Some background on issues in the recently decided Supreme Court case, Teva V. Sandoz, 2015 U.S. LEXIS 628

As to the recently-decided Supreme Court case in Teva v. Sandoz, 2015 U.S. LEXIS 628, one observes the last words of the dissent:

Although it relied on expert testimony to understand the science underlying petitioners’ claims, the District Court made no “findings of fact” as that term is used in Rule 52(a)(6). Thus, the Court of Appeals properly reviewed the District Court’s conclusions of law de novo. I respectfully dissent.

 

Rule 52(a)(1) states in part --the court must find the facts specially  --AND 52(a)(6) states - Findings of fact, whether based on oral or other evidence, must not be set aside unless clearly erroneous --

An interesting aspect is that there seem to be no explicit findings of fact specially found. 

As to the now-vacated Federal Circuit decision, one notes that Judge Moore wrote the underlying CAFC decision, 723 F.3d 1363 (CAFC 2013).

The portion of the CAFC decision investigated by the Supreme Court is relatively short:

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Appellants argue that the term "molecular weight" renders all of the asserted claims indefinite because it can refer to different measures, including M_p, M_w, and M_n. They contend that the scope of the claims varies significantly depending on the measure and that a skilled artisan cannot ascertain the boundaries of the claims. Appellants argue that Teva inconsistently defined "molecular weight" as M_w and M_p during prosecution of two of the familial patents, reinforcing the ambiguity. Further, Appellants contend that the specification does not resolve which molecular weight measure is intended.

Appellants also contend that their indefiniteness arguments apply equally to Group I and Group II claims. They argue that even Group II claims, which refer to a molecular weight range,  [] "necessarily refer to a copolymer-1 percentage above or below a certain average molecular weight." Sandoz Reply Br. 17. Appellants contend that, because all of the claims recite "molecular weight," they must be indefinite.

Teva counters that the prosecution history clarifies that "molecular weight" should be construed as M_p. It contends that its response to an indefiniteness rejection of the '539 patent claims unequivocally stated that a person of skill in the art reading the specification would understand that the term "molecular weight" refers to M_p. Teva argues that the district court correctly determined that its response during prosecution of the '847 patent, where it stated that "[o]ne of ordinary skill in the art could understand that kilodalton units implies [sic] a weight average molecular weight," was not contradictory. J.A. 3229. It contends that a skilled artisan would discount this statement because it does not explicitly define "molecular weight" as Mw and because it contains an evident scientific error—any molecular weight measurement, not just M_w, may be expressed in kilodalton units.

Teva also contends that the specification resolves any ambiguity in the meaning of "molecular  [] weight." Teva contends that the specification's reference to the Size Exclusion Chromatography (SEC) method indicates that "molecular weight" means M_p because determining M_n and M_w requires further calculations from SEC data that the specification does not describe. It further argues that Figure 1 confirms this conclusion because only M_p can be obtained directly from the molecular weight plot in that figure.

Finally, Teva contends that Group II claims refer to exact molecular weight values and are therefore not ambiguous. It argues that Group II claims recite percentages of molecules in a copolymer-1 sample that fall within a specified molecular weight range, not average values.

 [p. 1369]  We agree with Appellants that Group I claims are indefinite and agree with Teva that Group II claims are not. It is undisputed that Group I claims contain an ambiguity because their plain language does not indicate which average molecular weight measure is intended. Teva's attempt to resolve this ambiguity hinges in part on the prosecution history. But two of its prosecution statements directly contradict each other and render the ambiguity insoluble.

