DETAILED ACTION
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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 114 – 116, and 128 – 137 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
Regarding claims 114 – 116, and 128 – 137, Terwey’851 teach the treatment of mental disorders, in particular major depressive disorder, persistent depressive disorder, anxiety disorder, posttraumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorder and psychoactive substance abuse, comprising administering to a patient in need thereof a therapeutically effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT). See page 1 paragraph 1. See claim 114 limitation for a method of treating anxiety comprising administering 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT). Moreover, Terwey’851 teach that in a randomized, double-blind, cross-over trial comparing a very low placebo-like single dose of psilocybin, an alternative psychedelic, with a high single dose in 51 cancer patients with anxiety and/or mood symptoms, the high dose produced large decreases in clinician- and self-rated measures of depression, anxiety or mood disturbances and increases in measures of quality of life at five weeks after treatment, and these effects were sustained at 6-months. See page 6 paragraph 2. Additionally, Terwey’851 teach the disorder may be diagnosed in accordance with the Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition (DSM-5) published by the American Psychiatric Association. See page 2 paragraph 3.
Moreover, Terwey’851 teach that the patient may suffer from moderate or severe major depressive disorder as indicated by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or more or by a Hamilton Depression Rating Scale (HAM-D) score of 17 or more or the patient may suffer from severe major depressive disorder as indicated by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 35 or more or by a Hamilton Depression Rating Scale (HAM-D) score of 25 or more. See page 2 paragraph 1. Furthermore, Terwey’851 teach that 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via intravenous, intramuscular or subcutaneous administration. See page 2 paragraph 3. See claim 114 limitation for a method where the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. See claim 135 limitation for a method where the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via intravenous injection.
Additionally, Terwey’851 teach that treatment of patients with anxiety disorder includes, but is not limited to, patients with panic disorder, phobic anxiety disorders, social anxiety disorder and generalized anxiety disorder. See page 18 paragraph 1. Moreover, Terwey’851 teach embodiments where the treatment of patients with an anxiety disorder results in a clinical response, as assessed by at least a score of "much improved" in the Clinical Global Impression - Improvement (CGl-I) score or the Patient Global Impression – Improvement (PGl-I) score, occurs not later than about 2 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. See page 41 paragraph 4. Terwey’851 teach embodiments where the treatment of patients with an anxiety disorder results in a clinical response, as assessed by at least a score of "much improved" in the CGl-I score or the PGl-I score, persists until at least 6 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. See page 41 paragraph 5.
Terwey’851 teach that the oral administration of 12 mg of 5-MeO-DMT to 2 patients with treatment resistant major depressive disorder showing no adequate improvement to at least two adequate courses of pharmacological therapy in the current episode of depression. See page 97 Example 2 Clinical trial. See claim 115 limitation for a method where the patient is also suffering from a mental or nervous system disorder. See claim 116 limitation for a method where the mental or nervous system disorder is a treatment resistant for of the mental or nervous system disorder. See claim 128 limitation for a method where the 5-MeO-DMT or the pharmaceutically acceptable salt thereof is administered one to six administrations within 24 hours. Thus, Terwey’851 teach at least two patients where the patient has been diagnosed with treatment resistant major depressive disorder associated with anxiety in a current major depressive episode. Furthermore, Terwey’851 teach that the patients also improved on their ratings for suicidality after drug administration, as assessed using the suicidal thoughts item of the MADRS and the C-SSRS Suicidal Ideation items and other general psychiatric symptoms as assessed by the BPRS, e.g., somatic concern, anxiety, guilt and tension, also improved after the drug administration. See page 99 paragraph 3. Additionally, Terwey’851 teach that both reported a major improvement of their depressive symptoms as assessed by the MAD RS, PGI-S and PGl-I already at the first assessment time point at 2 hours after drug administration, with the effect further deepening over time. See pages 99 – 100 Table 4.
Moreover, Terwey’851 teach that both patients fulfilled standard criteria for MADRS response (at least 50% improvement from baseline) and MADRS remission (MADRS total score equal or less than 10), rated "Normal, not at all ill" on the PGI-S and reported that their depressive symptoms had "very much improved" or "much improved" on the PGl-I at all assessment time points after drug administration, which is a highly surprising result. See pages 99 – 100 Table 4. Furthermore, Terwey’851 teach that both patients’ other general psychiatric symptoms as assessed by the BPRS, e.g., somatic concern, anxiety, guilt and tension, also improved after the drug administration. In particular, Terwey’851 teach the treatment of Patient 1 in particular that scored the highest score of 7 for anxiety using the BPRS at baseline that reduced to 2 by 2 hr post the last administration then 1 on day 1 and 7. See pages 99 – 100 Table 4. Thus, Terwey’851 teach a patient where the patient has been diagnosed with treatment resistant major depressive disorder associated with anxiety.
In particular, Terwey’851 teach the intramuscular administration of 2 mg of 5-MeO-DMT in patients with treatment resistant major depressive disorder. See page 111 Example 6 Clinical trial prophetic example. See claim 115 limitation for a method where the patient is also suffering from a mental or nervous system disorder. See claim 116 limitation for a method where the mental or nervous system disorder is a treatment resistant for of the mental or nervous system disorder. See claim 128 limitation for a method where the 5-MeO-DMT or the pharmaceutically acceptable salt thereof is administered one to six administrations within 24 hours. Furthermore, Terwey’851 teach that in case a peak psychedelic experience (defined as at least 60% of the maximum possible score in each of the 4 subscales of the MEQ30 or at least a PPEQ Total Score of 75) occurred, the patient can be discharged, but at the earliest two hours after the last dose. See page 113 paragraph 1. See claim 132 limitation for a method where the interval between two administrations is 1 to 2 hours.
Additionally, Terwey’851 teach that if no peak psychedelic experience occurred, a higher dose of 5-MeO-DMT or placebo, now 5 mg, will be administered at 3 hours after the first dose according to the same procedure as for the first dose; a third dose, now 8 mg, can be given after another 3-hour interval, if no peak psychedelic experience has been achieved and no intolerable side effects have occurred with any of the prior doses. See page 113 paragraph 1. See claim 129 limitation for a method where each administration after the first administration uses a dosage amount higher than the previous psychedelic experience. See claim 130 limitation for a method where the patient receives a subsequent administration unless the patient experiences a peak psychedelic experience. See claim 131 limitation for a method where the interval between two administration is between 1 to 4 hours.
Moreover, Terwey’851 teach that the patients in the example 6 study will have follow-up visits on days 7, 14, and 28 after the last dose of study medication where efficacy and safety evaluations will be performed at each of those visits. See page 113 paragraph 2. Additionally, Terwey’851 teach that the primary endpoint of the study will be the change from baseline to day 7 in the MADRS total score. See page 113 paragraph 2. Terwey’851 teach that key secondary endpoints will be the sustained response in the MADRS total score (50% reduction from baseline in MADRS total score) at day 28 and the change from baseline in the 16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16) on day 7 and 28. See page 113 paragraph 2. Further, Terwey’851 teach that other efficacy assessments include achievement of remission, defined as a MADRS total score <=10, the Hamilton Depression Rating scale (HAM-D), the Clinical Global Impression - Severity (CGI-S) and the Patient Global Impression – Severity (PGI-S), and Generalized Anxiety Disorder 7-item Scale (GAD-7). See page 113 paragraph 2. Likewise, Terwey’851 teach that all endpoints will be assessed at each time point by a trained rater who is blinded for the assigned treatment group. See page 113 paragraph 2.
Specifically, Terwey’851 teach the intravenous administration of 1 mg of 5-MeO-DMT HCl salt with midazolam in patients in patients with treatment resistant anxiety disorders. See page 114 Example 7 Clinical trial prophetic example. See claim 114 for a method of treating anxiety in a patient comprising administering 5-MeO-DMT intravenously. See claim 115 limitation for a method where the patient is also suffering from a mental or nervous system disorder. See claim 116 limitation for a method where the mental or nervous system disorder is a treatment resistant for of the mental or nervous system disorder. Additionally, terway’851 teach that baseline assessments for the primary endpoint (the Hamilton Anxiety Scale (HAM-A)) and all relevant secondary endpoints will be performed by a trained rater who is blinded for the assigned treatment group. See page 115 paragraph 1. See claim 136 limitation for a method where the anxiety is measured using the Hamilton Anxiety Rating Scale (HAM-A).
Terwey’851 teach that after the subjective symptoms have subsided in both groups, the intensity of the subjective experience will be assessed by evaluating responses to the 30-item revised Mystical Experience Questionnaire (MEQ30) and the Peak Psychedelic Experience Questionnaire (PPEQ). See page 115 paragraph 2. See claim 128 limitation for a method where the 5-MeO-DMT or the pharmaceutically acceptable salt thereof is administered one to six administrations within 24 hours. See claim 133 limitation for a method further comprising identifying an occurrence of the peak psychedelic experience through achievement of at least 60% of the maximum possible score in each of a mystical subscale, a positive mood subscale, a transcendence of time and space subscale, and an ineffability subscale, of the 30-item revised Mystical Experience Questionnaire (MEQ3 0). See claim 134 limitation for a method further comprising identifying an occurrence of the peak psychedelic experience through achievement of a Peak Experience Scale (PES) Total Score of at least 75.
Furthermore, Terwey’851 teach that in case a peak psychedelic experience (defined as at least 60% of the maximum possible score in each of the 4 subscales of the MEQ30 or at least a PPEQ Total Score of 75) occurred, the patient can be discharged, but at the earliest two hours after the last dose. See page 115 paragraph 2. See claim 132 limitation for a method where the interval between two administrations is 1 to 2 hours. See claim 137 limitation for a method where the 5-MeO-DMT or the pharmaceutically acceptable salt thereof is administered at a dose or in a dosage regimen sufficient to result in the patient having a peak psychedelic experience.
Additionally, Terwey’851 teach that if no peak psychedelic experience occurred, a higher dose of 5-MeO-DMT or placebo, now 2 mg, will be administered at 3 hours after the first dose according to the same procedure as for the first dose; a third dose, now 3 mg, can be given after another 3-hour interval, if no peak psychedelic experience has been achieved and no intolerable side effects have occurred with any of the prior doses. See page 113 paragraph 1. See claim 129 limitation for a method where each administration after the first administration uses a dosage amount higher than the previous psychedelic experience. See claim 130 limitation for a method where the patient receives a subsequent administration unless the patient experiences a peak psychedelic experience. See claim 131 limitation for a method where the interval between two administration is between 1 to 4 hours.
Moreover, Terwey’851 teach that the patients in the example 7 study will have follow-up visits on days 1, 7, 14, and 28 after the last dose of study medication where efficacy and safety evaluations will be performed at each of those visits. See page 113 paragraph 2. Additionally, Terwey’851 teach that the primary endpoint of the study will be the change from baseline to day 28 in the HAM-A total score. See page 115 paragraph 3. Terwey’851 teach that key secondary endpoints will be the change from baseline to day 1, 7, 14 and 28 in Clinical Global Impression - Improvement (CGlI) and Patient Global Impression - Improvement (PGl-I). See page 115 paragraph 3. Further, Terwey’851 teach that other efficacy assessments include achievement of remission, defined as a MADRS total score <=10, the Hamilton Depression Rating scale (HAM-D), the Clinical Global Impression - Severity (CGI-S) and the Patient Global Impression – Severity (PGI-S), and Generalized Anxiety Disorder 7-item Scale (GAD-7). See page 113 paragraph 2. Likewise, Terwey’851 teach that all endpoints will be assessed at each time point by a trained rater who is blinded for the assigned treatment group. See page 115 paragraph 3.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 121 – 127 are rejected under 35 U.S.C. 103 as being unpatentable over by International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
The teachings of Terwey’851 as they relate to claim 124, from which claims 121 – 127 depend, are given previously in this office action and are fully incorporated here.
However, Terwey’851 fails to teach a method where the treatment reduces or eliminates anxiety. See claim 121 limitation. Terwey’851 fails to teach a method where the reduction or elimination of the anxiety is observed on day 7 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof; where the reduction or elimination of the anxiety is observed on day 1 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof; where the treatment leads to an improvement in the diagnosed disorder in a patient; where the improvement in the diagnosed disorder in a patient, as reflected by a reduction in the Clinical Global Impression - Severity (CGI-S) score, is observed 2 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof; where the improvement in the diagnosed disorder in a patient, as reflected by a reduction in the Clinical Global Impression - Severity (CGI-S) score, is observed on day 1 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof; and where the improvement in the diagnosed disorder in a patient, as reflected by a reduction in the Clinical Global Impression - Severity (CGI-S) score, is observed on day 7 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. See claims 122 – 127 limitations.
