Filewrapper® | A patent, trademark, and copyright law blog by MVS - Written description

Inventor's prior art patents and prosecution history lead to reversal of claim construction

Tue, 26 Oct 2010 12:55:00-0500

In a recent decision, the Federal Circuit reversed a district court's grant of summary judgment of noninfringement and invalidity based on inadequate written description. The issue of infringement was reversed based on the district court's incorrect construction of a critical claim limitation. While the court held it was a "close case," it held the patentee had not acted as his own lexicographer and the specification and file history showed a broader construction was appropriate. In addition, a broader construction was supported by usage of the term in prior art patents by the same inventor.

On the written description issue, the court held there was at least a factual issue as to whether limitation at issue, which permitted reinforcement of any portion of a portion of the claimed product, was inadequately described. The court observed that the allegedly limiting language was a "preferred aspect" of the invention, and thus the patentee's experts' testimony that one in the art would interpret the specification as more broadly disclosing the device was sufficient to generate a fact issue. The district court characterized this testimony as "not helpful" when granting summary judgment of invalidity.

More detail of Laryngeal Mask Co. v. Ambu A/S after the jump.

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En banc Federal Circuit reaffirms written description requirement is separate from enablement

Wed, 24 Mar 2010 17:23:00-0500

Monday the Federal Circuit released its en banc opinion in Ariad Pharmaceuticals, Inc. v. Eli Lily & Co., where the court addressed whether 35 U.S.C. § 112 has a written description requirement separate and apart from the enablement requirement. A substantial majority of the court (10 judges) joined in the majority opinion, with two judges dissenting. As summarized by the court:

We . . . read the statute to give effect to its language that the specification "shall contain a written description of the invention" and hold that § 112, first paragraph, contains two separate description requirements: a "written description [i] of the invention, and [ii] of the manner and process of making and using [the invention]."

The Federal Circuit analyzed several old Supreme Court cases, and concluded that the Supreme Court, while not specifically calling this requirement a "written description" requirement, has consistently held that an inventor must do more than simply enable one in the art to make and use the invention claimed, but also must describe what the invention is.

This decision is not unexpected, and leaves intact the Federal Circuit's jurisprudence on the subject. In fact, one of the grounds for retaining the requirement is that forty years of case law has held such a requirement exists, and inventors have relied upon the requirement over the course of that time. The court was reluctant to upset the settled expectations of the patent community. The court also declined to set forth a rule where original claims always meet the written description requirement, noting:

Although many original claims will satisfy the written description requirement, certain claims may not. For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result.

More detail of the en banc decision after the jump. Click here for our post regarding the original panel decision, which has much of the factual background of the invention at issue. Click here for a discussion of court's decision to grant en banc review, including the questions presented.

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Federal Circuit to consider whether a separate written description requirement exists in section 112

Sun, 23 Aug 2009 12:18:00-0500

In an en banc order Friday, the Federal Circuit announced it will rehear Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. en banc to consider whether there is a written description requirement in § 112 separate and apart from the enablement requirement. Specifically, the questions presented are:

Whether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from an enablement requirement?
If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?

Our post regarding the panel decision in the case may be found here. Judge Linn filed an opinion concurring in the panel's decision in order to restate his opinion that no such separate written description requirement exists in the statute. He now has his opportunity to convince his colleagues that there is no such requirement.

To read the order in Ariad Pharms., Inc. v. Eli Lilly & Co., click here.

When analyzing written description in interference, claims construed according to patent copied from

Tue, 16 Jun 2009 11:23:00-0500

In a recent decision, the Federal Circuit reversed a district court's grant of summary judgment in a § 146 action brought after an interference proceeding at the USPTO. The district court agreed with the Board's decision to award priority to the senior party in the interference, granting the senior party's motion for summary judgment that its specification satisfied the written description requirement for the interference count. In coming to this conclusion, the district court construed the count by reference to the specification of the senior party's application, rather than by reference to the specification of the junior party's issued patent. The district court also determined the proper standard of review was for substantial evidence, holding the junior party did not advance any "meaningful evidence" apart from what was considered by the Board.

The Federal Circuit reversed. The court determined the district court erred both with regard to its determination that 1) the claims should be construed in light of the host application whose written description was being challenged and 2) that evidence proffered to the district court was insufficient to require de novo determination of the facts under § 146. The court reconciled two prior decisions, In re Spina and Rowe v. Dror, dealing with the proper source for claim construction in an interference. As described by the court:

[W]hen 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, [the Federal Circuit] and the Board must interpret the claim in light of the specification in which it appears.

Applying this law, the court construed the count in light of the proper specification. In light of the revised construction, the Federal Circuit reversed the district court's grant of summary judgment that the senior party's disclosure met the written description requirement and remanded with instructions to enter summary judgment for the junior party.

More detail of Agilent Techs., Inc. v. Affymetrix, Inc. after the jump.

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Disclosure of compounds without link to claimed method fails to meet written description requirement

Tue, 14 Apr 2009 10:24:00-0500

In a recent decision, the Federal Circuit reversed a district court's denial of judgment as a matter of law after a jury determined the asserted claims of an invention were not invalid under the written description requirement. The court, however, affirmed the district court's determination of no inequitable conduct.

The Federal Circuit held the jury lacked substantial evidence for its verdict. Specifically, the court noted that vague functional descriptions are essentially invitations for skilled artisans to conduct further research and therefore are not sufficient description to meet the written description requirement of § 112. The specification disclosed three classes of compounds that could be used in the claimed methods. However, it only disclosed specific examples of one of the classes of compounds, and did not disclose any examples of the described compounds actually linked to use in the claimed method. The patentee was further hampered in that the jury held the patent was entitled to a priority date of 1989, but most of the patentee's testimony and other evidence regarding the written description issue centered on the application's filing date in 1991. The court held none of this evidence could support the jury's verdict, as it was directed to the wrong timeframe. Therefore, the court held the written description requirement not met, and the asserted claims invalid.

The court affirmed the district court's holding of no inequitable conduct. Neither party contested the relevant acts (failing to correct a figure and to disclose certain non-prior art references that were relevant to patentability) were properly held material. The Federal Circuit agreed with the district court that there was insufficient evidence of intent to deceive to support a finding of inequitable conduct.

More on Ariad Pharms., Inc. v. Eli Lilly & Co. after the jump.

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Federal Circuit hears arguments in In re Kubin; what will be obvious in biotechnology?

Sun, 11 Jan 2009 15:29:00-0500

Thursday, the Federal Circuit held oral arguments in In re Kubin, a biotechnology case involving a patent over a gene sequence in humans, and specifically whether the claims were obvious. This was the first precedential decision by the Board of Patent Appeals and Interferences on the issue of obviousness in this field after KSR, so how the Federal Circuit comes out on the issue has the potential to greatly affect examination of biotechnology applications at the USPTO. We previously covered the Board's decision in the case in July.

The key issues addressed in oral arguments were whether the prior art, particularly Valiente (a reference teaching a similar protein in mice), rendered the claimed invention obvious, and whether the disclosure of essentially one sequence was sufficient to provide written description for all sequences with 80% similarity that still retain the function of the original gene. Oral argument focused largely on the obviousness issue. Many attended the arguments, including representatives from our office.

Click below for more detail of the arguments in In re Kubin.

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On appeal, BPAI cannot group claims that do not share a common reason for rejection

Fri, 02 Jan 2009 15:07:00-0500

In a recent decision, the Federal Circuit affirmed a distirct court's vacatur of a decision of the Board of Patent Appeals and Interferences. In an appeal of rejections in twelve different applications involving approximately 2,400 claims, the Board only addressed the rejection of 21 "represntative" claims pursuant to 37 C.F.R. § 1.192(c)(7) [now 37 C.F.R. § 41.37(c)(vii)]. The Board took this position that each of the claims in the groupings were rejected under the same statutory provision, even though the rejections were not necessarily based on the same limitations.

The district court held this was improper. Specifically, the district court held the Board could only group claims if the basis for the rejection was the same, which requires both the same statutory provision and the same underlying basis for the rejection. Here, because the rejections at issue were predominantly under the written description requirement, the district court held claims could only properly be grouped if the limitation that was allegedly not described was present in each of the grouped claims.

The Federal Circuit affirmed, agreeing with the district court's analysis.

More detail of Hyatt v. Dudas after the jump.

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Disclosure of single antibody insufficient to describe genus of related antibodies

Thu, 06 Nov 2008 10:47:00-0500

In a recent decision, the Federal Circuit affirmed the decision of the Board of Patent Appeals and Interferences sustaining in part the examiner's final rejection of the broadest claim in an application, directed to methods of treating neurofibrosarcoma using monoclonal antibodies. The Board reversed the examiner's rejection of the claim for lack of enablement, but sustained the rejection for lack of adequate written description. The Board agreed with the examiner that the single example provided of a functional monoclonal antibody for use in treatment and the method of its production did not provide sufficient support for the genus encompassing all such antibodies.

The Federal Circuit affirmed, finding the Board's conclusion supported by substantial evidence. The question turned on the level of variability within the claimed genus. There was evidence in the record that the species in the genus "would be expected to vary substantially," based on statements made in scientific literature (including one paper authored by the inventor). As described by the court:

The specification of the '749 Application does not characterize the antigens to which the monoclonal antibodies must bind; it discloses only the molecular weight of the one antigen identified in Example 2. This is clearly insufficient. The specification teaches nothing about the structure, epitope characterization, binding affinity, specificity, or pharmacological properties common to the large family of antibodies implicated by the method. While Alonso's claim is written as a method, the antibodies themselves are described in purely structural language – "a monoclonal antibody idiotypic to the neurofibrosarcoma of said human." This sparse description of antibody structure in the claim stands in stark contrast to the detailed method of making the antibodies found in the specification.

Accordingly, the court affirmed the rejection on written description grounds.

More detail of In re Alonso after the jump.

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When factual inquiries underlying obviousness determination disputed, summary judgment improper

Thu, 25 Sep 2008 10:57:00-0500

In a decision Friday, the Federal Circuit affirmed a district court's summary judgment of no anticipation, no invalidity for failure to comply with the written description requirement, and infringement, but reversed the district court's summary judgment of no invalidity based on obviousness. In an unusual procedural move, the parties stipulated that for the issues on which both parties moved for summary judgment, the district court could make findings of fact based on the summary judgment record, making it similar to an inter partes proceeding at the TTAB for those issues. This stipulation included all issues except obviousness.

The Federal Circuit found no clear error in the district court's determination of the other issues, but held there was a genuine issue of fact that should have prevented summary judgment on obviousness. The court noted the Graham factual inquiries underlying the obviousness determination were legitimately in dispute, thus rendering summary judgment inappropriate on that issue.

More detail of Commonwealth Sci. & Indus. Research Org. v. Buffalo Tech., Inc. after the jump.

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Disclosure of gene from one bacterial source cannot support claims to gene from any bacterial source

Mon, 22 Sep 2008 09:46:00-0500

In a recent decision, the Federal Circuit affirmed a district court's grant of summary judgment of non-infringement and invalidity of various claims of three patents. The district court held no genuine issue of fact existed regarding noninfringement or invalidity under the written description requirement.

The patents related to DNA polymerases, and the claims at issue covered plasmids containing the gene coding region of DNA polymerase from any bacterial source. The specifications, however, only disclosed successful use of the DNA polymerase gene from E. coli. Based on this limited disclosure, the court affirmed the district court's decision that, under Regents of University of California v. Eli Lilly & Co., there was inadequate description to support the broad claims. Specifically, in order to support the broad claim, "a person of skill in the art [must] understand that the genus that is being claimed has been invented, not just a species of the genus." Here, only a single species was described, rendering the claims to DNA polymerases from any bacterial source invalid as inadequately described.

More details of Carnegie Mellon Univ. v. Hoffmann-La Roche, Inc. after the jump.

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When exclusion order based on multiple patents, failure to appeal under each may render appeal moot

Wed, 06 Aug 2008 16:20:00-0500

In a decision last week, the Federal Circuit affirmed the United States International Trade Commission's finding of infringement and validity.

The claims were brought under three patents that all claimed priority to a common parent application, and thus would ordinarily all expire on the same day. However, one of the three patents was subject to a 108 day term extension under 35 U.S.C. § 154(b). The final determination was only appealed as to two patents, one of which was the one subject to the extension. As the exclusion order was supportable for the full term of both the non-extended patents based on infringement of the non-appealed patent, the determination regarding the non-extended patent was moot, given it would have no effect on the exclusion order. The extended patent, however, would extend the order beyond the expiration of the non-appealed patent, making the appeal as to that patent not moot.

Turning to the merits, the court affirmed the ITC's finding that the patents were not invalid under the written description requirement of § 112. The patentee substituted the generic word "clearance" for other terms in the claims, but the court held this insufficient to show lack of possession of the invention as of the parent application's filing date.

More detail on Yingbin-Nature Wood Indus. Co. v. Int'l Trade Comm'n after the jump.

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Finding of inequitable conduct without considering materiality vacated

Wed, 06 Aug 2008 09:51:00-0500

In a decision on Friday, the Federal Circuit reversed a district court's summary judgment of invalidity and noninfringement and subsequent finding of inequitable conduct. The court also vacated the district court's exceptional case finding and the associated award of attorney's fees.

The plaintiff was initially awarded partial summary judgment of infringement of six patents. The district judge then assigned a special master to examine the remaining issues in the case, including invalidity and inequitable conduct. The case was then transferred to a new judge who, without written opinion, overturned the plaintiff's ruling of summary judgment and awarded partial summary judgment of noninfringment and invalidity. The judge then held a brief bench trial on the issue of inequitable conduct, where the plaintiff was only allowed to present inventor testimony regarding candor and good faith; all evidence of materiality was precluded. After this trail, the court, from the bench, made a ruling of inequitable conduct against the plaintiff, ruled the case was exceptional under § 285, and awarded attorney's fees.

The Federal Circuit reversed, vacated, or remanded every ruling made by the trial court. Specifically, the court held that in order to support a finding of inequitable conduct, there must be threshold findings of both materiality and intent to deceive. Here, the district court only examined intent, rendering the record insufficient to support a holding of inequitable conduct. The court also held the district court's findings regarding intent to deceive were clearly erroneous. On top of that, the court held the summary judgment rulings "lack[ed] findings for judicial review," and that "the record show[ed] many potential issues of fact that would prevent entry of summary judgment." Given the district judge's handling of the case, the court further ordered the case reassigned to a new trial judge on remand.

More on Research Corp. Tech., Inc. v. Microsoft Corp. after the jump.

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When priority not decided at PTO patentee bears burden of showing entitlement to earlier application

Mon, 14 Apr 2008 16:48:00-0500

In a decision Friday, the Federal Circuit affirmed a district court's grant of summary judgment of invalidity with respect to all asserted claims of two patents. More particularly, the court held that the claims of the patents were not entitled to the priority date of an earlier-filed application, and were therefore anticipated by intervening prior art. The original application was filed in 1997, however the court determined that written description support was not found in the application family until a 2000 CIP application. As a result, a prior product in public use in 1999 (which was the predecessor of the accused product) anticipated the asserted claims.

Of particular interest, however, was the Federal Circuit's treatment of the presumption of validity on appeal. The district court held that because the issue of priority was never addressed by the USPTO, the patentee had the burden to show it was entitled to the earlier priority date. The Federal Circuit agreed, stating:

When neither the PTO nor Board has previously considered priority, there is simply no reason to presume that claims in a CIP application are entitled to the effective filing date of an earlier filed application. Since the PTO did not make a determination regarding priority, there is no finding for the district court to defer to.

Of course, the logic of this holding could easily be extended to other issues not addressed by the PTO, such as whether claims of a patent are valid over a reference not considered during prosecution. As Professor Crouch points out at Patently-O, this issue is the subject of a petition for certiorari currently before the Supreme Court in the Microsoft v. z4 Technologies case. The response to Microsoft's petition for certiorari is due May 1.

More concerning PowerOasis, Inc. v. T-Mobile USA, Inc. after the jump.

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Ex parte Kubin: Obviousness at the USPTO in biotechnology

Wed, 18 Jul 2007 14:55:00-0500

As mentioned previously, the BPAI designated an opinion as precedential today addressing the issues of obviousness, enablement, and the written description requirement in the context of biotechnology inventions. These issues were addressed in the context of patenting a gene involved in regulating the immune system.

Addressing the obviousness issue, the board determined that the previous knowledge of the protein sequence in other species combined with the limited number of approaches to isolate the gene rendered the invention obvious under the "obvious to try" standard. Citing to KSR, the Board determined that the results obtained were merely the product of ordinary skill and common sense and affirmed the rejection of the examiner.

The enablement and written description issues stemmed from the claim of sequences with at least 80% identity to the isolated sequence. The enablement rejection was reversed because while extensive experimentation may be required, the experimentation would have been routine, not undue. However, the board upheld the written description rejection on the grounds that the two exemplary sequences provided in the specification were not sufficiently different to demonstrate possession of the entire genus claimed (all sequences with 80% similarity).

More detail of Ex parte Kubin after the jump.

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Federal Circuit approves MPEP guidelines for written description rejections

Thu, 28 Jun 2007 16:52:00-0500

The Federal Circuit addressed the standard applied by the USPTO for establishing a prima facie case of failure to meet the written description requirement in Hyatt v. Dudas today. The court found that compliance with MPEP § 2163.04(I)(B), by pointing out the nonexistence of support in the specification and identifying the claim limitation(s) at issue, is sufficient for an examiner to make out a prima facie case of failure to meet the written description requirement.

More detail on Hyatt v. Dudas after the jump.

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