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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 15 September 2026 has been entered.
Status of Claims
Claim(s) 1, 3 and 6 is/are currently amended. Claim(s) 2, 4 and 7-14, 16, 19-20 has/have been canceled. New claim(s) 23-24 has/have been added. Claim(s) 1, 3, 5-6, 15, 17-18 and 21-24 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 101 not reproduced has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.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(s), 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 Objections
Claim(s) 1, 3 and 6 is/are objected to because of the following informalities: "wherein the method further comprising" in each of the claims should either be amended/corrected to "wherein the method further comprises" or the "wherein" removed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 5-6, 17-18, 21-22, 24 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claims 5 and claims dependent thereon, the limitation "wherein the patient receives, has received, or had received a treatment of a MDD, 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" is indefinite in view of the amendments to claim 3. Claim 3 indicates a therapeutic treatment is administered upon determining that the MDD worsens in the patient. In view of said limitation, it is unclear if the limitations of claim 5 are intended to limit the determination to (i) or (iv) (i.e., determining the MDD worsens in the patient), i.e., the patient is limited to those patients in which, upon determining that the MDD worsens in said patient, a therapeutic treatment was administered, or is intended to indicate the patient had received a treatment of MDD prior to the sample of exhaled breath being obtained for analysis.
Regarding claims 6 and claims dependent thereon, the limitation "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" is indefinite. The claimed method requires the step of determining the patient responds to the therapeutic treatment upon particular conditions being met, such that it is unclear how and/or under what circumstances the above-noted condition is or would be met.
Regarding claims 17-18 and claims dependent thereon, the claims are dependent upon a canceled claim, claim 16, and are therefore indefinite. Claims 17-18 will be further discussed with the understanding they are each dependent on claim 1.
Regarding claims 21-22, claim 24 and claims dependent thereon, each claim is dependent upon a canceled claim, claim 20, and is therefore indefinite. Claims 21-22 and 24 will be further discussed with the understanding they are each dependent on claim 6.
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) 3 and 5 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception(s) without significantly more.
Claim 3 recites/requires the steps of comparing the level of at least one compound in a sample of exhaled breath obtained from a patient to a reference level, and determining if MDD in the patient is worsening, stable, or improving 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 steps 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 determining MDD is worsening, stable or improving 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), informing relevant users (e.g., doctors) about the relevant natural law indicating that they should consider the determination when making their assessment of the MDD state. 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 3 and 5 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. Further, while claim 3 recites therapy is administered when a certain condition is met (i.e., upon determining that the MDD worsens in the patient), claim 3 can be practiced without said condition being satisfied (e.g., by determining the patient's MDD is stable or by determining the patient's MDD is improving). In such instances, the claim does not require any therapeutic treatment to be administered. Accordingly, because claim 3 does not require a practical application of the recited judicial exception(s), claim 3 and 5 are not patent eligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2022/0039690 A1 (Rigas).
Regarding claim 15, the examiner first notes the limitation "instructions for a user to use the device by the method of claim 1" is directed to printed matter, i.e., the content of information. Because the printed matter and claimed device do not depend upon each other, no functional relationship exists. Accordingly, the printed matter is given no patentable weight. See MPEP 2111.05.
Rigas discloses a kit comprising: a device (Figs. 1-3, 9, etc., breath analyzer 10) that comprises: (i) an inlet for receiving exhaled breath (mouthpiece 12; ¶ [0077]); and (ii) an analysis unit configured to analyze the exhaled breath (main body 14 including a gas sensor(s) 50, a processor 22, etc.), wherein the analysis comprises the determination of the level of at least one compound in a sample of exhaled breath obtained from a patient (e.g., ¶ [0288]), and wherein 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 (e.g., ¶ [0262]); and instructions for a user to use the device (e.g., ¶ [0159] breath analyzer 10 will include instructions for the subject undergoing testing so as to allow the subject to interpret displayed results).
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, 15, 17-18 and 21-22 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 claims 1 and 17-18, 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]).
Bahn as modified 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 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); and
upon determining that the MDD worsens in the patient, administering to the patient a therapeutic treatment comprising antidepressant administration, psychotherapy, exercise training, cognitive training, or physical rehabilitation (e.g., ¶¶ [0084]-[0085] monitoring the therapeutic effectiveness of existing therapies, e.g., ¶ [0126] fine-tuning dosage or determining optimal dose).
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 claims 6 and 21-22, 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); and
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).
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.
Claim(s) 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bahn in view of Melker and Zheng '13 as applied to claim(s) 1 and 6 above, and further in view of US 20190271685 A1 (previously cited, "Haick").
Regarding claims 23-24, Bahn as modified discloses/suggests the limitations of claims 1 and 6, as discussed above, but does not disclose determining the level of at least two compounds in the sample of exhaled breath obtained from the patient, wherein the at least two compounds are selected from the group consisting of methylguanidine, lactic acid, butyric acid, tetrahydro-tiaphene, putrescine, acetamide, isoprene, toluene, and acetonitrile.
Haick discloses and/or suggests a method comprising determining the level of at least two compounds in the sample of exhaled breath obtained from a patient, wherein the at least two compounds are selected from the group consisting of methylguanidine, lactic acid, butyric acid, tetrahydro-tiaphene, putrescine, acetamide, isoprene, toluene, and acetonitrile (Abstract).
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(s) of Bahn with determining the level from the universal biomarker set disclosed by Haick, which includes at least two compounds selected from the group consisting of methylguanidine, lactic acid, butyric acid, tetrahydro-tiaphene, putrescine, acetamide, isoprene, toluene, and acetonitrile, in the sample of the exhaled breath obtained from the patient, in order to permit detection, monitoring, etc. of more than one disease/disorder of the patient (Haick, ¶ [0058]).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to the prior art rejections, Applicant contends the cited references "at best provide a person of ordinary skill in the art a motivation to try using lactic acid in a patient's exhaled breath as a potential biomarker for the presence and/or severity of MDD. However, a motivation to try alone is insufficient to meet the requirements for establishing prima facie obviousness, unless a reasonable expectation of success can be shown," asserting, "the inherently unpredictable nature of diagnostic biomarker research would have precluded any reasonable expectation of success in identifying the claimed biomarker as useful for its intended purpose prior to Applicant's claimed methods" (Remarks, pgs. 9-10).
The examiner respectfully disagrees. "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 blood 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 at least 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.
Allowable Subject Matter
The prior art of record fails to disclose/suggest, in combination with the remaining recited steps, comparing at least two of methylguanidine, lactic acid, butyric acid, tetrahydro-tiaphene, putrescine, acetamide, isoprene, toluene, and acetonitrile to their respective reference levels; and determining a patient has MDD, or determining a patient is responding to therapeutic treatment of MDD, based on at least two of the detections as set forth in claims 1 and 6, respectively. Accordingly, claims 23 and 24 would be allowable if amended to recite not only determining at least two of the claimed compounds in the breath sample, but also comparing the levels of each of said at least two compounds to a respective reference level as set forth in claims 1 and 6, and determining the patient has MDD or determining a patient is responding to therapeutic treatment of MDD upon at least two of the detections as set forth in claims 1 and 6.
Conclusion
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.
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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
