DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed 31 March 2026 has been entered. Claim(s) 1, 3 and 6 is/are currently amended. Claim(s) 4 and 7-14 has/have been canceled. New claim(s) 16-22 has/have been added. Claim(s) 1-3, 5-6 and 15-22 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 101, and/or rejections under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Interpretation
As noted in the prior Office action, claim(s) 15 includes at least one limitation that has been interpreted to invoke 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-3, 5-6 and 16-22 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception(s) without significantly more.
Claims 1, 3 and 6 recite/require the steps of comparing the level of at least one compound to a reference level, and diagnosing MDD based on the comparison, or determining MDD is worsening based on the comparison, or determining a patient is responding to treatment of MDD based on the comparison.
These limitations, as drafted, are a process that, under its BRI, cover performance of the limitations in the mind. That is, nothing in the claim elements preclude the step from practically being performed in the mind. For example, comparing a compound(s) level in a breath sample of a subject to a reference level of said compound(s) encompasses a user manually or mentally comparing a pair of numbers indicative of level/concentration of the compound(s) as determined by any known/suitable technique; and diagnosing, determining MDD is worsening, or determining the patient is responding to therapy encompasses a user manually or mentally making a judgement based on the comparison. If claim limitations, under their BRI, cover performance of the limitations in the mind but for the recitation of generic computer components, then they fall within the "mental processes" grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Alternatively/Additionally, said claims recite the naturally-occurring correlation between levels of the recited compounds in a breath sample (or changes in said levels over time) and MDD (or changes, e.g., progression, deterioration, response to treatment, therein over time), with various "wherein" clauses informing relevant users (e.g., doctors) about the relevant natural law indicating that they should consider the determination when making their diagnosis or assessment of patient state or treatment efficacy. This is comparable to concepts identified by the courts as laws of nature of natural phenomena (see MPEP 2106.04(b)(I)), such that the claims alternatively or additionally recite a law of nature or natural phenomenon. Therefore, claims 1-3, 5-6 and 16-22 recite at least one judicial exception.
This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claims recite the additional element of determining the level of at least one of the claimed compounds in a sample of exhaled breath from the patient. The step is highly generic encompassing any/all known or existing processes capable of such a determination and/or any process a user wishes to use, and comparable to steps identified by the courts as insignificant extra-solution activity. See MPEP 2106.05(g). Further, these determinations were well-known in the art at the time the invention was effectively filed, as evidenced by Applicant's disclosure (e.g., pg. 23, line 27 - pg. 24, line 20). Because methods for making the claimed determinations were well-known in the art, the additional element of the claims simply informs the user to engage in well-understood, routine, conventional activity previously engaged in the field, which is not sufficient to transform an unpatentable judicial exception into a patent-eligible application of said judicial exception. New claims 16-22 recite administering therapy upon a diagnosis or continuing or adjusting therapy based on determined progression/worsening of MDD state and/or treatment efficacy, wherein the therapy may be any one of known, existing MDD treatments. Applicant appears to acknowledge said therapies are well-known (i.e., typical) (e.g., pg. 5, lines 6-11), and this is further supported by the prior art of record (see Bahn, ¶ [0005]; "Depression Medicines," mailed herewith; etc.). Accordingly, the limitations of claims 16-22 merely require administering at least one known, existing for MDD based on the diagnosis/determinations in any manner a clinician desires (e.g., at any frequency, dosage, in any combination, etc. he/she feels appropriate), such that the administration step is not "particular," and therefore does not integrate the mental analysis step into a practical application. See MPEP 2106.04(d)(2).
In view of the above, claims 1-3, 5-6 and 16-22 are not patent eligible.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 1-3, 5-6 and 15-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0071340 A1 (previously cited, "Bahn") in view of US 2012/0016252 A1 (previously cited, "Melker") and "Peripheral Metabolic Abnormalities of Lipids and Amino Acids Implicated in Increased Risk of Suicidal Behavior in Major Depressive Disorder" (previously cited, "Zheng '13").
Regarding claim 1, Bahn discloses/suggests a method of diagnosing a MDD in a patient (Abstract; ¶ [0010]; etc.), the method comprising:
determining the level of at least one compound in a sample of exhaled breath from a patient (¶¶ [0011]-[0012] obtaining a biological sample from an individual, and quantifying the amounts of analyte biomarkers the sample; ¶ [0022] where the biological sample may be breath);
comparing the level of the at least one compound to a reference level of the at least one compound determined from at least one reference sample of exhaled breath obtained from at least one healthy subject (¶ [0013] comparing the amounts of the analyte biomarkers in the biological sample with the amounts present in a normal control biological sample from a normal subject, such that a difference in the level of the analyte biomarkers in the biological sample is indicative of major depressive disorder, or predisposition thereto); and
determining the patient has a MDD based on the comparison (¶ [0013] a difference in the level of the analyte biomarkers in the biological sample is indicative of major depressive disorder, or predisposition thereto).
Bahn does not disclose the at least one compound is selected from the group consisting of methylguanidine, lactic acid, butyric acid, tetrahydro-tiaphene, putrescine, acetamide, isoprene, toluene, and acetonitrile, but does disclose/suggests additional analyte biomarkers found to be significantly different between MDD and healthy controls (e.g., ¶¶ [0029]-[0039]).
Melker discloses determining the level of at least lactic acid in a sample of exhaled breath from a patient, wherein the level in the breath is correlated to the level in blood (e.g., ¶ [0061]). Melker further discloses lactic acid level is an indicator of numerous disease states, including acute and/or chronic stress (¶¶ [0035]-[0036]).
Zheng '13 discloses metabolites in blood, including lactate and other lipid metabolism-related molecules, are lower in MDD with increased risk of suicide than MDD with lower risk of suicide and/or than healthy controls (e.g., pg. 691).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Bahn with the biomarkers including lactic acid, and determining the patient has a MDD the level of lactic acid is below the reference level as taught/suggested by Melker and Zheng '13 in order to increase the effectiveness and/or sensitivity of the diagnosis by considering additional biomarkers that have found to be significantly altered between MDD and controls (Bahn, ¶¶ [0029]-[0039]; Zheng '13, pg. 691), to facilitate identifying MDD subjects with increased suicide risk (Zheng '13, pg. 691), etc. without requiring an additional and/or different type of biological sample from patient (e.g., Melker, ¶ [0061]).
Regarding claim 3, Bahn discloses/suggests a method of determining the course of a MDD in a patient comprising the step of:
determining the level of at least one compound in a sample of exhaled breath obtained from the patient at a first time point (¶¶ [0011]-[0012] obtaining a biological sample from an individual, and quantifying the amounts of analyte biomarkers the sample; ¶ [0022] where the biological sample may be breath) and in at least one further sample of exhaled breath obtained from the patient at a later time point (e.g., ¶¶ [0070]-[0077] detecting and/or quantifying the biomarker(s) in a biological sample from a test subject may be performed on two or more occasions);
comparing the level determined at the later time point to the level determined at the first time point; and determining if the MDD worsens, is stable, or improves based on the comparison (e.g., ¶¶ [0070]-[0077] monitoring the state, e.g., progression or amelioration, of MDD; ¶¶ [0080]-[0086] monitoring efficacy of therapy; ¶¶ [0070]-[0077] an increase in the level of the biomarker, over time is indicative of onset or progression, i.e. worsening of this disorder, whereas a decrease in the level of the peptide biomarker indicates amelioration or remission of the disorder, or vice versa; ¶¶ [0080]-[0086] e.g., for biomarkers which are decreased in patients with MDD, an increase in the level of the biomarker in the test sample relative to the level in a previous test sample taken earlier from the same test subject is indicative of a beneficial effect, e.g. stabilisation or improvement, of said therapy on the disorder).
Bahn does not disclose the at least one compound is selected from the group consisting of methylguanidine, lactic acid, butyric acid, tetrahydro-tiaphene, putrescine, acetamide, isoprene, toluene, and acetonitrile, but does disclose/suggest additional analyte biomarkers found to be significantly different between MDD and healthy controls (e.g., ¶¶ [0029]-[0039]). Additionally, as noted above, Bahn discloses, for biomarkers which are decreased in patients with MDD, an increase in the level of the biomarker in the test sample relative to the level in a previous test sample taken earlier from the same test subject is indicative of amelioration or improvement of the disorder (e.g., ¶ [0074]; ¶ [0084]; etc.).
