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 .
Current Status
This action is responsive to the amended claims of 03/06/2024. Claims 1, 3-9, and 11-17 are pending. Claims 12-17 are new. Claims 1, 3-9, and 11-17 have been examined on the merits.
Priority
The effective filing date is 08/04/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/10/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 3-9, and 11-17 are objected to because of the following informalities. Appropriate correction is required.
Claim 1 recites “treating posttraumatic stress disorder (PTSD) in an an individual in need thereof”. Please strike the second occurrence of “an”. Claims 3-9 and 11-17 are similarly objected to since the depend from claim 1 and do not rectify the underlying issue.
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 (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 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 1, 3-9, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over:
MAYO (Mayo, L.M. et al., Biol. Psychiatry, 15 March 2020, 87, 538-547; cited in IDS of 11/10/2025 – the supplemental information (SI) Pg. 1-21 is attached here by Examiner), as evidenced by JOHNSON (Johnson, D.S. et al., ACS Med. Chem. Lett., 2011, 2, 91-96),
in view of:
PFIZER (Pfizer,June 2016, NCT02216097, retrieved from ClinicalTrials.gov, accessed 03/02/2026, cited in IDS of 11/10/2025),
In view of:
FAY (WO 2008/047229, cited in IDS of 11/10/2025), and
In further view of:
ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed., 1999, pages 48-53).
Determining the Scope and Contents of the Prior Art:
MAYO teaches pharmacological potentiation of extinction learning and consolidation is an attractive strategy for improving treatment outcomes in posttraumatic stress disorder (PTSD) where treatment options are limited (Pg. 538 Left ¶1). MAYO teaches a double-blind, placebo-controlled study wherein healthy adults were randomized to receive a 4 mg oral dose once daily of an FAAH inhibitor PF-04457845 or placebo for 10 days; on days 9 & 10 participants completed tasks assessing fear learning, stress reactivity, and stress-induced affective responses (Pg. 538 Abstract Methods). Further, FAAH inhibition by PF-04457845 increased baseline anandamide (AEA) which was associated with potentiated recall of fear extinction memory and attenuated stress reactivity, and protected against stress-induced negative affect (Pg. 538 Abstract Results). MAYO states the “beneficial effects of FAAH inhibition on fear extinction, as well as stress- and affect-related behaviors, provide a strong rationale for developing this drug class as a treatment for posttraumatic stress disorder” (Pg. 538 Abstract Conclusions). MAYO teaches plasma concentrations of PF-04457845 in the treatment group were 21.7 ng/mL and the median AEA plasma concentration was 5.99 pmol/mL (Pg. 541 Right ¶1 & SI Pg. 13 Fig. S2). MAYO also teaches the participants included adult males and females (SI Pg. 13 Table S4).
PF-04457845 is the same compound as the claimed compound, as evidenced by JOHNSON:
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(Pg. 91 Abstract).
PFIZER teaches a phase II study in adult male and female subjects with moderate-to-severe PTSD wherein a dose of 4 mg of PF-04457845 is administered in the morning for 7 days (Pg. 1 Detailed Description) as a tablet (Pg. 5 Arms and Intervention). The study was stopped but this was not due to safety and/or efficacy concerns or a change in the benefit:risk assessment of PF-04457845 (Pg. 1 Terminated Status).
FAY teaches the compound PF-04457845 as N-pyridazin-3-yl-4-(3-{[5-(trifluoromethyl)pyridin-2-yl]oxy}benzylidene)piperidine-1-carboxamide or a pharmaceutically acceptable salt thereof (Pg. 124 claim 8). FAY further teaches a method of treating anxiety by administering to a subject the compound PF-04457845 or a salt thereof (Pg. 124 claim 10) wherein anxiety may refer to PTSD (Pg. 14 Lines 21-23).
ANSEL teaches the safe and effective dose of a drug depends on a number of factors including characteristics of the drug, the dosage form, and a variety of patient factors (Pg. 48 Left Col. para 2) and the effective dose may be different for different patients (Pg. 48 Left Col. para 4). ANSEL further teaches the schedule of dosage or the dosage regimen is determined based on a drug’s duration of action, pharmacokinetics, and characteristics of the dosage form (Pg. 40 Right Col. para 2).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
MAYO does not teach the instant dosage time course and only provides a strong rationale for, but not an exact teaching of, treatment of an individual with PTSD.
PFIZER does not teach the instant dosage time course.
FAY does not teach the instant dosage regimen nor an example wherein an individual with PTSD is treated with PF-04457845.
ANSEL does not teach treatment of PTSD with PF-04457845.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a method useful for treatment of PTSD and possesses the technical knowledge necessary to make adjustments to the method to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding FAAH inhibition and PTSD treatments and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references MAYO (evidenced by JOHNSON), PFIZER, FAY, and ANSEL.
The artisan would find it obvious to treat PTSD in an individual by administration of PF-04457845, as an oral dosage form as taught by MAYO (Pg. 538 Abstract Methods) and PFIZER (Pg. 5 Arms and Intervention). The artisan would do so in order to improve treatment outcomes in PTSD where treatment options are limited, as recognized by MAYO (Pg. 538 Left ¶1). Further, the artisan would have a reasonable expectation of success since MAYO states their results with PF-04457845 “provide a strong rationale” for developing treatment for PTSD (Pg. 538 Abstract Conclusions), PFIZER teaches a clinical trial for development of PF-04457845 in PTSD treatment (Pg. 1 Detailed Description), and FAY claims treatment of anxiety disorders (such as PTSD) with, specifically, PF-04457845 or a pharmaceutically acceptable salt thereof (Pg. 124 Claims 8 & 10; Pg. 14 Lines 21-23). Note that MAYO teaches the dose of 4 mg once a day (Pg. 538 Abstract Methods) as claimed in instant claims 1 and 4. MAYO further teaches an AEA plasma concentration of 5.99 pmol/mL which converts to 2.07 ng/mL (Pg. 541 Right Col. ¶1 & SI Pg. 13 Fig. S2) which falls within range “about 2 ng/mL to about 5 ng/mL” in instant claim 8.
Further regarding claims 1, 3-4, and 5, the artisan would have been motivated to optimize the dosage regimen of PF-04457845 – dose amount and length of treatment.
MPEP 2144.05(II)(A) provides guidance about the routine optimization of prior art conditions: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").”
Furthermore, MPEP 2144.05(I) provides guidance about overlapping ranges: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists…Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”
In the instant case, MAYO and PFIZER both teach a 4 mg dose of PF-04457845 once a day for 10 days and 7 days, respectively (Pg. 538 Abstract Methods; Pg. 1 Detailed Description) and MAYO further teaches a 1 mg dose effectively inhibits FAAH in the human brain (Sup. Info. Pg. 2 ¶2). These dosages are considered to overlap with/approach the instantly claimed 0.3-4 mg/once a day given for at least 8 weeks or at least 12 weeks. Since ANSEL teaches the dosage regimen is based on duration of action, pharmacokinetics, and the dosage form (Pg. 40 Right Col. para 2) and the effective dosing may be different for different patients (Pg. 48 Left Col. para 4), the artisan would recognize the dosage amount and duration of PF-04457845 as a result-effective variable, i.e., a variable that achieves a recognized result. Thus, the dosage regimen is analogous to the “concentration or temperature” recited in the MPEP and may be optimized by routine experimentation. Therefore, the determination of the optimum or workable dosage regimen of PF-04457845 would have been well within the practice of the artisan. The artisan would have been able to extrapolate a safe and efficacious dosing regimen (amount & length of time) for PF-04457845 based on the pharmacokinetics of the drug and the patient’s response. Furthermore, absent any evidence demonstrating a patentable difference between the instant and prior art compositions and the criticality of the claimed dosage regimen, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the artisan.
