Tag Archives: Written Description

35 U.S.C. 112 SPECIFICATION. (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

Understanding the Role of the Board of Patent Appeals: Ex Parte Rejection Rates on Appeal

BPAI, Patent, , , , , ,

Every proposed patent reform measure includes an expanded role for the US Patent & Trademark Office’s administrative patent court – known today as the Board of Patent Appeals and Interferences, the BPAI, or simply the Board. Even without legislation, the role of the BPAI has expanded greatly in the past few years. The number of ex parte appeals in FY2009 is expected to at least double the record-filing of 6,400 appeals in FY2008. I suggest that two factors have led to this short term dramatic rise in appeals: (1) an increase in rejection-rate by patent examiners; and (2) attempts by the PTO to limit non-appeal avenues for achieving full claim scope. These limits include the PTO’s proposed rules that would curtail the applicant’s ability to file multiple requests for continued examination (RCEs), continuation applications, and a multitude of claims. Although these rules have only been threatened, they impact appeal practice because they may apply to already-pending applications. Although more gradual, two additional influences on the rise in appeals include: (1) the continued perceived value of patent rights and (2) the continued rise in the number of patent application filed each year.

During patent prosecution, an applicant has a right to appeal to the Board after its application is twice rejected. 35 U.S.C. 134. In this short article, I look at how the Board responds to those rejections on appeal. Many appeals involve multiple rejections each of which may be affirmed or reversed. In addition, the Board occasionally introduces a new ground for rejection even after reversing an examiner decision. This analysis opens-up these decisions and provides data issue-by-issue.

My data comes from two primary sources. First, using Westlaw, I downloaded copies of the approximately 6,000 ex parte BPAI decisions issued between January 2008 and May 2009. Using an automated script, I extracted data from each of those appeals, including the holding and the extent of discussion of various issues. (i.e., how often “obviousness” or “enablement” is discussed in the opinion.) In addition, just under 200 ex parte decisions from 2009 were randomly selected and scored by hand to determine how the BPAI decided individual issues within the appeals. Board decisions typically identify a series of issues and then decide each issue. In Ex Parte Cypher, 2009 WL 1162435, 2008-4722, (Bd. Pat. App. Inter. 2009), for instance, the Board identified two issues: “(1) Claims 1-4 … are rejected under 35 U.S.C. § 103(a) as being unpatentable over Loh in view of McFarling. (2) Claims 9-11 … are rejected under 35 U.S.C. § 103(a) as being unpatentable over Loh and McFarling in view of Yeh.” In Cypher, both issues were affirmed. As a consequence, the data for this case reflects that two obviousness issues were raised, both of which were affirmed.

Results:

In the hand-scored sample, the average Board decision considered 2.1 issues (median of two issues). Approximately 61% of decided issues are affirmed on appeal and 39% are reversed. (In this study, fewer than 1% of issues were expressly not decided.) The issue-by-issue analysis fits with the overall holdings for cases on appeal. In the hand-scored sample, 59% of the cases were affirmed as a whole, 12% were affirmed-in-part, and 29% were reversed. (This sample parallels the Board’s own statistics for FY2009 which indicate that 60% of its decisions on the merits are affirmances, 15% affirmance in part, and 25% reversals). Table 1 shows the issue-by-issue results alongside the overall case-holding for the hand-scored sample.

  

Issue-by-Issue Results

Case-by-Case results

Affirmed

61% of issues affirmed

59% of cases affirmed

Affirmed-in-Part

N/A

12% of cases affirmed-in-part

Reversed

39% of issues reversed

29% of cases reversed

Table 1

    

As you might expect, when there is a strong correlation between the overall case holding of an appeal and the holdings on individual issues at issue in the appeal. When the overall case-holding is affirmed, the vast majority of issues are also affirmed. However, in the hand-scored sample, about 10% of cases that were affirmed included some individual issues that were reversed. Often, the reversed issues were rejections argued by the examiner in the alternative. In Ex Parte Mcquiston, 2009 WL 598537, 2008-3224 (Bd. Pat. App. Inter. 2009), for instance, applicant’s claim 1 had been rejected as (1) anticipated by Golds; (2) obvious over Golds; (3) anticipated by Simso; and (4) obvious over Simso. The Board rejected the first three of these rejections, but the claim remained unpatentable as obvious over Simso and the examiner’s decision affirmed as a whole.

Table 2 compares the case-holding with the issue-by-issue analysis based on our hand-scored sample of 200 BPAI decisions. As seen in Table 2, when a case is affirmed-in-part, roughly half (on average) of the issues are affirmed and half are reversed. In cases that were reversed, every issue was also reversed. (?2 P<.01).

Case Holding

Percent of Issued Affirmed

Percent of Issues Reversed

Affirmed

92%

8%

Affirmed-in-Part

51%

49%

Reversed

0%

100%

Table 2

    

Number of Issues on Appeal: In Mcquiston, the applicant needed to address each alternate reason for rejection in order to win on appeal. In most cases, however, each claim is rejected for only a single reason – usually obviousness. See infra. The applicant can then choose how to group issues on appeal. If, for instance, claims 1-10 are each rejected as obvious, the applicant could choose to argue each claim separately or cluster the claims into one or more groups that are then argued as a unit. Chart 1 uses the hand-scored data to presents the likelihood of a particular case-holding as a function of the number of issues on appeal.

When only one issue is presented, the result in the case tracks the result of that issue. As more issues are presented, the likelihood of a split affirmed-in-part decision rises dramatically while the likelihood of either complete affirmance or complete reversal drops. Chart 2 is a cumulative frequency for the number of issues presented on appeal. In our sample, the number of claims ranged from 1 to 8. The median was 2 claims and the mode 1 claim. About 94% of decisions discussed four or fewer issues.

The Board is authorized to offer new grounds for rejection, and did-so in about 4% of the cases in the hand-scored study. The most common new ground was for obviousness.

Obviousness: Obviousness is the bread and butter of patent examinations. In this study, I also show that it is the mainstay of BPAI ex parte appeals. 90% of appeals in my hand-scored study included at least one obviousness issue that was decided on appeal. More than half of the appeals (54%) focused only on obviousness. The closest runner-up issue – anticipation – was an issue in 37% of the appeals. Other issues on appeal (each with a frequency of < 5%) included in descending frequency: written description requirement; indefiniteness, patentable subject matter, obviousness-type double patenting, and enablement.

For applicants, the fact that the majority of issues involve obviousness spells trouble for applicants. In the hand-scored data, the Board affirmed obviousness findings much more often it did for other grounds of rejection. Specifically, the Board affirmed 65% of the appealed obviousness issues, but affirmed only 52% of the appeal issues made on grounds other than obviousness. Table 3 compares these results for the hand-scored sample of 200 cases. (?2 P<.05).

Issue Holding

Obviousness Rejection

Other Grounds of Rejection

Affirmed

65%

52%

Reversed

35%

48%

Table 3

    

The pervasiveness of obviousness issues is further confirmed by the larger sample of 6,000 ex parte decisions issued between January 2008 and May 2009. Using a parsing script, I looked for discussions of obviousness issues by counting the number of times that the terms such as “obvious” and “35 U.S.C. § 103(a)” appeared in each opinion. In that sample, 87% of the decisions discussion obviousness while only 13% do not discuss obviousness. Table 4 shows the roughly parallel results.

  

Hand-Scored Sample

Automatically Parsed Sample

  

(n ˜ 200)

(n ˜ 6,000)

Obviousness at Issue

90% of cases decide an obviousness issue

87% of cases discuss either obviousness or Section 103(a)

No Obviousness Issue

10% of cases do not decide any obviousness issue

13% of cases do not discuss obviousness or Section 103(a)

Table 4

    

In order to ensure that I was picking up an actual obviousness issue, I created a script that looked for cases where obviousness was more intensely discussed, i.e., where obviousness terms were mentioned at least three times. In those cases where obviousness was intensely discussed, the Board affirmed the examiner’s rejections decisions 59% of the time. In cases where obviousness was not discussed at all, the examiner was affirmed in only 37% of cases. Table 5 compares these results for the automatically-parsed sample of 6000 cases. (?2 P<.01).

Case Holding

Obviousness Intensely Discussed

No Discussion of Obviousness

No Discussion of Obviousness or Novelty

Affirmed

59%

37%

22%

Affirmed-in-Part

15%

10%

4%

Reversed

26%

47%

74%

Table 5

      

The far right column of Table 5 provides a compelling statistic. 358 cases in the sample had no discussion of either obviousness or novelty. Of those cases, 74% were reversed on appeal.

Technology Center Specific Results: Patent examination is divided amongst various technology centers. Although the substantive patent laws do not vary across technology lines, patent practice can vary greatly. The BPAI regularly updates a statistical breakdown of its opinions by tech center. [Link]. Table 6 is derived directly from the BPAI statistics for FY2009 through May 2009 and shows the percentage of decisions on the merits from each tech center that arrive affirm, affirm-in-part, or reverse, respectively.

Technology Center

Affirmed

Affirmed-In-Part

Reversed

1600 Biotechnology and Organic Chemistry

59%

15%

27%

1700 Chemical and Materials Engineering

69%

11%

20%

2100 Computer Architecture, Software, and Information Security

63%

13%

24%

2600 Communications

64%

14%

21%

2800 Semiconductors, Electrical and Optical Systems and Components

65%

11%

24%

3600 Transportation, Construction, Electronic Commerce, Agriculture,

47%

22%

31%

3700 Mechanical Engineering, Manufacturing, Products

53%

17%

30%

Table 6

      

Focusing in on obviousness again, it is interesting to see that appeals from Tech Center 1600 (Biotechnology and Organic Chemistry) are the least likely to discuss obviousness. The most appeal decisions emerge from Tech Center 1700 (Chemical and Materials Engineering), and those appeals are the most likely to include a discussion of obviousness. In particular, a discussion of obviousness is found in 92% of TC 1700 appeals but only 76% of TC 1600 appeals. (?2 P<.01). The difference is partially explained by TC 1600’s more rigorous application of the Section 112 issues of written description, enablement and indefiniteness. Table 6 is again derived from the automatically-parsed sample of 6,000 Board decisions. For each tech center, Table 7 indicates the percent of cases that discuss obviousness; both obviousness and novelty; novelty; and neither obviousness nor novelty. This table again highlights (1) the focus of the PTO on obviousness issues (and to a lesser extent novelty issues) and (2) the differences of TC 1600 from the rest of patent practice.

 

Percent of Cases Issue on Appeal

Technology Center

Obviousness+

Obviousness and Novelty

Novelty+

Neither Obviousness Nor Novelty

All

87%

31%

40%

4%

1600 Biotechnology and Organic Chemistry

76%

20%

26%

18%

1700 Chemical and Materials Engineering

92%

29%

34%

3%

2100 Computer Architecture, Software, and Information Security

82%

29%

43%

3%

2600 Communications

89%

31%

39%

3%

2800 Semiconductors, Electrical and Optical Systems and Components

88%

35%

45%

3%

3600 Transportation, Construction, Electronic Commerce, Agriculture,

87%

30%

40%

2%

3700 Mechanical Engineering, Manufacturing, Products

87%

37%

47%

2%

Table 7

        

 

Notes:

  • Thanks to two of my research assistants – Patrick Barnacle and Jaron Brunner – for helping me to score the individual decisions by hand.
  • The BPAI only publishes opinions once the underlying application is either published or issued as a patent. Consequently, this article misses those

Written Description: Araid Petitions en banc Federal Circuit to Eliminate Separate Written Description Requirement

En Banc, Enablement, Patent, Patent Cases 2009, ,

Ariad v. Eli Lilly (en banc suggestion 2009)

Ariad has petitioned the Federal Circuit for an en banc rehearing – boldly asking the court to eliminate the written description test as a distinct requirement of patentability under 35 USC Section 112, paragraph 1. The petition – drafted by Professors Duffy and Whealan – is essentially a well-formed collage of quotations from Federal Circuit dissents and 19th Century Supreme Court decisions.

The petition raises the following two questions:

(1) Whether this Court has erred by “engrafting . . . a separate written description requirement onto section 112, paragraph 1 …. ” Ariad Pharms., Inc. v. Eli Lilly & Co., 560 F.3d 1366, 1380 (Fed. Cir. 2009) (Linn, J., concurring).

(2) What is the proper test to satisfy the requirement in Section 112, paragraph 1, that a patent specification contain “a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same”?

Apart from the merits of this case, the brief notes that half of the Federal Circuit judges “have either voted to grant en banc review of this Court’s written description jurisprudence (Newman, Rader, Bryson, Gajarsa, and Linn, JJ.), or have expressly noted that future en banc review may be appropriate because this Court’s written description standards are unsatisfactory. (Dyk, J.).

Notes:

  • Ariad Brief: ariadrehearingpetition.pdf
  • Federal Circuit Decision
  • The original opinion was written by Judge Moore and joined by Judge Prost. Judge Linn wrote a concurring opinion as a reminder of his belief that the written description requirement should be eliminated and enablement be allowed to do its job.
  • Patent Docs has more.

Fractured Claim Construction

Claim Construction, Interference, Patent, Patent Cases 2009, , , ,

Agilent Tech., Inc. v. Affymetrix, Inc. (Fed. Cir. 2009)

Agilent’s microarray hybridization genetic analysis patent issued in 2003. After seeing those issued claims, Affymetrix amended a pending application by adding identical claims in order to provoke an interference. The Agilent patent has a priority date of 1998 while the Affymetrix application claims priority back to 1995. The Board of Patent Appeals and Interferences (BPAI) awarded priority to Affymetrix in 2006. That holding was upheld by a N.D. California district court in 2008.

Here, the Federal Circuit reverses – holding that Affymetrix cannot claim priority back to its 1995 filing because that original application “does not satisfy the written description requirement for the claims at issue.” Written description is particularly relevant in interference cases where one party typically copies claims from another patent document.

Claim Construction in an Interference: Several articles have been written on the complicated and ever-changing scope of a patent claim. At the PTO, claims are usually given their broadest reasonable meaning while in litigation, courts look for how a PHOSITA would interpret the scope, etc.. Phillips teaches that proper claim construction looks at the literal language of the claims as well as supporting information from the specification and prosecution history. In an interference, however, the copied claims originally came from another application.

Faced with a split of precedent, the Federal Circuit here decided to continue with multiple interpretations of an individual claim. Following Spina, the court holds that – for the purposes of the written description requirement – the newly added claims should be interpreted based on the specification and history of the opposing source application. However, following Rowe, the Federal Circuit held that for the purposes of novelty and nonobviousness, the newly added claims should be construed based on the specification and history of the amended application.

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.

This change in primary interpretative materials allowed the Federal Circuit to also change the claim construction and consequently hold that Affymetrix’s application “does not satisfy the written description requirement for the claims at issue.”

Notes:

  • As a pending application, Affymetrix’s claims had no presumption of validity. “Thus, Agilent’s burden of proving a lack of written description in Affymetrix’s Besemer application is a simple preponderance of the evidence. Eli Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1365 (Fed. Cir. 2004).”   

Pointing Out the Problem to be Solved or Objects of the Invention

Enablement, Patent, Patent Cases 2009

Revolution Eyewear v. Aspex Eyewear (Fed. Cir. 2009) 08-1267.pdf [UPDATED 5/7/09 – To correct a mix-up of parties]

The patents at issue in this litigation focus on eyeglasses configured to be fitted with a second set of sunglass lenses using magnets. Magnetic auxiliary frames were already in the prior art, but the apparent advance is that the magnets are located in projections rather than embedded in the frames — thus allowing for a stronger magnetic bond. The patent also identified a second deficiency in the prior art: insufficient “stability support.”

The district court held that Revolution infringes claim 22 of Patent No. RE37,545.

On appeal, Revolution argued that that the claim was invalid — raising three separate arguments: (1) failure of written description under Section 112 ¶ 1 because the apparatus as claimed does not address both deficiencies in the prior art; (2) failure to claim the “original” invention in the reissued patent under Section 251; and (3) improper expansion of claim scope in the reissue application under the recapture rule. The Federal Circuit rejected each of these invalidity arguments.

Written Description: The written description requirement is often raised when the issued claims are different than those originally filed. New claims must find support in the original specification in a way that “convey[s] with reasonable clarity to those skilled in the art that, as of the filing date sought, [the inventor] was in possession of the [claimed] invention.”

Revolution admits that all of the claimed elements are found in the original drawings. Of course, that is not conclusive for written description. Rather, in cases such as LizardTech and Liebel-Flarsheim, the Federal Circuit found claims invalid even though all the explicitly claimed limitations and arrangements were originally disclosed. The problem with the claims in those cases was that they did not include enough limits.

The invalidity argument in this case is actually more akin to Gentry Gallery. Here, Revolution argues that the patent is invalid because the claimed apparatus does not address both of the stated functions of the invention. The Federal Circuit found that argument lacked legal grounding: “when the specification sets out two different problems present in the prior art, it is unnecessary for each and every claim in the patent to address both problems.” Of course, the negative implication of the court’s statement is that the claim must address at least one of the stated problems. “Inventors can frame their claims to address one problem or several, and the written description requirement will be satisfied as to each claim as long as the description conveys that the inventor was in possession of the invention recited in that claim.” In this case, the claim addressed the magnetic strength problem – and thus satisfied the written description requirement.

Claiming the Same Invention: 35 USC Section 251 focuses on requirements of reissue applications. Under the statute, a reissued patent must be for the same “invention disclosed in the original patent.” Here, the Federal CIrcuit found that this requirement is “analogous to the written description requirement.” “Because we have held that the written description requirement is satisfied, we similarly hold that claim 22 complies with § 251.”

Recapture Rule in Reissue Patents: Reissue patents are intended to correct errors in the originally issued patents. Courts have created the recapture doctrine which would exclude certain intentional acts from the list of correctable ‘errors.’ In particular, under the recapture rule, an intentional and deliberate act of narrowing claims or disclaimer of claim scope in order move the patent application toward issuance will not be considered an “error” under Section 251. Akin to prosecution history estoppel, “the recapture rule is aimed at ensuring that the public can rely on a patentee’s admission during prosecution of an original patent.” On appeal, the Federal Circuit could find no admission or disclaimer being recaptured.

Affirmed.

Notes:

  • Pointing out deficiencies in the prior art: Most patent attorneys no longer discuss the prior art in the patent application because of the potential problems raised by this and other cases. Almost as an aside, this case also notes that by “pointing out the two deficiencies in the prior art, [the inventor] disclaimed an auxiliary frame that is not stably supported in top-mounting configuration and a primary frame that has embedded magnetic members.”

Trademark: Mark is Geographically Deceptively Misdescriptive Only if Deception is Material to a Substantial Portion of the Intended Audience

Patent

pic-25.jpgIn re Spirits International (Fed. Cir. 2009)

The Patent Office refused to register Spirits’ mark “Moskavskaya” to identify the company’s vodka — concluding that they mark was “primarily geographically deceptively misdescriptive.”

In Russian, Spirits’ mark is translated as “of or from Moscow.” Spirits’ vodka is not from Moscow, nor is Spirits located in Moscow. According to the Patent Office, registration of the mark would be inappropriate because the public would likely believe the goods were from Moscow.

15 U.S.C. § 1052(e)(3) prohibits the registration of primarily geographically deceptively misdescriptive of the goods. The doctrine barring registration requires that the “mark’s primary significance [ be ] a generally known geographic location”; that the relevant public would be likely to believe that the goods originate from the stated geographic location (when in fact they do not); and that the deception be “material.”

The materiality requirement is new, and had not been fully interpreted by the Federal Circuit. Here, the Federal Circuit drew parallels to subsection (a) of the same statute (addressing false advertising). “Under the circumstances it is clear that section (e)(3)– like subsection (a), the false advertising provision of the cat Lanham Act, and the common law — requires that a significant portion of the relevant consuming public be deceived. That population is often the entire US population interested in purchasing the product or service.”

Missing Link: In its decision, the Board recognized that Russian speakers would be the most likely to be deceived since the geographic description was in the Russian language. Additionally, the Board identified over 700,000 Russian speakers in the US based on the 2000 census. Of course, these facts do not prove that “a significant portion of the relevant consuming public” would be deceived by the mark. Notably, the patent office offered no proof that Russian speakers constitute a “substantial portion of the intended audience.”

We note that only 0.25% of the U.S. population speaks Russian. If only one quarter of one percent of the relevant consumers was deceived, this would not be, by any measure, a substantial portion. However, it may be that Russian speakers are a greater percentage of the vodka-consuming public; that some number of non-Russian speakers would understand the mark to suggest that the vodka came from Moscow; and that these groups would together be a substantial portion of the intended audience.

Vacated and Remanded

Note:

  • Some History: Spirits is a division of the SPI Group which purchased the former state-owned Russian and Baltic vodka companies. Moskavskaya brand name was introduced by the state in the 1800’s and has a long history – at least in Russia – as a brand name. A private comment indicated that the history of the Moskavskaya brand is not clear-cut. “Moskovskaya was a collective mark during Soviet times as many other mass-produces products were. After the collapse, Moskovskaya was produced not only in Russia but also in Ukraine, Belarus, Moldova and Kazakhstan.”
  • Another Source: John Welch has written about Spirits’ April 28 loss at the TTAB with the following headline: TTAB Finds “RUSSKAYA” for Vodka Abandoned, Cancels Registration.
  • Significant versus Substantial: As an anonymous comment noticed – the Federal Circuit appears to have used “substantial portion ” and “significant portion” interchangeably. From the case: “We hold … that the appropriate inquiry for materiality purposes is whether a substantial portion of the relevant consumers is likely to be deceived. . . . it is clear that section (e)(3) … requires that a significant portion of the relevant consuming public be deceived.”

Written Description: Pioneering Claims Require More Expansive Written Description

Patent, , , ,

Ariad v. Eli Lilly (08-1248.pdf, Fed. Cir. 2009) (Judge Moore; Concurring opinion by Judge Linn)

Ariad sued Lilly for infringing its patent that claims a method of reducing NF-κB (“en eff kappa be”) activity. The listed inventors of the patent include, inter alia, two Nobel Laureates, and the original assignees include Harvard, MIT, and the Whitehead Institute. A jury found that both Evista and Xigris infringe, and the judge denied Lilly’s JMOL motion on invalidity. The resulting judgment was for $65 million in past damages and an ongoing royalty of 2.3% of sales.

On appeal, the Federal Circuit reversed the lower court’s decision – finding the asserted claims invalid for lack of written description. The written description requirement is intended to ensure that the inventors “disclose the technologic knowledge upon which the patent is based [and] demonstrate that the patentee was in possession of the invention that is claimed.” (Quoting Capon). Consequently, the disclosure in the patent document “must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed” and was in “possession” of the invention at the time of filing including “all elements and limitations.” In other words, Ariad “must describe some way of performing the claimed methods.”  The actual level of disclosure depends upon several factors such as the extent of prior art, maturity of the science, and the “predictability of the aspects at issue.”

Here, it was clear that the invention was “extraordinarily creative” in a highly unpredictable field with little prior art available. Ariad’s expert even testified that the invention necessitated the development of a new vocabulary. All these factors indicate that the written description bar will be set high.

Here, Ariad’s description was scant on real examples

The ’516 patent discloses no working or even prophetic examples of methods that reduce NF-κB activity, and no completed syntheses of any of the molecules prophesized to be capable of reducing NF-κB activity.

Without specific examples, Ariad attempted to show that its description was sufficient by bolstering the skill of a PHOSITA. Unfortunately for the Patentee, the Jury found an early effective filing date and much of Ariad’s evidence showed skill in the art after that 1989 date.

Because written description is determined as of the filing date—April 21, 1989 in this case—evidence of what one of ordinary skill in the art knew in 1990 or 1991 cannot provide substantial evidence to the jury that the asserted claims were supported by adequate written description.  

Although important, these small date issues probably made no difference because the description was so lacking and the prior art so sparse.

The state of the art at the time of filing was primitive and uncertain, leaving Ariad with an insufficient supply of prior art knowledge with which to fill the gaping holes in its disclosure.

“We therefore conclude that the jury lacked substantial evidence for its verdict that the asserted claims were supported by adequate written description, and thus hold the asserted claims invalid.”

Caveat Vindicor: In its conclusion, the court noted that this result likely turned on clam construction. If Ariad had agreed to a narrower construction in litigation or narrower claim language during prosecution, then the written description requirement might have been satisfied. Of course, if it had pursued that strategy, infringement would have likely been lost.

Although Judge Linn concurred in the opinion, he wrote separately to remind readers of his belief that the written description requirement should be eliminated and enablement be allowed to do its job.

Notes:

  • Pioneering inventions are less likely to be found obvious or anticipated. However, one problematic result highlighted by this decision is that those pioneer patents are more likely to be trapped by the formalities of the patent system.

The Essential Element Test and ICU Medical

Enablement, Patent, Patent Cases 2009

In discussing the recent ICU Medical case, I noted that Judge Moore’s decision did not rely on the “essential element” test or even cite Gentry Gallery. In Gentry Gallery, the patent covered a sectional recliner. During prosecution, the patentee had amended its claims to drop any reference to the location of the recliner controls. The Federal Circuit held those later-drafted claims invalid because the location of the controls was an “essential element” of the invention that must be included in the claims – otherwise, the claim scope would be unduly broad. Following Gentry Gallery, however, the Federal Circuit stepped-back from the essential element language– instead narrowing the case holding to the well trod notion that claims should be limited to the supporting disclosure. In both Johnson Worldwide, and Cooper Cameron, for instance, the Federal Circuit explicitly denied that Gentry Gallery created any new requirement.

“[W]e did not announce a new ‘essential element’ test mandating an inquiry into what an inventor considers to be essential to his invention and requiring that the claims incorporate those elements.” Cooper Cameron, 291 F.3d 1317 (Fed. Cir. 2002)

In parallel fashion to Gentry Gallery, ICU had included a “spike” in every embodiment and each original claim. During prosecution, and apparently after seeing competing products, ICU amended its claims to drop the “spike” limitation. This was important because the market had moved to a spikeless version of IV valves. This district court in ICU discussed Gentry Gallery and the essential element test, but found no need to base its ruling on that “disfavored” theory. Rather, the court based its analysis on the traditional notion that claims must be described in the specification.

“[T]he Court’s analysis employs the accepted rule that the claims may be no broader than the supporting disclosure, or, conversely, that claims are invalid when the entirety of the specification clearly indicates that the invention is of a much narrower scope. By focusing on the language of the Common Specification in a manner that highlights the function of the “spike” element, and the frequency and ubiquity with which it is referenced, the Court is only attempting to discern the breadth and substance of the invention ICU actually disclosed in the original 1992 Application.”

Although the district court denied its application of any “essential element” test, it went on to hold that any valid claims must include a spike:

“The pervasiveness of the “spike” element in the invention description clearly informs the Court, and would inform any reasonable juror, that what was disclosed and claimed as the invention in the 1992 Application was a needleless medical valve with at a minimum, a “body,” a “seal” and a “spike.””

Likewise, the Federal Circuit’s version denies an omitted element test, but held that any valid claim must include a spike limitation because “a person of skill in the art would not understand the inventor … to have invented a spikeless medical valve.”

Notes:

  • ICU Medical Part I
  • ICU Medical Part II
  • ICU Medical Part III
  • The essential element and omitted element test are largely interchangeable, although some logical distinction could perhaps be made.

Written Description: Federal Circuit Again Invalidates Broadened Claims

Enablement, Patent, Patent Cases 2009, , , ,

ICU Medical v. Alaris Medical System (Fed. Cir. 2009)

This is the second post on the ICU case. Part I discusses the $4.6 million award of attorney fees to the accused infringer based on the patentee’s litigation misconduct.

The district court found several of ICU’s claims invalid for lack of written description under 35 U.S.C. § 112, ¶ 1. On appeal, the Federal Circuit affirmed. (Judges Michel (CJ), Prost, and Moore; Opinion by Moore). Although similar to enablement, the written description requirement pushes an applicant to “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.” Most often, written description arises in cases where new matter is added to the claims during prosecution. That is also the case here – during prosecution ICU amended its claims to include “spikeless” claims — directed to a valve mechanism for adding drugs to an IV without using needles.

To be clear – the original claims included the “spike.” That element was removed during prosecution – seemingly broadening the claims. As the court stated “we refer to these claims as spikeless not because they exclude the preferred embodiment of a valve with a spike but rather because these claims do not include a spike limitation—i.e., they do not require a spike.” It is that failure to include any discussion of a spike in the claim that lead to the claim being held invalid for lack of written description.

The Federal Circuit does not cite Gentry Gallery or the infamous “omitted element” or “essential element” theories. However, the court does rely heavily on LizardTech. In that case, the court did not point to any claim limitation that was not sufficiently described. Rather, the court found the claim invalid because an embodiment arguably covered by the claim was not sufficiently disclosed.

We addressed a similar issue in LizardTech . . . We explained that “the specification provides only one method for creating a seamless DWT, which is to ‘maintain updated sums’ of DWT coefficients. That is the procedure recited by claim 1. Yet claim 21 is broader than claim 1 because it lacks the ‘maintain updated sums’ limitation.” We determined, however, that “[a]fter reading the patent, a person of skill in the art would not understand how to make a seamless DWT generically and would not understand LizardTech to have invented a method for making a seamless DWT, except by ‘maintaining updat[ed] sums of DWT coefficients.'” We therefore concluded that claim 21 was invalid under the written description requirement of § 112, ¶ 1.

In LizardTech, the court explicitly rejected the argument that the written description requirement “requires only that each individual step in a claimed process be described adequately.”

In this case, ICU’s original disclosure focused on spiked embodiments, but the more generic claims are not so limited.

ICU’s asserted spikeless claims are broader than its asserted spike claims because they do not include a spike limitation; these spikeless claims thus refer to medical valves generically—covering those valves that operate with a spike and those that operate without a spike. But the specification describes only medical valves with spikes.

Since all the embodiments included the “spike,” the court concluded that “Based on this disclosure, a person of skill in the art would not understand the inventor … to have invented a spikeless medical valve.”

Invalidity affirmed

Notes:

  • This case also includes an important discussion of claim differentiation that will be dissected in a later post.  
  • Of course, this case suggests the best patent drafting practice of providing multiple embodiments of each claim element, and considering whether each and every limitation in the broadest original claims are necessary.
  • ICU broadened its claim by dropping a limitation — did ICU introduce new matter?
  • In a powerful rhetorical approach, Judge Moore chose to refer to the broad claims as “spikeless claims.” As mentioned, those claims do not include a “spikeless” limitation. Rather, they simply omit a “spike” element. As it turns out more than 99.9% all patent claims issued in 2008 are silent about “spikes,” and under the traditional interpretation of the “comprising” transition – all those claims would literally cover embodiments without spikes. The holding here cannot be that all those claims are invalid. I believe that the holding here is largely a result of the fact that the accused device was in-fact spikeless. Unfortunately, this decision does not provide helpful guidance as to when it will apply. Rather, it appears to simply be an additional vague tool available to defense attorneys.
  • The court did not mention enablement – since it was easy to remove the needle from a syringe and the disclosure includes a preslit seal that could arguably work with a spikeless syringe. That modification would have been enabled based on the original disclosure.

Patent Docs: Top Biotech and Pharma Patent Stories of 2008

Blogroll, Patent,

The Patent Docs of MBHB have created an excellent set of posts on the top biotech and pharma patent stories of 2008:

  1. Continuation and Claims Rules Enjoined in GSK/Tafas v. Dudas; USPTO Appeals Injunction
  2. The Rise and Fall of Other USPTO Rules Packages
  3. Patent Reform Stalls in the Senate
  4. New Written Description Guidelines Issued
  5. Examination of Obviousness in Group 1600
  6. The USPTO Comes under Attack
  7. Follow-on Biologics Debate Continues
  8. Impact of Presidential Election on U.S. Patent Practice
  9. The USPTO Tightens Its Grip on Practitioners
  10. USPTO’s PTA Calculations Called into Question
  11. Greater Cooperation between Patent Offices
  12. International Enforcement of Drug Patents
  13. Pharma Patent Injunctions in View of Amgen v. F. Hoffmann-La Roche

Read the reviews:

Gilbert Hyatt: BPAI Erred in Aggressive Grouping of Claims

Patent

Hyatt v. Dudas (Fed. Cir. 2008)

Gilbert Hyatt has been famous for his early microprocessor patents. This appeal “concerns the patentability of approximately 2,400 claims in twelve related patent applications … that claim priority … to the early 1980s or before.” Since being filed, all twelve applications have also been “amended to add hundreds of claims that were not included in the original applications.”

The PTO examiner rejected all the claims in all twelve applications – most commonly for lacking proper written description. On appeal, the BPAI refused to independently review each of Hyatt’s claims, and instead only considered the twenty-one claims that he had discussed in the “Summary of the Invention” section of the BPAI briefs. Appealing that decision, Hyatt convinced the DC district court that the BPAI had improperly selected the representative claims. The PTO now appeals that district court decision.

On appeal, the Federal Circuit affirmed – finding that the BPAI cannot create a representative claim by simply grouping all claims rejected for lacking written description under the same “ground of rejection” “unless the claims share a common limitation that lacks written description support.” 37 CFR 1.192(c)(7).

“[T]he applicant can waive appeal of a ground of rejection, and can waive the right to demand additional subgrouping of claims within a given appealed ground. But the applicant cannot waive the Board’s obligation to select and consider at least one representative claim for each properly defined ground of rejection appealed.”

Affirmed. On remand, the BPAI must consider “all grounds of rejection challenged by Hyatt. . . However, the Board is free on remand to apply the rule of waiver to any grounds of rejection not contested by Hyatt in his initial appeals to the Board, provided that such grounds do not become relevant on remand due to realignment of the representative claims or other aspects not previously at issue.”

Notes:

  • 2400 claiming priority thirty years back…

Applying Bilski to Biotechnology and the Life Sciences

Patent, , ,

By Professor Christopher M. Holman (University of Missouri at Kansas City School of Law and author of Holman’s Biotech IP Blog)

The Bilski majority characterizes its machine-transformation test as "the governing test for determining patent eligibility of a process under section 101." Under this test, a claim is patent-eligible if (and as applied in Bilski apparently only if): (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing." As explained by the Court, the test serves as a proxy for assessing the more fundamental concern – ensuring that the claim does not seek to impermissibly "preempt the use of a fundamental principle." This might make sense in the context of so-called business method patents, where the fundamental principle implicated is typically characterized as an abstract idea or mental process. But it is unclear to what extent this test will prove applicable to patent claims arising out of the life sciences, where patentable subject matter challenges more often allege preemption of a natural phenomena or law of nature, rather than an abstract idea or mental process.

For example, although Bilski states that a process claim is "surely" patent-eligible under section 101 if it complies with the machine-transformation test, this cannot be literally correct with respect to a naturally occurring biological process. Photosynthesis transforms carbon dioxide and water into sugar, and in Bilski the Court specifically points to chemical reactions as the sort of physical transformation that will render a process patentable, but a claim directed to photosynthesis would clearly violate Supreme Court precedent which bars the patenting of natural phenomena.

Bilski acknowledge that the machine-transformation test might require refinement or augmentation in the future, and I think this refinement will likely be necessary when the court addresses patentable subject matter challenges based on allegations that a patent claim preempts a biological natural phenomenon. Three such cases are currently on appeal to the Federal Circuit – Ariad v. Lilly, Classen v. Biogen, and Prometheus v. Mayo. Nevertheless, since for the time being the machine-transformation test is apparently the governing test, it is worth considering how the claims at issue in these case, and some other controversial biotechnology patent claims, might fare under this approach.

Ariad’s claims essentially recite methods of altering the activity of a regulatory protein (NF-kB) in a cell, which would seem to satisfy the transformation prong of the test. This outcome would be consistent with the District Court’s determination that the claims comply with section 101, albeit for an entirely different reason. But Lilly argues (reasonably I think) that the claims wholly preempt the use of a natural biological phenomenon, and since Bilski acknowledges that the machine-transformation test is really just a proxy for weeding out patent claims that preempt "fundamental principles," this argument might prevail even though the claim does recite a physical transformation.

The claims at issue in Classen, on the other hand, are directed to methods for determining an optimal immunization schedule based on comparing the observed incidence of immune-mediated disorders in treatment groups subjected to different vaccination schedules. Determining an immunization schedule does not appear to satisfy either prong of the machine-transformation test. The claims do include an additional step of immunizing patients, but under Bilski this step would likely be classified as "insignificant extra-solution activity." For example, the majority particularly points to data collection steps as insufficient to render patentable a claim that is essentially directed to a process of analyzing the data. Notably, the majority strongly suggests that the inclusion of a data-gathering step in the claim at issue in LabCorp v. Metabolite is insufficient to confer patentability on that claim, the essence of which is directed to the non-tranformative step of observing a correlation between homocysteine and vitamin B levels in a body fluid. In this regard, Bilksi appears to be consistent with the approach suggested by Justice Breyer in his dissent from the Supreme Court’s decision not to decide LabCorp.

Similarly, the claims at issue in Prometheus essentially target observing the level of a drug metabolite in a patient, and based on that observation recognizing that an adjustment in dosage may be required. The claims recite the administration of the drug to a patient and determining the level of metabolite in the patient’s body, but under Bilski these might well be treated as an insignificant extra solution data-gathering steps, analogous to the assay step in the claim challenged in LabCorp. If we disregard these steps, the claims would appear to fail machine-transformation test.

Note that at the core, the reason the claims in Prometheus and Classen might fail the machine-transformation test has little to do with any underlying natural phenomenon, but rather because they preempt an abstract idea/mental process without tying that process to a specific machine or apparatus. In contrast, the challenge to Ariad’s claims is fundamentally different, being based on preemption of a natural phenomenon rather than preemption of an abstract idea that could be implemented mentally without the use of a machine. In my view, the machine-transformation test just does not work for claims such as Ariad’s.

Some of the most controversial biotechnology patents are so-called human gene patents, particularly those relating to genetic diagnostic testing. For example, Myriad has been widely criticized for its perceived aggressive enforcement of patents relating to the BRCA breast cancer genes. Some of these patents broadly claim methods of identifying mutations, with no apparent extra-solution step that transforms a particular article or is tied to a particular machine or apparatus. For example, U.S. Patent No. 5,753,441 claims a "method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene . . . with germline sequences of wild-type BRCA1 gene . . ., wherein a difference in the sequence of the BRCA1 gene . . . of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.

Similarly, U.S. Patent No. 6,432,644 claims "a method for diagnosing the presence of a polymorphism in human KCNE1 . . . wherein said method is performed by means which identify the presence of said polymorphism . . .."

Arguably, these sorts of claims are merely directed to "comparing" naturally occurring genetic sequences, or "diagnosing" the presence of natural mutations, and lack the significant extra-solution step necessary for patent-eligibility under Bilski.

Finally, note that Bilski in effect treats the patentable subject matter doctrine as a mechanism for policing claim scope, a role more commonly associated with the enablement and written description requirements. For example, the majority points to its earlier decision in Abele as an example where a broad claim is invalid for encompassing patent-ineligible subject matter, but an appropriately narrowed dependent claim complies with Section 101. Similarly, genetic diagnostic testing claims might be fine if limited to a specific test or tests, but patent-ineligible if drafted so broadly as to effectively encompass any method for observing a genetic variation.

Written Description: Single Embodiment Insufficient

Enablement, Patent, Patent Cases 2008, ,

This decision is nothing new. Broad claims must either be supported by multiple embodiments or some general principles describing how the single embodiment is applicable to other configurations. Failing that, a broad claim may fail the enablement prong. As seen here, even when enabled, a broad claim without sufficient support will be invalid under the written description requirement.

In re Alonso (Fed. Cir. 2008)

The PTO Board of Appeals (BPAI) rejected claim 92 of Kenneth Alonso’s for failing the written description requirement of Section 112. “To satisfy this requirement, the specification must describe the invention in sufficient detail so that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.” (quoting case). In an opinion written by Judge Stearns (D.M.A.) sitting by designation, the Federal Circuit affirmed.

Claim 92 of the Alonso patent application claims a “method of treating neurofibrosarcoma in a human by administering an effective amount” of an idiotypic monoclonal antibody (mAb) secreted in a human-human cell hybridoma.

In his application, Alonso only described the preparation of a single mAb, but claimed essentially all Mab’s that bind to neurofibrosarcoma, and the PTO found that a “skilled artisan would reasonably conclude that applicant was clearly not in possession of the claimed genus of compounds. Applicant should direct the claim language toward the only described embodiment (e.g., a mAb produced by hybridoma HB983).”

Standard of Review: The PTO’s factual determinations are reviewed for “substantial evidence.” Thus, the Federal Circuit will affirm when “a reasonable mind might accept [the evidence] as adequate to support a conclusion.” Even if the Federal Circuit might ultimately have seen the facts differently, it will affirm if the PTO’s position is reasonable.

Predictability: The Federal Circuit acknowledged that disclosure of a single embodiment can be sufficient for a broader genus claim. However, more disclosure is necessary when the composition and effectiveness of members of the genus is heterogeneous or unpredictable.

We have previously held in a similar context that “a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.” Noelle v. Lederman, 355 F.3d 1343, 1350 (Fed. Cir. 2004).

Alonso argued that his single embodiment should be given more weight because he had actually reduced it to practice (unlike the Rochester COX-2 case). The Federal Circuit rejected that argument because Alonso had not provided the necessary predictive information – “nothing about the structure, epitope characterization, binding affinity, specificity, or pharmacological properties common to the large family of antibodies implicated by the method.”

Notes:

  • The court gives the following justification for the written description requirement: “The requirement ‘serves a teaching function, as a quid pro quo in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.'” quoting Univ. of Rochester, 358 F.3d 916 (Fed. Cir. 2004) (in turn quoting Enzo Biochem, 323 F.3d 956 (Fed. Cir. 2002)).
  • In his 2005 book on Electronic and Software Patents, Steve Lundberg, et al. include the understatement: “The purpose of the written description requirement has been in flux recently.”

The Trade Secret Value of Early Patent Filing

Academic Studies, Articles and Publications, Patent, Trade Secret, , , ,

Patent.Law168The patent laws promote an early filing doctrine.  Most directly, by filing patent application documents early, an applicant can avoid problems created by pre-filing disclosures that can negate patentability.[1]  Inter alia, early filing also provides a presumptive date of invention and reduction to practice that may have important evidentiary benefits for the applicant.[2]  Some doctrines push against early filing. Notably, earlier filed applications may be more likely to have inadequate disclosure.  A rushed disclosure could result in the patent application being rejected under the utility, written description, or enablement requirements of the Patent Act.[3] Alternatively, if the application is filed prior to gaining an understanding of the eventual market, an applicant may have insufficient disclosure to support the most valuable claims potential. 

Going unrecognized is another benefit of early filing – the ability to keep secret later developed innovations and parameters.  That secret information can then be protected and exploited as trade secret information.

At the time of filing, the applicant must provide a complete description including the best mode contemplated by the inventor. However, many if not most patent applications are filed well before the associated product or method is ready for public consumption – before the inventor knows the best commercially viable mode.  Post-application developments could take any number of forms, such as particularly operative formulations; ideal antibiotic manufacturing parameters; software code that implements a novel algorithm; a more durable circuit arrangement; etc. Commonly, these tweaks and advances may take the form of a specific species of a disclosed and claimed genus.  Of course, this later-stage developments could be incredibly important to anyone wanting to practice the invention or develop some follow-on technology.

Even though product development typically continues after the patent application is filed, the law allows the patent applicant to legitimately keep any later developed information as trade secret.  Patent applications are not allowed to add ‘new matter’ to a patent application during prosecution. Likewise, the applicant has no duty to otherwise inform the patent office or the public of ongoing development. Rather, the application is set at filing and ex post developments are generally irrelevant to patentability.[4]

In a later post, I’ll explore whether this potential overlap of patent and trade secret rights is good from a policy perspective.



[1] 35 U.S.C. §102(b).  This is especially critical if filing foreign applications.

[2] See, for example, 35 U.S.C. §102(g) and §102(a).

[3] See 35 U.S.C. §101 and §112¶1.

[4] There may be some exception here when arguing secondary factors of nonobviousness.

Tags:

Shifting Burden of Production Does Not Shift Burden of Proof; PTO Deference

Attorney Fees, Fee Shifting, Patent, , ,

Technology Licensing Corp v. Videotek (Fed. Cir. 2008)

The independent inventor J. Carl Cooper invented and patented technology separating a sync signal from a video signal to better ensure vertical and horizontal hold on a video screen. Cooper assigned his rights to TLC which sued Videotek for infringement. Videotek pulled-in its supplier Gennum for indemnification. Gennum now remains as the only defendant.

Priority Date: Cooper’s asserted patent claims priority to an earlier application filed in 1992. The district court found specifically that claim 33 could not claim priority all the way back because the claim included a limitation to an “other circuit” which was only disclosed in the subsequent continuation.

Burdens of Proof and Production: Although a defendant ultimately bears the burden of proving invalidity, the burden of producing evidence may shift back and forth during litigation. For instance, once a defendant provides evidence of anticipation, the patentee then has the “burden of going forward with evidence either that the prior art does not actually anticipate, or … that it is not prior art because the asserted claim is entitled to the benefit of a filing date prior to the alleged prior art.” Proving priority requires evidence of the priority claim and also evidence showing that “the written description in the earlier application supports the claim.” Here, the court required cooper to produce “sufficient evidence and argument to show that [the priority document] contains a written description that supports all the limitations of claim 33, the claim being asserted.” Once the evidence is on the table, the claim will only be invalid if the defendant’s proof remains is clear and convincing.

[B]ecause an issued patent is by statute presumed valid, a challenger has the burden of persuasion to show by clear and convincing evidence that the contrary is true. That ultimate burden never shifts, however much the burden of going forward may jump from one party to another as the issues in the case are raised and developed.

Here, the Federal Circuit agreed that the defendants had clearly proven that the original written description was insufficient – and thus that the patentee could not claim priority all the way back.

Deference To and Waiting For the PTO: The PTO issued Cooper’s patent and then, through a reissue, again allowed the challenged claim to issue even after considering the same prior art (the reissue issued while the appeal was pending). On appeal, the Federal Circuit distinguished Ralston v. Far-Mar-Co (Fed. Cir. 1985). In Ralston, the court deferred to the PTO’s determination of priority date. Here, however, there was no evidence that the PTO specifically considered the priority dates. However, the Federal Circuit refused to “add an additional deference-thumb to the scale, or, even more disruptive, our asking the trial court to reopen the entire invalidity question to reweigh the intangible worth of additional deference.”

This is not to say that the determinations made by the corps of examiners are not important, or should not be worthy of appropriate deference to their expertise in these technical matters, especially when we have the benefit of well-reasoned explications. It is to say that when dealing with the intangible worth to be accorded an administrative agency’s decision making, the judicial process cannot be held hostage to the timing of either the agency or the litigants who have invoked the agency’s further review. In some circumstances a party may be able to obtain a stay from the trial court while awaiting the sought-for agency action; absent that, and absent extenuating circumstances not here present, the case must be decided on the record the litigants present for appeal.

Inequitable Conduct:

There has never been an exception [requiring submission of] anticipatory cumulative references, and we are not inclined to create one now.

Definiteness of Means Plus Function Claim: A MPF claim must be supported by structural disclosure found in the patent specification – this requirement is akin to the written description requirement and focuses on actual disclosure rather than enablement.

The question is not whether one of skill in the art would be capable of implementing a structure to perform the function, but whether that person would understand the written description itself to disclose such a structure.

In electronic circuit cases the actual circuit disclosures are not necessarily required. Rather, generic “core logic” may be sufficient. Here, the defendants were unable to provide clear and convincing evidence of a lack of structure.

Patently-O Bits and Bytes: Judge Lourie on the Federal Circuit

Bits and Bytes, Patent
  • Federal Circuit Judge Lourie recently discussed the state of the court. Here are some points [LINK]:
    • 11.3 Months: Time from docketing to disposition of district court [patent] appeals in the past year.
    • 2.1 Months: Time from calendaring to disposition of the same cases.
      • Note: It is unclear from Judge Lourie’s speech if the times are averages or medians. The court has made great strides in keeping the average and median pendency quite low. There are however, a group of outliers with much longer pendency. The outliers are, for the most part, associated with a couple of particular Federal Circuit judges.
    • 50-mile rule: “On this issue of district court judges sitting with us, some recent patent bills have proposed to eliminate the current statutory requirement that judges on our court live within a 50-mile radius of the district. In my view, no persuasive reason has been given for that change. I believe it would be contrary to the best interest of the court and its functioning, and hence the law”
    • PTO Discussion: “No doubt an overcrowded examination system that places quotas on examiners plays a role in our less-than-perfect examination system.”
    • Pro Patent Court: “Since I have been on the court, over 18 years, not once have we [as a court] had a discussion as to what direction the law should take, whether we should be pro-patent or not. That is because we are not a policy-making body. We have just applied the law and precedent as best we could determine it to the cases that have come before us. In fact, we have been criticized for, in the view of some people, narrowing the doctrine of equivalents, emphasizing the need for a written description commensurate with the claims, and affirming summary judgments of non-infringement that in effect preclude juries from deciding these cases.”
    • Appellate Advice:
      • Make sure your case is final before filing the appeal
      • Cross appeals are only for the purpose of challenging the decision (not for arguing that the decision is correct)
      • Don’t allege that “every business fact is super-confidential. It makes it difficult for us to ask questions from the bench and write an opinion.”
    • Limit the issues: “Having more than three issues in a brief suggests to us that you don’t have a strong appeal.”

Combining References in Novelty; Slack in New Matter; No Decision on Injunction for NPE

Anticipation, Injunctions, Patent, Patent Cases 2008, , ,

CSIRO v. Buffalo Technology (Fed. Cir. 2008)

CSIRO is a nonpractising patent holder. It is also an arm of the Australian government. After winning an infringement suit against Buffalo Tech, CSIRO was awarded permanent injunctive relief to protect its spread spectrum WLAN technology.

On appeal, more than a half-dozen amici filed briefs arguing for and against injunctive relief in this situation. On appeal, however, the Federal Circuit vacated the infringement holding – leaving the discussion of injunctive relief for another day. The vacatur came from the district court’s pre-KSR strict requirement for a motivation to combine references.

Combining References For Novelty: On novelty, Buffalo asked the court to combine two references in its analysis because one of the reference cites the other in a footnote. The Federal Circuit rejected that argument — finding that the footnote discussion was insufficient to concatenate the two references. “In particular, the reference to Bingham does not ‘identify with detailed particularity what specific material it incorporates and clearly indicate where that material is found in the various documents.’ Advanced Display Systems, (Fed. Cir. 2000).”

New Matter: 35 USC 132 bars an applicant from presenting new matter once a patent application has been filed.  In litigation, the written description requirement of Section 112 serves as the basis for invalidating patents with added new matter.  The new matter limitation is not strict. Rather, when the claims are amended, the patent will only be invalidated if the original specification is not “sufficient to allow persons of ordinary skill in the art to recognize that the inventor invented the subject matter that is claimed in the asserted claims.”  Further, the PTO’s decision to allow an amendment provides a patent with “an especially weighty presumption of correctness.”

Here, CSIRO changed its claim limitation from “frequencies in excess of 10 GHz” to simply “radio frequencies.”  On appeal, the Federal Circuit affirmed the lower court’s factual finding that the amendment did not impermissibly add new matter. (No clear error). In particular, neither party suggested a technical distinction between handling lower frequencies. Further, the court found that the original specification was not limited to frequencies in excess of 10 GHz.

On remand, the lower court will reevaluate obviousness.

CAFC Applies Lilly to Invalidate Carnegie Mellon’s Plasmid Claims

Enablement, Patent, Patent Cases 2008,

Carnegie Mellon University v. Hoffman-La Roche (Fed. Cir. 2008)

Carnegie Mellon’s patents cover recombinant plasmids used to enhance expression of an DNA polymerase. On appeal, the CAFC affirmed the lower court holding that the patent claims fail to meet the written description requirement under Lilly.

35 U.S.C. §112 requires that the patent document “contain a written description of the invention and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

The written description requirement is used to make sure that the patentee only claims what has been invented. The public gets a “meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.” Quoting Enzo Biochem (Fed. Cir. 2002).

A common written description argument is that the claims have not been disclosed to their full scope. In the Lilly case, for instance, the CAFC found that a generic claim directed to “any vertebrate and mammalian cDNA” were not supported by a specification that only discussed one species – rat cDNA.

To be clear, written description is not about enablement. Patent claims may well be enabled based on PHOSITA’s knowledge of the art, but still fail the written description requirement because the patentee did not disclose the entire scope of its invention.

A representative claim from Carnegie’s patents reads as follows:

1. A recombinant plasmid containing a cloned complete structural gene coding region isolated from a bacterial source for the expression of DNA polymerase I, under operable control of a conditionally controllable foreign promoter functionally linked to said structural gene coding region, said foreign promoter being functional to express said DNA polymerase I in a suitable bacterial or yeast host system.

In reviewing the claim, the CAFC noted that the DNA coding sequence is “broadly defined … only by its function of encoding DNA polymerase I” and that the claims are not limited to any particular bacterial or yeast species.

The specification only discloses one operative gene – the E. coli polA gene. And at the time of the patent, only three polA genes had been cloned (out of thousands of bacteria strains). “[W]ith regard to the promoter, the patents fail to disclose the nucleotide sequence or other descriptive features for a polA gene (including the promoter sequence) from any bacterial source other than E. coli.”

“To satisfy the written description requirement in the case of a chemical or biotechnological genus, more than a statement of the genus is normally required. One must show that one has possession, as described in the application, of sufficient species to show that he or she invented and disclosed the totality of the genus. . . . [W]e conclude that that requirement was not met here.

Gentry Gallery: The district court also applied Gentry Gallery to invalidate other claims. In Gentry, the CAFC found a patent claim invalid because the claim failed to recite an “essential element” of the invention. Here, Roche argued that the patents were directed to avoiding the problem of lethality to host cells, but that the claims did not include that limitation. As it has done repeatedly, the CAFC rejected the idea that Gentry Gallery created an essential element test. (The claims remain invalid under the Lilly analysis.).

CAFC Flips Call Routing Decision

Patent,

800 Adept v. Murex Securities & Targus (Fed. Cir. 2008)

Adept and Targus both hold patents covering systems and methods for routing 1-800 calls to local franchises. In a multi-patent battle, the Orlando Florida jury found Targus liable for infringing the Adept patents and that the Targus patents were invalid.

Claim Construction: The Adept patents include the step of assigning the telephone number of each potential caller to a particular service location or franchise. The claims require that the assignment take place prior to the call being received, but there was a dispute as to whether the assignment can be stored as an algorithm rather than as a full database record-set. On appeal, the CAFC found that the patents focus on storing the assignment information in a database precludes the awkward twist that would all “assignment” to mean “implementing an algorithm to do the assignment.”

As summarized in the abstract, the patents make clear that assignment of service location telephone numbers to potential callers must be completed before a telephone call is ever placed: “Once all such assignments have been made, a database is assembled to be used by a long distance carrier for direct routing of telephone calls.”

Prosecution history: The prosecution history also supported this limited definition of assignment. Notably, the appellate panel agreed that the prosecution history was likely not clear enough for “prosecution disclaimer” but that it could still be used “as support for the construction already discerned from the claim language and confirmed by the written description.”

Because the Targus operation uses an on-the-fly algorithm to associate callers with franchises, it cannot infringe as a matter of law. Reversed.

All Claims Invalid: The jury found that all claims of the Targus patents were invalid. On appeal, the CAFC limited that holding to only the three claims that were actually included in the pretrial statement.

“Adept’s argument that it was unnecessary for its validity expert to put forth a claim-by-claim analysis of the unasserted claims is simply incorrect. Under the patent statute, the validity of each claim must be considered separately.

…

In this case, it is clear from the parties’ pretrial statement and from the trial proceedings that the unasserted claims were neither litigated nor placed in issue during the trial. We therefore reverse the trial court’s judgment of invalidity with respect to the unasserted claims.”

Expert Mistake = New Trial: Adept’s expert, Dr. Brody, made a few mistaken comments about scope of the company’s patent disclosure. According to the court, this was the “primary if not the entire evidence” that the jury could have used in its invalidity decision. New trial ordered on the claims affected.

Tortious Interference: Targus sent infringement allegations to Adept clients, and the jury found tortious interference with business relations. On appeal, the CAFC reversed.

“State tort claims against a patent holder, including tortious interference claims, based on enforcing a patent in the marketplace, are “preempted” by federal patent laws, unless the claimant can show that the patent holder acted in “bad faith” in the publication or enforcement of its patent.… As the Supreme Court said long ago, “Patents would be of little value if infringers of them could not be notified of the consequences of infringement, or proceeded against in the courts. Such action, considered by itself, cannot be said to be illegal.” Virtue v. Creamery Package (1913)”

In these cases, it is quite difficult to prove ‘bad faith’ because the claims of patent infringement must be objectively baseless. On appeal, the CAFC found that standard was not met because “Targus [could have had] a reasonable basis for believing that the patent was valid when it asserted the patent against Adept’s customers.”

Notes:

  • Adept has also sued various Targus customers in the E.D.Texas, including Federal Express, Enterprise Rent-A-Car, and Domino’s Pizza. Barnes & Thornburg, who represented Targus at trial, is representing the defendants in that case.

Patently-O Bits and Bytes No. 44: Deferred Examination

Accelerated Examination, Bits and Bytes, Patent, ,
  • Deferred Examination I: For the current state of PTO backlog, I am a strong believer in providing a mechanism to either (i) allowing the inventor pay to move to the front of the examination line if the patent needs to be obtained quickly or (ii) allowing the inventor to delay prosecution if it is unclear whether the invented technology will have any market value. There are some potential negative issues of allowing deferred prosecution — particularly the potential for submarining and shifting claim scope to encompass market changes. These problems would largely be limited through early publication of deferred applications as well as continued enforcement of the written description and enablement requirements.  In addition, the patent term should continue to run during deferment.
  • Deferred Examination II: In its response to congressional queries, PTO Director Jon Dudas has come-out in favor of a system that allows for deferred examination. The PTO’s tentatively proposed implementation scheme would move along a three-step process:
    • Allow a 14–month extendible period for responding to a notice to file missing parts.
    • Use a tiered payment structure that allows for delayed payment of the examination fee.
    • Empower Provisional Applications: Allow applicant to claim priority to a provisional application for up to five years.
  • Deferred Examination III: For many, including the PTO, the hope with deferred examination is that “many inventions … would be recognized as obsolete [or otherwise worthless] before expiration of the five year period and therefore would not require examination resources.”
  • Rocket Docket Examination: In the past, the AIPLA and others have argued against having a rocket-docket examination based simply on the payment of a fee. Their argument is that it is somehow inequitable and un-American to line-jump based on the availability of funds. That argument is largely hog-wash.  Many of the richest companies in the US maintain tight controls over patent prosecution costs. I suspect those companies would only rarely pay an additional $5,000 in PTO fees for rapid examination. (If a rocket docket for patent prosecution is created, the fee should be high enough to ensure that it does not simply create an additional bottleneck.)
  • Clear Channel Communications now owes $90 million to Grantley Patent Holdings. The Eastern District of Texas jury found the patent willfully infringed with damages of $66 million. Last week, the Judge awarded an additional $16 million in enhanced damages in addition to prejudgment interest and interim royalties due.

Two Hong Kong companies have been fighting over a coffee maker design patent.  Simatelex (who manufacturers for Sunbeam) has signed a consent decree admitting contributory infringement. The patentee’s case against Sunbeam is still pending in the Southern District of New York. Wing Shing v. Simatelex.

CAFC: Failing to Submit Invention Inspiration OK; Failing to Submit Product Code of Preferred Input Not OK.

Best Mode, CAFC, Patent, Patent Cases 2008, , ,

PatentLawPic305TALtech v. Esquel Apparel (Fed. Cir. 2008) (nonprecedential)


Summary: (1) An applicant need not disclose its own prior work or inspiration for invention if merely cumulative of other references cited; (2) Failing to identify the brand of adhesive tape used in the invention was a best mode violation — resulting in claim invalidation; (3) There is no presumptive order of the steps in a process claim – unless the claim language “requires an ordering of steps” either implicitly or explicitly.

One of TAL’s employees – John Wong – was inspired by TAL’s use of heat-fusible adhesive tape in manufacture raincoats. Over a long process of trial and error, Wong figured out how to use a particular variety of adhesive tape to create a dress shirt that does not pucker after washing. 

After receiving a US utility patent, TAL became embroiled an patent litigation with another Hong-Kong based manufacturer – Esquel Apparel. In that litigation, the district court found TAL’s patent unenforceable due to inequitable conduct during prosecution and invalid for failing to submit fulfill the “best mode” requirement of 35 U.S.C. 112 (inter alia).  Based on the inequitable conduct, the court also awarded attorney fees to Esquel.

Inequitable Conduct: “In this case, the district court found TAL liable for inequitable conduct because inventor John Wong had not disclosed the raincoat seam that inspired his invention to the PTO.” On appeal, the CAFC first dispelled any notion that a patent applicant is required to disclose the inspiration for the invention. Although not stated by the court, 35 U.S.C. 103(a) arguably indicates that the inspiration is not relevant to the patentability inquiry: “Patentability shall not be negatived by the manner in which the invention was made.”

Here, the CAFC noted that TAL’s raincoat may well have been “merely cumulative” to a German patent application that was submitted during prosecution. “If the undisclosed raincoat seam was merely cumulative to [the German application], then no inequitable conduct lies in its nondisclosure.”

Best Mode: At the time of filing, Wong had settled upon a particular type of adhesive tape – known as Vilene SL33 – as the best way to form the seams.  The patent application did not, however, disclose Vilene SL33.  A patent may be invalidated for failing to submit a “best mode” if (1) the inventor possessed a best mode at the time of filing; and (2) the written description fails to disclose the best mode in a way to allow one reasonably skilled in the art to practice that mode.


Possession of the Best Mode: The evidence clearly showed that Wong “experimented with many adhesives but settled on a preference for one.” Thus, the court agreed that the first prong was met — the inventor did possess a best mode at the time of filing – i.e., Vilene SL33.

On the second prong the CAFC disregarded the applicant’s argument that the PTO “prefers the use of generic names of products” and that there is no evidence that the Vilene brand products are actually better quality than other brands.  Instead, the court honed-in on the result of the first prong – that Vilene SL33 was the best mode known to the inventor – and agreed that the best mode had not been disclosed. “TAL has not explained how the written description teaches one having reasonable skill in the art the way to practice the best mode as found in the analysis of the first prong – the use of Vilene SL33.”

Process Order: “Generally, there is no presumption of order, and so a claim with many steps can be infringed by an accused process performing the claimed steps in any order. However, we will find that the claim requires an ordering of steps when the claim language, as a matter of logic or grammar, requires that the steps be performed in the order written, or the specification directly or implicitly requires such a narrow construction.”

In this case, the claimed process implicitly requires a particular ordering. In particular, the bonding adhesive must be presented before a folding step because the folding step requires that the garment abut the bonding element.

Conclusion: The asserted claims were found invalid and not infringed. The remand appears only necessary to determine inequitable conduct and consequently potential attorney fees.