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 Non-Final Office action based on the 18/634737 application RCE filed 04/08/2026.
Claims 1-3, 9, 22-23, 30, 137-139 & 143-144 are pending and have fully been examined.
Claims 4-8, 10-21, 24-29, 31-136, and 140-142 are cancelled.
Claims 143-144 are newly added.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/08/2026 has been entered.
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.
Claim 1-3, 9, 22-23, 30, 137-139 & 143-144 are rejected under 35 U.S.C. 101 because they are directed non-statutory subject matter as the claims include abstract ideas without practically applying or adding significantly more.
The invention of instant claims 1-3, 9, 22-23, 30,137-139 & 143-144 are drawn towards a method for treating a chronic disease.
Through 101, inquiry analysis:
Is the claim directed to a statutory category of invention?
Yes, Claim 1 is drawn towards a statutory category method.
Step 2A, Prong One-Does the claim involve a Judicial Exception?
Yes. The claims involve the judicial exception of an abstract idea. As claimed in independent Claim 1. The claimed “identifying,” and “determining,” and “providing results,” steps are an abstract idea performed by a general-purpose processor with a non-transitory computer readable medium as claimed (comparing to a list of drugs/ list of drugs that have drug-drug interaction).
Even further, “implementing a first treatment,” or the second treatment as claimed is a mental process that can include “performing assessments,” or “discontinuing administration,” which is a mental decision to stop a treatment. Therefore, as instantly claimed, the claimed treatments can be mental processes/abstract ideas as well.
Step 2A, Prong 2- Is the judicial exception integrated into a particular practical application?
For independent Claim 1, the answer is no.
For the claimed “identifying,” and “determining,” and “providing results,” it is claimed that these steps are performed on a general-purpose processor and a non-transitory computer readable medium.” It is claimed that the processor and computer-readable medium are “configured to perform,” these steps, “using the processor and instructions stored on a non-transitory computer-readable medium configured to electronically couple to the processor to perform the following steps:.”
However, with respect to the claimed steps—the examiner notes that as claimed all of these steps based on the claimed instructions seem to only be based on general/simple comparison to something such as look-up chart.
The values obtained from mass spectrometry are compared to the look-up chart or similar, if they are above a threshold, and then the chart indicates if there is drug-drug interaction or not. Claim 1 notes that the determining if drug-drug interaction works comprises mapping the drugs to a drug information database as assessing pair-wise comparison of drugs in a list of drugs. This is all simple math and or/general comparison, which can be performed by the human mind and instead is automated on a computer.
Therefore, these steps in the claims amount to performing, “mental processes on a generic computer.” See MPEP 2106.04 (a)(2). Therefore, nothing claimed makes the claims overall amount to “improvement to the functioning of a computer.” See MPEP 2106.05 (a).
The claims further include that both when DDI is present and when it is not determined to be present, “treatments,” are performed, however the claimed treatments in “(i),” are not actually required to be actual treatments nor are they considered to be further specific and particular practical application based on the judicial exceptions.
The claimed “first treatment, “and “second treatment,” can be further diagnostic or monitoring tests, “assessments.” The assessments can be the same no matter if drug-drug interaction is found or not. Therefore- these are considered extra-post-solution activity, and therefore this is not a practically application.
The treatments also can include “discontinuing,” treatment. Stopping of treatment is not consider particular and specific treatment.
The treatments claimed in “(e),” and “(f),” of Claim 1 also can require administration of increase or decrease in the drug. As claimed, the “drugs,” which are analyzed in the claim can include food and supplements or miscellaneous drugs. Therefore, this is also not considered particular practical application or treatment since this can be interpreted as eating more or less food, and again--- this is not a treatment, but instead this is something every human does on a daily basis.
With respect to the treatments, the above is especially true at the level of generality claimed are not particular and specific due to the wide array of treatments claimed which all can be used to many different diseases and conditions other than DDI. As claimed, this is akin to claiming “administering a suitable medication to a patient,” (or treatment in this case) --- which MPEP has shown to not be particular treatment and instead is merely instructions to “apply,” a judicial exception in a generic way.