Regarding claims 6-9, similarly, MAYO teaches plasma concentrations of both PF-04457845 (21.7 ng/mL – Pg. 541 Right Col. ¶1) and AEA (2.07 ng/mL – Pg. 541 Right Col. ¶1 & SI Pg. 13 Fig. S2). These concentrations are considered to overlap with/approach the instantly claimed plasma concentration of PF-04457845 (1-3 ng/mL, or at least 1 ng/mL for at least 12 hr – instant claims 6-7) and the plasma concentration of AEA (2-5 ng/mL or at least 2 ng/mL for at least 12 hr – instant claims 8-9). Since ANSEL teaches the dosage regimen is based on pharmacokinetics (Pg. 40 Right Col. para 2) and the effective dosing may be different for different patients (Pg. 48 Left Col. para 4), the artisan would recognize the pharmacokinetics of PF-04457845 as the result of a result-effective variable; i.e., PF-04457845 dosage. Since the PF-04457845 dosage regimen is established as a result-effective variable (above), optimization of the plasma concentration of the drug itself and AEA would naturally follow or, vis versa, optimization of plasma concentrations would lead to optimized drug dosages. Furthermore, the duration of the plasma concentration (i.e., at least 12 hours) would be inherently understood as part of the pharmacokinetics of the drug (i.e., kinetics require a time component). Thus, the determination of the optimum or workable pharmacokinetics given the guidance of the prior art would have been generally prima facie obvious to the artisan.
Note: while 21 ng/mL is an order of magnitude larger than 1-3 ng/mL, the teaching is considered relevant since the teaching derives from one of the instantly claimed doses: 4 mg/day. Also, the instant claims do not specify when the plasma concentration is determined (e.g., X time after first, second, or last administration or even Y number of days after administration). Thus, the teachings of MAYO are considered to approach the instant claims.
Regarding claims 15-17, both MAYO and PFIZER teach PF-04457845 is the only drug given (Pg. 538 Abstract Methods; Pg. 1 Detailed Description) and both references teach administration to adults and adult males (SI Pg. 13 Table S4; Pg. 1 Detailed Description). Thus, the artisan would be motivated, with an expectation of success, to perform the instant method wherein the drug is administered as a monotherapy and the individual is an adult or an adult male.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over:
MAYO (Mayo, L.M. et al., Biol. Psychiatry, 15 March 2020, 87, 538-547; cited in IDS of 11/10/2025 – supplemental information (SI) provided by Examiner), as evidenced by JOHNSON (Johnson, D.S. et al., ACS Med. Chem. Lett., 2011, 2, 91-96),
further in view of:
PFIZER (Pfizer,June 2016, NCT02216097, retrieved from ClinicalTrials.gov, accessed 03/02/2026, cited in IDS of 11/10/2025),
In view of:
FAY (WO 2008/047229, cited in IDS of 11/10/2025), and
In view of:
ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed., 1999, pages 48-53).
as applied to claim 1 above,
and further in view of:
KING (King, J.A. et al., Biol. Psychiatry, 2001,50, 231-237).
Determining the Scope and Contents of the Prior Art:
MAYO (evidenced by JOHNSON), PFIZER, FAY, and ANSEL teach the practice of instant claim 1, see ¶11 above. MAYO further teaches PTSD is an area of large unmet medical needs and is characterized by maladaptive stress responses (Pg. 538 Abstract Background).
KING teaches not all individuals exposed to similar traumatic events will develop PTSD, thus, the importance of factors which bestow vulnerability is apparent (Pg. 231 Right ¶2); at least 30% of PTSD symptoms might be based on genetic factors (Pg. 231 Right ¶4). KING also teaches support for the role of genetic predisposition in shaping the response to trauma and subsequent susceptibility to PTSD (Pg. 236 Left ¶2).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
MAYO, PFIZER, FAY, and ANSEL do not teach wherein the individual has a genetic predisposition to the PTSD.
KING does not teach administration of PF-04457845.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a method useful for treatment of PTSD and possesses the technical knowledge necessary to make adjustments to the method to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding susceptibility to PTSD and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references MAYO (evidenced by JOHNSON), PFIZER, FAY, ANSEL, and KING.
The combined references MAYO (evidenced by JOHNSON), PFIZER, FAY, and ANSEL teach the method of claim 1 (above).
Regarding claim 11, the artisan would be motivated to treat an individual with a genetic predisposition to PTSD since KING teaches genetic predisposition can shape response to trauma, susceptibility to PTSD, and PTSD symptoms (Pg. 236 Left ¶2 & Pg. 231 Right ¶4). Further, MAYO’s teaching of PTSD as an area of large unmet medical needs and related maladaptive stress responses (Pg. 538 Abstract Background), i.e., maladaptive response to trauma, the artisan would recognize individuals with a genetic predisposition to PTSD as falling into the category of patients which MAYO seeks to develop medical interventions for.
Claims 1 and 12 are rejected under 35 U.S.C. 103 as being unpatentable unpatentable over:
MAYO (Mayo, L.M. et al., Biol. Psychiatry, 15 March 2020, 87, 538-547; cited in IDS of 11/10/2025 – supplemental information (SI) provided by Examiner), as evidenced by JOHNSON (Johnson, D.S. et al., ACS Med. Chem. Lett., 2011, 2, 91-96),
further in view of:
PFIZER (Pfizer,June 2016, NCT02216097, retrieved from ClinicalTrials.gov, accessed 03/02/2026, cited in IDS of 11/10/2025),
In view of:
FAY (WO 2008/047229, cited in IDS of 11/10/2025), and
In view of:
ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed., 1999, pages 48-53).
as applied to claim 1 above, and
further in view of:
RUGGIERO (Ruggiero, G. et al., “Major Depressive Disorder.” Gale Encyclopedia of Medicine, 6th ed., 2020. Infobase, access.infobase.com/article/2215130-major-depressive-disorder?aid=279753).
Determining the Scope and Contents of the Prior Art:
MAYO (evidenced by JOHNSON), PFIZER, FAY, and ANSEL teach the practice of instant claim 1, see ¶11 above. PFIZER further teaches inclusion criteria included men and women 18-60 years old with a primary psychiatric diagnosis of PTSD, while exclusion criteria included other psychiatric illness requiring current treatment with medication (Pg. 4 Eligibility Criteria).
RUGGIERO teaches major depressive disorder (MDD) is a serious mental disorder characterized by long-lasting depressed mood and other symptoms which are sufficiently severe to interfere significantly with patient’s daily functioning (Pg. 1 Definition & Description ¶1). RUGGIERO also teaches because MDD can have a devastating impact on a person’s life, the importance of effective treatment cannot be overstated (Pg. 4 Treatment).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
MAYO and FAY are silent regarding the individual having a comorbid diagnosis of MDD.
PFIZER does not specifically name the “other psychiatric illness” as MDD.
ANSEL does not teach administration of PF-04457845.
RUGGIERO does not teach administration of PF-04457845.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a method useful for treatment of PTSD and possesses the technical knowledge necessary to make adjustments to the method to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding MDD and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references MAYO (evidenced by JOHNSON), PFIZER, FAY, ANSEL, and RUGGIERO.
The combined references MAYO (evidenced by JOHNSON), PFIZER, FAY, and ANSEL teach the method of claim 1 (above).
Regarding claim 12, the artisan would find it obvious to treat an individual who does not have a comorbid diagnosis of MDD since MAYO is directed to treatment of PTSD and not any comorbidities. Further, PFIZER teaches individuals with other psychiatric illnesses requiring treatment were excluded (Pg. 4 Eligibility Criteria) and RUGGIERO teaches MDD as a mental illness (i.e., psychiatric illness) requiring effective treatment (Pg. 1 Definition & Description ¶1). Thus, the artisan would recognize MDD as falling under the psychiatric illness requiring treatment as taught by PFIZER and would have an expectation of success in treating individuals not having comorbid MDD.
