step 2A, Prong 1 analysis of the subject matter eligibility analysis under 35 U.S.C. § 101, the Patent Office must find that the claims as a whole are directed to an abstract idea. It is not enough to find that a claim involves an abstract idea. Rather, the claim as a whole must directed to an abstract idea” and that “here, Applicant asserts that the claims as a whole are not directed to the abstract ideas of mental processes or mathematical concepts”.
It is respectfully submitted that with respect to the comments in Applicant’s remarks set forth on 20 October 2025, that the analysis of the claims was made with respect to the Framework set forth in the MPEP and the Guidance as published in 2019. With respect to step 2(A), prong one, the question is: Are the claims directed to a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea. This is taken from the Framework Analysis as set forth in the Guidance of 2019 and present in the MPEP in section 2106. When determining whether a claim is directed to a judicial exception, Prong One asks does the claim recite an abstract idea, law of nature, or natural phenomenon. When making said determination, it is decided whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. It is maintained herein that the claims are properly assessed as reciting judicial exceptions as stated above.
2. Applicant contends that, “the claims as a whole are not directed to a mental process. For example, the claims comprise more than just a mental determination; rather, the claims comprise converting each of the plurality of codes in a medical report into a vector representation. This conversion is based on the relation of the code to other codes in the set of reference medical reports, with relative values of a pair of vector representations being correlated with a co-occurrence of corresponding codes in a set of reference medical reports. Further, the claims comprise identifying a generated vector representations as an outlying vector representation relative to other vector representations, by determining that the vector representation is separated by more than a threshold separation from the other vector representations. Based on this identification, the code represented by the vector representation is determined to be erroneous.
Applicant further includes that, “converting the codes in a medical report into vector representations (based on the claimed process for conversion) is a clear and specific transformation of the original data (i.e., the medical code found in a medical report) to something else (i.e., a vector representation in a vector space relative to other vector representations)”.
It is respectfully submitted that this is not persuasive. First, the steps as recited in the instant claims involve those of “generating” vector representations; “identifying” generated vector representations and “determining” that a code is erroneous without any further steps delineating the specific nature of said operations beyond the BRI of mentally performing said steps. It is further noted that there are no steps of “converting”, for example, a code into a vector representation or “generating” a vector from a code with any specificity that would take it out of the realm of a step that can be performed using vector mathematics. This is performed using tools such as, Word2vec or GloVe, of which include algorithms to create word embeddings. More simplistically, however one could simply assign numbers to words based on features and create vector representations.
3. Applicant discusses examples 38, 39 and 41 as pertain to “mathematical concept” arguments presented. Applicant states that, “Applicant asserts that the claims as a whole are not directed to a mathematical concept. For example, the claims do not explicitly recite a mathematical process or equation” (emphasis added by Applicant).
It is respectfully submitted that this is not persuasive. With respect to Example 38 the claims in said example from the Office were found eligible because they included digital simulation of an analog mixer whereby the generation step for a circuit was performed using a random number generator which was not found to be an abstract element. The same is not the case in the instant application, as there are no step equivalent to a random number generator for a circuit element. With respect to Example 39, said steps were directed to training a neural network by applying transformations to a digital image that included steps of mirroring, smoothing or contrast reduction such that a training set could be formed from said images and further used to create a second training set. There are no equivalent steps herein whereby “training” a neural network is claimed.
It is further noted that, “a mathematical concept need not be expressed in mathematical symbols, because "[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). See, e.g., SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. Cir. 2018) (holding that claims to a ‘‘series of mathematical calculations based on selected information’’ are directed to abstract ideas); Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that claims to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea); and Bancorp Servs., LLC v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012) (identifying the concept of ‘‘managing a stable value protected life insurance policy by performing calculations and manipulating the results’’ as an abstract idea).
4. Applicant states that “the claims comprise a practical application at least because the invention applies and uses the alleged abstract idea in a particular technological environment. Applicant states that the claimed method and system takes a medical report with medical codes and determines that the codes are erroneous and thus converts the report into an identification of erroneous code, which is a practical application.
It is respectfully submitted that this is not persuasive as the claim results in a “determination” based on some identification of a vector outlier, which is under the BRI of the claim something that may be performed in an abstract (mental) capacity. As such, said step cannot represent the additional element in the claim (i.e., the practical application of the judicial exception).
Conclusion
No claims are allowed.
With respect to the prior art to Sun et al., the outstanding rejections are withdrawn as the art does not teach or fairly suggest the steps of obtaining a medical report with codes and further vectorizing said codes and identifying as currently claimed.
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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lori A. Clow, whose telephone number is (571) 272-0715. The examiner can normally be reached on Monday-Thursday from 11:00AM to 9:00PM ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached on (571) 272-9047.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/Lori A. Clow/Primary Examiner, Art Unit 1687
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