See MPEP 2106.04 (d)(2):
a. The Particularity Or Generality Of The Treatment Or Prophylaxis
The treatment or prophylaxis limitation must be “particular,” i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). For example, consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications. This falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). The claim also recites “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype.” This administration step is particular, and it integrates the mental analysis step into a practical application. Conversely, consider a claim that recites the same abstract idea and “administering a suitable medication to a patient.” This administration step is not particular, and is instead merely instructions to “apply” the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application.
Examiners may find it helpful to evaluate other considerations such as the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)), and the field of use and technological environment consideration (see MPEP § 2106.05(h)), when making a determination of whether a treatment or prophylaxis limitation is particular or general.
The claims also require an, “analyzing,” step, which in itself is a mental process. However, applicant claims that the analyzing is done by measuring using mass spectrometry- so therefore the analyzing requires a measurement device/sensor. Thought this is the case- as generally claimed the use of mass spectrometry amounts to mere data gathering which is then used to accomplish the claimed abstract ideas. Note--data gathering to be used in an abstract idea is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g).
This remains the case even though it is specified that oral fluid analyzed is obtained from a patient who has ingested a drug by mass spectrometry, as the same analysis (mass spectrometry data pull) occurs and the pre-treatment (ingesting of the drug) occurs outside of the boundaries of the claims.
This also applies to the claimed steps of “obtaining an oral fluid sample,” and “providing results to a processor,” as both are considered insignificant extra-solution activity, as are either the sample or data pull to perform the judicial exception from.
Step 2 B- Does the claim recite any elements which are significantly more than the judicial exception?
There are no features instantly claimed in independent Claim 1 which results in significantly more than the judicial exception.
The claimed “analyzing,” by using mass spectrometry—acts as merely a data pull to perform the abstract idea in the claims. Further- mass spectrometry is well understood routine and conventional in the art (WURC), especially at the level of generality claimed and therefore is not enough to make the claims significantly more than the abstract idea. See MPEP 2106.05 (g). This is evidenced by KIMMERLING in US 20200227136 which teaches of the analyzing the metabolome using mass spectrometry which would also show if drugs were present (paragraphs 0083 & 0084).
Further, both the claimed processor and the claimed non-transitory computer-readable medium, as claimed are general purpose computers. This is because- neither are claimed to perform more than a general comparison to charts and to perform general “instructions.” The claimed identification happens through these two device parts, but as claimed the processor and non-transitory computer medium are not claimed as configured or programmed to perform specific and non-general functions- so there is no structural change and they are general purpose computers. As claimed, it seems that the instructions claimed only require general comparison to a loo-up table or similar. The processor and non-transitory computer readable medium are claimed a configured to electronically couple together---however this is still general purpose- as these two types of computer parts are routinely coupled together in the art. This again is evidenced by KIMMERLING which teaches of accomplishing the instant method using a computer that has one or more processors (so processor and non-transitory computer readable medium) that is connected to the detection system, and further teach of using instructions stored on machine readable devices/software (non-transitory computer readable medium) to accomplish this method (paragraph 0070, 0091-0095).
In addition, the independent claim 1 also claims “obtaining and oral fluid sample from the patient.” Obtaining samples from patients is routine and conventional in the art though so this does not add enough to make the claim subject matter eligible. This is evidenced by KIMMERLING. KIMMERLING teaches of taking a sample from the patient which can be saliva (oral fluid) (paragraph 0015),
In addition, all treatments claimed are routine and conventional including mental “assessments,” increasing or decreasing dug dosage, and all others claimed)—and therefore reads as general, and also WURC in the art. This again is evidenced by KIMMERLING which teaches that further therapeutics used to treat based on the analysis (paragraph 0044-0045).
See Vanda memorandum. See MPEP 2106.05(b) & (d) which deals with what is considered “Well-Understood, Routine and Conventional,” and what is considered a Particular Machine.
Nothing in any of the dependent claims 2-3, 9, 22-23, 30, 137-139 & 143-144 change the matters above.
Claim 2—further specifies what is contained in a list (which can be a mental list) so is still an abstract idea.
Claim 3—specifies that an alternative intervention is administered, however it is not specified if the intervention is a specific treatment of some sort—and therefore reads as general, and therefore not a particular treatment. See Vanda memorandum.
Claim 9 specifies that HPLC MS/MS is used for the analysis. HPLC MS/MS is routine and conventional in the art though so this is not enough to move the claims to a practical application in a way that would make them fall outside the instant claiming of the abstract idea.
Claim 22-23, merely identifies what drug classes drugs could be monitored from and what disease the drugs monitored could be specific for. As claimed- it is not guaranteed that these drugs are even found, but they are only what is looked for which means they are still part of the claimed mental analysis/abstract idea and therefore they do not change the matters above.
Claim 30 does not change matters as it is stating what is occurring the patient outside of the instant method steps.
Claims 137 specifies what the patient was initially diagnosed as. Diagnosis is a natural correlation (biomarker correlation with disease) which is a law of nature which is another judicial exception itself.
Claims 138 specifies the timing of taking a sample. Timing does nothing to change the judicial exception/does not add significantly more or make it a practical application
Claim 139 specifies that the results are reported with EMR, fax or website. All of these things are well understood, routine and conventional in the art. As claimed- this does nothing to turn what is claimed into a particular machine or move it away from being done on a general-purpose computer and therefore does not add significantly more to the judicial exception.
Claim 143 claims that each analytes threshold is a normalized value. The examiner notes that a normalized value is still a numeric value. The claim does not specify what the value is being normalized to or if any equations are used for this within the boundaries of the claims. As what is claimed is a numeric value, this does nothing to practically apply at step 2A, 2, nor to add significantly more to the abstract ideas claimed at step 2B.
Claim 144 claims that each analytes threshold is “derived from a standard”. The examiner notes that what is claimed for the threshold is still a numeric value. The claim does not specify how if any equations are used to “derive,” the values within the boundaries of the claims. As what is claimed is a numeric value, this does nothing to practically apply at step 2A, 2, nor to add significantly more to the abstract ideas claimed at step 2B.
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.
Claims 1-3, 9, 22-23, 30 & 137-139 are rejected under 35 U.S.C. 103 as being obvious over KIMMERLING in US 20200227136 in view of BORISY in US 20030096309 and further in view of DENNIS in US 20070224128.
With respect to Claim 1, KIMMERLING teaches of a method of determining treatment in a cancer patient (cancer is a chronic disease) (abstract). KIMMERLING teach of taking a sample from the patient which can be saliva (oral fluid) (paragraph 0015), of analyzing the sample for biomarkers (which are originally present in the sample) (paragraph 0020), and further teach of analyzing therapeutic information such as drug interactions and past efficacy of drug, and then determining a practical new treatment from this (paragraphs 0053-0054).
KIMMERLING further teaches that the process includes identifying a list of potential therapies/treatments (paragraph 0044), and then taking criteria such as drug interactions (with drugs patient might already be taking) into account(determining if any drug-drug interactions are present), and then a subset of therapeutics is identified based on that--- this reads on the claimed treatment plan that if drug to drug interaction is there, the subset of therapeutics is different than if the drug-to-drug interaction is not there (paragraph 0044-0045). KIMMERLING teaches that thresholds are determined for these compounds and then determining if the measured values are above or below the thresholds and of outputting potential therapies/making therapy/treatment decision based on this- so “pairwise,” comparison to a “drug information database,” through broadest reasonable interpretation above or below a threshold is performed (paragraph 0043-0044, 0047). KIMMERLING teaches of databases including therapeutic (so therapy or drug) information (paragraph 0007, 0009).
KIMMERLING further teach that the cancer treatments that are analyzed and monitored include chemotherapeutics (paragraph 0032-0033). KIMMERLING teach of using mass spectrometry for the analysis (paragraph 0080, 0081, 0084).
KIMMERLING also teaches of accomplishing the instant method using a computer that has one or more processors with instructions (so processor and non-transitory computer readable medium) that is connected to the detection system, and further teach of using instructions stored on machine readable devices/software (non-transitory computer readable medium) to accomplish this method (paragraph 0070, 0091-0095).
Even further, KIMMERLING teach of the analyzing the metabolome using mass spectrometry which would also show if drugs were present (paragraphs 0083 & 0084).
Though the drugs would be present in the analysis of KIMMERLING, since detecting drugs (or three drugs) in the sample itself is not specifically called out, BORISY is used to remedy this. Also, if it is not clear that KIMMERLING calls out specific pairwise comparison.
BORISY teaches of a method of screening for drug-drug interactions using combinational arrays. The method includes the steps of: (a) providing (i) a test drug; (ii) a drug library; and (iii) an assay, (b) contacting the test drug and at least some of the library drugs from the drug library in the assay under conditions that ensure that each test drug/library drug contacting is segregated from the others, (c) recording the result of the contacting of the test drug and the library drug in the assay, and (d) identifying combinations of drugs that produce a result in the assay that is different from the results produced by either drug of the combination by itself. According to the method, each of the identified combinations indicates an interaction between the test drug and the library drug(abstract).
BORISY teaches that the assay used can include one or more living human or non-human cells (e.g., cancer cells, immune cells, neurons, or fibroblasts) or can employ a cell-free system, and further that one desirable assay is one that measures toxicity of the test drug/library drug combination (paragraph 0022) in samples from patients such as blood (paragraph 0126-0127, 0130) and cells (paragraph 0056 & 0057). BORISY teach of identifying a list of drugs that are co-prescribed for treatment of chronic conditions like osteoarthritis, and making adjustments on the co-prescribed list of drugs based on the conditions the patient is found to have after taking into account drug-to-drug interaction (this reads on/makes obvious continuing to administer drugs) (paragraph 0041). BORISY teaches of making determinations on therapeutic combinations based on the interactions of drugs in the assays (paragraph 0052). BORISY specifically teaches of analyzing cell samples (paragraph 0021) over time to determine changing physiological state or conditions (paragraph 0043), which include the effects to treatments (drugs) (this reads on analyzing the sample for “analytes,” of three drug classes) (paragraph 0052, 0050, Claims 13-15 & 20) and of determining whether changes in treatment dosages are needed (paragraph 0047).
BORISY also teaches of making pairwise comparison for drug-drug interactions (paragraph 0050, 0115, 0117-0118) and that all this is managed by computer software (paragraph 0108, 0109).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention, to detect how much drug analyte is in a blood sample as is done in BORISY in the method of KIMMERLING due to the advantage drug profiling has for determination of therapeutic combinations for clinical practitioners (BORISY, paragraph 0052).
Though KEMMERLING and BORISY make the claimed listing of multiple drug classes an monitoring their interactions obvious, DENNIS is used to remedy. Further, if it is unclear that KEMMERLING and BORISY teach of analyzing an oral fluid sample for drug compounds within 48 hours of ingesting the drug compound, or that the dosage of drug is increased or decreased based on the assessment or that further assessment such as glucose testing is performed, DENNIS is also used to remedy this.
DENNIS teaches of method of monitoring adherence in prescribed drugs (abstract). DENNIS teaches of non-invasive monitoring of drug adherence by a subject by detecting a marker in exhaled breath. DENNIS teaches that the drugs/ are prescribed (can read on the instant listing of the drugs a patient ingested), and then the breath is monitoring to see if the drug (or drugs) was actually taken by the subject, and even more specifically if the appropriate dosage of the drug was taken by the subject (paragraph 0037-0040). DENNIS teaches that a list of drugs is monitored for (paragraph 0154-0157) and then of identifying which drugs are taken in comparison to a baseline measure (paragraph 0067, Claim 16). DENNIS also teaches of monitoring multiple different drug classes (including 3 drug classes) and of monitoring their interactions together (paragraph 0146, 0138).
DENNIS further teaches that breath is a body fluid (this can be considered an “oral fluid,” as claimed) (paragraph 0003, 0070), and that the breath is analyzed about 24 hours after administration of the drug, which reads on “ingested by the patient in the last 48 hours,” (paragraph 0087), and that metabolites of the ingested drugs are monitored (paragraph 0011, 0048, 0138).
DENNIS further teaches of determining drug non-adherence and non-compliance (paragraphs 0005-0007), of listing and monitoring drug concentrations in blood (means drugs that are (paragraph 0154-0157), and further of the need to avoid potential drug-drug interaction (paragraph 0138). DENNIS further teaches that if the subject is taking the drug as prescribed that treatment is continued, but that if the patient isn’t an alert is sent to the healthcare personnel to alert of the non-compliance (this can be considered a different treatment than if adherence is found) (paragraph 0021, 0060).
DENNIS even further teaches of performing glucose testing and then determining of appropriate doses (which can be increase or decrease dependent on day)(paragraph 0244).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention, to monitor drug prescription adherence and non-adherence and listings of drugs ingested and compliance and non-compliance involving 3 drug classes as is done in DENNIS in the methods of KIMMERLING and BORISY due to how dangerous lack of drug adherence is and due to the fact that lack of drug adherence leads to ineffective medicine, therefore there being a need to monitor adherence (DENNIS, paragraph 0005).
With respect to Claim 2, KIMMERLING teaches the method as shown above, but does not call out prescribed drugs. BORISY teaches of the drugs being prescribed (paragraph 0029, 0041, 0047, 0048, 0049). Since Claim 2, depends on Claim 1- which only requires identifying drugs a patient is taking--- it is not required that the patient is taking prescription, non-prescription, and other miscellaneous substances. See reason for combination, Claim 1.
With respect to Claim 3, KIMMERLING teaches the method as shown above, but does not call out administering new drugs. BORISY teaches of making determinations on therapeutic combinations based on the interactions of drugs in the assays (paragraph 0052). This makes prescribing/administering “alternative treatments,” based on interactions obvious. BORISY further teaches of trying new drug combinations (paragraph 0041). See reason for combination, Claim 1.
With respect to Claim 9, KIMMERLING and BORISY teaches the method as shown above, but does not call out HPLC MS/MS. DENNIS teaches of using HPLC MS/MS (paragraph 0203-0204). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention, to use HPLC MS/MS as is done in DENNIS In the method of KIMMERLING And BORISY due to the fact that it is a known and commonly used alternative or subcategory for LC MS/MS.
With respect to Claim 22, KIMMERLING and BORISY teaches the method as shown above, but does not call out treating with methotrexate. DENNIS teaches of treating with methotrexate (paragraph 0157). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to treat with and detect methotrexate as is done DENNIS in KIMMERLING and BORISY since it is known to be advantageous for treating rheumatoid arthritis (DENNIS, paragraph 0154).
With respect to Claim 23, KIMMERLING teaches the method as shown above, but does not call out the disease being diabetes. BORISY teach of the chronic disease being diabetes (diabetes mellitus is the technical name) type II (paragraph 0029, 0041, 0048-0049). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to detect diabetes as is done in BORISY in KIMMERLING due to the fact that many diseases and conditions such as diabetes and inflammatory conditions exist at the same time and the need in the art to treat all negative conditions (BORISY, paragraph 0048).
With respect to Claim 30, KIMMERLING teaches the method as shown above, but does not call out identifying a list of drugs wherein 5 drugs are co-prescribed for treatment of chronic conditions like osteoarthritis, and making adjustments on the co-prescribed list of drugs based on the conditions the patient is found to have after taking into account drug-to-drug interaction (this reads on the claimed 2nd treatment of continuing to administer drugs). BORISY further teach that the patient can be administered 5 or more drugs concurrently (8 drugs) (paragraph 0041). See reason for combination, Claim 1.
With respect to Claims 137 KEMMERLING and BORISY teach of the invention as shown above but do not call out two indications of disease. DENNIS is used to remedy this and more specifically teach of detection hypertension and (paragraph 0154). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to detect and treat these conditions as is done in DENNIS in the method of KEMMERLING and BORISY due to the advantage the techniques of DENNIS have in effectively monitoring the diseases (paragraph 0154, 0006).
With respect to Claim 138, KIMMERLING teaches of performing the method within 48 hours (paragraph 0020).
With respect to Claim 139, KIMMERLING teaches of providing results via an interface module which can include a network interface (paragraph 0091, 0093).
Claims 143-144 are rejected under 35 U.S.C. 103 as being obvious over KIMMERLING in US 20200227136 in view of BORISY in US 20030096309 and further in view of DENNIS in US 20070224128 and further in view of PETRICOIN in US 20170363630.
With respect to Claim 143, KIMMERLING, BORISY, and DENNIS teach of the claimed invention as shown above. They do not teach of thresholds being normalized or standards.
PETRICOIN is used to remedy this and further teaches of determining threshold values for markers with respect to standards and that the threshold values can be normalized.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to determine the thresholds and normalize and standardize them as is done in PETRICOIN in the methods of KIMMERLING, BORISY and DENNIS due to the advantages these give in forming comparison to controls a optimization for statistical analysis (PETRICOIN, paragraph 0066).
With respect to Claim 144, KIMMERLING, BORISY, and DENNIS teach of the claimed invention as shown above. They do not teach of thresholds being normalized or standards.
PETRICOIN is used to remedy this and further teaches of determining threshold values for markers with respect to standards and that the threshold values can be normalized.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to determine the thresholds and normalize and standardize them as is done in PETRICOIN in the methods of KIMMERLING, BORISY and DENNIS due to the advantages these give in forming comparison to controls a optimization for statistical analysis (PETRICOIN, paragraph 0066).
Response to Arguments
Applicant's arguments filed 04/08/2026 have been fully considered but they are not persuasive.
Interview
With respect to applicant’s comments on the interview dated 01/07/2026, the examiner agrees with applicant’s comments provided in response dated 04/08/2026 that these generally reflects the substance of the interview. However, as claimed--- it is still not clearly claimed if the non-tangible computer medium and processor are performing more than a general comparison (as claimed a pairwise comparison is performed), and communication with eachother, based on general “instructions.” This all seems to be simple math and comparison, and mental process automated by a computer. If the comparisons are more complex or involve more, it is suggested that applicant make this clear in the claims through amendments.
SMED & 101
The substance of the SMED dated 04/08/2026 and applicant’s arguments dated 04/08/2026 greatly overlaps and is repetitive. Therefore, the examiner responds to them both below, however with respect to amendments made 04/08/2026--- please see the 101 rejection above as this subject matter was addressed there for the newly made amendments, and with respect to how they relate to other claimed parts.
The examiner has reviewed the SMED dated 04/08/2026 and the arguments and references contained therein. The examiner has found it informative with respect to subject matter of and related to the claims, however it is not convincing in overcoming the 101 rejection. The 101 rejection is maintained.
Applicant uses the SMED in attempt to demonstrate from prior art, that the “state of the art at the time of filing,” at step 2A, 2 of the 101 analysis would have known applicant’s claimed “analyzing, identifying, and determining,” steps yield objective measurements for DDI’s using patient samples, and that it provides “improvements to technology or technical field.”
The examiner notes that “objective measurements,” is not any kind of standard related to 101. The 101 analysis including steps 1, 2A1, 2A2, and 2B is the analysis.
The examiner assumes that that the claimed computer parts of a processor and non-transitory medium are meant to be doing more than just performing general comparison to a look-up chart, or similar, but this is not the case as claimed.
Further, applicant notes that for the state of the art at the time of the invention physicians needed to frequently override high-risk DDI alerts inappropriately and that there is difficulty in distinguishing drug interaction from no interaction, since there is a lack of an effective and standardized method to test for these conditions. Further applicant argues that the direct detection of DDI allows for improvement over standard care.
While the examiner appreciates that the problems in the art that applicant discussed in the SMED do exist, the examiner notes as claimed--- the examiner maintains that what is claimed is not a technological improvement to solve these issues or make technological advances in this field. This is for all of the reasons shown in the above 101 rejection.
Further with respect to applicant’s argument that the direct detection of DDI of a sample from a patient allows for improvement over standard care since it uses a direct measurement instead of relying on patient records or physician inquiry. If this is actually the case--- what exactly is the improvement in care? Does applicant think it is the claimed “first treatment,” or “second treatment,” as claimed? If so, the examiner disagrees as these treatment especially as claimed are not particular and specific. If applicant means the improved standard of care is something else entirely, then they should claim it and point it out. Further—in the cases where a patient tells a Doctor every single drug they ingested, is it actually an improvement at all?
