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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) was acknowledged. The instant application claims priority to U.S. Provisional Application No. 63/389,763, filed July 15, 2022. The instant application, filed July 17, 2023, is entitled to the claim for domestic benefit because July 15, 2023 fell on a Saturday. See 35 U.S.C. 119(e)(3).
Status of Claims
Claims 1-19 were pending and rejected in the Non-final Rejection mailed 11/28/2025. Applicant’s present amendments to the claims were received on 05/22/2026, which are acknowledged and entered. Claims 1 and 15 are amended. Claims 2-14 and 16-19 were maintained as previously presented.
Accordingly, claims 1-19 are pending and under consideration in the instant application.
The pending claims have been examined on their merits.
The previous rejections of claims 1-6, 8-12, and 15-18 under 35 U.S.C. 103 as being unpatentable over EP ’508 in view of Brown 2012 and WO ’949, are maintained.1
The previous rejection of claim 19 under 35 U.S.C. 103 as being unpatentable over EP ’508 in view of Brown 2012, WO ’949, Johnson 2011, Mayo 2020 and Doenni 2016, is maintained.
The previous rejections of claims 7 and 13 under 35 U.S.C. 103 as being unpatentable over EP’508 in view of Dubey 2015, are maintained.
The previous rejection of claim 14 under 35 U.S.C. 103 as being unpatentable over EP ’508 in view of Ahn 2011, is maintained.
The previous rejection of claim 1 on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 8,044,052, is maintained.
Specification Objections Withdrawn
Applicant submission of a Substitution Specification to resolve the blurry chemical structures is acknowledged and entered. The objections to the Specification are withdrawn.
Claim Objections Withdrawn
Applicant’s amendment to claim 1 to resolve the blurry chemical structure is acknowledged. The objection to claim 1 is withdrawn.
Claim Rejections - 35 USC § 112(d) - Withdrawn
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Response to Arguments:
Applicant’s arguments, see Remarks received 05/22/2026, at 8-9 of 13, with respect to rejections of claims 10, 12, and 15 under 35 USC 112(d) have been fully considered. The rejections of claims 10, 12, and 15 under 35 USC 112(d) have been withdrawn, in view of the amendments to claims resolving the USC 112(d) issues.
Claim Rejections - 35 USC § 103 - Maintained
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.
Claims 1-6, 8-12, and 15-18 are obvious over EP ‘508 in view of Brown 2012 and WO ’949:
The previous rejections of claims 1-6, 8-12, and 15-18 under 35 U.S.C. 103 as being unpatentable over EP ’508 in view of Brown 2012 and WO ’949, is maintained.2
Response to Arguments:
Applicant’s arguments, see Remarks received 05/22/2026, at 9-12 of 13, with respect to rejections of claims 1-6, 8-12, and 15-18 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant’s first position is “that there is no motivation to modify or combine EP '508 based on the teachings of Brown 2012 and WO '949.” Remarks received 05/22/2026, at 10. Applicant cites In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006), for its discussion of the motivation-suggestion-teaching test, and states that “In the present case, however, there is no motivation to modify or combine modify EP '508 based on the teachings of Brown 2012 and WO '949 simply because Brown 2012 indicates that OH is a bioisostere for H and WO '949 indicates that methyl substitution at that position resulted in a compound that inhibited the human FAAH enzyme.” Remarks received 05/22/2026, at 10. Applicant alleges “The Office has not articulated any clear rationale why one of ordinary skill in the art would be motivated to alter a compound which is already effective for inhibiting the activity of FAAH to arrive at the compound of the present claims.” Remarks received 05/22/2026, at 10.
The following figure summarizes the references EP ’508, Brown 2012, and WO ’949 cited in the rejections, and is provided as quick reference to their teachings.
PNG
media_image1.png
886
1822
media_image1.png
Greyscale
Applicant’s first position is not persuasive because the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, the knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made established that there was a reasonable expectation of success in making the claimed compound. The Example 5 compound of EP ’508 was an effective active pharmaceutical ingredient (an “API”) indicated for the treatment of conditions associated with elevated FAAH activity. It served as a natural, obvious starting place for any reasonable chemist seeking to develop an alternative FAAH inhibitor to administer to patients. The examiner cited MPEP § 2144.09 in the Non-Final Rejection mailed 11/28/2025 at 9 to explain that when compounds “have very close structural similarities and similar utilities”, that the “chemical structure and function entails the motivation of one skilled in the art to make a claimed compound”.
The examiner also provided an example of where this had already occurred based upon the Example 5 compound of EP ’508. WO ’949 taught the methyl analog of the Example 5 compound of EP ’508. That methyl analog had very close structural similarities and similar utilities to the Example 5 compound of EP ’508. See Non-Final Rejection mailed 11/28/2025 at 8, and the above figure.
The examiner also explained that bioisosteric replacements were well-known, routine optimization techniques employed by ordinary medicinal chemists at the time of filing. See Non-Final Rejection mailed 11/28/2025 at 7-8, discussion of Brown 2012. Again, the examiner provided an example where this had already occurred – the WO ’949 methyl analog was a classical bioisostere of the Example 5 compound of EP ’508.
Brown 2012 itself listed four different classical bioisosteric replacements for H that these ordinary medicinal chemists employed during their process of routine optimization. Each replacement provided a reasonable expectation of success, and one had already proven that fact. Just as expected, the inventors of the WO ’949 methyl analog learned that the bioisosteric API maintained potency towards FAAH but had slightly different properties. Methyl, for example, is slightly more non-polar and lipophilic than the hydrogen of the Example 5 compound of EP ’508.