Nevertheless, as taught above, Terwey’851 does teach prophetic examples 6 and 7 for future clinical trials for treating treatment resistant major depressive disorder and treatment resistant anxiety disorder. Moreover, Terwey’851 teach Terwey’851 teach that the primary endpoint of the study will be the change from baseline to day 28 in the HAM-A total score. See page 115 paragraph 3. Terwey’851 teach that key secondary endpoints will be the change from baseline to days 1, 7, 14 and 28 in Clinical Global Impression - Improvement (CGlI) and Patient Global Impression - Improvement (PGl-I). See page 115 paragraph 3. Further, Terwey’851 teach that other efficacy assessments include achievement of remission, defined as a MADRS total score <=10, the Hamilton Depression Rating scale (HAM-D), the Clinical Global Impression - Severity (CGI-S) and the Patient Global Impression – Severity (PGI-S), and Generalized Anxiety Disorder 7-item Scale (GAD-7). See page 113 paragraph 2. Likewise, Terwey’851 teach that all endpoints will be assessed at each time point by a trained rater who is blinded for the assigned treatment group. See page 115 paragraph 3. Given that the skill of one of ordinary skill in the clinical arts is relatively high being that of a Ph.D. or MD it would have been within the purview of such artisan to implement the prophetic examples taught by Terwey’851 in a clinical trial.
Therefore, it would have been obvious before the effective filing date of the instant application to apply the methods of Terwey’851 in particular the prophetic examples 6 and 7 into clinical trials and expect the results as delineated in claims 121 – 127. One of ordinary skill in the art would have been motivated to make this modification to treat treatment resistant anxiety disorders. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because in a randomized, double-blind, cross-over trial when psilocybin, an alternative psychedelic, was administered at high dose to patients with depression and anxiety, there was a decrease in clinician- and self-rated measures of depression, anxiety or mood disturbances and increases in measures of quality of life at five weeks after treatment, and these effects were sustained at 6-months.
Claims 117 – 120 are rejected under 35 U.S.C. 103 as being unpatentable over by International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
The teachings of Terwey’851 as they relate to claim 124, from which claims 117 – 120 depend, are given previously in this office action and are fully incorporated here.
However, Terwey’851 fails to teach a method where the patient suffering from a disorder characterized by depressive episodes associated with the anxiety. See claim 117 limitation. Moreover, Terwey’851 fails to teach a method where the patient is suffering currently from a current major depressive episode. See claim 118 limitation. Furthermore, Terwey’851 fails to teach a method where the patient is suffering from major depressive disorder (MDD) associated with the anxiety. See claim 119 limitation. Terwey’851 fails to teach a method where the patient suffering from MDD suffers from a treatment resistant form of the disorder. See claim 120 limitation.
Nevertheless, as taught above, Terwey’851 teach that the oral administration of 12 mg of 5-MeO-DMT to 2 patients with treatment resistant major depressive disorder showing no adequate improvement to at least two adequate courses of pharmacological therapy in the current episode of depression. See page 97 Example 2 Clinical trial. Thus, Terwey’851 teach at least two patients where the patient has been diagnosed with treatment resistant major depressive disorder associated with anxiety in a current major depressive episode. Furthermore, Terwey’851 teach that the patients also improved on their ratings for suicidality after drug administration, as assessed using the suicidal thoughts item of the MADRS and the C-SSRS Suicidal Ideation items and other general psychiatric symptoms as assessed by the BPRS, e.g., somatic concern, anxiety, guilt and tension, also improved after the drug administration. See page 99 paragraph 3. Additionally, Terwey’851 teach that both reported a major improvement of their depressive symptoms as assessed by the MAD RS, PGI-S and PGl-I already at the first assessment time point at 2 hours after drug administration, with the effect further deepening over time. See pages 99 – 100 Table 4.