The examiner would like to question though--- is what is being done by the non-transitory medium more than a pair-wise general comparison? Is the math more complicated than this? Further are the claimed treatments actually more specific than they are being claimed? Adding more information with respect to these things—could change this analysis, however especially at the level of generality claimed, the 101 rejection is maintained.
Further, with respect to 2A, 2, applicant argues that the claimed “analyzing, identifying, and determining,” steps yield objective measurements for DDI’s using patient samples makes the claims “particular treatment or prophylaxis.” The examiner vehemently disagrees with this. The claimed analyzing, identifying, and determining, have nothing to do with making a treatment based on the judicial exception. This step mentions absolutely no treatment nor any application of the judicial exception. Please see the 101 rejection above for further detail on this.
Further with respect to step 2A, 2, applicant argues that the claimed “analyzing, identifying, and determining,” for “particular treatment or prohylaxis involve the practical application of having a significantly higher likelihood of making a drug-drug interaction diagnosis. Applicant notes that this is step forth in the instant application specification paragraphs 0242, 0244. With respect to this, the examiner notes that a “diagnosis,” is not a practical application, but instead it is another judicial exception itself (natural correlation or abstract idea determined by mathematical comparison of two things). Further—if this instant claims do in fact allow for a higher likelihood of diagnosis in comparison to other such systems in the art, it is not clear if what exactly is responsible for this supposed advantage is claimed or not. Again--- due to the generally of how things are claimed as shown above, there is not considered to be a practical application or significantly more. If there is something more specific associated with the argued supposed “advantages,” it is suggested that applicant claim it.
Lastly with respect to the SMED, applicant argues that at step 2B, the claimed amount to significantly more. The examiner disagrees.
Applicant argues that “determining DDI…using three classes of drugs, by mass spectrometry,” was not WURC. The examiner disagrees. In fact, KIMMERLING evidences of all three of these things as shown above- to demonstrate that they are WURC.
Applicant also argues that the claimed treatment the claimed increasing or decreasing of a drug for drug-drug interaction is distinctly different from other medical context and therefore not WURC. With respect to this--- the examiner notes that so many other options of treatment, including no treatment and other testing are claimed. Therefore, this is not even commensurate in scope with the claims.
Therefore—especially at the level of generality claimed, the claims are not patent-eligible, there is not practical application claimed, nor is there anything which is non-WURC and the 101 rejection is maintained.
The examiner notes that she has considered the claim as a whole--- which applicant seemingly argues that she has not done. With respect to this, the examiner notes that applicant should consider the claim as a whole and especially with respect to how broadly and generally certain claim limitations can be interpreted--specifically with respect to how some of the claimed “first treatment,” and “second treatment,” can be interpreted, and further with respect to how general the determination of DDI is claimed. As claimed it is just claimed as a general comparison (“pairwise”) though the examiner assumes it must be more complicated than this. See the examiners comments with respect to this in the 101 rejection above.
Applicant further argues with respect to the 101 that the claimed that the analysis of “at least three drug classes,” for DDI, by mass spectrometry and then the claimed comparison by processor and computer readable medium is specialized function to be able to identify drug classes and not WURC. The examiner disagrees, as claimed this is just done by mass spectrometry. Mass spectrometry data gathering and identification is WURC. However--- with respect to this, the examiner would like to ask, is there more to this than is being claimed? Is applicant somehow converting the measured values to identify drugs and not just using a single/multiple measurement from the mass spectrometer?
Applicant further argues that the claimed processor and non-transitory computer readable medium are claimed as “configured to,” and that this indicates that it is a specialized computer. The examiner disagrees. As what these claimed elements are “configured to,” do is just a general comparison--- this is still considered a general purpose computer, and not programmed specially in a way which performs something more complicated that can be performed in a human mind.
Applicant further again argues that the claimed treatments are particular and specific. The examiner disagrees for the reasons shown in the above 101 rejection, and again notes that the treatments can seemingly be the same no matter whether DDI is detected or not, the treatment can include no treatment/stoppage of treatment, which is no treatment, and it also can include things like have a patient it more food which is one of the claimed “drugs.” None of these things are particular and specific treatment, for all these reasons in addition to what is shown in the 101 rejection above.