Seeking to maintain potency towards the same FAAH receptor, Brown 2012 explained that based on the well-known principles of classical bioisosterism, the medicinal chemist could also choose F, OH, or NH. Each bioisosteric compound would have slightly different properties due to the replacement (e.g., solubility or metabolism), but all would reasonably be expected to have antagonistic activity towards human FAAH. Accordingly, each replacement would offer a reasonable expectation of success in view of their function as classical bioisosteres.
Therefore, Applicant’s first position, that “there is no motivation to modify or combine modify EP '508 based on the teachings of Brown 2012 and WO '949 simply because Brown 2012 indicates that OH is a bioisostere for H and WO '949 indicates that methyl substitution at that position resulted in a compound that inhibited the human FAAH enzyme”, is not persuasive.
Applicant’s second position is that “any motivation to make the proposed modification is improper hindsight bias based solely on Applicant's disclosure.” Remarks received 05/22/2026, at 11. Applicant’s second position is not persuasive because Applicant has not identified any portion of the rejection as including knowledge gleaned only from Applicant's disclosure. EP '508, Brown 2012 and WO '949 were each published a decade prior to the filing of the instant application and established then that there was a reasonable expectation of success in making the claimed invention.
Accordingly, Applicant’s second position is not persuasive.
Restated Rejection:
Claims 1-6, 8-12, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Fay et al., European Patent Specification EP 2076508 B1, published on May 1, 2011 (hereinafter “EP ’508”), in view of Nathan Brown, Bioisosterism in Medicinal Chemistry, in Bioisosteres in Medicinal Chemistry 1, 1-14 (Nathan Brown ed., 1st ed. 2012) (hereinafter “Brown 2012”) and Meyers et al., International Application Publication No. WO 2009/127949 A1, published on October 22, 2009 (hereinafter “WO ’949”).
Claim 1 of the instant application is directed to compositions comprising a benzylidine piperidine substituted urea compound of Formula (I), and encompasses one disclosed compound, for example, Compound A:
PNG
media_image2.png
58
215
media_image2.png
Greyscale
(named 3-hydroxy-N-(pyridazin-3-yl)-4-(3-((5-trifluoromethyl)pyridine-2-yl)oxy) benzylidene)piperidine-1-carboxamide in paragraph [0047] of the Specification).3
EP ’508
EP ’508 teaches similar benzylidine piperidine substituted urea compounds, which differ primarily by the lack of substitution at the 3-position of the piperidine ring (i.e., the substituent labeled R6 in the instant application). For example, EP ’508 at claim 3 teaches:
PNG
media_image3.png
650
916
media_image3.png
Greyscale
EP ’508 at claim 3.
EP ’508 further teaches, and at claim 6, directly claims the compound N-pyridazin-3-yl-4-(3-{[5-(trifluoromethyl)pyridin-2-yl]oxy}benzylidene)piperidine-1-carboxamide (hereinafter the “Example 5 compound of EP ’508”). The chemical structure of this compound is provided below. Its synthesis is described in Example 5a and Example 5b of EP ’508 at page 26, lines 17-50, and its observed fatty acid amide hydrolase (“FAAH”) enzyme inhibition kinetics are provided in EP ’508 at page 82, Table 2, Ex. 5 (hFAAH kinact/Ki = 24700 M-1s-1). The Example 5 compound of EP ’508 is analogous to Compound A of the instant application, with the only change being that the 3-position of the piperidine ring lacks hydroxyl substitution (i.e., the substituent labeled R6 in claim 1 of the instant application is H).
PNG
media_image4.png
200
400
media_image4.png
Greyscale
The Example 5 compound of EP ’508 corresponds to the instant compound of Formula (I), wherein R1 is hydrogen, R2 is a 6-membered aromatic heterocycle containing 2 nitrogen ring heteroatoms (pyridazinyl), R3 is hydrogen, R4 is hydrogen, R5 is haloalkyl (trifluoromethyl), R6 is hydrogen, m is 0, n is 0, p is 1, Z1 is N, and Z2 is CH. It may be used in a pharmaceutical composition, as itself or as a pharmaceutically acceptable salt or solvate thereof, and in combination with an excipient. For example, EP ’508 teaches:
The compounds herein, and the pharmaceutically acceptable salts thereof, can be administered as crystalline or amorphous forms, hydrates, solvates, complexes, and tautomers thereof, as well as all isotopically-labeled compounds thereof. They may be administered alone or in combination with one another or with one or more pharmacologically active compounds which are different than the compounds described or specifically named herein, and the pharmaceutically acceptable salts thereof. Generally, one or more these compounds are administered as a pharmaceutical composition (a formulation) in association with one or more pharmaceutically acceptable excipients.
EP’508 at [0070].
While the Example 5 compound of EP ‘508 is identical to the exemplified embodiment of the instant claims (see Compound A above) except for the substitution of a hydroxyl group at the 3-position of the piperidine ring for one of the two hydrogen atoms, one of ordinary skill in the art would have a reasonable expectation of success in substituting a hydroxyl group (i.e., -OH) for a hydrogen at the 3-position of the piperidine ring because: 1) both groups are considered bioequivalent/bioisosteres in medicinal chemistry; and 2) the 3-position of the piperidine ring on this molecular scaffold is amendable to chemical modification for tuning activity. For example, see Brown 2012 and WO ’949.
Brown 2012
Brown 2012 teaches a definition of bioisosteres and identifies certain bioisosteres for H:
‘Compounds or groups that possess near-equal molecular shapes and volumes, approximately the same distribution of electrons, and which exhibit similar physiochemical properties….’
Brown 2012 at 8,
PNG
media_image5.png
658
884
media_image5.png
Greyscale
Brown 2012 at 7.
Brown 2012 further teaches the general acceptance of bioisosterism in the art of medicinal chemistry. For example, Brown 2012 explains that it is routine to identify substituents that are bioisosteric replacements:
When considering a medicinal chemistry project where a lead molecule has been identified, and also chemical handles, to permit the synthesis of many analogues, the project team will identify substituents that are potential bioisosteric replacements using a number of different methods.
Brown 2012 at 9, and
Bioisosteric replacement is often considered when the aims are to maintain enzyme potency while optimizing additional properties, such as cellular penetration, solubility, metabolism, toxicity, and so on.
Brown 2012 at 12.
WO ’949
WO ’949 teaches that the 3-position of the piperidine ring of the Example 5 compound of EP ’508 is amendable to chemical modification for tuning activity. For example, the synthesis of the R6 = CH3 analog of the Example 5 compound of EP ’508, (4E)-3-methyl-N-pyridazin-3-yl-4-(3-{[5-(trifluoromethyl)pyridin-2-yl]oxy}benzylidene)piperidine-1-carboxamide, is taught in WO ’949 at page 32, under Examples 1 and 2. The structure of this compound, hereinafter the “WO ’949 methyl analog”, is provided below. WO ’949 teaches that this compound also inhibits the human FAAH enzyme, specifically, with inhibition kinetics of hFAAH Kinact/Ki = 4590, 3120, 683, 495, 254 M-1s-1. WO ’949 at 43-45.4
PNG
media_image6.png
176
400
media_image6.png
Greyscale
The instant compound A was obvious at the time of filing
The following figure shows structures of the prior art active pharmaceutical ingredients (Example 5 of EP ’508 and the WO ’949 Methyl Analog, as well as the claimed invention – the Instant Compound A:
PNG
media_image1.png
886
1822
media_image1.png
Greyscale
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990). See also MPEP § 2144.09.
One having ordinary skill in the art at the time of the claimed invention would have found it obvious to substitute a hydroxyl group (i.e., -OH) for the hydrogen at the 3-position of the piperidine ring of the Example 5 compound of EP ’508, because Brown 2012 discloses that OH is a classical bioisostere for H. The skilled artisan would have been motivated to select the 3-position of the piperidine ring of the Example 5 compound of EP ’508 for substitution because WO ’949 taught that methyl substitution at that position resulted in a compound that inhibited the human FAAH enzyme. Being a bioisosteric equivalent of the Example 5 compound of EP ’508, it would be obvious to use the hydroxyl substituted compound for the same purposes, namely in a pharmaceutical composition comprising the compound or a pharmaceutically acceptable salt or solvate thereof, with at least one pharmaceutically acceptable excipient, as taught by EP ’508. There would have been a reasonable expectation of success, because Brown 2012 discloses that bioisosteres are groups that possess near-equal molecular shapes and volumes, approximately the same distribution of electrons, and which exhibit similar physiochemical properties.
While secondary considerations, such as unexpected results in the human FAAH enzyme inhibition kinetics determined for various embodiments of the claimed invention, may provide indicia of unobviousness, the Specification at Table 2, pages 38-39, reports IC50 values for various compounds of Formula (I) within the expected range based upon similar benzylidine piperidine compounds. For example, WO ’949 teaches that methyl substitution at 3-position of the piperidine ring of the Example 5 compound of EP ’508 decreases the human FAAH enzyme inhibition kinetics of the resulting compound, as determined by comparing the reported hFAAH Kinact/Ki values.5 One having ordinary skill in the art at the time of the claimed invention would expect a similar effect caused by hydroxyl substitution at the same position, because Brown 2012 teaches that CH3 and OH are bioisosteric equivalents for H. See supra Table 1.3 from Brown 2012 at 8. According to the Specification of the instant application, hydroxyl substitution at the at 3-position of the piperidine ring of the Example 5 compound of EP ’508 resulted in the expected decrease in the inhibition potency. See Table 2 of the Specification of the instant application, pages 38-39 (confirming that Human FAAH IC50 values reported for hydroxyl substitution (Compounds A-SE, A-RZ, A-RE, A-SZ) are higher than those for the Example 5 compound of EP ’508 (referred to in the Specification as Compound of Formula (II)).
Thus, the invention of claim 1 as a whole is prima facie obvious over the references, especially in absence of evidence to the contrary.
Claims 2-6 and 8-9 were obvious at the time of filing
Claims 2-6 and 8-9 read on Compound A and were prima facie obvious at the time of filing for the reasons presented in claim 1.
Claims 10-12 were obvious at the time of filing
Claim 10 is directed to the pharmaceutical composition according to claim 1, wherein the compound of Formula (I) is one of the four possible enantiomer/stereoisomers of the exemplified embodiment of the instant claims, Compound A, viz. the (R,E), (S,E), (R,Z), and (S,Z) stereoisomers of Compound A, or a pharmaceutically acceptable salt or solvate thereof.
Claim 11 is directed to the pharmaceutical composition according to claim 1, wherein the compound of Formula (I) is the (R,E) stereoisomer of Compound A, , or a pharmaceutically acceptable salt or solvate thereof.
Claim 12 is directed to the pharmaceutical composition according to claim 1, wherein the compound of Formula (I) is the (R,Z) stereoisomer of Compound A, , or a pharmaceutically acceptable salt or solvate thereof.
While the core structure of Compound A was prima facie obvious at the time of filing for the reasons presented in claim 1, one of ordinary skill in the art would have been motivated to prepare the four possible stereoisomers of the exemplified embodiment of Compound A because the different stereoisomers of the similar WO ’949 methyl analog were known.
WO ’949 teaches that the synthesis of the WO ’949 methyl analog resulted in both of its E and Z isomers, from which the two enantiomers of the E-olefin were isolated.
The reaction was concentrated to give the crude product as a racemic mixture of olefin isomers (-6:1 E:Z). The isomers were separated by chiral SFC on a Chiralpak AS-H column (15% isopropanol/C02) to give the two enantiomers of the E-olefin.
WO ’949 at 32.
A person having ordinary skill in the art at the time of filing would have had a reasonable expectation of success in selecting one of the four possible stereoisomers of the exemplified embodiment Compound A because WO ’949 taught that for the WO ’949 methyl analog, the resulting human FAAH inhibition kinetics were sensitive to the orientation of the methyl group at the 3-position of the piperidine ring.
For example, WO ’949 teaches that for the WO ’949 methyl analog, the human FAAH enzyme inhibition kinetics were dependent upon the chirality of the carbon pertaining to where the methyl substitution occurred. See WO ’949, page 43, Table entries for Ex. 1 and Ex. 2.6
While WO ’949 does not directly teach the human FAAH enzyme inhibition kinetics of the Z stereoisomers of the WO ’949 methyl analog, a person having ordinary skill in the art of medicinal chemistry at the time of filing would have been motivated to investigate the effect of the E/Z orientation of the benzylidine piperidine double bond on the human FAAH enzyme inhibition kinetics of a compound employing the same benzylidine piperidine molecular scaffold because the resulting human FAAH enzyme inhibition kinetics for the WO ’949 methyl analog were sensitive enough to impart an approximately 18-fold less potent hFAAH inhibitor based solely on chirality of the E isomer. Compare the hFAAH Kinact/Ki for Ex. 1 and Ex. 2 reported in the table on page 43 of WO ’949 (4590 and 254 M-1s-1, respectively).
Therefore, one of ordinary skill in the art would have found claims 10-12 prima facie obvious at the time of filing.
Claim 15 was obvious at the time of filing
Claim 15 recites:
PNG
media_image7.png
101
702
media_image7.png
Greyscale
Instant claim 15.
Claim 15 was prima facie obvious at the time of filing for the reasons presented in claim 1. As explained in claim 1, a pharmaceutical composition comprising a compound of Formula (I), or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, was prima facie obvious at the time of filing.
Therefore, claim 15 was prima facie obvious at the time of filing.
Claims 16-17 were obvious at the time of filing
Claim 16 is directed to the pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a solid oral dosage form.
Claim 17 is directed to the pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a tablet.
While EP ’508 does not specifically teach a solid oral dosage form or a tablet form of the pharmaceutical composition of claim 1, one of ordinary skill in the art would have a reasonable expectation of success in developing the pharmaceutical composition of claim 1 in a solid oral dosage form or in tablet form because EP ’508 teaches that the compounds used in the pharmaceutical compositions of EP ’508 may be used in a solid oral dosage form, one of which is in the form of tablets. For example, EP ’508 teaches:
Formulations suitable for oral administration include-solid, semi-solid and liquid systems such as tablets; soft or hard capsules containing multi- or nano-particulates, liquids, or powders; lozenges which may be liquid-filled; chews; gels; fast dispersing dosage forms; films; ovules; sprays; and buccal or mucoadhesive patches.
EP ’508 at 12, paragraph [0072], and
“Pharmaceutical composition" refers to the combination of one or more drug substances and one or more excipients. "Drug product," "pharmaceutical dosage form," "dosage form," "final dosage form" and the like, refer to a pharmaceutical composition that is administered to a subject in need of treatment and generally may be in the form of tablets, capsules, liquid solutions or suspensions, patches, films, and the like.
EP ’508 at page 5, lines 44-48.
Since Compound A, i.e., an exemplified embodiment of a compound encompassed by claim 1, is a bioisosteric equivalent of the Example 5 compound of EP ’508, it would be obvious to use it for the same purposes as taught by EP ’508, namely in a pharmaceutical composition, wherein the pharmaceutical composition is a solid oral dosage form or a tablet.
Therefore, claims 16 and 17 were prima facie obvious at the time of filing.
Claim 18 was obvious at the time of filing
Claim 18 is directed to a method of inhibiting FAAH in a subject in need thereof, comprising administering to the subject a pharmaceutical composition according to claim 1.
While EP ’508 does not specifically teach a method of inhibiting FAAH in a subject in need thereof, comprising administering to the subject a pharmaceutical composition according to claim 1, one of ordinary skill in the art would have a reasonable expectation of success in developing such a method because EP ’508 teaches that the compounds of its disclosure are effective for such a purpose. For example,
The present invention relates to compounds of Formula I, Formula II and Formula III, compounds specifically named below, and their pharmaceutically acceptable salts, which are effective for inhibiting the activity of FAAH.
