DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-11 are pending in the instant invention. According to the Amendments to the Claims, filed December 1, 2025, claims 9 and 10 were amended.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/CN2021/141243, filed December 24, 2021, which claims priority under 35 U.S.C. § 119(a-d) to: a) CN 202111000175.9, filed September 2, 2021; b) CN 202110403365.9, filed April 16, 2021; c) CN 202110109531.4, filed January 27, 2021; and d) CN 202011557297.3, filed December 25, 2020.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, with traverse, in the reply filed on December 1, 2025, is acknowledged: a) Group I - claims 1-9; and b) substituted carboxylic acid of formula (I) - p. 27, shown to the right below, and hereafter referred to as (S)-2-(4-(6-((4-cyano-2-fluorobenzyl)oxy)pyridin-2-yl)-2-fluorobenzyl)-1-(oxetan-2-ylmethyl)-1H-thieno[2,3-d]imidazole-5-carboxylic acid, where r = 0; L = -YCRLRL-, wherein Y = -O- and each RL = -H; R1 = -CH2-R1a, wherein R1a = -oxetan-3-yl; each R2 = -H; ring B = -1,4-phenylene-, substituted at
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C-2 with RB, wherein RB = -F; ring C = -2,6-pyridinylene-; ring D = -phenyl, substituted at C-2 with RD, wherein RD = -F and at C-4 with RD, wherein RD = -CN; and ring E = -thiophen-2,3-diyl. Claims 1-9 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that the traversal is on the grounds that the Office has not shown whether a search in different fields would be required for the alleged three groups of inventions. This is not found persuasive because the multiple inventions in the instant invention are independent or distinct for the reasons disclosed in the Requirement for Restriction / Election of Species, mailed on October 1, 2025.
Likewise, the inventor or joint inventor should further note that there would be a serious burden on the examiner if restriction was not required because the inventions have acquired a separate status in the art due to their divergent subject matter and would require a different field of search.
Next, the inventor or joint inventor should further note that, in accordance with MPEP § 803.02, the instant Markush claim has been examined, with respect to the elected species, and further to the extent necessary to determine patentability. In the instant case, the substituted carboxylic acids represented by the formula (I), where r = 0; L = -YCRLRL-, wherein Y = -O- and each RL = -H; R1 = -CH2-R1a, wherein R1a = -oxetan-3-yl; each R2 = -H; ring B = -optionally substituted phenylene-; ring C = -optionally substituted 2,6-pyridinylene-; ring D = -optionally substituted phenyl; and ring E = -thiophen-2,3-diyl, respectively, which encompass the elected species, have been found to be free of the prior art.
Accordingly, the inventor or joint inventor should further note that the examiner has expanded scope of the instant Markush claim to further encompass substituted carboxylic acids represented by the formula (I), where r = 0; L = -YCRLRL-, wherein Y = -O-; R1 = -CH2-R1a, wherein R1a = -optionally substituted 3- to 8-membered heterocycloalkyl or 5- to 12-membered heteroaryl; each R2 = -H, halogen, or C1-6 alkyl; ring B = -optionally substituted phenylene- or -optionally substituted -1,4-piperidinylene-; ring C = -optionally substituted 2,6-pyridinylene-; ring D = -optionally substituted phenyl; and ring E = -thiophen-2,3-diyl, respectively; however, the instant Markush claim now fails to be free of the prior art, since it is rejected herein below in the section entitled: Claim Rejections - 35 U.S.C. § 102.
Consequently, the inventor or joint inventor should further note that the instant Markush claim is hereby restricted to substituted carboxylic acids represented by the formula (I), where r = 0; L = -YCRLRL-, wherein Y = -O-; R1 = -CH2-R1a, wherein R1a = -optionally substituted 3- to 8-membered heterocycloalkyl or 5- to 12-membered heteroaryl; ring B = -optionally substituted phenylene- or -optionally substituted -1,4-piperidinylene-; ring C = -optionally substituted pyridinylene-; ring D = -optionally substituted phenyl; and ring E = -thiophen-2,3-diyl, respectively, particularly as stated in the section below entitled Claim Objections.
Then, the inventor or joint inventor should further note that scope of the instant Markush claim will not be extended to cover additional nonelected species and/or groups of patentably distinct species.
Moreover, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Also, the inventor or joint inventor should further note that claims 10 and 11 were withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking claim.
Thus, a first Office action and prosecution on the merits of claims 1-9 is contained within.
Specification Objection - Disclosure
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the inventor’s or joint inventor’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility invention should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase Not Applicable should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR
DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A
COMPACT DISC.
(f) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art (including information disclosed under 37 CFR 1.97
and 1.98).
(g) BRIEF SUMMARY OF THE INVENTION.
