Free Claim Construction Chart - District Court of Delaware - Delaware

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE MERCK & CO., INC., Plaintiff and Counterclaim Defendant, v. RANBAXY INC., and RANBAXY LABORATORIES LIMITED, Defendants and Counterclaim Plaintiffs. ) ) ) ) ) ) ) ) ) ) )

C.A. No. 07-229 (GMS)

PARTIES' JOINT CLAIM CONSTRUCTION CHART Pursuant to the Court's Scheduling Order, attached hereto as Exhibit A is the parties' Joint Claim Construction Chart for U.S. Patent No. 5,147,868. MORRIS, NICHOLS, ARSHT & TUNNELL LLP RICHARDS, LAYTON & FINGER, P.A.

/s/ James W. Parrett, Jr. (#4292)
Mary B. Graham (#2256) James W. Parrett, Jr. (#4292) 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19899-1347 302.658.9200 OF COUNSEL: Raymond N. Nimrod JENNER & BLOCK LLP 919 N. Third Avenue 37th Floor New York, NY 10022-3908 212.891.1600 Aaron A. Barlow Gregory D. Bonifield JENNER & BLOCK LLP 330 N. Wabash Avenue Chicago, IL 60611-7603 312.222.9350

/s/ Kelly E. Farnan (#4395)
Frederick L. Cottrell, III (#2555) Kelly E. Farnan (#4395) One Rodney Square 920 North King Street Wilmington, DE 19801 302.651.7700 OF COUNSEL: Mark Boland Michael Dzwonczyk SUGHRUE MION PLLC 2100 Pennsylvania Avenue, N.W. Washington, D.C. 20037 202.293.7060 Attorneys for Ranbaxy Inc. and Ranbaxy Laboratories Limited

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Paul D. Matukaitis Charles M. Caruso MERCK & CO., INC. One Merck Drive Whitehouse Station, NJ 08889-0100 Edward W. Murray MERCK & CO., INC. 126 E. Lincoln Avenue Rahway, NJ 07065-0907 Attorneys for Merck & Co., Inc. Dated: December 3, 2007
1327123

-2-

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EXHIBIT A

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MERCK & CO., INC. v. RANBAXY INC. AND RANBAXY LABS. INC. CIVIL ACTION NO. 07-229 (GMS) (D. DEL.) JOINT CLAIM CONSTRUCTION CHART Agreed Construction1 Claim Limitation witho Claim at Issue 22 Construction With

Asserted claims: 1, 2, 9, 19, 20, 22, 23, 24 U.S. Patent No. 5,147,868 Claim Limitation "A compound" 1, 9 Claims at Issue MERCK CONSTRUCTION "A substance composed of atoms or ions of two or more elements in chemical combination." INTRINSIC EVIDENCE `868 patent, Abstract, col. 1, lns. 20-43; col. 5, ln. 20 - col. 10, ln. 46; col. 19, lns. 35-67; col. 20, ln. 35 - col. 21, ln. 43; col. 38, ln. 9 - col. 40, ln. 40 (Claims 1-24); U.S. Appl. Ser. No. The parties jointly and respectfully submit that, if the Court deems it appropriate, the Court include the agreed-upon claim construction in its Claim Construction Order, or in the alternative, that this agreed upon construction is a binding stipulation between the parties. 1
1

RANBAXY CONSTRUCTION "A compound" excludes a combination product containing the compound and a thienamycin-type compound. INTRINSIC EVIDENCE '868 patent, 8:43-51 and applications/patents cited therein and stemming therefrom; '868 patent, 5:20-9:45.

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE 06/748,300 (6/5/86 Communication to the Examiner under 37 C.F.R. §1.56 enclosing Abstract and accompanying information from the ICAAC, Sept. 22-24, 1980).

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE

1

This formula needs no construction. The formula defines the structure illustrated, which shows the Zstereoconfiguration.

`868 Patent, col. 1, ln. 45 - col. 5, ln. 11; A. Srinavasan et al. Tetrahedron Lett., 891 (1976).

The formula includes racemates, mixtures, isomers, and enantiomers of the free acid form and salt forms of the compound, with the exception of the Estereoisomer form.

'868 patent, 2:18-5:10, Table I, cols. 11-20 and Examples 1-23, Claims 1, 9, 19 and 20; Application Ser. No. 06/465,577: Office Action dated February 24, 1984; Response under 37 C.F.R. §1.111 dated July 7, 1984; Office Action dated December 4, 1984; Application Ser. No. 06/748,300, Office Action of February 24, 1985, Amendment dated May 15, 1986,

2

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Communication to the Examiner under 37 C.F.R. §1.56, dated June 5, 1986; Ashton, et al. Abstract no. 271 and "poster session," (ICAAC) Sept. 22-24, 1980; Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1.116 received April 6, 1987; J. E. Blackwood et al., J. Am. Chem. Soc., 90, p. 509 (1968); A. Srinavasan et al. Tetrahedron Lett., 891 (1976).

pharmaceutically acceptable cation

1, 9

This term means "a cation acceptable for pharmaceutical use in connection with the claimed compounds."

`868 patent, col. 5, lns. 12-18; col. 34, lns. 1068; col. col. 38, lns. 9-66 (Claim 1); col. 39, lns. 18-36 (Claim 9); 3

Any cation useful in the salt form of the claimed pharmaceutical compound.

not defined (cf. '868 patent, 1:60-5:19, cols. 11-20 (Table 1).

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE U.S. Appl. Ser. No. 06/188,178 (9/17/80 Application).

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE

R1 is hydrogen or a 1 pharmaceutically acceptable cation;

This phrase as a whole needs no construction. The phrase "R1 is hydrogen" needs no claim construction. The term "pharmaceutically acceptable cation" is defined by the parties above.

`868 patent, col. 1, ln. 45 - col. 2, ln. 45; col. 5, lns. 12-18; col. 38, lns. 10-66 (Claim 1).

R1 defines two mutually exclusive subgenera: (1) a free acid form in which R1 is hydrogen, and (2) salt forms in which R1 is a pharmaceutically acceptable cation.

'868 patent 1:60-5:6, 5:11-19; 2:18-5:10, Table I, cols. 11-20 and Examples 1-23, Claims 1, 9, 19 and 20.

X

1

"X" needs no `868 patent, col. 1, ln. construction. The claim 45 - col. 5, ln. 10; col. defines "X" to mean: 10, ln. 45 - col. 38, ln. 8; col. 38, lns. 9-66 (Claim "unsubstituted or 1). substituted branched or linear alkyl of three to ten carbon atoms 4

X includes at least:

a branched or linear alkyl group of four carbons substituted with a cycloalkyl group of six Application Ser. No. 06/878,391: Office carbons (i.e., a Action dated Nov. 6, cyclohexyl group), 1986; Amendment

not defined (cf.. '868 patent, 1:60-5:19, cols. 11-20 (Table 1) and Examples 1-23).

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION wherein a non-terminal methylene can be replaced by oxygen, sulfur or SO2, where said substituents are selected from the group consisting of halogen or cycloalkyl of three to six carbon atoms, with the proviso that, when said alkyl is substituted by said cycloalkyl, X is not more than ten total carbon atoms, with the further proviso that not more than six hydrogens of said alkyl can be substituted by said halogen, and with the further proviso that the carbon adjacent to the carbonyl cannot be tertiary;" INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE under 37 C.F.R. §1. 116 received April 6, 1987; Office Action dated July 24, 1987; Amendment under 37 C.F.R. §1.116 dated Oct. 30, 1987; Office Action dated February 7, 1988; Amendment under 37 C.F.R. §1.116 dated May 24, 1988; Application Ser. No. 07/244,527: Preliminary Amendment dated January 23, 1989; Office Action dated March 14, 1990; Amendment dated August 6, 1980; Office Action dated October 12, 1990; Application Ser. No. 07/641,317: Preliminary Amendment dated Jan. 14, 1991; Office Action dated March 20, 1991; Amendment and 5

a branched or linear alkyl group of five carbons substituted with a cycloalkyl group of five carbons (i.e., a cyclopentyl group), a branched or linear alkyl group of six carbons substituted with a cycloalkyl group of four carbons (i.e., a cyclobutyl group), and a branched or linear alkyl group of seven carbons substituted with a cycloalkyl group of three carbons (i.e., a cyclopropyl group).

