Prosecution Insights
Last updated: April 19, 2026
Application No. 18/023,483

METHODS FOR FINE NEEDLE SAMPLE ANALYSIS VIA MASS SPECTROMETRY

Final Rejection §101§103§112
Filed
Feb 27, 2023
Examiner
FRITCHMAN, REBECCA M
Art Unit
1758
Tech Center
1700 — Chemical & Materials Engineering
Assignee
BOARD OF REGENTS OF THE UNIVERSITY OF TEXAS SYSTEM
OA Round
2 (Final)
46%
Grant Probability
Moderate
3-4
OA Rounds
4y 6m
To Grant
82%
With Interview

Examiner Intelligence

Grants 46% of resolved cases
46%
Career Allow Rate
294 granted / 642 resolved
-19.2% vs TC avg
Strong +36% interview lift
Without
With
+35.9%
Interview Lift
resolved cases with interview
Typical timeline
4y 6m
Avg Prosecution
94 currently pending
Career history
736
Total Applications
across all art units

Statute-Specific Performance

§101
10.9%
-29.1% vs TC avg
§103
50.4%
+10.4% vs TC avg
§102
8.4%
-31.6% vs TC avg
§112
23.7%
-16.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 642 resolved cases

Office Action

§101 §103 §112
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 . Detailed Action Summary This is the Final Office Action based on application 18/023483 response filed 12/08/2025. Claims 1, 4-8, 11, 14-17, 19-23, 26, 28, 37 & 71 are pending and have been fully considered. Claims 2-3, 9-10, 12-13, 18, 24-25, 27, 29-36 & 38-70 have been 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 ofmatter, or any new and useful improvement thereof, may obtain a patent therefor, subject to theconditions and requirements of this title. The claimed invention of Claims 1, 4-8, 11, 14-17, 19-23, 26, 28, 37 & 71 are directed to non-statutory subject matter. The invention of instant claims for independent claim 1 and those that depend therefrom are drawn towards a method of detecting cancer cells in lung cancer. “Detection,” of cancer cells, as broadly claimed is the same as diagnosis of cancer through broadest reasonable interpretation. This is because the correlation of the claimed. Though the word diagnosis is not used, the diagnosis/correlation is still implicitly in the claims. Through 101, inquiry: Inquiry: Are the claims directed to a statutory category of invention? Yes, independent Claim1 and all claims depending therefrom are drawn towards a statutory category (a method). Step 2A, Prong 1: Do the claims involve a Judicial Exception? Yes, independent Claim 1 and those that depend therefrom though are drawn towards a method of detecting cancer cells, but the claim body itself which is the limiting part is drawn towards an abstract idea, of “applying a statistical algorithm,” and “analyzing,” which are a mental processes or math. There is also the implicit natural correlation already discussed above. Step 2A, Prong 2: Has the natural correlation or abstract idea been integrated into a particular practical application? In Claim 1, there is no particular practical application. Nothing is done after the claimed, “applying a statistical algorithm,” and “analyzing types of cancer cells.” Determining a therapy or treatment is not actual treatment itself, so there is no practical application. Even further as generally claimed—“personalized therapy,” is not particular treatment since this is akin to just claiming, applying appropriate treatment, especially at the level of generality “personalized,” therapy is claimed. The only step in Claim 1 in addition to the judicial exception is performing DESI- MSI using a restricted mass range. This is done only to gather data to perform the judicial exception though. Therefore, this is extra-solution activity. See MPEP 2106.05 (g). Step 2B: Do the claims recite any elements which are significantly more than the natural correlation or abstract idea? Claim 1 is not significantly more than the judicial exception. The only step in Claim 1 in addition to the judicial exception is performing DESI- MSI using a restricted mass range. This is done only to gather data to perform the judicial exception though. Therefore, this is extra-solution activity. See MPEP 2106.05 (g). Further, using DESI- MSI and restricted ranges is well understood, routine and conventional in the art (WURC) and therefore not significantly more. Again- the claimed “analyzing,” “to determine,” is judicial exception itself and “personalized therapy,” at the level of generality claimed could be any therapy. For example (I have a heachache. I take an aspirin or I drink a water.) See MPEP 2106.05 (a) & MPEP 2106.05 (d). The dependent claims are reviewed for additional limitations dependent on the independent claim above. Claims 4, 7-8, 26, & 27 specify the cancer type or metabolites in profile. This does not practically apply nor add significantly more. Instead, this is almost alluding to the claiming of another judicial exception (a natural correlation/ abstract idea or law of nature). Claims 5-6, specifies 2D DESI-MSI and the mass range used. This does not practically apply nor add significantly more. This is still just used for data gathering or data pull as in Claim 1. Claim 14 specifies that the sample is from FNA biopsy. This does not practically apply nor add significantly more. Claims 15-17 & 19-23 claim what is involved in the statistical algorithm. This is all still math and mental process therefore does not change the analysis from above. Claim 37 claims that the method is performed in less than one hour. Timing does not change the fact that the claimed method is drawn towards an abstract idea. Claim 71, specifies that the personalized therapy is applied which is administration of at least one medication based on a cancer target or pathway. However—administering a medication, “based on,” a cancer target or pathway is not particular treatment for the claimed detection of lung cancer, so no practical application. Further- treatment specific to the type of cancer is WURC and therefore does not amount to significantly more. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1, 4-8, 11, 14-17, 19-23, 26, 28, 37 & 71 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites the limitation “the data.” There is insufficient antecedent basis for this limitation in the claim, and therefore the claim is unclear. Claims 4-8, 11, 14-17, 19-23, 26, 28, 37 & 71 are rejected due to their dependency on Claim 1. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or non-obviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 1, 4-8, 11, 14-17, 19-23, 26, 28, 32 & 37 is/are rejected under 35 U.S.C. 103 as being obvious by TAKATS in US 20180047554 in view of PORCARI in “Multicenter Study Using Desorption-Electrospray-Ionization-Mass-Spectrometry Imaging for Breast-Cancer Diagnosis” and further in view of EBERLIN in US 20180158661. With respect to Claim 1, TAKATS teaches of a method comprising providing a biological sample on a swab, directing a spray of charged droplets onto a surface of the swab in order to generate a plurality of analyte ions, and analyzing the analyte ions (abstract). The biological sample is analyzed by DESI (desorption electrospray ionization) mass spectrometry (MS) which can also be combined with ion mobility analysis (IMS) (paragraph 0002). TAKATS further teaches of detecting mass spectrometry images, and also of analyzing lung cancer samples (this can read on mass spectrometry imaging or MSI) (paragraph 0957-0958, 1114, 1117). TAKATS even further teaches of operating in negative ion mode (paragraph 0257-0258) in the mass range of mz 150-1000 (this is a “restricted,” mass range) (paragraph 0803, 0811-0812, 0628), and then analyzing the molecular ion patterns/profiles (paragraph 0795) which can comprise lipids (paragraph 0060, 0627, 0635, 0640) glycerophospholipids like PS 34:1 (paragraph 0799, 0805). TAKATS even further teaches that the sample comprise spatially resolved information (paragraph 0542-0543, 0574, 0948-0951) and of providing spatially resolved mass spectral data with the DESI-MS (paragraph 0958). TAKATS further teaches of performing statistical analysis thereon (paragraph 0683, 0768, 0796, 0806) and more specifically of performing binning and that the binning is performed first (paragraph 1079, 1078). The data is then resampled onto a logarithmic grid (paragraph 1079) and later the likelihood is calculated and Caudy distribution and Gaussian distribution is used (this reads on binning, “re-binning,” and then after that application of a statistical modeling) (paragraph 1080-1087). TAKATS even further teaches of using the instant method to determine a therapy which can be appropriate treatment/targeted treatment/particular treatment (paragraph 0007, 0820, 0868, 0951), effective treatment (paragraph 1148), or of using any of the drugs and detecting them listed in paragraph 1180-1181 (paragraph 1180-1181). All this reads on the claimed “determine a personalized therapy based on the types of cancer cells,” (paragraph 0083, 0548, 0912). TAKATS does not use the term, “restricted,” mass range. TAKATS also does not teach of the claimed parameters utilizing “total,” ion count. Further-though statistical models and algorithms are deeply linked (algorithms train models), if using a statistical algorithm specifically instead of a model after the claimed normalization or binning is unclear to one of ordinary skill, PORCARI and EBERLIN are used to remedy this. PORCARI teaches of analyzing lipid profiles across different cancer patients (Page 1, abstract). PORCARI further teaches of using a restricted mass range of m/z 700-1200 for DESI-MSI (Page 6, last paragraph). PORCARI also teaches of detecting ion abundances (total ion)/count (Page 6, last paragraph). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention and one would have had reasonable expectation of success of/to use a restricted mass range as is done in PORCARI in the method of TAKATS due to the advantage this offers in giving reproducible results (Page 7, lines 6-7). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention and one would have had reasonable expectation of success of/to determine ion abundance/total ion count as is done in PORCARI in the method of TAKATS due to the advantage this offers experimental detection and analysis of reproducibility of results (Page 6, last paragraph). If using a statistical algorithm specifically instead of a model after the claimed normalization or binning is unclear to one of ordinary skill after TAKATS and POCRAI, EBERLIN is used to remedy this. EBERLIN teaches of a method of assessing tissue sample, specifically liquid tissue sample after mass spectrometry analysis (abstract). EBERLIN further teaches of using DESI mass spec in negative ion mode (paragraph 0031) in the mass ranges of 500-1800, 500-1000, 785-809, 870-920 (restricted mass ranges) (paragraph 0038). EBERLIN further teaches that the mass spectra are normalized with respect to total ion count (paragraph 0124), and that then PCA (principle component analysis)—which is an unsupervised machine learning algorithm used for dimensionality reduction--- is performed (paragraph 0125). This reads on the instantly claimed, “wherein the statistical algorithm is applied after the data is processed with a total ion count (TIC) normalization and/or a binning data method.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success of/to pre-process data with normalization before putting into a statistical algorithm as is done in EBERLIN in the methods of TAKATS and PORCARI due to the advantage this offers for accounting for slight fluctuations in signal intensities (EBERLIN, paragraph 0124). With respect to Claim 4, TAKATS teaches that the cancer is non-small cell or small cell lung cancer (paragraph 1117). With respect to Claim 5, TAKATS teaches of using DESI as shown above, but does not teach of using 2D DESI. PORCARI is used to remedy this and teaches of using 2D DESI (Page 4, paragraph 3). It would have been obvious to one of ordinary skill in the art to use 2D DESI as is done in PORCARI in the method of TAKATS due to the advantage this offers in giving 2D imaging (Page 4, paragraph 3). With respect to Claim 6, TAKATS teaches of the restricted mass range being m/z 150-1000 (paragraph 0628), which overlaps with the claimed range of 500-1500. PORCARI further teaches of using a restricted mass range of m/z 700-1200 for DESI-MSI (Page 6, last paragraph), which falls in the claimed range. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention and one would have had reasonable expectation of success of/to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I. With respect to Claim 7, TAKATS teaches that the biomarker is fatty acids and lipids (paragraph 0060). With respect to Claim 8, TAKATS teaches of the analyzed sample and profile containing glycerophosphoserines (paragraph 0627). With respect to Claim 11, TAKATS teaches of comparison of the profile to a control/s (paragraph 0830-0831, 1142). With respect to Claim 14, TAKATS teaches of taking a fine needle aspiration biopsy sample (paragraph 0943). With respect to Claim 15, TAKATS teaches of identifying the subtype of cancer (paragraph 1124) in comparison to a healthy control (so differentiating between normal and cancer tissue) (paragraph 1142, 0548), and of using statistical analysis to do this (paragraph 0683, 0795, 0796). With respect to Claim 16, TAKATS teaches of identifying the subtype of cancer (paragraph 1124) in comparison to a healthy control (paragraph 1142, 0548), and of using statistical analysis to do this (paragraph 0683, 0795, 0796). With respect to Claim 17, TAKATS teaches of differentiating the cancer (paragraph 0549), in which the cancer can be an adenoma (carcinoma) (paragraph 1117), lung cancer (paragraph 0982, 1114). With respect to Claim 19, TAKATS teaches of using statistical analysis as shown above, but does not teach of using LASSO logistic regression. PORCARI is used to remedy this and teaches of using LASSO logistic regression (Page 4, paragraph 4). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention and one would have had reasonable expectation of success of/to use LASSO logistic regression as is done in PORCARI in the method of TAKATS due to the advantage this offers in analysis being predictive for breast cancer (Page 7, paragraph 1). With respect to Claim 20, TAKATS teaches of using statistical analysis as shown above, but does not teach of using two tier classification for the modeling. PORCARI is used to remedy this and teaches of using LASSO logistic regression (Page 4, paragraph 4), and further of using two classification models (two tier)(Page 8, paragraph 1). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention and one would have had reasonable expectation of success of/to use a two-tier classification model as is done in PORCARI in the method of TAKATS due to the advantages this modeling offers for classification (Page 8, paragraph 1). With respect to Claim 21, TAKATS teaches of using statistical analysis as shown above, but does not teach of using two tier classification for the modeling. PORCARI is used to remedy this and teaches of using LASSO logistic regression (Page 4, paragraph 4), and further of using two classification models, one after another (two tier sequential) (Page 8, paragraph 1). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention and one would have had reasonable expectation of success of/to use a two-tier classification model as is done in PORCARI in the method of TAKATS due to the advantages this modeling offers for classification (Page 8, paragraph 1). With respect to Claim 22, TAKATS teaches of identifying the subtype of cancer (paragraph 1124) in comparison to a healthy control (paragraph 1142, 0548), and of using statistical analysis to do this (paragraph 0683, 0795, 0796). TAKATS teaches of differentiating the cancer (paragraph 0549), in which the cancer can be an adenoma (carcinoma) (paragraph 1117), lung cancer (paragraph 0982, 1114). TAKATS teaches of using statistical analysis as shown above, but does not teach of using two tier classification for the modeling. PORCARI is used to remedy this and teaches of using LASSO logistic regression (Page 4, paragraph 4), and further of using two classification models, one after another (two tier sequential) (Page 8, paragraph 1). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention and one would have had reasonable expectation of success of/to use a two tier classification model as is done in PORCARI in the method of TAKATS due to the advantages this modeling offers for classification (Page 8, paragraph 1). With respect to Claim 23, TAKATS teaches of detecting PI 36:1 as an indicator of cancer at 863.85 (paragraph 0627) (one feature). TAKATS teaches of detecting peaks at the claimed m/z’s which would be the claimed compounds through the laws of physics (Figure 10 A, Figure 11, 12, 15 A-B, 17 A-B, 20 A-c). TAKATS also teaches of determining error (paragraph 1049). With respect to Claim 26, TAKATS teaches of detecting PI 36:1 as an indicator of cancer at 863.85 (paragraph 0627). With respect to Claim 28, TAKATS teaches of detecting peaks at the claimed m/z’s which would be the claimed compounds through the laws of physics (Figure 10 A, Figure 11, 12, 15 A-B, 17 A-B, 20 A-c). With respect to Claim 37, TAKATS teaches of the DESI occurring in minutes (which reads on the claimed under an hour) (paragraph 0682). With respect to Claim 71, TAKATS teaches of using the instant method to determine a therapy which can be appropriate treatment/targeted treatment/particular treatment/monitoring/administering treatment (paragraph 0007, 0820, 0868, 0951, 0717, 0771), effective treatment (paragraph 1148), or of using any of the drugs and detecting them listed in paragraph 1180-1181 (paragraph 1180-1181). All this reads on the claimed “determine a personalized therapy based on the types of cancer cells,” and “applying the personalized therapy comprising administering at least one medication (antibiotics) based on a cancer target or pathway) (paragraph 0083, 0548, 0912). Claim(s) 71 is rejected under 35 U.S.C. 103 as being obvious by TAKATS in US 20180047554 in view of PORCARI in “Multicenter Study Using Desorption-Electrospray-Ionization-Mass-Spectrometry Imaging for Breast-Cancer Diagnosis” and further in view of EBERLIN in US 20180158661 and further in view of JONES in US 20180059126. With respect to Claim 71, TAKATS teaches of a method comprising providing a biological sample on a swab, directing a spray of charged droplets onto a surface of the swab in order to generate a plurality of analyte ions, and analyzing the analyte ions (abstract). The biological sample is analyzed by DESI (desorption electrospray ionization) mass spectrometry (MS) which can also be combined with ion mobility analysis (IMS) (paragraph 0002). TAKATS further teaches of detecting mass spectrometry images, and also of analyzing lung cancer samples (this can read on mass spectrometry imaging or MSI) (paragraph 0957-0958, 1114, 1117). TAKATS even further teaches of operating in negative ion mode (paragraph 0257-0258) in the mass range of mz 150-1000 (this is a “restricted,” mass range) (paragraph 0803, 0811-0812, 0628), and then analyzing the molecular ion patterns/profiles (paragraph 0795) which can comprise lipids (paragraph 0060, 0627, 0635, 0640) glycerophospholipids like PS 34:1 (paragraph 0799, 0805). TAKATS even further teaches that the sample comprise spatially resolved information (paragraph 0542-0543, 0574, 0948-0951) and of providing spatially resolved mass spectral data with the DESI-MS (paragraph 0958). TAKATS further teaches of performing statistical analysis thereon (paragraph 0683, 0768, 0796, 0806) and more specifically of performing binning and that the binning is performed first (paragraph 1079, 1078). The data is then resampled onto a logarithmic grid (paragraph 1079) and later the likelihood is calculated and Caudy distribution and Gaussian distribution is used (this reads on binning, “re-binning,” and then after that application of a statistical modeling) (paragraph 1080-1087). TAKATS even further teaches of using the instant method to determine a therapy which can be appropriate treatment/targeted treatment/particular treatment (paragraph 0007, 0820, 0868, 0951), effective treatment (paragraph 1148), or of using any of the drugs and detecting them listed in paragraph 1180-1181 (paragraph 1180-1181). All this reads on the claimed “determine a personalized therapy based on the types of cancer cells,” (paragraph 0083, 0548, 0912). TAKATS does not use the term, “restricted,” mass range. TAKATS also does not teach of the claimed parameters utilizing “total,” ion count. Further-though statistical models and algorithms are deeply linked (algorithms train models), if using a statistical algorithm specifically instead of a model after the claimed normalization or binning is unclear to one of ordinary skill, PORCARI and EBERLIN are used to remedy this. PORCARI teaches of analyzing lipid profiles across different cancer patients (Page 1, abstract). PORCARI further teaches of using a restricted mass range of m/z 700-1200 for DESI-MSI (Page 6, last paragraph). PORCARI also teaches of detecting ion abundances (total ion)/count (Page 6, last paragraph). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention and one would have had reasonable expectation of success of/to use a restricted mass range as is done in PORCARI in the method of TAKATS due to the advantage this offers in giving reproducible results (Page 7, lines 6-7). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention and one would have had reasonable expectation of success of/to determine ion abundance/total ion count as is done in PORCARI in the method of TAKATS due to the advantage this offers experimental detection and analysis of reproducibility of results (Page 6, last paragraph). If using a statistical algorithm specifically instead of a model after the claimed normalization or binning is unclear to one of ordinary skill after TAKATS and POCRAI, EBERLIN is used to remedy this. EBERLIN teaches of a method of assessing tissue sample, specifically liquid tissue sample after mass spectrometry analysis (abstract). EBERLIN further teaches of using DESI mass spec in negative ion mode (paragraph 0031) in the mass ranges of 500-1800, 500-1000, 785-809, 870-920 (restricted mass ranges) (paragraph 0038). EBERLIN further teaches that the mass spectra are normalized with respect to total ion count (paragraph 0124), and that then PCA (principle component analysis)—which is an unsupervised machine learning algorithm used for dimensionality reduction--- is performed (paragraph 0125). This reads on the instantly claimed, “wherein the statistical algorithm is applied after the data is processed with a total ion count (TIC) normalization and/or a binning data method.