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 .
Current Status of 17/989,981
The rejections of record are maintained below.
This Office Action is responsive to the amended claims of 10/09/2025.
The Markush search has been extended to a compound with a CAS# of 313523-51-2 (the elected species), depicted below.
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The Markush extension reads on claims 26, 67-69, and 96-99.
Claims 100-110 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/20/2023.
Priority
The instant application claims priority to abandoned US application 16/961,201, which is a 371 of PCT/US2019/012612, filed on 01/08/2019, which claims priority to 62/615,886, filed on 01/10/2018.
Claims have support from 62/615,886, therefore 01/10/2018 is assigned as the instant application’s effective filing date.
Response to Arguments
Applicants’ claim amendments and Remarks of 10/09/2025 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
Applicants amended base claim 26 to compounds of formula V. New claim 100 recites a pharmaceutical composition comprising a compound of Formula VIII.
In regard to the 103 rejection, this rejection is maintained (and updated below due to the amended claims of 10/09/2025). The previously cited compound (with CAS # 313523-51-2) still maps to Formula V wherein E2 is COOH, E1 is COOH, t is 0, s is 0, n is 0, R1 is H, and R2 is H. The instant claims do not recite a specific amount. The instant specification does describe amounts (paragraph [00244]); however, this does not impact the scope of the instant claims. Furthermore, the artisan would have been motivated to optimize an amount of compound with CAS # 313523-51-2 in order to maximize solubility. The rationale may be different from applicant’s. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144.IV. Additionally, from MPEP 2112.01, teaches that “Products of identical chemical composition can not have mutually exclusive properties.” The fact that the compound with CAS # 313523-51-2 maps to instant formula V and is present in an amount to be soluble inherently teaches that the compound attenuates an amyloid beta activity. "In a subject in need thereof," is an intended use recitation.
Response to Amendment
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 26, 67-69, and 97-98 are rejected under 35 U.S.C. 103 as being unpatentable over Chemical Abstracts (Chemical Abstracts STN REGISTRY Database, Record for 313523-51-2, entered into STN January 11, 2001) in view of PurdueChem (“Solubility Product Constants, Ksp”, Purdue Chemistry, January 31, 2002).
ACS teaches the compound with a CAS# of 313523-51-2.
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This compound maps to Formula V (of claim 26) wherein E2 is COOH, E1 is COOH, t is 0, s is 0, n is 0, R1 is H, and R2 is H.
This compound maps to Formula V (of claim 96) wherein E2 is COOH, E1 is COOH, t is 0, s is 0, n is 0, R1 is H, and R2 is H.
This teaches claims 97-98.
ACS predicts solubility data of compound #313523-51-2.
While ACS teaches the compound and teaches some predicted properties such as solubility, ACS does not teach measuring the solubility by dissolving the composition in water.
PurdueChem teaches calculating the solubility of a compound by dissolving the compound in water and measuring solubility which would be dissolving a certain amount of the compound in water. (pages 1-2).
It would be obvious to dissolve compound #313523-51-2 in water. The artisan would be motivated to confirm with the predicted solubility data and to determine experimentally solubility.
Thus while the combination of the teachings above do not specifically teach that water is a pharmaceutically acceptable excipient, as evidenced by the instant specification defines an option of excipients as any liquid (see e.g., Spec. paragraph [0033]). As such, the combination (compound #313523-51-2 in water) appears to meet the limitation of pharmaceutical composition. Moreover, it is noted that the limitations of claim 68 and 69 appear to be intended uses. Since water is an art recognized pharmaceutically acceptable excipient, burden is on applicants to show that the composition could not be used for the purposes claimed in claim 68 or 69.
Absent evidence to the contrary, a composition containing compound #313523-51-2 would necessarily contain the stereoisomers (Formula VIa of claim 27 where t, n and s are 0, and R-2 and R1 are H; the first compound of claim 67). Alternatively, the artisan would have been motivated and expected to include both stereoisomers. See MPEP 2144.09(I) and (II). See also In reMay, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.).
The instant claims do not recite a specific amount. The instant specification does describe amounts (paragraph [00244]); however, this does not impact the scope of the instant claims.
Furthermore, the artisan would have been motivated to optimize an amount of compound with CAS # 313523-51-2 in order to maximize solubility. The rationale may be different from applicant’s. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144.IV.
Additionally, from MPEP 2112.01, teaches that “Products of identical chemical composition can not have mutually exclusive properties.” The fact that the compound with CAS # 313523-51-2 maps to instant formula V and is present in an amount to be soluble inherently teaches that the compound attenuates an amyloid beta activity. "In a subject in need thereof," is an intended use recitation.
This teaches claims 26, 67-69, and 97-98.
Conclusion
Claims 26, 67-69, and 97-98 are rejected as currently written.
Claim 99 is objected to as being dependent upon a rejected base claim. The disposition of these claims is dependent upon not finding other prior art rejections in future Markush Search Extensions.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625