During prosecution of the '539 patent, the Examiner rejected  [] pending claims as indefinite, stating that "the term 'average molecular weight' . . . is indefinite since its method of measurement is not specified, i.e. [M_n], [M_w] . . . etc." J.A. 3245. Teva stated in its response that "[o]ne of ordinary skill in the art, upon reviewing the specification, would understand that 'average molecular weight' refers to the molecular weight at the peak of the molecular weight distribution curve shown in Figure 1," i.e., M_p. J.A. 3258. The claims were allowed. During prosecution of the '847 patent, the Examiner made an analogous rejection over the same claim term, stating that "the term 'average' molecular weight . . . is meaningless as a limitation without specifying its basis, e.g., [M_w], [M_n], etc." J.A. 3220. Teva overcame the rejection by responding that "[o]ne of ordinary skill in the art could understand that kilodalton units implies [sic] a weight average molecular weight," i.e., M_w. J.A. 3229. The only basis upon which the Examiner could have agreed that the '539 patent claims were not indefinite was that "molecular weight" means M_p. In contrast, the only basis for the Examiner's withdrawal of the indefiniteness rejection of the '847 patent claims  [] was that the same term means M_w. Teva's two definitions cannot be reconciled.

The specification does not resolve the ambiguity. Teva's expert, Dr. Gregory Grant, testified that after examining the curve depicted in Figure 1 and the accompanying legend, a skilled artisan would know that the claim terms "molecular weight" and "average molecular weight" denote M_p. Dr. Grant also testified that Example 1's discussion of gel filtration, which refers to the SEC method for measuring molecular weight, tells a skilled artisan that "molecular weight" refers to M_p. See '808 patent, col. 3 ll. 6-8. He explained that only M_p, which is simply the highest point of a molecular weight curve, can be read directly from a plot of SEC data.

On de novo review of the district court's indefiniteness holding, we conclude that Dr. Grant's testimony does not save Group I claims from indefiniteness. As Dr. Grant himself opined, SEC does not exclusively provide M_p—both M_n and M_w can also be obtained from the data generated by the SEC method after some calculations. J.A. 1005. His testimony is consistent with that of one of Appellants' experts, who opined that SEC "can give at least peak average, number average,  [] and weight average 'molecular weights.'" J.A. 1229. Furthermore, as illustrated in the figure below, the peaks of the curves in Figure 1 do not correspond to the values denoted as "average molecular weight" in the figure's legend (Appellants' additions in color). In fact, the 7.7 kDa value is closer to the M_w than to the M_p of the corresponding batch, which makes it difficult to conclude that M_p is the intended measure. J.A. 5285. Thus, we hold that Group I claims are indefinite.

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The Supreme Court decision makes reference to 810 F. Supp. 2d 578.  
 
-->from  810 F. Supp. 2d 578 (SDNY 2011) -->

Outside the context of copolymer-1 mixtures, there is virtually no dispute that "molecular weight" means the sum of the atomic weights of the atoms making up a molecule. ⁶ (See Sandoz Opening Claim Construction Br. at 9 (conceding that Teva's proposed construction "may be  [] an acceptable definition for 'molecular weight' when referring to a small molecule, such as water, in which every molecule has the same molecular weight"); see also Grant Decl. ¶¶ 24, 54 (Teva v. Sandoz claim construction).) Because complex non-uniform mixtures, such as copolymer-1, often include molecules of varying weights, however, the molecular weight of such mixtures cannot be characterized by the molecular weight of any single species. (Id. ¶ 36.) "The most precise way of describing the molecular weight of such" mixtures, according to Dr. Grant, "is a complete molecular weight distribution." (Id.) For practical purposes, "the molecular weight of a polymer is often expressed in a single, average molecular weight" ("AMW"). (Id.)

The parties agree that for mixtures such as copolymer-1, several different types of AMW can be determined, including number average molecular weight ("Mn"), weight average molecular weight ("Mw"), z average molecular weight ("Mz"), viscosity average molecular weight ("Mv"), and peak average molecular weight ("Mp"). ⁷ (See Ryu Decl. ¶¶ 23, 41 (Teva v. Mylan claim construction); see also Grant Decl. ¶¶ 38-39 (Teva v. Sandoz claim construction).)

The "'claims themselves'" are silent as to the meaning of AMW. Accordingly, the Court looks to "'the specification, the prosecution history, and extrinsic evidence.'" Id. at 1314 (citations omitted). In Phillips, the Federal Circuit explained that the specification is usually "'dispositive; it is the single best guide to the meaning of a disputed term.'" Id. at 1315 (citation omitted). "The close kinship between the written description and the claims is enforced by the statutory requirement that the specification describe the claimed invention in 'full, clear, concise, and exact  [*588]  terms.'" Id. at 1316 (quoting 35 U.S.C. § 112, para. 1).

