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 .1
Status of Claims
Claims 1-20 are pending.
Election/Restrictions
Applicant’s election of the species in the reply filed on Aug 29, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The species elected are those psychiatric disorders of claim 5, autistic spectrum disorder, a social anxiety disorder, a depressive disorder including major depressive disorder, and schizophrenia and compound species:
PNG
media_image1.png
114
102
media_image1.png
Greyscale
Compound (xliv):.
Claims 2-4, 6 and 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 29, 2025.
Note that claim 6 is considered withdrawn as substance abuse disorders are not elected within the scope psychiatric disorders of claim 5 (for example, depression and anxiety). The scope of examined compounds is expanded as detailed in the prior art rejections detailed below.
Claims 1, 5, and 7-13 are under examination.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
The present application is a continuation of parent application, 16439570, which in turn is a continuation of International Application PCT/AU2017/051371. Priority to the earlier filed foreign patent (AU 2016905126, filed 12.12.2016) was perfected in International Application PCT/AU2017/051371
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 13 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 10 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation “depressive disorder”, and the claim also recites “including major depressive disorder and schizophrenia” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 10 and 11 are indefinite as follows. Claim 10 recites “the cyclic structure of claim 1”, where claim 1 contains a multitude of cyclic structures from those noted in Formula I per se, to the various functional groups R1-R6, X and X1. It is unknown if the “cyclic” limitation is meant to refer solely to the term “X” which expressly recites “cyclic structure” or is meant to claim any and all cyclic groups recited in claim 1 as aryl, heterocyclyl, cycloalkyl etc.
PNG
media_image2.png
318
360
media_image2.png
Greyscale
Claim 11 recites the “the aryl group” of claim 1, where claim 1 contains a multitude of aryl groups in functional groups R1-R6, X and X1. It is unclear if the limitation is meant to apply to a specific aryl group or all aryl groups of claim 1. Clarification is requested.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, 7 and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2006/021213 (WO 213).
WO 213 is cited on the IDS dated 4/13/2023 as For Ref 007.
Claim 1 is directed towards a method of treating or preventing a condition selected from a social dysfunction, a substance abuse disorder, and a psychiatric disorder ln a subject in need thereof, comprising administering to the subject in need thereof
PNG
media_image2.png
318
360
media_image2.png
Greyscale
Claim 1 encompasses compounds of formula I wherein R1, R3-R6 are H and alkyl; R2 is H; X is a cycloalkyl or aryl, both substituted and unsubstituted, X1 is OH.
It is noted that claim 1 explicitly excludes R2 as unsubstituted methyl.
Regarding claim 1, WO ‘213 teaches the following compound2, that falls within the scope of formula I, where R1, R3-6 are H and R2 is H, where X is a phenyl and substituted with X1 as OH.
PNG
media_image3.png
173
180
media_image3.png
Greyscale
See page 206, Example E75.
See also the compounds 30-31 of page 238, where X is aryl (phenyl)
PNG
media_image4.png
200
400
media_image4.png
Greyscale
Also note WO 213 discloses various compounds such as compound 150, where X is a substituted unfused cycloalkyl (cyclohexyl), as detailed below that fall within the scope of formula I.
WO ‘213 discloses compound 150 that falls within the scope of formula I, where R1, R3-6 are H and R2 is H, where X is a substituted alkyl (cycloalkyl) and substituted with CH2NH2, and X1 is H, see page 253 reproduced below. As the specification does not explicitly recite the substitutions of X, the CH2NH2 group is reasonably interpreted to anticipate said substitution as claimed.
PNG
media_image5.png
405
485
media_image5.png
Greyscale
See also page 253 for compounds 151-156.
PNG
media_image6.png
574
616
media_image6.png
Greyscale
As the specification does not explicitly recite the substitutions of X, the CH2NHR1 group is reasonably interpreted to anticipate said substitution as claimed.
Regarding claim 1 and the claimed subject in need suffering from the psychiatric disorder of depression, WO 213 teaches the use of its compounds for the treatment of the psychiatric disorder depression as well as anxiety as claimed. See claims 72-24.
Per MPEP 2131.02 III. to support the anticipation rejection, a person having ordinary skill in the art (PHOSITA) would immediately envisage the compounds of WO 213 to treat the psychiatric disorders of depression and anxiety as claimed. See above detailing the compounds that fall within the scope of examined claim 1’s formula I.
Regarding claim 5, WO 213 teaches the psychiatric disorder, depression, as well as anxiety, to be treated. See claims 72-24. As per MPEP 2131.02 III., a PHOSITA would immediately envisage using a compound of WO 213 to treat the claimed subject in need of claim 5.
Regarding claim 7, the above E75 compound of WO 213 teaches an unfused aryl group, i.e., phenyl.
Regarding claim 9, WO 213 teaches the following compounds where X is a substituted unfused cycloalkyl (cyclohexyl).
PNG
media_image5.png
405
485
media_image5.png
Greyscale
See also page 253 for compounds 151-156.
PNG
media_image6.png
574
616
media_image6.png
Greyscale
Regarding claim 10 and the limitation of a 6 membered mono-cycloalkyl group. WO ‘213 teaches compounds 149-156 where X is cycloalkyl, see above. NOTE, for claim 10 for purposes of art rejections, the limitation of the cyclic group is interpreted to mean X is an unfused cycloalkyl (cyclohexyl).
Regarding claims 11 and the limitations(s)of an unfused aryl group, such as phenyl, WO ‘213 teaches the above E75 compound which falls within the scope of the invention’s compounds where X as a cyclic structure is a substituted unfused aryl group as claimed. See also the compounds 30-31 of page 238, where X is aryl (phenyl)
PNG
media_image4.png
200
400
media_image4.png
Greyscale
NOTE, for claim 11, for purposes of art rejections, the limitation of the cyclic group is interpreted to mean X is an unfused aryl group, i.e. phenyl.
Regarding claim 12 and the limitation wherein R1, R3, R4, R5, and R6 are each independently selected from the group consisting of: H, WO ‘213 teaches compound E75, and multiple compounds, detailed above where R1-R6 is H, see above.
Regarding claim 13 and the limitation of the compound xvii,
PNG
media_image7.png
316
216
media_image7.png
Greyscale
This compound is anticipated by WO 213 as detailed above.
PNG
media_image3.png
173
180
media_image3.png
Greyscale
See page 206, Example E75.
Claims 1, 5, 7, 10 and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Frantz et al. (Subtlety of the Structure-Affinity and Structure-Efficacy Relationships around a Nonpeptide Oxytocin Receptor Agonist, Journal of Medicinal Chemistry (2010), 53(4), pages 1546-1562).
WO 213 is cited on the IDS dated 4/13/2023 as NPL Ref No. 014.
Regarding claim 1 and the subject in need to be treated (psychiatric disorders inclusive of autism and social anxiety), Frantz teaches compounds, such as oxytocin, and therefore its non-peptide compounds with oxytocin receptor agonist activity, are known to decrease fear associated to social phobia (i.e. notice take to mean social anxiety) and symptoms related to autism. See page 1546, column 1.
With regard to the compound aspect of claim 1 with oxytocin activity, Frantz relates to the design and synthesis of several truncated analogues of compound 1 (table 1, page 1547). See also compound 1 (table 3, page 1550) is shown as potent V1a and/or V2 receptors antagonist.
PNG
media_image8.png
203
734
media_image8.png
Greyscale
Frantz’s compound 1 is equivalent to Formula I’s compound where R1-R6 are hydrogen. Frantz’s compound 1 has a substituted phenyl corresponding to X as a substituted aryl group, where the methyl will correspond to claim 1’s X1 group (a substituted alkyl), and the
PNG
media_image9.png
67
95
media_image9.png
Greyscale
moiety will correspond to a substitution upon X.
The specification does not define or limit the substitutions that occur on the substituted aryl of claim 28 so said carbamido-like group is reasonably interpreted to be a substitution claim 28’s substituted phenyl group (the cyclic group X).
Note that Frantz’s compound 1 exhibits OT Ki activity so as treat autism and social anxiety as claimed.
Per MPEP 2131.02 III. to support the anticipation rejection a person having ordinary skill in the art (PHOSITA) would immediately envisage Frantz’s Compound 1 to treat the psychiatric disorders of social anxiety and autism as claimed.