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Response dated September 23, 1981; Office Action dated December 9, 1991; Application Ser. No. 07/839,725: Preliminary Amendment and Response dated Feb. 19, 1992; Examiner Interview Summary dated March 30, 1992; Notice of Allowability dated March 30, 1992.

Y

1

"Y" needs no construction. The claim defnes "Y" to mean: "cycloalkyl of three to six carbon atoms, unsubstituted or substituted with one or two substituents where said substituents are selected from the group consisting of halogen or

`868 patent, col. 1, ln. 45 - col. 5, ln. 10; col. 10, ln. 45 - col. 38, ln. 8; col. 38, lns. 9-66 (Claim 1).

Y includes at least: cyclopropyl, cyclobutyl, cyclopentyl, and cyclohexyl, unsubstituted or substituted with one or two substituents including alkyl of one to four carbon atoms, provided that the total number of carbon atoms in substituted Y is not

not defined (cf. '868 patent, 1:60-5:19, cols. 11-20 (Table 1) and Examples 1-23). Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1. 116 received April 6, 1987; Office Action dated July 24, 1987; Amendment

6

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION alkyl of one to four carbon atoms, with the proviso that, when said cycloalkyl is substituted by said alkyl, Y is not more than ten total carbon atoms;" INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION more than ten carbon atoms. INTRINSIC EVIDENCE under 37 C.F.R. §1.116 dated Oct. 30, 1987; Office Action dated February 7, 1988; Amendment under 37 C.F.R. §1.116 dated May 24, 1988; Application Ser. No. 07/244,527: Preliminary Amendment dated January 23, 1989; Office Action dated March 14, 1990; Amendment dated August 6, 1980; Office Action dated October 12, 1990; Application Ser. No. 07/641,317: Preliminary Amendment dated Jan. 14, 1991; Office Action dated March 20, 1991; Amendment and Response dated September 23, 1981; Office Action dated December 9, 1991; 7

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Application Ser. No. 07/839,725: Preliminary Amendment and Response dated Feb. 19, 1992; Examiner Interview Summary dated March 30, 1992; Notice of Allowability dated March 30, 1992.

trialkylammonium, quaternary hydroxyalkyldialkylammonium, phosphonylalkylamino, hydroxyalkylamino, alkylamidino, N,Ndialkyguanidino,

1

The term "alkyl" means "a paraffinic hydrocarbon group which may be derived from an alkane by dropping one hydrogen from the formula." The term "alkyl" used as part of a larger chemical group or moiety has the meaning understood by persons of ordinary skill in the art in the context of that larger chemical group or moiety.

`868 patent, col. 1, ln. 45 - col. 5, ln. 10; col. 21, ln. 44 - col. 23, ln. 23; col. 31, ln. 37 - col. 38, ln. 8; col. 38, lns. 966 (Claim 1).

Each alkyl group in each substituent includes a linear, branched, or cyclic alkyl group without limitation as to number of carbon atoms.

not defined (cf. '868 patent, 1:60-5:6, cols. 11-20 (Table 1), and Examples 1-23); Claims 1, 9, 22). Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1. 116 received April 6, 1987; Office Action dated July 24, 1987; Amendment under 37 C.F.R. §1.116 dated Oct. 30, 1987; Office Action dated

8

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U.S. Patent No. 5,147,868 Claim Limitation alkylcarbonyloxy, alkoxycarbonyl, N,Ndialkylcarbamoyl

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE February 7, 1988; Amendment under 37 C.F.R. §1.116 dated May 24, 1988; Application Ser. No. 07/244,527: Preliminary Amendment dated January 23, 1989; Office Action dated March 14, 1990; Amendment dated August 6, 1980; Office Action dated October 12, 1990; Application Ser. No. 07/641,317: Preliminary Amendment dated Jan. 14, 1991; Office Action dated March 20, 1991; Amendment and Response dated September 23, 1981; Office Action dated December 9, 1991; Application Ser. No. 07/839,725: Preliminary 9

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Amendment and Response dated Feb. 19, 1992; Examiner Interview Summary dated March 30, 1992; Notice of Allowability dated March 30, 1992.

said one to fifteen carbon alkyl

1

"said two to fifteen carbon alkyl" (typographical error)

'868 Patent, col. 38, lns. said one to fifteen 9-66 (Claim 1); carbon alkyl U.S. Appl. Ser. No. 07/244,527 (3/14/90 Office Action; 8/8/90 Amendment; 10/12/90 Office Action); U.S. Appl. Ser. No. 07/641,317 (1/14/91 Application; 1/14/91 Preliminary Amendment; 3/20/91 Office Action; 9/23/91 Amendment and Response; 12/9/91 Office Action; 1/28/92 Examiner Interview Summary Record); U.S. Appl. Ser. No. 10

'868 patent, 1:55-61; 2: 11-17; 2:47-4:34; Table I, cols 11-20, compounds 2a, 2b, 2c, 3-11, 18-32, 34-38, 40, 42-44; Examples 2, 3, 4, 5, 6, 8, 9, 10, 16; Claim 1. Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1. 116 received April 6, 1987; Office Action dated July 24, 1987; Amendment under 37 C.F.R. §1.116 dated Oct. 30, 1987; Office Action dated February 7, 1988;

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE 07/839,725 (2/19/92 Application; 2/19/92 Preliminary Amendment and Response; 3/26/92 Examiner Interview Summary Record; 3/30/92 Notice of Allowability).

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Amendment under 37 C.F.R. §1.116 dated May 24, 1988; Application Ser. No. 07/244,527: Preliminary Amendment dated January 23, 1989; Office Action dated March 14, 1990; Amendment dated August 6, 1980; Office Action dated October 12, 1990; Application Ser. No. 07/641,317: Preliminary Amendment dated Jan. 14, 1991; Office Action dated March 20, 1991; Amendment and Response dated September 23, 1981; Office Action dated December 9, 1991; Application Ser. No. 07/839,725: Preliminary Amendment and 11

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Response dated Feb. 19, 1992; Examiner Interview Summary dated March 30, 1992; Notice of Allowability dated March 30, 1992. The Z stereoconfiguration is defined according to the system described in J. E. Blackwood et al., J. Am. Chem. Soc., 90, p. 509 (1968). '868 patent, 2:18-5:10, Table I, cols. 11-20 and Examples 1-23, Claims 1, 9, 19 and 20; Application Ser. No. 06/465,577: Office Action dated February 24, 1984; Response under 37 C.F.R. §1.111 dated July 7, 1984; Office Action dated December 4, 1984; Application Ser. No. 06/748,300, Office Action of February 24, 1985, Amendment dated May 15, 1986, Communication to the Examiner under 37 12

the compound of the structural formula given above has the Z stereoconfiguration

1

`868 Patent, col. 1, ln. 45 - col. 5, ln. 11; A. Srinavasan et al. Tetrahedron Lett., 891 (1976); J. E. Blackwood et al., J. Am. Chem. Soc., 90, p. 509 (1968).

The picture shows the Z configuration of the compound.

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE C.F.R. §1.56, dated June 5, 1986; Ashton, et al. Abstract no. 271 and "poster session," (ICAAC) Sept. 22-24, 1980; Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1. 116 received April 6, 1987; J. E. Blackwood et al., J. Am. Chem. Soc., 90, p. 509 (1968); A. Srinavasan et al. Tetrahedron Lett., 891 (1976).

2,2-dimethylcyclopropyl

2, 9, 19, 20

This term needs no construction. The term means "2,2dimethylcyclopropyl."

`868 patent, col. 38, lns. 67-68 (Claim 2); col. 39, lns. 18-35 (Claim 9); col. 40, lns. 21-23 (Claim 19).

S-2-(2,2dimethylcyclopropyl) enantiomer, R-2-(2,2dimethylcyclopropyl) enantiomer, and mixtures thereof.

'868 patent, 2:18-5:10, Table I, cols. 11-20, Examples 1-23; Application Ser. No. 06/748,300, Office Action of February 24, 1985, Amendment dated

13

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE May 15, 1986, Communication to the Examiner under 37 C.F.R. §1.56, dated June 5, 1986; Ashton, et al. Abstract no. 271 and "poster session, " (ICAAC) Sept. 22-24, 1980; J. E. Blackwood et al., J. Am. Chem. Soc., 90, p. 509 (1968); A. Srinavasan et al. Tetrahedron Lett., 891 (1976).

9

This formula needs no construction. The formula defines the structure illustrated, which shows the Zstereoconfiguration.

`868 Patent, col. 1, ln. 45 - col. 5, ln. 11; col. 38, lns. 10-66 (Claim 1); col. 39, lns. 18-36 (Claim 9); A. Srinavasan et al. Tetrahedron Lett., 891 (1976).

The formula includes racemates, mixtures, isomers, and enantiomers of the free acid form, salt forms, and ester forms of the compound, including the Z-stereoisomer form and the E-stereoisomer form.

'868 patent, 2:18-5:10, Table I, cols. 11-20 and Examples 1-23, Claims 1, 9, 19 and 20; Application Ser. No. 06/465,577: Office Action dated February 24, 1984; Response under 37 C.F.R. §1.111 dated July 7, 1984; Office Action dated December 4, 1984;

14

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Application Ser. No. 06/748,300, Office Action of February 24, 1985, Amendment dated May 15, 1986, Communication to the Examiner under 37 C.F.R. §1.56, dated June 5, 1986; Ashton, et al. Abstract no. 271 and "poster session," (ICAAC) Sept. 22-24, 1980; Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1. 116 received April 6, 1987; J. E. Blackwood et al., J. Am. Chem. Soc., 90, p. 509 (1968); A. Srinavasan et al. Tetrahedron Lett., 891 (1976).

15

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U.S. Patent No. 5,147,868 Claim Limitation R1 is hydrogen, loweralkyl of 1-6 carbon atoms, dialkylaminoalkyl, or a pharmaceutically acceptable cation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE `868 patent, col. 1, ln. 45 - col. 2, ln. 45; col. 5, lns. 12-18; col. 39, lns. 18-36 (Claim 9).

RANBAXY CONSTRUCTION R1 defines three mutually exclusive subgenera: (1) a free acid form in which R1 is hydrogen, (2) ester forms in which R1 is loweralkyl of 1-6 carbon atoms, or dialkylaminoalkyl, and (3) salt forms in which R1 is a pharmaceutically acceptable cation. INTRINSIC EVIDENCE '868 patent 1:60-5:6, 5:11-19; 2:18-5:10, Table I, cols. 11-20 and Examples 1-23, Claims 1, 19 and 20. Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1. 116 received April 6, 1987; Office Action dated July 24, 1987; Amendment under 37 C.F.R. §1.116 dated Oct. 30, 1987; Office Action dated February 7, 1988; Amendment under 37 C.F.R. §1.116 dated May 24, 1988; Application Ser. No. 07/244,527: Preliminary Amendment dated January 23, 1989; Office Action dated March 14, 1990; Amendment dated August 6, 1980; Office 16

9

This phrase as a whole needs no construction. The phrase "R1 is hydrogen" needs no claim construction. The term "loweralkyl of 1-6 carbon atoms" needs no construction. The term "dialkylaminoalkyl" is discussed by the parties below. The term "pharmaceutically acceptable cation" is defined by the parties above.

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Action dated October 12, 1990; Application Ser. No. 07/641,317: Preliminary Amendment dated Jan. 14, 1991; Office Action dated March 20, 1991; Amendment and Response dated September 23, 1981; Office Action dated December 9, 1991; Application Ser. No. 07/839,725: Preliminary Amendment and Response dated Feb. 19, 1992; Examiner Interview Summary dated March 30, 1992; Notice of Allowability dated March 30, 1992.

dialkylaminoalkyl

9

The term "alkyl" means "A paraffinic

`868 patent, col. 1, ln. 45 - col. 5, ln. 10; col.

Each of the three alkyl groups includes a linear,

not defined (cf. '868 patent, 1:60-5:6, 1:11-

17

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION hydrocarbon group which may be derived from an alkane by dropping one hydrogen from the formula." The term "alkyl" used as part of the term "dialkylaminoalkyl" has the meaning understood by persons of ordinary skill in the art in the context of a dialkylaminoalkyl. INTRINSIC EVIDENCE 10, ln. 45 - col. 38, ln. 8; col. 39, lns. 18-36 (Claim 9); col. 39, lns. 38-41 (claim 11).

RANBAXY CONSTRUCTION branched, or cyclic alkyl group without limitation as to number of carbon atoms. INTRINSIC EVIDENCE 17, cols. 11-20 (Table 1), Claims 1, 9, 22). Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1. 116 received April 6, 1987; Office Action dated July 24, 1987; Amendment under 37 C.F.R. §1.116 dated Oct. 30, 1987; Office Action dated February 7, 1988; Amendment under 37 C.F.R. §1.116 dated May 24, 1988; Application Ser. No. 07/244,527: Preliminary Amendment dated January 23, 1989; Office Action dated March 14, 1990; Amendment dated August 6, 1980; Office Action dated October 12, 1990; 18

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE Application Ser. No. 07/641,317: Preliminary Amendment dated Jan. 14, 1991; Office Action dated March 20, 1991; Amendment and Response dated September 23, 1981; Office Action dated December 9, 1991; Application Ser. No. 07/839,725: Preliminary Amendment and Response dated Feb. 19, 1992; Examiner Interview Summary dated March 30, 1992; Notice of Allowability dated March 30, 1992.

7-(L-2-amino-2carboxyethylthio)2-(2,2dimethylcyclopropanecarbox-

19

This term means "the free acid, ester and salt forms of 7-(L-2-amino2-carboxyethylthio)-2(2,2-dimethylcyclo-

'868 Patent, col. 5, lns. 11-19; col. 8, ln. 42-col. 9, ln. 45; col. 10, lns. 25-44; col. 19, lns. 3567; col. 20, ln. 35-col. 19

the free acid form of 7(L-2-amino-2carboxyethylthio)-2(2,2-dimethylcyclopropanecarboxamido)-2-

'868 patent 1:60-5:6, 5:11-19; 2:18-5:10, Table I, cols. 11-20 , Claims 1, 9, 19 and 20.

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U.S. Patent No. 5,147,868 Claim Limitation amido)-2-heptenoic acid

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION heptenoic acid, excluding a pharmaceutically acceptable cation, the free acid form including the Esteriosomer form, the Zstereoisomer form, the S-2-(2,2dimethylcyclopropyl) enantiomer form, the R2-(2,2-dimethylcyclopropyl) enantiomer form, and mixtures thereof. INTRINSIC EVIDENCE

propanecarboxamido)-2- 23 ln. 23; col. 34, lns. 9heptenoic acid." 68; col. 38, lns. 9-66 (Claim 1); col. 39, lns. 19-35 (Claim 9); col. 40, lns. 21-25 (Claims 1920).

'868 patent, 2:18-5:10; Table I, cols. 11-20; Claims 1, 9, 19 and 20; Application Ser. No. 06/465,577: Office Action dated February 24, 1984; Response under 37 C.F.R. §1.111 dated July 7, 1984; Office Action dated December 4, 1984; Application Ser. No. 06/748,300, Office Action of February 24, 1985, Amendment dated May 15, 1986, Communication to the Examiner under 37 C.F.R. §1.56, dated June 5, 1986; Ashton, et al. Abstract no. 271 and "poster session,"

20

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE (ICAAC) Sept. 22-24, 1980; Application Ser. No. 06/878,391: Office Action dated Nov. 6, 1986; Amendment under 37 C.F.R. §1. 116 received April 6, 1987; J. E. Blackwood et al., J. Am. Chem. Soc., 90, p. 509 (1968); A. Srinavasan et al. Tetrahedron Lett., 891 (1976).

the sodium, potassium calcium or magnesium salt form

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This term needs no construction. This term means "the sodium, potassium, calcium, or magnesium salt form."

'868 Patent, col. 5, lns. 11-19; col. 8, ln. 42-col. 9, ln. 45; col. 10, lns. 25-44; col. 19, lns. 3567; col. 20, ln. 35-col. 23 ln. 23; col. 34, lns. 968; col. 38, lns. 9-66 (Claim 1); col. 39, lns. 19-35 (Claim 9); col. 40, lns. 3-8 (Claims 13-14); col. 40, lns. 21-25 (Claims 19-20).

the sodium, potassium calcium or magnesium salt form, excluding the free acid form.

'868 patent 1:60-5:6, 5:11-19; 2:18-5:10, Table I, cols. 11-20, Claims 1, 9, 19 and 20.

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Case 1:07-cv-00229-GMS

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U.S. Patent No. 5,147,868 Claim Limitation R2

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE `868 patent, col. 40, lns. 28-33 (Claim 22).

RANBAXY CONSTRUCTION R2 includes at least: cyclopropyl substituted by two substituents of one, two, or three carbon atoms each; INTRINSIC EVIDENCE not defined (cf. '868 patent, 1:60-5:6, cols. 11-20 (Table I), Examples 1-23; Claims 1-22).

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"R2" needs no construction. The claim defines "R2" to mean: "cycloalkyl of three to six carbon atoms substituted by two alkyl substituents of one to three carbon atoms each, with the proviso that R2 cannot contain more than ten carbon atoms."

Application Ser. No. 06/878,391: Office cyclobutyl substituted Action dated Nov. 6, by two substituents of 1986; Amendment one, two, or three under 37 C.F.R. §1. 116 carbon atoms each; received April 6, 1987; Office Action dated July cyclopentyl substituted 24, 1987; Amendment by one substituent of under 37 C.F.R. §1.116 one, two, or three dated Oct. 30, 1987; carbon atoms and by one substituent of one or Office Action dated February 7, 1988; two carbon atoms; and Amendment under 37 C.F.R. §1.116 dated cyclohexyl substituted May 24, 1988; by one substituent of one, two, or three Application Ser. No. carbon atoms and by 07/244,527: one substituent of one Preliminary Amendment carbon atom, or dated January 23, 1989; cyclohexyl substituted Office Action dated by one substituent of one or two carbon atoms March 14, 1990; Amendment dated and by one substituent 22

Case 1:07-cv-00229-GMS

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Filed 12/03/2007

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U.S. Patent No. 5,147,868 Claim Limitation

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION of one or two carbon atoms. INTRINSIC EVIDENCE August 6, 1980; Office Action dated October 12, 1990; Application Ser. No. 07/641,317: Preliminary Amendment dated Jan. 14, 1991; Office Action dated March 20, 1991; Amendment and Response dated September 23, 1981; Office Action dated December 9, 1991; Application Ser. No. 07/839,725: Preliminary Amendment and Response dated Feb. 19, 1992; Examiner Interview Summary dated March 30, 1992; Notice of Allowability dated March 30, 1992.

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