DETAILED ACTION
Claims 1-7 and 9-11 are currently pending in the instant application.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/17/2026 has been entered.
Response to Amendment
Applicant’s amendments filed 09/17/2026 have been fully considered and entered into the application. Applicant has overcome
The objection to claim 1.
The 35 U.S.C. 102(a)(1) rejection of claims 1, 3, 6-7 and 10 over CA Reg. No. 1715755-67-1 in view of Applicant’s amendment to the claims.
The 35 U.S.C. 103 rejection of claims 1, 4-7 and 10-11 over Wanaksi in view of Applicant’s amendment to the claims.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to claims 1-7 and 10-11, with election of species of a compound of Formula III
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in the reply filed on 04/25/2025 is acknowledged.
Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04/25/2025.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
Applicant's elected species appears allowable over the prior art of record. Therefore, the search of the Markush-type claim has been extended to the non-elected species of
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. As prior art has been found which anticipates the above identified nonelected species, the Markush-type claims are rejected as follows and the subject matter of the claims drawn to nonelected species held withdrawn from consideration. Claims 1-7 and 10-11 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since art was found on the nonelected species, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
The remaining subject matter of claims 1-7 and 10-11 that are not drawn to the above elected invention stand withdrawn under 37 CFR 1.142(b) as being non-elected subject matter. The remaining compounds which are not within the elected invention are independent and distinct from the elected invention as they differ in structure and composition. Therefore the compounds, which are withdrawn, have been restricted as the withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference, which anticipates one group, would not render obvious the other. Thus all claims containing compounds falling outside the search strategy of the elected compound and structure shown above are heretofore directed to non-elected subject matter and are withdrawn from consideration under 35 U.S.C. § 121 and 37 C.FR. § 1.142(b).
Claim Rejections - 35 USC § 112
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 11 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 an agent for delaying or treating Alzheimer’s Disease, does not reasonably provide enablement for preventing Alzheimer’s Disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims. The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988).
In In re Wands. 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
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,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The nature of the invention
In the instant case, the nature of the invention is for a composition comprising an agent for preventing, delaying or treating Alzheimer’s Disease.
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening invitro and in vivo to determine which pharmaceutically active agents exhibit the desired pharmacological activities (i.e. what pharmaceutically active agents can prevent, delay or treat Alzheimer’s Disease). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that that contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any preventive regimen on its fact.
The instant claimed invention is highly unpredictable as discussed below:
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427F.2d833, 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. The burden of enabling one skilled in the art to prevent Alzheimer’s Disease would be much greater than that of enabling delaying or treating Alzheimer’s Disease. In the instant case, the specification does not provide guidance as to how one skilled in the art would accomplish the objective of preventing Alzheimer’s Disease. Nor is there any guidance provided as to a specific protocol to be utilized in order to show the efficacy of the presently claimed active ingredients for preventing Alzheimer’s Disease.
"To prevent" actually means to anticipate or counter in advance, to keep from happening etc. (as per Webster's II Dictionary) and there is no disclosure as to how one skilled in the art can reasonably establish the basis and the type of subject to which the instant compositions can be administered to order to have the "prevention" effect. There is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with Alzheimer’s Disease in general. Since applicants "preventive" assertion is contrary to what is known in medicine, proof must be provided that this revolutionary assertion has merits.
According to Al-Chalabi (see Brain, 2021, vol. 144, p. 1279-1280), the remarkable ability of the body to buffer and compensate for change means that in fact, neurodegeneration begins well before first symptoms. In Alzheimer's, there is a long pre-symptomatic prodrome. For those with a monogenic basis of their illness, the underlying pathological cause is present at birth but only manifests in symptoms decades later. Prevention of neurodegenerative diseases would be of enormous benefit to society, but while it might seem practical for common conditions like Alzheimer's disease, preventing the rarer neurodegenerative diseases throws up challenges. Primary prevention of rare neurodegenerative diseases at a population level is therefore largely impractical because the target group as a whole has a low risk of disease. The second challenge is the underlying assumption that detection of the markers of future symptoms of neurodegenerative disease means that prevention is possible. While this is likely to be true, it is important to remember that the mechanism of disease progression is not necessarily the same as the mechanism of disease onset, and risk factors for disease may not therefore be the key to prevention.
The amount of direction or guidance present and the presence or absence
of working examples
The specification does not provide examples of pharmaceutically active agents that can prevent Alzheimer’s Disease.
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure, specifically, the instant claims include compositions comprising pharmaceutically active agents that can prevent Alzheimer’s Disease. However the specification fails to teach any agents that prevent Alzheimer’s Disease.
The quantity or experimentation needed and the level of skill in the art
It would require undue experimentation of one of ordinary skill in the art to ascertain the effectiveness of pharmaceutically active agents that can prevent Alzheimer’s Disease. Factors such as "sufficient working examples", "the level of skill in the art" and "predictability", etc. have been demonstrated to be sufficiently lacking in the instant case for the composition with intended use claims. Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, it is apparent that undue experimentation is necessary because of variability in prediction of outcome that is not addressed by the present application disclosure, examples, teaching and guidance presented. Absent factual data to the contrary, the amount and level of experimentation needed is undue.
New Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 3, 6-7 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CA Reg No. 1772287-29-2, entered into STN on 06/03/2015. CA Reg No. 1772287-29-2 corresponds to structure
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which is a compound of claim 6. In regards to claim 7, according to MPEP 2111.02, Section II, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”).
In re Tuominen (213 USPQ 89) states the following:
The composition is the same no matter what its intended use is, and consequently, the appealed claims are not seen to distinguish over the art which also discloses a composition of the recited active ingredient. We will not construe the instant claims to be limited to compositions also containing other ingredients usually utilized in sunscreening compositions merely by the fact that the introductory clause of the claims recites a different contemplated utility for the claimed composition not taught by the art. Rather, as done by the Examiner, we interpret the claims to be drawn to a composition of the active ingredients, per se, and, as such, under the rationale of Pearson, they fail to distinguish over the references.
The compound of CA Reg No. 1772287-29-2 corresponds to the same compound described in claim 7, and since the preamble of claim 7 merely recites the intended use of the compound, CA Reg No. 1772287-29-2 anticipates claim 7.
Regarding the composition of claim 10, which comprises the anticipatory compound and an excipient, the Registry entry for Registry no. 1772287-29-2 discloses a mass solubility of 0.0 g/L, in unbuffered water at pH 3.90. This teaching of water anticipates the claimed composition, wherein the compounds are present with an excipient (i.e., water).
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
Allowable Subject Matter
Claims 2 and 4-5 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
