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.

It is unnecessary for the Specification to provide a description of proteins which are already known in the prior art.

Ex parte ALA FISHMAN et al.
Appeal 2009-1258
Application 10/096,840
Technology Center 1600
Decided: March 20, 2009

Claims at issue:
22. A chimeric protein for therapy of allergic responses by targeted elimination of FCεRI expressing cells wherein the chimeric protein comprises a cell targeting moiety consisting of an Fc region of an IgE molecule genetically fused to a cell killing moiety.

29. A pharmaceutical composition comprising the chimeric protein of claim 22, wherein said composition is in a form suitable for injection, intra-nasal, intra-thecal, intra-dermal, trans-dermal, inhalation, topical application, oral administration, sustained release, or ethereal administration.

43. A chimeric protein for therapy of allergic responses by targeted elimination of FCεRI expressing cells wherein the chimeric protein comprises a cell targeting moiety consisting of an Fc region of an IgE molecule genetically fused to a cell killing moiety, and the chimeric protein does not cause degranulation of target cells.

Examiner rejected claims as lacking written description because the specification "does not reasonably provide a written description of any and all chimeric protein comprising any cell targeting moiety consisting of an Fc region of any IgE molecule genetically fused to any cell killing moiety as set forth in claims." The Board following Capon v. Eshhar and Falkner v. Inglis reversed the Examiner.

"Simply stated, there is no evidence on this record to support a conclusion that the cell killing and cell targeting moieties set forth in Appellants’ claims were not known to those of ordinary skill in this art at the time the invention was made. It is unnecessary for the Specification to provide a description of proteins which are already known in the prior art. Capon, 418 F.3d at 1357-58."

The Board affirmed that the claims were obvious, in part, because the appellants mischaracterized the prior art (according to the Board) and, therefore, the contention was not persuasive.

Case can be found here

X-ray Powder Diffraction Pattern is Relevant for Obviousness Analysis regardless of whether or not the compound has unexpected properties. (BPAI)

Ex parte MANNE SATYANARAYANA REDDY et al (BPAI)
Appeal 2008-4197
Application 10/651,306
Technology Center 1600
Decided: March 18, 2009

Claims at issue:
1. A hydrous compound of the formula …

42. Hydrous (S)-5-methoxy-2-[[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole magnesium in the form of an amorphous solid made by a process comprising:…

44. A solid pharmaceutical composition comprising a hydrous (S)-5-methoxy-2-[[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole magnesium in the form of an amorphous solid, wherein the esomeprazole magnesium has substantially the same X-ray powder diffraction pattern as shown in Figure 1, and a pharmaceutically acceptable carrier.

45. A method for reducing gastric acid secretion in a subject which comprises administering to the subject a solid pharmaceutical composition comprising an amount of the compound of claim 1 effective to reduce gastric acid secretion by said subject.

The Examiner rejected claim 42 under 112, second paragraph for the use of product-by-process claim language. The Examiner argued that since they could describe the product as evidence by claim 1, product by process claims are improper. The Board reversed citing, SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1315 (Fed. Cir. 2006), citing that rule the Examiner was using is not the correct standard.

The Examiner rejected claims 44 and 45 for lack of written description and enablement. The Board emphasized that written description and enablement are distinct and noted that the Examiner did not provide any argument regarding written description and therefore reversed that rejection. With regards to enablement the Examiner was concerned that the form claimed could transform in the solid form and therefore the claim was not enabled for some reason. Appellants pointed out that if there was a transformation that changed the x-ray diffraction pattern then it would be outside the scope of the claim and thus not part of the claim. Appellants also supplied evidence stating that conversion from one form to another is "so slow as to be negligible" and that even if it was converted it does not impact the activity of the compound. Examiner never responded to these arguments and therefore they reversed.

The claims were also rejected as obvious. The Examiner cited references describing related compounds that disclosed that some drugs may exist in amorphous forms but do not refer to the claimed compound. The Examiner also stated that an X-ray diffraction pattern although a property is not enough to overcome obviousness unless the X-ray form has an advantage or unexpected results. The prior art references failed to show any compound with a similar X-ray powder diffraction pattern. Therefore, the Board found that the claims were not obvious and reversed the Examiner.

Case can be found here.

"Conclusive Evidence" showing possession is not required for Written Description; "Mere Assertions" not enough to show lack of enablement (BPAI)

Ex parte SAMUEL LOCKWOOD et al. (BPAI)
Appeal 2008-5693
Application 10/793,676
Technology Center 1600
Decided: March 2, 2009

Claim:
A method of reducing C-reactive protein (CRP) levels in a subject comprising administering to a subject who would benefit from such treatment, an effective amount of a pharmaceutically acceptable formulation to reduce the level of circulating CRP in the subject, said pharmaceutically acceptable formulation comprising a non naturally occurring carotenoid analog or derivative; wherein the synthetic carotenoid analog or derivative has the structure …

The Examiner rejected the claims as lacking written description and lacking enablement. The Examiner alleged that the specification "fails to disclose any treatable diseases caused by increased C-reactive protein (CRP), and how reducing CRP is the same as treating the diseases” and characterized the claims as reach through claims, which according to the Examiner are unpatentable. Applicants countered showing that there is a correlation with CRP and certain known diseases.

The Board stated reversed the Examiner. The Board found that the "specification provides direct descriptive support of an association between many ischemic disease states and reperfusion injury (FF 1-2). The Specification directly teaches that levels of C-reactive protein are associated with reperfusion injury and that treatment of these conditions with carotenoids “is expected to inhibit and/or ameliorate . . . disease conditions” (Spec. 7, ll. 2-5; FF 3-4). The Specification also teaches possession of a large number of specific carotenoids (FF 5)." The Examiner had argued that there was no "no conclusive evidence that reduction of circulating CRP is ‘a powerful anti-inflammatory therapeutic modality’ and/or ‘a strong therapeutic modality’” The Board held that for written description this standard is incorrect you only have to show possession of the invention, not conclusive evidence of a link.

The claims were also rejected as being non-enabled. The Examiner did not provide any evidence other than opinion that the claims were not enabled. The Examiner seemed to rely upon the step of detecting and diagnosing CRP to perform the claim. The Board noted that this is routine and not undue. The Examiner also argued that it is not known all diseases arising from CRP are known. The Board held that it is not a requirement and there can be some inoperative embodiments. The Examiner argued that there could be some mutations that cause constituve expression of CRP rather than heart injury. But this argument was not supported by any evidence just Examiner opinion.

The Board Concluded: "The Examiner has not provided the required evidence or scientific reasoning to show that one of ordinary skill in the art would find that reduction of CRP levels in a patient would have required “undue experimentation”. The Examiner's mere assertions to that effect are not sufficient for establishing a prima facie case of lack of enablement. Balancing the factors in the Wands analysis, upon which the rejection is based, demonstrates that there is no prima facie case of lack of enablement.

The claims were rejected for being indefinite but the Examiner failed to say why and thus the rejection was reversed. The claims were also rejected for containing new matter because an R group was not in the specification. This was a new ground of rejection and was remanded to the Examiner for further prosecution.

Case can be found here

Written Description Requires Specification to be Read as a Whole (BPAI)

Ex parte FREDERICK KHACHIK (BPAI)
Appeal 2009-25571
Application 11/702,486
Technology Center 1600
Decided: February 20, 2009

21. A lutein composition suitable for human consumption which
comprises:
(a) at least about 90% lutein having been extracted and purified from plant extracts which contain 10% or less of non-lutein carotenoids,

(b) no traces of toxic chemicals that would render the lutein composition unsuitable for human consumption, and
(c) significantly less than about 10% of non-lutein carotenoids obtained by purification of said plant extracts.

The examiner rejected the claim for lacking written description. The Examiner alleges that the specification would be understood to only include a limitation of at least 97%, not 90%. The patent disclosed two statements that are relevant:

1. "after recrystallization, the purity of “the resulting lutein is usually greater than 90%, most often greater than 97%." with two working examples of greater than 97%.

2. The specification also disclosed “[w]hile 70% pure lutein may be acceptable for use in animal feed, further purification of this compound may be employed to produce lutein with purity greater than 97% for human consumption”

The examiner relied upon the second to state that specification only described greater than 97% while ignoring the first statement. The Board disagreed finding that read as a whole the specification adequately described the 90% limitation. The Board stated that the second phrase only says that further purification may be employed, "but [the specification] does not say that only lutein compositions with 97% purity are suitable for human consumption." Therefore, the claim satisfied the written description requirement.

Case can be found here

Ex parte MATHAI MAMMEN and DAVID OARE

Ex parte MATHAI MAMMEN and DAVID OARE
Appeal 2008-5874 (BPAI)
Application 10/426,364
Decided: February 4, 2009

Claim at issue was a composition claim. The Office alleged that the claim was not entitled to priority to the priority documents. The BPAI agreed holding that the priority documents did not contain enough "blaze marks" that would have identified the sub-genus based upon the genus that was disclosed in the priority document. "In order to obtain benefit of priority for Appellants’ claim . . ., the skilled artisan would have been required to make a large number of specific selections." They explained "the Specification does not provide the clear blaze marks which would have lead to the genus which is now claimed."

The explained "The skilled artisan would have had to select formula (a) from among the nine formulas disclosed as muscarinic receptor antagonists (FF 1-2). Following that selection, the skilled artisan would have had to select NH for
the B” group (FF 3) from among at least six different possibilities (FF 4-5) where –O- and not NH, is indicated as preferred (FF 6). Among the 662 compounds expressly made in U.S. Application 09/456,170, none of them
selected NH for the B” group (FF 7). The skilled artisan would also have had to select a particular group of
six compounds for the B group (FF 8) with the N in the B group linking to the X group (see claim 52). However, U.S. Application 09/456,170 does not require that the N in the B group function as a linker, though it does teach
that linkage (FF 9-12). Additionally, U.S. Application 09/456,170 teaches a significantly larger genus as possible preferred B groups (FF 12). The skilled artisan would also have been required to select a K” group
as a bond, which is indicated as preferred (FF 13-14) and select the R2 group as formula (iii) from four possible choices (FF 15-16)."

This was too much in view of the Examiner and the BPAI

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: