Whither Obviousness: Narrow Range Anticipated by Broader Range in Disclosure

By Dennis Crouch

ClearValue v. Pearl River Polymers (Fed. Cir. 2012) (Opinion by Judge Moore, joined by Judges PROST and SCHALL)

This case presents a classic law school hypothetical of an invention that is anticipated but likely not obvious. According to the appellate panel, the prior art fully discloses and enables the invention but also teaches that the proposed invention is impractical and does not work well. As discussed below, however, the anticipation holding itself is somewhat controversial because it is based upon the conclusion that a broad range disclosure found in the prior art ("less than 150 ppm") anticipates the narrower range found in the claims ("less than 50 ppm").

A jury found ClearValue’s patent valid and infringed and the district court denied the defendants motions to set the patent verdict aside. On appeal the Federal Circuit reversed based upon the appellate court's own factual finding that a single prior art reference teaches and enables each element of the asserted patent claim.

Background: The patent at issue is directed to a process for clarifying water using a flocculated suspension of aluminum along with high molecular weight quarternized polymers. The listed inventor, Richard Haase continues to be an owner of the patent and also CEO of ClearValue. Haase has filed more than 50 water purification and energy related patents and is also a graduate of the University of Missouri (ChemE + Mathematics + Economics). The defendant, Pearl River was once ClearValue’s customer but later began making its own version of the patented process.  ClearValue and Haase sued for patent infringement and for trade secret violation (for using the process without authority even before he filed for patent protection).

Anticipation versus Obviousness: The appeal focused on anticipation. Pearl River argued that all of the elements of CV's asserted claim were previously disclosed in U.S. Patent No. 4,800,039 (Hassick). The jury found otherwise. As a matter of procedure, a jury's verdict must be supported by "substantial evidence." If not, it must be set aside either by the district court or on appeal. At trial, the defendants had presented their case that Hassick taught each element of the claimed invention while the plaintiffs pointed only to "teaching away" found in patent. Unfortunately for the plaintiffs, "teaching away" is legally irrelevant to the question of anticipation. See Celeritas Techs., Ltd. v. Rockwell Int'l Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998). Rather, under 35 U.S.C. § 102 a claim will be anticipated and therefore invalid if a single prior art reference describes "each and every claim limitation and enable[s] one of skill in the art to practice an embodiment of the claimed invention without undue experimentation." Quoting Am. Calcar, Inc. v. Am. Honda Motor Corp., 651 F.3d 1318, 1341 (Fed. Cir. 2011).

Genus Species Anticipation: The only gap in the prior art disclosure was that Hassick generally disclosed "low-alkalinity systems (i.e., 150 ppm or less)" and "alkalinity of between 60-70 ppm" while the asserted patent claimed "alkalinity less than or equal to 50 ppm." In its 2006 Atofina decision, the Federal Circuit addressed a similar genus-species situation involving a narrow claimed temperature range and a broader temperature range found in the prior art. Atofina v. Great Lakes Chem. Corp., 441 F.3d 991 (Fed. Cir. 2006). In Atofina, the court held that a broad genus range disclosure in the prior art did not anticipate the narrow species range claimed. There, both the hypothetical “person having skill in the art”  (PHOSITA) and the patentee agreed that there was something special or “critical” about the claimed temperature range. The court distinguished this case from Atofina based upon its factual conclusion that “there is no allegation of criticality or any evidence demonstrating any difference across the range.”  Based upon the logical analysis that the narrow range is not critically different from the broad range, the Federal Circuit held that the claimed narrow range was fully disclosed by the broad range and therefore is unpatentable.

Comment – Whither Obviousness: Interesting notion: The mechanism that the court used to distinguish this case from Atofina are very much akin to obviousness principles — looking essentially for synergy or unexpected results that make the narrow range qualitatively different from the broad range.  It seems to me, however, that if these obviousness principles can be used to extend the anticipatory scope of prior art, then other obviousness principles (such as teaching away) should also be relevant.

Trade Secret Negated by Prior Art?: The Texas jury found Pearl River liable for trade secret misappropriations. However, the district court rejected that conclusion based upon an implicit admission by ClearValue that all of the elements of the alleged trade secret were publicly known at the time and found in the Hassick reference.  On appeal, the Federal Circuit affirmed without further analyzing the extent that public availability of knowledge in the form of a third-party prior art document is sufficient to disqualify the knowledge as a trade secret. I am not an expert on Texas trade secret law, but the at least the Restatement of Torts is clear that a trade secret “may be a device or process which is clearly anticipated in the prior art.”

 

 

In re Glatt Air Techniques, Inc.: Single Embodiment Commercial Success

By Jason Rantanen

In re Glatt Air Techniques, Inc. (Fed. Cir. 2011)
Panel: Newman, Prost (author), Moore

Glatt Air Techniques involves the reexamination of Patent No. 5,236,503, relating to an improvement to an apparatus known as a Wurster coater used to coat particles such as pharmaceutical ingredients.  The improvement comprises a shield means, such as a physical shield or air wall, positioned adjacent the spray nozzle that prevents particles from prematurely entering the stream of the coating spray before the spray pattern has fully developed, thus causing blockages in the apparatus.  During reexamination, the examiner rejected the claim at issue as obvious in light of the prior art, a determination that was upheld by the Board of Patent Appeals and Interferences.  In reaching its conclusion, the Board also rejected Glatt's commercial success evidence because it related only to a single embodiment – a physical shield – and the claim also covered the use of an air wall.  Thus, the Board concluded, the evidence was not commensurate in scope with the claim.

On appeal, the CAFC first found that the Board had failed to establish a prima facie case of obviousness.  It also disagreed with the Board's rejection of Glatt's evidence of commercial success, expanding on its past holding that "commensurate" does not mean "every" embodiment.   "The fact that Glatt’s commercial products only contain one type of shielding means does not make its commercial success evidence irrelevant. Under the PTO’s logic, there would never be commercial success evidence for a claim that covers more than one embodiment."  Slip Op. at 10.  Citing past precedent, the CAFC went on to state that "we have consistently held that a patent applicant “need not sell every conceivable embodiment of the claims in order to rely upon evidence of commercial success.” Id. (quoting In re DBC, 545 F.3d 1373, 1384 (Fed. Cir. 2008).  Thus, "commercial success evidence should be considered should be considered 'so long as what was sold was within the scope of the claims.'” Id.

Comment: Note that simply being commensurate with the scope of the claim does not necessarily satisfy the nexus requirement, as illustrated by the outcome of In re DBC.

Update: PharmaPatents Blog provides a detailed discussion of the CAFC's reversal of the Board's prima facie case of obviusness, asking whether there was anything else the applicant could have done to avoid a rejection by the examiner and Board.   

Statutory Bar Prior Art in the Nonobviousness Analysis

I am continually troubled with disconnects between the text of 35 U.S.C. § 103(a) and its application by the courts. 

Section 103(a) defines the doctrine of nonobviousness and reads (in part) as follows:

(a) A patent may not be obtained . . . if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. . . .

A plain reading of the statute that considers the obviousness of an invention “at the time the invention was made.”  In its 1965 Foster decision, the Court of Customs and Patent Appeals (CCPA) made clear that “the existence of unobviousness under that section, as a necessary prerequisite to patentability, we reiterate, must be determined as of 'the time the invention was made' without utilizing after-acquired knowledge.”  343 F.2d 980 (CCPA 1965).

Despite that seeming clarity, in its obviousness analyses, the Foster Court (and subsequently, the CAFC) has given full 103(a) consideration to post-invention activities that qualify as prior art under Section 102(b).  The justification for this interpretation appears to come in the form of an estoppel that blocks inventors who “sleep on [their] rights more than a year after the invention has become entirely obvious to the public.”  Foster indicated that any other interpretation of the statute would be an interpretation that “Congress could not possibly have intended in view of its express indication that section 102(b) is merely a continuation of the prior law.” 