Moreover, Terwey’851 teach that both patients fulfilled standard criteria for MADRS response (at least 50% improvement from baseline) and MADRS remission (MADRS total score equal or less than 10), rated "Normal, not at all ill" on the PGI-S and reported that their depressive symptoms had "very much improved" or "much improved" on the PGl-I at all assessment time points after drug administration, which is a highly surprising result. See pages 99 – 100 Table 4. Furthermore, Terwey’851 teach that both patients’ other general psychiatric symptoms as assessed by the BPRS, e.g., somatic concern, anxiety, guilt and tension, also improved after the drug administration. In particular, Terwey’851 teach the treatment of Patient 1 in particular that scored the highest score of 7 for anxiety using the BPRS at baseline that reduced to 2 by 2 hr post the last administration then 1 on day 1 and 7. See pages 99 – 100 Table 4. Thus, Terwey’851 teach a patient where the patient has been diagnosed with treatment resistant major depressive disorder associated with anxiety. Given that the skill of one of ordinary skill in the clinical arts is relatively high, that of a Ph.D. or MD it would have been within the purview of such artisan to modify the method of treatment in example 2 in view of the teachings of examples 6 – 7 for future clinical trials to administer 5-MeO-DMT intravenously.
Therefore, it would have been obvious before the effective filing date of the instant application to apply the methods of Terwey’851 in particular the prophetic examples 6 and 7 into clinical trials to treat a patient suffering from a disorder characterized by depressive episodes associated with the anxiety in a current major depressive episode or to treat a patient suffering from MDD associated with anxiety that is treatment resistant. One of ordinary skill in the art would have been motivated to make this modification to treat treatment resistant depressive disorders associated with anxiety disorders. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because both patients in example 2 that received 5-MeO-DMT improved their ratings for suicidality after drug administration, as assessed using the suicidal thoughts item of the MADRS and the C-SSRS Suicidal Ideation items and other general psychiatric symptoms as assessed by the BPRS, e.g., somatic concern, anxiety, guilt and tension, also improved after the drug administration.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 114 – 137 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 38 of copending Application No. 18/373904 Terwey et.al. (Terwey’904) in view of International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
Terwey’904 recite a method of treating a patient suffering from postpartum depression (PPD), wherein the patient suffers from moderate or severe depression and from compromised or severely compromised maternal functioning, comprising administering to the patient suffering from postpartum depression (PPD), wherein the patient suffers from moderate or severe depression and from compromised or severely compromised maternal functioning, an effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof wherein the 5-MeO-DMT or the pharmaceutically acceptable salt thereof is administered via the intravenous, intramuscular, or subcutaneous route. See reference claim 1.
However, Terwey’904 fail to recite a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. See examined claim 114.
The prior art teachings of Terwey’851 as they relate to the prior art rejections of examined claims 114 – 137, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the method of copending Terwey’904 to use the 5-MeO-DMT in view of Terwey’851 that is, to treat anxiety in a patient. One of ordinary skill in the art would have been motivated to make this modification because the prior art taught that 5-MeO-DMT was useful for treating both anxiety disorders and depressive disorders. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because in a randomized, double-blind, cross-over trial when psilocybin, an alternative psychedelic, was administered at high dose to patients with depression and anxiety, there was a decrease in clinician- and self-rated measures of depression, anxiety or mood disturbances and increases in measures of quality of life at five weeks after treatment, and these effects were sustained at 6-months.
This is a provisional nonstatutory double patenting rejection.
Claims 114 – 137 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 4, 6, 15 – 17, 19 – 24, 28 – 31 of copending Application No. 18/675614 Terwey et.al. (Terwey’904) in view of International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
Terwey’614 recite method of treating major depressive disorder, the method comprising administering to a patient who is diagnosed with major depressive disorder a therapeutically effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the patient is suffering from a treatment-resistant form of major depressive disorder. See reference claim 1.
However, Terwey’614 fail to recite a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. See examined claim 114.
The prior art teachings of Terwey’851 as they relate to the prior art rejections of examined claims 114 – 137, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the method of copending Terwey’614 to use the 5-MeO-DMT in view of Terwey’851 that is, to treat anxiety in a patient. One of ordinary skill in the art would have been motivated to make this modification because the prior art taught that 5-MeO-DMT was useful for treating both anxiety disorders and depressive disorders. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because in a randomized, double-blind, cross-over trial when psilocybin, an alternative psychedelic, was administered at high dose to patients with depression and anxiety, there was a decrease in clinician- and self-rated measures of depression, anxiety or mood disturbances and increases in measures of quality of life at five weeks after treatment, and these effects were sustained at 6-months.
This is a provisional nonstatutory double patenting rejection.
Claims 114 – 137 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 115 – 144 of copending Application No. 18/850348 Terwey et.al. (Terwey’348).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending applications direct to methods of treating anxiety using 5-MeO-DMT. Terwey’348 recite method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof. See reference claim 115. See examined claim 114.