Here, the specification expressly describes use of a method called size exclusion chromatography ("SEC"), in which a sample is passed  [] through a gel-filled column. ('808 patent at 3:3-8.) SEC, which "was well understood at the time the patent applications were filed in 1994[,]" according to Dr. Grant, is typically "performed by passing a solution of a polymer down a column packed with a porous gel." (Grant Decl. ¶ 40 (Teva v. Sandoz claim construction).) The gel contains pores of varying sizes into which some, but not all, of the copolymer molecules may fit. (Id.) When a polymer sample is run through the size exclusion column, Dr. Grant explains, the larger molecules that cannot fit in all of the pores go ground them and come out of the column earlier. (Id.) Smaller molecules, by contrast, diffuse more easily into the pores, thus taking a longer route through the gel and coming out later. (Id.) As a sample comes out of the column, the polypeptides are measured by ultraviolet ("UV") light absorption. (Id. ¶ 41.) The amount of UV light absorbed is proportional to the amount of polypeptide present. (Id. n.12.) SEC generates a chromatogram "by plotting UV absorbance versus elution volume or retention time. The peak on the chromatogram corresponds to a fraction that contains the largest amount of polymer, the molecular  [**32] weight of which is the peak or 'peak average' molecular weight." (Id. ¶ 41.) Thus, Teva (and Dr. Grant) conclude, Mp can be read from the chromatogram generated by SEC without any "further calculation" and would be understood by a person of ordinary skill in the art to be the presumed meaning of AMW in the context of the patents-in-suit. (Id. ¶ 61.)

Dr. Grant adds that while "[p]eak molecular weight can be obtained directly from the chromatogram and the calibration curve, . . . further data manipulation and calculation is needed to calculate either the weight average molecular weight or the number average molecular weight." (Id.) Because "[t]he specification does not describe the calculation of the average molecular weight," a person of ordinary skill in the art would have understood, according to Dr. Grant, that the AMW "referred to is a peak molecular weight." (Id.)

The Court credits and accepts all of Dr. Grant's opinions regarding SEC. See Phillips, 415 F.3d at 1318 ("expert testimony can be useful . . . to provide background on the technology at issue . . . [and] to ensure that the court's understanding of the technical aspects of the patent is consistent with that of a person of  [] skill in the art") (citations omitted).

Example 1 in the specification describes a method for measuring the AMW of a sample of copolymer-1 using SEC. ('808 patent at 3:3-8.) Teva argues, and the Court agrees, that a person of ordinary skill in the art would understand that Figure 1 in the specification relates to Example 1. Figure 1 depicts three molecular weight distributions curves. ('808 patent at Fig. 1.) Two have an AMW of 7.7 kilodaltons ("kDa"). (Id.) The other has an AMW of 12.0 kDa. (Id.) The specification states that Figure 1 "displays the molecular weight distribution of three batches of copolymer-1, showing the proportion of species with molecular weight above 40 KDa." (Id. at 1:57-59.) Dr. Grant explains that a person of ordinary skill in the art would understand that Figure 1 does not represent raw data off of a size exclusion column, but, rather, would understand that the SEC apparatus and its UV detector would generate a chromatogram, which would have to be converted into the graph shown in Figure 1 in the patent. (Grant Decl. ¶¶ 41, 62 (Teva v. Sandoz claim construction).)

 [*589]  Finding that the samples described in Example 1 correspond to the data described in Figure 1, a  [**34] person of ordinary skill in the art would understand, according to Dr. Grant, that the listed AMWs fall approximately at the peaks of the curves. (Id. ¶ 62.) A person of ordinary skill in the art would also understand, Dr. Grant explains, "that the process of transferring the data from the chromatogram would likely cause the peak on each curve to shift slightly." (Id.) Thus, a person of ordinary skill in the art would understand that any discrepancy between the peak values read from the chromatogram (7.7 kDa and 12.0 kDa) and the peak of Figure 1 is merely a byproduct of the process by which the data from the chromatogram would have been used to generate Figure 1. (Id.) The Court credits all of Dr. Grant's explanation regarding Example 1 and Figure 1. See Phillips, 415 F.3d at 1318.

In addition to the specification, the prosecution history also indicates AMW refers to Mp in the context of the patents-in-suit. The prosecution history, which, along with the specification, is referred to as "'intrinsic evidence,' consists of the complete record of the proceedings before the [Patent and Trademark Office ("PTO")] and includes the prior art cited during the examination of the patent." Id. at 1317  [] (citation omitted). The prosecution history, like the specification, "provides evidence of how the PTO and the inventor understood the patent." Id. (citation omitted). Since "the prosecution history represents an ongoing negotiation between the PTO and the applicant, rather than the final product of that negotiation," however, "it often lacks the clarity of the specification and thus is less useful for claim construction purposes." Id. (citations omitted). Here, the prosecution history is just as useful as the specification.

The term "average molecular weight" was first used during the prosecution of the '539 patent. Teva stated it sought claims to "[a] copolymer-1 composition comprising a mixture of polypeptides composed of glutamic acid, lysine, alanine and tyrosine, wherein the mixture has an average molecular weight of about 4 to about 9 kilodaltons." (Crystal Decl. Ex. 13 at TEV000304783 (Teva v. Mylan claim construction).) The patent examiner rejected the claims directed to "average molecular weight" as indefinite on the basis that the PTO could not determine what average was being claimed:

Where a claimed value varies with its method of measurement and several alternative methods  [] of measurement are available, the claimed value is indefinite without knowing which method of measurement was used. Honeywell Intl., Inc. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). Accordingly, the term "average molecular weight" . . . is indefinite since its method of measurement is not specified, i.e., number average molecular weight, weight average molecular weight, average molecular weight as determined by light scattering, etc.

(Crystal Decl. Ex. 12 at TEV000304691 (Teva v. Mylan claim construction).)

In response to the rejection, Teva pointed to the specification to explain that a person of ordinary skill in the art would understand AMW to mean "peak average molecular weight":

According to the examiner, the term "average molecular weight" is indefinite. Applicants respectfully disagree. One of ordinary skill in the art, upon reviewing the specification, would understand that "average molecular weight" refers to the molecular weight at the peak of the molecular weight distribution curve shown in Figure 1, which is "% of the total mass" versus "molecular weight." As shown in Figure 1, the "average molecular  []  weight" is 7.7 kDa for the separated copolymer-1 ("Batch  [] A") described in Example 1, and 12.0 kDa for the unseparated copolymer-1."

(Crystal Decl. Ex. 13 at TEV000304803 (Teva v. Mylan claim construction).) The patent examiner accepted Teva's explanation and issued a Notice of Allowability, specifically noting Teva's "remarks and amendments." (Crystal Decl. Ex. 14 (Teva v. Mylan claim construction).)

In situations like this, where a patent examiner has specifically raised an indefiniteness objection and the issue has been resolved to the patent examiner's satisfaction, "[t]here is a 'heavy presumption against [a party] arguing that the patents and claims do not comply with 35 U.S.C. § 112." See Mas-Hamilton Grp. v. LaGard, Inc., 21 F. Supp. 2d 700, 717 (E.D. Ky. 1997) (citations omitted).

(...)

Second, although SEC can provide Mp, this disclosure is insufficient, Mylan argues, in view of the fact that it can also provide Mw and Mn. (Ryu Decl. ¶ 41.) This argument fails because, as explained above, Mp is the only type of AMW that can be provided directly by SEC without "further data manipulation and calculation." (Grant  [] Decl. ¶ 70 (Teva v. Mylan claim construction).) Since the patents-in-suit do not disclose any additional calculations, the Court credits Dr. Grant's representation that a person of ordinary skill in the art would understand that AMW means Mp. (See id.)

Lastly, Mylan concedes that Mp may be derived from Figure 1, but argues that Figure 1 does not show peaks of either 7.7 kDa or 12.0 kDa. (Ryu Decl. ¶ 42.) This argument fails because, as Dr. Grant explained, a person of ordinary skill in the art would understand, based on Example 1's reference to SEC, that Figure 1 was created by transforming data from a chromatogram to the curves depicted in Figure 1. (Grant Decl. ¶¶ 44-53 (Teva v. Mylan claim construction); see also Grant Decl. ¶ 62 (Teva v. Sandoz claim construction).) A person skilled in the art would understand, according to Dr. Grant, "that the process of transferring the data from the chromatogram would likely cause the peak on each curve to shift slightly." (Grant Decl. ¶ 62 (Teva v. Sandoz claim construction); see also Grant Supp. Decl. ¶ 7 (Teva v. Mylan claim construction).) As a  [*591]  result, the fact that the peaks in Figure 1 do not match the listed AMWs precisely would not dissuade  [**40] a person of ordinary skill in the art from concluding that AMW refers to Mp in the context of the patents-in-suit.

Sandoz, for its part, devotes substantial energy to discrediting Dr. Grant and his explanation regarding how one of ordinary skill in the art would understand Figure 1. Sandoz relies almost exclusively, however, on unsubstantiated attorney-argument. The Court finds that Sandoz's unsubstantiated attorney-argument is insufficient to cast doubt on Dr. Grant's opinions, which, as explained above, the Court credits and accepts. See Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1068 (Fed. Cir. 2005) (^HN12"Unsubstantiated attorney argument regarding the meaning of technical evidence is no substitute for competent, substantiated expert testimony.")

**The 2011 case includes the text 
--SUBSEQUENT HISTORY: Findings of fact/conclusions of law at Teva Pharms. United States v. Sandoz, Inc., 876 F. Supp. 2d 295, 2012 U.S. Dist. LEXIS 91022 (S.D.N.Y., 2012)
Affirmed in part and reversed in part by Teva Pharms. USA, Inc. v. Sandoz, Inc., 2013 U.S. App. LEXIS 15208 (Fed. Cir., July 26, 2013)  -- 

It is not clear that 876 F. Supp. 2d 295 sets out distinct findings of fact and conclusions of law, as required by FRCP 52. 

--->from 876 F. Supp. 2d 295 (SDNY 2012), June 29, 2012, Filed-->


As to molecular weight:

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i. Average Molecular Weight Limitations

Claim 1 of the '808 patent, claim 1 of the '589 patent, claims 1 and 6 of the '847 patent and claims 1, 8, 9, 10, 12, 23, 30, and 31 of the '539 patent are directed to copolymer-1 having an "average molecular weight" falling within a particular numeric range. (PTX 1; PTX 2; PTX 7; PTX 8.) For example, claim 1 of the '539 patent provides:

A copolymer-1 composition   comprising a mixture of polypeptides composed of glutamic acid, lysine, alanine and tyrosine, wherein the mixture has an average molecular weight of about 4 to about 9 kilodaltons, wherein the mixture of polypeptides is non-uniform with respect to molecular weight and sequence, and wherein the composition is suitable for treating multiple sclerosis.

(PTX 8 at 5:18-24 (emphasis added).)

The asserted claims containing "average molecular weight" limitations require copolymer-1 having an average molecular weight of "about 5 to 9 kilodaltons" (claim 1 of the '808 patent and claim 1 of the '589 patent), "about 4 to about 9 kilodaltons" (claims 1 and 6 of the '847 patent and claims 1, 8, 9, 12, 23, 30, and 31 of the '539 patent), and "6.25 to 8.4 kilodaltons" (claim 10 of the '539 patent). (PTX 1; PTX 2; PTX 7; PTX 8.)

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1) Average Molecular Weight Limitations

The Court construed "average molecular weight" to mean "peak molecular weight detected using an appropriately calibrated suitable gel filtration column." (CCO at 40 and n.10; Sept. Tr. (Grant) 211:5-15; PTX 986 at 25.) Mylan's method for determining the peak molecular weight values of its product involves using an appropriately  [] calibrated suitable gel filtration column. (Sept. Tr. (Grant) 250:23-254:22; PTX 318 at MYL0000111-12; PTX 330 at MYL0000765-66.)

 [p. 348]  Based on Dr. Grant's testimony, which the Court credits, and the peak molecular weight data in Mylan's ANDA, Mylan's proposed product meets the molecular weight limitations of claim 1 of the '808 patent and claim 1 of the '589 patent, which require a copolymer-1 having an average molecular weight of "about 5 to 9 kilodaltons;" claims 1 and 6 of the '847 patent and claims 1, 8, 9, 12, 23, 30, and 31 of the '539 patent, which require a copolymer-1 having an average molecular weight of "about 4 to about 9 kilodaltons;" and claim 10 of the '539 patent, which requires a copolymer-1 with an average molecular weight of "6.25 to 8.4 kilodaltons." (Sept. Tr. (Grant) 259:24-260:22; PTX 986 at 24, 45.)

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Why molecular weight was important:

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Finally, the Teva and Weizmann scientists discovered that toxicity—the cause of the side effects Dr. Bornstein observed during his clinical trial—was related to the molecular weight of the product. (July Tr. (Pinchasi) 27:25-28:25.) The higher the average molecular weight of a copolymer-1 batch, the higher the probability that the batch would be toxic. (July Tr. (Pinchasi) 27:25-28:25; July Tr. (Arnon) 332:8-333:6; DTX 3567 (Konfino Dep. Tr. Vol. 1) at 62:24-63:9.) In particular, they discovered that there was a narrow molecular weight range between 5,000 and 9,000  [**50] daltons in which there is a high probability that a copolymer-1 batch will be both active and non-toxic. (July Tr. (Arnon) 333:7-17; July Tr. (Pinchasi) 34:6-35:5.)

<--end 2012="" br="" case="" nbsp="">

From FRCP 52(a):


In an action tried on the facts without a jury or with an advisory jury, the court must find the facts specially and state its conclusions of law separately. The findings and conclusions may be stated on the record after the close of the evidence or may appear in an opinion or a memorandum of decision filed by the court.




As to Rule 52, note:


Unt v. Aerospace Corp., 765 F.2d 1440, 1444 (9th Cir. 1985) (holding that factual findings made by a judge after a bench trial "must be explicit enough to give the appellate court a clear understanding of the basis  of the trial court's decision, and to enable it to determine the ground on which the trial court reached its decision"


from 458 F.3d 955 (CA9 2005)

***from page 717 of  21 F. Supp. 2d 700 :

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Plaintiff insists that this information  [*717]  is critical to practicing the '656 patent lock. Consequently, the alleged inventors were [**30]  well aware of this critical and necessary requirement and a better way of practicing the alleged invention, but concealed and failed to disclose it.

55. The testimony heard at trial compels the conclusion that one of ordinary skill in the art would appreciate that the solenoid must contain some magnetic material in order to work properly. Likewise, the lack of detailed tolerancing or solenoid energization timing information in the '656 patent would not prevent one of ordinary skill in the art from practicing the '656 patent. Therefore, the Court finds that Plaintiff has failed to establish by clear and convincing evidence that the '656 patent is invalid for failing to meet the best mode requirement.

G. ENABLEMENT

56. Mas-Hamilton asserts that the '656 patent is invalid for failing to meet the enablement requirement. The specification of a patent must contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same. 35 U.S.C. § 112. In order to be considered []  enabling, a patent must give persons of ordinary skill in the relevant art enough information to practice the invention disclosed in the specification without undue experimentation. In re Alton, 76 F.3d 1168, 1172, n. 5 (Fed. Cir. 1996). A patent is invalid if a person skilled in the pertinent art, using the knowledge available to that person, and the disclosure in the patent document, could not make and use the invention without undue experimentation. Northern Telecom, Inc. v. Datapoint, Inc., 908 F.2d 931, 941 (Fed. Cir. 1990). The purpose of this requirement is to insure that the inventor provides sufficient information about the claimed invention. Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565, 1571 (Fed. Cir. 1991). It is not sufficient that a person following the disclosure might obtain the results set forth in the claims; it must invariably happen. Gubelmann v. Gang, 56 C.C.P.A. 1013, 408 F.2d 758, 766 (C.C.P.A. 1969).

57. Plaintiff argued at trial that the '656 patent provides insufficient information concerning solenoid timing, construction of the solenoid housing, and relative tolerancing of the solenoid housing and lever in order []  to enable a person of ordinary skill in the art to build a working lock mechanism.

58. Having heard the testimony at trial, the Court finds that the information contained in the '656 patent would allow one of ordinary skill in the art to practice the '656 patent. Thus, Plaintiff has failed to establish by clear and convincing evidence that the '656 patent is invalid for failing to meet the enablement requirement.

H. INDEFINITENESS

59. Mas-Hamilton asserts that the claims at issue are invalid because they are indefinite as written or as asserted by LaGard. Patent claims must particularly point out and distinctly claim the subject matter which the patentee regards as his invention. 35 U.S.C. § 112. A claim is invalid for failing to meet this requirement if those in the relevant art would not understand what is being claimed in the patent. Amgen, Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 1217 (Fed. Cir. 1991). Thus, the requirement is that the language of the claims must make it clear what subject matter they encompass. PPG Industries, Inc. v. Guardian Industries Corp., 75 F.3d 1558, 1562 (Fed. Cir. 1996). The statute sets forth a requirement [**33]  for precision and definiteness of claim language. Id.

60. The Patent Office understood the terms used in the '656 patent claims. There is a "heavy presumption against [Mas-Hamilton] in arguing that the patents and claims do not comply with 35 U.S.C. § 112 where the Examiner reviewed the adequacy of the descriptions and found the patent descriptions to be definite and allowed the patents thereafter." Water Tech. Corp. v. Calco Ltd., 658 F. Supp. 961, 972 (N.D.Ill.1986), aff'd in part, rev'd in part, 850 F.2d 660 (Fed.Cir.), cert. denied, 488 U.S. 968 (1988).

 [*718]  61. Based on the evidence and testimony presented at trial, the Court finds that the '656 patent claims make clear what subject matter is covered and encompassed in the patent. Plaintiff has therefore failed to establish by clear and convincing evidence that the '656 patent is invalid on grounds of indefiniteness.

I. ANTICIPATION/OBVIOUSNESS

62. ^HN20A patent may be found invalid based upon various types of prior art. 35 U.S.C. § 102. A patent may also be invalid if the differences between the subject matter patented and the prior art are such that the subject matter as a whole would have [**34]  been obvious at the time the invention was made to a person having ordinary skill in the art. 35 U.S.C. § 103.

63. Plaintiff argues that according to LaGard, the primary difference between the alleged invention in the '656 patent and the prior art was the concept of positively moving the lever into contact with the cam wheel only after the proper combination was entered. Plaintiff contends that LaGard admitted that it has in its possession "voluminous" prior art documents showing this concept. However, Plaintiff claims that LaGard failed to produce those documents, in violation of this Court's order. Thus, Plaintiff invites the Court to draw an adverse inference that those documents, if produced, would invalidate the asserted claims of the '656 patent either as an anticipation or as obvious.

64. Having heard the testimony and arguments at trial, the Court finds that there is no evidence that the '656 patent is invalid due to prior art. Further, the Court will draw no adverse inference from LaGard's production of documents, or lack thereof, during discovery. Accordingly, the Court finds that Plaintiff failed to establish by clear and convincing evidence that the '656 patent [**35]  is invalid due to anticipation or obviousness.

CONCLUSION ON VALIDITY

65. Based on the evidence produced at trial, and for the reasons expressed above, the Court finds that Plaintiff has failed to establish by clear and convincing evidence that the '656 patent is invalid for any reason. Thus, Plaintiff has failed to rebut the presumption that a patent issued by the Patent Office is valid. Accordingly, the Court finds that the '656 patent is valid.

IV. PATENT INFRINGEMENT

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