(h) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(i) DETAILED DESCRIPTION OF THE INVENTION.
(j) CLAIM OR CLAIMS (commencing on a separate sheet).
(k) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(l) SEQUENCE LISTING (See MPEP § 2424 and 37 CFR 1.821-1.825).
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(b) above and 37 CFR 1.77(c). Revisions should particularly include and/or address: a) section headings (b-i), where applicable; and b) bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests identifying: a) the substituted carboxylic acids represented by the formula (I); and b) a particular utility for the substituted carboxylic acids represented by the formula (I).
The following title is suggested: SUBSTITUTED CARBOXYLIC ACIDS AS GLP-1 RECEPTOR STIMULATORS.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b), and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
A compound represented by formula (I):
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(I)
or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof,
wherein:
ring D is phenyl, wherein the phenyl is optionally substituted with 1, 2, 3, 4, or 5 independently selected RD substituents;
each RD is independently halogen, CN, C1-6 alkyl, CF3, NH2, OH, OC1-6 alkyl, =O, SH, or C3-6 cycloalkyl;
wherein each C1-6 alkyl and OC1-6 alkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, NH2, OH, OC1-6 alkyl, =O, and C3-6 cycloalkyl; and
wherein each C3-6 cycloalkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, C1-6 alkyl, NH2, OH, OC1-6 alkyl, =O, and C3-6 cycloalkyl;
L is -CRLRL-Y- or -Y-CRLRL-;
Y is -O-;
each RL is independently H, halogen, CN, C1-6 alkyl, CF3, NH2, OH, OC1-6 alkyl, SH, or C3-6 cycloalkyl;
wherein each C1-6 alkyl and OC1-6 alkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, NH2, OH, OC1-6 alkyl, =O, and C3-6 cycloalkyl; and
wherein each C3-6 cycloalkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, C1-6 alkyl, NH2, OH, OC1-6 alkyl, =O, and C3-6 cycloalkyl;
ring C is pyridinylene, wherein the pyridinylene is optionally substituted with 1, 2, 3, or 4 independently selected RC substituents;
each RC is independently halogen, CN, C1-6 alkyl, CF3, NH2, OH, OC1-6 alkyl, =O, SH, or C3-6 cycloalkyl;
wherein each C1-6 alkyl and OC1-6 alkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, NH2, OH, OC1-6 alkyl, =O, and C3-6 cycloalkyl; and
wherein each C3-6 cycloalkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, C1-6 alkyl, NH2, OH, OC1-6 alkyl, =O, and C3-6 cycloalkyl;
ring B is 1,4-piperidinylene or phenylene, wherein the 1,4-piperidinylene or phenylene is optionally substituted with 1, 2, 3, or 4 independently selected RB substituents;
each RB is independently halogen, CN, C1-6 alkyl, CF3, NH2, OH, OC1-6 alkyl, =O, SH, or C3-6 cycloalkyl;
wherein each C1-6 alkyl and OC1-6 alkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, NH2, OH, OC1-6 alkyl, =O, and C3-6 cycloalkyl; and
wherein each C3-6 cycloalkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, C1-6 alkyl, NH2, OH, OC1-6 alkyl, =O, and C3-6 cycloalkyl; or
each R2 is independently H, halogen, or C1-6 alkyl;
R1 is CH2-R1a;
wherein the CH2-R1a is optionally substituted with 1 or 2 substituents independently selected from the group consisting of halogen, CN, NR1bR1b, OH, OC1-6 alkyl, =O, C3-6 cycloalkyl, 3- to 6-membered heterocycloalkyl, and 5- to 10-membered heteroaryl; and
wherein each 3- to 6-membered heterocycloalkyl and 5- to 10-membered heteroaryl substituent independently contains 1, 2, or 3 heteroatoms or heteroatomic groups independently selected from the group consisting of N, NH, O, and S;
R1a is 3- to 8-membered heterocycloalkyl or 5- to 12-membered heteroaryl;
wherein the 3- to 8-membered heterocycloalkyl or 5- to 12-membered heteroaryl contains 1, 2, or 3 heteroatoms or heteroatomic groups independently selected from the group consisting of N, NH, O, and S; and
wherein the 3- to 8-membered heterocycloalkyl or 5- to 12-membered heteroaryl is optionally substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, C1-6 alkyl, NR1bR1b, OH, OC1-6 alkyl, and =O;
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is:
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or
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;
wherein the S-containing ring is optionally substituted with 1 substituent selected from the group consisting of halogen, CN, C1-6 alkyl, NH2, OH, OC1-6 alkyl, and C3-6 cycloalkyl; and
r is 0.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b), 35 U.S.C. § 112(d), and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
each RD is independently halogen, CN, C1-4 alkyl, CF3, NH2, OH, OC1-4 alkyl, =O, SH, or C3-6 cycloalkyl;
wherein each C1-4 alkyl and OC1-4 alkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, NH2, OH, OC1-4 alkyl, =O, and C3-6 cycloalkyl; and
wherein each C3-6 cycloalkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, C1-4 alkyl, NH2, OH, OC1-4 alkyl, =O, and C3-6 cycloalkyl;
each RL is independently H, halogen, CN, C1-4 alkyl, CF3, NH2, OH, OC1-4 alkyl, SH, or C3-6 cycloalkyl;
wherein each C1-4 alkyl and OC1-4 alkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, NH2, OH, OC1-4 alkyl, =O, and C3-6 cycloalkyl; and
wherein each C3-6 cycloalkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, C1-4 alkyl, NH2, OH, OC1-4 alkyl, =O, and C3-6 cycloalkyl;
each RC is independently halogen, CN, C1-4 alkyl, CF3, NH2, OH, OC1-4 alkyl, =O, SH, or C3-6 cycloalkyl;
wherein each C1-4 alkyl and OC1-4 alkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, NH2, OH, OC1-4 alkyl, =O, and C3-6 cycloalkyl; and
wherein each C3-6 cycloalkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, C1-4 alkyl, NH2, OH, OC1-4 alkyl, =O, and C3-6 cycloalkyl;
each RB is independently halogen, CN, C1-4 alkyl, CF3, NH2, OH, OC1-4 alkyl, =O, SH, or C3-6 cycloalkyl;
wherein each C1-4 alkyl and OC1-4 alkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, NH2, OH, OC1-4 alkyl, =O, and C3-6 cycloalkyl; and
wherein each C3-6 cycloalkyl is optionally and independently substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, C1-4 alkyl, NH2, OH, OC1-4 alkyl, =O, and C3-6 cycloalkyl;
R1 is CH2-R1a;
wherein the CH2-R1a is optionally substituted with 1 or 2 substituents independently selected from the group consisting of halogen, CN, NR1bR1b, OH, OC1-4 alkyl, =O, C3-6 cycloalkyl, 3- to 6-membered heterocycloalkyl, and 5- or 6-membered heteroaryl; and
wherein each 3- to 6-membered heterocycloalkyl and 5- or 6-membered heteroaryl substituent independently contains 1, 2, or 3 heteroatoms or heteroatomic groups independently selected from the group consisting of N, NH, O, and S; and
R1a is C1-4 alkyl, OC1-4 alkyl, C3-6 cycloalkyl, 3- to 6-membered heterocycloalkyl, phenyl, or 5- or 6-membered heteroaryl;
wherein the 3- to 6-membered heterocycloalkyl or 5- or 6-membered heteroaryl contains 1, 2, or 3 heteroatoms or heteroatomic groups independently selected from the group consisting of N, NH, O, and S;
wherein the C1-4 alkyl or OC1-4 alkyl is optionally substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, NR1bR1b, OH, OC1-4 alkyl, =O, and C3-6 cycloalkyl; and
wherein the C3-6 cycloalkyl, 3- to 6-membered heterocycloalkyl, phenyl, or 5- or 6-membered heteroaryl is optionally substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of halogen, CN, C1-4 alkyl, NR1bR1b, OH, OC1-4 alkyl, and =O.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b), 35 U.S.C. § 112(d), and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound according to claim 2, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
each RD is independently F, Cl, CN, CH3, CH2F, CHF2, CF3, CH2CN, CH2OH, CH2CH3, ethyl-F1-3, CH(CH3)CN, CH2CH2CN, CH(CH3)OH, CH2CH2OH, CH2CH2CH3, NH2, OH, OCH3, OCH2CH3, OCH2CH2CH3, OCH(CH3)2, OC(CH3)3, OCF3, =O, cyclopropyl, cyclobutyl, or cyclopentyl;
each RL is independently H, F, Cl, CN, CH3, CH2CN, CH2F, CHF2, CF3, CH2OH, CH2CH3, ethyl-F1-3, CH(CH3)CN, CH2CH2CN, CH(CH3)OH, CH2CH2OH, CH2CH2CH3, NH2, OH, OCH3, OCH2CH3, cyclopropyl, cyclobutyl, or cyclopentyl;
each RC is independently F, Cl, CN, CH3, CH2F, CHF2, CF3, CH2CN, CH2OH, CH2CH3, ethyl-F1-3, CH(CH3)CN, CH2CH2CN, CH(CH3)OH, CH2CH2OH, CH2CH2CH3, NH2, OH, OCH3, OCH2CH3, OCH2CH2CH3, OCH(CH3)2, OC(CH3)3, OCF3, =O, cyclopropyl, cyclobutyl, or cyclopentyl;
