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 the 18/634737 RCE application response filed 08/04/2025.
Claims 1-3, 9, 22-23, 30, 63-65, 67, 71, 83 & 137-142 are pending and have fully been examined.
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 1-3, 9, 22-23, 30, 63-65, 67, 71, 83 & 137-142 are directed to non-statutory subject matter.
The invention of instant claims 1-3, 9, 22-23, 30, 63-65, 67, 71, 83 & 137-142 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, the claim 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 Claims 1 & 63. The claimed “identifying,” and “determining,” and “providing results,” steps are an abstract idea performed by a general-purpose computer 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.” As instantly claimed, this step can be mental processes/abstract ideas.
Step 2A, Prong 2- Is the judicial exception integrated into a particular practical application?
For independent Claim 1 & 63, the answer is no.
For the claimed “identifying,” and “determining,” and “providing results,” it is claimed that these steps are performed on a computer, non-transitory computer readable medium,” and a processor and that these items are “configured to perform,” these steps, “wherein the instructions are executed on the processor.” With respect to this 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.
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 treatments, but instead can be further diagnostic or monitoring tests. Therefore- these are considered extra-solution activity.
The treatments claimed in “(ii),” and “(iii),” require administration of increase or decrease in the drug, which can be food and supplements or miscellaneous drugs. Therefore, neither ii or iii are 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 and since there is not specific guidance claimed for which treatment is to be used when. 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 in the 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 amendments dated 08/04/2025 specify that the oral fluid analyzed is obtained from a patient who has ingested a drug, as the same analysis occurs and the pre-treatment 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.
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 Claims 1 & 63 which result 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).
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, and again there is no claimed configuration or programming claimed for how they operate once coupled together.
In addition, the independent claims 1 & 63 also both claim “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.
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.
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, 63-65, 67, 71, 83 & 137-142 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.
Claims 9 & 71 specify 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, & 83 does not change matters as it is stating what is occurring the patient outside of the instant method steps.
Claim 64—specifies how a mental decision is made and therefore does not change matters above.
Claim 65—further specifies what is contained in a list (which can be a mental list) so is still an abstract idea.
Claim 67—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.
Claims 137 & 140 specify 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 & 141 specify 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
Claims 139 & 142 specify 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 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, 63-65, 71, 83, & 138-142 are rejected under pre-AIA 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 further teach that the cancer treatments that are analyzed and monitoring include chemotherapeutics (paragraph 0032-0033). KIMMERLING teach of using mass spectrometry for the analysis (paragraph 0080, 0081, 0084).
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.
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 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).
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 drug obvious since they do not specifically call this out, DENNIS is used to remedy. Further, if it is unclear that KEMMERLING and BORISY teach of analyzing an oral fluid sample for drug compounds with in 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 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 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 Claim 63, 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 (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, and then a subset of therapeutics is identified based on that--- this reads on 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 further teach that the cancer treatments that are analyzed and monitoring include chemotherapeutics (paragraph 0032-0033).
Even further, KIMMERLING teach of the analyzing the metabolome using mass spectrometry which would also show if drugs were present (paragraphs 0083 & 0084).
KIMMERLING teaches of accomplishing the instant method using a computer that has one or more processors 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)- which reads on the instantly claimed parts of these device parts and their “configured to,” functions.
KIMMERLING teach of using mass spectrometry (paragraph 0080, 0081, 0084).
Though the drugs would be present in the analysis of KIMMERLING, since detecting drugs in the sample itself is not specifically called out, BORISY is used to remedy this.
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 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 one or more dug classes) (paragraph 0052, 0050).
BORISY further 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 (which reads on first treatment plan and second treatment plan) (paragraph 0041). BORISY further teaches of adjusting dosages of the treatment (paragraph 0047).
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).
KEMMERLING and BORISY do not call out monitoring adherence versus non-adherence.
DENNIS is 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 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 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).
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 compliance and non-compliance as is done in DENNIS in the methods of KIMMERLING and BORISY due to how dangerous lack of drug adherence is and dude to the fact that lack of drug adherence leads to ineffective medicine (paragraph 0005).
With respect to Claim 64, KIMMERLING and BORISY teaches the method as shown above, but does not call out detecting compliance and adherence. DENNIS teaches that compliance and adherence is dependent upon dose and time intervals given for prescription drugs (paragraph 0005, 0061) and that a list of drug regimens is held in data analyzer (paragraph 0061, 0108) (paragraph 0157, 0155, 0156). See reason for combination from Claim 63.
With respect to Claim 65, KIMMERLING teaches the above shown for Claim 63, but does not call out that the drugs are prescribed. BORISY teaches of the drugs being prescribed (paragraph 0029, 0041, 0047, 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 prescribe and detect prescribed drugs as is done in BORISY in KIMMERLING since most drugs are prescribed.
With respect to Claim 67, KIMMERLING teaches the above shown for Claim 63, but does not call out monitoring therapeutic combinations. 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. See reason for combination from Claims 1 & 63.
With respect to Claim 71, 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 due to the fact that it is a known and commonly used alternative or subcategory for LC MS/MS.
With respect to Claim 83, KIMMERLING teaches the method as shown above, but does not call identifying co- prescribed drugs. 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 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). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to prescribe and detect prescribed drugs as is done in BORISY in KIMMERLING since most drugs are prescribed.
With respect to Claims 137 & 140 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).
With respect to Claim 141, KIMMERLING teaches of performing the method within 48 hours (paragraph 0020).
With respect to Claim 142, KIMMERLING teaches of providing results via an interface module which can include a network interface (paragraph 0091, 0093).
Response to Arguments
Applicant's arguments filed 08/04/2025 have been fully considered but they are not persuasive.
