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 .
Status of Claims
Claims 32-42 are pending in the instant application.
Priority
The instant application is a continuation of application number 15/780,913, filed on June 1, 2018 which is a 371 of PCT/IB2016/001853 filed on December 2, 2016, which claims foreign priority of AU2015905047, filed on December 4, 2015.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 09/15/2025 was considered by the Examiner.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 15th, 2025 has been entered.
Response to Remarks
Applicant’s arguments and amendments, filed on September 15th, 2025, with respected to the 103 rejection of claims 32-42 under Weiser and DSM-IV have been fully considered and are persuasive.
Applicant’s addition of “wherein the mammal does not suffer from anxiety” in claim 32 has overcome the previous art rejection. The rejection 103 rejection of claims 32-42 has been withdrawn. However, Applicant’s amendments have necessitated a new grounds rejection.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 32-42 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Applicant has amended claim 1 to include the negative proviso, “wherein the mammal does not suffer from anxiety.” However, the instant specification does not provide the necessary support for the proviso. See MPEP 2173.05(i).
Applicant points to paragraphs [0013] and [0017], for support. Paragraphs [0013] and [0017] of the instant disclosure merely disclose that in one aspect of the invention, there is provided a method for the treatment a mental disorder, wherein the mental disorder is selected from an obsessive compulsive disorder, an anxiety disorder or a condition characterized by one or more symptoms of obsessive compulsive disorder or an anxiety disorder. Further, the instant specification discloses that “obsessions are not pleasurable or voluntary, but case marked distress or anxiety in most individuals,” (paragraph [0047], when discussing the symptoms of OCD. The instant specification also discloses that “A change in the normal pattern of the day can cause severe anxiety and/or distress for an individual suffering from OCD.” (paragraph [0049])
The instant disclosure also provides specific examples dealing with an Aromatase Knockout mouse (ArKO) model. The instant specification describes that the models may exhibit behavioral phenotypes reflective of some of the key diagnostic behaviors and symptoms of OCD disorder. However, the instant disclosure also disclose that, still, other behavioral phenotypes exhibited by the male ArKO mouse may be reflective of some of the key diagnostic behaviors and symptoms of anxiety disorders (paragraphs [0055]-[0056]). Further, the instant specification describes that the ArKO model was developed in a way which presents the core OCD and anxiety disorder-like features (paragraph [0125]).
For the reasons above, the specification does not provide support for the now embraced embodiment where the mammal suffers from OCD, but does not suffer from anxiety. Dependent claims 33-42 are rejected as containing new matter for the same reasons as claim 32.
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.
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.
Claim(s) 32-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiser et al (WO 2015/171960 A1) in view of Tuna et al (Behavior Research and Therapy 43 (2005) 15–27).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Weiser teaches a method of improving cognitive performance in a subject in need thereof comprising administering a therapeutically effective amount of 10-Hydroxy-2-decenoic acid or a derivative thereof (claim 23). Weiser teaches that cognitive performance comprises increased speed of learning, improved memory retention and combinations thereof (paragraph [0043]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Weiser does not explicitly teach that the subject has obsessive compulsive disorder (OCD).
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Tuna teaches that OCD patients show impairment in both recall and recognition when compared to patients without OCD (abstract). Tuna further teaches that there is a general memory and metamemory deficit in patients with OCD (abstract). Tuna also reaches that there was a consistent demonstration that there is a memory deficit in patients with OCD, along with poorer cued-recall and recognition memory (discussion).
As such, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date to utilize the method of improving memory taught by Weiser to treat OCD since Tuna teaches that there is a consistent demonstration of a memory deficit in patients with OCD. Motivation to administer 10-hydroxy-2-decenoic acid to a patient suffering from OCD would have resulted from the fact that Tuna demonstrates that subjects with OCD also suffer from memory issues, thus resulting in the practice of the method of claim 32 with a reasonable expectation of success.
Regarding instant claims 33-35, Weiser et al. taught a composition comprising 10-hydroxy-2-decenoic acid. Weiser does not explicitly teach specific isomers; thus the teachings of Weiser are construed to read on a racemic mixture comprising both cis- and trans- isomers of 10-hydroxy-2-decenoic acid. Moreover, regarding the isomers of instant claims 33-35, MPEP 2144.09. states:
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) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.). In the instant case, the stereoisomers and racemic mixture of 10-hydroxy-2-decenoic acid are of sufficient structural similarity that the skilled artisan would have reasonable expectation that each isomer alone or in combination would result in improvement of memory in a subject having OCD. Further, the skilled artisan in the art of developing pharmaceutical composition would have found motivation to administer a specific isomers (e.g., cis) for improving the purity and therapeutic properties of the composition. Taken together, this would result in the practice of the method of claims 33-35 with a reasonable expectation of success.
Regarding claim 36, the method rendered obvious above reads on unspecified obsessive-compulsive disorder.
Regarding claim 37, the prior art is silent regarding "alleviating one or more behavioral disturbances selected from obsessions, compulsions and repetitive behavioral patterns". However: " alleviating one or more behavioral disturbances selected from obsessions, compulsions and repetitive behavioral patterns " will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same compound (10-hydroxy-2-decenoic acid) is being administered to the same subjects (subjects suffering from an obsessive compulsive disorder). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding " alleviating one or more behavioral disturbances selected from obsessions, compulsions and repetitive behavioral patterns” by practicing the method made obvious by the prior art: “the administration of an effective amount of 10-hydroxy-2-decenoic acid to a mammal in need thereof", one will also be " alleviating one or more behavioral disturbances selected from obsessions, compulsions and repetitive behavioral patterns ", even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("alleviating one or more behavioral disturbances selected from obsessions, compulsions and repetitive behavioral patterns ") of the method made obvious by the prior art ("the administration of an effective amount of 10-hydroxy-2-decenoic acid to a mammal in need thereof ").
MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Regarding claim 38, Weiser teaches that the 10-hydroxy-2-decenoic acid can be administered as a composition (claims 1 and 21).
Regarding claim 39, Weiser further teaches that queen bee acid (10-hydroxy-2-decenoic acid) is the predominant fatty acid constituent of royal jelly (paragraph [0003]). This reads on an extract of royal jelly.
Regarding the amounts of instant claims 40-41, Weiser teaches a therapeutically effective amount administered to a human subject in ranges from about 0.2 mg/day to about 5000 mg/day (citation). In addition, Weiser teaches “therapeutically-effect amount” and/or dosage range for compounds used in the method of treatment of the invention may be determined by one of ordinary skill in the art via known criteria including age, weight, and response of the individual patient, and interpreted within the context of the disease being treated and/or prevented.
The skilled artisan would have been motivated to use the amount disclosed by Weiser et al. since such amounts are effective in the treatment of memory issues and suitable for a human administration. Further motivation to adjust the amounts of would have resulted from Weiser et al. since the prior art disclose that amounts can be adjusted according to the patient’s needs. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) MPEP
§
2144.05(I).
Regarding claim 42, Weiser teaches that the subject is preferably a human (paragraph [0070]).
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 32-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,197,840.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method of treatment of obsessive compulsive disorder comprising administering to a mammal in need thereof an effective amount of 10-hyrdoxy-2-decenoic acid or a pharmaceutically acceptable salt thereof.
The previously allowed claims are directed to a method for the treatment of a repetitive behavioral pattern in a subject having obsessive compulsive disorder comprising administering to a mammal in need thereof an effective amount of 10-hyrdoxy-2-decenoic acid or a pharmaceutically acceptable salt thereof, wherein the 10-hyrdoxy-2-decenoic acid is trans, cis or a racemic mixture, wherein the composition is an extract of royal jelly, wherein the effective amounts are the same or very similar to the instantly claimed amounts.
Thus, U.S. Patent No. 11197840 anticipates the claims of the instant application.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699