each RB is independently F, Cl, CN, CH3, CH2F, CHF2, CF3, CH2CN, CH2OH, CH2CH3, ethyl-F1-3, CH(CH3)CN, CH2CH2CN, CH(CH3)OH, CH2CH2OH, CH2CH2CH3, NH2, OH, OCH3, OCH2CH3, OCH2CH2CH3, OCH(CH3)2, OC(CH3)3, OCF3, =O, cyclopropyl, cyclobutyl, or cyclopentyl;
each R2 is independently H, F, CH3, or CH2CH3;
R1 is CH2-R1a;
wherein the CH2-R1a is optionally substituted with 1 or 2 substituents independently selected from the group consisting of F, Cl, CN, NR1bR1b, OH, OCH3, OCH2CH3, OCH(CH3)2, =O, cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, aziridinyl, oxiranyl, azetidinyl, oxetanyl, pyrrolidinyl, piperidinyl, tetrahydrofuranyl, tetrahydro-2H-pyranyl, imidazolidinyl, oxazolidinyl, dioxolanyl, dioxanyl, hexahydropyrimidinyl, piperazinyl, morpholinyl, oxazinanyl, pyrrolyl, furanyl, thiophenyl, pyrazolyl, imidazolyl, isoxazolyl, oxazolyl, thiazolyl, triazolyl, oxadiazolyl, isothiazolyl, tetrazolyl, pyridinyl, pyridazinyl, pyrimidinyl, and pyrazinyl; and
R1a is CH3, CH2CH3, CH2CH2CH3, CH(CH3)2, OCH3, OCH2CH3, OCH2CH2CH3, OCH(CH3)2, cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, aziridinyl, oxiranyl, azetidinyl, oxetanyl, pyrrolidinyl, piperidinyl, tetrahydrofuranyl, tetrahydro-2H-pyranyl, imidazolidinyl, oxazolidinyl, dioxolanyl, dioxanyl, hexahydropyrimidinyl, piperazinyl, morpholinyl, oxazinanyl, phenyl, pyrrolyl, furanyl, thiophenyl, pyrazolyl, imidazolyl, isoxazolyl, oxazolyl, thiazolyl, triazolyl, oxadiazolyl, isothiazolyl, tetrazolyl, pyridinyl, pyridazinyl, pyrimidinyl, or pyrazinyl;
wherein the CH3, CH2CH3, CH2CH2CH3, CH(CH3)2, OCH3, OCH2CH3, OCH2CH2CH3, or OCH(CH3)2 is optionally substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of F, CN, NR1bR1b, OH, OCH3, OCH2CH3, and =O; and
wherein the cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, aziridinyl, oxiranyl, azetidinyl, oxetanyl, pyrrolidinyl, piperidinyl, tetrahydrofuranyl, tetrahydro-2H-pyranyl, imidazolidinyl, oxazolidinyl, dioxolanyl, dioxanyl, hexahydropyrimidinyl, piperazinyl, morpholinyl, oxazinanyl, phenyl, pyrrolyl, furanyl, thiophenyl, pyrazolyl, imidazolyl, isoxazolyl, oxazolyl, thiazolyl, triazolyl, oxadiazolyl, isothiazolyl, tetrazolyl, pyridinyl, pyridazinyl, pyrimidinyl, or pyrazinyl is optionally substituted with 1, 2, 3, or 4 substituents independently selected from the group consisting of F, CN, CH3, CH2CH3, CH2CH2CH3, NR1bR1b, OH, OCH3, OCH2CH3, and =O.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b), 35 U.S.C. § 112(d), and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound according to claim 3, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
L is -CHRL-Y- or -Y-CHRL-;
Y is -O-; and
each RL is independently H, F, CH3, CH2CH3, or CH2CH2CH3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b), 35 U.S.C. § 112(d), and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound according to claim 4, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
each RD is independently F, Cl, CN, CH3, CHF2, CF3, CH2CH3, OCH3, OCH2CH3, OC(CH3)3, or OCF3;
each RL is independently H or CH3;
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is:
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,
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,
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,
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, or
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,
wherein the left side of ring C is connected to L; and
wherein ring C is optionally substituted with 1, 2, or 3 independently selected RC substituents;
each RC is independently F, Cl, CN, CH3, CF3, CH2CH3, CH2CH2CH3, NH2, OH, OCH3, OCH2CH3, cyclopropyl, cyclobutyl, or cyclopentyl;
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is:
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,
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, or
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,
wherein the left side of ring B is directly connected to ring C; and
wherein ring B is optionally further substituted with 1, 2, or 3 independently selected RB substituents; and
