Standard for Claim Construction in Interference

In Agilent Technologies v. Affymetrix, Agilent challenged the BPAI's and district court's finding that Affymetrix's claims satisfied the written description requirement. This case was based upon an interference between the two companies. After an Agilent patent issued Affymetrix copied the claims into a continuation application. Agilent challenged the claims claiming that they did not have written description support. Part of determining whether there was written description was how to construe the claim that was involved in the interference. There are two options to use the specification from where the claims were copied from or to use the copier's specification. The court reviewed two previous cases that appear contradictory but are applied in two separate situations. The cases were In re Spina, 975 F.2d 854 (Fed. Cir. 1992), and Rowe v. Dror, 112 F.3d 473 (Fed. Cir. 1997). After reviewing the cases the court in this case stated the following rule:

To be clear, as this court explained in Rowe, when a party challenges written description support for an interference count or the copied claim in an interference, the originating disclosure provides the meaning of the pertinent claim language. When a party challenges a claim’s validity under § 102 or § 103, however, this court and the
Board must interpret the claim in light of the specification in which it appears.

Since the claims were construed using the wrong specification, the CAFC reconstrued the claims and ultimately found that the claims did not have adequate written description support. Affymetrix attempted to argue that the element was inherently produced in the method described but this was rebutted by an admission of their own expert. As the court explained inherency is not mere probabilities but always be present. This panel also included language that it must be recognized by one of skill in the art but did not elaborate on this point.

The CAFC also discussed whether the new evidence presented during the district court trial had been given proper review. The district court however "discarded this evidence, concluding that “Agilent does not present any new evidence concerning this issue, [so] the Court reviews [the Board’s decision on written description] for substantial evidence.” The CAFC rejected this review holding:

The district court’s decision to deferentially review the Board’s written description holding in the face of newly submitted conflicting evidence constituted legal error. Section 146 affords a litigant the option of shoring up evidentiary gaps that may have been evident by the end of the inter partes interference procedure. In this case, the Board explicitly notified Agilent of such gaps, and Agilent endeavored to fill them. Thus, Section 146 permits such new evidence and authorizes the trial court to review the Board’s treatment of the written description issue. This court will examine Agilent’s newly proffered testimony without deference to the Board’s finding.

Ultimately, Affymetrix lost the interference. The full opinion can be found here.

Post-filing art can be used to show that there is no reasonable expectation of success (BPAI)

Ex parte ATUL VARADHACHARY

Appeal 2008-3921

Application 10/732,429

Technology Center 1600

Decided: March 5, 2009

The claims at issue were

1. A method of treating tissue or organ transplant rejection in a recipient comprising the step of orally administering to the recipient an effective amount of a lactoferrin composition to attenuate the tissue or organ transplant rejection.

34. A method of modulating the immune response against an organ or tissue transplant in a recipient comprising the step of orally administering to the recipient an effective amount of a lactoferrin composition to modulate the response against the organ or tissue transplant.

Claim 1 was rejected as being inherently anticipated by a single reference; claims 1 and 34 were rejected as allegedly obvious. A prior art reference taught the administration of lactoferrin in organ transplant patients and immunocompromised patients. However, the reference only taught that it could be used to prevent infections not to attenuate rejection or modulate the response against the organ transplant. The case nicely summarizes inherent anticipation

"To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently." In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Thus, "[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent." Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001). "Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient." In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations and internal quotation marks omitted). Therefore, the Examiner cannot establish inherency merely by demonstrating that the asserted limitation is probable or possible. In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). However, "'[i]n general, a limitation or the entire invention is inherent and in the public domain if it is the 'natural result flowing from' the explicit disclosure of the prior art.'" Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005) (quoting Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1379 (Fed. Cir. 2003). Therefore, "when considering a prior art method, the anticipation doctrine examines the natural and inherent results in that method without regard to the full recognition of those benefits or characteristics within the art field at the time of the prior art disclosure." Perricone, 432 F.3d at 1378.

The Examiner appeared to be arguing that since the compound was used in organ transplant cases it was necessarily and always being used to prevent rejection. The Board noted that some transplant patients will not have rejection and only infection and therefore the result will not always necessarily result from the prior art. "No evidence has been put forward by the Examiner that all, or even substantially all, transplant patients with infection are also experiencing rejection" Therefore, no anticipation.

With regards to obviousness the Examiner found a reference that discussed the oral administration of lactoferrin. However, the applicant submitted a post-filing reference that stated "[i]t has been reported in the literature that oral lactoferrin is not absorbed systemically through the mature gut to any significant degree." The Board when stating the law regarding obviousness stated, "An obviousness analysis requires that the prior art both suggest the claimed subject matter and reveal a reasonable expectation of success to one reasonably skilled in the art. In re Vaeck, 947 F.2d 488, 493 (Fed. Cir. 1991)." Here, the BPAI found no reasonable expectation of success because of the post-filing reference. The Board concluded: "Thus, while [the primary reference] teaches that oral administration may be contemplated, the prior art at the time Appellants' claimed invention was made establishes that a person of ordinary skill in the art would have no expectation of successfully using orally administered lactoferrin in [the primary reference's] method." Therefore, "A person of ordinary skill in the art would not have a reasonable expectation of successfully practicing the claimed invention in view of the combination of" the cited references.

Case can be found here

Ex parte GERHARD JAEHNE

Ex parte GERHARD JAEHNE 

Appeal 2008-4548 

Application 10/463,789 

Technology Center 1600 

BPAI

__________ 

Decided:1 February 2, 2009 

This case had claims to a pharmaceutical composition and a method of using.  The Examiner rejected the claims for lack of written description and not being enabled.  The BPAI reversed the enablement rejection because the Examiner only found that the claim was broad but did not find that any of the other Wands factors tended toward a showing of lack of enablement.  The written description was satisfied because although there was no ipsis verbis support one of skill in the art would have recognized possession because the term that was being used was inherently needed for the composition to even exist.  "The Specification "provides adequate direction which reasonably leads persons skilled in the art to the later claimed compound."

Case can be found here: