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
The amendments to the claims filed January 8, 2024 are acknowledged and entered. Claims 1-6, 9-11, 17-25 and 27-28 are pending.
Priority
This application is a 371 of PCT/US21/64070, filed December 17, 2021, which claims the benefit of 63/127,624, filed December 18, 2020.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statement filed on January 8, 2024. All references have been considered except where marked with a strikethrough.
Specification
The disclosure is objected to because of the following informalities:
Two chemical structures on page 14 of the specification (structures pictured below) are blurry and difficult to read. In response to this objection Applicant should amend the specification to include clear structures of these two compounds. Appropriate correction is required.
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The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Election/Restriction
Applicant’s election without traverse of Group I (claims 1-6, 23-25 and 27-28, drawn to a method of treating or preventing a neurodegenerative disease or neuronal damage, comprising administering a therapeutically effective amount of a SlQEL or a S3QEL to a subject in need thereof) and the species of disease and a SlQEL or a S3QEL corresponding Alzheimer’s disease and compound S3QEL-2, respectively (pictured below for convenience), in the reply filed on January 20, 2026 is acknowledged. Claims 9-11 and 17-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 20, 2026
Elected Species:
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The guidelines in MPEP § 803.02 provide that upon examination if prior art is found for the elected species, the examination will be limited to the elected species. The elected species were found in the prior art. The search has therefore been limited to the elected species indicated above.
Claim 27 (in full) is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. Claims 1-6, 23-25 and 28 are withdrawn in part, other than the above indicated subgenus, with regard to prior art search as being drawn to a nonelected species.
Drawings
Figure 2A and Figure 3 submitted June 16, 2023 are objected to because the text in each in figure is blurry and unreadable (see X axis in Figure 2A and text in columns of Figure 3). 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 Rejections - 35 USC § 112a
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 1-6 and 23-25 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.
The claims require a “S1QEL” or a “S3QEL”. The claims do not require that the S1QEL or the S3QEL possess any particular conserved structure, or other distinguishing feature. The specification teaches newly discovered SELs, including SlQELs and S3QELs, are innovative due to their ability to block ROS production from a single site in the mitochondria without altering normal functions like ATP production or inducing various other mitochondria and cellular off-target effects (see page 8, lines 20-30); however, the specification does not describe or teach any particular conserved structure, or other distinguishing feature which defines this genus of compounds. Therefore, the full breadth of the claims fails to meet the written description provision of 35 U.S.C. §112, first paragraph.
To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 [41 USPQ2d 1961] (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”); In re Gosteli, 872 F.2d 1008, 1012 [10 USPQ2d 1614] (Fed. Cir. 1989) (“the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”). Thus, an applicant complies with the written-description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572.
According to the MPEP §2163 I. A. “the issue of a lack of adequate written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art.” The MPEP states in §2163 II 3 ii) “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 (see i)(A), above), reduction to drawings (see i)(B), above), 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 i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.”
According to the MPEP §2163.02 Standard for Determining Compliance With the Written Description Requirement,
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed". In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter". Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
Applicants are reminded of what the U.S. Court of Appeals Federal Circuit wrote in University of California v. Eli Lilly and Co. 43 USPQ2d 1398, "In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus." "A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is.” See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). "It is only a definition of a useful result rather than a definition of what achieves that result." "The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.")".
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision
Applicant may overcome this rejection by amending the claims to recite a specific compound or compounds which are regarded as a S1QEL or a S3QEL and for which Applicant has written support in the specification.
Claims 1-6, 23-25 and 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating a neurodegenerative disease or neuronal damage selected from a tauopathy, Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, argyrophilic grain disease, chronic traumatic encephalopathy, corticobasal degeneration, dementia, progressive supranuclear palsy, frontotemporal dementia, cerebral amyloid angiopathy, chronic pain, Creutzfeldt-Jakob disease, depression, Huntington's disease, spinal cord injury, traumatic brain injury, HIV-associated neurodegeneration, intracerebral hemorrhage, multiple sclerosis, stroke, vascular dementia, medullary thyroid carcinoma, or glioblastoma multiforme in a subject, does not reasonably provide enablement for
A method of generally treating or preventing of a neurodegenerative disease or neuronal damage in a subject
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.
Applicant teaches that a compound of claim 1 corresponding to a S1QEL or a S3QEL is an inhibitor of mitochondrial reactive oxygen species (ROS) (see Summary of Invention at page 1 of the specification) that has the effect of reducing tauopathy, reducing neuroinflammation and reducing FTD-linked pathologies (See Example 3). However, these biological activities (e.g. reducing neuroinflammation) are not known to be correlated with the treatment of the entire scope of conditions embraced by the claims or prevention of any condition embraced by the claims. Moreover, tau, neuroinflammation and FTD-linked pathologies are not known to be associated with all conditions embraced by the claims and so there is no mechanistic rationale which can be relied upon to support the breath of the claim. Applicant’s disclosure is only enabling for the treatment of conditions which Applicant has demonstrated may be treated by the instant compound, and of conditions which the prior art is already aware may be treated by a compound with the disclosed activity (e.g. reduction in neuroinflammation) and for which Applicant has written support. Case law is clear on this point. In an unpredictable art, such as drug therapy to treat disease, models may be used for enablement only if there is a reasonable correlation between the activity in question and the asserted utility. Given the guidance provided by Applicant, one skilled in the art would not be able to practice the full scope of the invention without undue experimentation.
In evaluating the enablement question, several factors are to be considered. Note In re Wands, 8 USPQ2d 1400 and Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed. The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations.
Nature of the Invention and Breath of the Claims
Instant claim 1 is drawn to a method of treating or preventing a neurodegenerative disease or neuronal damage, comprising administering a therapeutically effective amount of a SlQEL or a S3QEL to a subject in need thereof. The specification teaches compounds of the invention inhibit the production of mitochondrial reactive oxygen species (ROS) (see Summary of Invention at page 1 of the specification) and have the effect of reducing tauopathy, reducing neuroinflammation and reducing FTD-linked pathologies (See Example 3).
Instant claims 2, 23-25 and 28 depend from claim 1 and include the limitations treating or preventing a neurodegenerative disease or neuronal damage.
Instant claims 3-6 depend from claim 1 and include the limitation “preventing”.
The specification teaches “subject” refers to either a human or a non-human animal (page 17, lines 15-20)
The specification teaches “Treating" a condition or patient refers to taking steps to obtain beneficial or desired results, including clinical results (see page 17, lines 20-25)
The specification teaches the term “preventing” is an art-recognized term and includes administration of a composition which reduces the frequency of, or delays the onset of, symptoms of a medical condition in a subject relative to a subject which does not receive the composition (see page 17, lines 30-34).
The nature of the invention is thus a method of treating or preventing a neurodegenerative disease or neuronal damage in a subject comprising administration of a S1QEL or S3QEL and wherein the disease is treated or prevented by reducing tauopathy, reducing neuroinflammation or reducing FTD-linked pathologies. The specification does not provide a definition of neurodegenerative disorders or conditions associated with neuronal damage. The broadest reasonable interpretation of these terms would include any condition which the prior art regards as a neurodegenerative disease or associated with neuronal damage. The scope of the claims therefore is very broad.
The state of the prior art
State of the prior art reference Koh et al. (Translational Neurodegeneration 9, 42, pages 1-12, published November 26, 2020) teaches neuroinflammation is associated with some neurodegenerative disease such as Alzheimer’s disease, Parkinson’s disease and ALS (Abstract, Background). Koh teaches investigations are underway to examine drugs than can modulate and reduce neuroinflammation to treat neurodegenerative disease (page 2, col 1, paragraph 1; page 9, col 1, paragraph 1). The state of the prior art would thus acknowledge there is an association with neuroinflammation and some neurodegenerative diseases, and that reducing neuroinflammation may be therapeutic in the treatment of conditions which are known to be associated with neuroinflammation. The state of the prior are appears to be aware that neuroinflammation is correlated with the conditions recited in claims 3-6 and therefore a reduction in neuroinflammation by administration of a compound of the claims would be regarded as a potential treatment of these conditions.
However, the state of the prior art does not recognize that all neurodegenerative diseases or conditions associated with neuronal damage which are embraced by the claims may be treatable by a reduction in neuroinflammation or the other biological activities of the claimed compounds (i.e. reduction in tauopathy or reduction in FTD-related pathologies). Armstrong (Folia Neuropathologica 58, 2, 93-112, published June 6, 2020) explores causes of neurodegenerative disease (Title; Abstract) and teaches neurodegenerative disease is characterized by heterogeneity (page 101, Proposition 7). Armstrong teaches that it is unlikely that neurodegenerative disease will be amenable to treatment by simple pharmacological intervention (Implications, page 105, col 1) and that there is unlikely to be a simple solution to the treatment of neurodegenerative disease (Conclusion, page 105). As a whole, Armstrong illustrates that there is unlikely to be any single therapeutic agent which treats all forms of neurodegenerative diseases as is presently claimed.
Armstrong also teaches neurodegenerative disease is caused by neuronal damage (Introduction, page 94, col 1, age-related neuronal degeneration in AD). Therefore neuronal damage of the claims would at least include neurodegenerative disease. Armstrong suggests a single agent is unlikely to treat all of neurodegenerative disease and this suggestion would also apply to neuronal damage which embraces neurodegenerative disease.
Furthermore, the state of the prior art is not aware that any agent prevents a neurodegenerative disease or neuronal damage as is claimed in a human.
The Level of One of Ordinary Skill
The level of skill in the art is high. The artisan using the claimed invention would be a person with medical training such as a medical doctor or physician with an MD degree or the equivalent
Predictability in the art
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved”. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Amount of guidance/working examples
Applicant provides evidence that the compounds of the claims reduce tauopathy, neuroinflammation, and early mortality in transgenic mice with FTD-linked pathology (see Example 3).
Applicant provides evidence that the compounds of the claims may treat glioblastoma (see Example 6) and medullary thyroid carcinoma (see Example 5).
However, the conditions embraced by the claims are highly varied and there is no reasonable basis to expect that a single therapeutic agent will treat the full scope of conditions embraced by the claims. There is no evidence that the models used by Applicant are representative of the full scope of conditions embraced by the claims and Applicant has not provided any other direction to enable the broad treatment of conditions embraced by the claims.
As per “preventing”, there is no evidence in the record to suggest the claimed invention prevents any condition claimed. It is presumed “prevention” of the claimed disease would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. Nothing in the specification teaches how one skilled in the art identifies a subject who’s disease will be prevented. Moreover, there is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted and then compare these individuals to an untreated control group (see definition of “preventing” above).
The quantity of experimentation needed:
MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on theevidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)."
That conclusion is clearly justified here and one skilled in the art could not practice the full scope of the claimed invention without undue experimentation.
This rejection could be overcome by amending claim 1 to delete “preventing” and to incorporate the limitations of claims 3-6.
Claim Rejections - 35 USC § 112b
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.
Claim 6 is 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.
Regarding claim 6, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is suggested that Applicant amend the claim to delete the phrase “such as”.
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.
Claims 1-6, 23-25 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (Nature Chemical Biology 2015, 11, 834-836) (hereinafter “Orr”) in view of Reddy (Journal of Biomedicine and Biotechnology 2006, 6, article 31372, pages 1-13) (hereinafter “Reddy”).
Orr teaches mitochondria produce reactive oxygen species (ROS) such as superoxide and H2O2 that cause oxidative damage and pathology (page 834, col 1, paragraph 2). Orr teaches ROS production is implicated in specific pathologies including neurodegenerative diseases such as Parkinson’s disease and Huntington’s disease (page 834, col 1, paragraph 3). Orr teaches compound S3QEL-2, which corresponds to the instantly elected species of S1QEL or S3QEL, inhibits the production of ROS (see Figures 1-2 on page 835). Orr states “A major challenge in understanding the physiological roles of specific mitochondrial sites of ROS production has been the inabil-ity to manipulate ROS production without altering ATP synthesis and other metabolic processes… Here, we identify S3QELs as the first (to our knowledge) suppressors of superoxide production at site IIIQo that are selective, do not affect oxidative phosphorylation and exert effects in cells and isolated tissues” (page 836, col 1, paragraph 2). Orr states “S3QELs.. provide the first means to eliminate IIIQo superoxide production under physiologically relevant condi-tions without altering underlying metabolism” (page 836, col 1, paragraph 3). Taken as a whole, Orr discloses the elected species of compound, S3QEL-2, provides a way of eliminating ROS production, thereby reducing oxidative damage resulting from ROS, without the disadvantages of also altering underlying metabolism.
Orr does not specifically recite a method of treating a neurodegenerative disease, including Alzheimer’s disease, comprising administration of the elected species S3QEL-2, an inflammatory marker is reduced (claim 2), routes of administration (claims 23-24) or wherein the compound is active in the brain for at least 2-20 hours (claim 25); however, Reddy teaches mitochondrial oxidative damage is associated with Alzheimer’s disease (AD, Title and introduction, col 1). Reddy teaches a large body of data suggests that oxidative damage is extensive in the brains of AD patients (see page 3, Oxidative Stress and Antioxidant Therapy, paragraph 1). Reddy teaches that orally administered antioxidant therapy may be beneficial in the treatment of AD (see page 5, Antioxidant Treatment, columns 1-2, Vitamin E is an antioxidant; see e.g. mice with a vitamin E-supplemented diet, researchers in in vivo studies reported decreased Aβ; The administration of curcumin (an antioxidant) to Tg2576 mice also showed encouraging results when both oxidative damage and Aβ deposits were reduced). Reddy teaches findings from these aging studies suggest that mitochondrially targeted antioxidants reduce ROS production and oxidative damage in that the flies were diseased and also contribute to healthy aging at least in laboratory mice. However, the effects of mitochondrial antioxidants in healthy humans and humans with neurodegenerative disease still need to be determined (page 6, col 1, paragraph 4).
Taken together, the prior art references do not explicitly recite a method of treating Alzheimer’s disease comprising administration of S3QEL-2, an inflammatory marker is reduced (claim 2), or wherein the compound is active in the brain for at least 2-20 hours (claim 25). However, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the instant application to combine the teachings of the prior art references into a method of treating Alzheimer’s as is claimed because S3QEL-2 of the claims was known to reduce oxidative damage through inhibition ROS production (see Orr) and there was evidence that reduction of oxidative damage may have the effect of treating AD (see Reddy). Moreover, a person skilled in the art would have recognized that pharmacokinetic properties of a compound (e.g. duration of activity in the brain as recited in instant claim 25) and biological activity of a compound (e.g. causes reduction in inflammatory markers as recited in claim 2) are properties which are intrinsic to a particular compound. An activity in the brain of at least 2-20 hours as well as wherein the compound reduces an inflammatory marker would thus be recognized as being included in the scope of, or resulting from, administration of S3QEL-2.
One would have been motivated to use S3QEL-2 in the treatment of AD because at the time it was believed that reducing oxidative damage may treat AD (see Reddy). One would have specifically chosen S3QEL-2 because this compound had advantageous properties that would have been regarded as potentially beneficial to a method of treatment (see Orr S3QELs.. provide the first means to eliminate superoxide production under physiologically relevant condi-tions without altering underlying metabolism).
One would have had a reasonable expectation of success because there was evidence in the prior art that reducing oxidative damage had the effect of reducing pathologies associated with AD (see Reddy, above). One could have thus reasonably expected that administration of S3QEL-2 to a subject may have the effect of treating AD.
Conclusion
No claim is allowed.
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February 27, 2026
/KEVIN S MARTIN/Examiner, Art Unit 1624