each RB is independently F, CN, CH3, CF3, CH2CH3, CH2CH2CH3, OH, OCH3, OCH2CH3, =O, cyclopropyl, cyclobutyl, or cyclopentyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: for brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b), 35 U.S.C. § 112(d), and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound according to claim 5, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
each RD is independently F, Cl, CN, CH3, CHF2, CF3, or CH2CH3;
L is -CH2-O-, wherein the right side of L is connected to ring C;
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or
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,
wherein the left side of ring C is connected to L; and
wherein ring C is optionally substituted with 1, 2, or 3 independently selected RC substituents; or
each RC is independently F, Cl, CN, CH3, CF3, CH2CH3, OCH3, or OCH2CH3;
each RB is independently F, CN, CH3, CF3, CH2CH3, =O, or cyclopropyl;
R1 is CH2-R1a; and
R1a is CH3, CH2CH3, CH2CH2CH3, CH(CH3)2, OCH3, OCH2CH3, OCH2CH2CH3, OCH(CH3)2, cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, oxiranyl, azetidinyl, oxetanyl, pyrrolidinyl, piperidinyl, tetrahydrofuranyl, tetrahydro-2H-pyranyl, furanyl, thiophenyl, pyrazolyl, imidazolyl, isoxazolyl, oxazolyl, thiazolyl, 1,2,3-triazolyl, 1,2,4-triazolyl, 1,2,4-oxadiazolyl, isothiazolyl, pyridinyl, or pyrimidinyl;
wherein the CH3, CH2CH3, CH2CH2CH3, CH(CH3)2, OCH3, OCH2CH3, OCH2CH2CH3, or OCH(CH3)2 is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of F, CN, OCH3, and OCH2CH3; and
wherein the cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, oxiranyl, azetidinyl, oxetanyl, pyrrolidinyl, piperidinyl, tetrahydrofuranyl, tetrahydro-2H-pyranyl, furanyl, thiophenyl, pyrazolyl, imidazolyl, isoxazolyl, oxazolyl, thiazolyl, 1,2,3-triazolyl, 1,2,4-triazolyl, 1,2,4-oxadiazolyl, isothiazolyl, pyridinyl, or pyrimidinyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of F, CN, CH3, CH2CH3, CH2CH2CH3, OCH3, and OCH2CH3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b), 35 U.S.C. § 112(d), and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound according to claim 6, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
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wherein the left side of ring B is directly connected to ring C; and
wherein ring B is optionally further substituted with 1, 2, or 3 independently selected RB substituents;
each R2 is independently H;
R1 is CH2-R1a; and
CH2-R1a is:
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.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b), 35 U.S.C. § 112(d), and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a stereoisomer thereof, wherein the compound, or stereoisomer thereof, is selected from the group consisting of:
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or a pharmaceutically acceptable salt or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. § 112:
(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.
Deuterated substances, solvates, prodrugs, metabolites, and/or co-crystals of substituted carboxylic acids represented by the formula (I)
Claims 1-9 are rejected under 35 U.S.C. § 112(a) because the specification, while being enabling for substituted carboxylic acids represented by the formula (I), does not reasonably provide enablement for deuterated substances, solvates, prodrugs, metabolites, and/or co-crystals of substituted carboxylic acids represented by the formula (I). 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 and/or use the invention commensurate in scope with these claims. Deuterated substances, solvates, prodrugs, metabolites, and/or co-crystals of substituted carboxylic acids represented by the formula (I), as recited in claims 1-9, respectivly, have not been adequately enabled in the specification to allow any person having ordinary skill in the art, at the time this invention was made, to make and/or use deuterated substances, solvates, prodrugs, metabolites, and/or co-crystals of substituted carboxylic acids represented by the formula (I).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor or joint inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. {See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986); and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988)}.