This is a provisional nonstatutory double patenting rejection.
Claims 114 – 137 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 33 – 68 of copending Application No. 18/850394 Terwey et.al. (Terwey’394).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending applications direct to methods of treating mental or nervous system disorder using 5-MeO-DMT. Terwey’394 recite a method for treating a mental or nervous system disorder in a breastfeeding mother comprising administering an effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeODMT) or a pharmaceutically acceptable salt thereof. See reference claim 33. See examined claim 114.
This is a provisional nonstatutory double patenting rejection.
Claims 114 – 137 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 68 of copending Application No. 18/851311 Terwey et.al. (Terwey’311) in view of International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
Terwey’311 recite 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in treating a patient suffering from psychomotor retardation, wherein the 5-MeO-DMT is administered via the intravenous, intramuscular or subcutaneous route. See reference claim 1.
However, Terwey’311 fail to recite a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. See examined claim 114.
The prior art teachings of Terwey’851 as they relate to the prior art rejections of examined claims 114 – 137, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the copending Terwey’311 that is to use the 5-MeO-DMT in view of Terwey’851 that is, to treat anxiety in a patient. One of ordinary skill in the art would have been motivated to make this modification because the prior art taught that 5-MeO-DMT was useful for treating both anxiety disorders and depressive disorders. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because in a randomized, double-blind, cross-over trial when psilocybin, an alternative psychedelic, was administered at high dose to patients with depression and anxiety, there was a decrease in clinician- and self-rated measures of depression, anxiety or mood disturbances and increases in measures of quality of life at five weeks after treatment, and these effects were sustained at 6-months.
This is a provisional nonstatutory double patenting rejection.
Claims 114 – 137 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 113 of copending Application No. 18/851346 Terwey et.al. (Terwey’346) in view of International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
Terwey’346 recite 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in treating a patient suffering from psychomotor retardation, wherein the 5-MeO-DMT is administered via the intravenous, intramuscular or subcutaneous route. See reference claim 1.
However, Terwey’346 fail to recite a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. See examined claim 114.
The prior art teachings of Terwey’851 as they relate to the prior art rejections of examined claims 114 – 137, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the copending Terwey’346 that is to use the 5-MeO-DMT in view of Terwey’851 that is, to treat anxiety in a patient. One of ordinary skill in the art would have been motivated to make this modification because the prior art taught that 5-MeO-DMT was useful for treating both anxiety disorders and depressive disorders. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because in a randomized, double-blind, cross-over trial when psilocybin, an alternative psychedelic, was administered at high dose to patients with depression and anxiety, there was a decrease in clinician- and self-rated measures of depression, anxiety or mood disturbances and increases in measures of quality of life at five weeks after treatment, and these effects were sustained at 6-months.
This is a provisional nonstatutory double patenting rejection.
Claims 114 – 137 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 112 of copending Application No. 18/851349 Terwey et.al. (Terwey’349) in view of International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
Terwey’349 recite 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in treating a patient suffering from sleep disturbance, wherein the 5-MeO-DMT is administered via the intravenous, intramuscular or subcutaneous route. See reference claim 1.
However, Terwey’349 fail to recite a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. See examined claim 114.
The prior art teachings of Terwey’851 as they relate to the prior art rejections of examined claims 114 – 137, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the copending Terwey’349 that is to use the 5-MeO-DMT in view of Terwey’851 that is, to treat anxiety in a patient. One of ordinary skill in the art would have been motivated to make this modification because the prior art taught that 5-MeO-DMT was useful for treating both anxiety disorders and depressive disorders. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because in a randomized, double-blind, cross-over trial when psilocybin, an alternative psychedelic, was administered at high dose to patients with depression and anxiety, there was a decrease in clinician- and self-rated measures of depression, anxiety or mood disturbances and increases in measures of quality of life at five weeks after treatment, and these effects were sustained at 6-months.
This is a provisional nonstatutory double patenting rejection.
Claims 114 – 137 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 48 – 82 of copending Application No. 18/851322 Terwey et.al. (Terwey’322) in view of International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
Terwey’322 recite a method for treating postpartum depression (PPD) in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof. See reference claim 44.
However, Terwey’322 fail to recite a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. See examined claim 114.
