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 .
Election/Restrictions
Applicant's election with traverse of Group I, encompassed by claims 1-4, and 11-12, drawn to a method of inhibiting neuroinflammation by upregulating the expression and/or activity of ABCF1, in the reply filed on 6/17/2026, is acknowledged. The traversal is on the ground(s) that “Groups I, II, and III share the special technical feature that all three inventions identified by the Examiner share a single inventive concept, namely psychedelic-induced ABCF1 upregulation suppressing neuroinflammation to treat dementia” (Remarks filed 06/17/2026, page 5).
This is found persuasive. All three groups of inventions have unity in that they are all drawn to a method of inhibiting neuroinflammation via the upregulation of ABCF1 after administering a psychedelic.
The restriction requirement is hereby withdrawn.
Applicant has elected without traverse the following species:
A selection of a single psychedelic: Applicant elects psilocybin (claims 3-10 cover this elected species);
A selection of a single dementia-related disease: Applicant elects Alzheimer’s disease (claims 2, 5-11 cover this elected species).
The elected species of Alzheimer’s disease was found in the prior art and the search and examination is limited to the elected species. Therefore, claim 12 is withdrawn from further consideration.
In the amendment as filed on 6/17/2026, applicants have amended no claims; cancelled no claims; and added no new claims. Claim 12 is withdrawn as being drawn to a non-elected species. Therefore, claims 1-12 are currently pending and claims 1-11 are presently under examination.
Priority
The instant application is a 35 U.S.C. § 371 national stage filing of No. PCT/CA2022/050468, filed March 29, 2022, which claims the benefit of U.S. Provisional Application No. 63/167,897, filed March 30, 2021.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
Applicant is reminded of the proper contents of the specification, which includes:
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
The specification is objected to because: it lacks a section that cross-references to related applications.
The specification is objected to because of the following informality: on page 12, for the primer represented by SEQ ID NO:4, Applicant should add a left parenthesis before “SEQ ID NO:4)” so as to read “(SEQ ID NO:4)”.
Acknowledgement is made of the drawings received September 29, 2023.
The drawings are objected to because:
In FIG. 1 and FIG. 2, the text is illegible and blurry. As recited in 37 CFR 1.84:
(l) Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-4 and 11 are objected to for the following informality: they are not consistent with proper claim writing process. Every claim has three parts: a preamble, a transitional phrase, and a body. Currently, all claims are missing a transitional phrase. The transitional phrases "comprising", "consisting essentially of" and "consisting of" define the scope of a claim with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim. Relevant guidance can be found in the MPEP § 2111.03, titled “Transitional Phrases”, which details claim construction using transitional phrases. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: first, “dimthyltryptamine” is missing the letter ‘e’ and should properly read “dimethyltryptamine”. Second, there is a semicolon between the listing of “4-Acetoxy-N, N-dimthyltryptamine; O-Acetyl Psilocin Fumerate” when there should be a comma instead. Third, there is an additional space between the “N, N” of “4-Acetoxy-N, N-dimthyltryptamine” that should be removed. Fourth, the listed psychedelics of claim 4 should be written in lowercase. For instance, “O-Acetyl Psilocin Fumerate” should be written as “O-acetyl psilocin fumerate”. Last, “Fumerate” is incorrectly spelled and should instead read “fumarate”. Altogether, Examiner recommends amending claim 4 to recite, “The method of claim 3, wherein the one or more psychedelics are selected from the group consisting of psilocybin, psilocin, 4-acetoxy-N,N-dimethyltryptamine, O-acetyl psilocin fumarate, and 4-acetoxyindole.” Appropriate correction is required.
Claim 9 is objected to because of the following informality: the additional space between the “down regulate” should be removed to instead recite “downregulate”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-11 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.
Claims 1-4 and 11 are rejected as indefinite as claim 1 recites a method for inhibiting neuroinflammation and claim 2 recites a method wherein inhibiting neuroinflammation treats, delays and/or prevents dementia, without reciting a subject who is need of such treatment. As claims 3-4 and 11 depend on claim 1 and do not resolve the issue, they are similarly rejected.
Claim 3-4 are rejected as vague. The current claims recite “a method…wherein said upregulating the expression and/or activity of ABCF1 is by administration of one or more psychedelics.” Is Applicant administering any amount (which could be suboptimal and have no therapeutic benefit), or a therapeutically effective amount? Examiner recommends adding a “therapeutically effective amount” into the claim language.
Claims 5-10 are rejected as being indefinite. Claim 5 and claim 8 recite the phrase “or in combination with other therapeutics”. The phrase has not been clearly defined anywhere in the specification so that one of ordinary skill would know what additional therapeutics are included or excluded by the above limitation. Applicant does contemplate a list of psychedelics (page 7-11) but there is no mention of what is contemplated by “in combination with other therapeutics”. Since dependent claims 6-7 and 9-10 do not resolve the issue, they are similarly rejected.
Claims 7 and 10 recite both "psilocybin derivatives” and “psilocybin like compounds". The term "derivative" and “like” renders claims 7 and 10 as vague as a “derivative” or “like” compound do not have a defined structure known in the art. A derivative is a substance or compound obtained from, or regarded as derived from, another substance or compound. What are these derivatives? Regarding “like”, a compound that is “like” another compound has no meaning as the limits or extent of “like”-ness are not known. For example, one could not ascertain as to which modifications to psilocybin is like another compound, resulting in thousands of possible compounds. Absent of specific compounds, the Examiner suggests deleting these terms from claims 7 and 10.
Claim 9 is rejected as vague for its recitation of the phrase “restore blood brain barrier”. It is unclear how the claimed method would restore a blood brain barrier? Was the blood brain barrier altogether missing, was it partially missing? Does applicant mean restore blood brain barrier function, instead?
Claim 11 recites the limitation "the dementia”. There is insufficient antecedent basis for this limitation in this claim.
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.
Written Description
Claims 1, 3, 5-6, and 8-9 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 written description rejection.
The analysis for adequate written description considers the following:
(a) Actual reduction to practice;
(b) Disclosure of drawings or structural chemical formulas;
(c) Sufficient relevant identifying characteristics, such as (i) complete/partial structure, (ii) physical and/or chemical properties, and (iii) functional characteristics when coupled with known or disclosed correlation with structure; and
(d) Representative number of samples.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571,39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written description on the bases of any of the agents demonstrating wherein possession of use of the broad term: psychedelics. The mere fact that Applicant may have discovered one specific type of psychedelic or class of psychedelics that can be used to inhibit neuroinflammation is not sufficient to claim the entire genus. The claims lack written description because the genus of “psychedelic” of compounds has substantial variance while the specification lacks sufficient variety of species to reflect the variance within the genus, and because of the lack of common structural attributes of the claimed genus, combined with a correlation between structure and function. The specification does not tell one of ordinary skill what variation is permitted by “psychedelic”, and the different types of “psychedelics” would not be expected to act similarly.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
Thus, 3, 5-6, and 8-9 are rejected under 35 USC 112(a), (Written Description).
Scope of Enablement - Prevention
Claims 1, 2 and 5-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first paragraph, because the specification, while being enabling for treating and/or delaying dementia, does not reasonably provide enablement for preventing dementia. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The following Wands factors have been considered if not explicitly discussed: (A) The breadth of the claims, (B) The nature of the invention, (C) The state of the prior art, (D) The level of one of ordinary skill, (E) The level of predictability in the art, (F) The amount of direction provided by the inventor, (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Claims 1, 2, 5, and 8-9 are drawn to preventing dementia. It is presumed “prevention” of the claimed condition would require a method of identifying those individuals who will develop the claimed condition before they exhibit symptoms. The current state of the art is that that full scope of diseases claimed within instant claims is not preventable or curable.
There is no evidence in the prior art that the instant composition would be usable as a preventative method, particularly for preventing diseases such as dementia. “Preventing” connotes an absolute absence of a condition which cannot reasonably be achieved with regard to infections, with few exceptions (such as vaccines to prevent the development of pathogen-borne illnesses). In addition, there is no definitive method by which to determine whether a patient will develop a particular condition and, thus, be in need of preventive therapy. This is distinguished from preventing the relapse or recurrence of certain conditions, in which case an objective basis may exist to identify patients at risk of disease or infection, and could reasonably be construed as treatment. Prior to the initial onset or occurrence, however, even if a patient can be identified as having known risk factors for a condition, there is no certainty that the patient would in fact develop the condition. Further, the failure of a disease, infection, or condition to develop cannot reliably be attributed to the claimed active agent(s). The non-development of a condition such as diseases such as dementia may be due to other factors such as lifestyle. In this sense, in the context of preventing a disease, the level of unpredictability is extremely high.
The factors to be considered in making an enablement rejection were summarized above. 1) Preventing diseases requires identifying those patients who will acquire the condition before the symptoms occur. This would require extensive and potentially open-ended clinical research on healthy subjects. 2) There is no working example of such a preventive procedure in man or animal in the specification. 4) The claims rejected are drawn to clinical pharmacology and are therefore physiological in nature. 5) The state of the art is that no general procedure is art-recognized for determining which patients generally will develop dementia before the fact. 6) The artisan using Applicants invention would be a Board Certified physician. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of dementia. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable for any agent to be able to prevent dementia. 7) It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved" and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed conditions.
As claims 6-7 and 10 depend on claims 5 and 8 and do not resolve the issue, they are similarly rejected.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Londesbrough et al. (CA 3138008 A1, published October 22, 2020)(hereinafter, ‘Londesbrough’).
It should be noted that the present claims are directed to the mechanism by which known therapeutic agents (e.g. psychedelics) achieve their known therapeutic results. As such, any disclosure of the treatment of dementia using a psychedelic anticipates the claimed subject matter: if the same psychedelics upregulate ABCF1 and inhibit neuroinflammation in the present application, then they must necessarily do so in the prior art. Note that an inventor need not know how their invention works, only that it does. The discovery of how a known therapeutic agent achieves its known therapeutic effect, such as done in the present application, does not bestow novelty on the claimed subject matter.
Londesbrough discloses (Abstract; claims 1-3) a method of treating a subject in need thereof comprising administering to the subject a therapeutically effective dose of psilocybin, for use in treating a variety of neurocognitive disorders, such as Alzheimer’s disease. While Londesbrough does not disclose the upregulation of ABCF1 due to psilocybin, as noted earlier, if psilocybin works by this mechanism in the present application, then it must work by the same mechanism in the prior art.
Each and every required element of the claims are taught, and the claims are anticipated.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Powell et al. (“ATP-binding cassette sub-family F member 1 (ABCF1) is identified as a putative therapeutic target of escitalopram in the inflammatory cytokine pathway”, published July 2013)(hereinafter, ‘Powell’) and Cirrito et al. (Effect of escitalopram on Aβ levels and plaque load in an Alzheimer mouse model”, published November 10, 2020)(hereinafter, ‘Cirrito’).
Powell teaches patients with major depressive disorder (MDD) were administered the serotonin reuptake inhibitor, escitalopram, at a dose of 10-30 grams daily for 12 weeks, and that escitalopram treatment resulted in significantly increased levels of ABCF1 expression (Abstract; page 610, under ‘Sample’; page 611, under ‘Results’; page 613, Fig. 1). Escitalopram is a known antidepressant (page 611, 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 (page 613 [last paragraph] to page 614).
Powell does not teach escitalopram is used to treat dementia, or specifically Alzheimer’s disease (AD).
Cirrito teaches (page e2667, first paragraph) that AD is characterized by the accumulation of β-amyloid (Aβ) plaques, high levels of Aβ form high-ordered, toxic species, and mechanisms that regulate Aβ levels could be therapeutic targets to maintain low levels of Aβ oligomers to reduce or eliminate toxic Aβ species from the brain, thereby treating AD. In a mouse model for AD, Cirrito shows (page e2670, under ‘Chronic escitalopram effect on brain plaque load in mice’; page e2671, under ‘Discussion’; Fig 4A, 4B, 4C) that chronic administration of escitalopram blocked the growth of amyloid plaques and significantly reduced the appearance of new plaques.
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, at the time before the effective filing date of the claimed invention, to practice the disclosed treatment of Cirrito with the mechanism taught by Powell in order to develop a method of inhibiting neuroinflammation by upregulating the expression and/or activity of ABCF1. Powell teaches that escitalopram is a known antidepressant that upregulates the expression of ABCF1. Cirrito teaches that escitalopram is used to block the growth of, and reduce the appearance of, amyloid plaques, in an AD mouse model. Therefore, it would have been obvious to use escitalopram to treat AD via upregulation of the expression and/or activity of ABCF1.
Thus, said claims are rendered obvious.
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 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14-15, and 17-18 of copending Application No. 18/035,578 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Both sets of claims encompass inhibiting neuroinflammation by upregulating the expression of ABCF1. Instant claim 2 recites inhibition of neuroinflammation to be linked to treating dementia, and treatment of dementia would have been encompassed as copending claim 1 is broadly drawn to inhibiting neuroinflammation. 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 (instant claim 4 & copending 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 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 8, 10-12, 16, and 18 of copending Application No. 18/726,726 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 is drawn to a method of upregulating ABCF1 expression, comprising administering or more agonists of ABCF1. Reference claims 5-6, 8, and 10-12 are drawn to the type of agonist (for instance, a natural product or analog thereof). Reference claim 12 is drawn to a method of claim 1, wherein upregulating ABCF1 expression inhibits neuroinflammation. Reference claim 16 further specifies that inhibiting neuroinflammation treats comorbid neuropsychiatric disorders, which includes dementia. Instant claims 1-2 and 11 recite the same method as combined reference claims, and 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.
Conclusion
All claims are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUKE ALAN BORALSKY whose telephone number is (571)272-9746. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 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 H Murray can be reached at 571-272-9023. 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.
/L.A.B./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
Prosecution Insights