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' REVISED JOINT CLAIM CONSTRUCTION CHART Attached hereto as Exhibit A is the parties' Revised Joint Claim Construction Chart for U.S. Patent No. 5,147,868. This revises the parties' Joint Claim Construction Chart (D.I. 33) filed on December 3, 2007. MORRIS, NICHOLS, ARSHT & TUNNELL LLP RICHARDS, LAYTON & FINGER, P.A.

/s/ Mary B. Graham
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 Aaron A. Barlow Gregory D. Bonifield JENNER & BLOCK LLP 330 N. Wabash Avenue Chicago, IL 60611-7603 Attorneys for Merck & Co., Inc. Dated: December 11, 2007
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/s/ Kelley E. Farnan
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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EXHIBIT A

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MERCK & CO., INC. v. RANBAXY INC. AND RANBAXY LABS. INC. CIVIL ACTION NO. 07-229 (GMS) (D. DEL.) REVISED 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); 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.

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

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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. 06/748,300 (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

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 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).

pharmaceutically acceptable cation

1, 9

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

`868 patent, col. 5, lns. 12-18; col. 34, lns. 1068; col. col. 38, lns. 9-66 (Claim 1); col. 39, lns. 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 claimed compounds." INTRINSIC EVIDENCE 18-36 (Claim 9); 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 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

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 ten carbon atoms 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 cyclohexyl group), 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). INTRINSIC EVIDENCE 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; Application Ser. No. 07/641,317: Preliminary Amendment dated Jan. 14, 1991; Office Action 5

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

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE 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.

Y

1

"Y" needs no construction. The claim defines "Y" to mean: "cycloalkyl of three to six carbon atoms, unsubstituted or substituted with one or two substituents where said substituents are

`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

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;

6

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

Claims at Issue

MERCK CONSTRUCTION selected from the group consisting of halogen or 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 number of carbon atoms in substituted Y is not more than ten carbon atoms. INTRINSIC EVIDENCE 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 Response dated September 23, 1981; 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 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.

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

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

`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

8

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

Claims at Issue

MERCK CONSTRUCTION of that larger chemical group or moiety. INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE 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;

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 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.

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

'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;

10

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

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE Summary Record); U.S. Appl. Ser. No. 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 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; Application Ser. No. 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 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.

2,2-dimethylcyclopropyl

2, 9

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)-2,2dimethylcyclopropyl, (R)-2,2dimethylcyclopropyl, 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 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);

12

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

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE 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, 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, Communication to the Examiner under 37 C.F.R. §1.56, dated June 5, 1986; Ashton, et al. Abstract no. 271 and "poster session,"

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 (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).

R1 is hydrogen, loweralkyl of 1-6 carbon atoms, dialkylaminoalkyl, or a pharmaceutically acceptable cation

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

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

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

'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

14

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

Claims at Issue

MERCK CONSTRUCTION "dialkylaminoalkyl" needs no construction. The term "pharmaceutically acceptable cation" is defined by the parties above. INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION acceptable cation. INTRINSIC EVIDENCE 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 Response dated September 23, 1981; Office Action dated 15

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

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE 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-219 carboxyethylthio)2-(2,2dimethylcyclopropanecarboxamido)-2-heptenoic acid

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

'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. 21-25 (Claims 1920).

the free acid form of 7(L-2-amino-2carboxyethylthio)-2(2,2-dimethylcyclopropanecarboxamido)-2heptenoic acid, excluding a pharmaceutically acceptable cation, the free acid form including the (S)-(2,2dimethylcyclopropanecarboxamido) form, the (R)-(2,2-

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

'868 patent, 2:18-5:10; Table I, cols. 11-20; Claims 1, 9, 19 and 20; Application Ser. No.

16

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

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION dimethylcyclopropanecarboxamido) form, and mixtures thereof. INTRINSIC EVIDENCE 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," (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. 17

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

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE 509 (1968); A. Srinavasan et al. Tetrahedron Lett., 891 (1976).

the sodium, potassium calcium or magnesium salt form

20

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). `868 patent, col. 40, lns. 28-33 (Claim 22).

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.

R2

22

"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

R2 includes at least: cyclopropyl substituted by two substituents of one, two, or three carbon atoms each; cyclobutyl substituted by two substituents of one, two, or three carbon atoms each;

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

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

Claims at Issue

MERCK CONSTRUCTION than ten carbon atoms." INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION cyclopentyl substituted by one substituent of one, two, or three carbon atoms and by one substituent of one or two carbon atoms; and cyclohexyl substituted by one substituent of one, two, or three carbon atoms and by one substituent of one carbon atom, or cyclohexyl substituted by one substituent of one or two carbon atoms and by one substituent of one or two carbon atoms. INTRINSIC EVIDENCE 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 Response dated September 23, 1981; 19

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

Claims at Issue

MERCK CONSTRUCTION INTRINSIC EVIDENCE

RANBAXY CONSTRUCTION INTRINSIC EVIDENCE 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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