The leading opinion on-point is likely In re Corcoran, 640 F.2d 1331 (CCPA 1981) which was written by Judge Rich.  In that decision, the court held that the application of 102(b) prior art in 103(a) rejections “finds its statutory base in both of those sections.”  See also Lough v. Brunswick Corp., 86 F.3d 1113, 1121 n.5 (Fed. Cir. 1996); Baker Oil Tools v. Geo Vann, Inc., 828 F.2d 1558, 156 (Fed. Cir. 1987) (what was offered for sale before the critical date becomes a "reference under section 103 against the claimed invention").

Although the weight of precedent is on the side of the current rule, the current statutory-language-focused Supreme Court just might have a point of view.  Let me know if you get a test-case going.

See also, Rethinking the Scope of Prior Art in Obviousness Cases.

Split Court Denies Rehearing En Banc in Sun Pharmaceuticals v. Eli Lilly

By Jason Rantanen

Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. 2010) (denial of rehearing and rehearing en banc)

In Sun Pharmaceutical, a Federal Circuit panel affirmed a district court determination that Eli Lilly's patent for a method of using gemcitabine to treat cancer was invalid due for obviousness-type double patenting based on another application, filed the same day, claiming the compound gemcitabine and disclosing its use for treating cancer.  (The previous Patently-O write-up is here).  This morning the Federal Circuit issued an order denying Eli Lilly's petition for rehearing and rehearing en banc.  The court was closely split on the latter, with four of the nine currently sitting judges dissenting on the decision not to rehear the decision en banc.

The dissent's principal concern was that, in its view, the panel opinion involved a departure from precedent, thus creating an intra-circuit split.  According to the dissent,

the panel held the claims to the anticancer use to be invalid for double patenting because the anticancer use was mentioned (but not claimed) in the continuation-in-part specification that is not prior art, stating that “[t]he asserted claims of the later ’826 patent simply claim the anticancer use disclosed in the specification of the ’614 patent,” reported at 611 F.3d at 1389.

The dissent pointed out that this approach, which focused on the disclosure of the simultaneously filed patent, not its claims, was contrary to precedent:

Uniformly, unlike examination for obviousness based on prior art, the issue of obviousness-type double patenting is directed to whether the invention claimed in a later patent is an obvious variant of the invention claimed in an earlier patent. The panel opinion violates a vast body of precedent.

Furthermore, according to the dissent, expanding the doctrine of obviousness-type double patenting to the facts of this case serves no good policy purpose and creates a schism in the law – a schism that should be addressed by the court en banc:

A change of law “in ways that negatively impact the patentability of important later-discovered uses” serves no public purpose in areas in which commercial development requires patent protection. Id. If the majority of the court now believes, as a matter of policy, that the law should be changed in this new direction, en banc treatment is particu-larly appropriate, for the court’s rule is that the earlier precedent prevails unless overruled en banc. A situation in which the court ignores this rule, and applies whatever law the panel prefers, is an indictment of the ability of this court to provide stable law in the areas entrusted to us.

Comment: Given that there are currently only nine sitting Federal Circuit judges, it seems unlikely that the court will grant a rehearing en banc absent extraordinary circumstances – especially in cases where the panel decision was unanimous.  In that situation, in order for an appeal to be reheard en banc, at least five of the six judges who did not participate on the panel would need to vote to rehear the decision en banc.  Of course, there are instances when this would not apply, as senior judges and visiting judges frequently participate in panel determinations, but it is something to keep in mind for the near future.

USPTO Guidelines for Determining Obviousness

The USPTO has released a set of updated examination guidelines on the core patentability issue of obviousness. The 18–page guidelines do not have the force of law, but will impact how examiners judge obviousness in practice. The updates primarily focus on Federal Circuit opinions that interpret and implement the holdings of KSR v. Teleflex, 550 U.S 398 (2007). I have copied the following tables from the Federal Register. [http://edocket.access.gpo.gov/2010/pdf/2010-21646.pdf].

 

Combining Prior Art Elements

In re Omeprazole Patent Litigation, 536 F.3d 1361 (Fed. Cir. 2008).

Even where a general method that could have been applied to make the claimed product was known and within the level of skill of the ordinary artisan, the claim may nevertheless be nonobvious if the problem which had suggested use of the method had been previously unknown.

Crocs, Inc. v. U.S. Int'l Trade Comm'n., 598 F.3d 1294 (Fed. Cir. 2010).

A claimed combination of prior art elements may be nonobvious where the prior art teaches away from the claimed combination and the combination yields more than predictable results.

Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356 (Fed. Cir. 2008).

A claimed invention is likely to be obvious if it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they have been combined.

Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed. Cir. 2009).

A combination of known elements would have been prima facie obvious if an ordinarily skilled artisan would have recognized an apparent reason to combine those elements and would have known how to do so.

Wyers v. Master Lock Co., No. 2009–1412, —F.3d—, 2010 WL 2901839 (Fed. Cir. July 22, 2010).

The scope of analogous art is to be construed broadly and includes references that are reasonably pertinent to the problem that the inventor was trying to solve. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning.

DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314 (Fed. Cir. 2009).

Predictability as discussed in KSR encompasses the expectation that prior art elements are capable of being combined, as well as the expectation that the combination would have worked for its intended purpose. An inference that a claimed combination would not have been obvious is especially strong where the prior art's teachings undermine the very reason being proffered as to why a person of ordinary skill would have combined the known elements.

   

Substituting One Known Element for Another

In re ICON Health & Fitness, Inc., 496 F.3d 1374 (Fed. Cir. 2007).

When determining whether a reference in a different field of endeavor may be used to support a case of obviousness (i.e., is analogous), it is necessary to consider the problem to be solved.

Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337 (Fed. Cir. 2008).

Analogous art is not limited to references in the field of endeavor of the invention, but also includes references that would have been recognized by those of ordinary skill in the art as useful for applicant's purpose.

Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318 (Fed. Cir. 2008).

Because Internet and Web browser technologies had become commonplace for communicating and displaying information, it would have been obvious to adapt existing processes to incorporate them for those functions.

Aventis Pharma Deutschland v. Lupin, Ltd., 499 F.3d 1293 (Fed. Cir. 2007).

A chemical compound would have been obvious over a mixture containing that compound as well as other compounds where it was known or the skilled artisan had reason to believe that some desirable property of the mixture was derived in whole or in part from the claimed compound, and separating the claimed compound from the mixture was routine in the art.

Eisai Co. Ltd. v. Dr. Reddy's Labs., Ltd., 533 F.3d 1353 (Fed. Cir. 2008).

A claimed compound would not have been obvious where there was no reason to modify the closest prior art lead compound to obtain the claimed compound and the prior art taught that modifying the lead compound would destroy its advantageous property. Any known compound may serve as a lead compound when there is some reason for starting with that lead compound and modifying it to obtain the claimed compound.

Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc., 566 F.3d 989 (Fed. Cir. 2009).

It is not necessary to select a single compound as a ''lead compound'' in order to support an obviousness rejection. However, where there was reason to select and modify the lead compound to obtain the claimed compound, but no reasonable expectation of success, the claimed compound would not have been obvious.

Altana Pharma AG v. Teva Pharms. USA, Inc., 566 F.3d 999 (Fed. Cir. 2009).

Obviousness of a chemical compound in view of its structural similarity to a prior art compound may be shown by identifying some line of reasoning that would have led one of ordinary skill in the art to select and modify a prior art lead compound in a particular way to produce the claimed compound. It is not necessary for the reasoning to be explicitly found in the prior art of record, nor is it necessary for the prior art to point to only a single lead compound.

   

The Obvious To Try Rationale

In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009).

A claimed polynucleotide would have been obvious over the known protein that it encodes where the skilled artisan would have had a reasonable expectation of success in deriving the claimed polynucleotide using standard biochemical techniques, and the skilled artisan would have had a reason to try to isolate the claimed polynucleotide. KSR applies to all technologies, rather than just the ''predictable'' arts.

Takeda Chem. Indus. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007).

A claimed compound would not have been obvious where it was not obvious to try to obtain it from a broad range of compounds, any one of which could have been selected as the lead compound for further investigation, and the prior art taught away from using a particular lead compound, and there was no predictability or reasonable expectation of success in making the particular modifications necessary to transform the lead compound into the claimed compound.

Ortho-McNeil Pharmaceutical, Inc. v. Mylan Labs, Inc., 520 F.3d 1358 (Fed. Cir. 2008).

Where the claimed anti-convulsant drug had been discovered somewhat serendipitously in the course of research aimed at finding a new anti-diabetic drug, it would not have been obvious to try to obtain a claimed compound where the prior art did not present a finite and easily traversed number of potential starting compounds, and there was no apparent reason for selecting a particular starting compound from among a number of unpredictable alternatives.

Bayer Schering Pharma A.G. v. Barr Labs., Inc., 575 F.3d 1341 (Fed. Cir. 2009).

A claimed compound would have been obvious where it was obvious to try to obtain it from a finite and easily traversed number of options that was narrowed down from a larger set of possibilities by the prior art, and the outcome of obtaining the claimed compound was reasonably predictable.

Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. 2008).

A claimed isolated stereoisomer would not have been obvious where the claimed stereoisomer exhibits unexpectedly strong therapeutic advantages over the prior art racemic mixture without the correspondingly expected toxicity, and the resulting properties of the enantiomers separated from the racemic mixture were unpredictable.

Rolls-Royce, PLC v. United Technologies Corp., 603 F.3d 1325 (Fed. Cir. 2010).

An obvious to try rationale may be proper when the possible options for solving a problem were known and finite. However, if the possible options were not either known or finite, then an obvious to try rationale cannot be used to support a conclusion of obviousness.

Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324 (Fed. Cir. 2009).

Where there were a finite number of identified, predictable solutions and there is no evidence of unexpected results, an obvious to try inquiry may properly lead to a legal conclusion of obviousness. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning.

   

Consideration of Evidence

PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342 (Fed. Cir. 2007).

Even though all evidence must be considered in an obviousness analysis, evidence of nonobviousness may be outweighed by contradictory evidence in the record or by what is in the specification. Although a reasonable expectation of success is needed to support a case of obviousness, absolute predictability is not required.

In re Sullivan, 498 F.3d 1345 (Fed. Cir. 2007).

All evidence, including evidence rebutting a prima facie case of obviousness, must be considered when properly presented.

Hearing Components, Inc. v. Shure Inc., 600 F.3d 1357 (Fed. Cir. 2010).

Evidence that has been properly presented in a timely manner must be considered on the record. Evidence of commercial success is pertinent where a nexus between the success of the product and the claimed invention has been demonstrated.

Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310 (Fed. Cir. 2008).

Evidence of secondary considerations of obviousness such as commercial success and long-felt need may be insufficient to overcome a prima facie case of obviousness if the prima facie case is strong. An argument for nonobviousness based on commercial success or long-felt need is undermined when there is a failure to link the commercial success or long-felt need to a claimed feature that distinguishes over the prior art.

Interval Licensing v. AOL, Apple, eBay, Facebook, Google, etc.

Interval Licensing LLC v. AOL, Apple, eBay, Facebook, Google, Netflix, Office Depot, OfficeMax, Staples, Yahoo!, and YouTube (W.D. Wash. 2010).

Microsoft co-founder Paul Allen started Interval Research in 1992. During the 1990’s, the company filed for several user-interface related patents that were primarily intended to improve a computer user's online experience. The patents focus on what I might call “lightweight” usability ideas such as a occupying the peripheral attention of a user; organizing audio/visual for display in a browser; and alerting users to items of current interest.

When Interval closed its doors, the patents were transferred to Vulcan Patents LLC (presumably another Paul Allen company) and then to Interval Licensing which remains a Paul Allen company.

PatentLawPic1133

The patents are well drafted. Of course, even excellent drafting cannot cure obviousness problems. I suspect that the litigation will focus primarily on whether these inventions were obvious back when the patents were filed? In addition to arguing in court, I expect that the defendants will also appeal to the US Patent Office — asking the agency to take a second look at the patents via reexamination.

Take claim 1 of asserted Patent No. 6,757,682 (filed in 2000) as an example.

1. A system for disseminating to a participant an indication that an item accessible by the participant via a network is of current interest, comprising:

a computer configured to

receive in real time from a source other than the participant an indication that the item is of current interest;

process the indication;

determine an intensity value to be associated with the indication and an intensity weight value, and adjusting the intensity value based on a characteristic for the item provided by the source; and

inform the participant that the item is of current interest; and

a database, associated with the computer, configured to store data relating to the item.

I don’t have any prior art on hand, but the claim sure feels obvious (in hindsight)…

Of course, the system embodied in claim 1 above represents an important core feature of services provided by all of the listed defendants. (A similar story can be told of the other asserted patents.) Thus, if the patents are valid, the damage award could be quite large.

It may be important to note that the complaint does not suggest that any of the defendants copied the invention from Paul Allen's company or that the defendants even knew about the patents before today. Of course, a patentee does not have to show copying in order to prove patent infringement and back-damages can still be available even when the infringement occurred without knowledge of the patent. (Additional punitive damages may be awarded if the infringement was willful).

It will be interesting to see how the Supreme Court’s foray into patent law over the past four-years will impact this case. I look to three important decisions:

  1. In KSR v. Teleflex, the Supreme Court raised the patentability standard of nonobviousness — making it more likely that these patents will be held invalid as obvious.
  2. In Bilski v. Kappos, the Supreme Court held that certain business method inventions are not patentable. Some of the claims in the patents-in-suit may be susceptible to a similar attack. However, most of the asserted claims appear to be tied closely to a technological implementation in a way that may avoid problems under Bilski.
  3. In EBay v. MercExchange, the Supreme Court made it more difficult for patent holding companies (such as the plaintiff here) to obtain an injunction to stop ongoing infringement. Of course, it is unlikely that Interval actually wants to stop infringement — rather, the company is looking for a large license fee.

Final point: The vast majority of patent cases settle. Here, however, all of the parties have large amounts of cash-on-hand. In addition, some of the defendants are repeat patent infringement defendants. Those factors tend to make settlement less likely.

Lack of “Engineering Details” in Claim Hampers NonObviousness Argument

Martin v. Alliance Machine (Fed. Cir. 2010)

In considering secondary indicia of nonobviousness, Chief Judge Rader tends to focus on whether a nexus exists between the presented objective evidence and the invention as claimed. Here, Judge Rader applied a similar methodology in examining the differences between the prior art and the claimed invention. (Deere).

Martin's patent covers an improved machine for splitting cardboard bundles. The patented design uses top-down pneumatic pistons to hold the bundles in place. The prior art design uses bottom-up pneumatic pistons. In arguing non-obviousness, Martin's expert pointed-out that it would not work to simply flip the prior-art design on its head. Rather, any such conversion would require extensive engineering detail. Judge Rader rejected that argument — holding that the "engineering details" argument was irrelevant because the claims did not identify any of those details.

[Martin] relies on the testimony of Alliance’s own Director of Research and Development that, “from an engineering standpoint,” one cannot simply take the Pallmac design and flip it from bottom to top. That testimony, however, is irrelevant to the obviousness analysis. With one exception, discussed below, the claims themselves do not recite engineering details but merely require that the compliance structures be mounted to clamps that are “above” the conveyor belts.

After rejecting all of Martin's nonobviousness arguments, the appellate panel affirmed the lower court's invalidity holding.

Transocean v. Maersk: Speeding Up Deepsea Drilling

By Jason Rantanen

Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc. (Fed. Cir. 2010)
Panel: Gajarsa, Mayer, Moore (author)

Drilling rigTransocean brought suit against Maersk for infringement of three patents relating to an improved apparatus for offshore drilling.  Offshore drilling involves lowering a variety of equipment, including the drill bit, a series of long pipes, and a blow-out-preventor, to the ocean floor in order to drill and stabilize a borehole that reaches a subterranean oil reservoir.  These components are moved by a derrick (the tower on the picture to the right), which is equipped with a station that raises and lowers them to the ocean floor.  To begin the drilling process, the rig lowers the drill bit to the ocean floor, adding sections of pipe until the bit reaches the floor.  Periodically as the drill descends into the seabed, it must be brought back up to the surface so that casings can be inserted into the borehole.  Conventional rigs utilized a derrick with only a single station for performing these steps, thus requiring that they be performed sequentially – a time consuming process. 

The patents-in-suit describe a derrick that includes two stations – a main advancing station and an auxiliary advancing station – that can each assemble the strings of drilling materials and lower them to the ocean floor.  According to the patent, this "dual-activity" rig can significantly decrease the time required to complete a borehole.  The accused infringer, Maersk, contracted with a U.S. company to build a rig with two stations for use in the Gulf of Mexico.  However, prior to delivery of the rig, Maersk implemented a modification that, it argued, precluded Transocean from claiming infringement.  It also argued that the claims were invalid.

The district court granted summary judgment in favor of Maersk, holding that the asserted claims were obvious and not enabled.  The court further ruled that Maersk's activities did not constitute either an offer for sale or a sale within the United States.  Transocean appealed these rulings, along with the district court's grant of summary judgment of collateral estoppel and no willful infringement.

Obviousness
The Federal Circuit's obviousness ruling is notable because, although it found that the references cited by Maersk created a prima facie case of obviousness, it concluded that the district court had erred by ignoring Transocean's significant objective evidence of nonobviousness.  This included evidence of industry skepticism about a dual drill string approach, industry praise for its dual activity rig, copying, and commercial success, in that its dual activity rigs commanded a higher licensing premium then standard rigs.  Although Maersk presented counter evidence, the Federal Circuit concluded that it was improper to resolve these disputes on summary judgment. 

Enablement
The Federal Circuit also reversed the grant of summary judgment of lack of enablement, finding that factual issues precluded such a ruling.  In particular, it noted that while the patent must enable one of ordinary skill in the art to practice the claimed invention without undue experimentation, it does not need to enable the most optimized configuration (unless it is an explicit part of the claims). 

Infringement
The district court's noninfringement ruling did not rest on a comparison of the accused device to the claim, but rather on a conclusion that there was no offer for sale or sale within the United States.  Although the contract at issue was between two U.S. companies, and specified an "Operating Area" for the rig that was in U.S. territorial waters, it was negotiated and signed outside of the United States.

The Federal Circuit disagreed that these activities fell outside the scope of 35 U.S.C. 271(a).  With respect to the "offer for sale" provision, after reviewing the legislative history of this language, analyzing its literal text, and considering the policy implications, the court concluded that it covered a contract between two U.S. companies for performance in the U.S., regardless of whether it was negotiated or signed within the U.S.  Likewise, the court concluded that, because the contract was for the sale of a patented invention with delivery and performance in the U.S., it constituted a sale for purposes of 271(a) as  a matter of law.

Note: Although the court used the term "patented invention," it was careful to note that there remained a dispute over whether the rig described in the contract actually infringed the patents-in-suit.

The Federal Circuit did, however, affirm the district court's ruling that Transocean was collaterally estopped from arguing that the rig Maersk ultimately delivered infringed the patents.  In another litigation, Transocean had obtained by an injunction requiring the defendant GlobalStantaFe Corp. ("GSF") to make a particular modification to its rig in order to avoid infringing the patents-in-suit.  Prior to delivering the rig to the United States, Maersk had learned about this injunction and made the relevant modification.  The Federal Circuit concluded that the ruling in the GSF litigation estopped Transocean from arguing that rigs with the modification infringed its patents.

The panel also affirmed the district court's ruling of no willful infringement, concluding that Maersk's activities were insufficient to create an objectively high risk of infringement.

Sun Pharmaceuticals v. Eli Lilly: obviousness-type double patenting in the pharmaceutical context

Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010)

By Jason Rantanen

Double-patenting issues arise when two commonly owned applications cover the same or similar inventions.  The issues in this appeal revolved around an earlier patent claiming a composition of matter and describing a method for using that composition, and a later patent claiming that method of use. 

Both of the patents in this case, Patent No. 4,808,614 (the '614 patent) and Patent No. 5,464,826 (the '826 patent) relate to gemcitabine, the active ingredient of Lilly's Gemzar® product.  The '614 patent claims both gemcitabine itself, as well as a method of using it to treat viral infections.  In addition, the '614 patent's specification discloses using gemcitabine to treat cancer.  The '826 patent claims a method of treating cancer comprising administering a therapeutically effective amount of gemcitabine.  The difference was important: the '614 patent expired on May 15, 2010, while the '826 patent does not expire until November 7, 2012.

Note: The applications leading to both the '614 and '826 patents were filed on the same day, December 4, 1984.  The '614 was a continuation-in-part of application No. 473,883 ("the '883 application"), which did not disclose using gemcitabine to treat cancer.  That information was added as part of the continuation-in-part. 

After filing an Abbreviated New Drug Application ("ANDA") for a generic version of Gemzar®, Sun Pharmaceuticals, sought a declaratory ruling that the '826 patent was invalid and not infringed.  Lilly counterclaimed for infringement of the '826 and '614 patents.  The '614 patent was not at issue in this appeal.

Obviousness-type double patenting applies
Applicants are barred from obtaining multiple patents covering the same invention by the doctrine of double patenting.  There are two types of double patenting: statutory double patenting, which prohibits a later patent from covering the identical invention, and obviousness-type double patenting, which prevents a later patent from covering a slight variation of an earlier patented invention.

On appeal, the panel agreed with the district court and Sun that the latter type of double patenting occurred here, thus invalidating the asserted claims of the '826.  The basis for the court's decision were two prior opinions, Geneva v. GlaxoSmithKline, 349 F.3d 1373, and Pfizer v. Teva, 518 F.3d 1353.  In Geneva, the earlier patent claimed a compound and the specification disclosed its effectiveness for inhibiting beta-lactamase.  The later patent claimed a method of using the compound to affect beta-lactamase inhibition.  Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflamation; the later patent claimed a method of using these compounds for treating inflammation.  In both cases, the court ruled that the claims were not "patentably distinct," and thus the latter claims were invalid for obviousness-type double patenting.  

While Lilly argued that Geneva and Pfizer did not apply because "the specification of the earlier patent disclosed a single use for the claimed compound, which was an essential part of the patented invention and thus necessary to patentability," Slip Op. at 8, the court rejected that argument for two reasons.  First, the court disagreed that the specification in Pfizer disclosed more than one utility for the claimed compound.  In addition, the court read the rule of Pfizer as simply that "obviousness-type double patenting encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound and is later claimed as a method of using that compound.  Pfizer never implies that its reasoning depends in any way on the number of uses disclosed in the specification of the earlier patent."  Slip Op. at 10. 

The court also rejected Lilly's argument that the specification of an earlier application should have been consulted, as opposed to the specification of the '614 patent.  Drawing upon its claim construction precedent, the court noted that the specification is relevant to determining the coverage of the claims, which is at the heart of the obviousness-type double patenting analysis.  The court further noted that "consulting the specification of the issued patent, as opposed to an earlier version, is consistent with the policy behind double patenting," which rests "on the fact that a patent has been issued and later issuances of a second patent will continue protection, beyond the date of expiration of the first patent of the same invention or an obvious variation thereof."  Slip Op. at 14-15.

Wyers v. Master Lock

Is "obviousness" a question of law or fact?  The rote answer is that it's both: it's a question of law based on underlying findings of fact.  Drawing that line, however, can be tricky, especially when the jury issues a general verdict.  In addition to addressing this issue, the case discussed below is also noteworthy due to its commentary on KSR on the subject of  motivation to combine. 

Wyers v. Master Lock Co.
(Fed. Cir. July 22, 2010)
Wyers involved three patents relating to trailer hitch locks.  Trailer hitch locks are mechanisms used to secure trailers to towing vehicles.  It was undisputed that the prior art disclosed the use of dumbbell-shaped locks for this purpose, so the case turned on the the patentee's modifications to these types of locks.  The following images illustrate the prior art:

Wyers 1 Wyers 2

Wyers' patents claimed dumbbell-shaped locks with two additional elements: a series of sleeves that could be placed over the center section (the "shank") in order to increase its diameter, and an external seal designed to keep dirt out of the locking mechanism.  The only issue before the jury was whether it was obvious to add these two elements to the prior art locks.

The jury concluded that it was not, and issued a general verdict of nonobviousness. After the district court denied Master Lock's motion for Judgment as a Matter of Law, Master Lock appealed. 

Opinion of the Court
Drawing heavily on KSR, the Federal Circuit concluded that the patents were obvious as a matter of law.  The court considered each of the factual questions before it: whether the art was analogous, whether there was sufficient motivation to combine the reference, and the secondary considerations of nonobvious, and concluded that none favored the patentee.

In reaching this conclusion, the Federal Circuit gave no deference to the jury.  On each issue of fact, the panel found that no evidence supported nonobviousness.  For example, when addressing the issue of whether the prior art was analogous, the court reasoned that it was "clearly within the same field of endeavor as the sleeve patents," and was pertinent as a matter of law.

Particularly interesting, however, were the panel's views on motivation to combine.  While recognizing this as an important aspect of the obviousness inquiry, the panel applied the "common sense" approach outlined in KSR:

"We conclude that it was a matter of common sense to combine the Down patent with the prior art barbell locks in order to arrive at the invention claimed in the ’115 and ’426 patents, and that one of ordinary skill in the art would have had a reasonable expectation of success in doing so."

Slip Op. at 23. Furthermore, "where all the limitations of the patent were present in the prior art references, and the invention was addressed to a 'known problem,' 'KSR … compels the grant of summary judgment ofobviousness.'"  Id. at 17.  Such an approach is particularly appropriate when the technology is "easily understandable." 

Finally, on the issue of secondary considerations, the court concluded that, even if Wyers had established the requisite nexus, it would have been insufficient:

Moreover, secondary considerations of nonobviousness—considered here by the district court—simply cannot overcome a strong prima facie case of obviousness.

Slip Op. at 28

Concurrence
Judge Linn concurred with the opinion, but wrote separately to warn parties of the dangers of general verdicts.  He noted that although the law permits general verdicts, verdicts involving special interrogatories are encouraged in the obviousness context due to the mixed question of law and fact.  He further noted that, while the court must presume that the jury resolved the underlying factual disputes in favor of the verdict winner when there are no special interrogatories,

"[b]ecause there is no way to determine from a general verdict on obviousness the specific findings of fact made by a jury on the factual questions underlying its verdict, the court in examining the first part of the obviousness question is left to infer whether substantial evidence existed from which the jury could have made the factual findings necessary to support the verdict. Here, the majority examined the record and after considering the factual inferences concluded that support was lacking and that the claims at issue would have been obvious as a matter of law."

Slip op., concurrence at 4-5.  In other words, when a general verdict is give, the Federal Circuit has to attempt to reconstruct the underlying findings of fact.  Here, it could not discern anything that might reasonably have been in dispute, and thus judgment as a matter of law was appropriate. 

Guest Post on Bilski: Throwing Back the Gauntlet

Guest Post by Shubha Ghosh, Vilas Research Professor & Professor of Law at the University of Wisconsin Law School

A year and a half ago, the Federal Circuit threw down a gauntlet in its Bilski opinion, extensively citing Supreme Court precedent to come up with the “machine or transformation test” to determine when a process constitutes patentable subject matter. Now the Supreme Court has rejected the Federal Circuit’s conclusion that “machine or transformation” is the only test to use and provided an additional basis for why Bilski’s patent for a method of hedging risk is not patentable. In doing so, the Supreme Court has thrown back the gauntlet, leaving scholars and the Patent Bar to speculate on where the USPTO and the Federal Circuit might go with using patentable subject matter as a limit on patentability. When the smoke clears, the Bilski opinion will appear a lot like the KSR decision from 2007 and that should not be surprising since Justice Kennedy authored both.

Here are the highlights of Bilski v. Kappos.Justice Kennedy‘s opinion of the court unanimously affirmed the Federal Circuit’s ruling that Bilski’s patent should be rejected. Where the nine justices agree is that the Federal Circuit erred in distilling from precedents the “machine or transformation” test as the sole one to determine when a process is patentable subject matter. The Court based this ruling on the definition of process in Section 100 of the Patent Act and its own precedents (from the 1970’s and 1981) in Gottschalk v Benson, Parker v Flook, and Diamond v Diehr. There also was agreement that patentable subject matter is broad with limits that are finite and discernible, rather than open ended.   One of these limits is no patents for abstract ideas, and there is unanimity that Bilski’s claims for methods of hedging were too abstract, describing a general process well established in the field. In short, there was unanimity in rejecting the “machine or transformation” test as the sole test for identifying a patentable process and affirming the well known exceptions from patentable subject matter: laws of nature, physical phenomenon, and abstract ideas.

PatentLawPic1009In terms of method, Bilski v. Kappos reminds me of the Canadian Supreme Court’s 2002 decision in Harvard College v. Canada (Commissioner of Patents), which rejected a patent on a multicellular living organism.   Both decisions relied heavily on a strict reading of the statute with the Canadian Supreme Court ruling that the word “invention” in the Canadian patent statute did not include living organisms. The Canadian Supreme Court decision, however, seemed to be sending a clear message to the Canadian Parliament to amend the statute if necessary. By contrast, it is not clear what the U.S. Supreme Court’s message is in Bilski. The opinion was a response to the Federal Circuit’s mischaracterization of Supreme Court precedent as a “machine or transformation” test. But at a deeper level, one is left wondering what guidance the Supreme Court is providing for practitioners, scholars, and policymakers. The Court throws the gauntlet back to the Federal Circuit, and presumably they will now take the new precedent and use it to mold patent practice.

The lack of clarity is reflected in part in the Justice Breyer concurrence, joined by Justice Scalia, providing four guiding principles for how to determine whether a process is patentable subject matter. The four principles are: (i) there are limits on patentable subject matter; (ii) transformation is an important “clue” to when a process is patentable subject matter: (iii) machine or transformation is not the sole test for determining when a process is patentable subject matter; and (iv) the “useful, concrete, tangible” test does not describe the full scope of what constitutes patentable subject matter.   These four distill down to the principle that limits on patentable subject matter have something to do with transformation to a physical state, but that usefulness, concreteness, and tangibility do not describe the extent of patentable subject matter. Justice Breyer’s principles imply that there are limitations on “dubious” patents, such as those for “exercising a cat with a laser pointer” that have nothing to do with machine or transformation. The problem is we have no sense of what those additional limitations are.

Undoubtedly, more litigation is on the way, and perhaps the Court will hear another case involving either a medical diagnostic patent or a “dubious” patent. But the Bilski case will have immediate impact on how patents are prosecuted.   After the Supreme Court’s 2007 KSR decision, patent examiners latched onto the Supreme Court’s language about “common sense” to issue obviousness rejections because a claimed combination was deemed “common sensical.” We can predict similar responses post-Bilski. The Court did not kill machine or transformation; it is now just one test. Patent examiners can still use the test as a basis for rejection. In addition, the Court’s emphasis on abstract ideas creates another basis for rejecting patents for lack of patentable subject matter.

Specifically, the Court has now revived the Gottschalk-Parker-Diehr line of cases, which were established before the creation of the Federal Circuit and which the Federal Circuit had distilled over time into the expansive “useful-concrete-tangible” approach to patentable subject matter and then into the “machine or transformation test.” In effect, the Supreme Court by reviving its precedent has negated over twenty-five years of the Federal Circuit’s attempts at doctrine. This revival opens up possibilities for examiners to rethink the relationships among process, machine, and the physical world. “Dubious” patents may be rejected because the physical phenomenon is trivial or too preemptive of the field. Patent claims might require closer connection to a machine embodiment as opposed to an abstracted, disembodied form.   An interesting question to ask is whether the patent at issue in State Street would survive the analysis proposed by Bilski.   On the one hand, the asset allocation method at issue is arguably as abstract as the hedging method. On the other hand, the method seems closely tied to a machine to give the process some specific limits.  

pic-99.jpgUltimately, Bilski v Kappos says more about how patent law is made in the United States than about patentable subject matter. By setting the clock back to 1982, the Supreme Court is telling the Federal Circuit to try again in devising workable rules for patent law. The Federal Circuit wrote an opinion that was goading the Supreme Court to address the issue of patentable subject matter after nearly three decades. The resulting opinion raises some fundamental and unsettled questions and, unfortunately, gives us the same, old answers.

BPAI Review of Obviousness Rejections

Ex parte Quist (BPAI 2010) (precedential opinion)

In only its second precedential opinion of 2010, the Board of Patent Appeals and Interferences (BPAI) has further developed its procedures for its review of obviousness rejections and consideration of evidence of nonobviousness.

On Board review, if the appellant raises the issue as to whether the examiner’s conclusion of obviousness was in error, based in part on the proffered evidence of secondary considerations, the panel must consider if the examiner erred in determining patentability, based upon the totality of the record. In such instances, the Board panel must consider anew all the relevant evidence of obviousness, both for and against, in view of the argument on the issue. One such instance requiring a reweighing is seen in the present appeal – if the Appellants argue that the Examiner erred in determining that the weight of the evidence supports a conclusion of obviousness, the Board must review that conclusion of obviousness anew to see if the preponderance of relevant evidence properly before the Office supports that conclusion.

This decision should be seen as a continuation of the Ex parte Frye (BPAI 2010) holding that the Board must review "the particular finding(s) contested by an appellant anew in light of all the evidence and argument on that issue.”

Despite taking a fresh look at the evidence and conclusions, the BPAI held that the examiner had been correct in determining that the claimed "process for the manufacturing of decorative boards with an abrasion resistant surface and edges" was indeed obvious.

Over 85% of BPAI appeals focus on obviousness. The BPAI has a current backlog of over 16,000 cases. At its current rate of disposal, this figure represents a 29-month backlog.

 

Terminal Disclaimers and PTO: Proposal for a Test Case

Obviousness-type non-statutory double patenting is a judicially created doctrine that operates to prevent patentees from improperly extending a patent's effective term through successive patent grants.

The non-statutory double patenting doctrine was created at a time when patent term was measured from the grant date. At that time, it was easy to "play games" with the patent terms by using a series of continuation applications. Because patent term (for new patents) is now defined by the filing/priority date, most of the potential for games has been eliminated because a family of related applications will typically have the same term. However, a growing issue is patent term adjustment (PTA) that increases the patent term for applications with long prosecution pendency. Because of the increased backlog and changes to PTA calculations, it is likely that later-issued applications in a family will have a longer PTA.

Courts and the PTO have agreed that a patentee can overcome a non-statutory double patenting problem by filing a terminal disclaimer that ties the patent-term of a later-granted patent to the patent term of an earlier-granted patent.

The impact of a terminal disclaimer depends upon what was actually disclaimed. Although applicants can draft their own terminal disclaimer, most folks use the form provided by the USPTO. (SB-0025). The PTO Form disclaims the term of the later-issued patent that extends beyond the earlier-issued patent's term. Regarding PTA, the Form expressly ties the later-issued patent's term to the PTA-adjusted term of the earlier-issued patent.

Although not expressly stated, the Form seems to imply that the PTA of the later-issued patent can be cut-short by the disclaimer. That result, however, is not compelled by the law. In theory (and largely in practice) PTA is based on patent office delay. As such, the equitable basis of the non-statutory double patenting doctrine might not apply to require disclaimer of PTA.

A patent applicant may want to pursue a test-case by modifying the terminal disclaimer form to expressly state that the disclaimer does not cut short the PTA of that later-issued patent. Thus, the term of a later-issued patent with a 400-day PTA and a terminal-disclaimer would limited to the term of the earlier-issued patent plus 400-days.

 

Federal Circuit Affirms Summary Judgment of Obviousness for Bulk EMail Patent

Perfect Web Technologies v. InfoUSApic-79.jpg (Fed. Cir. 2009)

Perfect Web’s asserted patent covers a method of managing bulk e-mail distribution. Claim 1 of the application (filed in 2000) reads as follows:

1. A method for managing bulk e-mail distribution comprising the steps:

(A) matching a target recipient profile with a group of target recipients;

(B) transmitting a set of bulk e-mails to said target recipients in said matched group;

(C) calculating a quantity of e-mails in said set of bulk e-mails which have been successfully received by said target recipients; and,

(D) if said calculated quantity does not exceed a prescribed minimum quantity of successfully received e-mails, repeating steps (A)-(C) until said calculated quantity exceeds said prescribed minimum quantity. (Pat. No. 6,431,400).

The district court held the claims invalid as anticipated and obvious as well as for failing to claim statutory subject matter under Section 101. On appeal, the Federal Circuit upheld the obviousness finding and left the alternative reasons undecided.

Of course, in 2000, targeted bulk e-mail was already around, and the defendants provided prior art evidence of steps (A)-(C). That is, marketers were already identifying target recipients, sending out e-mails, and calculating the percent received. Missing from the prior art was step (D) – iteratively repeating steps (A)-(C) until the number of recipients reaches the a prescribed quantity.

Evidence of Common Sense: The district court held on summary judgment that KSR style “common sense” would lead one of ordinary skill in the art to perform the iterative step (D). On appeal, the Federal Circuit affirmed that finding – holding particularly that the finding of common sense does not require “explication in any reference or expert opinion.”

Although a court need not have documentary support of its common sense analysis, a court (or patent examiner) must at least clearly explain its reasoning.

We reiterate that, on summary judgment, to invoke “common sense” or any other basis for extrapolating from prior art to a conclusion of obviousness, a district court must articulate its reasoning with sufficient clarity for review.

In this case, the appellate panel agreed that the idea of repeating already known steps until a threshold is met was simply a common sense extension:

Thus, this last step, and the claim as a whole, simply recites repetition of a known procedure until success is achieved. Recognizing this, the district court explained: “If 100 e-mail deliveries were ordered, and the first transmission delivered only 95, common sense dictates that one should try again. One could do little else.”

The court added an interesting caveat regarding expert testimony and the level of one of skill in the art — noting that expert testimony may well be necessary for “complex” technology.

If the relevant technology were complex, the court might require expert opinions. Here, however, the parties agreed that ordinary skill in the relevant art required only a high school education and limited marketing and computer experience. No expert opinion is required to appreciate the potential value to persons of such skill in this art of repeating steps (A)-(C).

Obvious to Try: As a corollary to its common sense holding, the appellate court also held that the additional step (D) would have been “obvious to try” under KSR. “[S]imple logic suggests that sending messages to new addresses is more likely to produce successful deliveries than re-sending messages to addresses that have already failed. . . . [I]ndeed, the predictable and actual result of performing step (D) is that more e-mail messages reach more recipients.”

Long-felt Need: The patentee argued that a nonobviousness conclusion was supported by evidence of the secondary consideration of long-felt need. Particularly, the method helps solve the recognized competing problems of reaching customers without “burning up” the mailing list by oversending.

The Federal Circuit rejected these arguments because the patentee had failed to provide any evidence of improved efficiency beyond “bare assertion.” In addition, the court suggested that any proof of long-felt need would be insufficient to “overcome [the] strong prima facie showing of obviousness.” (quoting Asyst Techs (2008))

Claim Construction: Interestingly, the court issued its summary judgment order prior to claim construction. The Federal Circuit found no error because construction of the disputed claim terms would not have changed the obviousness outcome.

Notes: The patent was originally titled “Statement regarding federally sponsored research or development.” That is apparently a typographical error fixed in a subsequent certificate of correction.   

Bits and Bytes No. 127: Patentability shall not be negatived by the manner in which the invention was made.

Upcoming Conferences:

  • World Research Group, a Patently-O job board sponsor, will be holding a TechNet Patents Forum in New York on November 5-6. Patently-O readers will receive a $300 discount by using the promo code EAG476.

Federal Circuit En Banc:

  • On September 18, the Court of Appeals for the Federal Circuit will sit en banc to hear two non-patent cases.
  • Nebraska Public Power v. US:
    • The Nebraska case is one of several dozen Federal Claims actions against the US Government for breach of contract and takings for the Government’s failure to begin removing spent nuclear fuel.
    • Question: Does the mandamus order issued by the United States Court of Appeals for the District of Columbia Circuit in Northern States Power Co. v. United States Dep’t of Energy, 128 F.3d 754 (D.C. Cir. 1997) preclude the United States from pleading the “unavoidable delay” defense to the breach of contract claim pending in the United States Court of Federal Claims, and if so, does the order exceed the jurisdiction of the District of Columbia Circuit?
  • Henderson v. Dep’t of Veteran Affairs:
    • Equitable tolling of claims for veteran’s benefits
    • Question: Does the Supreme Court’s decision in Bowles v. Russell, 127 S. Ct. 2360 (2007), require or suggest that this court should overrule its decisions in Bailey v. West, 160 F.3d 1360 (Fed. Cir. 1998) (en banc), and Jaquay v. Principi, 304 F.3d 1276 (Fed. Cir. 2002) (en banc), holding that 38 U.S.C. § 7266 is subject to equitable tolling?.

Relevance of the “manner in which the invention was made:”

  • 35 U.S.C. 103(a) makes clear that “[p]atentability shall not be negatived by the manner in which the invention was made.” That final sentence of the paragraph was apparently intended to contrast the 1952 law from the Supreme Court’s loose statement in Cuno that a patentable invention must “reveal the flash of creative genius.” 314 U.S. 84 (1941).
  • Should this statement be interpreted to mean that the inventor’s actual process has no relevance to the questions of novelty and nonobviousness? Or, is there still room for a jury to consider the actual creativity and genius of the inventor and the process used. (This question was suggested by a comment on the blog).

Bits and Bytes No. 127: Patentability shall not be negatived by the manner in which the invention was made.

Upcoming Conferences:

  • World Research Group, a Patently-O job board sponsor, will be holding a TechNet Patents Forum in New York on November 5-6. Patently-O readers will receive a $300 discount by using the promo code EAG476.

Federal Circuit En Banc:

  • On September 18, the Court of Appeals for the Federal Circuit will sit en banc to hear two non-patent cases.
  • Nebraska Public Power v. US:

    • The Nebraska case is one of several dozen Federal Claims actions against the US Government for breach of contract and takings for the Government’s failure to begin removing spent nuclear fuel.
    • Question: Does the mandamus order issued by the United States Court of Appeals for the District of Columbia Circuit in Northern States Power Co. v. United States Dep’t of Energy, 128 F.3d 754 (D.C. Cir. 1997) preclude the United States from pleading the “unavoidable delay” defense to the breach of contract claim pending in the United States Court of Federal Claims, and if so, does the order exceed the jurisdiction of the District of Columbia Circuit?
  • Henderson v. Dep’t of Veteran Affairs:

    • Equitable tolling of claims for veteran’s benefits
    • Question: Does the Supreme Court’s decision in Bowles v. Russell, 127 S. Ct. 2360 (2007), require or suggest that this court should overrule its decisions in Bailey v. West, 160 F.3d 1360 (Fed. Cir. 1998) (en banc), and Jaquay v. Principi, 304 F.3d 1276 (Fed. Cir. 2002) (en banc), holding that 38 U.S.C. § 7266 is subject to equitable tolling?.

Relevance of the “manner in which the invention was made:”

  • 35 U.S.C. 103(a) makes clear that “[p]atentability shall not be negatived by the manner in which the invention was made.” That final sentence of the paragraph was apparently intended to contrast the 1952 law from the Supreme Court’s loose statement in Cuno that a patentable invention must “reveal the flash of creative genius.” 314 U.S. 84 (1941).
  • Should this statement be interpreted to mean that the inventor’s actual process has no relevance to the questions of novelty and nonobviousness? Or, is there still room for a jury to consider the actual creativity and genius of the inventor and the process used. (This question was suggested by a comment on the blog).

Bits and Bytes No. 127: Patentability shall not be negatived by the manner in which the invention was made.

Upcoming Conferences:

  • World Research Group, a Patently-O job board sponsor, will be holding a TechNet Patents Forum in New York on November 5-6. Patently-O readers will receive a $300 discount by using the promo code EAG476.

Federal Circuit En Banc:

  • On September 18, the Court of Appeals for the Federal Circuit will sit en banc to hear two non-patent cases.
  • Nebraska Public Power v. US:
    • The Nebraska case is one of several dozen Federal Claims actions against the US Government for breach of contract and takings for the Government’s failure to begin removing spent nuclear fuel.
    • Question: Does the mandamus order issued by the United States Court of Appeals for the District of Columbia Circuit in Northern States Power Co. v. United States Dep’t of Energy, 128 F.3d 754 (D.C. Cir. 1997) preclude the United States from pleading the “unavoidable delay” defense to the breach of contract claim pending in the United States Court of Federal Claims, and if so, does the order exceed the jurisdiction of the District of Columbia Circuit?
  • Henderson v. Dep’t of Veteran Affairs:
    • Equitable tolling of claims for veteran’s benefits
    • Question: Does the Supreme Court’s decision in Bowles v. Russell, 127 S. Ct. 2360 (2007), require or suggest that this court should overrule its decisions in Bailey v. West, 160 F.3d 1360 (Fed. Cir. 1998) (en banc), and Jaquay v. Principi, 304 F.3d 1276 (Fed. Cir. 2002) (en banc), holding that 38 U.S.C. § 7266 is subject to equitable tolling?.

Relevance of the “manner in which the invention was made:”

  • 35 U.S.C. 103(a) makes clear that “[p]atentability shall not be negatived by the manner in which the invention was made.” That final sentence of the paragraph was apparently intended to contrast the 1952 law from the Supreme Court’s loose statement in Cuno that a patentable invention must “reveal the flash of creative genius.” 314 U.S. 84 (1941).
  • Should this statement be interpreted to mean that the inventor’s actual process has no relevance to the questions of novelty and nonobviousness? Or, is there still room for a jury to consider the actual creativity and genius of the inventor and the process used. (This question was suggested by a comment on the blog).

Appealing BPAI Rejections to the Federal Circuit

In re Baggett (Fed. Cir. 2009) (nonprecedential)

The Board rejected Bagget's patent claims as obvious. On appeal, the Federal Circuit largely affirmed – holding that the the administrative body's factual findings were supported by the requisite "substantial evidence" and that the Board had properly “articulated [its] reasoning with some rational underpinning to support the legal conclusion of obviousness" as required by KSR. (Quoting KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)).

The only portion vacated involves an error interpreting the term "memoization." The Board had initially misinterpreted the term as memorization. After a petition for rehearing, the Board corrected its mistake – but only as to one of the four claims containing the term. On appeal, PTO Solicitor Chen explained that Baggett had only addressed the one claim in the petition for rehearing, but offered that a remand would still be appropriate.

Notes:

  • This case may serve to emphasize the difficulty in appealing an obviousness decision from the Board of Patent Appeals & Interferences. The "substantial evidence" standard is low, i.e., "more than a mere scintilla of evidence." Likewise, the legal conclusion of obviousness now looks merely for "some rational underpinning."
  • In a note, Hal Wegner identifies four Federal Circuit appeals up for review that may focus on obviousness: In re Applied Materials Israel Ltd., Fed. Cir. No. 2009-1083 (argument July 7, 2009); In re Mettke, Fed. Cir. No. 2009-1125; In re Roth, Fed. Cir. No. 2009-1223; and In re Rivera, Fed. Cir. No. 2009-1123.
  • Although it may have been amended during prosecution, the original claim 1 reads as follows: 1. A method of producing constructed fares that includes an arbitrary added to a published fare, said method executed in a computer system, the method comprising: determining interior cities that appear with gateway cities in arbitraries for the airline; searching for gateway cities corresponding to the determined interior cities appearing in the arbitraries; and applying an arbitrary corresponding to one of the interior cities to a published fare involving one of the gateway cities to produce the constructed fare.
  • Read the decision: 09-1029.pdf

Irreparable Harm of Generic Competition: Federal Circuit Affirms Finding that Generic Entry Does not Cause Irreparable Harm

Altana Pharma & Wyeth v. Teva (Fed. Cir. 2009)200905141300.jpg

Altana’s Patent No. 4,758,579 claims the proton pump inhibitor pantoprazole – the active ingredient the anti-ulcer drug Protonix®. Of course, PPI’s were known before Altana’s patent and even one of Altana’s own prior patents discusses a “compound 12″ that is structurally similar to those claimed in the ’579 patent.

Teva and Sun filed for permission to begin making generic versions of the drug, and Altana subsequently filed this infringement action. (Altana filed separate actions that were consolidated.)

This appeal stems from the New Jersey district court’s denial of Altana’s motion for a preliminary injunction. The lower court found that the patentee had failed to prove two critical prerequisites of equitable preliminary relief: (1) a likelihood of success on the merits and (2) irreparable harm.

The equitable test for preliminary injunctive relief requires that the requesting party prove:

  1. a reasonable likelihood of success on the merits;
  2. irreparable harm if an injunction is not granted;
  3. a balance of hardships tipping in its favor; and
  4. the injunction’s favorable impact on the public interest.

Although the ultimate grant or denial of preliminary relief is within the “sound discretion of the district court,” failure to abide by these four factors would be reversible error. Orders to grant or deny a preliminary injunction are immediately appealable.

Likelihood of Success: The Federal Circuit has held that preliminary relief should be denied if the accused infringer raises a “substantial question” of invalidity of the asserted claims. At the PI stage, the court need not consider the ultimate “clear and convincing” standard. Rather, the focus is on “vulnerability.”

Obviousness of Chemical Compound: When considering the obviousness of a chemical compound, courts ordinarily first look for a “lead compound” known in the prior art and then consider whether a chemist would have had some reason to modify the known compound in the particular manner to achieve the new compound. Courts are not rigidly bound by this ordinary approach – thus, for instance, a court may look to multiple lead compounds:

Moreover, to the extent Altana suggests that the prior art must point to only a single lead compound for further development efforts, that restrictive view of the lead compound test would present a rigid test similar to the teaching-suggestion-motivation test that the Supreme Court explicitly rejected in KSR.

Here, the appellate panel found “ample evidence” that a chemist would have chosen “compound 12″ as a natural choice for further PPI research. The particular modification of compound 12 was then suggested in articles by Sachs and Bryson who were researching properties of effective PPIs.

Considering this evidence as a whole, the Federal Circuit found it sufficient to raise a substantial question of obviousness.

Irreparable Harm: The district court could not find any irreparable harm of allowing infringement during the course of the litigation. Often, money damages are seen as insufficient when the defendant does not have cash-on-hand. Here, however, Teva and Sun both have plenty. The court also found that Altana almost certainly has a business plan to deal with the launch of generics. During the litigation, Nycomed purchased Altana — seemingly in the lower court’s view, that purchase also indicates that money damages are adequate (since a price can be placed on the company & its patent rights).

Perhaps most harmful to Altana was that the lower court found the patentee’s statements of harms “exaggerated” and lacking “credibility.” A court sitting in equity righty places a dim light on activities suggestive of unclean hands.

On appeal, the Federal Circuit affirmed without significantly commenting on the merits. Rather, the court made this case about equitable discretion: “the law cited by the district court highlights this court’s deference to a district court’s determination whether a movant has sufficiently shown irreparable harm.”

Denial of Preliminary Injunction Affirmed

Judge Newman wrote a short concurring opinion.

Although the evidence presented to the district court does not, in my view, establish invalidity of the patent on the pharmaceutical product pantoprazole, see, Gonzales v. O Centro Espirita Beneficente Uniao do Vegetal, 546 U.S. 418, 429 (2006) (“the burdens at the preliminary injunction stage track the burdens at trial.”) at this preliminary stage deference is warranted to the district court’s weighing of the conflicting expert opinions interpreting the evidence. On this basis, I concur in sustaining this discretionary action.

Actonel Patent Validity Affirmed: Nonobviousness of Positional Isomer

Procter & Gamble (P&G) v. Teva Pharmaceuticals (Fed. Cir. 2009)

P&G’s osteoporosis drug Actonel reportedly has $1.5 billion in annual sales. Hoping to manufacture a generic version, Teva challenged P&G’s patent – arguing obviousness in light of a prior P&G patent (the ’406 patent) and obviousness-type double patenting. The district court rejected those challenges, and on appeal the Federal Circuit affirmed the patent’s validity. The patent is set to expire in 2013.

New Compound is Nonobvious: The claimed active compound – risedronate – is a bisphosphonate. In arguing obviousness, Teva pointed to P&G’s ’406 patent which listed “central problems” in using bisphosphonates to treat osteoporosis. Although the prior art patent does not list risedronate, it does suggest the use of thirty-six similar molecules in the same class including one a positional isomer of the claimed risedronate. The positional isomer (2-pyr EHDP) includes the same atoms as risedronate, but those atoms are arranged in a somewhat different order.

In risedronate, the hydroxy-ethane-diphosphonate group is connected to the #3 carbon of a pyridine ring, while in 2-pyr EHDP, the hydroxy-ethane-diphosphonate group is connected to the #2 carbon. Because the nitrogen atom is in a different position in the two molecules, they differ in three dimensional shape, charge distribution and hydrogen bonding properties.

In addition to these structural differences, P&G pointed to “contemporaneous writings from Herbert Fleisch, the preeminent authority on bisphosphonates during the relevant time period.” Fleisch wrote that “every … bisphosphonate, exhibits its own physical-chemical, biological and therapeutic characteristics, so that each bisphosphonate has to be considered on its own. To infer from one compound the effects in another is dangerous and can be misleading.”

On appeal, the Federal Circuit agreed that these differences were sufficient to push development of the new compound beyond the obvious – additionally noting that Teva had not shown that a PHOSITA would have had a “‘reasonable expectation of success’ in synthesizing and testing risedronate.” Here, the court quoted its 1988 O’Farrell decision: “Patents are not barred just because it was obvious ‘to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.’”

This holding further supports the conventional wisdom that the KSR case will have much less impact in the area of pharmaceutical research.

Secondary Factors: In arguing secondary considerations of nonobviousness, TEVA argued that the element of long-felt but unmet need could not be proven because another drug (aledronate) was available prior to risedronate. The Federal Circuit rejected that argument – holding that the need may still have existed because the P&G patent application was filed before the other drug was on the market. “Under Monarch, we look to the filing date of the challenged invention to assess the presence of a long-felt and unmet need.”

Swearing Behind Not Allowed: P&G’s researcher had evidence that it had invented risedronate prior to the filing of the ’406 patent. In particular, the inventor submitted a lab notebook with detailing the structure of risedronate and the procedure for its synthesis. However, the Federal Circuit rejected the evidence because the entry “was unwitnessed and was not corroborated by any other evidence.”

Double Patenting: “Having concluded that risedronate was not obvious under 35 U.S.C. § 103, we similarly conclude that the [risedronate] patent is not invalid for obviousness-type double patenting … [because] the claims of the [risedronate] patent are distinct from the claims of the ’406 patent.”

Further Discussion: