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 1-20 are pending in the instant invention. According to the Amendments to the Claims, filed August 31, 2026, claims 21-29 were cancelled.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2022/032900, filed June 9, 2022, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 63/231,558, filed August 10, 2021.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on August 31, 2026, is acknowledged: a) Group I - claims 1-12; and b) substituted (arylalkyl)amine of Formula (I) - p. 156, Comp. No. 131, shown to the right below, and hereafter referred to as N,N-bis(3-methoxybenzyl)-4-((2-(tetra-hydro-2H-pyran-4-yloxy)ethoxy)methyl)thiazol-2-amine, where Ar1 = -phenyl, substituted with p-OCH3; R1 = -phenyl, substituted with p-OCH3; T = -2,4-thiazolylene-; at C-4, X = -(CH2)zO-(CH2CH2O)p-, wherein p = 1 and z = 1; and Y = -tetrahydro-2H-pyran-4-yl. Claims 1-5 and 8-10 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, 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 (arylalkyl)amines of the Formula (I), where Ar1 = -phenyl, substituted -OCH3; R1 = -phenyl, substituted with -OCH3; T = -2,4-thiazolylene-; at C-4, X = -(CH2)zO-(CH2CH2O)p-, wherein p = 1 and z = 1; and Y = -tetrahydropyranyl, 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 (arylalkyl)amines of the Formula (I), where Ar1 = -optionally substituted aryl; R1 = -H, optionally substituted lower alkyl, or optionally substituted aryl; T = -2,4-thiazolylene- or -2,5-thiazolylene-; X = -(CH2)z- or -(CH2)zO-(CH2CH2O)p-; and Y = -optionally substituted heterocyclyl or optionally substituted aryl, 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 (arylalkyl)amines of the Formula (I), where Ar1, R1, T, X, and Y, respectively, are particularly as stated herein in the section below entitled Claim Objections.
Likewise, 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.
Next, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Moreover, the inventor or joint inventor should further note that claims 13-20 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 1-12 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address 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 the substituted (arylalkyl)amines of the Formula (I).
The following title is suggested: SUBSTITUTED (ARYLALKYL)AMINES AS INTEGRIN AGONISTS.
Appropriate correction is required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of Formula (I) into the abstract, to overcome this objection.
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(b) and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
A compound of Formula (I):
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Formula (I)
or a pharmaceutically acceptable salt or stereoisomer thereof,
wherein:
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is:
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or
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;
Ar1 is aryl, wherein the aryl is optionally substituted with one or more substituents independently selected from the group consisting of lower alkyl, alkylene-OH, alkylene-O(alkyl), alkylene-cycloalkyl, alkylene-heterocyclyl, alkylene-aryl, NHC1-C3 alkyl, OH, O(alkyl), O(alkylene)-O(alkyl), cycloalkyl, heterocyclyl, heterocyclylene-alkyl, aryl, and arylene-alkyl;
R1 is H, lower alkyl, or aryl;
wherein the lower alkyl is optionally substituted with one or more substituents independently selected from the group consisting of N(C1-C3 alkyl)2, OH, O(alkyl), O(alkylene)-O(alkyl), cycloalkyl, heterocyclyl, heterocyclylene-alkyl, aryl, and arylene-alkyl; and
wherein the aryl is optionally substituted with one or more substituents independently selected from the group consisting of lower alkyl, alkylene-OH, alkylene-O(alkyl), alkylene-cycloalkyl, alkylene-heterocyclyl, alkylene-aryl, N(C1-C3 alkyl)2, OH, O(alkyl), O(alkylene)-O(alkyl), cycloalkyl, heterocyclyl, heterocyclylene-alkyl, aryl, and arylene-alkyl;
M is H, halogen, CN, lower alkyl, CF3, alkylene-OH, alkylene-O(alkyl), alkylene-cycloalkyl, alkylene-heterocyclyl, C(O)aliphatic, C(O)heterocyclyl, N(C1-C3 alkyl)2, OH, O(alkyl), O(alkylene)-O(alkyl), cycloalkyl, heterocyclyl, or heterocyclylene-alkyl;
X is -(CH2)z-, -(CH2)z-C(O)NR2-, -(CH2)zC(O)NR2-(CH2)z-, -(CH2)zNR2-, -(CH2)zNR2-(CH2)z-, -(CH2)zNR2-(CH2CH2O)p-, -(CH2)zO-, -(CH2)zO-(CH2)z-, -(CH2)zO-(CH2)zO-(CH2)z-, -(CH2)zO-(CH2CH2O)p-, -(CH2)zO-(CH2CH2O)p-(CH2)z-, -(CH2CH2O)p-, -(CH2CH2O)p-(CH2)zNR2-, -C(O)NR2-, -C(O)NR2-(CH2)z-, -O(CH2)z-, -O(CH2)z-C(O)NR2-, -O(CH2)z-C(O)NR2-(CH2)z, -O(CH2)zNR2-, -O(CH2)zNR2-(CH2)z-, -O(CH2)zNR2-(CH2CH2O)p-, -O(CH2)zO-(CH2)z-, -O(CH2CH2O)p-, or -O(CH2CH2O)p-(CH2)zNR2-;
p is 1, 2, 3, 4, 5, or 6;
each Z is independently 1, 2, 3, 4, 5, or 6;
R2 is H, lower alkyl, C(O)CH3, or S(O)2CH3; and
Y is H, C1-C4 alkyl, N(alkyl)2, cycloalkyl, heterocyclyl, aryl, aryl-N(alkyl)N(aralkyl), or aryl-N(aralkyl)2;
wherein the C1-C4 alkyl, each alkyl of N(alkyl)2, each alkyl of aryl-N(alkyl)N(aralkyl), or each alkyl of aryl-N(aralkyl)2 is optionally and independently substituted with one or more substituents independently selected from the group consisting of halogen, CN, N(C1-C3 alkyl)2, OH, O(alkyl), O(alkylene)-O(alkyl), cycloalkyl, heterocyclyl, heterocyclylene-alkyl, aryl, and arylene-alkyl;
wherein the cycloalkyl or heterocyclyl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, CN, lower alkyl, CF3, alkylene-OH, alkylene-O(alkyl), alkylene-O(aryl), alkylene-cycloalkyl, alkylene-heterocyclyl, alkylene-aryl, C(O)aliphatic, N(C1-C3 alkyl)2, OH, O(alkyl), O(alkylene)-O(alkyl), =O, cycloalkyl, heterocyclyl, heterocyclylene-alkyl, aryl, and arylene-alkyl; and
wherein the aryl, each aryl of aryl-N(alkyl)N(aralkyl), or each aryl of aryl-N(aralkyl)2 is optionally and independently substituted with one or more substituents independently selected from the group consisting of halogen, CN, lower alkyl, CF3, alkylene-OH, alkylene-O(alkyl), alkylene-O(aryl), alkylene-cycloalkyl, alkylene-heterocyclyl, alkylene-aryl, C(O)aliphatic, N(C1-C3 alkyl)2, OH, O(alkyl), O(alkylene)-O(alkyl), cycloalkyl, heterocyclyl, heterocyclylene-alkyl, aryl, and arylene-alkyl;
with the provisos that:
(1) if Ar1 is phenyl and R1 is phenyl, then the 2 and 6 positions of Ar1 are unsubstituted and the 2 and 6 positions of R1 are unsubstituted;
(2) if X contains -C(O)NR2- and -C(O)NR2- directly attaches to T, then R2 is H;
(3) for any combination of X groups, p and Z do not create a chain of greater than 20 atoms; and
(4) if at the 4-position of the thiazolylene, X and Y, taken together, is C1-C8 alkyl, then at the 5-position of the thiazolylene, M is H.