Melker discloses determining the level of at least lactic acid in a sample of exhaled breath from a patient, wherein the level in the breath is correlated to the level in blood (e.g., ¶ [0061]). Melker further discloses lactic acid level is an indicator of numerous disease states, including acute and/or chronic stress (¶¶ [0035]-[0036]).
Zheng '13 discloses metabolites in blood, including lactate and other lipid metabolism-related molecules, are lower in MDD with an increased risk of suicide than MDD with a lower risk of suicide and/or than healthy controls (e.g., pg. 691).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Bahn with the biomarkers including lactic acid, wherein the level of lactic acid decreasing over time indicates that the MDD worsens in the patient, not changing over time indicates that the MDD does not worsen/is stable, and/or increasing over time indicates that the MDD improves, as taught/suggested by Melker and Zheng '13 in order to increase the effectiveness/sensitivity of the monitoring by considering additional biomarkers that have found to be significantly altered between MDD and controls (Bahn, ¶¶ [0029]-[0039]; Zheng '13, pg. 691), to facilitate monitoring changes in suicide risk for the patient (Zheng '13, pg. 691), etc. without requiring an additional and/or different type of biological sample from patient (e.g., Melker, ¶ [0061]).
Regarding claim 5, Bahn as modified discloses/suggests the patient receives, has received, or had received a treatment of a MDD (¶¶ [0080]-[0086] monitoring efficacy of therapy), wherein the treatment of a MDD is selected from the group consisting of the administration of a drug, psychotherapy, exercise training, cognitive training, and physical rehabilitation (e.g., ¶ [0086] anti-depressant therapy).
Regarding claim 6, Bahn discloses/suggests a method of determining whether a patient responds to a therapeutic treatment of a MDD (e.g., ¶¶ [0080]-[0086] monitoring efficacy of therapy) comprising the step of:
determining the level of at least one compound in a sample of exhaled breath obtained from a patient (¶¶ [0011]-[0012] obtaining a biological sample from an individual, and quantifying the amounts of analyte biomarkers the sample; ¶ [0022] where the biological sample may be breath) to whom the therapeutic treatment has been/is administered after at least the first administration of the therapeutic treatment (e.g., ¶ [0086] samples may be taken prior to and/or during and/or following an anti-depressant therapy);
comparing the level of the at least one compound to a reference level of the at least one compound determined from a reference sample of exhaled breath obtained from the patient prior to the administration of the therapeutic treatment; and determining if the patient is responding to the therapeutic treatment based on the comparison (e.g., ¶¶ [0080]-[0086] detecting and/or quantifying the biomarker level present in a biological sample from said subject from test samples taken on two or more occasions and comparing the level of the biomarker(s) present in the test sample with one or more previous test sample(s) taken earlier from the same test subject, e.g. prior to commencement of therapy, and/or from the same test subject at an earlier stage of therapy), wherein a change, e.g., increase, in the level of the compound relative to the reference level indicates that the patient has responded to said treatment (¶¶ [0080]-[0086] for biomarkers which are decreased in patients with MDD, an increase in the level of the biomarker in the test sample relative to the level in a previous test sample taken earlier from the same test subject is indicative of a beneficial effect, e.g. stabilisation or improvement, of said therapy on the disorder, suspected disorder or predisposition thereto).
Bahn does not disclose the at least one compound is selected from the group consisting of methylguanidine, lactic acid, butyric acid, tetrahydro-tiaphene, putrescine, acetamide, isoprene, toluene, and acetonitrile, but does disclose/suggest additional analyte biomarkers found to be significantly different between MDD and healthy controls (e.g., ¶¶ [0029]-[0039]). Additionally, as noted above, Bahn discloses, for biomarkers which are decreased in patients with MDD, an increase in the level of the biomarker(s) in the test sample relative to the level in a previous test sample taken earlier from the same test subject is indicative of a beneficial effect of therapy (e.g., ¶ [0084]).