The above factors, regarding the instant invention, are summarized as follows:
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(a) Breadth of the claims - the breadth of the claims includes substituted carboxylic acids represented by the formula (I), shown to the right below, as well as the myriad of potential deuterated substances, solvates, prodrugs, metabolites, and/or co-crystals formulated from these substituted carboxylic acids represented by the formula (I), shown to the right above, respectively;
(b) Nature of the invention - the nature of the invention is evaluation of substituted carboxylic acids represented by the formula (I), shown to the right above, and/or deuterated substances, solvates, prodrugs, metabolites, and/or co-crystals thereof, and the pharmacokinetic behavior of these substances as glucagon-like peptide-1 (GLP-1) receptor stimulators;
(c) State of the prior art - Nature Reviews: Drug Discovery offers a snapshot of the state of the drug development art. Herein, drug development is stated to follow the widely accepted Ehrlich model which includes: (1) development of a broad synthetic organic chemistry program; (2) subsequent testing of compounds in an appropriate laboratory model for the disease to be treated; and (3) screening of compounds with low toxicity in prospective clinical trials (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205). Moreover, WO 21/244645, as provided in the file and cited on the IDS, provides a synthesis of the instantly recited substituted carboxylic acids represented by the formula (I) {Yu et al. WO 21/244645, 2021};
(d) Level of one of ordinary skill in the art - the artisans synthesizing the inventor’s or joint inventor’s substituted carboxylic acids represented by the formula (I), and/or deuterated substances, solvates, prodrugs, metabolites, and/or co-crystals thereof, would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience;
(e) Level of predictability in the art - Synthetic organic chemistry is quite unpredictable (See In re Marzocchi and Horton 169 USPQ at 367 ¶3). Similarly, it is unclear based on the combination of the instant specification and Yu et al. in WO 21/244645, whether the instantly recited deuterated substances, solvates, prodrugs, metabolites, and/or co-crystals of substituted carboxylic acids represented by the formula (I), are enabled. Likewise, the following excerpt is taken from Dörwald, which has relevance to the synthesis of deuterated substances, metabolites, and/or co-crystals of substituted carboxylic acids represented by the formula (I) {Dörwald, F. Zaragoza. Side Reactions in Organic Synthesis: A Guide to Successful Synthesis Design, Weinheim: WILEY-VCH Verlag GmbH & Co. KGaA, 2005, Preface}:
Most non-chemists would probably be horrified if they were to learn how many attempted syntheses fail, and how inefficient research chemists are. The ratio of successful to unsuccessful chemical experiments in a normal research laboratory is far below unity, and synthetic research chemists, in the same way as most scientists, spend most of their time working out what went wrong, and why.
Despite the many pitfalls lurking in organic synthesis, most organic chemistry textbooks and research articles do give the impression that organic reactions just proceed smoothly and that the total synthesis of complex natural products, for instance, is maybe a labor-intensive but otherwise undemanding task. In fact, most syntheses of structurally complex natural products are the result of several years of hard work by a team of chemists, with almost every step requiring careful optimization. The final synthesis usually looks quite different from that originally planned, because of unexpected difficulties encountered in the initially chosen synthetic sequence. Only the seasoned practitioner who has experienced for himself the many failures and frustrations which the development (sometimes even the repetition) of a synthesis usually implies will be able to appraise such work.
Chemists tend not to publish negative results, because these are, as opposed to positive results, never definite (and far too copious).
Next, the following excerpt is taken from Vippagunta, et al., with respect to the synthesis of solvates of substituted carboxylic acids represented by the formula (I) {Vippagunta, et al. Advanced Drug Delivery Reviews, 48, 2001, 18}:
Predicting the formation of solvates or hydrates of a compound and the number of molecules of water or solvent incorporated into the crystal lattice of a compound is complex and difficult. Each solid compound responds uniquely to the possible formation of solvates or hydrates and hence generalizations cannot be made for a series of related compounds. Certain molecular shapes and features favor the formation of crystals without solvent; these compounds tend to be stabilized by efficient packing of molecules in the crystal lattice, whereas other crystal forms are more stable in the presence of water and/or solvents. There may be too many possibilities so that no computer programs are currently available for predicting the crystal structures of hydrates and solvates.
Moreover, the following excerpt is taken from Burger’s, with respect to the synthesis of prodrugs of carboxylic acids represented by the formula (I) {Wolff, Manfred E., Ed. Burger’s Medicinal Chemistry and Drug Discovery - Fifth Edition, Volume 1: Principles and Practice, New York: John Wiley & Sons, 1994, 975-977}:
The design of prodrugs in a rational manner requires that the underlying causes which necessitate or stimulate the use of the prodrug approach be defined and clearly understood. It may then be possible to identify the means by which the difficulties can be overcome. The rational design of the prodrug can thus be divided into three basic steps: (1) identification of the drug delivery problem; (2) identification of the physiochemical properties required for optimal delivery; and (3) selection of a prodrug derivative that has the proper physiochemical properties and that will be cleaved in the desired biological compartment.
The difficulty of extrapolating data from animal to humans encountered during toxicokinetic and toxicologic studies with drugs is amplified with prodrugs, since not only metabolism of the active moiety might differ, but also its availability from the prodrug. As a matter of fact, there is presently no published rational for the conduct of animal and human pharmacokinetic programs during prodrug research and development.
