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 .
Examiner Note
While not a grounds for rejection or objection, the Examiner notes species of instant independent claim 29 do not belong to the genus of independent claim 1 Formula 1 (e.g. R7 and R8 are both methyl, or one of R7 and R8 is hydrogen).
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.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over US 20050256164 A1 to O’Neill et. al.1
O’Neill teaches NK-1 and NK-3 antagonists for treating conditions or disorders such as autism, schizophrenia, generalized anxiety disorder, major depression, bipolar disorder, epilepsy, attention deficit hyperactivity disorder, neck pain, and back pain (see O’Neill at pp. 1-2 ¶[0017]-[0018]). O’Neill teaches the species of CAS# 869722-67-8 (see O’Neill at ¶[0254] and p. 45 Example 188) and CAS# 869722-98-5 (see O’Neill at ¶[0281] and p. 46 Example 215), both excluded by claim 31 Formula 1’s proviso (iii) as shown below.
Instant Claim 31 Formula 1
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(iii)
CAS# 869722-67-8
CAS# 869722-98-5
if X is CR1, n is 1, L6 is -O-, R7 is methyl or ethyl, R1, R2, R3, R4, R5, R8, R10, R11, R12, R13, R14 and R15 are each hydrogen, then R9 is not unsubstituted phenyl
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The prior art differs from the instant claims as follows: While O’Neill teaches structurally similar species for treating overlapping diseases, the species are excluded by claim 31’s proviso (iii).
However,
O’Neill teaches the genus of Formula I (see O’Neill at claim 1).
O’Neill Formula I
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O’Neill Formula 1 says X and Y may be H, alkyl, CF3, OH, alkoxy, aryl, heteroaryl, cycloalkyl, NO2, halogen, CN, and more (see O’Neil at claim 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
The prior art suggests substituents at the X and Y positions of Formula I. It would have been obvious to substitute the phenyls on CAS# 869722-67-8 or CAS# 869722-98-5 (which belong to O’Neill Formula I) with a halogen as this is specifically contemplated by the reference to be a suitable alternative. The resulting structure would thus read on the genus of claim 31 (wherein R9 may be a phenyl substituted with 1-3 halo substituents).
Furthermore, it is well-within the ordinary skill in art to incorporate a substituted phenyl in lieu of an unsubstituted phenyl on a known compound.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim Rejections - 35 USC § 112(a) – Scope of Enablement
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.
Claim 31 is 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 alleviating or inhibiting Alzheimer's disease, depression, anxiety, schizophrenia, bipolar disorder, autism, epilepsy, pain, or a hyperactivity disorder, does not reasonably provide enablement for treating/preventing/reversing Alzheimer's disease, depression, anxiety, schizophrenia, bipolar disorder, autism, epilepsy, pain, or a hyperactivity disorder. 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.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the nature of the invention,
2- the breadth of the claims,
3- the state of the prior art,
4- the predictability of the art,
5- the amount of direction or guidance provided
6- the presence or absence of working examples,
7- the quantity of experimentation necessary, and
8- the relative skill of those in the art.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Undue experimentation is required by one skilled in the art to determine enablement of the instant disclosure as claimed due to the following:
The nature of the invention (1) and the breadth of the claims (2)
The nature of the invention and breadth of the claim is the treatment, prevention, or reversal of Alzheimer's disease, depression, anxiety, schizophrenia, bipolar disorder, autism, epilepsy, pain, or a hyperactivity disorder.
The instant specification defines treating as
“reversing, alleviating, inhibiting the progress of, or preventing a disease, disorder, or condition to which such term applies, or to reversing, alleviating, inhibiting the progress of, or preventing one or more symptoms of such disease, disorder, or condition” (emphasis added, see instant spec. at p. 13 ¶[0048]).
The instant specification defines a subject as a mammal (see instant spec. at p. 13 ¶[0046]).
Furthermore since subjects are mammals and treatment includes prevention, the broadest reasonable interpretation includes a patient population of anyone, since anyone would want to avoid Alzheimer’s disease, depression, anxiety, schizophrenia, bipolar disorder, autism, epilepsy, pain, or a hyperactivity disorder.
The state (3) and predictability (4) of the art
MPEP § 2164.05(a) states if a publication demonstrates that those of ordinary skill in the art would not find that a particular invention was not enabled years after the filing date, the publication would be evidence that the claimed invention was not possible at the time of filing.
In regards to the unpredictability in preventing or treating CNS diseases, Danon et. al.2 teaches challenges in developing treatments for CNS diseases include an incomplete understanding of the biology of multifaceted CNS conditions such as Alzheimer’s disease, the presence of a blood–brain barrier that restricts the flow of molecules to the brain, and a lack of clinically relevant animal models in which to test new drugs (see Danon at Abstract). Danon teaches CNS diseases include a diverse range of conditions such as social and mood disorders (e.g., clinical depression, addiction), neurodegenerative diseases (e.g., Alzheimer’s, Huntington’s, and Parkinson’s diseases), brain cancers (e.g., glioblastoma), neuropathic pain, and stroke (see Danon at p. 1 ¶2). Danon even states "once a lead compound has been developed, the journey is far from over" when reflecting on the challenges CNS drugs face in clinical trials like off-target effects (see Danon at p. 9 ¶4 and p. 10 Boxes 1 and 2).
In regards to preventing Alzheimer’s disease, Alzheimer’s Association3 teaches Alzheimer’s prevention has no definitive answer, and that some risk factors such as age or genes can’t be changed (see Alzheimer’s Association at p. 6).
In regards to preventing autism, Michaelis et. al.4 teaches autism likely has a genetic cause (see Michaelis at p. 298 right col. ¶2).
In regards to SSTR4 agonists and therapeutic uses, Szoke et. al.5 teaches SSTR4 agonists are analgesic drug candidates for treating neuropathic pain (see Szoke at Abstract). Qiu et. al.6 teaches SSTR4 is an antiepileptic drug candidate target (see Qiu at Abstract). Sandoval et. al.7 teaches SSTR4 agonists are potential Alzheimer’s disease treatments (see Sandoval at Abstract). Michaelis teaches SSTR4 may be involved in higher cognitive functions such as those disrupted in patients with autism (see Michaelis at p. 302 left col. ¶1).
The prior art provides enablement for alleviating or inhibiting the progress of:
Alzheimer’s disease, depression, anxiety, schizophrenia, bipolar disorder, autism, epilepsy, pain, and hyperactivity disorders
The prior art does not provide enablement for preventing or reversing:
Alzheimer’s disease or autism
The amount of direction or guidance provided (5) and the presence or absence of working examples (6)
The specification provides the following embodiments:
Binding assay, 71 compound species were tested in competitive binding of SSTR4 and SSTR1 (see instant spec. at pp. 99-101 Table 1).
STR4 Agonism study, 71 compound species were tested for SSTR4 activity (see instant spec. at pp. 99-101 Table 1).
The specification provides enablement for the claimed species as SSTR4 agonists.
Nowhere in the specification is it explained how the conditions or diseases of claim 31 are to be prevented through the administration of the claimed compounds.
Therefore, the full scope of treatment in the methods of claim 31 is not enabled.
The quantity of experimentation necessary (7) and the relative skill of those in the art (8)
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. Because of the unknown predictability in the art (as discussed above) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that compounds of Formula 1 could be used as prevention for the full scope diseases specifically listed in claim 31.
As noted above, little experimentation provided is drawn to treatment or prevention of diseases listed in claim 31. A review of the state of the art fails to reveal that SSTR4 agonists are useful as therapeutic treatment as claimed (e.g. preventing Alzheimer’s or autism). Determining if compounds of Formula 1 would be therapeutic for any particular disease state would require careful analysis and replicability of a composition comprising a compound of Formula 1, formulation into a suitable dosage form, assay testing to correlate clinical efficacy, identifying off-targets, subjecting to animal trials, and subjecting to clinical trials.
All this is undue experimentation given the limited guidance and direction provided by Applicants.
Conclusion
Accordingly, the invention of claim 31 does not comply with the enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Suggested Amendment
Examiner suggests either amending the specification to omit prevention and reversing from the definition of treatment, or amending claim 31 as follows:
Claim 31. A method of alleviating or inhibiting the progress of a disease, disorder, or condition in a subject, the method comprising administering to the subject compound of… wherein the disease, disorder, or condition is selected from Alzheimer’s disease, depression, anxiety, schizophrenia, bipolar disorder, autism, epilepsy, pain, and hyperactivity disorders.
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 1-2, 5, 6, 8, 10, 12, 14-15, 17, 19-22, 24-25, 27 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.
Regarding R5, Claim 1 states “R5 is hydrogen” but in a later proviso states “(i) if X1 is CR1, L6 is -CH2-, and R7 and R8 form a cyclopropylidene, then at least one of R1, R2, R3, R4, R5, R9, R10, R11, R12, R13, R14 and R15 is not hydrogen” (emphasis added) which appears to allow for R5 to be something other than hydrogen. The scope of R5 is thus unclear. Claims 2, 5, 6, 8, 10, 12, 14-15, 17, 19-22, 24-25, 27, depend from claim 1 and do not remedy the issue of R5’s scope and are thus included in instant rejection.
Regarding R10, Claim 1 states “R10 is hydrogen” but in later provisos states:
“(ii) if X1 is CR1, L6 is -CH2-, n is 0, R1, R2, R4, R5, R11, R12, R14 and R15 are each hydrogen, R7 and R8 form a cyclopropylidene, and R9, R10 and R13 are each methyl, then R3 is not fluoro or hydroxy” (emphasis added),
“(iii) if X1 is CR1, L6 is -CH2-, n is 0, R1 is fluoro, R2, R3, R4, R5, R11, R12, R14 and R15 are each hydrogen, and R7 and R8 form a cyclopropylidene, then R9, R10 and R13 are not all hydrogen and not all methyl”, (emphasis added)
“(vi) if X1 is CR1, n is 0, R1, R2, R3, R4, R5, R11, R12, R14 and R15 are each hydrogen, R7 and R8 form a cyclopropylidene, R9 and R10 are each methyl, and R13 is ethyl, then L6 is not -O- or -NH-” (emphasis added)
“(vii) if X1 is CR1, L6 is -CH2-, n is 0, R1, R2, R4, R5, R11, R12, R14 and R15 are each hydrogen, R7 and R8 form a cyclopropylidene, R9 and R10 are both methyl, and R13 is ethyl, then R3 is not hydroxy;” (emphasis added)
“(viii) if X1 is CR1, L6 is -CH2-, n is 1, R7 and R8 form a cyclopropylidene, and R13 and R14 together form a propane-1,3-diyl bridging the nitrogen and carbon atoms to which they are respectively attached, then at least one of R1, R2, R3, R4, R5, R9, R10, R11, R12 and R15 is not hydrogen” (emphasis added)
which appear to allow for R10 to be something other than hydrogen. The scope of R10 is thus unclear. Claims 2, 5, 6, 8, 10, 12, 14-15, 17, 20-22, 24-25, 27 depend from claim 1 and do not remedy the issue of R10’s scope and are thus included in instant rejection.
Regarding R12, Claim 1 states “R12 is hydrogen” but goes on to say “no more than one of R11 and R12 is methyl” (emphasis added) and later states in a proviso “(i) if X1 is CR1, L6 is -CH2-, and R7 and R8 form a cyclopropylidene, then at least one of R1, R2, R3, R4, R5, R9, R10, R11, R12, R13, R14 and R15 is not hydrogen” (emphasis added) which appears to allow for R12 to be something other than hydrogen. The scope of R12 is thus unclear. Claims 2, 5, 6, 8, 10, 12, 14-15, 17, 19-22, 24-25, 27 depend from claim 1 and do not remedy the issue of R12’s scope and are thus included in instant rejection.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 12, 20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 12, claim 1 states “R5 is hydrogen”. Claim 12 depends from claim 1, but broadens the scope of R5 by stating “wherein R5 is selected from hydrogen, halo, cyano, methyl, methoxy, and cyclopropyl”.
Regarding claim 20, claim 1 states “R12 is hydrogen”. Claim 20 depends from claim 1, but broadens the scope of R12 by stating “wherein R11 and R12 are each independently selected from hydrogen, halo and methyl”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claim 28 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art to claim 28 appears to be the compound species excluded by the provisos of instant claim 1 (see Table below) as taught by STN8.
Per MPEP § 2144.09(VI), if the prior art does not teach any specific or significant utility for the disclosed compounds, then the prior art is unlikely to render structurally similar claims prima facie obvious in the absence of any reason for one of ordinary skill in the art to make the reference compounds or any structurally related compounds. In re Stemniski, 444 F.2d 581, 170 USPQ 343 (CCPA 1971). The prior art species do not appear to have a known utility; therefore, an artisan would not be motivated to modify them to arrive at an instant species.
Instant Claim 1 Formula 1
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Claim 1 Proviso
Prior Art Species
(i)
CAS# 1833879-54-1
CAS# 1836965-82-2
if X1 is CR1, L6 is -CH2-, and R7 and R8 form a cyclopropylidene, then at least one of R1, R2, R3, R4, Rs, R9, R10, RII, R12, R13, R14 and R15 is not hydrogen
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102
258
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98
244
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(ii)
CAS# 2401943-54-0
CAS# 2404807-87-8
if X1 is CR1, L6 is -CH2-, n is 0, R1, R2, R4, R5, RII, R12, R14 and R15 are each hydrogen, R7 and R8 form a cyclopropylidene, and R9, R10 and R13 are each methyl, then R3 is not fluoro or hydroxy
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108
288
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118
294
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(iii)
CAS# 2396992-36-0
CAS# 2393093-86-0
if X1 is CR1, L6 is -CH2-, n is 0, R1 is fluoro, R2, R3, R4, R5, RII, R12, R14 and RI5 are each hydrogen, and R7 and R8 form a cyclopropylidene, then R9, R10 and R13 are not all hydrogen and not all methyl
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126
262
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112
214
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(iv)
CAS# 1832747-72-4
if X1 is CR1, L6 is -CH2-, n is 1, R1, R2, R3, R4, R5, R10, RII, R12, R13, R14 and RI5 are each hydrogen, and R7 and R8 form a cyclopropylidene, then R9 is not methyl
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102
262
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(v)
CAS# 1828787-12-7
if X1 is CR1, L6 is -CH2-, n is 1, R1, R2, R3, R4, R5, R9, R10, R12, R13, R14 and R15 are each hydrogen, and R7 and R8 form a cyclopropylidene, then R11 is not methyl
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102
280
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(vi)
CAS# 2393411-42-0
CAS# 2405802-53-9
if X1 is CR1, n is 0, R1, R2, R3, R4, R5, RII, R12, R14 and R15 are each hydrogen, R7 and R8 form a cyclopropylidene, R9 and R10 are each methyl, and R13 is ethyl, then L6 is not -O- or -NH-
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108
276
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(vii)
CAS# 2406915-14-6
if X1 is CR1, L6 is -CH2-, n is 0, R1, R2, R4, R5, RII, R12, R14 and R15 are each hydrogen, R7 and R8 form a cyclopropylidene, R9 and R10 are both methyl, and R13 is ethyl, then R3 is not hydroxy
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324
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(viii)
CAS# 2467091-74-1
if X1 is CR1, L6 is -CH2-, n is 1, R7 and R8 form a cyclopropylidene, and R13 and R14 together form a propane-1,3-diyl bridging the nitrogen and carbon atoms to which they are respectively attached, then at least one of R1, R2, R3, R4, R5,R9, R10,R11, R12 and R15 is not hydrogen
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96
292
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(ix)
CAS# 2464570-91-8
if X1 is CR1, L6 is -CH2-, n is 1, R7 and R8 form a cyclopropylidene, and R13 and R14 together form a propane- 1,3-diyl bridging the nitrogen and carbon atoms to which they are respectively attached, and R2, R3, R4, R5,R9, R10, R11, R12 and R15 are each hydrogen, then R1 is not fluoro
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112
292
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(x)
CAS# 2426288-62-0
if X1 is CR1, L6 is -CH2-, n is 1, R7 and R8 form a cyclopropylidene, and R13 and R14 together form a propane- 1,3-diyl bridging the nitrogen and carbon atoms to which they are respectively attached, and R1,R2, R4, R5,R9, R10, R11, R12 and R15 are each hydrogen, then R3 is not fluoro
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The closest prior art to instant claim 29 is WO 2018192461 A1 to Sun et. al.9
Sun teaches CAS# 2247669-82-3 (see Sun at p. 49 and SunT at p. 225 [0572]). CAS# 2247669-82-3 is structurally similar to a species of instant claim 29, differing by defined stereochemistry and a methyl. While these modifications might be obvious to an artisan, CAS# 2247669-82-3 is taught as an intermediate (SunT at p. 225 [0572]). Per MPEP § 2144.09(VI), an artisan would not be motivated to modify an intermediate.
Instant Claim 29 Species
CAS# 2247669-82-3
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Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claim 29 is allowable.
Claim 28 is objected to.
Claims 1-2, 5, 6, 8, 10, 12, 14-15, 17, 19-22, 24-25, 27, 31 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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, KORTNEY KLINKEL can be reached at 571-270-5239. 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.
/SOPHIA REILLY/Examiner, Art Unit 1627
1 Published November 17, 2005. Hereinafter O’Neill.
2 Danon et. al. "Challenges and Opportunities in Central Nervous System Drug Discovery" Trends in Chemistry, 2019, 1, 6, 612-624. DOI: 10.1016/j.trechm.2019.04.009. Hereinafter Danon.
3 Alzheimer's Association. Can Alzheimer's Disease Be Prevented? Accessed October 8, 2026.
https://www.alz.org/alzheimers-dementia/research-and-progress/prevention.
4 Michaelis et. al. "Intersitial Deletion of 20p: New Candidate Region for Hirschsprung Disease and Autism?" American Journal of Medical genetics 1997, 71, 298-304. DOI: 10.1002/(SICI)1096-8628(19970822)71:3<298::AID-AJMG10>3.0.CO;2-F. Hereinafter Michaelis.
5 Szoke et. al. "Small molecule somatostatin receptor subtype 4 (sst4) agonists are novel anti-inflammatory and analgesic drug candidates" Neuropharmacology 2020, 178, 108198, 1-11. DOI: 10.1016/j.neuropharm.2020.108198. Hereinafter Szoke.
6 Cite No. 021 in the IDS filed June 20, 2026. Qiu et. al. "Somastatin receptor subtype 4 couples to the M-current to regulate seizures" J Neurosci 2008, 28, 14, 3567-3576. DOI: 10.1523/JNEUROSCI.4679-07.2008. Hereinafter Qiu.
7 Sandoval et. al. "Somatostatin Receptor Subtype-4 Regulates mRNA Expression of Amyloid-Beta Degrading Enzymes and Microglia Mediators of Phagocytosis in Brains of 3xTg-AD Mice" Neurochemical Research 2019, 44, 2670-2680. DOI: 10.1007/s11064-019-02890-6. Hereinafter Sandoval.
8 STN refers to the following CAS registry database entries:
CAS 1833879-54-1 CAS Registry File Accessed October 8, 2026 from STN, entered into STN December 20, 2015.CAS 1836965-82-2 CAS Registry File Accessed October 8, 2026 from STN, entered into STN December 20, 2015.
CAS 2401943-54-0 CAS Registry File Accessed October 8, 2026 from STN, entered into STN January 8, 2020.
CAS 2404807-87-8 CAS Registry File Accessed October 8, 2026 from STN, entered into STN January 12, 2020.
CAS 2396992-36-0 CAS Registry File Accessed October 8, 2026 from STN, entered into STN December 31, 2019.
CAS 1832747-72-4 CAS Registry File Accessed October 8, 2026 from STN, entered into STN December 20, 2015.
CAS 1828787-12-7 CAS Registry File Accessed October 8, 2026 from STN, entered into STN December 15, 2015.
CAS 2393411-42-0 CAS Registry File Accessed October 8, 2026 from STN, entered into STN December 18, 2019.
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