Regarding claim 5, as discussed above Frantz anticipates the claimed method of treating autism and social anxiety as claimed.
As required by claims 7, 10 and 11 where X is an substituted unfused aryl, Frantz Compound 1 has an unfused substituted phenyl as detailed above. Note that with regard to claim 11, the limitation that aryl is an unfused aryl group is interpreted to be where X is an unfused aryl group.
Regarding claim 12 and the limitation wherein R1, R3, R4, R5, and R6 are each hydrogen, Frantz’s compound 1 teaches at equivalent positions to claim 12, there are hydrogens, see above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 5, and 7-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,491,165 in view of WO 2006/021213 (WO 213). US 11,491,165 is cited on the 4/13/2023 IDS as US Patent Doc 001.
Note that the examined application is a continuation of the parent application 16/439,570 that issued as US 11491165. As the parent application is a continuation of the parent, and not a divisional application, the examined claims are not eligible for the safe harbor provisions against double patenting under 35 U.S.C. § 121.
Although the claims at issue are not identical, they are not patentably distinct
from each other. The reference patent claims recite all of the features instantly recited
with regard to the compounds and a pharmaceutical composition thereof, but do not recite limitations with regard to the treatment of the species of treatment of psychiatric disorders as claimed.
Regarding claim 1 and the claimed subject in need suffering from the psychiatric disorders of depression and anxiety, WO 213 teaches the use of its compounds, determined to be with scope of the claimed compounds, for the treatment of the psychiatric disorder depression as well as anxiety as claimed. See claims 72-24.
Prior to the filing of the present patent application, it would have been prima facie obvious to a PHOSITA following the teachings of the primary reference patent and its compounds and pharmaceutical compositions to be modified by the teachings of secondary reference WO 213 that these compounds can treat psychiatric disorder such as depression and anxiety. The PHOSITA would have had a reasonable expectation of success because the reference patent claims are noted to be pharmaceutical compositions with compounds of similar scope to those of WO 213, where it is taught, these type of compounds are used to treat depression and anxiety.
Claims 1, 5, and 7-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,491,165 in view of Frantz et al, Subtlety of the Structure-Affinity and Structure-Efficacy Relationships around a Nonpeptide Oxytocin Receptor Agonist, Journal of Medicinal Chemistry (2010), 53(4), pages 1546-1562.
US 11491165 is cited on the 4/13/2023 IDS as US Patent Doc 001.
Note that the examined application is a continuation of the parent application 16/439,570 that issued as US 11491165. As the parent application is a continuation of the parent, and not a divisional application, the examined claims are not eligible for the safe harbor provisions against double patenting under 35 U.S.C. § 121.
Although the claims at issue are not identical, they are not patentably distinct
from each other. The reference patent claims recite all of the features instantly recited
with regard to the compounds and a pharmaceutical composition thereof, but do not recite limitations with regard to the treatment of the species of treatment of psychiatric disorders as claimed.
Regarding claim 1 and the claimed subject in need suffering from the psychiatric disorders of social anxiety and autism, Frantz teaches compounds, such as oxytocin, and therefore its non-peptide compounds with oxytocin receptor agonist activity, are known to decrease fear associated to social phobia (i.e. notice take to mean social anxiety) and symptoms related to autism. See page 1546, column 1.
Prior to the filing of the present patent application, it would have been prima facie obvious to a PHOSITA following the teachings of the primary reference patent and its compounds and pharmaceutical compositions to be modified by the teachings of secondary reference Frantz teaching these compounds can treat psychiatric disorder such as autism and social anxiety. The PHOSITA would have had a reasonable expectation of success because the reference patent claims are noted to be pharmaceutical compositions with compounds of similar scope to those of WO 213, where it is taught, these type of compounds are used to treat autism and social anxiety.
Conclusion and Correspondence
In summary no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. 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.
/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 CONTINUING DATA
This application is a CON of 16/439,570 06/12/2019 PAT 11491165
16/439,570 is a CON of PCT/AU17/51371 12/12/2017
FOREIGN APPLICATIONS
AUSTRALIA 2016905126 12/12/2016
This Application has published as US 20230330103.
2CAS Reg. No. 877859-10-4