If applicant can remedy the issues with respect to how general the claimed “treatments,” can be interpreted and how exactly the processor and non-transitory computer readable medium is performing the analysis (is it doing more than just a communication between the two parts and general mathematical comparison?) then it might be possible to overcome the 101 rejection.
For the claims as amended 04/08/2026- 101 rejection is maintained.
103
With respect to the prior art, applicant repeatedly argues that the prior art does not teach of the newly amended subject matter from amendments made 04/08/2026. The examiner disagrees. Since this subject matter was newly amended, it is shown how the prior art reads on it, in the rejection above.
Also, within applicant’s arguments about the prior art and the 103 rejection they note—that during the interview dated 01/09/2026 the examiner noted that “Clarifications regarding the processor with respect to the 35 USC 101 rejection would help with overcoming the 35 USC 103 rejection.” With respect to this, while this general statement is true—no amendments were provided during the interview so no decision was reached. As instantly amended 04/08/2026 the 101 rejection is not overcome and neither is the 103 rejection. As claimed, again, the examiner asks if the processor and non-transitory computer readable medium that couples with it, is doing more than just a general comparison.
Applicant argues that the prior art does not teach of the claimed processor and non-transitory computer readable medium which does pairwise comparison to a drug information database. The examiner first notes that this subject matter was amended 04/08/2026, so how the prior art teaches of it is shown in the rejection above. Though the examiner disagrees with applicant’s arguments, and notes the “pairwise,” comparisons and “drug information database,” can be interpreted very broadly through broadest reasonable interpretation.
Specifically, in the prior art for the newly amended subject matter- KIMMERLING teaches of accomplishing the instant method using a computer that has one or more processors with instructions (so processor and non-transitory computer readable medium) that is connected to the detection system, and further teach of using instructions stored on machine readable devices/software (non-transitory computer readable medium) to accomplish this method (paragraph 0070, 0091-0095). Specifically, one thing KIMMERLING teaches can be accomplish using the processor system is that thresholds are determined for these compounds and then determining if the measured values are above or below the thresholds and of outputting potential therapies/making therapy/treatment decision based on this- so “pairwise,” comparison above or below a threshold is performed (paragraph 0043-0044, 0047). KIMMERLING teaches of databases including therapeutic (so therapy or drug) information (paragraph 0007, 0009).
Applicant argues that KIMMERLING teaches of using “in silico,” tools for determining therapies as assessing “in vitro”, but does not argue how this differs from what is instantly claimed. The examiner notes that “in silico,” means “performed on a computer,” and “in vitro,” means outside of the body, but can include a bodily fluid sample analysis. Applicant’s instant method also uses a computer to perform the analysis as claimed, and takes samples from the body. Therefore, it is unclear what applicant means by this argument--- as both the instant method and KIMMERLING seem to teach the same thing with respect to this.
Applicant also argues that the prior art including KIMMERLING, BORISY and DENNIS do not teach of analyzing for “three drug classes,” of “ingested drugs from a prior treatment.”
The examiner disagrees. Specifically, KIMMERLING teaches of monitoring drug interactions and that the drugs are ingested/administered by/to the patient (paragraph 0043, 0006, 0032, 0073)—so these means interactions with different types/classes of drugs. DENNIS also teaches of monitoring multiple different drug classes (including 3 different drug classes) and of monitoring their interactions together (paragraph 0146, 0138).
BORISY teaches of the drug-drug interactions monitoring and specifically of a method of screening for drug-drug interactions using combinational arrays. The method includes the steps of: (a) providing (i) a test drug; (ii) a drug library; and (iii) an assay, (b) contacting the test drug and at least some of the library drugs from the drug library in the assay under conditions that ensure that each test drug/library drug contacting is segregated from the others (abstract).
Applicant argues that DENNIS’s teaching of drug drug interaction of this is “only in the context of the marker.” The examiner notes that DENNIS was used to teach of detection of 3 different classes of drugs, and that KIMMERLING and BORISY already taught of this of what applicant is arguing.
With respect to applicant’s arguments about each reference individually, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant does not make substantive arguments about any other reference or claim.
All claims remain rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20130015346 by Aegis Sciences is also considered to be relevant.
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.
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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.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
Prosecution Insights