101
The 101 rejection above has been clarified for the amended claims, and in in line with the Prongs set out with respect to the 101 eligibility guidelines set forth in the MPEP.
The examiner disagrees with applicant’s arguments that the instant claims are patent eligible for the reasons shown in the updated rejection as shown above.
Applicant argues that the claims need to be analyzed as “a whole,” to determine eligibility. The examiner maintains that this was done, as shown in the above rejection.
On Pages 5-7 of applicant’s arguments dated 08/04/2025 applicant gives a quick analysis of what they think the answers at particular steps of the 101 analysis should be. The examiner disagrees with applicant’s analysis and maintains the analysis that is shown in the 101 rejection above.
Applicant further argues that they think the instant method requires a particular machine and therefore the claims are patent eligible. The examiner disagrees, as the mass spectrometry is only used for a data pull so is not a particular machine. And also is not significantly more since at the level of generality mass spectrometry use is claimed, it is WURC in the art. This also applies to the claimed computer and processors claimed as “configured to,” perform the claimed “instructions.” As the instructions are so generally claimed though- this does not read on a particularly programmed computer, but instead is a general purpose computer, as shown in the 101 rejection above.
Applicant further argues that the claimed mass spectrometry analyzes “at least three drug classes,” is highly specialized. With respect to this—the examiner points that this claimed analysis of “at least three drug classes,” does not actually require that the drug classes are found to be present, only that analysis of performed and that mass spectrometry will find whatever is present in the oral fluid. Therefore- this is not highly specialized and it seems nothing particular or special is down in effort to separate out or determine presence of specific drug classes. Also, as shown in the rejection above--- the processor and non-transitory medium are not claimed in a way in which they more than a general-purpose computer. Therefore- due to all of these reasons and the reasons shown in the rejection above, there is not particular practical application.
Applicant further argues that the claims include additional elements which make them amount of significantly more than the judicial exceptions the examiner says are present. Applicant argues this with respect to the claimed treatments and further argues that their treatments are not general. The examiner disagrees that there are additional elements which amount to significantly more. This is due to the reasons set forth in the 101 rejection shown above. Specifically, due to the amount and generality of the claimed treatments, they are not particular or specific and also are not significantly more than the judicial exceptions as at the level of generality claimed are all WURC, and since they are not all actually even “treatments,” but instead can be further diagnostic tests or things like food, they are not particular and specific treatments.
Applicant argues that one of ordinary skill in the art would understand that the recited treatment “plans,” are performed based on results of a direct, objective, assessment, and that the instant method leads to improvement over current clinical practice which is subjective, incomplete, or error-ridden. The examiner disagrees with this, and maintains, that if an improvement is present, it is not claimed. Further- the instant claimed treatments are so general--- that they also are subjective. No real guidance is claimed for when to perform the different treatments, and further many of the claimed treatments aren’t even actual treatments. This is shown in the 101 rejection above.
All claims remain rejected under 101.
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 08/04/2025. The examiner disagrees. Since this subject matter was newly amended, it is shown how the prior art reads on it, in the rejection above.
Applicant also argues that there is not reasonable expectation of success, especially with respect to the newly recited subject matter of “ingested drugs from a prior treatment.” The examiner disagrees and maintains that there is reasonable expectation of success as shown in the rejection above.
With respect to the prior art, applicant also argues that the prior art does not teach of the claim limitations, specifically the analyzing, identifying, determining, and implementing steps including, “ analyzing a patient’s oral fluid for analytes of three drug classes using mass spectrometry, identifying a list of drugs recently ingested by the patient based on the analyzing step using instructions stored on a non-transitory computer-readable medium, determining whether any drug-drug interaction (DDI) is present between the drugs in the list using instructions stored on the non-transitory computer-readable medium, and if DDI is present, implementing a first treatment plan that accounts for DDI being identified, or if DDI is not present, implementing a second treatment plan that accounts for DDI not being identified.”
The examiner disagrees. It is shown how the prior art reads on this in the rejection above. Specifically though KIMMERLING in view of BORISY made the list of drugs obvious, DENNIS also teaches of this, in the event there are any questions about this limitation.
With respect to BORISY, applicant seems to argue- though unclearly so, that BORISY does not teach of using an oral fluid sample as instantly claimed. With respect to this--- the examiner will point out that KIMMERLING taught of this as shown above, and a 103 rejection was made, so BORISY does not need to teach of this. Also, DENNIS teaches that “breath,” is a fluid as shown in the rejection above.
Applicant also argues that in DENNIS there are “major limitations,” and “tremendous drawback,” to detection of the actual drug or metabolite in the patient sample (which is what is instantly claimed). Applicant argues that this is a teaching away from the instantly claimed method. The examiner disagrees—and DENNIS still teaches of performing these methods, and that there is reason for combination, as there is, “a dangerous lack of drug adherence is and due to the fact that lack of drug adherence leads to ineffective medicine (paragraph 0005),” and this would hold advantage in that it would be a method to monitor adherence.
Applicant also argues that DENNIS does not adequately teach of monitoring DDI. The examiner disagrees with this (see paragraph 0138 of DENNIS). Further, KIMMERLING already taught this. Specifically, KIMMERLING teaches of determining drug interactions and past efficacy of drug, and then determining a practical new treatment from this (paragraphs 0053-0054).
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).
Further- it is noted that Oath/Declaration submitted 08/21/2025. Applicant makes no arguments with respect to it, and it appear to be only a listing of Trademarks associated with the instant Applicant, Aegis Scientific Corporation. Therefore, the examiner has no comment on this Oath/Declaration, as it does not seem to pertain to matters relevant to the instant pending claims.
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.
period for reply expire later than SIX MONTHS from the date of this final action.
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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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758