(f) Amount of direction provided by the inventor - the invention lacks direction with respect to making and/or using deuterated substances, solvates, prodrugs, metabolites, and/or co-crystals of substituted carboxylic acids represented by the formula (I);
(g) Existence of working examples - the inventor or joint inventor has provided sufficient guidance to make and/or use substituted carboxylic acids represented by the formula (I); however, the disclosure is insufficient to allow extrapolation of the limited examples to enable the instantly recited deuterated substances, solvates, prodrugs, metabolites, and/or co-crystals of substituted carboxylic acids represented by the formula (I). The specification lacks working examples of deuterated substances, solvates, prodrugs, metabolites, and/or co-crystals of substituted carboxylic acids represented by the formula (I).
Within the specification, [A]t least one specific operative embodiment or example of the invention must be set forth. The example(s) and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP § 608.01(p) and MPEP § 2173.05.
(h) Quantity of experimentation needed to make or use the invention based on the content of the disclosure - predicting whether a recited compound, and/or a deuterated substance, solvate, prodrug, metabolite, and/or co-crystal thereof, is in fact one that produces a desired physiological effect at a therapeutic concentration and with useful kinetics, is filled with experimental uncertainty, and without proper guidance, would involve a substantial amount of experimentation (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205-213). Similarly, the specification, as originally filed, including any references incorporated therein, fails to provide the necessary support
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required by 35 U.S.C. § 112(a) to enable the instantly recited deuterated substances, solvates, prodrugs, metabolites, and/or co-crystals of substituted carboxylic acids represented by the formula (I). Thus, it is unclear, based on the guidance provided by the specification, whether a solvate of a substituted carboxylic acid of the formula (I), such as (S)-2-(4-(6-((4-cyano-2-fluorobenzyl)oxy)pyridin-2-yl)-2-fluorobenzyl)-1-(oxetan-2-ylmethyl)-1H-thieno-[2,3-d]imidazole-5-carboxylic acid dihydrate, shown to the left above, is either synthetically feasible or possesses utility as a glucagon-like peptide-1 (GLP-1) receptor stimulator.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the invention was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {See In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
The determination that undue experimentation would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. (See In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404). These factual considerations are discussed comprehensively in MPEP § 2164.08 (scope or breadth of the claims), § 2164.05(a) (nature of the invention and state of the prior art), § 2164.05(b) (level of one of ordinary skill), § 2164.03 (level of predictability in the art and amount of direction provided by the inventor or joint inventor), § 2164.02 (the existence of working examples) and § 2164.06 (quantity of experimentation needed to make or use the invention based on the content of the disclosure).
Based on a preponderance of the evidence presented herein, the conclusion that the inventor or joint inventor is insufficiently enabled for making and/or using deuterated substances, solvates, prodrugs, metabolites, and/or co-crystals of substituted carboxylic acids represented by the formula (I), is clearly justified.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 3-6 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 3 recites the limitation, The compound… according to claim 2,… wherein… R1a is optionally further substituted with… CF3,… and cyano substituted ethyl. There is insufficient antecedent basis, in claim 2, for this limitation, with respect to the substituted carboxylic acids represented by the formula (I). According to claim 1, R1a is not recited as optionally further substituted with… CF3,… and cyano substituted ethyl, with respect to the substituted carboxylic acids represented by the formula (I).
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 6 and 7 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 6 recites the limitation, The compound… according to claim 5,… wherein… R1a is optionally further substituted with… CF3. There is insufficient antecedent basis, in claim 5, for this limitation, with respect to the substituted carboxylic acids represented by the formula (I). According to claim 3, R1a is not recited as optionally further substituted with… CF3, with respect to the substituted carboxylic acids represented by the formula (I).
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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Claims 1-8 are rejected under 35 U.S.C. § 102(a)(2) as being anticipated by Yu, et al. in WO 21/244645.
The inventor or joint inventor should note that the instant invention recites a substituted carboxylic acid represented by the formula (I), shown to the right above, where r = 0; L = -YCRLRL-, wherein Y = -O- and each RL = -H; R1 = -C1-4 alkylene-R1a, wherein R1a = -3- to 8-membered heterocycloalkyl; each R2 = -H; ring B = -4- to 12-membered heterocyclylene-; ring C = -5- to 10-membered heteroarylene-; ring D = -C6-10 aryl, optionally substituted with 2 RD, wherein RD = -halogen and RD = -CN; and ring E = -5-membered heterocyclylene, respectively, as a glucagon-like peptide-1 (GLP-1) receptor stimulator.
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Similarly, the inventor or joint inventor should further note that Yu, et al. (WO 21/244645), as provided in the file and cited on the IDS, teaches a substituted carboxylic acid represented by the formula (I), shown to the left, where r = 0; L = -YCRLRL-, wherein Y = -O- and each RL = -H; R1 = -CH2-R1a, wherein R1a = -oxetan-3-yl; each R2 = -H; ring B = -1,4-piperidinylene; ring C = -2,6-pyridinylene; ring D = -phenyl, substituted at C-2 with RD, wherein RD = -F and at C-4 with RD, wherein RD = -CN; and ring E = -thiophen-2,3-diyl, respectively, as a glucagon-like peptide-1 (GLP-1) receptor stimulator [p. 14; and p. 4 in CN 202010499820].