Claims 1 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over:
MAYO (Mayo, L.M. et al., Biol. Psychiatry, 15 March 2020, 87, 538-547; cited in IDS of 11/10/2025 – supplemental information (SI) provided by Examiner), as evidenced by JOHNSON (Johnson, D.S. et al., ACS Med. Chem. Lett., 2011, 2, 91-96),
further in view of:
PFIZER (Pfizer,June 2016, NCT02216097, retrieved from ClinicalTrials.gov, accessed 03/02/2026, cited in IDS of 11/10/2025),
In view of:
FAY (WO 2008/047229, cited in IDS of 11/10/2025), and
In view of:
ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed., 1999, pages 48-53).
as applied to claim 1 above, and
further in view of:
SHIN (Shin, H.J. et al., Psychiatric Services, 2014, 65(10), 1244-1248).
Determining the Scope and Contents of the Prior Art:
MAYO (evidenced by JOHNSON), PFIZER, FAY, and ANSEL teach the practice of instant claim 1, see ¶11 above. MAYO further teaches PTSD is an area of large unmet medical needs (Pg. 538 Abstract Background). PFIZER further teaches inclusion criteria included men and women 18-60 years old with a primary psychiatric diagnosis of PTSD, while exclusion criteria included other psychiatric illness requiring current treatment with medication (Pg. 4 Eligibility Criteria).
SHIN teaches fewer than two-thirds of Veteran’s Affairs (VA) patients with PTSD who were prescribed SSRIs or SNRIs refilled the prescriptions (Pg. 1245 Col. 1 ¶1). SHIN further teaches 45% of study participants received no SSRIs or SNRIs, suggesting that many patients did not receive any first-line treatments for PTSD from the VA (Pg. 1247 Col. 2 ¶2). Furthermore, participants who completed a 90-day trial of SSRIs or SNRIs showed less improvement than those who did not have medication (Pg. 1247 Col. 1 ¶1).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
MAYO, PFIZER, FAY, and ANSEL are silent as to the individual not receiving treatment with an SSRI or SNRI.
SHIN does not teach administration of PF-04457845.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a method useful for treatment of PTSD and possesses the technical knowledge necessary to make adjustments to the method to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding SSRI and SNRI treatments in PTSD and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references MAYO (evidenced by JOHNSON), PFIZER, FAY, ANSEL, and SHIN.
The combined references MAYO (evidenced by JOHNSON), PFIZER, FAY, and ANSEL teach the method of claim 1 (above).
Regarding claims 13-14, the artisan would be motivated to treat individuals who are not concurrently receiving or priorly received SSRIs or SNRIs based on the combined teachings. Since PTSD is an area of large unmet medical needs (MAYO Pg. 538 Abstract Background), the artisan would find it pertinent to provide treatment to those who were not receiving any treatment or those who did not benefit from other treatment. SHIN’s teachings point to either a lack of treatment for PTSD patients (Pg. 1245 Col. 1 ¶1 & Pg. 1247 Col. 2 ¶2) or a lack of efficacy of SSRIs and SNRIs in this patient population (Pg. 1247 Col. 1 ¶1). Thus, the artisan would recognize those who were not concurrently taking or had not previously taken SSRIs/SNRIs as a patient population in need.
Moreover, since PFIZER teaches patients receiving other medications were not treated, the artisan would find it obvious to treat patients not receiving SSRIs/SNRIs. Furthermore, both MAYO and PFIZER teach the administration of PF-04457845 as a monotherapy (Pg. 538 Abstract Methods; Pg. 1 Detailed Description). Thus, the artisan would have a reasonable expectation of success in treating individuals not concurrently or priorly being treated with SSRIs/SNRIs.
Conclusion
Claims 1, 3-9, and 11-17 are rejected.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625