Judge Mayer Raises 101 When Not In Issue: Other Panelists Don’t

I am sure Dennis will do his usual full and grand treatment, but this one is sort of the counter-punch to Ultramercial. In I/P Engine, Inc. v. AOL Inc. (Fed. Cir. Aug. 15, 2014) (per curiam), the court split on whether the claims were properly found by the jury to have been not obvious, with Judge Chen dissenting on that point and the per curiam opinion reversing the finding of no invalidity. (The other panel members were Judge Wallach and Judge Mayer).

Recall that in Ultramercial the court emphasized that 101 was seemingly a defense, and so evidence was needed and the usual presumption of validity applied, and so on.  Here, Judge Mayer seemed to take precisely the opposite tact, though it’s not quite clear.  In addition to writing at length about what he perceives the “technological arts” test to mean and require, he wrote:

The Supreme Court has dictated that the subject mat- ter eligibility analysis must precede the obviousness inquiry. Flook, 437 U.S. at 593 (“The obligation to determine what type of discovery is sought to be patented” so as to determine whether it falls within the ambit of sec- tion 101 “must precede the determination of whether that discovery is, in fact, new or obvious.”); Bilski, 130 S. Ct. at 3225 (explaining that the issue of whether claims are directed to statutory subject matter is “a threshold test”); see also In re Comiskey, 554 F.3d 967, 973 (Fed. Cir. 2009) (“Only if the requirements of § 101 are satisfied is the inventor allowed to pass through to the other requirements for patentability, such as novelty under § 102 and . . . non-obviousness under § 103.” (citations and internal quotation marks omitted)). To fail to address at the very outset whether claims meet the strictures of section 101 is to put the cart before the horse. Until it is determined that claimed subject matter is even eligible for patent protection, a court has no warrant to consider subordinate validity issues such as non-obviousness under 35 U.S.C. § 103 or adequate written description under 35 U.S.C. § 112.

From a practical perspective, there are clear advantages to addressing section 101’s requirements at the outset of litigation. Patent eligibility issues can often be resolved without lengthy claim construction, and an early determination that the subject matter of asserted claims is patent ineligible can spare both litigants and courts years of needless litigation. To the extent that certain classes of claims—such as claims on methods of doing business—are deemed presumptively patent ineligible, moreover, the United States Patent and Trademark Office will have more resources to devote to expeditiously processing applications which disclose truly important advances in science and technology.

Even more fundamentally, the power to issue patents is not unbounded. To the contrary, the constitutional grant of authority “[t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries,” U.S. Const. art. I, § 8, cl. 8, “is both a grant of power and a limitation,” Graham v. John Deere Co., 383 U.S. 1, 5 (1966); see Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 146 (1989). Section 101’s vital role—a role that sections 103 and 112 “are not equipped” to take on, Mayo, 132 S. Ct. at 1304— is to insure that patent protection promotes, rather than impedes, scientific progress and technological innovation. A robust application of section 101 ensures that the nation’s patent laws remain tethered to their constitutional moorings.

I am guessing we’ll see another en banc case soon…

Funk Brothers v Kalo – Eligibility or Unobviousness?

Guest post by Paul Cole, European Patent Attorney, Partner, Lucas & Co; Visiting Professor, Bournemouth University, UK.

New patent eligibility guidance issued by the USPTO (Andrew Hirshfeld, 4th March) will be the subject of a discussion forum this Friday 9th May.

Since the Kalo case, 333 U.S. 127 (1948) has been discussed in recent Supreme Court opinions including Chakrabarty, Myriad, and Mayo and is proposed to form the subject of an example forming part of that guidance, reflection on the true legal basis of the opinion is timely. Despite dicta in Chakrabarty and Myriad it is arguable that when viewed in its timeframe Funk concerned unobviousness not eligibility. If that view is correct, then the Kalo fact pattern should not be used as an eligibility example under current law.

The Kalo appeal was from a lengthy and careful opinion by Judge Walter C. Lindley in the Court of Appeals for the 7th circuit, 161 F.2d 981 (1947). At first instance the claimed subject matter which related to a composite culture of mutually non-inhibitive bacteria for inoculation of leguminous plants was held to be a product of nature and hence not patent-eligible. Judge Lindley reversed this finding in the following terms:

The mistake of the District Court, we think, lay in its conclusion that this did not amount to patentable invention within the meaning of the statute. Though the court recognized the value of Bond’s work, it thought that he had merely discovered a law of nature, whereas in fact the evidence is clear that what he discovered was that certain existing bacteria do not possess the mutually inhibitive characteristics which had previously prevented a successful commercial composite inoculant and that those uninhibitive species may be successfully combined. It was this contribution of noninhibitive strains which successfully combine that brought about a new patentable composition. This was application of scientific knowledge to things existing in nature and the utilization of them in a desirable composite product which had not been previously achieved but which he did achieve and of which the public now has the benefit.

We think this is clearly within the decisive definitions of patentable invention… Bond taught the method by which the composite is to be made and claims the product composed by that method, namely, a composite inoculant, comprised of different species of bacteria in sufficient numbers of each species. The noninhibitive property of bacteria was not previously known and when Bond discovered it and taught a successful composition of noninhibitive strains in combination of elements in one inoculant operating successfully on several different groups of legumes, he did much more than discover a law of nature. He made a new and different composition, one contributing utility and economy to the manufacture and distribution of commercial inoculants.”

A reader of Lindley is bound to wonder why such a conventional and straightforward opinion should have been selected for certiorari. An explanation of the significance of new effect in established patent law can be found as long ago as 1822 in Evans v Eaton 20 U.S. 356 (1822) and its evidential nature was explained by Justice Bradley in Webster Loom v Higgins
105 US 580 (1881), subsequently approved e.g. by Justice Brown in Carnegie Steel v Cambria Iron Co 185 US 402 (1902):

It may be laid down as a general rule, though perhaps not an invariable one, that if a new combination and arrangement of known elements produce a new and beneficial result, never attained before, it is evidence of invention.

The majority opinion of the Supreme Court Kalo decision was authored by Justice William O. Douglas.

His starting position was that a law of nature cannot be monopolised and he recognised the existence of the relevant non-inhibitory bacterial strains as an example of such a law. He went on to hold that invention must come from the application of the law of nature to a new and useful end and that the aggregation of select strains of the several species into one product was an application of the newly discovered natural principle. He acknowledged that there was advantage in the combination because the farmer need not buy six different packages for six different crops. He could buy one package and use it for any or all of his crops. The packages of mixed inoculants held advantages for dealers and manufacturers by reducing inventory problems, and the claimed subject-matter provided an important commercial advance.

Against this strong evidential background what was the basis for his reversal? A key to his reasoning may be found in his earlier opinion in Cuno Engineering Corp. v. Automatic Devices Corp., 314 U.S. 84 (1941) that (as the law then stood) novelty and utility were necessary but not sufficient requirements for patentability. In addition the claimed subject-matter had to reach the level of inventive genius that the Constitution authorized Congress to reward.

Several reasons supported the conclusion that the Kalo invention did not meet the standard of inventive genius. Each of the species of root nodule bacteria contained in the package infected the same group of leguminous plants that it always infected. No species acquired a different use. The combination of species produced no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species had the same effect it always had. The bacteria performed in their natural way. Their use in combination did not improve in any way their natural function. They served the ends nature originally provided, and acted quite independently of any effort of the patentee. The claimed inoculant was not the product of invention unless invention borrowed from the discovery of the natural principle itself. It was hardly more than an advance in the packaging of the inoculants. Packaging was a simple step once the discovery had been made and all that remained were the advantages of the mixed inoculants themselves which were not enough.

The Funk opinion, amongst others, was relied on in Chakrabarty for the proposition that laws of nature, physical phenomena, and abstract ideas are not patent-eligible. As to the patentability of the Chakrabarty microorganism it was distinguished on the facts.

In Myriad Justice Thomas treated Funk as a patent-eligibility case, observing that the Bond composition fell squarely within the law of nature exception because the patent holder did not alter the bacteria in any way. Arguably such a position is inconsistent with the finding of Justice Douglas that the claimed product was an application of the principle discovered by Bond and hence implicitly patent-eligible. Classification of Funk as an unobviousness opinion accords with the reasoning of Justice Douglas whereas classification as an eligibility opinion is difficult to reconcile with his reasoning, especially against the background of his explicit reference to Cuno.

The USPTO example takes the position that the bacteria in Funk were not changed in any way, but that position is factually untrue. The naturally occurring bacteria have been the subject of a selection process to identify those strains that do not interfere, and the non-interfering strains have been cultivated and mixed. The claimed composition does not occur in nature, is produced by human intervention and has new utility. It is far from clear that the decision that was reached in 1948 would have been reached under the law as it exists post-1952 since the “flash of genius” test was rejected by Congress in favour of § 103.

For the above reasons it is submitted that the wiser course would be to delete Example D from the USPTO guidance.