The prior art teachings of Terwey’851 as they relate to the prior art rejections of examined claims 114 – 137, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the method of copending Terwey’322 to use the 5-MeO-DMT in view of Terwey’851 that is, to treat anxiety in a patient. One of ordinary skill in the art would have been motivated to make this modification because the prior art taught that 5-MeO-DMT was useful for treating both anxiety disorders and depressive disorders. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because in a randomized, double-blind, cross-over trial when psilocybin, an alternative psychedelic, was administered at high dose to patients with depression and anxiety, there was a decrease in clinician- and self-rated measures of depression, anxiety or mood disturbances and increases in measures of quality of life at five weeks after treatment, and these effects were sustained at 6-months.
This is a provisional nonstatutory double patenting rejection.
Claims 114 – 137 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 78 – 84, 86 – 88, 90 – 92, and 97 – 112 of copending Application No. 18/851356 Terwey et. al. (Terwey’356) in view of International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
Terwey’356 recite a method for treating postpartum depression (PPD) in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeODMT) or a pharmaceutically acceptable salt thereof. See reference claim 78.
However, Terwey’356 fail to recite a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. See examined claim 114.
The prior art teachings of Terwey’851 as they relate to the prior art rejections of examined claims 114 – 137, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the method of copending Terwey’356 to use the 5-MeO-DMT in view of Terwey’851 that is, to treat anxiety in a patient. One of ordinary skill in the art would have been motivated to make this modification because the prior art taught that 5-MeO-DMT was useful for treating both anxiety disorders and depressive disorders. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because in a randomized, double-blind, cross-over trial when psilocybin, an alternative psychedelic, was administered at high dose to patients with depression and anxiety, there was a decrease in clinician- and self-rated measures of depression, anxiety or mood disturbances and increases in measures of quality of life at five weeks after treatment, and these effects were sustained at 6-months.
This is a provisional nonstatutory double patenting rejection.
Claims 114 – 137 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 24 of copending Application No. 18/920063 Northen et.al. (Northen’063) in view of International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
Northen’063 recite a salt of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), wherein the salt is 5-MeO-DMT hydrobromide and is in crystalline form. See reference claim 1.
However, Northen’063 fail to recite a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. See examined claim 114.
The prior art teachings of Terwey’851 as they relate to the prior art rejections of examined claims 114 – 137, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the copending Northen’063 that is to use the 5-MeO-DMT in view of Terwey’851 that is, to treat anxiety in a patient. One of ordinary skill in the art would have been motivated to make this modification because the prior art taught that 5-MeO-DMT was useful for treating both anxiety disorders and depressive disorders. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because in a randomized, double-blind, cross-over trial when psilocybin, an alternative psychedelic, was administered at high dose to patients with depression and anxiety, there was a decrease in clinician- and self-rated measures of depression, anxiety or mood disturbances and increases in measures of quality of life at five weeks after treatment, and these effects were sustained at 6-months.
This is a provisional nonstatutory double patenting rejection.
Claims 114 – 137 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 38 of copending Application No. 19/732033 Terwey et.al. (Terwey’033) in view of International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
Terwey’033 recite 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in treating a patient suffering from postpartum depression (PPD), wherein the patient suffers from moderate or severe depression and from compromised or severely compromised maternal functioning, wherein the 5-MeO-DMT or the pharmaceutically acceptable salt thereof is administered via the intravenous, intramuscular or subcutaneous route. See reference claim 1.
However, Terwey’033 fail to recite a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. See examined claim 114.
The prior art teachings of Terwey’851 as they relate to the prior art rejections of examined claims 114 – 137, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the copending Terwey’033 that is to use the 5-MeO-DMT in view of Terwey’851 that is, to treat anxiety in a patient. One of ordinary skill in the art would have been motivated to make this modification because the prior art taught that 5-MeO-DMT was useful for treating both anxiety disorders and depressive disorders. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because in a randomized, double-blind, cross-over trial when psilocybin, an alternative psychedelic, was administered at high dose to patients with depression and anxiety, there was a decrease in clinician- and self-rated measures of depression, anxiety or mood disturbances and increases in measures of quality of life at five weeks after treatment, and these effects were sustained at 6-months.
This is a provisional nonstatutory double patenting rejection.
