DETAILED ACTION
This is an initial Office action for non-provisional application 18/487841 filed October 16, 2023, which claims priority to provisional application 63/416250 filed October 14, 2022.
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 . 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.
Elections/Restrictions
In response to the election of species requirement mailed 2/20/26, it is acknowledged that applicant elected the compound:
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encompassing claims 15-18 and 20-28 without traverse. As such, the election of species requirement is deemed proper and made FINAL.
Claim Status
Claims 1-31 are pending. Claims 1-14, 19 and 29-31 are withdrawn. Claims 15-18 and 20-28 are drawn to the elected species.
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 15-18 and 20-28 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.
In the last line of claim 15, the claim refers to Rx as being selected from -C(=O)NR2R3. However, R2 and R3 are not defined in the claim. Thus, it is unclear what variables R2 and R3 represent according to Formula II. Applicant’s clarification is respectfully requested.
Claim 26 recites a list of alternatives of psychiatric disorders. However, the claim recites a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim). This is 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). For example, claim 26 recites the broad recitation “anxiety disorder” and the claim also recites types of anxiety disorders under “including” language, such as “acute stress disorder agoraphobia”, which is the narrower statement of the 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 16-18, 20-25 and 27-28 are rejected as being dependent on rejected claim 15 and not remedying the deficiencies of claim 15.
Claim Rejections - 35 USC § 103
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.
Claims 15-17 and 20-27 are rejected under 35 U.S.C. 103 as being unpatentable over Matinkhoo et al (WO 2023173229; cited in PTO-892 herein).
Regarding claim 15, Matinkhoo et al teach compositions and methods related to a class of chemical compounds known as tryptamines to treat brain neurological disorders (abstract, whole document, paragraph 002). One of the compounds disclosed is:
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(pg. 9), which meets the compound of Formula II, wherein A is aryl, R’ and R’’ are independently methyl and each Rx is independently hydrogen.
However, the compound of Formula II is not immediately envisaged within the teachings of Matinkhoo et al.
Nevertheless, it would have been obvious to select and use the compound of Formula II within the teachings of Matinkhoo et al for the intended use of treating brain neurological disorders. In KSR v. Telefex, 82 USPQ2d 1385, 1397 (U.S. 2007), the Supreme Court has held that when there is market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person has good reason to pursue known options within his or her technical grasp. The court has reasoned a reasonable expectation of success in the art by stating that reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle. Sinclair & Carroll Co., 325 U.S. at 335, 65 USPQ at 301.
Regarding claim 16, Matinkhoo et al teach the compound according to Formula II wherein R’ and R’’ are each methyl.
Regarding claim 17, Matinkhoo et al teach the compound according to Formula II wherein Rx is independently hydrogen.
Regarding claim 20, Matinkhoo et al teach the compound according to Formula II wherein A is aryl.
Regarding claim 21, Matinkhoo et al teach the compound, bis(3-(2-(dimethylamino) ethyl-1H-indol-4-yl) isophthalate (see pg. 9).
Regarding claim 22, Matinkhoo et al teach the compound according to Formula II in pharmaceutical compositions with a pharmaceutically acceptable carrier (paragraphs 00298-00299).
Regarding claims 23-26, Matinkhoo et al teach the compound according to Formula II is contained within compositions that are used to treat brain neurological disorders including anxiety disorders (conditions responsive to serotonin receptor activation), like generalized anxiety disorder among many others, etc. (paragraph 00319).
Regarding claim 27, Matinkhoo et al teach the compounds according to Formula II are contained within compositions that are used to treat diseases associated with pain (i.e., headache disorders including migraines) (paragraph 00319).
Claims 15-18 and 20-28 are rejected under 35 U.S.C. 103 as being unpatentable over Giles et al (WO 2023122320; cited in PTO-892 herein).
Giles et al teach polypodal compounds and prodrugs of serotonergic compounds for treating and preventing a variety of human conditions (pg. 1, lines 10-12). One of the compounds disclosed is:
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(pg. 26, compound 1K), which meets the compound of Formula II, wherein A is C1-C12 alkyl, R’ and R’’ are independently methyl and each Rx is independently hydrogen.
However, the compound of Formula II is not immediately envisaged within the teachings of Giles et al.
Nevertheless, it would have been obvious to select and use the compound of Formula II within the teachings of Giles et al for the intended use of treating brain neurological disorders. In KSR v. Telefex, 82 USPQ2d 1385, 1397 (U.S. 2007), the Supreme Court has held that when there is market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person has good reason to pursue known options within his or her technical grasp. The court has reasoned a reasonable expectation of success in the art by stating that reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle. Sinclair & Carroll Co., 325 U.S. at 335, 65 USPQ at 301.
Regarding claim 16, Giles et al teach the compound according to Formula II wherein R’ and R’’ are each methyl.
Regarding claim 17, Giles et al teach the compound according to Formula II wherein Rx is independently hydrogen.
Regarding claim 18, Giles et al teach the compound according to Formula II wherein A is C1-C6 alkyl.
Regarding claim 20, Giles et al teach the compound according to Formula II wherein A is C1-C6 alkyl.
Regarding claim 21, Giles et al teach the compound, bis(3-(2-(dimethylamino) ethyl-1H-indol-4-yl) glutarate (pg. 26, compound 1K).
Regarding claim 22, Giles et al teach the compound according to Formula II in pharmaceutical compositions with a pharmaceutically acceptable carrier (pg. 60, lines 22-31).
Regarding claims 23-26, Giles et al teach the compounds according to Formula II are contained within compositions that are used to treat brain neurological disorders including anxiety disorders (conditions responsive to serotonin receptor activation), like posttraumatic stress disorder among many others, etc. (pg. 58, line 35—pg. 59, line 13).
Regarding claim 27, Giles et al teach the compounds according to Formula II are used to treat pain and diseases associated with pain (pg. 59, lines 29-31).
Regarding claim 28, Giles et al teach the compound, bis(3-(2-(dimethylamino) ethyl-1H-indol-4-yl) glutarate (pg. 26, compound 1K), which is the claimed compound and applicant’s elected species.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL E BREDEFELD whose telephone number is (571)270-5237. The examiner can normally be reached 8:00-5:00 Monday-Friday.
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/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786