Court Expands Doctrine of Obviousness Type Double Patenting

By Dennis Crouch

Gilead Sciences v. Natco Pharma (Fed. Cir. 2014)

Gilead’s two virus inhibition patents at issue in this case are quite similar to one another, although there is no priority claim creating an official family relationship between the patents. Patent Nos. 5,763,483 and 5,952,375. In a not-uncommon fashion, the application resulting in the ‘375 patent was filed first, but, because of a variety of prosecution delays, was the last to issue. The ‘375 patent is also set to be the first-to-expire. Note, after the ‘483 patent issued, Gilead filed a one-way terminal disclaimer for the ‘375 patent – limiting that patent’s term so that it cannot extend beyond the term of the ‘483 patent. Of course, that limitation is meaningless since the ‘375 patent naturally expires first anyway. The following timeline may help illustrate the relevant dates:

Double Patenting: This setup raises the prospect of obvious-type double-patenting. That doctrine is not based upon any statute, but has been applied by courts as a mechanism to prevent patentees from prolonging their patent term by obtaining a second-patent with claims that are not patentably distinguishable from the claims in the first patent. The general rule is that a terminal disclaimer cures the obviousness-type double patenting. However, here, one of the patents (the ‘483) patent does not have a terminal disclaimer.

Later Issued but Earlier Expiring Patent: The district court ruled in favor of Gilead – holding that, as a matter of doctrine, a later-issued but earlier-expiring patent cannot serve as a double-patenting reference against an earlier issued but later-expiring patent. That rule cited here by Judge Wigenton (D.N.J.) follows two Delaware district court cases stating the same proposition. Abbott Labs. v. Lupin Ltd., 2011 WL 1897322 (D. Del. May 19, 2011) and Brigham & Women’s Hosp. Inc. v. Teva Pharm. USA, Inc., 761 F. Supp. 2d 210 (D. Del. 2011). Those cases are in conflict with a PTAB decision on the same topic: Ex Parte Pfizer, Inc., 2010 WL 532133 (Bd. Pat. App. & Interf. Feb. 12, 2010).

On appeal, the Federal Circuit focused on the particular legal question: “Can a patent that issues after but expires before another patent qualify as a double patenting reference for that other patent?” The answer: Yes it can. With the result here being that the district court’s decision is in error. The majority’s reasoning makes sense – the primary purpose of the double-patenting doctrine is to prevent a patentee from unduly extending its patent term and here, Gilead is attempting to do so by an additional 22-months.

The majority opinion was filed by Judge Chen and joined by Judge Prost. Chief Judge Rader filed a dissenting opinion arguing that the court should have acted more cautiously in extending the judge-made rule. Judge Rader writes:

Under the AIA’s new “first-inventor-to-file” framework, prospective patentees are under tremendous pressure to file their applications early. I am concerned that today’s opinion will have unforeseen consequences in this new race to the Patent Office.

I would suggest that – most likely – the doctrine of obviousness-type double patenting would have never been created if the current regime had been in place way back when. Most notably, calculating patent term as 20-years from filing eliminates most potential game playing and the publication rules would typically result in an earlier filed patent being seen as prior art – even if jointly owned.

Extension and Adjustment: Although this issue has been addressed somewhat in other cases, this decision does not offer any insight as to how double-patenting applies to cases where the difference in patent term is due to a patent term adjustment or extension.

= = = = =

The currently proposed legislative patent reforms would codify the double patenting exception in a somewhat narrower fashion. This would potentially limit any further judicially motivated alterations in its scope.

Design patent nonobviousness jurisprudence — going to the dogs?

Guest post by Sarah Burstein, Associate Professor of Law at the University of Oklahoma College of Law

MRC Innovations, Inc. v. Hunter Mfg., LLP (Fed. Cir. April 2, 2014) 13-1433.Opinion.3-31-2014.1

Panel:  Prost (author), Rader, Chen

MRC owns U.S. Patent Nos. D634,488 S (“the D’488 patent”) and D634,487 S (“the D’487 patent”). Both patents claim designs for sports jerseys for dogs—specifically, the D’488 patent claims a design for a football jersey (below left) and the D’487 patent claims a design for a baseball jersey (below right):

Design Patents

Mark Cohen is the principal shareholder of MRC and the named inventor on both patents. Hunter is a retailer of licensed sports products, including pet jerseys. In the past, Hunter purchased pet jerseys from companies affiliated with Cohen. The relationship broke down in 2010. Hunter subsequently contracted with another supplier (also a defendant-appellee in this case) to make jerseys similar to those designed by Cohen.

MRC sued Hunter and its new supplier for patent infringement. The district court granted summary judgment to the defendants, concluding that the patents-in-suit were invalid as obvious in light of the following pieces of prior art:

Prior Art ChartThe Federal Circuit uses a two-step test to determine whether a design is obvious. First, the court must identify a proper primary reference—i.e., a “something in existence” that has “basically the same” appearance as the claimed design. Second, other references can be used to modify the primary reference “to create a design that has the same overall visual appearance of the claimed design.” Any such secondary references must be “so related [to the primary reference] that the appearance of certain ornamental features in one would suggest the application of those features to the other.”

Step One – Primary References

On appeal, MRC argued that the district court erred in identifying the Eagles jersey as a primary reference for the D’488 patent. The Federal Circuit disagreed, stating that either the Eagles Jersey or the V2 jersey could serve as a proper primary reference for the D’488 patent.

MRC also argued that the Sporty K9 jersey could not serve as a proper primary reference for the D’487 patent. Again, the Federal Circuit disagreed, stating that the Sporty K9 jersey had “basically the same” appearance as the patented design.

Step Two – Secondary References

In its analysis, the district court used the V2 jersey and Sporty K9 jersey as secondary references for the D’488 patent and the Eagles jersey and V2 jersey as secondary references for the D’487 patent. On appeal, “MRC argue[d] that the district court erred by failing to explain why a skilled artisan would have chosen to incorporate” features found in the secondary references with those found in the primary references. The Federal Circuit did not agree, stating that:

It is true that “[i]n order for secondary references to be considered, . . . there must be some suggestion in the prior art to modify the basic design with features from the secondary references.” In re Borden, 90 F.3d at 1574. However, we have explained this requirement to mean that “the teachings of prior art designs may be combined only when the designs are ‘so related that the appearance of certain ornamental features in one would suggest the application of those features to the other.’” Id. at 1575 (quoting In re Glavas, 230 F.2d 447, 450 (CCPA 1956)). In other words, it is the mere similarity in appearance that itself provides the suggestion that one should apply certain features to another design.

The Federal Circuit noted that in Borden, it found that designs for dual-chambered containers could be proper secondary references where the claimed design was also directed to a dual-chambered container. And in this case, “the secondary references that the district court relied on were not furniture, or drapes, or dresses, or even human football jerseys; they were football jerseys designed to be worn by dogs.” Accordingly, the Federal Circuit concluded that they were proper secondary references.

Secondary Considerations

MRC also argued that the district court failed to properly consider its evidence of commercial success, copying and acceptance by others. The Federal Circuit disagreed, concluding that MRC had failed to meet its burden of proving a nexus between those secondary considerations and the claimed designs.


The Federal Circuit hasn’t actually reached the second step of this test in a while. That’s because it has been requiring a very high degree of similarity for primary references (see High Point & Apple I). For a while there, it looked like it was becoming practically impossible to invalidate any design patents under § 103. Now we at least know that it’s still possible.

But we don’t have much guidance as to when it’s possible. In particular, it’s difficult to reconcile the Federal Circuit’s decision on the primary reference issue with its decision in High Point. The Woolrich slipper designs that were used as primary references by the district court in High Point were, at least arguably, as similar to the patented slipper design as the Eagles and Sporty K9 jerseys are to MRC’s designs. But in High Point, the Federal Circuit suggested that there were genuine issues of fact as to whether the slippers were proper primary references.

And unfortunately, the Federal Circuit seems to have revived the ill-advised Borden standard. As I’ve argued before, the second step of the § 103 test has never made much sense. Even the judges of the C.C.P.A., the court that created the test, had trouble agreeing about how it should be applied. But the Borden gloss—that there is an “implicit suggestion to combine” where the two design features that were missing from the primary reference could be found in similar products—is particularly nonsensical. At best, this Borden-type evidence suggests that it would be possible to incorporate a given feature into a new design, from a mechanical perspective—not that it would be obvious to do so, from an aesthetic perspective.

All in all, this case provides an excellent illustration of the problems with the Federal Circuit’s current test for design patent nonobviousness. Perhaps now that litigants can see that § 103 challenges are not futile, the Federal Circuit will have opportunities to reconsider its approach.

Supreme Court: The Right to a Jury Trial on Obviousness

By Dennis Crouch

Soverain v. Newegg (on petition for writ of certiorari)

After a trial on the merits, Judge Davis (E.D.Tex.) found that the accused infringer (Newegg) had presented insufficient evidence of obviousness and refused to let that issue go to the jury. Instead, the judge awarded a directed verdict for the patentee (Soverain) that the asserted claims were not invalid as obvious. The jury went on to find Newegg liable for infringement and awarded $2.5 million in damages and also found the patent not anticipated. Following trial, the district court denied Newegg's motion for new trial on obviousness grounds. On appeal, the Federal Circuit took the almost unprecedented stance of reversing the non-obviousness decision. One reason for the rarity of a full-reversal (rather than vacatur) is largely explained by the substantial factual foundation that serves as the basis of an obviousness decision. In its opinion, the Federal Circuit couched its discussion in terms of questions of law – following the Supreme Court's lead from KSR International Co., v. Teleflex, Inc., 550 U.S. 398 (2007). In that case, the Supreme Court was able to make the legal conclusion that the asserted claims were obvious because the factual underpinnings of obviousness were seemingly not in material dispute.

In its petition for writ of certiorari, Soverain focuses on the Seventh Amendment right to a jury trial and argues that the Federal Circuit's approach effectively and improperly redefines obviousness as a pure question of law.

Question Presented:

Whether the Federal Circuit's effective redefinition of obviousness as a pure question of law, allowing it to resolve disputed factual questions in the first instance on appeal, violates the Seventh Amendment and this Court's precedent.

