DETAILED ACTION
Notice of 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 .
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.
Withdrawal Objections and Rejections
Applicant's response, filed 12/29/2025, has been fully considered.
In view of the amendment and remarks from 12/29/2025, the objection to the claims and the rejection of the following claims are withdrawn:
claims 3-8, 10, 12-13, 15-19 and 21-23 under 35 USC § 112(b);
claims 2 and 12 under 35 U.S.C. § 101; and
claim 24 under 35 U.S.C. § 103.
The following rejections and/or objections are either maintained or newly applied for claims 1, 3-11 and 13-24. They constitute the complete set applied to the instant application. Herein, "the previous Office action" refers to the Non-Final Rejection of 10/01/2025.
Status of the Claims
Claims 1, 3-11 and 13-24 are pending.
Claims 2 and 12 are cancelled.
Claims 1, 14, 21 and 24 are objected to.
Claims 1, 3-11 and 13-24 are rejected.
Priority
This US Application is a CIP of PCT/US2020/057967 (10/29/2020) which claims benefit of 62/928,114 (10/30/2019) and 63/010,756 (04/16/2020); as reflected in the filing receipt mailed on 04/30/2024. The claims to the benefit of priority are acknowledged and the effective filing date of claims 1, 3-11 and 13-24 is 10/30/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/29/2025 and 12/29/2025 were considered.
Claim objections
Claims 1, 14, 21 and 24 are objected to because of the following informalities related to grammar/punctuation. Appropriate correction is required.
In claim 1, there are recited claim elements not properly indented. For example: the recited "a concentration of cartilage oligomeric matrix protein (COMP) in the sample; and a concentration of interleukin-8 (IL-8) in the sample" should be further indented relative to the parent step, with "a concentration of interleukin-8 (IL-8) in the sample" recited in a new line, Colons should begin lists in which list elements are separated by newlines. As set forth in 37 CPR 1.75, each element or step of the claim should be separated by a line indentation (608.01(m) Form of Claims). Sub-steps / elements should be indented from their parent step / element. This rule should be applied throughout the claims as needed.
Claim 1 repeats the issue for the elements that follow "inflamed and/or painful joint by:" and "diagnostic protocol comprising:"
Claim 14 repeats the issues above for the elements that follow "processing circuitry and storing:", "database comprising:", "perform operations comprising:", and "value of 4.3 wherein:"
Claim 24 repeats the issues above for the elements that follow "test result data comprising:", and "assessment report comprising:"
In claim 1, the recited "from the laboratory immunoassay testing" should be underlined for proper annotation of claim amendments.
In claim 1, the recited "the additional laboratory test data comprising -white" has an extra dash before "white."
In claim 1, the recited "or septic arthritis" is missing semi colon at the end of the term.
In claim 21, the recited "presence of absence or rheumatoid factor" should be corrected.
Claim interpretation
Claim Terminology
In claim 1, the recited "wherein the method improves diagnostic efficiency of arthritis diagnosis by using the COMP/IL-8 ratio threshold of 4.3 to screen for OA before conducting comprehensive inflammatory marker testing, thereby avoiding unnecessary testing for patients with degenerative joint disease" is interpreted as intended use not required steps.
In claim 14, the recited " a display device, for use by a clinician in patient treatment planning … a screening parameter that enables target inflammatory marker analysis only for patients classified as non-OA, thereby reducing necessary laboratory testing and diagnostic time for AO patients" is interpreted as intended use not required steps.
In claim 24, the recited "wherein the method improves surgical outcome prediction accuracy by incorporating the diagnostic classification based on COMP/IL-8 ratio and inflammation severity into a risk assessment model" is interpreted as intended use not required steps.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 6-7, 10 and 14-23 are rejected under 35 U.S.C. 112(b)as being indefinite for failing to particularly point out and distinctly claim the subject matter the invention. Dependent claims are rejected similarly, unless otherwise noted below. Any newly recited portions are necessitated by claim amendment. The following issues cause the respective claims to be rejected under 112(b) as indefinite:
The following recitations require but lack antecedent basis, rendering their claims indefinite because there is no previous recitations of the followings terms as written:
claim 14, "the stored ratio"
Claims 6-7, 10, 18 and 21 recite the term “Microbial ID” which is indefinite due to its description not being properly defined. It is unclear what the term relates to: an identification number, a value measured or to the fact that a microbial was identified. The amended "which are Synovasure® Microbial Identification assays" does not clarify the issue described. It is unclear if the "Microbial ID" obtained by Synovasure® Microbial Identification assays or if "Microbial ID" is a short name for Synovasure® Microbial Identification assays. For compact prosecution, the “Microbial ID” is being interpreted as the former. To overcome this rejection, the claim may be amended to read "Microbial ID which are obtained by Synovasure® Microbial Identification assays."
Claims 6-7, 10, 18 and 21 recite the term “Synovasure® Microbial Identification assays" which describes a trademark product. The claims are indefinite because trademarks are not allowed when referring to a product used. If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b). MPEP 2173.05(u)
Response to applicant's remarks in regard to Claim Rejection 35 U.S.C. ~ 112(b)
The Remarks of 12/29/2025 have been fully considered but are not persuasive for the reasons below:
Applicant asserts in pg. 36 para. 2:
While Applicant does not agree that some of the issues raised with regard to these claims rendered the claims indefinite to one of ordinary skill in the relevant art, various of the claims have been amended or canceled. Applicant thanks the Examiner for bringing these issues to the attention of Applicant. Applicant submits that the cancelation or amendments to the claims render the rejections under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AJA), second paragraph, moot
It is respectfully submitted that this is not persuasive because the amendments do not address the standing issues as addressed above related to the lack of clarity associated to the recited terms.
