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
This application, filed 05/05/2023 is a National Stage entry of PCT/CA2021/051579, International Filing Date: 11/05/2021. PCT/CA2021/051579 Claims Priority from Provisional Application 63110421, filed 11/06/2020.
Status of Claims
Claims 1, 3-9, 11, and 13-18 are pending as of the response filed on 6/29/26. Claims 2, 10, and 12 have been canceled.
Applicant’s election without traverse of an agonist of ABCF1 in the reply filed on 6/29/26 is acknowledged.
Claims 1, 3-9, 11, and 13-18 were examined and are rejected.
Sequence Listing Deficiency
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). See for instance the sequences cited on pp. 5-6 and p. 19 of the specification.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See reference 3 on p. 20 of specification. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 4, 13, and 16 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 4 recites the broad recitation “loss of interest in things once pleasurable”, and the claim also recites “including sex” 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. To provide compact prosecution the claim was interpreted with respect to the broader limitation.
Claim 13 depends directly from claim 1 and recites “wherein the depressive disorder”, however, claim 1 doesn’t reference a depressive disorder. There is insufficient antecedent basis for this limitation in the claim, and the claim is indefinite. To overcome this rejection, it is suggested the claim be amended to depend directly from claim 3.
Claim 16 is indefinite for referring to a compound as set forth in Table 1 or 2, however, the actual compounds, either by name or chemical structure, are not shown in the claim. The claim as such refers to tables in the specification, without actually reciting the compounds by chemical structure or name. The claim is therefore indefinite, as it is uncertain what compounds are actually encompassed by the claim. See MPEP 2173.05(s): Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
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.
Claim(s) 1, 3-4, 9, 13, 16, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Powell et. al., J. Psychopharmacology, vol. 27(7), pp. 609-615, publ. 2013.
Powell teaches patients with major depressive disorder (MDD) were administered the serotonin reuptake inhibitor, escitalopram, at a dose of 10-30 g. daily for 12 weeks, and that escitalopram treatment resulted in significantly increased levels of ABCF1 expression (abstract; p. 610, Sample para; p. 611, 3rd para under Results; p. 613, Fig. 1). Escitalopram is a known antidepressant (p. 611, right col., 1st para under Discussion). Powell further teaches ABCF1 negatively regulates the translation of proinflammatory cytokines TNF and IL6, both of which have been shown to be increased in MDD patients (p. 613, right col., last para-p. 614, left col., top para).
Powell discloses administration of the ABCF1 agonist, escitalopram, to patients diagnosed with MDD. Therefore, inhibition of neuroinflammation would have necessarily occurred, as Powell teaches treatment of the same patient population as claimed (see claim 3), subjects with MDD, by administering an agonist of ABCF1, escitalopram. See MPEP 2112.02(II): The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). Regarding instant claim 3, “treats or alleviates one or more symptoms of depression in the patient”, escitalopram is taught as a known antidepressant for treating MDD, thereby meeting this limitation. Regarding instant claim 4, “wherein the one or more symptoms are selected from….”, the cited symptoms are all symptoms of depression, and escitalopram is disclosed to treat MDD, thereby one or more symptoms of MDD including those recited would have been necessarily treated. Regarding instant claims 13 and 18, Powell discloses proinflammatory cytokines TNF and IL6 are increased in MDD patients, thereby meeting these limitations. Powell as such anticipates the claims.
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.
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Powell et. al., J. Psychopharmacology, vol. 27(7), pp. 609-615, publ. 2013 (of record), in view of Jefferies et. al., WO 2020163959 A1, publ. 8/20/2020 (int. filing date 2/14/2020), further in view of Neuendorf et. al., J. Psychosomatic Res., vol. 87, pp. 70-80, publ. 2016.
Powell teaches patients with major depressive disorder (MDD) were administered the serotonin reuptake inhibitor, escitalopram, at a dose of 10-30 g. daily for 12 weeks, and that escitalopram treatment resulted in significantly increased levels of ABCF1 expression (abstract; p. 610, Sample para; p. 611, 3rd para under Results; p. 613, Fig. 1). Escitalopram is a known antidepressant (p. 611, right col., 1st para under Discussion). Powell further teaches ABCF1 negatively regulates the translation of proinflammatory cytokines TNF and IL6, both of which have been shown to be increased in MDD patients (p. 613, right col., last para-p. 614, left col., top para).
Powell doesn’t teach or suggest treating a comorbid autoimmune disease in a patient.
Jefferies teaches methods of modulating the immune system via modulation of ABCF1 (abstract; p. 2, last para). Specifically, Jefferies teaches inhibiting an inflammatory response and/or an immune response in a patient in need thereof comprising administering an agonist of ABCF1, an ABCF1 protein, or a polynucleotide encoding ABCF1 (p. 3, 1st 2 para). Jefferies teaches an embodiment of treating an autoimmune disease by administering an agonist of ABCF1 (p. 3, 5th para), wherein autoimmune diseases to be treated including inflammatory bowel diseases such as Crohn’s disease or ulcerative colitis, rheumatoid arthritis, or pancreatitis (p. 5, 1st para). Jefferies exemplifies escitalopram as an ABCF1 agonist, for administration in the treatment of Crohn’s disease (CD) (p. 59, 1st 3 para; p. 60, see both para under Experiments).
Neuendorf et. al. teaches inflammatory bowel disease (IBD) as chronic inflammatory conditions characterized by damage to the mucosal surface of the GI tract, inclusive of CD and ulcerative colitis (UC) (p. 70, 1st para of Intro). Neuendorf teaches depression incidence was higher in CD patients, and in IBD patients with active disease compared to patients in remission (abstract; pp. 75-76, 1st 2 para under Discussion).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claim, to have treated IBD comorbid with depression in a patient in need thereof by administering an agonist of ABCF1, such as escitalopram, in consideration of the combined teachings of Powell, Jefferies, and Neuendorf. Powell teaches escitalopram as an agonist of ABCF1 as an antidepressant used for treating MDD, while Jefferies teaches agonists of ABCF1, of which escitalopram is taught as exemplary, for treating inflammatory and autoimmune diseases, such as IBD. Neuendorf further teaches depression and IBD as comorbid, and that depression occurs at an increased rate in patients with IBD, particularly in active disease.
Therefore, one of ordinary skill in the art would have been motivated to have administered an agonist of ABCF1 to a patient experiencing an autoimmune disease, such as IBD, particularly CD or UC, comorbid with depression, as agonists of ABCF1 are taught to have utility for both depression and autoimmune diseases such as IBD, and have had a reasonable expectation of success.
Claim Rejections-Nonstatutory 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, and 14-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, and 11-12 of copending Application No. 18285019 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass inhibiting neuroinflammation by upregulating the expression of ABCF1. Copending claim 5 recites inhibition of neuroinflammation to be linked to treating dementia; as the instant claims are broadly drawn to inhibiting neuroinflammation, treatment of dementia would have been encompassed. Additionally, both sets of claims recite administering a compound selected from psilocybin, psilocin, 4-acetoxy-N,N-dimethyltryptamine, O-acetyl psilocin fumarate, and 4-acetoxyindole (copending claim 4 & instant claim 15). As such, the instant and copending claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-9, 11, and 13-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16, and 18-19 of copending Application No. 18726726 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because are drawn to inhibiting neuroinflammation by administering an agonist of ABCF1 (see copending claims 1 & 12). Both sets of claims further recite inhibition of neuroinflammation to treat symptoms of depression (copending claim 13 & instant claim 3); treating a patient with an autoimmune disease (copending claim 16 & instant claims 5 & 11); and administering one or more additional therapeutics (copending claim 18 & instant claim 17); wherein the ABCF1 agonist is psilocybin, psilocin, 4-acetoxy-N,N-dimethyltryptamine, O-acetyl psilocin fumarate, and 4-acetoxyindole (copending claim 11 & instant claim 15). Therefore, the instant and copending claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627
Prosecution Insights