EP ’508 at page 6, paragraph [0032], and
The invention also discloses in part, methods of treating FAAH-mediated diseases or conditions including acute pain, chronic pain, neuropathic pain, nociceptive pain, inflammatory pain urinary incontinence, overactive bladder, emesis, cognitive disorders, anxiety, depression, sleeping disorders, eating disorders, movement disorders, glaucoma, psoriasis, multiple sclerosis, cerebrovascular disorders, brain injury, gastrointestinal disorders, hypertension, or cardiovascular disease in a subject by administering to a subject in need thereof a therapeutically effective amount of one or more of the compounds herein, and the pharmaceutically acceptable salts thereof,.
EP ’508 at page 3, paragraph [0009].
Since Compound A, i.e., an exemplified embodiment of a compound encompassed by claim 1, is a bioisosteric equivalent of the Example 5 compound of EP ’508, it would be obvious to use it for the same purposes as taught by EP ’508, namely in a method of inhibiting FAAH in a subject in need thereof, comprising administering to the subject a pharmaceutical composition according to claim 1.
Therefore, claim 18 was prima facie obvious at the time of filing.
Claim 19 is obvious over EP ‘508 in view of Brown 2012, WO ’949, Johnson 2011, Mayo 2020 and Doenni 2016:
The previous rejection of claim 19 under 35 U.S.C. 103 as being unpatentable over EP ’508 in view of Brown 2012, WO ’949, Johnson 2011, Mayo 2020 and Doenni 2016, is maintained.
Response to Arguments:
Applicant’s arguments, see Remarks received 05/22/2026, at 9-12 of 13, with respect to rejections of claim 19 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant alleges in its Remarks at 11 that each of the references Johnson 2011, Mayo 2020, and Doenni 2016 individually “fails to provide the one of ordinary skill in the art the requisite motivation to modify EP '508 based on the teachings of Brown 2012 and WO '949”.
Applicant’s arguments against the references individually are not persuasive because 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).
Moreover, Johnson 2011, Mayo 2020, Doenni 2016, and Ahn 2011 each discuss the known pharmaceutical properties of the API designated PF-04457845, which is the Example 5 compound of EP ’508. Johnson 2011, Mayo 2020, and Doenni 2016 each provide motivation to further utilize the API designated PF-04457845, which is the Example 5 compound of EP ’508, as a chemical scaffold to modify to develop an alternative FAAH inhibitor to administer to patients.
The motivation was clear, even in Applicant’s own words. See, e.g., Remarks received 05/22/2026, at 11 (“… Johnson 2011 discloses that PF-04457845 is a highly efficacious and selective FAAH inhibitor.”); id. (“… Mayo 2020 discloses that PF-04457845 provides evidence that human FAAH inhibition may provide a means for the treatment of post-traumatic stress disorder.”); id. (“… Doenni 2016 discloses that FAAH inhibition by PF-04457845 could be a novel target for disorders involving social deficits such as social anxiety disorders or autism.”).
The alternative bioisosteric API would reasonably be expected to share similar efficacy as well as indications for the treatment of PTSD and social anxiety disorders or autism. The motivation to prepare the bioisosteric API flows from the reasonable expectation of success in utilizing it for treating the same conditions already known for PF-04457845, i.e., the Example 5 compound of EP ’508.
Therefore, Applicant’s arguments against the references individually are not persuasive.
Restated Rejection:
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over EP ’508 in view of Brown 2012, WO ’949, Johnson et al., “Discovery of PF-04457845: A Highly Potent, Orally Bioavailable, and Selective Urea FAAH Inhibitor,” ACS Medicinal Chemistry Letters, vol. 2, no. 2, pages 91-96 (2011) (hereinafter “Johnson 2011”), Mayo et al., “Elevated Anandamide, Enhanced Recall of Fear Extinction, and Attenuated Stress Responses Following Inhibition of Fatty Acid Amide Hydrolase: A Randomized, Controlled Experimental Medicine Trial,” Biological Psychiatry, vol. 87, no. 6, pages 538-547 (2020) (hereinafter “Mayo 2020”), and Doenni et al., “Deficient adolescent social behavior following early-life inflammation is ameliorated by augmentation of anandamide signaling,” Brain, Behavior, and Immunity, vol. 58, pages 237-247 (2016) (hereinafter “Doenni 2016).
Claim 19 is directed to a method of treating an autism spectrum disorder or post-traumatic stress disorder in a subject in need thereof, comprising administering to the subject a pharmaceutical composition according to any one of claim 1.
EP ’508, Brown 2012, and WO ’949 are relied upon as above.
While EP ’508, Brown 2012, and WO ’949 do not teach a method of treating an autism spectrum disorder or post-traumatic stress disorder in a subject in need thereof, comprising administering to the subject a pharmaceutical composition according to any one of claim 1, one of ordinary skill in the art would have a reasonable expectation of success in using such a composition in a method for treating post-traumatic stress disorder in a subject in need thereof, because the Example 5 compound of EP ’508 was used in such a manner. For example, see Johnson 2011 and Mayo 2020.
Johnson 2011
As background, Johnson 2011 teaches that PF-04457845 is the name assigned to the Example 5 compound of EP ’508.
Herein, we report the discovery and characterization of a highly efficacious and selective FAAH inhibitor PF-04457845 (23).
PNG
media_image8.png
356
873
media_image8.png
Greyscale
Johnson 2011 at Abstract.
Mayo 2020
Mayo 2020 teaches that PF-04457845 was used as an FAAH inhibitor to assess evidence that human FAAH inhibition may provide a means for the treatment of posttraumatic stress disorder. For example, Mayo 2020 teaches:
METHODS: In this double-blind, placebo-controlled experimental medicine study, healthy adults were randomized to an FAAH inhibitor (PF-04457845, 4 mg orally, once daily; n = 16) or placebo (n = 29) for 10 days. On days 9 and 10, participants completed a task battery assessing psychophysiological indices of fear learning, stress reactivity, and stress-induced affective responses.
Mayo 2020 at Abstract, and
CONCLUSIONS: Our data provide preliminary human evidence that FAAH inhibition can improve the recall of fear extinction memories and attenuate the anxiogenic effects of stress, in a direct translation of rodent findings. 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.
Mayo 2020 at Abstract.
Since Compound A, i.e., an exemplified embodiment of a compound encompassed by claim 1, is a bioisosteric equivalent of the Example 5 compound of EP ’508 (i.e., PF-04457845), it would be obvious to use it for the same purposes as taught by Mayo 2020, namely in a method of treating post-traumatic stress disorder in a subject in need thereof, comprising administering to the subject a pharmaceutical composition according to any one of claim 1.
Furthermore, one of ordinary skill in the art would have a reasonable expectation of success in using such a composition in a method for treating an autism spectrum disorder in a subject in need thereof, because the Example 5 compound of EP ’508 was used in such a manner. For example, see Doenni 2016.
Doenni 2016
Doenni 2016 teaches the administration of PF-04457845 in female Sprague Dawley rats:
Oral administration of the FAAH inhibitor PF-04457845 (1 mg/kg) prior to the social interaction task normalizes LPS-induced alterations in social behavior, while not affecting social behavior in the control group. Infusion of 10 ng PF-04457845 into the basolateral amygdala normalized social behavior in LPS injected females. These data suggest that alterations in eCB signaling following postnatal inflammation contribute to impairments in social behavior during adolescence and that inhibition of FAAH could be a novel target for disorders involving social deficits such as social anxiety disorders or autism.
Doenni 2016 at Abstract.
Since Compound A, i.e., an exemplified embodiment of a compound encompassed by claim 1, is a bioisosteric equivalent of the Example 5 compound of EP ’508 (i.e., PF-04457845), it would be obvious to use it for the same purposes as taught by Doenni 2016, namely in a method of treating an autism spectrum disorder in a subject in need thereof, comprising administering to the subject a pharmaceutical composition according to any one of claim 1.
Therefore, claim 19 was prima facie obvious at the time of filing.
Claims 7 and 13 are obvious over EP ‘508 in view of Dubey 2015:
The previous rejections of claims 7 and 13 under 35 U.S.C. 103 as being unpatentable over EP’508 in view of Dubey 2015, are maintained.
Response to Arguments:
Applicant’s arguments, see Remarks received 05/22/2026, at 9-12 of 13, with respect to rejections of claims 7 and 13 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant alleges in its Remarks at 12 that
PNG
media_image9.png
123
682
media_image9.png
Greyscale
Remarks received 05/22/2026 at 12.
Dubey 2015 was not combined with EP ’508 in view of Brown 2012 and WO '949. Therefore, Applicant has not articulated a position regarding the combination of EP ’508 in view of Dubey 2015. Therefore, the examiner cannot respond to Applicant’s positions regarding the combination of references utilized in the rejections of claims 7 and 13.
Restated Rejection:
Claims 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over EP’508 in view of Sonal Dubey and Pradnya A. Bhosle, “Pyridazinone: an important element of pharmacophore possessing,” Med. Chem. Res., vol. 24, pp. 3579-3598 (2015) (hereinafter “Dubey 2015).
Claim 7 is directed to the pharmaceutical composition according to claim 1, wherein R6 is H and R2 is —C(O)—C1-C6 alkyl—C(O)—R7 or dihydropyridazinone.7
Claim 13 is directed to the pharmaceutical composition according to claim 1, wherein the compound of Formula (I) is the compound referred to as “Compound B” in the Specification of the instant application, e.g., at [0051], or a pharmaceutically acceptable salt or solvate thereof. Compound B is reproduced below:
PNG
media_image10.png
310
1072
media_image10.png
Greyscale
Compound B reads on the “wherein R6 is dihydropyridazinone” element of claim 7, as the examiner interprets the 6-oxo-1,4,5,6-tetrahydropyridazin-3-yl group as an example of a dihydropyridazinone.
EP ’508 is relied upon as above to teach the Example 5 compound of EP ’508, its use in a composition comprising the compound or a pharmaceutically acceptable salt or solvate thereof; and at least one pharmaceutically acceptable excipient.
While the Example 5 compound of EP ’508 is identical to the exemplified embodiment of the instant claims (see Compound B above) except for the 6-oxo-1,4,5,6-tetrahydropyridazin-3-yl group in Compound B which replaces the pyridazin-3-yl group in Example 5 compound of EP ’508, one of ordinary skill in the art would have a reasonable expectation of success in substituting the 6-oxo-1,4,5,6-tetrahydropyridazin-3-yl group for a pyridazin-3-yl group because pyridazinones, a class of molecules of which the 6-oxo-1,4,5,6-tetrahydropyridazin-3-yl group belongs to, were known in medicinal chemistry to impart a wide range of pharmaceutical benefits when incorporated into drug substances. For example, see Dubey 2015.
Dubey 2015
As background, Dubey 2015 teaches:
Pyridazinone, a derivative of pyridazine, was initially exploited in search of cardiovascular drugs and for its use in agrochemicals, but later on this nucleus was found to be associated with plethora of activities.
Dubey 2015 at Abstract, and
In the past, a lot of research work has been done on pyridazinones. This nucleus is also known as ‘‘wonder nucleus’’ as it has given many compounds with a varied range of pharmacodynamic profile….
Dubey 2015 at 2579.
In its review of the literature surrounding the incorporation of pyridazinones in the chemical structure of drug substances, Dubey 2015 identifies multiple drugs that feature the 6-oxo-1,4,5,6-tetrahydropyridazin-3-yl pharmacophore. For example, Dubey 2015 provides the structure of the following drugs which incorporate the similar dihydropyridazinone motif:
PNG
media_image11.png
191
300
media_image11.png
Greyscale
PNG
media_image12.png
246
306
media_image12.png
Greyscale
Dubey 2015 at 3580, and
PNG
media_image13.png
228
308
media_image13.png
Greyscale
PNG
media_image14.png
243
316
media_image14.png
Greyscale
Dubey 2015 at 3581.
Dubey 2015 further provides examples of drug substances incorporating pyridazinones that possess qualities that overlap with those reported for the Example 5 compound of EP ’508, such as analgesic, anti-inflammatory, antihypertensive, antidepressant-anxiolytic, qualities and activity for neurological disorders. See Dubey 2015 at 3579 (last paragraph) – 3580.
Claims 7 and 13 were obvious at the time of filing
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990). See also MPEP § 2144.09.
One having ordinary skill in the art at the time of the claimed invention would have found it obvious to substitute a pyridazinone, an in particular the dihydropyridazinone (6-oxo-1,4,5,6-tetrahydropyridazin-3-yl) group for the pyridazin-3-yl group in Example 5 compound of EP ’508, because Dubey 2015 discloses that incorporating pyridazinones as a pharmacophore in a drug substance can impart a wide range of pharmaceutical benefits. The skilled artisan would have been motivated to select the pyridazin-3-yl group of the Example 5 compound of EP ’508 for substitution because Dubey 2015 teaches that pyridazinones are a derivative of pyridazines. Having very close structural similarities to the Example 5 compound of EP ’508, it would be obvious to use the 6-oxo-1,4,5,6-tetrahydropyridazin-3-yl substituted compound for the same purposes, namely in a pharmaceutical composition comprising the compound or a pharmaceutically acceptable salt or solvate thereof, with at least one pharmaceutically acceptable excipient, as taught by EP ’508. There would have been a reasonable expectation of success, because Dubey 2015 discloses that incorporating pyridazinones into drug substances imparts them with many beneficial pharmaceutical properties that overlap with those reported for the Example 5 compound of EP ’508.
Therefore, claims 7 and 13 were prima facie obvious at the time of filing.
Claim 14 is obvious over EP ‘508 in view of Ahn 2011:
The previous rejection of claim 14 under 35 U.S.C. 103 as being unpatentable over EP ’508 in view of Ahn 2011, is maintained.
Response to Arguments:
Applicant’s arguments, see Remarks received 05/22/2026, at 9-12 of 13, with respect to rejections of claim 14 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant alleges in its Remarks at 12 that
PNG
media_image15.png
164
705
media_image15.png
Greyscale
Remarks received 05/22/2026 at 12.
Ahn 2011 was not combined with EP ’508 in view of Brown 2012 and WO '949. Therefore, Applicant has not articulated a position regarding the combination of EP ’508 in view of Ahn 2011. Therefore, the examiner cannot respond to Applicant’s positions regarding the combination of references utilized in the rejection of claim 14.
Restated Rejection:
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over EP’508 in view of Ahn et al., “Mechanistic and Pharmacological Characterization of PF-04457845: A Highly Potent and Selective Fatty Acid Amide Hydrolase Inhibitor That Reduces Inflammatory and Noninflammatory Pain,” The Journal of Pharmacology and Experimental Therapeutics, vol. 338, no. 1, pp 114-124 (2011) (hereinafter “Ahn 2011”).
Claim 14 is directed to the pharmaceutical composition according to claim 1, wherein the compound of Formula (I) is the compound referred to as “Compound C” in the Specification of the instant application, e.g., at [0052], or a pharmaceutically acceptable salt or solvate thereof. Compound B is reproduced below:
PNG
media_image16.png
215
762
media_image16.png
Greyscale
EP ’508 is relied upon as above to teach the Example 5 compound of EP ’508, its use in a composition comprising the compound or a pharmaceutically acceptable salt or solvate thereof; and at least one pharmaceutically acceptable excipient.
While the Example 5 compound of EP ’508 is identical to the exemplified embodiment of the instant claims (see Compound C above) except for the 4-oxo-butanoic acid group in Compound C which replaces the pyridazine-3-yl group in the Example 5 compound of EP ’508, one of ordinary skill in the art would have a reasonable expectation of success in substituting the 4-oxo-butanoic acid group for a pyridazin-3-yl group because substitution with the 4-oxo-butanoic acid group would: 1) not be expected to interfere with the known mechanism of human FAAH enzyme inhibition that results in inactivation of human FAAH by the Example 5 compound of EP ’508, and 2) allow for tuning of the various physiochemical properties of the resulting compound. For example, see Ahn 2011.