Likewise, the inventor or joint inventor should further note that, although not explicitly discussed herein, this reference contains additional species that may anticipate the instantly recited substituted carboxylic acids represented by the formula (I). Consequently, any amendments to the claims and/or arguments formulated to overcome rejections rendered under 35 U.S.C. § 102 should address this reference as a whole and should not be limited to the species discussed or disclosed explicitly herein.
Moreover, the inventor or joint inventor should further note that in the event the determination of the status of the invention as subject to AIA 35 U.S.C. § 102 (or as subject to pre-AIA 35 U.S.C. § 102) is incorrect, any correction of the statutory basis for the instant 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.
Claim Rejections - Improper Markush Grouping
A Markush claim recites a list of alternatively useable members. The listing of specified alternatives within a Markush claim is referred to as a Markush group or a Markush grouping. {see Abbott Labs v. Baxter Pharmaceutical Products, Inc., 334 F.3d 1274, 1280-81, 67 USPQ2d 1191, 1196-97 (Fed. Cir. 2003). The claim language defined by a Markush grouping requires selection from a closed group consisting of the alternatively useable members (Id. at 1280, 67 USPQ2d at 1196). {See MPEP § 2111.03, subsection II, for a discussion of consisting of in the context of Markush groupings}.
A Markush grouping may be rejected under the judicially-approved improper Markush grouping principles when the Markush claim contains an improper Markush grouping of alternatively useable members, where either: (1) the alternatively useable members of the Markush group do not share a single structural similarity, or (2) the alternatively useable members of the Markush group do not share a common use. {See the Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications (Supplementary Guidelines), 76 Fed. Reg. 7162 (February 9, 2011), particularly at 7166 (citing In re Harnisch, 631 F.2d 716, 721-22, 206 USPQ 300, 305 (CCPA 1980)}.
The inventor or joint inventor should note that claims 1-9 are rejected on the judicially-approved principles that they contain an improper Markush grouping of alternatively useable members. {See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980); and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984)}.
Similarly, the inventor or joint inventor should further note that a Markush grouping is proper if: (1) the alternatively useable members of the Markush group (i.e. alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a single structural similarity and belong to the same recognized physical or chemical class or to the same art-recognized class, and (2) the alternatively useable members of the Markush group (i.e. alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a common use and are disclosed in the specification or known in the art to be functionally equivalent. {See Supplementary Guidelines at 7166 and MPEP § 2117; and see MPEP § 2111.03 and MPEP § 2173.05(h) for discussions of when a Markush grouping may be indefinite under 35 U.S.C. § 112(b)}.
Likewise, the inventor or joint inventor should further note that the Markush grouping consisting of substituted carboxylic acids represented by the formula (I) is improper, since the substituted carboxylic acids represented by the formula (I), as recited in claims 1, 8 and 9, respectively, do not consist of alternatively useable members that share a single structural similarity and a common use that flows from the single structural similarity. {See MPEP § 803.02; and MPEP § 2117}.
Next, the inventor or joint inventor should further note that the rejection of the Markush claims under the judicially-approved principles that they contain an improper Markush grouping of alternatively useable members will be maintained until (1) the Markush claims are amended to recite alternatively useable members that share a single structural similarity and a common use that flows from the single structural similarity, or (2) the inventor or joint inventor presents convincing arguments illustrating why the alternatively useable members recited in the Markush claims share a single structural similarity and a common use. {See MPEP § 803.02 and MPEP § 2117}.
Moreover, the inventor or joint inventor should further note that this is a rejection on the merits and may be appealed to the Patent Trial and Appeal Board in accordance with 35 U.S.C. § 134 and 37 CFR 41.31(a)(1).
In accordance with the principles of compact prosecution, MPEP § 803.02, and MPEP § 2117, respectively, the examiner suggests the inventor or joint inventor amend the scope of the substituted carboxylic acids represented by the formula (I) to recite substituted carboxylic acids represented by the formula (I), where r = 0; L = -YCRLRL-, wherein Y = -O-; R1 = -CH2-R1a, wherein R1a = -optionally substituted 3- to 8-membered heterocycloalkyl or 5- to 12-membered heteroaryl; ring B = -optionally substituted phenylene- or -optionally substituted -1,4-piperidinylene-; ring C = -optionally substituted pyridinylene-; ring D = -optionally substituted phenyl; and ring E = -thiophen-2,3-diyl, respectively, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624