Here, Sovarain points to a number of factual issues that the Federal Circuit identified as questions of law, including assessing credibility of the witnesses, resolving conflict between witness testimony resolving the teaching of prior art references.

The Seventh Amendment provides that:

In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved…

The Seventh Amendment "preserve[s]" the "common law" right to jury trial and, as a consequence, presents an oddball test that roughly asks whether the cause of action at issue was (or is analogous to) a common law cause of action that was tried before an English jury back in in 1791 and then whether the particular trial decision in question is one that was (or would have been) decided by a jury. See Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996).

The Supreme Court has indicated that patent infringement lawsuits where the patentee is seeking damages are cases at law protected by the Seventh Amendment right to a jury trial. However, as far as I know, the Supreme Court has never held that the right to a jury particularly to an obviousness challenge or to the underlying factual conclusions that serve as the basis for an obviousness decision. 1800's cases do suggest that the factual underpinnings to the "invention" requirement are subject to a jury determination. See, for example, Battin v. Taggert, 58 U.S. (17 How.) 74 (1854); and Turrill v. Michigan S. & N. Ind. R.R. Co., 68 U.S. (1 Wall.) 491 (1864) ("[T]here was an important question of fact which should have been left to the jury, whether … any of the prior movable pressblocks … were substantially the same as the machine of the patentee."). However, the 1952 Patent Act expressly eliminated the doctrine of invention in favor of the new doctrine of obviousness. In its last foray into this area, the Supreme Court recognized in Markman that claim construction included both questions of fact and questions of law, but ultimately determined that no fundamental right to a jury trial existed for that doctrine.

An interesting inside issue here is that Judge Newman has been a strong proponent of the right to a jury trial on obviousness. See Newell Cos. v. Kenney Manufacturing Co., 864 F.2d 757 (Fed.Cir. 1988) (J. Newman dissenting from holding that ultimate question of obviousness may be decided by judge over party's objection). However, it was Newman who found Soverain's patent obvious in the present case. In the 1988 Newell case, the majority held that the patentee has no right to a jury trial on obviousness unless the factual underpinnings are in dispute.

The defendant was, of course, entitled to have a jury summoned in this case, but that right was subject to the condition, fundamental in the conduct of civil actions, that the court may withdraw a case from the jury and direct a verdict, according to the law if the evidence is uncontradicted and raises only a question of law.

Of course, Judge Nies did not walk through the weeds of history (as required by the Supreme Court) to arrive at this answer but instead only looked to the "fundamental notion" that there is no right to a jury decision regarding a question of law. See also, In re Lockwood, 50 F.3d 966 (Fed. Cir. 1995) (Nies, C.J. writing in dissent) (arguing that a patent is a public right created by Congress and "[a] constitutional jury right to determine validity of a patent does not attach to this public grant") (mandamus vacated without opinion by the Supreme Court).

Focusing back, the Soverain petition does not ask the Supreme Court to overrule Newell, but rather to merely limit courts ability to unilaterally expand take would-be factual question and then make those factual conclusions under the guise of legal determinations. Soverain writes:

The Federal Circuit's decision to take for itself questions this Court has reserved for the trier of fact has significant consequences that threaten the stability and predictability of the patent system. This decision shifts the boundary between the ultimate legal question of obviousness and the underlying factual questions. It thus paves the way for district courts and other panels to decide factual questions and undermines the role that the jury and procedural safeguards play in ensuring that hindsight bias does not skew the analysis of obviousness. By downplaying the factual component of obviousness, the Federal Circuit's decision also erodes the clear and convincing evidence standard for proving invalidity, which this Court reaffirmed in Microsoft Corp. v. i4i Limited Partnership, 131 S. Ct. 2238 (2011).

I also see this case as asking for clarification of the KSR decision in terms of what elements of the "common sense" analysis should be considered determinations rightfully before a jury. I suspect that the brief strategically avoided that issue because the Federal Circuit is a much riper target for review than a recent unanimous and popular Supreme Court opinions.

In an amicus brief supporting the petition, Professor Eileen Herlihy argues that the Federal Circuit systematically gets Seventh Amendment questions wrong and needs to be set straight by the Supreme Court. Herlihy has written two articles on how the Seventh Amendment should be applied to patent cases.


Prior Art for Obviousness

In re Winslow, 365 F.2d 1017 (C.C.P.A. 1966)

In the 1966 decision Judge Rich described the scope of prior art for §103 using the tableau framework:

We think the proper way to apply the 103 obviousness test to a case like this is to first picture the inventor as working in his shop with the prior art references — which he is presumed to know — hanging on the walls around him.

I wonder if today, the proper legal analysis would begin with a Google’s search engine that has indexed the prior art references?

Also, did the AIA eliminate the “pertinent art” requirement?

Judge Rader’s Obviousness Tutorial: Including the Conclusion that Older Prior Art is Less Credible and a Restatement that Objective Indicia of Nonobviousness Play a Critical Role

By Dennis Crouch

Leo Pharmaceutical Products, Ltd. v. Rea, 2013 WL 4054937 (Fed. Cir. 2013)

In a pre-AIA filing, Galderma challenged Leo’s U.S. Patent No. 6,753,013 in an inter partes reexamination before the USPTO’s now renamed Board of Patent Appeals. The patent claims a “storage stable and non-aqueous” pharmaceutical composition used to treat skin conditions such as psoriasis. Prior to the invention, it was well known that a combination of Vitamin-D along with a corticosteroid could form the basis of an effective treatment. However, no one had been able to manufacture a storage stable form of the combination. This was especially challenging because the stable forms of the active ingredients prefer different pH levels. To achieve the storage stable results, Leo added a solvent to the mixture. The claim identifies the solvent in a markush group that likely includes thousands of potential compounds. During the reexamination, Leo also added the particular limitation that “said pharmaceutical composition is storage stable and non-aqueous.”

In reviewing the case, the Board first construed these new terms “storage stable” and “non-aqueous” and then found the patent invalid as obvious over the prior art. On appeal, the Federal Circuit has reversed.

Claim Construction: The Federal Circuit continues, for the time being, to give no deference to PTO claim construction decisions. Here, the term “storage stable” was difficult to construe because it was never used during prosecution of the original patent application and only added during reexamination. However, the patent does discuss the composition’s “ability to resist degradation” according to test results presented in the specification and the PTO accepted that definition as proper. Noting that one of ordinary skill “would have reasonably looked to the described stability test as defining what was meant by ‘storage stable.'” On appeal, the Federal Circuit rejected that definition as impermissibly narrow and that instead allowed a broader definition. Although not elucidated by the opinion, the patentee is walking a fine line with this amendment between (1) having a sufficiently broad patent and (2) improperly adding new matter to the claims in violation of the written description requirement.

Obviousness: This decision may become a somewhat important obviousness case for patentees. The Board found the patent claims obvious in light of a combination of three prior art references. The Board basically found that it would have been obvious for someone of skill in the art to take the prior art combination of Vitamin-D and corticosteroids and add in the claimed solvent in order to achieve storage stability.

On appeal, the Federal Circuit faulted the Board for failing to give credence to the patentee’s identification of the problem (that a stable form should be designed). The prior art did not particularly recognize the problem but rather “either discouraged combining vitamin D analogs and corticosteroids … or attempted the combination without recognizing or solving the storage stability problems.” Leo also presented evidence that, at the time of the invention, researchers were being “warned that vitamin D should not be combined with other drugs requiring a low pH ( e.g., corticosteroids).”

[T]he record shows no reason for one of ordinary skill in the art to attempt to improve upon either Dikstein or Serup using Turi. The ordinary artisan would first have needed to recognize the problem, i.e., that the formulations disclosed in Dikstein and Serup were not storage stable. To discover this problem, the ordinary artisan would have needed to spend several months running storage stability tests Only after recognizing the existence of the problem would an artisan then turn to the prior art and attempt to develop a new formulation for storage stability. If these discoveries and advances were routine and relatively easy, the record would undoubtedly have shown that some ordinary artisan would have achieved this invention within months of Dikstein or Serup. Instead this invention does not appear for more than a decade.

Now, the Federal Circuit’s language here obviously includes some amount of doublespeak or could perhaps be described as slicing the bologna awfully thin since according to the court, researchers (1) recognized that vitamin D could not be stably combined with low pH drugs such as corticosteroids but (2) did not recognize that vitamin-D could not be stably combined with corticosteroids.

Old Prior Art: In the discussion, Judge Rader uses an interesting between-the-lines or perhaps behind-the-scenes analysis of the prior art:

First, the Board found motivation to combine Dikstein or Serup with Turi because one of ordinary skill would have used vitamin D to solve the well-known side effects of steroid treatment. However, combining Turi and vitamin D to address the side effects of a steroid treatment is only straightforward in hindsight. Turi was publicly available in the prior art for twenty-two years before the ′013 patent was filed, yet there is no evidence that anyone sought to improve Turi with vitamin D. According to the record, even when Serup published the well-known side effects of steroid-induced atrophy in 1994, no one—including Serup—sought to improve Turi by adding vitamin D to Turi’s corticosteroid composition. Serup even targeted the precise side effects that the Board believed would have motivated the addition of a vitamin D analog to Turi’s corticosteroid composition, yet Serup did not seek to improve Turi by adding vitamin D. . . .

The elapsed time between the prior art and the ′013 patent’s filing date evinces that the ′013 patent’s claimed invention was not obvious to try. Indeed this considerable time lapse suggests instead that the Board only traverses the obstacles to this inventive enterprise with a resort to hindsight. It took over a decade—after Dikstein’s disclosure of the benefits of combining vitamin D and corticosteroid treatments into one formulation—for Dikstein’s formulations to be tested for storage stability. And, until the advancement made by the inventors of the ′013 patent, no one had proposed a new formulation that would be storage stable. The problem was not known, the possible approaches to solving the problem were not known or finite, and the solution was not predictable. Therefore, the claimed invention would not have been obvious to try to one of ordinary skill in the art. Indeed ordinary artisans would not have thought to try at all because they would not have recognized the problem.

Under Judge Rader’s point of view here, older prior art should be seen as less credible in the obviousness analysis. The logic obvious improvements would have happened quickly and the long time span between improvements suggest that the improvement was not an obvious one. This logic is bolstered in cases such as this where research is ongoing in the area and a market has already developed.

Although the patentee claimed a wide variety of solvents, the Federal Circuit also found that there were many more potential solvents available to try and the PTO did not offer specific reasons why the ones selected would have been particularly obvious to try.

In addition, the Board found that a person of ordinary skill in the art would have been capable of selecting the correct formulation from available alternatives. Specifically, the Board found more than eight different classes of additives ( e.g., diluents, buffers, thickeners, lubricants). The Board also found more than ten different categories of composition forms ( e.g., liniments, lotions, applicants, oil-in-water or water-in-oil emulsions such as creams, ointments, pastes, or gels). “Based on these broad and general disclosures,” the Board reasoned that an artisan would have been able to “mak[e] choices about what ingredients to include, and which to exclude” in formulating a composition with a vitamin D analog and steroid. To the contrary, the breadth of these choices and the numerous combinations indicate that these disclosures would not have rendered the claimed invention obvious to try. See Rolls–Royce PLC v. United Techs. Corp., 603 F.3d 1325, 1339 (Fed.Cir.2010) (claimed invention was not obvious to try because the prior art disclosed a “broad selection of choices for further investigation”). . . . .

This court and obviousness law in general recognizes an important distinction between combining known options into “a finite number of identified, predictable solutions,” KSR, and ” ‘merely throwing metaphorical darts at a board’ in hopes of arriving at a successful result,” Cyclobenzaprine, quoting Kubin. While the record shows that, as early as 1995, the prior art indicated that both vitamin D analogs and corticosteroids were effective treatments for psoriasis, that same prior art gave no direction as to which of the many possible combination choices were likely to be successful. Instead, the prior art consistently taught away from combining vitamin D analogs and corticosteroids.

One important feature of PTO decision making is that Board conclusions of fact only require substantial evidence to be affirmed on appeal. Here, the Federal Circuit avoided that issue by indicating that all of its decisions were based upon the Board failure to properly apply the law to those facts. “In this case, however, with no material factual disputes, this court cannot share the Board’s analysis and application of the law to those facts.”

Objective Indicia of Non-Obviousness: Judge Rader writes:

The court now turns to the Board’s analysis of the objective indicia of nonobviousness. The Board reasoned that “the strong case of obviousness outweighs the experimental evidence and testimony about the advantages of the claimed composition.” Contrary to the Board’s conclusion, this court finds the objective indicia, in concert with the entire obviousness analysis, present a compelling case of nonobviousness. In fact, the objective indicia of nonobviousness highlight that the Board’s analysis regarding the combination of Serup or Dikstein with Turi was colored by hindsight.

Whether before the Board or a court, this court has emphasized that consideration of the objective indicia is part of the whole obviousness analysis, not just an afterthought. … When an applicant appeals an examiner’s objection to the patentability of an application’s claims for obviousness, the PTO necessarily has the burden to establish a prima facie case of obviousness which the applicant then rebuts. However, during inter partes reexamination, the Board is reviewing evidence of obviousness—including objective indicia—submitted by two adversarial parties for the claims of an issued patent. Thus, the Board should give the objective indicia its proper weight and place in the obviousness analysis, and not treat objective indicia of nonobviousness as an afterthought.

Objective indicia of nonobviousness play a critical role in the obviousness analysis. They are “not just a cumulative or confirmatory part of the obviousness calculus but constitute[ ] independent evidence of nonobviousness.” Ortho–McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1365 (Fed.Cir.2008). This case illustrates a good reason for considering objective indicia as a critical piece of the obviousness analysis: Objective indicia “can be the most probative evidence of nonobviousness in the record, and enables the court to avert the trap of hindsight.” Crocs, Inc. v. Int’l Trade Comm’n, 598 F.3d 1294, 1310 (Fed.Cir.2010) (internal quotation marks omitted). Here, the objective indicia of nonobviousness are crucial in avoiding the trap of hindsight when reviewing, what otherwise seems like, a combination of known elements.

Unexpected results are useful to show the “improved properties provided by the claimed compositions are much greater than would have been predicted.” See In re Soni, 54 F.3d 746, 751 (Fed.Cir.1995) (internal quotation marks omitted). This record shows “extensive experimental evidence” of unexpected results that contradict the Board’s obviousness finding. J.A. 14. The Board concluded that the “unexpected results” claimed by Leo Pharmaceuticals were not surprising or unexpected. J.A. 19. However, substantial evidence does not support the Board’s conclusion.

During reexamination, the inventors of the ′013 patent submitted test results that analyzed the Dikstein and Serup formulations. The inventors found that the formulations disclosed by Dikstein and Serup result in significant degradation of the vitamin D analog and corticosteroid. See J.A. 1041–46 (testing formulations in Serup); J.A. 1625–27, 2152–2154 (testing formulations in Dikstein). The inventors also tested an improvement of Serup using Turi, by replacing Serup’s solvent with POP–15–SE, and still found significant degradation of the corticosteroid component. See J.A. 1045–46. These test results are a strong indication that the ′013 patent’s combination of known elements yields more than just predictable results.

In addition to evidence of unexpected results, Leo Pharmaceuticals provided other objective indicia of non-obviousness. For example, the commercial success of Leo Pharmaceutical’s Taclonex® ointment is a testament to the improved properties of the ′013 patent’s claimed invention. Taclonex® is the first FDA-approved drug to combine vitamin D and corticosteroids into a single formulation for topical application. While FDA approval is not determinative of nonobviousness, it can be relevant in evaluating the objective indicia of nonobviousness. See Knoll Pharm. Co., Inc. v. Teva. Pharm. USA, Inc., 367 F.3d 1381, 1385 (Fed.Cir.2004). Here, FDA approval highlights that Leo Pharmaceutical’s formulation is truly storage stable, something that the prior art formulations did not achieve.

The record also shows evidence of long felt but unsolved need, i.e., the need for a single formulation to treat psoriasis. The length of the intervening time between the publication dates of the prior art and the claimed invention can also qualify as an objective indicator of nonobviousness. See Ecolochem, Inc. v. S. Cal. Edison Co., 227 F.3d 1361, 1376–77 (Fed.Cir.2000). Here, the researchers were aware of the benefits of using both vitamin D and corticosteroids in the treatment of psoriasis as early as 1986. See, e.g., Dikstein col. 1, ll. 9–16. And Turi, upon which the Board relied to make its case, issued in 1978. Yet, it was not until the ′013 patent’s filing in 2000— twenty-two years after Turi and fourteen years after Dikstein-that the solution to the long felt but unsolved need for a combined treatment of vitamin D and corticosteroid was created. The intervening time between the prior art’s teaching of the components and the eventual preparation of a successful composition speaks volumes to the nonobviousness of the ′013 patent.

Here, the objective indicia—taken in sum—are the most “probative evidence of nonobviousness … enabl[ing] the court to avert the trap of hindsight.” Crocs, Inc., 598 F.3d at 1310. Viewed through the lens of the objective indicia, as opposed to the hindsight lens used by the Board, the ′013 patent would not have been not obvious over Turi in combination with Dikstein or Serup. Therefore, this court reverses the Board’s obviousness determination.

Impact of Restriction/Election on Claim Scope and Integrating Objective Indicia Into the Obviousness Analysis

By Dennis Crouch

Plantronics is an important case for patent prosecutors both for its discussion of proper restriction/election technique and for its language requiring the consideration of objective indicia of nonobviousness prior to reaching a conclusion of obviousness.

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Plantronics, Inc. v. Aiph, Inc. (Fed. Cir. 2013)

On summary judgment, district court Judge Bernard Zimmerman found Plantronics’ concha-style headset patent (5,712,453) to be both invalid (obvious) and not infringed. On appeal, the Federal Circuit has rejected that decision on several grounds.

Impact of Election on Claim Scope: Early in prosecution, the PTO issued a restriction requirement – noting that the original application improperly included multiple inventions. Plantronics elected to limit the claim scope to claim species of “Figures 1a and 1b.” Those figures both show the headset stabilizer support as an elongated member while other non-elected figure-species were structurally different (arguably without the elongated member). The district court relied upon that the restriction/election to construe “stabilizer support” as an elongated member that is longer than it is wide. On appeal, the Federal Circuit rejected that claim scope narrowing because the reason for the restriction requirement was not necessarily the elongated structural difference. Judge Wallach writes:

The PTO’s restriction requirement did not suggest that the different inventions it found were based on differences in structure (i.e., “elongated” versus an “arch”). Indeed, the PTO found four patentably distinct inventions in the figures of the ‘453 patent without providing any reasons why in its view the application presented differing inventions. Likewise, other figures of the ‘453 patent depicting other unelected species of the invention also reveal a “stabilizer support” that appears “elongated,” which refutes Aliph’s contention that the restriction requirement was based on that structural difference. The election of an invention in response to an ambiguous restriction requirement in turn cannot be said to provide any guidance forming a basis for narrowing a broadly drafted claim. … Neither the PTO nor Plantronics made any particular remarks regarding the differences (e.g., in structure) of what the PTO found to be different inventions, and while Plantronics elected without traverse the invention of Figures 1A and 1B, Plantronics did disagree with the PTO’s comments on claim 11 when it responded that claim 11 is a generic claim that read on all the embodiments illustrated in the application. This exchange with the PTO thus does not amount to anything clear or unambiguous to disclaim claim scope otherwise encompassed by the broadly drafted claims.