Ahn 2011 provides the schematic mechanism of covalent, irreversible inhibition of FAAH by PF-04457845 (i.e., the Example 5 compound of EP ’508):
PNG
media_image17.png
377
1225
media_image17.png
Greyscale
Anh 2011 at 117.
As taught by Anh 2011, PF-04457845 interacts with the catalytic triad Ser241-Ser217-Lys142 and proceeds to carbamylate the FAAH enzyme, resulting in the irreversible inhibition of FAAH and release of 3-pyridazinamine.
A person having ordinary skill in the art would have a reasonable expectation of success in replacing a 4-oxo-butanoic acid group for the pyridazine-3-yl group in the Example 5 compound of EP ’508, because the 4-oxo-butanoic acid group would be expected to act as a leaving group to form succinamic acid in the same manner as the 3-pyridazinamine group of the Example 5 compound of EP ’508 leaves to form 3-pyridazinamine. The skilled artisan would be motivated to select the pyridazin-3-yl group of the Example 5 compound of EP ’508 for replacement because substituting that group with another group that may function equally well as a leaving group would allow tuning of the various physiochemical properties of the resulting compound, such as in the lipophilicity, solubility, and overall metabolic stability of the drug product.
Therefore, claim 14 was prima facie obvious at the time of filing.
Double Patenting - Maintained
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.
Claim 1 of the instant application is not patentably distinct from claim 8 of the ’052 patent:
The previous rejection of claim 1 on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 8,044,052, is maintained.
Response to Arguments:
Applicant’s position, see Remarks received 05/22/2026, at 13 of 13, with respect to rejection of claim 1 under 35 USC 103 have been fully considered. See Remarks received 05/22/2026, at 13 of 13:
PNG
media_image18.png
213
719
media_image18.png
Greyscale
Remarks received 05/22/2026, at 13 of 13.
The nonstatutory double patenting rejection is maintained as there has been no indication of allowable subject matter.
Restated Rejection:
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 8,044,052, issued October 25, 2011, assigned to Jazz Pharmaceuticals Therapeutics, Inc. on August 7, 2025 (hereinafter “the ’052 patent”) in view of Brown 2012 and WO ’949.
As discussed above, claim 1 of the instant application is directed to compositions comprising a benzylidine piperidine substituted urea compound of Formula (I), and encompasses one disclosed compound, for example, Compound A:
PNG
media_image2.png
58
215
media_image2.png
Greyscale
Claim 8 of the ’052 patent claims a pharmaceutical composition comprising N-pyridazin-3-yl-4-(3-{[5-(trifluoromethyl)pyridin-2-yl]oxy}benzylidene)piperidine-1-carboxamide or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable excipient.
As explained supra, the compound named in claim 8 of the ’052 patent is also referred to as the Example 5 compound of EP ’508 (as well as PF-04457845). As further explained above, the exemplified embodiment of the instant claim 1 (see Compound A above) was prima facie obvious over the Specification of EP ’508, and in particular the structure of the Example 5 compound of EP ’508 in view of Brown 2012 and WO ’949.
Because the named compound in claim 8 of the ’052 patent and the Example 5 compound of EP ’508 are identical, the same analysis applies. However, while claim 8 of the ’052 patent does not specify that the claimed pharmaceutical composition comprise solvates of the named compound, one having ordinary skill in the art would have a reasonable expectation of success in preparing such solvates because WO ’949 taught that such solvates were forms of the compounds that WO ’949 disclosed, such as the WO ’949 methyl analog. For example, WO ’949 explains:
The compounds described and specifically named herein may form pharmaceutically acceptable complexes, salts, solvates and hydrates.
WO ’949 at 11, paragraph 4.
Since the compound named in claim 8 of the ’052 patent is a bioisosteric equivalent of the WO ’949 methyl analog, it would be obvious to use it the same forms as taught by WO ’949, namely as a solvate.
Therefore, claim 1 of the instant application is not patentably distinct from claim 8 of the ’052 patent.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christopher Evan Redwood whose telephone number is (571) 272-8882. The examiner can normally be reached Monday - Friday 6:15 AM - 4:45 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.E.R./ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
1 All references are the same as those designated in the Non-Final Rejection mailed 11/28/2025.
2 The references are the same as those designated in the Non-Final Rejection mailed 11/28/2025.
3 Compound A is selected as the compound of Formula (I) in pending claim 9 of the instant application.
4 Examples 1 and 2 on page 43 refer to enantiomers of the methyl analog compound possessing (E) stereochemistry. See WO ’949 at 32.
5 Compare hFAAH kinact/Ki values for the Example 5 compound of EP ’508, 24700 M-1s-1, EP ’508 at 82, and the WO ’949 methyl analog, 4590, 3120, 683, 495, 254 M-1s-1, WO ’949 at 43-45, discussed supra.
6 WO ’949 does not assign the R/S nomenclature to the enantiomers of Examples 1 and 2, described in WO ’949 at page 32.
7 Claim 1 defines R7 as hydrogen, halogen, —C1-C6 alkyl, —OH, —O-C1-C6 alkyl, or —O—haloalkyl.
Prosecution Insights