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(b), 35 U.S.C. § 112(d) and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound of claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein M is halogen, CN, lower alkyl, CF3, alkylene-OH, alkylene-O(alkyl), alkylene-cycloalkyl, alkylene-heterocyclyl, C(O)aliphatic, C(O)heterocyclyl, N(C1-C3 alkyl)2, OH, O(alkyl), O(alkylene)-O(alkyl), cycloalkyl, heterocyclyl, or heterocyclylene-alkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity, precision and to avoid issues under 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 of claim 2, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
Ar1 is phenyl, pyrrolyl, thiophenyl, isoxazolyl, oxazolyl, or pyridinyl;
wherein the phenyl is substituted with one or more substituents independently selected from the group consisting of lower alkyl, alkylene-OH, alkylene-O(alkyl), alkylene-cycloalkyl, alkylene-heterocyclyl, alkylene-aryl, NHC1-C3 alkyl, OH, O(alkyl), O(alkylene)-O(alkyl), cycloalkyl, heterocyclyl, heterocyclylene-alkyl, aryl, and arylene-alkyl; and
wherein the pyrrolyl, thiophenyl, isoxazolyl, oxazolyl, or pyridinyl is optionally substituted with one or more substituents independently selected from the group consisting of lower alkyl, alkylene-OH, alkylene-O(alkyl), alkylene-cycloalkyl, alkylene-heterocyclyl, alkylene-aryl, NHC1-C3 alkyl, OH, O(alkyl), O(alkylene)-O(alkyl), cycloalkyl, heterocyclyl, heterocyclylene-alkyl, aryl, and arylene-alkyl; and
R1 is H, C1-C4 alkyl, phenyl, pyrrolyl, thiophenyl, isoxazolyl, oxazolyl, or pyridinyl;
wherein the phenyl is substituted with one or more substituents independently selected from the group consisting of lower alkyl, alkylene-OH, alkylene-O(alkyl), alkylene-cycloalkyl, alkylene-heterocyclyl, alkylene-aryl, N(C1-C3 alkyl)2, OH, O(alkyl), O(alkylene)-O(alkyl), cycloalkyl, heterocyclyl, heterocyclylene-alkyl, aryl, and arylene-alkyl; and
wherein the pyrrolyl, thiophenyl, isoxazolyl, oxazolyl, or pyridinyl is optionally substituted with one or more substituents independently selected from the group consisting of lower alkyl, alkylene-OH, alkylene-O(alkyl), alkylene-cycloalkyl, alkylene-heterocyclyl, alkylene-aryl, N(C1-C3 alkyl)2, OH, O(alkyl), O(alkylene)-O(alkyl), cycloalkyl, heterocyclyl, heterocyclylene-alkyl, aryl, and arylene-alkyl.
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(b), 35 U.S.C. § 112(d) and/or Improper Markush Grouping, the existing recitation should be replaced with the following recitation:
The compound of claim 2, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein M is H or C1-C4 alkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for clarity, precision and to avoid issues under 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 of claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein Y is oxetan-3-yl, pyrrolidin-1-yl, 3-hydroxypyrrolidin-1-yl, 3-hydroxypyrrolidin-2-on-1-yl, 4-hydroxypyrrolidin-2-on-1-yl, tetrahydrofuran-3-yl, piperidin-1-yl, tetrahydro-2H-pyran-4-yl, piperazin-1-yl, piperazin-2-on-1-yl, piperazin-3-on-1-yl, piperazin-2,5-dion-1-yl, morpholin-4-yl, morpholin-3-on-4-yl, 2-oxa-5-azabicyclo[2.2.1]heptan-5-yl, 2-oxa-5-azabicyclo[4.1.0]heptan-5-yl, 6-oxa-3-azabicyclo[3.1.1]heptan-3-yl, hexahydro-2H-furo[3,2-b]pyrrol-4(5H)-yl, phenyl, imidazol-1-yl, aryl-N(alkyl)N(aralkyl), or aryl-N(aralkyl)2;
wherein each alkyl of aryl-N(alkyl)N(aralkyl) or each alkyl of aryl-N(aralkyl)2 is optionally and independently substituted with one or more substituents independently selected from the group consisting of halogen, CN, N(C1-C3 alkyl)2, OH, O(alkyl), O(alkylene)-O(alkyl), heterocyclyl, and heterocyclylene-alkyl;
wherein the oxetan-3-yl, pyrrolidin-1-yl, 3-hydroxypyrrolidin-1-yl, 3-hydroxypyrrolidin-2-on-1-yl, 4-hydroxypyrrolidin-2-on-1-yl, tetrahydrofuran-3-yl, piperidin-1-yl, tetrahydro-2H-pyran-4-yl, piperazin-1-yl, piperazin-2-on-1-yl, piperazin-3-on-1-yl, piperazin-2,5-dion-1-yl, morpholin-4-yl, morpholin-3-on-4-yl, 2-oxa-5-azabicyclo[2.2.1]heptan-5-yl, 2-oxa-5-azabicyclo[4.1.0]heptan-5-yl, 6-oxa-3-azabicyclo[3.1.1]heptan-3-yl, or hexahydro-2H-furo[3,2-b]pyrrol-4(5H)-yl is optionally substituted with one or more substituents independently selected from the group consisting of halogen, CN, lower alkyl, CF3, alkylene-O(alkyl), alkylene-heterocyclyl, N(C1-C3 alkyl)2, OH, O(alkyl), O(alkylene)-O(alkyl), heterocyclyl, and heterocyclylene-alkyl; and
wherein the phenyl, imidazol-1-yl, each aryl of aryl-N(alkyl)N(aralkyl), or each aryl of aryl-N(aralkyl)2 is optionally and independently substituted with one or more substituents independently selected from the group consisting of halogen, CN, lower alkyl, CF3, alkylene-O(alkyl), alkylene-heterocyclyl, N(C1-C3 alkyl)2, OH, O(alkyl), O(alkylene)-O(alkyl), heterocyclyl, and heterocyclylene-alkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: a) for brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(b), The compound of claim 1, wherein the VLA-4 integrin agonist of the formula (I) is selected from the group consisting essentially of: should be replaced with The compound of claim 1, wherein the compound is selected from the group consisting of: ; b) for clarity, where a claim sets forth a plurality of species, each species of the claim should be separated by a line indentation {see 37 CFR 1.75(i)}; and c) for clarity, or a pharmaceutically acceptable salt thereof should be inserted after the last species and before the period. Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: a) for brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(b), The compound of claim 1, wherein the VLA-4 integrin agonist of the formula (I) is selected from the group consisting essentially of should be replaced with The compound of claim 1, wherein the compound is selected from the group consisting of: ; b) for clarity, where a claim sets forth a plurality of species, each species of the claim should be separated by a line indentation {see 37 CFR 1.75(i)}; and c) for clarity, or a pharmaceutically acceptable salt thereof should be inserted after the last species and before the period. Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: a) for brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(b), The compound of claim 1, wherein the VLA-4 integrin agonist of the formula (I) is selected from the group consisting essentially of: should be replaced with The compound of claim 1, wherein the compound is selected from the group consisting of: ; b) for clarity, where a claim sets forth a plurality of species, each species of the claim should be separated by a line indentation {see 37 CFR 1.75(i)}; and c) for clarity, or a pharmaceutically acceptable salt thereof should be inserted after the last species and before the period. 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(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 the compound of claim 1, or a pharmaceutically acceptable salt or stereoisomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 is objected to because of the following informalities: for clarity, precision and to avoid issues under 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 the compound of claim 5, or a pharmaceutically acceptable salt or stereoisomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 11 is objected to because of the following informalities: for clarity, precision and to avoid issues under 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 the compound of claim 1, or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 12 is objected to because of the following informalities: for clarity, precision and to avoid issues under 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 the compound of claim 1, or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
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 2-4 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 2 recites the limitation, The compound of claim 1, wherein… (1) M… may be selected… from a group comprising… and (2) X is… selected from a group of radicals comprising….
Similarly, the inventor or joint inventor should further note that MPEP § 2111.03 states the transitional term, comprising, which is synonymous with including, containing, or characterized by, is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. {See Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004); Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948); and Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005)}.
Likewise, the inventor or joint inventor should further note that [A] Markush group must be definite and complete as to its membership. A Markush group is indefinite, and claims are rejected, where the Markush group is defined as comprising. {See Ex parte Morrell, 100 USPQ 317 (Bd. Pat. App. & Int. 1953)}.
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)(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 1-5 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Gillon, et al. in Journal of the Chemical Society, Perkin Transactions 1: Organic and Bio-Organic Chemistry (1972-1999), 12, 1983, 341-347.
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The inventor or joint inventor should note that the instant invention recites a substituted (arylalkyl)amine of the Formula (I), shown to the left, where Ar1 = -optionally substituted aryl; R1 = -H; T = -arylene-; X = -(CH2)z-, wherein z = 1; and Y = -optionally substituted aryl, respectively, as an integrin agonist.
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Similarly, the inventor or joint inventor should further note that Gillon, et al. (Journal of the Chemical Society, Perkin Transactions 1: Organic and Bio-Organic Chemistry (1972-1999), 12, 1983) teaches the characterization of a substituted (arylalkyl)amine of the Formula (I), shown to the right above, where Ar1 = -phenyl; R1 = -H; T = -2,4-thiazolylene-; at C-4, X = -(CH2)z-, wherein z = 1; and Y = -phenyl, respectively [p. 345, Table 2, compound (1f)].
Likewise, the inventor or joint inventor should further note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Next, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Then, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Moreover, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Also, 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 1-12 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 (arylalkyl)amines of the Formula (I) is improper, since the substituted (arylalkyl)amines of the Formula (I), as recited in claims 1 and 6-9, 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 (arylalkyl)amines of the Formula (I) to recite substituted (arylalkyl)amines of the Formula (I), where Ar1, R1, T, X, and Y, respectively, are particularly as stated herein 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.
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/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
