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Cytologic, Inc. v. Biopheresis GMBH

January 15, 2010


The opinion of the court was delivered by: Colleen Kollar-kotelly United States District Judge


Plaintiffs, Cytologic, Inc. and Colorado State University Research Foundation (collectively, "Cytologic"), filed the above-captioned action challenging the actions and decision of the Board of Patent Appeals and Interferences of the United States Patent and Trademark Office pursuant to 35 U.S.C. § 146. Cytologic named as Defendants Biopheresis GMBH, and Biopheresis Technologies, Inc. (collectively, "Biopheresis"). Presently before the Court is Cytologic's [20] Motion for Summary Judgment to Vacate Interference Pursuant to 35 U.S.C. § 135(b)(1) and Request for Oral Hearing. After a searching review of the parties' briefing, the administrative record, the relevant case law, and the entire record herein, the Court shall DENY Cytologic's [20] Motion for Summary Judgment to Vacate Interference Pursuant to 35 U.S.C. § 135(b)(1) and Request for Oral Hearing, for the reasons set forth below. Specifically, the Court finds that the Board of Patent Appeals and Interferences (the "Board") correctly allocated the burden of proof with respect to Cytologic's preliminary Section 135(b)(1) Motion and that Cytologic is precluded from raising new arguments regarding materiality before this Court that were not presented to the Board below.


As is explained in more detail below, Cytologic's now-pending motion for summary judgment is narrow in focus and raises only two discrete challenges to the Board's decision below. Consequently, much of the proceedings before the Board are not directly relevant to the instant Memorandum Opinion. Indeed, given the Court's ultimate resolution of Cytologic's motion, the Court does not herein reach the substantive merits of any of the Board's findings of fact in the interference proceedings. Nonetheless, in order to better understand Cytologic's pending motion and the arguments raised therein, it is necessary to provide a brief review of the relevant patent and interference law as well as the general factual background of this case so that Cytologic's current arguments may be placed in the proper context.

A. Patent and Interference Background

1. Patent Prosecution

The process of obtaining a patent is known as "prosecution"and begins with the filing of an application with the Patent and Trademark Office ("PTO"). See Intervet, Inc. v. Merial Ltd., 643 F. Supp. 2d 97, 99 (D.D.C. 2009); see generally 37 C.F.R. § 1.51. A patent application consists of a specification of the proposed patent, including a claim or claims, an oath or declaration, drawings as may be necessary, and the appropriate filing fee. 37 C.F.R. § 1.51(b).

Focusing on the specification in particular, as Judge Henry H. Kennedy, Jr. aptly explained in a recent decision,

[a] specification must include both a written description of the invention and an enablement for a claimed invention that explains the "manner and process of making and using [the invention], in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same." At the end of the written description and enablement, a proper specification should conclude with a list of "claims," which identify the specific innovations, components or subparts of the invention, the applicant regards as hers. A claim is a single sentence description of what the applicant believes to be her invention, setting the boundaries of the invention the applicant wishes the PTO to examine. A single claim can be composed of multiple elements and/or limitations.*fn1 Elements are the previously known physical components that make up the claimed invention. Limitations, on the other hand, usually describe the claim's restrictions. An application may contain several claims, and each claim usually contains several restrictions. It is these claims that define the scope of patent protection.

Intervet, 643 F. Supp. 2d at 99 (internal citations omitted).

A patent examiner then reviews the application to determine whether a patent should issue. "On taking up an application for examination or a patent in a reexamination proceeding, the examiner shall make a thorough study thereof and shall make a thorough investigation of the available prior art relating to the subject matter of the claimed invention." 37 C.F.R. § 1.104(a)(1). If the patent examiner determines that the applicant is entitled to a patent under the law, a "Notice of Allowance" is issued. Id. § 1.311(a). If, however, the patent examiner determines that there are deficiencies or problems with the application, the examiner will issue an "Office Action" advising the applicant as to the "reasons for any adverse action or any objection or requirement." Id. § 1.104(a)(2). Upon receipt of an Office Action, an applicant may amend the claims, argue as to the merits of the examiner's findings, or both. See id. § 1.111. This back and forth between the applicant and the patent examiner continues until a patent is issued or a final rejection occurs.

2. Patent Interference Practice

United States patent law, unlike much of the rest of the world, is premised on the principle that the first to invent - rather than the first to file a patent application - is granted the patent right. ROBERT L. HARMON, PATENTS AND THE FEDERAL CIRCUIT, 1151 (2009). As a consequence of this rule, there must be a mechanism for determining who among multiple patent applicants, or, as in this case, among an applicant and a patentee, was the first to invent the claimed subject matter. That mechanism is known as an interference, which is a "proceeding [] principally declared to permit a determination of priority." Minnesota Mining and Mfg. Co. v. Norton Co., 929 F.2d 670, 674 (Fed. Cir. 1991). As is oft-repeated, "[i]nterference practice is highly arcane and specialized," Conservolite, Inc. v. Widmayer, 21 F.3d 1098, 1100 (Fed. Cir. 1994), and can be "virtually incomprehensible to the uninitiated," PATENTS AND THE FEDERAL CIRCUIT,supra p. 3, at 1152.

"An interference exists if the subject matter of a claim of one party would, if prior art, have anticipated or rendered obvious the subject matter of a claim of the opposing party and vice versa." 37 C.F.R. § 41.203. Either the patent applicant or the patent examiner may suggest an interference. See id. § 41.202. If the Director of the PTO agrees that an interference is warranted - i.e., that "an application is made for a patent which would interfere with any pending application, or with any unexpired patent" - he may declare an interference and provide notice of such declaration to the applicants, or applicant and patentee, as the case may be. 35 U.S.C. § 135(a); see also 37 C.F.R. § 41.203.*fn2 The Board determines questions of priority of the inventions and may determine questions of patentability as well. 35 U.S.C. § 135(a).

As is relevant to the case at hand, once an interference is determined to be warranted and notice has been provided to the parties, a period is then set for the filing of preliminary statements and preliminary motions with the Board. Gen. Instrument Corp., Inc. v. Scientific-Atlantic, Inc., 995 F.2d 209, 211 (Fed. Cir. 1993). "The 'preliminary' motions are usually a critical part of an interference." Id. at 212. In particular, as is of import in this case, a party may file a preliminary motion under 35 U.S.C. § 135(b)(1).Section 135(b)(1) motions are threshold motions that should be resolved before issues of priority and/or patentability are addressed, as resolution in favor of the movant would end the interference proceedings. See Berman v. Housey, 291 F.3d 1345, 1352 (Fed. Cir. 2002); see also 37 C.F.R. § 41.201.

"[S]section 135(b) was enforced to codify a legal principle akin to laches, imposing 'a statute of limitations, so to speak, on interferences so that the patentee might be more secure in his property right.'" In re Berger, 279 F.3d 975, 982 (Fed. Cir. 2002) (quoting Corbett v. Chisholm, 568 F.2d 759, 764-65 (C.C.P.A. 1977)). It provides that:

[a] claim which is the same as, or for the same or substantially the same subject matter as, a claim of an issued patent may not be made in any application unless such a claim is made prior to one year from the date on which the patent was granted.

35 U.S.C. § 135(b)(1). As the Federal Circuit has explained, "[t]his provision requires an applicant wishing to provoke an interference with an issued patent to do so by filing a claim which is 'for the same or substantially the same subject matter' as a claim of the issued patent, prior to one year from the issue date of the patent." In re Berger, 279 F.3d at 981.

To further its purpose of imposing a statute of limitations-like bar on interference proceedings, "[a]mended or supplemental claims added to a pending application after the one year anniversary of the issuance of a patent may benefit from the timely filings of original patent claims so long as the 'the later filed claim does not differ from an earlier claim in any 'material limitation.'" Sears Ecological Applications Co., LLC v. MLI Assocs., LLC, 652 F. Supp. 2d 244, 269 (N.D.N.Y. Sept. 1, 2009) (quoting In re Berger, 279 F.3d at 981); see also In re Berger, 279 F.3d at 982 ("To further that purpose, a copied claim may be entitled to the earlier effective date of prior claims in an application only if the copied claim does not differ from the prior claims in any material limitation."). "The analysis focuses on the copied claim to determine whether all material limitations of the copied claim necessarily occur in the prior claims." In re Berger, 279 F.3d at 982. "If all material limitations of the copied claim are present in, or necessarily result from, the limitations of the prior claims, then the copied claim is entitled to the earlier effective filing date of those prior claims for purposes of satisfying 35 U.S.C. § 135(b)." Id.

B. Factual Background*fn3

1. Cytologic Patent

Cytologic was granted the patent at issue on April 30, 2002, which issued from a patent application filed on November 20, 1999. Joint Appendix, Docket No. [25] (hereinafter "JA-1"), Ex. P10 (Board's Decision on Motions, dated Jan. 25, 2007) (hereinafter, "Bd. Dec."), at 4; see also id., Ex. P1 (U.S. Patent 6,379,708 B1) (hereinafter "Cytologic patent"). The Cytologic Patent is directed to a method for enhancing an immune response by selectively removing immune system inhibitors present in the blood. See Cytologic Patent at cols. 11-4. This is accomplished by bringing the blood into contact with a binding partner (e.g., antibodies or fragment of antibodies) capable of selectively binding to targeted immune system inhibitors. Id. at. col. 5, lines 26-34. This method is believed to be effective in the treatment of some types of cancer. See id. at col. 6, lines 15-34. In discussing Cytologic's patent, the critical date for purposes of 35 U.S.C. § 135(b)(1) - i.e., one year from the date on which the patent was granted - is April 30, 2003. For convenience, the Court shall refer to this date as the "critical date."

2. Biopheresis' Patent Application

Given the importance of clearly demarcating which relevant events occurred before the critical date and which events occurred after, the Court divides the discussion of Biopheresis' patent application and related events accordingly.

i. Pre-critical date events.

Biopheresis filed the patent application now at issue on November 10, 2000, Patent Application 09/709,045. Bd. Dec. at 5. As originally filed, Biopheresis' application contained 16 claims. Id. at 12. On January 22, 2003, the application was amended to include new claims 17-22, which the application stated "essentially correspond to" the claims of Cytologic's patent. Id. at 12; see also JA-1, Ex. P3 (Biopheresis Amendment and Response to Office Action, dated Jan. 22, 2003) (hereinafter "Biopheresis Jan. 22, 2003 Amend."), at 6.*fn4 In particular, the parties' dispute focuses on claims 17 and 22, which read as follows:

17. A method of enhancing an immune response to a patient comprising:

a. obtaining whole blood from the patient;

b. separating out the plasm;

c. contacting the plasma with antibody specifically binding to a targeted ...

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