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 .
Priority
The present Application, filed October 7, 2022, is a national stage entry under 35 U.S.C. § 371 of International Patent Application No. PCT/US2021/026792, filed April 12, 2021, which claims priority to U.S. Provisional Patent Application No. 63/009,727, filed April 14, 2020.
Status of the Claims
In the amendment filed December 4, 2025, claims 1-27 are canceled and new claims 28-43 are added. Claims 28-43 are currently pending.
Previous Rejections and/or Objections
The previous rejections are mooted by Applicant’s cancelation of the previous claims.
Response to Arguments
Applicant’s arguments pertaining to the previous rejections are mooted by the cancelation of the previous claims, and by the new grounds of rejection described below.
Claim Rejections - 35 USC § 102/103 – Necessitated by Amendment/New Claims
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.
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 28-30 are anticipated by, or alternatively obvious over, Tormo i Blasco:
Claims 28-30 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2007/0078149 to Tormo i Blasco et al. (hereinafter, “Tormo i Blasco2”).
New claim 28 recites a compound that is selected from a list of twenty-four specified triazolopyrimidine species and twenty-eight compounds (including two rotamers of the same compound), such as
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Tormo i Blasco2 teaches triazolopyrimidines of the formula I
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in which the substituents are as defined (Abstract), the compounds being suitable as fungicides (paragraph [0467]). Tormo i Blasco2 teaches that in some preferred embodiments, X is chlorine, Hal is fluorine, L1 and L2 are hydrogen, L3 is cyano, and the combination of R1 and R2 correspond for each compound to one row of Table A (paragraph [0243]). These compounds thus are
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Table A states that, in different examples, R1 and R2 can be:
A-55 (S) CH(CH3)-CF3 and H, respectively
A-110 −(CH2)5−, cyclized together
A-121 −(CH2)6−, cyclized together
A-34 (±) CH(CH3)-CH(CH3)2 and H, respectively
A-43 (±) CH(CH3)-C(CH3)3 and H, respectively
The first three of these compounds thus correspond to the first three compounds of instant claim 28 listed above. While it is unclear whether these compounds were synthesized as working examples in the disclosure of Tormo i Blasco2, they are expressly described in the text, with reference to paragraph [0243] and Table A. As such these disclosures at least render the recited species of claim 28 obvious, and arguably anticipate them. Similarly the last two compounds of Tormo i Blasco2 listed above, racemic mixtures, encompass the last three enantiomerically pure compounds listed above of instant claim 28. It is noted that the last two compounds of instant claim 28 listed above are also atropisomers. The disclosed racemic mixtures of Tormo i Blasco2 render the enantiomerically pure species, as well as the atropisomers, obvious. See, for example, In re May, 574 F.2d 1082, 1093-95 (CCPA 1978), discussing the obviousness of stereoisomers when there is no showing of enhanced or otherwise unexpected results in the purified stereoisomer; the same reasoning applies to atropisomers.
Thus, Tormo i Blasco2 expressly discloses, as a matter of preferred combinations, several species of instant claim 28. For the aforementioned reasons, claim 28 is at least obvious over, and arguably anticipated by, Tormo i Blasco2.
Claim 29, depending from claim 28, recites wherein the compound is one of four, each of which is among those discussed above and disclosed by Tormo i Blasco2.
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Claim 29 is therefore anticipated by, or in the alternative, obvious over, Tormo i Blasco2 for essentially the same reasons as is claim 28. Likewise, claim 30 recites that the compound is one of four, two of which are among those listed above
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Claim 30 is therefor anticipated by, or in the alternative, obvious over, Tormo i Blasco2.
Claims 32-35 and 37-43 are obvious over Tormo i Blasco2 and Zhang:
Claims 32-35 and 37-43 are rejected under 35 U.S.C. § 103 as being unpatentable over Tormo i Blasco2, in view of International Patent Application Publication No. WO2005/030775 to Zhang et al. (hereinafter, “Zhang”).
Claim 32 recites a composition for treating a neurodegenerative disease or cancer in a subject in need thereof, the composition comprising a therapeutically effective amount of a compound of claim 28. Claim 33 recites a method for treating a neurodegenerative disease or cancer in a subject in need thereof, the method comprising administering a therapeutically effective amount of a compound selected from a group of twenty-six compounds, including all the compounds of claim 28 plus two additional compounds. Tormo i Blasco2 is applied to claims 32-33 as to claim 28, above, but does not explicitly teach that its antifungal compounds are employed in compositions or methods for the treatment of a neurodegenerative disease or cancer. It would have been obvious, however, to employ the compounds of Tormo i Blasco2 in such compositions and methods for the treatment of cancer, because the use of antifungal triazolopyrimidine compounds, having high functional and structural similarity to the compounds of Tormo i Blasco2, as therapeutics for cancer, was well-known in the art. See, for example, Zhang.
Zhang teaches triazolopyrimidine compounds of formulae Ia,Ib (enantiomers of one another; pg. 6, lines 1-25 and pg. 10, line 12 through pg. 11, line 4), of the type known in the art as being fungicides (pg. 4, lines 14-15).
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In the above formula corresponding to Ia and Ib, variable moieties are as disclosed. Zhang discloses Example 13 (pg. 79, lines 14-190), which is highly similar to at least one species of instant claim 28, differing only in instant moiety R6.
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Zhang teaches that these compounds are potently cytotoxic to many human cancer cell lines (pg. 5, lines 13-14)
Relevant to instant claim 33, and consistent with the disclosed cytotoxicity to cancer cells, Zhang teaches a method of treating or inhibiting the growth of cancerous tumor cells and associated diseases (i.e. cancer) in a mammal by administering a disclosed triazolopyrimidine compound (pg. 8, lines 21-24). It would have been obvious to one of ordinary skill in the art to utilize a compound, such as any of the preferred compounds of Tormo i Blasco2 highlighted above, in place of the compound of formula Ia,b in the method of Zhang due to the equivalent function and highly similar structure of the Tormo i Blasco2 compounds to the compounds of formula Ia,b of Zhang. As such, instant claim 3 would have been obvious.
Similarly, and with respect to claim 32, Zhang teaches a pharmaceutical composition containing a therapeutically effective amount of a disclosed anticancer compound (pg. 9, lines 16-21). As above, it would have been obvious to substitute a preferred compound of Tormo i Blasco2 for the structurally and functionally similar compound of Zhang in the composition for treating cancer.
With respect to claims 34-35, as with claims 29 and 30, above, these claims limit the compound to be used in the method to a smaller number of compounds, but the compounds recited in the claims again contain multiple preferred compounds disclosed by Tormo i Blasco2. With respect to claims 37-41, these claims require further limitations on the nature of the neurodegenerative disease, but are only applicable if the method is deployed in treatment of a neurodegenerative disease; these claims do not exclude the method from being deployed in the treatment of cancer, as in the base claim 33. As such, claims 37-41 are obvious over Tormo i Blasco2 and Zhang for the same reasons as is claim 33.
With respect to claim 42, Zhang teaches the compounds can be useful as anticancer agents against brain cancer (pg. 37, line 34). With respect to claim 43, Zhang teaches that representative examples of disclosed compounds (e.g. compound 2a) are active as anti-tumor agents in mice bearing tumor xenografts of glioblastoma (a glioma). As such, it would have been obvious to apply the method of Tormo i Blasco2/Zhang to the treatment of a glioma.
Allowable Subject Matter
Claims 31 and 36 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
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER K SHOWALTER whose telephone number is (571)270-0610. The examiner can normally be reached M-F 9:00 am to 5:00 pm, eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629