The court thus indicates that restriction/response do have the potential of limiting claim scope, but not in this case.

Further, the court went on to note the standard rule that structure found in the patent drawings should not be seen as limiting to the claim scope – unless the structure is written into the claims. Further, because the drawings do not provide particular dimensions, they “may not be relied upon to show particular sizes” or proportions. See MPEP 2125.

Because the district court had unduly limited the claim scope, the Federal Circuit vacated the non-infringement finding and remanded for additional review.

Obviousness: The district court also found the claims invalid as obvious. On appeal, the Federal Circuit vacated – finding that the record was not sufficiently clear for such a ruling as a matter of law. Rather, on remand, the issue of obviousness will go to trial.

In its analysis, the district court missed two key points: (1) identifying the motivation for combining prior art references and (2) fully considering objective indicia that may negate obviousness.

Motivation to Combine: It is often the case that combination inventions are deemed nonobvious (and thus patentable) even when all of the claim elements are individually found in the prior art. In KSR v. Teleflex, the Supreme Court noted that there must also be some reasoning as to why someone of skill in the art would seek to combine the reference in the manner claimed. That motivation to combine may be found explicitly or implicitly in market forces; design incentives; as well as by considering the background knowledge, creativity, and common sense of the person of ordinary skill in the art.

Although KSR added flexibility to the process, the motivation to must still be based upon evidence. Here, the district court indicated that “common sense” serves as the motivation. On appeal, the Federal Circuit found that explanation insufficient without more extensive reasoning with evidentiary support. As the court wrote in Mintz, “the mere recitation of the words ‘common sense’ without any support adds nothing to the obviousness equation.”

Objective Indicia of Nonobviousness: The appellate court linked the above discussion of “common sense” with an analysis of objective indicia of nonobviousness – noting that these considerations (such as commercial success, copying, or prior failures) could weigh against a KSR-style finding of common-sense motivation to combine.

Here, the district court did consider the patentee’s evidence regarding copying and commercial success however, the appellate panel found that the district court’s decision provided insufficient written analysis of the patentee’s evidence. In addition the appellate panel found that the lower court had mis-ordered its analysis by first finding a prima facie case of obviousness and then considering whether the objective factors negate that original conclusion. Rather, according to the panel here, the objective indicia of nonobviousness must be considered prior to reaching an obviousness conclusion.

Here, the district court concluded that the ‘453 patent was invalid as obvious before considering objective indicia of nonobviousness. . . . The district court addressed Plantronics’ objective evidence of nonbviousness—including copying and commercial success—only after reaching this conclusion. It stated: “Even accepting as true Plantronics’ assertions on these secondary considerations, they do not save Plantronics from summary judgment here since such secondary considerations simply cannot overcome a strong prima facie case of obviousness.” To the extent the district court conducted a post hoc analysis of objective considerations, it was improper.

This court has consistently pronounced that all evidence pertaining to the objective indicia of nonobviousness must be considered before reaching an obviousness conclusion. See, e.g., In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1076 (Fed. Cir. 2012). The significance of this fourth Graham factor cannot be overlooked or be relegated to “secondary status.”

When done properly, this ordering could be irrelevant. However, the court argues that including the secondary factors as an integrated element of the analysis helps “guard against the dangers of hindsight bias.” The court writes:

Failure to give proper consideration to such evidence, as in this case, can be fatal because “common sense” may not be so apparent in view of objective evidence of nonobviousness (e.g., commercial success and copying), particularly when all reasonable inferences are drawn in favor of the patentee.

In the end, the court sided with the patentee – finding that the evidence presented raise a genuine issue of material fact – sufficient to overcome the summary judgment motion and proceed to trial.

The commercial success of Aliph’s alleged copied product and the failure of attempts to combine the prior art elements before the ‘453 patent provide a genuine issue of material fact as to whether it would be “common sense” to combine the elements in the prior art to arrive at the claimed invention. Because evidence pertaining to objective considerations raises genuine issues of material fact, the district court’s decision is reversed as to all the asserted claims in this case.


Allergan v. Sandoz: The Thin Line of Nonobviousness

By Jason Rantanen

Allergan, Inc. v. Sandoz Inc. (Fed. Cir. 2013) Download Allergan v Sandoz
Panel: Dyk (dissenting-in-part), Prost (author), O'Malley

Allergan illustrates how thin the line between obvious and nonobvious can sometimes be.  Allergan owns several patents relating to its COMBIGAN combination ophthalmic drug treatment: Patent Nos. 7,323,463, 7,642,258, 7,320,976, and 7,030,149.  Representative claim 1 of the '463 patent states:

1. A composition comprising about 0.2% timolol by weight and about 0.5% brimonidine by weight as the sole active agents, in a single composition.

Sandoz sought to market a generic version of COMBIGAN, triggering Allergan to file suit under 35 U.S.C. § 271(e)(2)(A) alleging infringement of its four patents.  Sandoz stipulated to infringement of most of the asserted claims following claim construction and the district court subsequently found that all of the remaining asserted claims were not invalid after a bench trial.  Sandoz's appeal focused primarily on the district court's nonobviousness ruling. For purposes of the appeal, the asserted claims of the '463, 258, and '976 patents were treated as a single group (I'll refer to these collectively as the '463 claims, since that's how the court refers to them) with claim 4 of the '149 patent treated separately.

The '463 claims – obvious: On appeal, the court unanimously reversed the district court's determination that the claims of the '463 patent were nonobvious.  Both timolol (a beta blocker) and brimodine (an alpha2-agonist) were commercially available in their claimed concentrations at the time of the invention and were used to treat opthalmic conditions.  The primary prior art reference, DeSantis, expressly taught serially administering both a beta blocker, such as timolol, with a brimodine in a fixed combination.  It also provided "an express motivation to combine alpha2-agonists and beta blockers in order to increase patient compliance."  Slip Op. at 8.

So where did the district court go wrong?  First, the Federal Circuit held that it committed clear error by finding that "“while patient compliance may have created a need for fixed combination products, it did not motivate a person of skill in the art to develop fixed combinations with a reasonable expectation of success, because the FDA did not consider improving patient compliance as a factor in its approval decision.” Id. at 9, quoting district court.  While FDA approval may be relevant to the motivation inquiry:

There is no requirement in patent law that the person of ordinary skill be motivated to develop the claimed invention based on a rationale that forms the basis for FDA approval. Motivation to combine may be found in many different places and forms; it cannot be limited to those reasons the FDA sees fit to consider in approving drug applications.

The CAFC also concluded that the district court erred by over-relying on the recognized unpredictability in the formulation carts.  While unpredictablity is also relevant to the obviousness inquiry, it can be overcome simply by establishing that there was a reasonable probability of success.  Furthermore, Allergan's challenges in developing its commercial COMBIGAN product were not particularly probative of the obviousness inquiry because the relevant inquiry is whether a person of ordinary skill in the art would have a reasonable expectation of success in developing the claimed invention, not COMBIGAN (which contains many elements in addition to those embodied in the claims). 

In addition, the Federal Circuit concluded that the district court's factual findings on teaching away were insufficient to overcome the motivation provided by DeSantis and that the secondary considerations of nonobviousness did not weigh heavily in this analysis. 

Claim 4 of the '149 patent – nonobvious: While the full panel agreed on the obviousness of the '463 claims, it split over claim 4 of the '149 patent. Claim 4 states:

4. A method of reducing the number of daily topical ophthalmic doses of brimondine administered topically to an eye of a person in need thereof for the treatment of glaucoma or ocular hypertension from 3 to 2 times a day without loss of efficacy, wherein the concentration of brimonidine is 0.2% by weight, said method comprising administering said 0.2% brimonidine by weight and 0.5% timolol by weight in a single composition.

The underlined language is essentially the same as claim 1 of the '463 patent.  Central to the majority's conclusions was thus its treatment of the italicised language as a claim limitation: even though the creation of a single composition of 0.2% brimonidine by weight and 0.5% timolol by weight was obvious, administering it twice a day instead of three times a day without loss of efficacy was not.

The majority reached this because it was understood at the time of the invention that when brimonidine is dosed twice per day as opposed three times per day there is a loss of efficacy in the afternoon (the "afternoon trough") and Sandoz did not identify any "evidence in the prior art that would allow us to conclude that the addition of timolol to brimonidine dosed twice per day would eliminate the afternoon trough issue."   Slip Op. at 13.  Furthermore, even though it was "true that the prior art shows concomitant administration of brimonidine and timolol was dosed twice per day," that was insufficient to establish the obviousness of claim 4 because "this art does not show that there was no loss of efficacy associated with that treatment, let alone an elimination of the afternoon trough."  Id. at 14.

Judge Dyk's dissent:   Writing in dissent, Judge Dyk would have found Claim 4 invalid.  Judge Dyk's disagreement highlights the issue of whether a claim can nonobvious if it is drawn to an unknown – but inherent – property of an obvious invention.  "While a new and nonobvious method of using an existing (or obvious) composition may itself be patentable, [] a newly-discovered result or property of an existing (or obvious) method of use is not patentable."  Slip Op. at 18 (internal citations omitted).

In Judge Dyk's view, claim 4 includes only a single limitation (in this case, a step): "applying a fixed combination of 0.2% brimonidine and 0.5% timolol twice a day."  Given the prior art, [t]he method of applying a fixed combination of 0.2% brimonidine and 0.5% timolol twice a day would therefore have been obvious over the prior art." Id. at 19. 

This did not end the nonobviousness inquiry for the majority, however.  "The majority’s outcome appears to rest, therefore, on the notion that claim 4 was not obvious because it claims the result of twice-a-day dosing—avoiding “a loss of efficacy in the afternoon.”  Id., quoting Maj. Op. 13.  This is not a limitation: "[a]voiding a “loss of efficacy” is not a separate step, but rather a result of the claimed method. []. We should recognize in this case, as we did in Bristol-Myers Squibb, that '[n]ewly discovered results of known processes directed to the same purpose are not patentable.' Bristol-Myers Squibb, 246 F.3d at 1376."  Slip Op. at 19 (internal citations omitted).  

Consequences: It's worth noting that even though it prevailed in establishing the obviousness of the asserted claims of the '463 patent, Sandoz still cannot market its generic version of COMBIGAN: "The ’258, ’976, and ’149 patents each expire on April 19, 2022. Because we concludd that claim 4 of the ’149 patent is not invalid, the Appellants will be unable to enter the market until that date. Accordingly, we find it unnecessary to address the claims of the ’258 and ’976 patents."  Slip Op. at 15.

The Federal Circuit’s New Obviousness Jurisprudence: An Empirical Study

By Jason Rantanen

[Download the draft article]

Obviousness remains one of the primary issues raised in patent cases.  A few weeks ago, Dennis noted that "the vast majority of BPAI/PTAB decisions focus on the question of obviousness,"  and 5 of the 11 opinions involving utility patents issued by the Federal Circuit this past month addressed obviousness.  Many of these cases revolve around application of the Supreme Court's decision in KSR v. Teleflex, and reflect disagreements over the interpretation of the Court's opinion 

This article presents the results of an empirical examination of the Federal Circuit's obviousness jurisprudence over a period of fifteen years, asking whether the Federal Circuit really changed its behavior as a result of KSR.  In systematically examining the court's opinions, I found the following:

  • Following KSR the Federal Circuit has become substantially less favorable to patentees on the issue of obviousness. 
  • The Federal Circuit’s ubiquitous pre-KSR requirement that patent challengers identify a “teaching, suggestion, or motivation” (“TSM”) to combine or modify the prior art has largely disappeared, at least in formal terms.
  • Although the concept underlying TSM has endured, in the form of a “reason to combine” requirement, the post-KSR form of that requirement differs substantially from its pre-KSR incarnation.
  • The Federal Circuit now routinely relies on language from KSR that “[a] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions”  and the use of “common sense” to find combinations and modifications of the prior art to be obvious.
Although there may be some disagreement within the court, taken as a whole this study provides strong evidence that the Federal Circuit has both changed what it says and does when reviewing appeals involving the issue of obviousness. The magnitude of some of my findings was particularly surprising: for example, in the five years after KSR the Federal Circuit affirmed the PTO on the issue of obviousness 91% of the time (94 out of 103 times).
Over the next few weeks I'll be posting some of my findings that didn't make it into the article. 

How [Not] to Fight PTAB Obviousness Decisions

By Dennis Crouch

In re Chevalier (Fed. Cir. 2013) (nonprecedential) (Patent Application Ser. No. 11/407,778)

In a non-precedential but instructive opinion, the Federal Circuit has affirmed the USPTO's obviousness rejection of L'Air Liquide's application covering devices used to form gas-liquid dispersions. The Board rejected claim 1 as obvious, over a combination two prior art references – finding that it "would have been obvious to one skilled in the art to modify the Kwak device in view of the teachings of Howk."

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The difficulty with appealing PTAB decisions is that conclusions of fact made by the USPTO's appellate board are reviewed for substantial evidence. In order to win an appeal on a factual question, the patent applicant must go quite a bit further than simply proving that the PTAB's decision was wrong. Rather, the PTAB decision will only be overturned if not based on "more than a mere scintilla" of evidence. Restated, the question is whether the factual conclusion is based upon "such relevant evidence as a reasonable mind might accept as adequate to support a conclusion." "[T]he possibility of drawing two inconsistent conclusions from the evidence does not prevent an administrative agency's finding from being supported by substantial evidence." Consolo v. Fed. Mar. Comm'n, 383 U.S. 607 (1966).

This case represent the most frequent form of PTAB decision – that the applied-for patent claim is unpatentable as obvious over a combination of references. The ultimate question of obviousness is a question of law (reviewed de novo on appeal). However, that ultimate conclusion is based upon a set of factual underpinnings as explained by Graham v. Deere. The Federal Circuit has also held that "[t]he presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact." In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000).

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Chevalier challenged the combination of references – arguing that the combination of Kwak and Howk would be inoperable. Apparently Chevalier took the drawings from Kwak and Howk and unsuccessfully tried to jam them together. The Federal Circuit saw that process as "misapprehend[ing] the nature of the obviousness inquiry."

The obviousness inquiry does not ask "whether the references could be physically combined but whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole." In re Etter, 756 F.2d 852 (Fed. Cir. 1985) (en banc); see also In re Keller, 642 F.2d 413 (CCPA 1981) (stating "[t]he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference"). Rather, in a case such as this where each of the elements of the claim are known to the art, the obviousness inquiry requires a finding that the combination of known elements was obvious to a person with ordinary skill in the art.

Here, each of the elements of the claim is taught by Kwak with the exception that the Kwak deflector is not attached to the drive shaft. This deficiency in Kwak is supplemented by Howk, which teaches a deflector attached to the drive shaft. The examiner found, and the Board affirmed, that one of ordinary skill would be motivated to modify Kwak in view of Howk because the modification "would facilitate a more rapid and more complete conversion from axial flow to radial flow of the liquid exiting from the bottom of the device." Ex Parte Gilbert Chevalier, 2011 WL 6747404 (B.P.A.I. Dec. 21, 2011). Chevalier does not challenge this finding. Accordingly, we find no error in the Board's determination that Kwak and Howk could be combined to achieve the claimed invention, nor do we find any error in the Board's determination that one of ordinary skill would be motivated to combine these references to achieve an aeration device that more rapidly and more completely converts axial flow to radial flow in the gas-liquid mixture.

The appellate panel then moved to KSR v. Teleflex to bolster its decision:

Our conclusion is strengthened by Chevalier's admission that the deflectors of Kwak and Howk are "recognized equivalents performing the same function of converting axial flow to radial flow." Appellant's Br. 9. The Supreme Court stated in KSR that "when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result." KSR. Here, the claimed invention merely substitutes the deflector of Howk, which is attached to the drive shaft, for the deflector of Kwak, which is attached to the floor of the basin. This substitution achieved only the predictable result of converting the axial flow of the gas-liquid mixture to radial flow.

Rejection affirmed

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The problem with the appeal here is that the appellate arguments are essentially a repeat of the lawyerly discussion of facts made to the examiner and PTAB. When those do not work at the PTO, they are highly unlikely to work on appeal to the Federal Circuit. (No factual affidavits were submitted in the case at the PTO). If Air Liquide had wanted to win the case, they would have been better served to hire expert witnesses to provide testimony either as affidavits to the PTAB or else bring forth that evidence in a civil action. Of course, that approach is likely more expensive and raises a greater potential of inequitable conduct charges down the line – especially in cases like these where other members of the patent family have already issued.

CAFC Obviousness Decision Trends and KSR

By Jason Rantanen

Following up on Dennis's post earlier this morning, below I've provided a few charts showing the Federal Circuit's practice of citing KSR in its obviousness opinions.  The data comes from a study of the court's post-KSR obviousness jurisprudence that I'm currently writing up; as a result, it only runs through April 30, 2012.  The pattern is noticibly different from that of the BPAI/PTAB data that Dennis provided, both for all opinions involving obviousness and for just those arising from the PTO. 

The first chart shows the rate at which the Federal Circuit cited KSR at least once in an opinion addressing obviousness.  The rate at which the court cited KSR actually climbed a bit in 2011. 

CAFC KSR Citations by Year

The next chart is a moving (lagged) average, which means that each point represents the average rate that the Federal Circuit cited KSR over the 20 preceding opinions.  For example, the first point represents the average rate at which the Federal Circuit KSR in opinions 1-20 following KSR, the second point opinions 2-21, etc. The first data point thus corresponds with the Federal Circuit's 20th opinion on obviousness after KSR while the last data points corresponds with the Federal Circuit's 155th opinion after KSR.

CAFC Citations of KSR lagged
The last chart follows the same format as the first chart, limited to appeals arising from the PTO.

CAFC citations of KSR by Year - PTO only

BPAI/PTAB Obviousness Decision Trends

The vast majority of BPAI/PTAB decisions focus on the question of obviousness. Basically, the Board is reviewing whether or not an examiner's obviousness rejection is proper. I created the chart above by using a simple text search for obviousness related terms within each BPAI/PTAB merits decision during the past six years and found that roughly 80-85% of Board decisions discuss obviousness to some degree. I previously tested this methodology against an actual reading of cases and found that my automated methodology correlates quite well. The results for the percentage of obviousness decisions are in blue. A subset of those cases are found in red and represent the percentage of Board merits decisions that cite to the Supreme Court's decision in KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). That decision was important because it changed the law of obviousness as applied by the USPTO.

Apparent from the chart is the fact that the BPAI/PTAB is citing KSR much less frequently in 2012 than it did in 2008-2009. My hypothesis is that a smaller percentage of applicants are fighting about the law of obviousness and more are now focused on application of that law. Mixed into this is the reality that the Board is also writing shorter opinions — leaving less room for pesky citations.

Transocean v. Maersk, Part II: Secondary Indicia of Nonobviousness Outweigh Prima Facie Case of Obviousness

Guest post by Professor Lucas Osborn, Campbell University School of Law.  Before joining the academy in 2009, Professor Osborn worked on the Transocean case while at Fulbright & Jaworski, which represented Transocean.

Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc. (Fed. Cir. 2012)

Panel: Prost, Wallach, Moore (author)

This is the second Federal Circuit opinion in this litigation.  Jason Rantanen wrote about the first opinion in 2010.  The patented technology involves offshore deepwater drilling vessels have "dual activity" capability, which is roughly a vessel with two advancing stations that can cooperate together to drill and finish a single oil well at the ocean floor.  The technology decreases the time it takes to drill and complete an oil well compared to the prior art.  Since offshore drilling rigs rent for around $500,000 a day, every time savings counts.  In Transocean I, the Federal Circuit overturned the district court's summary judgment finding of obviousness, noting that although Maersk provided prior art that made a prima facie case of obviousness, the summary judgment was improper in view of Transocean's significant secondary indicia of nonobviousness.  On remand, the trial jury found Transocean's patents were not obvious and awarded Transocean $15,000,000 in damages.  The district court granted Maersk's motion for JMOL notwithstanding the jury's verdict.

Obviousness – Secondary Considerations and Weighing the Strength of the Prima Facie Case

In Transocean I, the Federal Circuit found Maersk had made a prima facie case of obviousness based on two prior art references, and thus the remand was focused on secondary indicia of nonovbiousness.  On remand, the parties fought over whether the jury could consider the two prior art references in addition to the secondary indicia evidence.  Transocean, apparently believing the prima facie case was weak, wanted the jury to consider the two prior art references for two purposes: (1) to determine whether the references taught each limitation of the claims and provided a motivation to combine, and (2) to consider the strength of the prima facie case.  Maersk opposed both, insisting that the only issue was the secondary indicia of non-obviousness.  The district court allowed the jury to review the prior art references for both purposes.  The Transocean II panel said it was error to allow the jury to reconsider whether the references taught each limitation of the claims and provided a motivation to combine: because that issue was decided in Transocean I, it was the "law of the case."  On the other hand, the court held it was not error to allow the jury to weigh the strength of the prima facie case together with the objective evidence of nonobviousness.

This presents a nice strategy for patentees to (essentially) re-litigate the prima facie obviousness determination.  While the jury technically does not get to decide whether a prima facie case of obviousness exists, it might be difficult for jurors to avoid forming their own opinion about the prima facie obviousness issue if it is allowed to learn about the prior art in detail. 

On the ultimate issue of nonobviousness, the court reinstated the jury verdict as supported by substantial evidence.  The evidence of nonobviousness included evidence of commercial success (including customers willing to pay a premium or even requiring rigs with the patented features), industry praise and unexpected results, copying (including by Maersk itself), industry skepticism, licensing, and long-felt but unsolved need.  The court concluded that "Few cases present such extensive objective evidence of nonobviousness, and thus we have rarely held that objective evidence is sufficient to overcome a prima facie case of obviousness. . . . This, however, is precisely the sort of case where the objective evidence establishes that an invention appearing to have been obvious in light of the prior art was not."

The panel also held that substantial evidence supported the jury's finding of enablement. 

Infringement and Damages – Option to Modify to Avoid Infringement

The court also reiterated its Transocean I holding that Maersk may have infringed even though its original contract for "sale" of the rig contained an option to modify the rig before delivery if any patent infringement was likely.  The jury found that Maersk committed infringement when it "offered to sell" and "sold" its rig to Statoil.  The contract evidencing the sale/offer expressly indicated that Maersk could modify the final rig design based on the outcome of then-pending district court litigation between Transocean and a third party based on the same patents.  Before actually delivering the rig, Maersk modified it to avoid infringement.  But the Federal Circuit reiterated that the option to modify and subsequent modification could not save Maersk.  The jury found that the specifications of the rig offered and sold met all the claim limitations.  Post-offer/sale modifications did not matter even though they occurred before actual delivery.

Moving to damages, the panel reinstated the jury's award, but it was sympathetic to Maersk's apparent good intentions to avoid infringement.  The court stated, "We are sympathetic to Maersk's arguments. It offered drilling services which would use an infringing drill, but expressly reserved the right to modify the drill to avoid infringement. It did then modify the drill prior to delivery to avoid infringement – hence never actually using an infringing dual-activity drill."  Nevertheless, the court held that the $15,000,000 reasonable royalty verdict was supported by substantial evidence. 

What can defendants take away from this?  A contract with an option to modify the product will not avoid infringement.  It would seem defendants in situations like Maersk's (i.e., watching a patent to see if it issues or is held valid) should contract not for an "option" to modify, but for a mandatory modification to avoid infringement upon the triggering event (patent issuance or litigation upholding the patent's validity).

The Ignored Issue – When is a "Lease" a "Sale" Under Section 271?

As in Transocean I, the court did not reach a potentially dispositive issue that the parties strongly contested at times in the litigation.  Section 271(a) provides that "sales" and "offers to sell" can be acts of infringement.  Here, however, Maersk did not offer to sell or sell its drilling rig.  Rather, it "leased" and offered to "lease" its rig to a third party.  While previous cases have found that some leases can be tantamount to a sale (and thus infringe under 271), those cases primarily involved the transfer of property indefinitely or for its entire useful life (think of your typically software "license").  See Minton v. Nat'I Ass'n. of Secs. Dealers, Inc., 336 F.3d 1373, 1378 (Fed. Cir. 2003).  This case presented a closer issue:  Here, Maersk argued that it (1) the lease did not last for the entire useful life of the drilling rig, and (2) the contract was for the provision of drilling services and at all time Maersk maintained possession of the rig.  The court ignored this issue and, as it did in Transocean I, referred to the transaction as a "sale" without comment.   

From an economic perspective, "sales" and "leases" would seem to present the same harm to the patentee.  On the other hand, the statute only mentions sales, not leases.  For whatever reason, the Federal Circuit didn't want to touch this issue.  Maybe we will have to wait for Transocean III to know the answer?

Who Decides Obviousness: Judge or Jury?

By Dennis Crouch

Kinetic Concepts and Wake Forest University v. Smith & Nephew (Fed. Cir. 2012)

Wake Forest’s asserted patents cover a medical technique that uses suction to close a gaping wound.  In certain situations, the suction method – also called Negative Pressure Wound Therapy – is apparently better than stitches or – my personal favorite – super glue.  Smith & Nephew’s product has become popular – thus the lawsuit. My wife is an MD, so my usual wound therapy involves me saying “go see your momma.”

The issue in the Kinetic appeal involves the question of obviousness and whether the ultimate question of obviousness should be decided by a judge or by the jury.  The Supreme Court has repeatedly stated that obviousness is a question of law based upon a set of underlying facts.  However, most district court judges allow the jury to decide the legal question of obvious. Further, few judges pose interrogatory questions to the jury regarding the factual underpinnings of their legal determination.

Here, S&N proposed that the jury only be asked to resolve the disputed questions of fact outlined in the Supreme Court’s landmark 1966 decision Graham v. John Deere — questions such as the level of skill in the art and the scope and content of the prior art.  Under S&N’s proposal, the judge would then take those answers and form a conclusion on the ultimate legal question of obviousness.  The patentees responsive brief identified this process as “one of the worst suggestions of all time.” Here, the district court took a somewhat middle ground – deciding to give the legal issue to the jury, but also ask the jury to identify the underlying factual Graham factors.  In addition, the district court indicated that it would see the jury’s obviousness conclusion “as advisory.”  

The court wanted some factual guidance from the jury, but was also wary of asking the jury to write its response in narrative form. (Why?) In the end, the jury was asked several yes/no questions about the scope of the prior art; the differences between the prior art and the claimed invention; and whether secondary indicia of non-obviousness existed. After eight days of deliberation, the jury returned its verdict. Samples from the verdict form are shown below.


In its verdict, the jury concluded that the defendant had failed to prove the asserted claims to be obvious.

On JMOL, the district court rejected the jury verdict and held instead that the differences between the prior art and the claimed invention were so minimal as to be obvious to anyone of skill in the art. This holding thus left the asserted claims invalid. On appeal, the Federal Circuit has reinstated the jury verdict upholding the patent and held that the “district court committed error by failing to defer to the jury’s factual findings and granting JMOL on obviousness.” Professor Jason Rantanen wrote on this earlier:

Wake Forest, the patent holder, appealed a district court grant of JMOL of invalidity for obviousness of a claimed invention for treating difficult-to-heal wounds by applying suction (negative pressure). The CAFC reversed, holding that (1) the jury’s “advisory” opinion on the ultimate issue obviousness gave rise to implied findings of facts that the district court was required to accept provided that they were supported by substantial evidence, despite the presence of special interrogatories on the verdict form; (2) the jury’s implied findings of facts on the Graham factors were supported by substantial evidence; and (3) the ultimate conclusion of obviousness was that the claims were not obvious.

In arriving at the ultimate (legal) conclusion of nonobvious, the Federal Circuit focused its discussion on the lack of a reason to combine the prior art references (itself a factual finding), referencing concerns about hindsight reconstruction. In a statement suggesting a technology-based limitation on the use of common sense, the court held that “although expert testimony regarding motivation to combine is not always required, the technology at issue here is not the type of technology where common sense would provide the motivation to combine these references.”

The court’s usual approach to jury obviousness decisions typically begins with the jury’s ultimate conclusion of obviousness/nonobviousness and then works back to the factual determinations necessary to reach that conclusion. In the absence of a special verdict spelling out the factual determinations, the court presumes that the jury made those necessary factual determinations and will affirm the jury verdict so long as those facts were supported by substantial evidence at the trial. In Kinetic, there was a special verdict where the jury particularly identified some of its factual conclusions. However, even here, there were a number of factual determinations necessary to reach the nonobviousness verdict – and those are typically implied into the jury verdict. The basic conclusion of the Federal Circuit in this case was that Smith & Nephew’s obviousness argument was – at base – an attempt to challenge those underlying assumed factual determinations and, that challenge must fail because those determinations were supported by substantial evidence presented at trial.

Smith & Nephew challenged this working-back approach as wrong on (at least) two levels. First, since obviousness is a conclusion of law, the adjudged infringer argued that it couldn’t be the basis for presuming particular factual conclusions that were not expressly decided by the jury. This is even further bolstered by the fact that the district court judge identified the jury’s conclusion on obviousness as ‘advisory.’ The appellate court rejected those arguments by relying on its own precedent supporting the working-back approach and by determining that the district court’s reference to the ‘advisory’ nature of the jury verdict had no meaning.

The court went on to specifically indicate that it is proper to submit legal arguments to a jury:

[I]t is neither error nor dangerous to justice to submit legal issues to juries, the submission being accompanied by appropriate instructions on the law from the trial judge. The rules relating to interrogatories, jury instructions, motions for directed verdict, JNOV, and new trial, and the rules governing appeals following jury trials, are fully adequate to provide for interposition of the judge as guardian of the law at the proper point and when necessary. There is no question that the judge must remain the ultimate arbiter on the question of obviousness. He or she exercises that role first in exercising the judge’s duty of giving proper instructions on the law to the jury before it considers its verdict. The judge exercises control on the question again when presented with a motion for JNOV or new trial. In no sense need the judge abdicate the guardianship role.

R.R. Dynamics, Inc. v. A. Stucki Co., 727 F.2d 1506 (Fed. Cir. 1984).

En Banc Rehearing: Now, Smith & Nephew is preparing to ask the Court of Appeals for the Federal Circuit to rehear the case en banc asking the Federal Circuit to give meaning to the legal nature of an obviousness conclusion and ensure that an accused infringer has a right to an independent determination by a judge on the ultimate question of obviousness.


Recent Federal Circuit Nonobviousness Opinions: Kinetic Concepts

By Jason Rantanen

Kinetic Concepts, Inc. v. Smith & Nephew, Inc. (Fed. Cir. 2012)  Panel: Bryson, Dyk (concurring in the result), O'Malley (author) Download 11-1105

Dennis will be writing about the advisory jury issue in Kinetic Concepts in more detail, so I'll provide only a brief summary here.  Wake Forest, the patent holder, appealed a district court grant of JMOL of invalidity for obviousness of a claimed invention for treating difficult-to-heal wounds by applying suction (negative pressure).  The CAFC reversed, holding that (1) the jury's "advisory" opinion on the ultimate issue obviousness gave rise to implied findings of facts that the district court was required to accept provided that they were supported by substantial evidence, despite the presence of special interrogatories on the verdict form; (2) the jury's implied findings of facts on the Graham factors were supported by substantial evidence; and (3) the ultimate conclusion of obviousness was that the claims were not obvious. 

In arriving at the ultimate (legal) conclusion of nonobvious, the Federal Circuit focused its discussion on the lack of a reason to combine the prior art references (itself a factual finding), referencing concerns about hindsight reconstruction.  In a statement suggesting a technology-based limitation on the use of common sense, the court held that "although expert testimony regarding motivation to combine is not always required, the technology at issue here is not the type of technology where common sense would provide the motivation to combine these references."  Slip Op. at 45.

Recent Federal Circuit Nonobviousness Opinions: Alcon v. Apotex

By Jason Rantanen

I'm catching up with recent Federal Circuit opinions this week.  First up, a trio of precedential opinions involving nonobviousness, a surprisingly hot topic.

Alcon Research, Ltd. v. Apotex Inc. (Fed. Cir. 2012).  Panel: Prost, Moore (author), O'Malley Download 11-1455

Apotex submitted an Abbreviated New Drug Application to the FDA seeking approval to market a generic version of the anti-allergy eye drop PATANOL; in response, Alcon sued Apotex for patent infringement under 271(e)(2)(A).  In a bench trial, the district court held that eight of the asserted claims of the patent were nonobvious, and Apotex appealed.

The Federal Circuit reversed on six of the claims.  Focusing on the primary issue, whether there was a motivation to adapt the formulation disclosed in the prior art (which was tested in guinea pigs) for use in in treating humans, the CAFC concluded that the district court had applied an overly strict reason to modify requirement to the six claims involving a range that overlapped with the prior art.   Given the district court's factual finding that "animal tests, including guinea pig models, are predictive of a compound's antihistaminic activity and its topical ocular activity in humans," the "district court clearly erred when it concluded that a person of skill in the art would not have been motivated to use the olopatadine concentration disclosed in Kamei in human eyes."  Slip Op. at 12.  It did not help Alcon's argument that its patent was based only on in vitro tests of the compound in human cells. 

The CAFC reached a different conclusion on two claims that did not cover a range of the active compound that overlapped with the prior art, finding no clear error in the district court's conclusion that "a person of ordinary skill in the art would not have a reasonable expectation of success for increasing the highest dosage used in [the prior art] by an order of magnitude."  Slip Op. at 17. 

While the CAFC considered the objective evidence, it played a relatively secondary role.  On the six claims that the panel concluded were obvious, despite agreeing with the district court that the objective considerations fell in Alcon's favor, the CAFC nevertheless concluded that after balancing the objective evidence against the strong case of obviousness presented by Apotex the claims were obvious.  No explanation of why this was so was offered.  Similarly, on the two claims in which there was no reasonable expectation of success, the court commented that the objective evidence "further supports" the nonobvious holding, citing particularly evidence of commercial success.

Comment:  The opinion avoids labeling the first part of the analysis as a "prima facie" case of obviousness, perhaps in response to recent concerns about the confusing use of that term in infringement suits.  See In Re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, 676 F.3d 1063 (Fed. Cir. 2012)The court refers to it only as the "evidence of obviousness discussed above" when contrasting it with the objective indicia of nonobviousness.  But this is somewhat cumbersome, and sparks the question of how should we refer to this stage of the obviousness analysis if not as the "prima facie case of obviousness?"  Possible suggestions, all of which have their problems: the first three Graham factors; the 'paper case' of obviousness; the 'theoretical' case of obviousness. Other suggestions? 


Appealing Obviousness not the Factual Basis for Obviousness

Plasmart v. Kappos & Wang (Fed. Cir. 2012)

Jar Chen Wang‘s company Wincell sells the TwistCar and owns patent No. 6,722,674. PlaSmart sells the similar product – PlasmaCar. The toy cars look virtually identical to one another and operate the same way – twisting the handlebars make them go. 

Wang threatened, PlaSmart sued for DJ and then filed for inter partes reexamination in 2008. As with all reexaminations, the issue is whether the prior art renders the claimed invention unpatentable. The BPAI found several of the claims patentable. On appeal, however, the Federal Circuit has reversed.

USPTO Board factual findings are reviewed for substantial evidence. This is a low standard that results in an affirmance so long as more than a scintilla of evidence supports the Board’s conclusions. Legal conclusions made by the Board are reviewed de novo. Thus, as you might imagine,

Obviousness is somewhat tricky – the ultimate conclusion of obviousness is a question of law. However, that conclusion must be based upon factual predicates outlined in Graham v. John Deere Co., 383 U.S. 1 (1966). In KSR, the Supreme Court wrote that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007). That statement seems to be one applied as part of the final question of obviousness that would also be reviewed de novo on appeal.

Factual versus Legal Conclusions: The language of the opinion here is somewhat unclear, but the Federal Circuit appears to have accepted all of the BPAI’s factual findings regarding the scope and content of the prior art; the level of skill in the art; and the differences between the claimed invention and the prior art. However, the court rejected the BPAI’s ultimate conclusion obvious – holding that the “minor distinctions” identified by the Board were insufficient to distinguish the claimed invention from the prior art.  Another way to look at the case is that the court rejected the Board’s factual conclusion that the differences between the claimed invention and the prior art were major.

This case highlights the trouble that I have in our obviousness jurisprudence. In most cases, the Graham analysis does not do a very good job of leading to an answer of the obviousness question.  Thus, even after determining the scope and content of the prior art; the differences between the claimed invention and the prior art; the level of ordinary skill in the prior art; and any secondary factors, the court (or PTO) still has a large amount of analysis/discretion in determining whether those factors lead to a conclusion of obviousness. 

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.