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 .
Claim Status
Claims 1-21 and 23-26 are pending. Claims 1-4 and 6 are rejected. Claims 5 and 7-14 are objected to. Claims 15-21 and 23-26 are allowed.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/13/2026 has been entered.
Response to Amendment/Arguments
Applicant’s amendments have overcome the previously presented rejections.
Claim Rejections - 35 USC § 112
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 2 and 6 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.
Instant claim 2 recites the following for R5:
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However, instant claim 1 specifically lists one, two, three or four possible substituents for the substituted benzoxazolyl or benzothioxazolyl of R5. Accordingly, claim 2 is the “one or more substituents” broader than the scope of claim 1.
Regarding instant claim 6, the following compounds are broader than the scope of claim 1:
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Instant claim 1 recites compounds wherein R5 is substituted benzoxazolyl but does not list OCF3 or NO2 as possible substituents.
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.
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.
Claim(s) 1 and 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over WO2013043192A1 by Boxer et al.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches (title) “galactokinase inhibitors for the treatment and prevention of associated diseases” and Boxer et al. disclose the following compounds which are analogous to compounds of claims 1 and 3-4 where R1 and R2 taken together form a 5-membered carbocycle, R3 is -NR7R8 where R7 is hydrogen and R8 is C7-heteroaryl, R4 is C1 alkyl, and R6 is hydrogen (page 17):
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.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art compounds are analogous to compounds of instant formula (I) but differ from the instant compounds by the absence of a methyl substituent on R5 (corresponding to instant claims 1 and 3-4).
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 1-4, Boxer et al. teach that the heteroaryl corresponding to the benzoxazole ring of the compounds above may be substituted with alkyl substituents (paragraph [0011], lines 18-21). MPEP 2188.06 states:
“Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210 at 1214. Furthermore MPEP 2144.09 (II) states: “Compounds which are […] homologs (…) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).”
Furthermore, it is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Wood, 199 U.S.P.Q. 137 (C.C.P.A. 1978) and In re Lohr, 137 U.S.P.Q. 548, 549 (C.C.P.A. 1963).
The motivation to make a substitution of a hydrogen for an alkyl group stems from the fact that a person having ordinary skill in the art would expect that the compounds would have the same utility as the compounds taught by the prior art. In the interest of generating additional compounds that have the same utility as the compounds taught by the prior art, a person having ordinary skill in the art would seek to make additional compounds that are most closely related to compounds specifically taught by the prior art that have been demonstrated to have the desired utility. The replacement of hydrogen for a methyl group falls under the well-established doctrine of homology, which assumes that homologous compounds are likely to have similar properties. Therefore, the instantly claimed compound which differs by hydrogen/methyl, over the compound of the prior art is unpatentable absent a showing of unexpected results. MPEP 2144.09 (VIII) states, “[a] prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963).”
The resulting compounds (shown below) read on instant claims 1 and 3-4 where R1 and R2 taken together form a 5-membered carbocycle, R3 is -NR7R8 where R7 is hydrogen and R8 is C7-heteroaryl, R4 is C1 alkyl, R5 is one of 5-methyl-benzoxazol-2-yl, 6-methyl-benzoxazol-2-yl, or 7-methyl-benzoxazol-2-yl and R6 is hydrogen:
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,
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,
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,
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, and
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.
Allowable Subject Matter
Claims 15-21 are allowed.
Claims 5 and 7-14 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 ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626