Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This Office Action is in response to Applicant’s Arguments and Amendment filed, 07/15/2026, wherein the Amendment amended claims 1, 2, 11, and 53-54, and added claims 55-57.
Claims 1-57 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Claim Objections
Applicant’s amendment to claim 1 is sufficient to overcome this objection.
35 U.S.C. § 112(b)
Applicant’s amendments to claims 2, and 53-54 are sufficient to overcome these rejections.
REJECTIONS MAINTAINED
The prior art rejections are slightly modified in view of the amendments to the claims.
Claim Rejections - 35 USC § 103
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 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 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.
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.
(Slightly Modified) Claims 1-50 and 52-57 are rejected under 35 U.S.C. 103 as being unpatentable over Carhart-Harris (Psilocybin with psychological support for treatment-resistant depression: six-month follow up,” Psychopharmacology, published 2018, IDS of 07/11/2023) in view of Keks (Switching and stopping antidepressants, Australian Prescriber, published 2016, PTO-892), Nutt (Psychedelic drugs-a new era in psychiatry? Dialogues in Clinical Neuroscience, published 2019, PTO-892), US 2023/0277568 to Bridges (effectively filed 07/10/2020, PTO-892 of 08/13/2025), Jha (When Discontinuing SSRI Antidepressants Is a Challenge: Management Tips, American Jn. of Psychiatry, published 2018, PTO-892), and Collett (Dosage Regimens, published 2016, PTO-892).
Independent claim 1 recites:
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Carhart-Harris teaches a method of treating treatment resistant depression with psilocybin (title, abstract). Carhart-Harris teaches its patients as previously receiving SSRI’s (Table 1, pg. 623).
Regarding claim 1, while Carhart-Harris teaches a method of administering psilocybin after ceasing of SSRI therapy, it differs from that of instant claim 1 in that it does not teach the method of ceasing SSRI therapy, i.e., ceasing SSRI therapy 1-35 days prior to administration of psilocybin.
Keks teaches that switching from one antidepressant to another is frequently indicated due to an inadequate treatment response or unacceptable adverse effects, and teaches that all antidepressant switches must be carried out cautiously and under close observation. Conservative switching strategies involve gradually tapering the first antidepressant followed by an adequate washout period before the new antidepressant is started. Keks teaches that clinical expertise is needed for more rapid or cross-taper switching as drug toxicity may result (abstract).
Keks further teaches that gradual dose reduction over days to weeks reduces the risk and severity of complications (abstract).
Keks further teaches that the usual recommended period for antidepressant dose reduction is a minimum of four weeks, but that abrupt cessation may at times be unavoidable on clinical grounds, and further teaches that the time frame for dose reduction also depends on individual risk for withdrawal symptoms, patient preference and experience during withdrawal, and drug characteristics such as half-life. Some patients experience little discomfort despite abrupt cessation, while others are severely affected. In a minority, withdrawal symptoms are not diminished by extending the duration of dose taper. Such patients may prefer rapid cessation and a briefer withdrawal period (pg. 76, Col. 2 “Withdrawing antidepressants”).
Keks teaches that a number of strategies are available for switching between antidepressants, and that individual patient factors and illness factors may require considerable modification of a switching strategy. The most conservative strategy, with the lowest risk of drug interactions, is to gradually taper the dose of the first antidepressant to minimize withdrawal symptoms, then start a washout period equivalent to five half-lives of the drug. The second antidepressant is then introduced according to the starting dose recommendations. As the conservative switch can take quite a long time and usually includes at least several days where the patient is not on an antidepressant, a compromise strategy is the moderate switch. Here the washout period can generally be shortened to about two days. Direct and cross-taper switch methods can also be used (pgs. 77-78, “Switching Strategies” and Table 2).
