Bausch & Lomb, Inc. v. Alcon Laboratories, Inc., 94-CV-6534L.

• Decision Date: 22 December 1999
• Docket Number: No. 94-CV-6534L.,94-CV-6534L.
• Citation: 79 F.Supp.2d 243
• Parties: BAUSCH & LOMB, INC., Plaintiff, v. ALCON LABORATORIES, INC., Defendant.
• Court: U.S. District Court — Western District of New York

Page 243

79 F.Supp.2d 243

BAUSCH & LOMB, INC., Plaintiff, v. ALCON LABORATORIES, INC., Defendant.

No. 94-CV-6534L.

United States District Court, W.D. New York.

December 22, 1999.

Michael Wolford, Wolford & Leclair LLP, Rochester, NY, Denis A. Polyn, Jill K. Schultz, Bausch & Lomb, Incorporated, Rochester, NY, Robert L. Baechtold, Scott K. Reed, Steven C. Kline, Dominick A. Conde, Gregory B. Sephton, Daniel R. Cahoy, Fitzpatrick, Cella, Harper & Scinto, New York City, for Bausch & Lomb Inc.

William L. Dorr, Harris, Beach & Wilcox, Rochester, NY, W. Edward Bailey, Kevin J. Culligan, A. Peter Adler, Charles

A. Krauss, Fish & Neave, New York City, for Alcon Laboratories, Inc.

DECISION AND ORDER

LARIMER, Chief Judge.

INTRODUCTION

This is a patent infringement action brought by Bausch & Lomb Incorporated ("B & L") against Alcon Laboratories, Inc. ("Alcon"). B & L alleges that Alcon has infringed on United States Patent No. 5,096,607 ("the '607 patent"), which claims an invention in a process for simultaneously cleaning and disinfecting contact lenses using a single solution.

On September 16, 1999, this court issued a Decision and Order that, inter alia, denied Alcon's Motion for Summary Judgment of Indefiniteness. See Bausch & Lomb Inc. v. Alcon Labs., Inc., 64 F.Supp.2d 233 (W.D.N.Y.1999). In its motion, Alcon asserted that the statement in one of the claims of the '607 patent that its method for simultaneously cleaning and disinfecting contact lenses "does not substantially inhibit the activity of the antimicrobial agent" rendered the '607 patent indefinite because the patent does not explicitly define the phrase "does not substantially inhibit," nor does it set forth any objective, quantifiable parameters by which one could determine whether the activity of an antimicrobial agent has been "substantially inhibited."

In my September 16 Decision and Order, familiarity with which is assumed, I found that issues of fact existed regarding whether the '607 patent is indefinite, and therefore not in compliance with the requirements of 35 U.S.C. § 112 ¶ 2, which states that "[t]he specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention." In particular, I noted that Alcon had not submitted any expert testimony of its own, but instead relied almost entirely on alleged inconsistencies and contradictions in the testimony of B & L's expert, Dr. Barbara Iglewski. I therefore denied Alcon's motion for summary judgment, but set the matter down for an evidentiary hearing at which the court would take testimony and consider evidence regarding the issue of indefiniteness.

That hearing commenced on November 15, 1999, and ended on November 18. In addition to hearing live testimony at the hearing, the court has also read portions of deposition excerpts of a number of witnesses that had been designated by the parties, and has reviewed the documentary evidence submitted by both sides. This Decision and Order, then, constitutes my ruling on the issue of whether the '607 patent is sufficiently definite to meet the requirements of § 112.

DISCUSSION

I. General Standards

The standards relating to § 112's definiteness requirement have been set forth in my September 16 Decision and Order, but bear repeating here. In short, patent claims must be sufficiently clear to allow one skilled in the art to understand what is claimed. Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1217 (Fed. Cir.), cert. denied, 502 U.S. 856, 112 S.Ct. 169, 116 L.Ed.2d 132 (1991). Where the claims do not "have a clear and definite meaning when construed in the light of the complete patent document," the patent is rendered invalid. Miles Labs., Inc. v. Shandon Inc., 997 F.2d 870, 874-75 (Fed. Cir.1993), cert. denied, 510 U.S. 1100, 114 S.Ct. 943, 127 L.Ed.2d 232 (1994).

The definiteness requirement serves two purposes. First, by clearly pointing out and distinctly claiming an invention, the claim alerts the public to what the patentee has claimed, so that potential infringers will be on notice of what might constitute infringement. Second, such a claim "makes clear any distinction that is supposed to exist between the patent and the prior art — i.e., it explains why the invention is novel." Aluminum Co. of America v. Reynolds Metals Co., No. 88 C 6019, 1989 WL 165064 *4 (N.D.Ill.Dec.21, 1989). See also United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 236, 63 S.Ct. 165, 87 L.Ed. 232 (1942); In re Vamco Mach. and Tool Inc., 752 F.2d 1564, 1577 n. 5 (Fed.Cir.1985).

Citing Amgen, Alcon takes the position that a claim must be as precise as the subject matter permits. The court in Amgen did state that "[c]laims must ... be `as precise as the subject matter permits.'" 927 F.2d at 1217. That statement, however, was contained in a parenthetical characterization of the holding in Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613 (Fed.Cir.), cert. denied, 474 U.S. 976, 106 S.Ct. 340, 88 L.Ed.2d 326 (1985), but the court in Shatterproof Glass did not actually state that claims must be as precise as the subject matter permits. Rather, the court there stated that "[i]f the claims, read in the light of the specifications, reasonably apprise those skilled in the art both of the utilization and scope of the invention, and if the language is as precise as the subject matter permits, the courts can demand no more.'" Id. at 624 (quoting Georgia-Pacific Corp. v. United States Plywood Corp., 258 F.2d 124, 136 (2d Cir.), cert. denied, 358 U.S. 884, 79 S.Ct. 124, 3 L.Ed.2d 112 (1958)) (emphasis added).

Were these the only two cases on the issue, there might be some ambiguity as to whether being as precise as the subject matter permits is a necessary, or merely a sufficient, condition for a claim to pass muster under § 112. Federal Circuit cases do not insist on the kind of precision urged by Alcon. The Federal Circuit has never said that all claims must be made as precise as humanly possible, without exception. In fact, in a case decided after Amgen, the court observed that "[c]laims are often drafted using terminology that is not as precise or specific as it might be. As long as the result complies with the statutory requirement to `particularly point[] out and distinctly claim[] the subject matter which the applicant regards as his invention,' 35 U.S.C. § 112, para. 2, that practice is permissible." PPG Indus. v. Guardian Indus. Corp., 156 F.3d 1351, 1355 (Fed.Cir.1998).

The focus, then, is whether, given the nature of the subject matter, the claim is precise enough to make clear to a person skilled in the art what is claimed. There may be times when, for one reason or another, it is impossible, unnecessary, or undesirable to state a claim in terms of precise, quantified measurements. See, e.g., United States v. Telectronics, Inc., 857 F.2d 778, 786 (Fed.Cir.1988) (district court erred as a matter of law in holding that if claim were read to mean that electric current must be applied "so as to minimize fibrous tissue formation," it would be invalid under § 112 because it would be "impossible to determine when sufficient minimization takes place to determine what current range is involved"), cert. denied, 490 U.S. 1046, 109 S.Ct. 1954, 104 L.Ed.2d 423 (1989). That is permissible as long as the dictates of § 112 are met.

In addition, as noted in my September 16, 1999 Decision and Order, "the law is clear that the use of terms of degree, such as `substantially,' in patent claims does not necessarily render the claims indefinite. In fact, the Court of Appeals for the Federal Circuit has recognized that such `words are ubiquitous in patent claims.'" Bausch & Lomb, 64 F.Supp.2d at 240 (quoting Andrew Corp. v. Gabriel Electronics, Inc., 847 F.2d 819, 821 (Fed.Cir.) (referring to, inter alia, phrase "substantially equal"), cert. denied, 488 U.S. 927, 109 S.Ct. 312, 102 L.Ed.2d 330 (1988)); see also Atmel Corp. v. Information Storage Devices, Inc., 997 F.Supp. 1210, 1228 (N.D.Cal.1998) (holding term "substantially all" not to be indefinite); Pave Tech, Inc. v. Snap Edge Corp., 952 F.Supp. 1284, 1292 (N.D.Ill.1997) (term "substantial," when considered in light of entire claimed invention, was as accurate as subject matter permitted, and provided sufficient guidance to one skilled in the art); James River Corp. of Virginia v. Hallmark Cards, 915 F.Supp. 968, 989 (E.D.Wis.1996) (word "substantially" in term "substantially integrated" was sufficiently defined, since one skilled in the art could recognize the difference between prior art and the claimed invention); BOC Health Care, Inc. v. Nellcor Inc., 892 F.Supp. 598, 613 (D.Del.1995) (finding phrase "substantially planar" to be sufficiently defined to those skilled in the art to avoid invalidity), aff'd, 98 F.3d 1357, 1996 WL 518067 (Fed.Cir.1996); Tuff Torq Corp., 1994 WL 827767 *12-13 (denying motion for summary judgment of indefiniteness with respect to term "substantially level"). Therefore, "[t]hat some claim language may not be precise ... does not automatically render a claim invalid." Seattle Box Co., 731 F.2d at 826.¹

"Precision" should also not be equated with quantification. Not every claim must be expressed in terms of specific numerical values; rather, the degree of precision with which the claims must be stated to meet the definiteness requirement "is a function of the nature of the subject matter." Miles Labs., 997 F.2d at 875. Thus, "[t]he amount of detail required to be included in claims depends on the particular invention and prior art, and is not to be viewed in the abstract ...," but in conjunction with the specifications of the patent. Shatterproof Glass, 758 F.2d at 624. Accordingly, "[t]hat some claim language may not be precise ... does not automatically render a claim invalid. When a word of degree is used the district court must determine whether the patent's specification...