Melker discloses determining the level of at least lactic acid in a sample of exhaled breath from a patient, wherein the level in the breath is correlated to the level in blood (e.g., ¶ [0061]). Melker further discloses lactic acid level is an indicator of numerous disease states, including acute and/or chronic stress (¶¶ [0035]-[0036]).
Zheng '13 discloses metabolites in blood, including lactate and other lipid metabolism-related molecules, are lower in MDD with an increased risk of suicide than MDD with a lower risk of suicide and/or than healthy controls (e.g., pg. 691).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Bahn with the biomarkers including lactic acid, wherein a level of lactic acid above the reference level indicates the patient is responding to said treatment as taught/suggested by Melker and Zheng '13 in order to increase the effectiveness and/or sensitivity of the monitoring by considering additional biomarkers that have found to be significantly altered between MDD and controls (Bahn, ¶¶ [0029]-[0039]; Zheng '13, pg. 691), to facilitate monitoring efficacy of the treatment relative to suicide risk (Zheng '13, pg. 691), etc. without requiring an additional or different type of biological sample from patient (e.g., Melker, ¶ [0061]).
Regarding claim 15, Bahn as modified with respect to claim 1 discloses/suggests a kit comprising:
a device that comprises:
an inlet for receiving exhaled breath (inherent to and/or at once envisaged for embodiments in which the biological sample is breath, as discussed below); and
an analysis unit configured to analyze exhaled breath (¶¶ [0011]-[0012] obtaining a biological sample from an individual, and quantifying the amounts of analyte biomarkers the sample; ¶ [0022] where the biological sample may be breath; ¶ [0092] where said quantifying can be performed by any number of known techniques/analyzers), wherein the analysis comprises the determination of the level of at least one compound in a sample of exhaled breath obtained from a patient (¶¶ [0011]-[0012] obtaining a biological sample from an individual, and quantifying the amounts of analyte biomarkers the sample; ¶ [0022] where the biological sample may be breath), wherein the at least one compound includes at least lactic acid (see rejection of claim 1 above); and
instructions for a user to use the device by the method of claim 1 (e.g., ¶ [0023] instructions for use in accordance with any of the methods defined herein).
While Bahn does not explicitly describe an "inlet," one of ordinary skill in the art would readily appreciate a means must exist to introduce the obtained breath sample to the analyzer (i.e., Bahn implicitly discloses an inlet). Alternatively/Additionally, Melker more expressly discloses and/or suggests a comparable device comprising (i) an inlet for receiving exhaled breath (¶¶ [0129]-[0130] means for interfacing a patient or a previously-collected breath sample with a sensor/analyzer), such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bahn to comprise an inlet for receiving exhaled breath as taught/suggested by Melker in order to facilitate providing a collected breath sample to the analysis unit.
Regarding claims 16-18, Bahn as modified discloses/suggests the limitations of claim 1, as discussed above, but does not expressly disclose the method comprises upon determining the patient has a MDD, administering to the patient a therapeutic treatment comprising antidepressant administration, psychotherapy, exercise training, cognitive training, or physical rehabilitation. However, Bahn does disclose it is well-known in the art that most patients, upon diagnosis of MDD, are treated with anti-depressant medication, including citalopram, escitalopram, paroxetine, sertraline, fluoxetine, venlafaxine, duloxetine, milnaciprame, bupropion or mirtazapine; psychotherapy, including electroconvulsive therapy; and/or counseling (e.g., ¶ [0005] most patients are treated with ECT, counseling and/or known/existing antidepressant medications, which one of ordinary skill in the art would readily appreciate encompasses at least one of the recited medications, as evidenced by "Depression Medicines" mailed herewith, e.g., pgs. 5-14). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Bahn with, upon determining the patient has a MDD, administering to the patient a therapeutic treatment comprising antidepressant administration including at least one of the recited medications of claim 18 and/or psychotherapy including ECT in order to facilitate identifying the most appropriate treatment for a subject (Bahn, ¶ [0079]).
