Opinion ID: 208706
Heading Depth: 3
Heading Rank: 1

Heading: crystalline

Text: The Eastern District of Virginia's construction of crystalline in claims 1-5 as Crystal A included the important caveat as outlined in the specification. Lupin CC Order, 484 F.Supp.2d at 459. Although the Eastern District noted the parties agreed that crystalline ordinarily means exhibiting uniformly arranged molecules or atoms, id. at 454, the court relied on the language of the claims themselves, the specification, and the prosecution history to arrive at the more specific meaning recited in the specification. The '507 specification states that Crystal A of the compound (I) [cefdinir] shows its distinguishing peaks at the seven particular PXRD angles enumerated in claim 1. '507 patent col.1 ll.51-62. Indeed, the phrase Crystal A of the compound (I) appears throughout the written description, and the patent offers the following definition: any crystal of the compound (I) which shows substantially the same diffraction pattern [as in the table in col.1/claim 1] is identified as Crystal A of the compound (I). Id. at col.1 l.67-col.2 l.2. As the Eastern District correctly concluded: Had Astellas intended, in the chart found in column 1, to distinguish Crystal A from other forms of crystalline cefdinir that also fall within the scope of claim 1, it would have listed, at a minimum, an eighth peak associated only with Crystal A. However, by listing in column 1 only the same seven `distinguishing' peaks featured in Claim 1, Astellas confirmed that Crystal A was synonymous with the invention listed in Claim 1. Lupin CC Order, 484 F.Supp.2d at 456-57. The problem, within the confines of claim 1, is that defining crystalline as Crystal A, where Crystal A incorporates the seven PXRD peak limitations, arguably renders the remainder of that claim redundant. To distinguish the invention, however, the specification refers several times to Crystal A of the compound (I) of the present invention, see, e.g., '507 patent, col.2 ll.15-17, and offers no suggestion that the recited processes could produce non-Crystal A compounds, even though other types of cefdinir crystals, namely Crystal B, were known in the art. As noted earlier, the Crystal B formulation actually appears in the parent JP '199 application. Thus, Abbott knew exactly how to describe and claim Crystal B compounds. Knowing of Crystal B, however, Abbott chose to claim only the A form in the '507 patent. Thus, the trial court properly limited the term crystalline to Crystal A. The trial court's definition correctly identifies claim 1's literal scope. Unlike claim 1, claims 2-5 do not recite the seven PXRD peaks expressly associated with Crystal A in the '507 specification. Nonetheless, the Eastern District of Virginia limited crystalline to Crystal A in these claims as well, The trial court gave two reasons for this limitation. First, [t]he process steps detailed in those claims [claims 2-5] correspond with the processes for making Crystal A disclosed in the specification under the heading `The Process For Preparing Crystal A of The Compound (I).' Id. at 457 (quoting '507 patent, col.2 ll.13-14). Second, the parent JP '199 application recited these steps to distinguish between preparations of Crystal A and Crystal B. Id. (citing JP '199 application, col.6 ll.1-25). In limiting crystalline to Crystal A in claims 1-5, the Eastern District of Virginia did not improperly import the preferred embodiment into the claims. Initially, Crystal A is the only embodiment described in the specification. As discussed above, the specification's recitation of Crystal A as its sole embodiment does not alone justify the trial court's limitation of claim scope to that single disclosed embodiment. See Liebel-Flarsheim, 358 F.3d at 906 ([T]his court has expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment.). In this case, however, the rest of the intrinsic evidence, including the prosecution history and the priority JP '199 application, evince a clear intention to limit the '507 patent to Crystal A as defined by the seven PXRD peaks in the specification and in claim 1. Initially, the Eastern District of Virginia properly considered the JP '199 application as relevant objective evidence of the inventor's knowledge at the filing of the '507 patent. While statements made during prosecution of a foreign counterpart to a U.S. patent application have a narrow application to U.S. claim construction, Pfizer Inc. v. Ranbaxy Labs. Ltd., 457 F.3d 1284, 1290 (Fed.Cir.2006), in this case the JP '199 application is part of the prosecution history of the '507 patent itself. Indeed the '507 patent claims priority from the JP '199 application. Furthermore, the trial court did not rely on attorney argument or amendments during a foreign prosecution as in Pfizer, but consulted only the contents of the foreign priority application. The JP '199 application strongly suggests that the '507 patent intentionally excluded Crystal B compounds. As discussed above, the JP '199 application establishes unequivocally that Abbott knew and could describe both Crystal A and Crystal B. Abbott could have retained the disclosure of Crystal B to support the broader claims of the '507 patent, but instead disclosed and claimed A alone. Furthermore, the prosecution history of the '507 patent shows a clear and intentional disavowal of claim scope beyond Crystal A. Co-inventor Takao Takaya, who prepared samples according to Examples 14 and 16 of the prior art '334 patent and a sample of Crystal A of the present application, offered a declaration that Crystal A was more stable than the prior art samples from the '334 patent. An analytical chemist, Yoshihiko Okamato, corroborated this evidence. J.A. 501-04. Beyond these declarations, the applicant specifically limited the invention to Crystal A: the method of preparation of the crystalline form of the presently claimed compounds is not considered the heart of the present invention. The crystalline form of the compound represents the inventive concept hereof, and it is clear that [the '334 patent] does not anticipate or suggest said crystalline form. J.A. 511 (Response to Office Action of May 11, 1989, received October 27, 1989, at 6). Given the exclusive focus on Crystal A in the specification as well as the prosecution history of the '507 patent, the Eastern District of Virginia properly limited crystalline in claims 1-5 to Crystal A.