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 and 13-24 are rejected under 35 USC § 101 because the claimed inventions are directed to one or more Judicial Exceptions (JEs) without significantly more. Regarding JEs, "Claims directed to nothing more than abstract ideas..., natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 §I). Abstract ideas include mathematical concepts and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)). Any newly recited portions are necessitated by claim amendment.
101 background
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Analysis of instant claims
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The instant claims are directed to a method (claims 1, 2-11, 13 and 24), and a system (claims 14-23), each of which falls within one of the categories of statutory subject matter.
[Step 1: claims 1, 3-11 and 13-24: Yes].
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Background
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Analysis of instant claims
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims are found 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) are as follows:
• "calculating, by the processor executing the diagnostic instructions, a COMP/IL-8 ratio by dividing the measured COMP concentration by the measured IL-8 concentration" (independent claim 1);
• "determining, by the processor executing diagnostic instructions, whether osteoarthritis (OA) is the cause of the inflamed and/or painful joint" (independent claim 1);
• "comparing the calculated COMP/IL-8 ration to a threshold ratio value of 4.3 stored in the memory; when the COMP/IL-8 ratio is greater than or equal to 4.3, classifying the joint as having OA and storing an OA classification in the memory; and when the COMP/IL-8 ratio is less than 4.3, storing a non-OA classification in the memory and proceeding to a secondary diagnostic protocol" (independent claim 1);
• "processing the additional laboratory test data by the processor according to a multi-parameter classification algorithm to determine if the cause is inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, possible septic arthritis, or septic arthritis" (independent claim 1);
• "determining with the patient risk stratification tool a predicted post-surgical patient outcome or risk based upon the result data: (claim 11);
• "computing a COMP/IL-8 ratio by executing a mathematical division operation that divides the received COMP concentration value by the received IL-8 concentration value to produce a numerical ratio output" (independent claim 14);
• "executing a first-tier diagnostic determination by comparing the computed COMP/IL-8 ratio to the stored ratio threshold of 4.3, wherein: if the computed ratio is greater than or equal to 4.3, the processing circuitry generates a diagnostic classification of osteoarthritis (OA) or; if the computer ratio is less than 4.3, the processing circuitry activates a second-tier diagnostic determination" (independent claim 14);
• "applying a multi-parameter decision algorithm to the additional biomarker data by evaluating the additional biomarker data against the predefined diagnostic criteria stored in the diagnostic threshold database to classify the cause as on the inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, possible septic arthritis or septic arthritis" (independent claim 14);
• "determine, according to a risk stratification tool a predicted patient outcome based upon the result data" (claim 22);
• "computing the inflammation severity score by mathematically combining the weighted inflammation severity category and the weighted patient demographic factors according to a risk scoring equation" (independent claim 24);
• " assessing, by the one or more processors executing a risk stratification algorithm, an inflammation severity score to the patient" (independent claim 24);
• "categorizing the diagnostic classification into one of a plurality of predefined inflammation severity categories stored in the risk stratification database, wherein each category corresponds to a different expected level of post-surgical inflammatory response" (independent claim 24);
• "applying a first numerical weighting factor to the inflammation severity category based on historical correlation data stored in the risk stratification database that quantifies correlation strength between the inflammation severity category and incidence of post-surgical complications" (independent claim 24);
• "applying a second numerical weighting factor to patient demographic factors including at least one of patient age, body mass index, or comorbidity status" (independent claim 24);
• "computing the inflammation severity score by mathematically combining the weighted inflammation severity category and the weighted patient demographic factors according to a risk scoring equation" (independent claim 24);
• "predicting, by the one or more processors executing the risk stratification algorithm, a likelihood of post-surgical complications following joint surgery by comparing the computed inflammation severity score to a plurality of risk threshold values stored in the risk stratification database, wherein each risk threshold value corresponds to a different probability range of post-surgical complications derived from historical surgical outcome data of patients with similar diagnostic classifications" (independent claim 24); and
• "assigning the patient to a post-surgical risk category based on which risk threshold range the computed inflammation severity score falls within" (independent claim 24).
Dependent claims 3-4, 16 and 18-19 recite further details about “determining the cause of the inflamed joint”; dependent claims 10, 13, 20-21 recite further details about “categorizing the diagnosis” into classes.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined to each cover performance either in the mind and/or by mathematical operation. Without further detail as to the methodology involved in processing data by applying algorithms and mathematical equations, under the BRI, one may simply, for example, use pen and paper to perform mathematical steps to arrive at a classification inflammation severity to predict the likelihood of post-surgical complications. Further support for the mathematical techniques used in the claims is provided in the specification at pgs. 2 para. 1, pg. 28 para. 2, which describes calculations applied for classification and diagnostic purposes. Thus, the recited terms correspond to verbal equivalents of mathematical concepts because they constitute actions executed by a group of mathematical steps in a form of a mathematical algorithm; thus mathematical concepts (MPEP 2106.04(a)(2)). A mathematical concept need not be expressed in mathematical symbols, because "words 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). MPEP 2106.04(a)(2) pertains. The human mind is also sufficiently capable of compare values to a threshold, determine/assess risk based on data values and categorize the diagnostic classification into one of a plurality of predefined inflammation severity categories.
[Step 2A Prong One: claims 1, 3-11 and 13-24: Yes ]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Background
MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using 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, as discussed in MPEP § 2106.05(e).
Analysis of instant claims
Instant claims 1, 11, 14, 22, and 24 recite additional elements that are not abstract ideas:
• "obtaining a sample that is a joint specific biological material from the inflamed and/or painful joint of the patient" (independent claim 1);
• "performing laboratory immunoassay testing on the joint specific biological material sample to quantitatively measure: a concentration of cartilage oligomeric matrix protein (COMP) in the sample; and a concentration of interleukin-8 (IL-8) in the sample" (independent claim 1);
• "receiving, at an electronic diagnostic deice comprising a processor coupled to memory storing executable diagnostic instructions, electronic signals representing the measured COMP concentration and the measured IL-8 concentration from the laboratory immunoassay testing" (independent claim 1);
• "electronically generating, by the processor, by the processor, a diagnostic report comprising the determined cause and measured biomarker values, wherein the method improves diagnostic efficiency of arthritis diagnosis by using the COMP/IL-8 ratio threshold of 4.3 to screen for OA before conducting comprehensive inflammatory marker testing, thereby avoiding unnecessary testing for patients with degenerative joint disease" (independent claim 1);
• "electronically transmitting the diagnostic report from the electronic diagnostic device to a clinical information system for use by a clinician" (independent claim 1);
• "electronically communicating the result data as an input to a pre-operative patient risk stratification tool" (claim 11);
• "processing circuitry comprising one or more hardware processors configured to execute computational operations" (independent claim 14);
• "non-transitory computer readable memory coupled to the processing circuitry and storing: a diagnostic threshold database comprising: a predetermined COMP threshold value; a predetermined COMP/IL-8 ratio threshold value of 4.3 for distinguishing osteoarthritis from inflammatory arthritides; and predefined diagnostic criteria for classifying inflammatory arthritis subtypes based on combinations of white blood cell counts, polymorphonuclear cell percentages, crystal detection results, and antibody levels" (independent claim 14);
• "automatically retrieving additional biomarker data from the laboratory analysis equipment via the data acquisition interface, the additional biomarker data comprising white blood cell (WBC) count, percentage of polymorphonuclear cells (%PMN), crystal presence indicators, anti-cyclic citrullinated peptide antibody levels, and rheumatoid factor level" (independent claim 14);
• "generating structure electronic diagnostic result data comprising the classified cause and associated biomarker values" (independent claim 14);
• "a communication output interface configured to transmit the structured electronic diagnostic result data to an external clinical system selected from an electronic health record system, a clinical decision support system, and a display device, for use by a clinician in patient treatment planning; wherein the diagnostic computing system improves diagnostic speed and accuracy over conventional arthritis diagnostic systems by using COMP/IL-8 ratio threshold of 4.3 as a screening parameter that enables target inflammatory marker analysis only for patients classified as non-OA, thereby reducing necessary laboratory testing and diagnostic time for AO patients" (independent claim 14);
• "processing circuitry; and a memory" (claim 22);
• "communicate with the first system to retrieve the result data" (claim 22);
• "receiving, at a surgical risk assessment computing system comprising one or more processors and memory storing a risk stratification database, diagnostic test result data from laboratory analysis of a joint specific biological material obtained from the patient, the diagnostic test result data comprising: a measured cartilage oligomeric matrix protein (COMP) concentration; a measured interleukin-8 (IL-8) concentration; a COMP/IL-8 ratio calculated from the measured concentrations; white blood cell count and differential data; and a diagnostic classification indicating whether an inflamed joint of the patient is caused by osteoarthritis (OA) inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, possible septic arthritis, or septic arthritis, wherein the diagnostic classification was determined based on the COMP/IL-8 ratio and the white blood cell data" (independent claim 24);
• "automatically generating, by the one or more processors, a surgical risk assessment report comprising: the assigned post-surgical risk category; the predicted likelihood of post-surgical complications; recommended pre-operative treatment modifications specific to the assigned risk category wherein the recommended pre-operative treatment modifications include administration of anti-inflammatory medications when the patient is classified as having inflammatory arthritis with high inflammation severity score" (independent claim 24); and
• "transmitting the surgical risk assessment report to a surgical planning system or surgeon workstation for use in pre-operative evaluation and treatment planning, wherein the method improves surgical outcome prediction accuracy by incorporating the diagnostic classification based on COMP/IL-8 ratio and inflammation severity into a risk assessment model" (independent claim 24).
Considerations under Step 2A, Prong Two
The recited limitations in 1, 11, 14, 22, and 24 are interpreted as requiring the use of a computer. Hence, the claims explicitly recite steps executed by computers and therefore can be described as computer functions or instructions to implement on a generic computer.
Further steps directed to additional non-abstract elements of a computing device/computer do not describe any specific computational steps by which the "computer parts" perform or carry out the judicial exceptions, nor do they provide any details of how specific structures of the computer are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the judicial exceptions.
Claims reciting "obtaining a sample" and "performing laboratory immunoassay testing" read on data gathering and insignificant extra-solution activity since this limitation serve to gather data that is utilized as input for the judicial exception.
Claims reciting "receiving .. electronic signals" (claim 1); "generating … a diagnostic report" (claim 1), "receiving … test data" (claims 1 and 24); "receive … concentration measurements" (claim 14); "generating … result data" (claim 14); "retrieving … biomarker data" (claim 14); "communicate with the first system to retrieve the result data" (claim 22); "automatically generating .. a surgical risk assessment report" (claim 24); and "transmitting the surgical risk assessment report" (claim 24) read on receiving or transmitting data over a network -Symantec, 838 F.3d at 1321 - MPEP 2106.05(a) pertains; which constitutes just necessary data gathering and therefore correspond to insignificant extra-solution activity.
Claims directed to "determining …the cause of the inflamed and/or painful joint” are considered as using a computer to perform an abstract idea, which is not sufficient to integrate an abstract idea into a practical application (see MPEP 2106.05(f)); since steps that can be performed mentally and merely performing the mental process in a computer environment do not negate the fact that something that can be carried out in the human mind. See MPEP 2106.04(a)(2).III.C. Claims directed to generating reports also read on using a computer to execute an abstract idea since said reports contain the results from the judicial exceptions.
Hence, these are mere instructions to apply the abstract idea using a computer and insignificant extra-solution activity and therefore the claims do not integrate that abstract idea into a practical application (see MPEP 2106.04(d) § I; 2106.05(f); and 2106.05(g)). None of the dependent claims recite any additional non-abstract elements; they are all directed to further aspects of the information being analyzed, the manner in which that analysis is performed, or the mathematical operations performed on the information.
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs).
In this Step 2A, Prong Two immediately above claim steps and/or elements were identified as part of one or more additional elements. Additional elements are further discussed in Step 2B below.
Here in Step 2A, Prong Two, no additional step or element clearly demonstrates integration of the JE(s) into a practical application.
[Step 2A Prong Two: claims 1, 3-11 and 13-24: No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
According to analysis so far, the additional elements described above do not provide significantly more than the judicial exception. A determination of whether additional elements provide significantly more also rests on whether the additional elements or a combination of elements represents other than what is well-understood, routine, and conventional. Conventionality is a question of fact and may be evidenced as: a citation to an express statement in the specification or to a statement made by an applicant during examination 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).
Claims 1, 11, 14, 22, and 24 recite a computer or computer functions, interpreted as instructions to apply the abstract idea using a computer, where the computer does not impose meaningful limitations on the judicial exceptions; which can be performed without the use of a computer (MPEP 2106.04(d) § I; and MPEP 2106.05(f)).
Further, the courts have found that receiving and outputting data are well-understood, routine, and conventional functions of a computer when claimed in a generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network), Versa ta Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015), and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93, as discussed in MPEP 2106.05(d)(Il)(i)).
With respect to the instant claims, the prior art review to Nguyen ("Review of prospects of biological fluid biomarkers in osteoarthritis." International journal of molecular sciences 18(3):601 (2017)); newly cited) discloses that measuring COMP (pg. 3 Table 1) and IL-8 markers (pg. 8 Table 2) while investigating joint diseases is routine, well-understood and conventional in the art.
When the claims are considered as a whole, they do not integrate the abstract idea into a practical application; they do not confine the use of the abstract idea to a particular technology; they do not solve a problem rooted in or arising from the use of a particular technology; they do not improve a technology by allowing the technology to perform a function that it previously was not capable of performing; and they do not provide any limitations beyond generally linking the use of the abstract idea to a broad technological environment. See MPEP 2106.05(a) and 2106.05(h).
The instant claims constitute insignificant extra solution activity, and when considered individually, are insufficient to constitute inventive concepts that would render the claims significantly more than an abstract idea (see MPEP 2106.05(g)). Hence, these elements, when considered individually, are insufficient to constitute inventive concepts that would render the claims significantly more than an abstract idea (see MPEP 2106.05(d)).
[Step 2B: claims 1, 3-11 and 13-24: No]
Conclusion: Instant claims are directed to non-statutory subject matter
For the reasons above, the claims in this instant application, when the limitations are considered individually and as a whole, are directed to an abstract idea and lack an inventive concept not clearly anything significantly more.
Response to applicant's remarks in regard to Claim Rejection 35 U.S.C. ~ 101
The Remarks of 12/29/2025 have been fully considered but are not persuasive for the reasons below:
Applicant asserts in pg. 13 para. 1:
Claims 1 and 14 parallel Example 40's conditional data collection that improves efficiency and Example 42's medical information processing that provides technological improvements, reciting specific implementation details showing how diagnostic functions are performed, explicit improvement statements regarding diagnostic efficiency and accuracy, integration with physical laboratory procedures and clinical information systems, and particular machine architectures with specialized components. Claim 24 parallels Example 49's particular treatment for specific patient populations, reciting specific risk assessment methodology with inflammation severity scoring, particular treatment recommendations including anti-inflammatory medications for identified high-risk populations, explicit improvement to surgical outcome prediction accuracy, and integration into practical application of pre-operative surgical planning. The claims satisfy all statutory requirements for patentability under § 101. The rejection should be withdrawn, and favorable action is respectfully requested.
The remarks above notes the comparison between subject matter from Examples identified by the Office to this instant claims. The applicant further expands the remarks for each example in later paragraphs. The examiner will address each Example argued in the paragraphs below.
Applicant asserts in pg. 13 para. 2:
The amended claims recite specific diagnostic and prognostic methods solving the technical problem of accurately differentiating between osteoarthritis and inflammatory arthritides. Current diagnostic methods as explained in specification paragraphs [0003] through [0005] cannot reliably distinguish between these conditions, leading to misdiagnosis, inappropriate treatment, poor outcomes, and inefficient use of expensive comprehensive inflammatory marker testing. The claimed invention provides a technical solution through novel use of COMP/IL-8 ratio with threshold 4.3 as a screening parameter enabling conditional two-tier testing architecture where comprehensive inflammatory testing is performed only when screening indicates non-OA etiology, and multiparameter classification algorithms for accurate inflammatory subtyping. This provides technological improvements including faster diagnosis through rapid screening, improved efficiency through reduced unnecessary testing, enhanced accuracy through novel biomarker combination, and better clinical utility through integration with clinical information systems.
It is respectfully submitted that this is not persuasive because the fact that the argued improvement regarding solving the technical problem of accurately differentiating between osteoarthritis and inflammatory arthritides are provided by the identified judicial exceptions (i.e. multiparameter classification algorithms). Regarding improvement to technology, the improvement cannot be in the judicial exception itself. Rather, the improvement is provided by the additional elements either on their own or in combination with the judicial exception. If the improvement is not realized in the additional elements then the improvement is in the judicial exception itself, which is not considered an improvement to technology.
Applicant asserts in pg. 14 para. 2:
The structural parallel between Example 40 and amended claims l and 14 is direct and dispositive. Where Example 40 collects initial traffic data to assess network conditions, amended claims collect initial biomarker data measuring COMP and IL-8 concentrations to assess joint inflammation. … Where Example 40 resulted in improved network monitoring, amended claims result in improved arthritis diagnosis including faster diagnostic timelines for OA patients who avoid waiting for comprehensive panel results, maintained comprehensive evaluation for inflammatory patients ensuring accurate subtyping, reduced laboratory resource utilization through targeted testing, and improved clinical decision-making through accurate differential diagnosis … This finding is directly applicable to the instant claims. The conditional collection of additional inflammatory marker data triggered only when CONIP/IL-8 ratio screening indicates non-OA etiology represents the same type of improvement that Example 40 identified as sufficient for patent eligibility. … Under the reasoning explicitly articulated by the USPTO in Example 40, amended claims 1 and 14 integrate any alleged mental process or abstract idea into practical applications of medical diagnosis and are therefore patent-eligible.
It is respectfully submitted that this is not persuasive because the instant claims are not analogous to Example 40. Example 40 acquires data via a network visibility tool and it improves the network by varying the amount of data collected and only collecting/exporting data when abnormal network conditions are detected. Here, there is no improvement to technology by the data gathered via the "collecting data only when CONIP/IL-8 ratio screening indicates non-OA etiology", therefore the claims are not analogous.
Applicant asserts in pg. 15 para. 3:
USPTO Example 42 titled "Method for Transmission of Notifications When Medical Records Are Updated" provides additional controlling authority supporting eligibility … The USPTO concluded that … recite a specific improvement over prior art systems by allowing remote users to share information in real time in standardized format regardless of the format in which information was input by the user, and thus the claim is eligible because it is not directed to the recited judicial exception. … The parallel to amended claims is compelling. … Both claims process medical information from diverse sources, both standardize that information for clinical use through computational processing, both generate outputs automatically upon completion of processing, and both transmit to healthcare information systems for patient care applications. The USPTO found in Example 42 that conversion of diverse medical information formats into standardized outputs, automatic generation of messages upon information updates, and real-time transmission to clinicians constituted sufficient additional elements to integrate organizing human activity into practical application because these elements provided specific improvement over prior art medical information systems. The amended claims similarly convert diverse biomarker formats into standardized diagnostic classifications, automatically generate clinical reports upon completion of diagnostic analysis, and transmit results to clinical infom1ation systems in structured formats usable for patient care decisions, thereby providing specific improvements over prior art diagnostic systems. Both claims improve medical information technology for patient care applications. If Example 42's medical information processing was integrated into practical application sufficient for eligibility, the instant claims' diagnostic information processing must similarly be integrated into practical applications and patent-eligible
It is respectfully submitted that this is not persuasive because the instant claims are not analogous to Example 42. Example 42 describes the creation of a network-based patient management via a graphical user interface, and the improvement over prior art system came from the fact that the network allowed remote users to share information in real time in a standardized manner. Here, there is no improvement to technology because the argued improvement related to converting biomarker formats into standardized diagnostic classifications is performed via the judicial exception and there is no evidence of any additional element that realizes the improvement via a real life practical application. As it appears in the claims, there is no requirement for the method to be performed in real time. Furthermore, the generation of clinical reports upon completion of diagnostic analysis is not sufficient to integrate the identified judicial exception into a practical application as described in the Claim Rejection above.
Applicant asserts in pg. 17 para. 3:
The 2024 AI Subject Matter Eligibility Example 49 titled "Fibrosis Treatment" published in July 2024 provides the most recent and most directly applicable USPTO guidance for amended claim 24. Example 49 directly addresses diagnostic methods that identify patient risk and provide treatment recommendations, making it controlling authority ... Despite this claim reciting use of an AI model and weighted risk scoring methodology, it ,vas held INELIGIBLE. .. In stark contrast, Example 49, Claim 2 depends from Claim l and adds a single wherein clause specifying "wherein the appropriate treatment is Compound X eye drops," and this addition alone rendered the claim ELIGIBLE. ... The USPTO found that under broadest reasonable interpretation, the additional element being the treatment specification and the wherein clause encompass administration of a "particular treatment" when considered in context of the claim as a whole. … Amended claim 24 precisely follows the eligible pattern that the USPTO approved in Example 49 Claim 2. … Under the USPTO's explicit and recent holding in Example 49 published in July 2024, amended claim 24 integrates any judicial exception into a practical application and is patent-eligible. This conclusion is further reinforced by Federal Circuit precedent in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018), which held patent eligible claims that measured a patient's CYP2D6 genotype, determined whether the patient was a poor metabolizer, and if so, administered a reduced dosage of iloperidone. ... Under both Example 49 and Vanda, amended claim 24 is patent-eligible.
It is respectfully submitted that this is not persuasive because the instant claims are not analogous to Example 49. Example 49 claim 2 provided the administration of a "particular treatment" when considered in context of the claim as a whole. Here, there is no affirmative particular treatment recited in the claims. Claim 24 does not provide said particular treatment because the claim is directed to a classification report that contains the results yielded in the judicial exceptions (i.e. classification algorithms involving mathematical calculations and mental processes such as observations and evaluation of data) and is merely transmitted to a system or workstation, which recites the insignificant extra-solution activity of data outputting. Regarding the analogy to Vanda case law, the amended claim are not analogous because Vanda's case also involved the administration of a "particular treatment" when considered in context of the claim as a whole; which is not the case in the instant application.
Applicant asserts in pg. 21 para. 2:
The 2024 AI Examples provide critical recent guidance on technological improvements in AI and computational contexts. Example 47 titled ''Anomaly Detection'' demonstrates the distinction between eligible and ineligible AI implementations. Example 47, Claim 2 reciting a method of using an ANN comprising receiving training data, training the ANN, detecting anomalies using the trained ANN, analyzing detected anomalies using the trained ANN, and outputting anomaly data was held INELIGIBLE. … However, Example 47, Claim 3 adds steps of detecting a source address associated with malicious network packets in real time, dropping the malicious network packets in real time, and blocking future traffic from the source address, and was held ELIGIBLE … Amended claims follow the eligible pattern rather than ineligible pattern. The claims do not simply recite "using a diagnostic algorithm" or "using a computer to diagnose" generically. Instead, claim l recites that the processor executes specific diagnostic instructions to automatically calculate by performing division operations on measured concentrations, …Similarly, claim 14 recites specific system architecture including data acquisition interface configured for laboratory equipment communication receiving measurements in specific units, … Example 48 titled "Speech Separation" provides additional support. Example 48, Claim 2 reciting a speech separation method including mathematical operations such as converting signals using short-time Fourier transforms, clustering embeddings, and applying binary masks was held ELIGIBLE. The USPTO explained that while mathematical operation steps recite judicial exceptions, the ordered combination reflects technical improvement. The USPTO found the claim is directed to improvement to existing speech-to-text technology, and integrates abstract ideas into practical application of speech-to-text conversion. …. Both generate new useful outputs from processed data. Both improve existing technology in specific technical fields. Under Example 48's reasoning, amended claims integrate any judicial exception into practical applications and are patent-eligible.
It is respectfully submitted that this is not persuasive because the instant claims are not analogous to Examples 47-48. The argued Example 47 claim 3 describes an improvement to technology by the improved network security using the information from the detection to enhance security by taking proactive measures to remediate the danger by detecting the source address associated with the potentially malicious packets. The argued Example 48 claim 2 describes an improvement to technology by creating a new speech signal that no longer contains extraneous speech signals from unwanted sources. The instant invention is not analogous to either examples because it describes classification diagnostic steps involving mathematical calculations and mental processes such as observations and evaluation of data. Limitations considered as using a computer to perform a judicial exception are not sufficient to integrate an abstract idea into a practical application (see MPEP 2106.05(f)); since steps that can be performed mentally and performing the mental process in a computer environment, in an automatic manner, do not negate the fact that something that can be carried out in the human mind, and are merely instructions to apply the judicial exceptions to a computer. See MPEP 2106.04(a)(2).III.C.
Applicant asserts in pg. 24 para. 1:
The amended claims recite specific implementation details that distinguish them from generic computer implementation. Claim 1 now explicitly recites obtaining a joint specific biological material sample from the inflamed joint through physical arthrocentesis or blood draw procedures, performing laboratory immunoassay … specific software-hardware integration architecture, electronic signals representing measured concentrations transmitted from laboratory information systems in specific electronic data formats, automatically calculating … implementing conditional logic where when ratio is greater than or equal to 4.3 … These are not generic computer operations but specific diagnostic operations implemented through specific system architecture. … The multi-parameter classification algorithm is not generic data analysis … The executable diagnostic program instructions that configure the processing circuitry to perform the specific operational sequence of automatic ratio computation, first-tier and second-tier diagnostic determinations with conditional activation, automatic data retrieval via specialized interface, multi-parameter decision algorithm application, and structured diagnostic result data generation represent specialized diagnostic decision support software implementing the inventors' novel diagnostic methodology, not generic software. The communication output interface configured to transmit structured diagnostic result data to external clinical systems selected from electronic health record systems, clinical decision support systems, and display devices represents a specialized healthcare information exchange interface formatted to deliver diagnostic data according to health information interoperability standards, not a generic output device. These components collectively constitute a particular machine specifically configured for arthritis differential diagnosis using the novel COMP/IL-8 ratio screening methodology.
It is respectfully submitted that this is not persuasive because the arguments described simply rephrase claim elements that have been already identified in the Previous Office Action and concluded under step 2A Prong 2 as being not sufficient to integrate the judicial exception into a practical application. For example, "obtaining … a sample" and "performing laboratory immunoassay" reads on data gathering steps; the "multi-parameter classification algorithm" and "system architecture" read on judicial elements and have been identified as abstract ideas; and the "displaying" and "transmitting" steps read on data outputting. The argued system architecture constitutes the programmed computer performing the judicial exception, which reads on an "apply it" limitation at Step 2A Prong 2. The delivery or diagnostic data does not read on an affirmative treatment application (See Claim Rejection above). There is no indication of a particular machine being improved or optimized. Limitations considered as using a generic computer to perform a judicial exception are not sufficient to integrate an abstract idea into a practical application (see MPEP 2106.05(f)); since steps that can be performed mentally and performing the mental process in a computer environment do not negate the fact that something that can be carried out in the human mind. See MPEP 2106.04(a)(2).III.C.
Applicant asserts in pg. 26 para. 2:
While claims include ratio calculations and comparisons, they are not directed to
mathematical concepts as abstract ideas. USPTO Example 41 titled "Cryptographic Communications" held eligible a claim explicitly reciting the mathematical formula … combination of elements uses mathematical formulas and calculations in a specific manner that sufficiently limits use of mathematical concepts to practical application of transmitting ciphertext word signals to computer terminals over communication channels. ... All mathematical operations are sufficiently limited to practical applications in medical diagnosis and surgical planning, just as Example 41 's mathematical formula was sufficiently limited to practical application of secure communications. Moreover, MPEP 2106.04(a)(2)(I) explicitly teaches that claims do not recite mathematical concepts as judicial exceptions when merely based on or involving mathematical concepts rather than reciting them as the invention. … The invention is the diagnostic method using COMP/IL-8 ratio threshold mechanism and the prognostic method using inflammation severity scoring for surgical planning, which happen to involve mathematical operations in their implementation but are not directed to those operations as abstract concepts. This is confirmed by USPTO Example 38 titled "Simulating an Analog Audio Mixer" which stated that the claim does not recite a mathematical relationship, formula, or calculation, and while some limitations may be based on mathematical concepts, the mathematical concepts are not recited in the claims, and the claim is eligible because it does not recite a judicial exception. The same analysis applies where amended claims do not recite mathematical concepts as the invention even though diagnostic and prognostic processes involve mathematical operations.
It is respectfully submitted that this is not persuasive because the instant claims are not analogous to Examples 41 and 38. The argued Example 47 describes an important improvement to computer technology by establishing cryptographic communications because by using only the variables n and e, a plaintext can be encrypted by anyone. Example 38 is patent eligible for not reciting judicial exceptions. The instant invention is not analogous to either examples because it describes classification diagnostic steps involving mathematical calculations and mental processes such as observations and evaluation of data; and does not provide an improvement to computer technology. The claims actively recite calculating ratios and applying weighting factors, which are limitations which directly recite math and are not just based on it. Limitations considered as using a computer to perform a judicial exception are not sufficient to integrate an abstract idea into a practical application (see MPEP 2106.05(f)); since steps that can be performed mentally and performing the mental process in a computer environment do not negate the fact that something that can be carried out in the human mind. See MPEP 2106.04(a)(2).III.C.
Applicant asserts in pg. 27 para. 3:
Even if claims were found directed to judicial exceptions after Step 2A analysis, which Applicants vigorously dispute, claims contain additional elements amounting to significantly more than any alleged exception under Step 2B. The Federal Circuit in BASCOM Global Internet Services Inc. v. AI'&T Mobility LLC, 827 F.3d 1341, 1349-50 (Fed. Cir. 2016), held that an inventive concept can be found in non-conventional and non-generic arrangements of known, conventional pieces, and the inventive concept inquiry requires more than recognizing each claim element by itself was known in the art… The ordered combination recited in amended claims 1 and 14 represents a non-conventional arrangement. … measured biomarker values in structured format, and electronically transmitting to clinical information system for integration with electronic health records and clinical decision support. … Amended claim 24 similarly recites non-conventional ordered combination integrating diagnostic classification with surgical risk assessment. …This ordered combination represents novel integration of diagnostic information derived from COMP/IL-8 ratio with surgical outcome prediction through specific risk stratification methodology not disclosed in prior art.
It is respectfully submitted that this is not persuasive because under step 2B the additional elements do not recite a non-conventional and non-generic arrangement of known, conventional pieces, and the inventive concept. MPEP 2106.05.I states "An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims?") (emphasis added)); RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). Instead, an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966)." This makes clear that the inventive concept is furnished by the additional elements, either alone or in combination, not the judicial exception as argued above.
Applicant asserts in pg. 30 para. 2:
USPTO Example 37 titled "Relocation Icons on a Graphical User Interface" demonstrates that processor-implemented methods with specific improvements are patent-eligible even when some limitations could be characterized as mental processes. … Despite the determining step being characterized as a mental process in Step 2A Prong One analysis, the claim was held ELIGIBLE under Step 2A Prong Two. The USPTO explained that the claim recites combination of additional elements including receiving via GUI a user selection, a processor for performing the determining step, and automatically moving most used icons to position closest to start icon, and the claim as a whole integrates mental process into practical application. The USPTO found that specifically, additional elements recite a specific manner of automatically displaying icons to the user based on usage which provides a specific improvement over prior systems resulting in improved user interface for electronic devices, and thus the claim is eligible because it is not directed to the recited judicial exception. … systems as practical application demonstrating improved diagnostic technology. ff Example 3Ts relatively simple processor-implemented icon rearrangement providing specific improvement to user interface technology was sufficient for patent eligibility, then amended claims' substantially more detailed processor-implemented diagnostic method with specific improvements to diagnostic technology stated explicitly in the claim language must be sufficient for patent eligibility. The USPTO cannot consistently hold Example 37's simple processor implementation eligible ,while holding the instant claims' detailed processor implementation ineligible when the instant claims recite greater specificity, more detailed operations, and more significant technological improvements.
It is respectfully submitted that this is not persuasive because the instant claims are not analogous to Example 37. The argued Example 37 claim 1 was eligible for providing an specific improvement over prior systems, resulting in an improved user interface. The instant invention is not analogous because it describes classification diagnostic steps involving mathematical calculations and mental processes such as observations and evaluation of data; and does not provide an improvement to computer technology. Limitations considered as using a computer to perform a judicial exception are not sufficient to integrate an abstract idea into a practical application (see MPEP 2106.05(f)); since steps that can be performed mentally and performing the mental process in a computer environment do not negate the fact that something that can be carried out in the human mind. See MPEP 2106.04(a)(2).III.C.
Applicant asserts in pg. 31 para. 3:
The Office Action suggests claims amount to insignificant extra-solution activity or mere field of use limitations. … The amended claims do not merely gather data and display results, which would be insignificant extra-solution activity. Rather, they perform substantive computational processing that transforms data and generates new clinical outputs. The automatic calculation of COMP/IL-8 ratio from laboratory measurements generates a new diagnostic metric not present in the original laboratory data. The comparison of this calculated ratio to the threshold 4.3 performs a classification function assigning patients to diagnostic categories. The conditional initiation of secondary testing based on the classification result implements a workflow management function that determines which patients require which tests. The multi-parameter classification algorithm integrates diverse data types including quantitative measurements, binary presence/absence determinations, and microbiological identifications to generate a diagnostic determination that is not present in any individual test result. The generation of diagnostic rep01is synthesizes all testing results into structured clinical documents formatted for integration with healthcare information systems. The transmission to clinical information systems delivers actionable diagnostic information to clinicians for treatment planning. These operations transform laboratory data into clinical diagnoses and represent substantive computational processing, not mere data gathering and display. The claims are also not mere field of use limitations that simply apply abstract ideas to a medical setting. Field of use limitations simply indicate where an abstract idea is used without imposing meaningful limits on how it is used. … These technical implementations impose meaningful limits showing the claims are directed to specific technological solutions, not abstract ideas applied generally in a medical field.
It is respectfully submitted that this is not persuasive because the arguments described simply rephrase claim elements that have been already identified in the Previous Office Action as being not sufficient to integrate the judicial exception into a practical application. For example, "obtaining … a sample" and "performing laboratory immunoassay" reads on data gathering steps; the "multi-parameter classification algorithm" and "system architecture" read on judicial elements and have been identified as abstract ideas; and the "displaying" and "transmitting" steps read on data outputting. The delivery or diagnostic data does not read on an affirmative treatment application (See Claim Rejection above). There is no indication of a particular machine being improved or optimized or any indication of meaningful limits showing the claims are directed to specific technological solutions because limitations considered as using a generic computer to perform a judicial exception are not sufficient to integrate an abstract idea into a practical application (see MPEP 2106.05(f)); since steps that can be performed mentally and performing the mental process in a computer environment do not negate the fact that something that can be carried out in the human mind. See MPEP 2106.04(a)(2).III.C.
Furthermore, it appears that the Applicant argued a transformation of lab assays into new types of data.; which it is not convincing because the transformation from raw data to clinically relevant decisions alleged by Applicant is not a particular transformation which can provide a practical application. For data, mere "manipulation of basic mathematical constructs [i.e.,] the paradigmatic ‘abstract idea,’" has not been deemed a transformation (see CyberSource v. Retail Decisions, 654 F.3d 1366, 1372 n.2, 99 USPQ2d 1690, 1695 n.2 (Fed. Cir. 2011) (quoting In re Warmerdam, 33 F.3d 1354, 1355, 1360, 31 USPQ2d 1754, 1755, 1759 (Fed. Cir. 1994)); MPEP 2106.05(c)).
Applicant asserts in pg. 33 para. 1:
The 2019 Revised Patent Subject Matter Eligibility Guidance published at 84 Fed. Reg. 50 (January 7, 2019) clarifies that Step 2AProng Two analysis of whether claims integrate judicial exceptions into practical applications does not evaluate whether additional elements are well understood, routine, conventional. The guidance states at page 55 that "the 'applied in a practical manner' consideration overlaps with the 'well-understood, routine, conventional activity' consideration, but they are distinct concepts." The guidance emphasizes that Step 2A Prong Two focuses on whether the claim as a whole integrates exceptions into practical applications through improvements to technology, particular machines, particular transformations, or other meaningful ways, while Step 2B focuses on whether individual elements or combinations are more than well understood, routine, conventional activity. This means that even elements that might be conventional in isolation can integrate exceptions into practical applications when they provide technological improvements or meaningful limitations on claim scope. …This teaching applies directly to the instant claims where receiving laboratory data, calculating ratios, and transmitting reports may use conventional operations in their implementation, but the specific diagnostic methodology using COMP/IL-8 ratio threshold for conditional testing provides technological improvement that integrates any exception into practical application.
It is respectfully submitted that this is not persuasive. MPEP 2106.05(d) sets forth that, at Step 2B, it is the additional elements which are examined to determine whether they are well-understood, routine, conventional activities previously known to the industry. The analysis at Step 2A, Prong 2, considers the claims as a whole, i.e., the additional elements in combination with the judicial exceptions (see MPEP 2106.05(a)), although the integration or improvement provided in the claim must flow from the additional elements and not the judicial exceptions to be considered persuasive. However, Step 2B requires examining only the additional elements, either alone or in combination with one another, for conventionality. An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself (Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966)). The limitations 1, 3-11 and 13-24 pointed to be Applicant are considered to recite a judicial exception as described above and are therefore not considered at Step 2B.
No prior art has been applied to the following claims
Claims 1, 3-11 and 13-24 are free of the analogous art at least because close art, e.g. Heard and Martadiani, as cited on the 10/01/2025 Form PTO-892, does not teach the recited combination of "wherein the diagnosing is based upon a level of cartilage oligomeric matrix protein (COMP) and a ratio of COMP to interleukin-8 (IL-8) in the joint specific biological material; if the one or more of the tests indicate OA is not the cause of the inflamed joint, determining with the electronic device if inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, possible septic arthritis or septic arthritis is the cause of the inflamed joint based upon a further plurality of the tests” (claim 1); “determine if osteoarthritis (OA) is the cause of the inflamed and/or painful joint based upon one or more of the tests, wherein the diagnosing is based upon a level of cartilage oligomeric matrix protein (COMP) and a ratio of COMP to interleukin-8 (IL-8) in the joint specific biological material; determine, if the one more of the tests indicate OA is not the cause of the inflamed joint, if inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, possible septic arthritis or septic arthritis is the cause of the inflamed joint based upon a further plurality of the tests” (claim 14); and "a diagnostic classification indicating whether an inflamed joint of the patient is caused by osteoarthritis (OA) inflammatory arthritis, crystalline arthritis, rheumatoid arthritis, possible septic arthritis, or septic arthritis, wherein the diagnostic classification was determined based on the COMP/IL-8 ratio and the white blood cell data" (claim 24).
Conclusion
No claims are allowed.
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.
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/F.F.L./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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