In conclusion, Keks states, “Switching antidepressants involves drug cessation, which may cause withdrawal symptoms and relapse or exacerbation of the psychiatric illness. Gradual antidepressant withdrawal reduces the risk of complications. If the washout period is not long enough (defined by half-life of the drug), introducing a new antidepressant can cause drug interactions leading to toxicity, particularly serotonin syndrome. Switching from one antidepressant to another requires careful observation and caution” (pg. 79, “Conclusion”).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the cessation of SSRI therapy 1-35 days prior to administration of psilocybin, to arrive at steps a) and c) of instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
- Carhart-Harris teaches a method of treating treatment resistant depression with psilocybin, wherein patients were previously treated with SSRIs,
-Nutt teaches psilocybin for the treatment of depression (pg. 142, paragraph spanning Cols. 1 and 2; paragraph spanning pgs. 142 and 143; Table 1, pg. 144), and teaches that SSRIs desensitize 5-HT2A receptors to psilocybin, reducing its effects, and that stopping SSRIs is necessary (pg. 145, Col. 1, last full paragraph),
-Keks teaches that when switching from one antidepressant to another, it can be done gradually or immediately depending on the patient and the clinical circumstances, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at the most therapeutically effective method of ceasing SSRI therapy in order to begin psilocybin therapy, such that the method is optimized to minimize withdrawal effects of the SSRI and maximize psilocybin 5-HT2A receptor effect.
Further regarding claim 1, and regarding claims 9-33, and 48 while the combination of Carhart-Harris, Nutt, and Keks teaches a method of administering psilocybin comprising instant steps a) and c), it differs from that of instant claim 1 in that it does not teach step b).
Bridges teaches the administration of psilocybin with an additional compound, such as the benzodiazepine lorazepam (abstract).
Bridges teaches that the benzodiazepine is formulated in the same composition as the psilocybin or is formulated in a separate composition from the psilocybin ([0073]).
Bridges teaches that “The benzodiazepine may be administered to the patient to dampen anxiety-producing effects of the psilocybin. As a result, the benzodiazepine may decrease the intensity of the experience of the subject being administered the psilocybin. Therefore, benzodiazepine may be administered in order to limit, stop, or prevent any negative side effects (such as psilocybin induced anxiety or psilocybin-induced anxiety) from the psilocybin or psilocin that the patient may experience” ([0077]).
See also pg. 20, claims 10-11, 13-16, 19-20, 39, 42-44.
Jha teaches management tips when discontinuing SSRI antidepressants is a challenge (title).
Jha teaches that benzodiazepines for anxiety or agitation can be used if discontinuation symptoms of an SSRI are severe (pg. 1182, Col. 1, 1st full paragraph).
Collett teaches that the design of a dosage regimen determines the therapeutic benefit for patients. The principles of clinical pharmacokinetics are applied to design a dosage regimen for a patient that ensures the appropriate formulation of drug is chosen for an appropriate route of administration. One the basis of the patient’s drug handling parameters, which require an understanding of absorption, distribution, metabolism and excretion, the dosage regimen for the medicine in a particular patient, can be optimized. The pharmacist needs to ensure the appropriate regimen is prescribed to achieve optimal efficacy and minimal toxicity (pg. 2, 1st paragraph).
Collett teaches that clinical pharmacokinetics provides a basic understanding of the principles required to design a dosage regimen, wherein pharmacokinetics provides a mathematical basis to assess the time course of drug and their concentration in the body and enables absorption, distribution, metabolism, and excretion (ADME) to be quantified (pg. 2, 2nd paragraph).
Collett teaches that the design of the regimen, i.e. formulation, route of administration, dose size, and dose frequency, are important factors which influence what plasma concentration is achieved and maintained in the body over the prescribed course of drug treatment. Collett further teaches that other factors that require consideration are patients’ individual needs and lifestyles (pg. 3, 3rd paragraph).
Collett teaches that to understand how the design of dosage regimen influences the time course of a drug in the body, consideration of the complex pharmacokinetic process of drug input, output, and distribution within the body must be considered (pg. 3, last paragraph). Collett teaches that pharmacokinetic models are hypothetical constructs which describe the fate of a drug in a biological system following its administration. The purpose of modeling is to characterize the ADME profile for a drug to indicate how the drug is handled by the patient and to characterize basic parameters (pg. 4, 1st paragraph).
Collett teaches that the greater the rate of drug input relative to the rate of drug output from the body compartment over the net absorption phase, the higher will be the peak concentration achieved in the body or plasma following oral administration of a single dose of drug.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to add at least once daily administration a benzodiazepine 1-35 days prior to administration of psilocybin, to the combined method of Carhart-Harris, Nutt, and Keks, to arrive at instant claim 1 and claims 9-33, and 48. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Jha teaches that benzodiazepines can be used for anxiety or agitation when SSRIs are being discontinued,
-Bridges teaches that co-administering psilocybin and a benzodiazepine dampens the anxiety-producing effects of the psilocybin and limits negative side effects,
-Collett teaches that its known in the art to modify dosage regimens to optimize therapeutic effects, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a method that it optimized to minimize SSRI cessation side effects and/or minimize psilocybin negative side effects.
Specifically regarding the specific combination of days of ceasing SSRI therapy and beginning benzodiazepine therapy, an ordinary skilled artisan would have been motivated to modify the dosage regimen, to predictably arrive at a method that minimizes the withdrawal effects of SSRI cessation, while maximizing the therapeutic effects of psilocybin, and minimizing the time between ending one depression therapy and beginning another.
Regarding claims 2, 6, 34-47, and 49-50, while the combination of Carhart-Harris, Nutt, Keks, Bridges, Jha, and Collett, teaches a method of administering psilocybin comprising ceasing SSRI therapy 1-35 days prior to psilocybin administration, administering one or more benzodiazepine at least once daily, at least 1-35 days prior to psilocybin administration, and administering psilocybin, it differs from that of claims 2, 6, 34-47, and 49-50, in that it does not explicitly teach cessation of the SSRI therapy during the titration period, immediate cessation of an SSRI, and the percentage by which SSRI therapy is reduced on different days.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify ceasing SSRI therapy immediately or in a titration period wherein the maintenance dose is decreased incrementally, in the combined method of Carhart-Harris, Nutt, Keks, Bridges, Jha, and Collett, to arrive at instant claims 2, 6, 34-47, and 49-50. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Keks teaches that abrupt cessation is sometimes required due to clinical grounds or patient preference,
-Keks teaches that antidepressant dose reduction of a minimum of four weeks is usually recommended and that the time frame for dose reduction depends on individual risk for withdrawal symptoms, patient illness, patient preference and experience during withdrawal, and individual drug characteristics such as half-life,
-Keks teaches that the lowest risk of drug interactions is to gradually taper the dose of the antidepressant to minimize withdrawal symptoms, and then start a washout period equivalent to five half-lives of the drug,
-Keks teaches that since the gradual taper can take a long time and can include several days where the patient is not on an antidepressant, a moderate switch can be implemented wherein the washout period can be shortened to about two days,
-Keks teaches that a direct and cross-taper switch method can also be applied,
-Collett teaches that the design of a dosage regimen determines the therapeutic benefit for a patient and is dependent on the patient’s drug handling parameter of absorption, distribution, metabolism, and excretion, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such modifications, to predictably arrive at the most therapeutically effective and safe method of ceasing SSRI therapy in a patient to decrease withdrawal symptoms, while minimizing the time between treatments for depression.
Regarding claims 3-5, 7-8, and 55-57, the combination of Carhart-Harris, Nutt, Keks, Bridges, Jha, and Collett, does not explicitly teach the timing of the administration of the benzodiazepine in relation to the SSRI discontinuation and/or withdrawal period, or the timing and/or dosing regimen of the administration of the benzodiazepine.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the timing of the administration of the benzodiazepine, to arrive at instant claims 3-5, 7-8, and 55-57. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Jha teaches that for those experiencing anxiety or agitation during SSRI discontinuation, benzodiazepine therapy can be used to treat these symptoms,
-Bridges teaches that administration of benzodiazepine with psilocybin can decrease the negative side effects of psilocybin, such as anxiety,
-Collett teaches that the design of a dosage regimen determines the therapeutic benefit for a patient and is dependent on the patient’s drug handling parameter of absorption, distribution, metabolism, and excretion, and
- "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such a modification to predictably arrive at a benzodiazepine dose regimen that optimizes the treatment of the anxiety and/or agitation experienced by SSRI withdrawal, while optimizing the treatment of the negative side-effects of the psilocybin therapy.
Regarding claim 52, Bridges teaches lorazepam and other benzodiazepines (abstract, [0003], [0006], [0029], [0074]-[0077], [0128], [0130], pg. 21, claims 17-18).
Regarding claims 53-54, Jha teaches that administration of benzodiazepine during SSRI cessation decreases anxiety and/or agitation.
