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 instant application is a 371 National Stage Entry of PCT/IB2022/053721 filed on April 21, 2022 which claims priority to foreign application No. KR10-2021-0053352 filed on April 23, 2021.
No English Translation
Examiner notes that no certified translation of the Foreign Application KR10-2021-0053352 (filed April 23, 2021) has been placed on record. If applicant wants the application to be accorded benefit of the non-English language application, a certified translation is required (see 35 U.S.C. 119(b)(3), 37 CFR 1.55(g)(1)-(4)). Applicant is advised that any showing of priority that relies on a non-English language application is prima facie insufficient if no certified translation of the application is on file. See 37 CFR 41.154(b).
Status of Claims
Acknowledgement is made of original (1-6, 8-10), amended (7, 11-12), cancelled (13-14), and new (15-20) claims filed on October 20, 2023. Claims 1-12, 15-20 are pending in instant application.
Information Disclosure Statement
The information disclosure statements filed on November 28, 2023; August 28, 2024; December 17, 2024; August 21, 2025; November 10, 2025 have been considered except where lined through.
Claim Interpretation
Claims 8-11, 16-19 are product claims drawn to compositions reciting intended uses. The limitations of the claims are fulfilled by the structural elements (a composition comprising a compound of Formula 1 or a species of claim 5).
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 1-4, 7-12, 15-20 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 claim 1, the phrase "(a and b are each independently 1 or 2, W3 is CH or N, W4 is CH2 or O, in which if W3 is CH, then W4 is not CH2)" regarding R2, along with five other incidents of parentheses on p. 4 renders the claim indefinite because it is unclear whether the limitation(s) following in the parentheses are part of the claimed invention.
Regarding claim 2, the phrase “(in which y is any one integer of 1 to 3, and Rb is a 5- or 6-membered heterocycloalkyl including O)”, along with three other incidents of parentheses on p. 6 renders the claim indefinite because it is unclear whether the limitation(s) following in the parentheses are part of the claimed invention.
Regarding claim 3, the phrase “(in which La is a single bond or C1-C3 alkylene”, along with two other incidents of parentheses on p. 7 and two on p. 8 renders the claim indefinite because it is unclear whether the limitation(s) following in the parentheses are part of the claimed invention.
Regarding claim 4, the phrase "(in which at least one H of the N-containing heterocycloalkyl may be each independently substituted with C1-C5 alkyl or OH)” regarding R2 and R3 renders the claim indefinite because it is unclear whether the limitation(s) following in the parentheses are part of the claimed invention.
Claims 7-12, 15-20 do not further define the parentheses limitations and thus do not resolve the issue of indefiniteness; they are included in instant rejection.
Claim Rejections - 35 USC § 102
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 1-2, 7-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 03/048163 A1 to Neustadt et. al.1
Regarding claims 1-2 and compounds of instant Formula 1, Neustadt teaches compounds of Formula I (see Neustadt at claim 1) including CAS# 539822-79-2 (see Neustadt at p. 33 Example 13).
Neustadt
Formula I
Neustadt
CAS# 539822-79-2
Instant Formula 1
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CAS# 539822-79-2 reads on Formula 1 when W1 is O, W2 is CH, R1 is H, Z1 is CH, Z2 is N, Z3 is N, R2 is C1-C5 alkyl specifically methyl, Q is CR4 and R4 is H, R3 is H, R5 is
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118
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, n is 0, Rc-Rg are H, L1 and L2 are a bond, Rh is phenyl with two H’s substituted for halogen specifically fluorine.
Regarding instant claims 7-11 and compositions and claim 12 a method of treating, Neustadt teaches the disclosed compounds comprised in pharmaceutical compositions with carriers (see Neustadt claim 8). Neustadt teaches methods of treating Parkinson’s with the disclosed compounds or compositions (see Neustadt claims 11-12). Neustadt teaches the disclosed compounds are adenosine A2a receptor antagonists useful for treating central nervous system diseases such as Parkinson’s (see Neustadt at p. 1 lines 14-17), reading on instant an instant “adenosine A2a receptor-associated disease”. While Neustadt does not mention the conditions of instant claims 10-11, the instant composition is still anticipated and therefore would be capable of performing the intended use of instant claims 10-11.
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 3, 5, 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Neustadt as applied to claims 1-2, 7-12 above and in further view of US 20200102319 A1 to Crosignani.
Recall Neustadt teaches CAS# 539822-79-2, compositions comprising (instant claims 15-19), and methods of treating adenosine A2a receptor associated diseases such as Parkinson’s (instant claim 20). While Neustadt does not mention the conditions of instant claims 10-11, the instant compositions are rendered obvious as discussed below and therefore would be capable of performing the intended use of instant claims 10-11.
Neustadt
Formula I
Neustadt
CAS# 539822-79-2
Instant Formula 1
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Neustadt
Narrowed Formula
Instant Species 15
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68
152
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The prior art differs from the instant claims as follows: While Neustadt teaches compounds of Formula 1, the prior art differs in
H vs Methyl (instant claim 3 R2 is H, instant claim 5 species)
C vs N (instant claim 5 species)
However,
Regarding instant claim 3 and R2 H vs Me, Neustadt teaches Formula I teaches X may be N(R9) (see above Neustadt Narrowed Formula I and at Neustadt p. 24) and R9 may be H (as in instant claim 3) or C1-C6 alkyl (as in CAS# 539822-79-2 methyl).
Regarding instant claim 5 and C vs N, Crosignani teaches adenosine A2a inhibitors (see Crosignani at p. 1 ¶[0002]) of Formula I-1 (a [1,2,4]triazolo[1,5-a][1,3,5]triazine core) and Formula I-6 (a pyrazolo[1,5-a]-1,3,5-triazine core) (see Crosignani at claim 3).
Neustadt
CAS# 539822-79-2
Instant Species 15
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Crosignani Formula I-6
pyrazolo[1,5-a]-1,3,5-triazine
Crosignani Formula I-1
[1,2,4]triazolo[1,5-a][1,3,5]triazine
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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):
Regarding H for Me, per MPEP § 2143(I)(B), a prima facie case of obviousness exists for simple substitution of one known element for another to obtain predictable results. One skilled in the art would have a reasonable expectation of success for selecting H or methyl at the N position of a known compound because the prior art teaches H or Me as suitable alternatives at the R9 position (as taught by Neustadt).
Regarding C vs N, per MPEP § 2143(I)(B), a prima facie case of obviousness exists for simple substitution of one known element for another to obtain predictable results. The prior art teaches an adenosine A2a inhibitor with a pyrazolo[1,5-a]-1,3,5-triazine core (as taught by Neustadt). It would have been obvious to exchange the pyrazolo[1,5-a]-1,3,5-triazine core for a [1,2,4]triazolo[1,5-a][1,3,5]triazine core with a reasonable expectation of success because the prior art teaches both cores are suitable for adenosine A2a receptor inhibitors (as taught by Crosignani).
Furthermore, it is well-within the ordinary skill in art to incorporate H in lieu of methyl. Furthermore, it is well-within the ordinary skill in art to exchange a known suitable moiety for another in a known compound when both moieties are known for the same purpose as taught by the prior art.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Allowable Subject Matter
Claim 6 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.
Conclusion
Claims 1-5, 7-12, 15-20 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.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Cite No. 6 in the IDS filed November 11, 2023. Hereinafter Neustadt.
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