Regarding claim 19, Bahn as modified discloses/suggests the limitations of claim 6, as discussed above, and further discloses/suggests, upon determining the patient responds to the therapeutic treatment, continuing administration of the therapeutic treatment or reducing dosage of the therapeutic treatment; or upon determining the patient does not respond to the therapeutic treatment, increasing dosage of the therapeutic treatment or changing type or mode of the therapeutic treatment (e.g., ¶¶ [0084]-[0085] monitoring the therapeutic effectiveness of existing therapies, e.g., ¶ [0126] fine-tuning dosage or determining optimal dose), wherein the therapeutic treatment comprises antidepressant administration, such as citalopram, escitalopram, paroxetine, sertraline, fluoxetine, venlafaxine, duloxetine, milnaciprame, bupropion, or mirtazapine; and/or psychotherapy, such as ECT (¶ [0005] where existing therapies include ECT, counseling and/or known/existing antidepressant medications, which one of ordinary skill in the art would readily appreciate encompasses at least one of the recited medications, as evidenced by "Depression Medicines" mailed herewith, e.g., pgs. 5-14).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to eligibility under 35 U.S.C. 101, Applicant contends, "Even assuming the correlation between each of the 9 compounds with the presence and/or status of MDD is properly characterized as a judicial exception, Applicant contends that the selection of these 9 particular compounds and their use in the context of diagnosing a MDD, determining the course of a MDD, or determining whether a patient responds to a MDD therapy must be recognized as 'significantly more.' Indeed, no prior publication has been identified for disclosing the exact same selection and usage of these 9 compounds in the same context. Thus, the selection and usage of the 9 compounds in these applications is both novel and non-obvious, in other words, it mounts [sic] to 'significantly more'" (Remarks, pg. 7).
The examiner respectfully disagrees. As noted in MPEP 2106.04(I), court decisions make it clear that judicial exceptions need not be old or long-prevalent, and that even newly discovered or novel judicial exceptions are still exceptions.
Applicant further submits additional treatment steps are now recited in the newly added claims (Remarks, pg. 7), presumably implying that said treatment steps amount to a practical application of the recited judicial exception(s).
The examiner respectfully disagrees the reasons noted in the rejection of record above. The limitations of claims 16-22 merely require administering at least one known, existing for MDD based on the diagnosis/determinations in any manner a clinician desires (e.g., at any frequency, dosage, in any combination, etc. he/she feels appropriate), such that the administration step is not "particular," and therefore does not integrate the mental analysis step into a practical application.
With respect to the prior art rejections under 35 U.S.C. 103, regarding claims 1, 3 and 6, Applicant contends, "Even if a skilled person is to interpret the teaching of Bahn, Melker, and Zhang as proposed by the Examiner, at best the three references together provide the skilled person a motivation to try using lactic acid in a patient's exhaled breath as a biomarker for the presence and/or severity of a MDD. The motivation to try alone, however, is insufficient to meet the requirements for establishing prima facie obviousness, unless a reasonable expectation of success can be shown. As it is well known to those of skill in the diagnostic field, biomarkers for disease diagnosis, disease monitoring, or assessing patient responsiveness to disease therapy are highly unpredictable in their performance. Only after actual experimentation can one learn for certain whether a proposed biomarker in fact is useful for its intended purpose. In other words, the very nature of diagnostic biomarkers would have precluded any reasonable expectation of success before the present invention was completed" (Remarks, pg. 9).
Applicant's references to "Zhang" are presumed to refer to Zheng '13, relied on in the rejection of record. Even assuming the cited prior art only provides a motivation to try as Applicant contends, which the examiner does not concede, the examiner respectfully disagrees. In the present case, there is a reasonable expectation of success. "Obviousness does not require absolute predictability of success." In re O'Farrell, 853 F.2d 903, 7 USPQ2d 1681. Zheng '13 discloses metabolites in blood, including lactate and other lipid metabolism-related molecules, are lower in MDD with increased risk of suicide than MDD with lower risk of suicide and/or than healthy controls (e.g., pg. 691), indicating that experimentation has been done that at least suggests lactic acid levels are indicative of MDD and/or a degree of MDD. Melker discloses the level of lactic acid in breath samples is correlated with lactic acid levels in blood (e.g., ¶ [0061]). Accordingly, there is a reasonable expectation that lactic acid levels in breath are similarly lower in MDD with increased risk of suicide than MDD with lower risk of suicide and/or than healthy controls.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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