Claims 114 – 137 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 34 – 43 of copending Application No. 19/739909 Terwey et.al. (Terwey’909) in view of International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
Terwey’909 recite a method of treating major depressive disorder, the method comprising administering to a patient who is diagnosed with major depressive disorder a therapeutically effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT is administered via an intravenous, intramuscular or subcutaneous route; and wherein a clinical response, as assessed by at least 50% improvement of a MontgomeryAsberg Depression Rating Scale (MADRS) score or a Hamilton Depression Rating Scale (HAMD) score, compared to a respective score prior to treatment, occurs not later than about 2 hours after administration of the 5-MeO-DMT or the pharmaceutically acceptable salt thereof. See reference claim 34.
However, Terwey’909 fail to recite a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. See examined claim 114.
The prior art teachings of Terwey’851 as they relate to the prior art rejections of examined claims 114 – 137, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the method of copending Terwey’909 to use the 5-MeO-DMT in view of Terwey’851 that is, to treat anxiety in a patient. One of ordinary skill in the art would have been motivated to make this modification because the prior art taught that 5-MeO-DMT was useful for treating both anxiety disorders and depressive disorders. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because in a randomized, double-blind, cross-over trial when psilocybin, an alternative psychedelic, was administered at high dose to patients with depression and anxiety, there was a decrease in clinician- and self-rated measures of depression, anxiety or mood disturbances and increases in measures of quality of life at five weeks after treatment, and these effects were sustained at 6-months.
This is a provisional nonstatutory double patenting rejection.
Claims 114 – 137 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 22 of U.S. Patent No. US 12172960 B2 Northen et.al. (Northen’960; cited on the IDS dated March 28th, 2025) in view of International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
Northen’960 recite a hydrobromide salt of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in crystalline form, comprising peaks in an x-ray powder diffraction (XRPD) diffractogram at 2θ values of 14.5° ±0.2°, 16.7° ±0.2°, 20.7° ±0.2°, 24.2° ±0.2°, 24.8° ±0.2° and 27.4° ±0.2° as measured using an x-ray wavelength of 1.5406 Å. See reference claim 1.
However, Northen’960 fail to recite a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. See examined claim 114.
The prior art teachings of Terwey’851 as they relate to the prior art rejections of examined claims 114 – 137, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the invention Northen’960 that is to use the 5-MeO-DMT in view of Terwey’851 that is, to treat anxiety in a patient. One of ordinary skill in the art would have been motivated to make this modification because the prior art taught that 5-MeO-DMT was useful for treating both anxiety disorders and depressive disorders. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because in a randomized, double-blind, cross-over trial when psilocybin, an alternative psychedelic, was administered at high dose to patients with depression and anxiety, there was a decrease in clinician- and self-rated measures of depression, anxiety or mood disturbances and increases in measures of quality of life at five weeks after treatment, and these effects were sustained at 6-months.
Claims 114 – 137 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 12 of U.S. Patent No. US 12685721 B2 Terwey et.al. (Terwey’721) in view of International Publication Number WO 2020/169851 A1 to Terwey (Terwey’851; cited on the ISR form).
Terwey’721 recite a method of treating major depressive disorder in a patient comprising administering a pharmaceutical aerosol to the patient, the pharmaceutical aerosol comprising: (a) air; and (b) aerosol particles of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) freebase and/or a pharmaceutically acceptable salt thereof; wherein the pharmaceutical aerosol has an aerosol particle mass density of 1 mg/l to 10 mg/l, the pharmaceutical aerosol has a mass median aerodynamic diameter (MMAD) of 0.1 μm to 3 μm, and the pharmaceutical aerosol has a volume of about 1 .5 to about 3 liters. See reference claim 1.
However, Terwey’721 fail to recite a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. See examined claim 114.
The prior art teachings of Terwey’851 as they relate to the prior art rejections of examined claims 114 – 137, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the method of invention Terwey’721 to use the 5-MeO-DMT in view of Terwey’851 that is, to treat anxiety in a patient. One of ordinary skill in the art would have been motivated to make this modification because the prior art taught that 5-MeO-DMT was useful for treating both anxiety disorders and depressive disorders. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because in a randomized, double-blind, cross-over trial when psilocybin, an alternative psychedelic, was administered at high dose to patients with depression and anxiety, there was a decrease in clinician- and self-rated measures of depression, anxiety or mood disturbances and increases in measures of quality of life at five weeks after treatment, and these effects were sustained at 6-months.
Conclusion
Claims 114 – 137 are rejected.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
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