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention and one would have had reasonable expectation of success of/to pre-process data with normalization before putting into a statistical algorithm as is done in EBERLIN in the methods of TAKATS and PORCARI due to the advantage this offers for accounting for slight fluctuations in signal intensities (EBERLIN, paragraph 0124). TAKATS, PORCARI, and EBERLIN teach of performing particular and targeted treatment as shown above. In case it is not clear to one of ordinary skill that they teach of administration of the treatment, JONES is used to remedy this. JONES teaches of a method of analyzing a cell population by mass spectrometry (Abstract), by DESI- MS to determine if the patient has cancer (paragraph 0006-0014), and then administering a therapeutically effective treatment based on the analysis based on identifying the target entity and based on cancer type (paragraph 0136, 0333, 0521, 0629, 0280). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to administer cancer therapy based on cancer cell type to make it effective due to the advantage this would offer in providing an effective treatment (JONES, paragraph 0136, 0210, 0272). Response to Arguments Applicant's arguments filed 12/08/2025 have been fully considered but they are not persuasive. With respect to the 101 rejection, applicant argues that the amendments dated 12/08/2025 make the claims patent eligible. The examiner disagrees. Applicant argues that the instant claims offer a technical improvement. The examiner does not agree as both the EBERLIN and TAKATs reference teach of what applicant is arguing is the technical improvement, using DESI- MS to diagnose disease and pre-processing of data using binning or normalization before a statistical algorithm. Applicant argues that this constitutes “a concrete application of an algorithm to physical, transformed data.” The examiner disagrees with this. Statistical algorithms as claimed are well known and routine and so is the pre-processing, or transformation of data as claimed. This is true especially at the level of generality claimed. The examiner notes that applicant mentions “10-fold cross validation ,” in their arguments and that this is no longer claimed--- so this argument is not commensurate in scope with the claims. Applicant further argues that a “personalized therapeutic decision, “ is practical application. The examiner disagrees, again especially at the level of generality claimed, since any treatment can be considered to be “personalized,” with respect to whoever is taking the treatment---through BRI. Further—especially as recited in claim 1, no actual treatment is performed and instead it is only, “analyzing,” which is a mental process. Applicant further argues that DESI- MS is a specific technological process. With respect to this--- the examiner maintains that DESI- MS is only used for gathering data to perform either the non specifically claimed diagnosis or the specifically claimed analyzing--- which are both shown to be judicial exceptions. Applicant argues that the instant method offers surprising and unexpected improved results. With respect to this--- the examiner maintains that the claims as instantly worded are not patent eligible. Further—it there are actually surprising and unexpected results, it is not clear what is responsible for these results is in the instant claims. Therefore, all claims remain rejected under 101. With respect to the prior art, applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. New references were added due to the instantly made amendments, and it is shown of the prior art reads on the claims in the 103 rejections above. Conclusion 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
Read full office action

Prosecution Timeline

Feb 27, 2023
Application Filed
Sep 05, 2025
Non-Final Rejection — §101, §103, §112
Dec 08, 2025
Response Filed
Dec 15, 2025
Final Rejection — §101, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
46%
Grant Probability
82%
With Interview (+35.9%)
4y 6m
Median Time to Grant
Moderate
PTA Risk
Based on 642 resolved cases by this examiner. Grant probability derived from career allow rate.

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