Thus, claims 1-50 and 52-57 are rendered obvious.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Carhart-Harris (Psilocybin with psychological support for treatment-resistant depression: six-month follow up,” Psychopharmacology, published 2018, IDS of 07/11/2023), Keks (Switching and stopping antidepressants, Australian Prescriber, published 2016, PTO-892), Nutt (Psychedelic drugs-a new era in psychiatry? Dialogues in Clinical Neuroscience, published 2019), US 2023/0277568 to Bridges (effectively filed 07/10/2020, PTO-892 of 08/13/2025), Jha (When Discontinuing SSRI Antidepressants Is a Challenge: Management Tips, American Jn. of Psychiatry, published 2018, PTO-892), and Collett (Dosage Regimens, published 2016, PTO-892). as applied to claims 1-50 and 52-57 above, and further in view of MayoClinic (Selective Serotonin Reuptake Inhibitors (SSRIs), published 2020, PTO-892).
The combination of Carhart-Harris, Nutt, Keks, Bridges, Jha, and Collett is applied as discussed above and incorporated herein.
While the combination of Carhart-Harris, Nutt, Keks, Bridges, Jha, and Collett teaches a method of administering psilocybin comprising ceasing SSRI therapy 1-35 days prior to psilocybin administration, administering one or more benzodiazepine at least once daily, at least 1-35 days prior to psilocybin administration, and administering psilocybin, it differs from that of instant claim 51, in that it does not teach species of SSRIs.
MayoClinic teaches citalopram, escitalopram, fluoxetine, paroxetine, and sertraline as approved SSRIs to treat depression (pg. 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select citalopram, escitalopram, fluoxetine, paroxetine, and/or sertraline, as the SSRI taught in the combination of Carhart-Harris, Nutt, Keks, Bridges, Jha, and Collett, to arrive at instant claim 52. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because Carhart-Harris teaches its subjects as previously administered SSRIs and MayoClinic teaches citalopram, escitalopram, fluoxetine, paroxetine, and sertraline as FDA approved SSRIs to treat depression.
As such, an ordinary skilled artisan would have been motivated to select citalopram, escitalopram, fluoxetine, paroxetine, or sertraline as the SSRIs taught by Carhart-Harris since these SSRIS are approved by the FDA to treat depression.
Thus, claims 1-57 are rendered obvious.
Response to Arguments
On pgs. 11-13, Remarks, Applicant argues that there is no teaching of benzodiazepine pre-treatment prior to psilocybin administration.
Regarding the arguments directed toward Carhart-Harris, Nutt, Keks, and Collett, on pg. 12, Remarks, is respectfully pointed out that the instant rejection is a 35 USC 103 obviousness-rejection, and not a 35 USC 102, anticipation rejection. As such, it is the combination of references that is relied upon to teach the limitations of the instant claims. Moreover, none of Carhart-Harris, Nutt, Keks, or Collett are relied upon to teach benzodiazepine.
Regarding Jha, Applicant argues on pg. 12, Remarks, that Jha only teaches benzodiazepine use in response to severe SSRI discontinuation symptoms and teaches benzodiazepines as a one-time last resort symptom management measure, not a daily pre-treatment regimen as claimed.
Regarding Bridges, on pg. 13, Remarks, Applicant argues that Bridges teach co-administering psilocybin in combination with a benzodiazepine, which is fundamentally different from the claimed step (b) requiring daily administration prior to psilocybin.
These arguments have been fully considered, but are not found persuasive. Jha teaches that it is known in the art to administer benzodiazepines for anxiety or agitation if SSRI discontinuation symptoms are severe, or if resumption of an SSRI is not prudent (pg. 1182, Col. 1, 1st full paragraph). Bridges teaches that it is known in the art to administer benzodiazepine to limit, stop, or prevent any negative side effects from psilocybin. Bridges additionally teaches that the psilocybin and benzodiazepine can be administered separately and not concurrently.
As such, Bridges is not limited to teaching “co-administering.” And in view of the teachings of Collett, an ordinary skilled artisan would have been motivated to administer the benzodiazepine after or during the cessation of the SSRI therapy and prior to the administration of the psilocybin, to predictably arrive at a method optimized to minimize SSRI cessation side effects and/or minimize psilocybin negative side effects, since Collett teaches that it is known in the art to modify dosing regimens to arrive at the most therapeutically effective effect for the patient.
Moreover, it is respectfully pointed out that Jha does no teach “benzodiazepines as a one-time, last-resort symptom management measure,” as argued by Applicant on pg. 12, Remarks.
On pgs. 12-13, Remarks, Applicant argues that Collett is “impermissibly broad and provides no specific motivation to arrive at the precise timing, frequency, or clinical context of the claimed method.”
This argument has been fully considered, but is not found persuasive. Collett is relied upon to teach that it is known in the art to modify dosage regimens to optimize therapeutic effect. In the instant case, since cessation of SSRI therapy in order to begin psilocybin therapy is known in the art, and since benzodiazepine is known in the art to decrease the negative side effects of SSRI cessation and the negative side effects of psilocybin therapy, Collett shows that an ordinary skilled artisan would have the skills required to optimize such a method to arrive at the instantly claimed methods.
On pg. 14, Applicant argues that Bridges and Nutt teach away from the claimed method because Bridges expressly discloses that benzodiazepines decrease the intensity of the psilocybin experience and because Nutt describes benzodiazepine as escape medication to rescue someone form a severe bad trip.
These arguments have been fully considered, but are not found persuasive. It is first respectfully pointed out that Nutt is relied upon for its teachings that psilocybin is used for the treatment of depression, and is relied upon for its teachings that SSRIs desensitize psilocybin, reducing its effects, thereby necessitating the cessation of SSRIs prior to psilocybin treatment. Regarding the one reference to psilocybin in Nutt, it is respectfully pointed out that this is in reference to studying the effects of psilocybin in patients with a variety of disorders, wherein when conducting studies with the psilocybin, benzodiazepine was on hand to treat a bad response to the study. As such, this argument against Nutt is not persuasive.
Regarding Bridges, as discussed above, Bridges teaches that psilocybin and benzodiazepine can be administered separately. And though Bridges teaches that it is known in the art to administer benzodiazepine to limit, stop, or prevent any negative side effects from psilocybin, Applicant has pointed to no teaching or data as to why this teaching would strongly discourage a POSA from administering the benzodiazepine for fear of undermining the therapeutic goal. Alternatively, a POSA would be motivated to administer the benzodiazepine prior to administration of the psilocybin to a) decrease the negative effects of SSRI cessation, and b) reduce the negative effects of psilocybin treatment from the onset of psilocybin treatment. As such, Bridges and Nutt do not teach away from the instant methods.
It is also respectfully pointed out that Applicant is arguing against the references individually when the rejection is made over a combination of references; one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On pgs. 15-17, Remarks, Applicant argues that unexpected results have been achieved. In the instant specification, Examples 3 and 4, the data specifically shows that benzodiazepine pretreatment potentiates the effects of psilocybin, which is unexpected in view of the teachings of the prior art that teaches that benzodiazepine would be expected to reduce the effects of psilocybin.
While the examiner agrees that Examples 3 and 4 do provide data that show that benzodiazepine increases the effectiveness of psilocybin, as measured by head twitch response, the data in Examples 3 and 4 is not commensurate in scope with the instantly claimed method.
Example 3 is limited to 4mg/kg diazepam dose followed by 0.3mg/kg, 1mg/kg, or 3mg/kg psilocybin 1 hour later.
Example 4 is limited to 1.25mg/day administered twice daily for 14 days, followed by 0.3mg/kg psilocybin 2 hours later.
However, the instant claims are not limited to any dosage amount of the benzodiazepine or the psilocybin, are not limited diazepam as the benzodiazepine, are not limited to 14 days pre-treatment with diazepam, and are not limited to administration of psilocybin one or two hours following a dosage of diazepam. Moreover, the data does not show how these results are modified when the additional step of “ceasing SSRI therapy 1-35 days prior to administration of psilocybin,” is added, as instantly claimed.
Applicant is respectfully reminded that MPEP 716.02 states that unexpected results a) are greater than expected results, b) show superiority of a property shared with the prior art, c) exhibit the presence of an unexpected property, and/or d) exhibit the absence of an expected property. MPEP 716.02 additionally states that unexpected results must be commensurate in scope with the claimed invention and provide a comparison with the closest prior art.
For these reasons, Applicant’s arguments are not persuasive to overcome the instant rejections.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LAUREN WELLS/Examiner, Art Unit 1622
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