Dr. Rentrop is the chief of research at St. Vincent’s Hospital in NYC. For several years Rentrop used Spectranetics optical catheters to deliver LASER treatment. The Spectranetics catheters came in various tip diameters ranging from 1.4 mm to 2 mm. Finding those diameters too inflexible, Rentrop had the idea of using a 0.9 mm tip. Rentrop told Spectranetics of his idea and help them to create a prototype. Eventually Spectranetics obtained FDA approval and began marketing. In the meantime, the parties began to dispute over financial issues. Rentrop wanted a cut of the profits and so he filed for patent protection and eventually sued Spectranetics for infringement. The jury awarded $500,000 in damages.
On appeal, the Federal Circuit quickly affirmed. The most interesting legal issue of the case involves the pre-KSR jury instructions. The first part focused on the teaching-suggestion-motiviation test:
“In evaluating the scope and content of the prior art, you should keep in mind that there must have been some suggestion for a person skilled in the art to make the combination covered by the claims of the patent in issue in order for the claims to have been obvious. In other words, a claim in a patent is not obvious and invalid, simply because the claim combines elements that can all be found among the prior art references. It must have been a motivation or a suggestion to combine the limits in a manner disclosed by the patent.”
The Federal Circuit found this instruction proper – in context – because the instructions defined motivation as potentially arising “from common knowledge, or common sense of the person of ordinary skill in the art, without any specific hint or suggestion in a particular reference.”
Obvious to Try: The jury instruction on obviousness also included the statement that a “the test for obviousness is not whether or not it would have been obvious to try to make the invention.” The defendant argued that the instruction violates KSR. In KSR, the Supreme Court held that the Federal Circuit was in error to hold that a “patent claim cannot be proved obvious merely by showing that the combination of elements was obvious to try.” The Federal Circuit, however, was able to logically reconcile the two statements – noting that the jury instruction “does not imply that a showing that the specific combination of elements was obvious to try is insufficient to find obviousness.”
Notes:
Northern District of California Chief Judge Vaughn Walker authored the opinion while sitting by designation on the Federal Circuit.
Spectranetics recently filed for ex parte reexamination of two of Rentrop’s patents. [LINK]
Andersen sued Pella and WL Gore for infringement of its window screen patent. Apparently, the patented screen allows ventilation and blocks insects, but is easier to see through than traditional screens. The claims focus on the diameter and strength of the screen wires and as well as on the screen’s “transmittance” and “reflectance” properties.
Prior to KSR, the district court had rejected the defendant’s summary judgment motions on obviousness – finding that the prior art references lacked a motivation to combine. After KSR, the district court reversed course – this time granting summary judgment of invalidity based on obviousness of the claimed screen. In its analysis, the district court asked and answered the following question: “would an insect screen manufacturer of ordinary skill have found it obvious to use the [prior art] screening material, decrease its reflectance value, bond it, and place it in a window frame? The answer, plain and simple is ‘Yes.'” According to the lower court, the prior art mesh was the “heart” of the claimed invention, and it was a “simple act of common sense” to slightly modify the mesh and apply it to a window. Although secondary factors of nonobviousness were shown, the lower court found they were not enough to rebut a strong showing of obviousness.
Analogous Arts: On appeal, the Federal Circuit vacated – finding material facts that prevent summary judgment of obviousness. In particular, the appellate panel found that the prior art mesh might not count as nonobviousness type prior art because it “outside the scope and content of the prior art.” The court based its decision on three issues: (1) the prior mesh was not in the same “insect screen manufacturing field”; (2) there was some evidence that the prior mesh would not be useable for an insect screen (teaching away); and (3) the PTO specifically considered the reference before granting the patent and should be given some deference.
Upon our review of the record in the light most favorable to Andersen, we find support adequate to overcome summary judgment on the question of whether the TWP mesh was outside the scope and content of the prior art. Andersen put forth evidence in the record that, one, the TWP mesh was not part of the insect screen manufacturing field, and, two, an insect screen manufacturer would have read the prior art to teach away from using a mesh with the characteristics possessed by the TWP mesh. This field-of-invention and teaching-away evidence, combined with the deference owed to the PTO’s issuance of this patent after reviewing the same prior art references that form the basis of this obviousness challenge, raises a genuine issue of material fact as to whether an ordinarily skilled insect screen designer would have found the combination of the TWP mesh with the other prior art references obvious.
Teaching away and price feasibility: One of the ‘teaching away’ arguments accepted by the Federal Circuit was that of price infeasibility. Andersen had argued that the prior mesh would not have been considered by a designer because it was quite “extraordinarily expensive.” In its holding, the appellate panel gave backing to the notion that a high price would discourage consideration of a potential prior art reference.
As to the third characteristic, pricing, Andersen’s expert, Laurence Armstrong, stated that the TWP mesh was “extraordinarily expensive in comparison with traditional insect screen material, costing about $75.00 per square foot.” It is not unreasonable to suggest that a significant difference in cost could discourage an insect screen designer from using the more expensive mesh. . . . On the whole, we think, the record creates a genuine issue of material fact as to whether the durability, transparency, and pricing of the TWP mesh would have discouraged an ordinarily skilled artisan from incorporating the mesh into an insect screen.
CSIRO is a nonpractising patent holder. It is also an arm of the Australian government. After winning an infringement suit against Buffalo Tech, CSIRO was awarded permanent injunctive relief to protect its spread spectrum WLAN technology.
On appeal, more than a half-dozen amici filed briefs arguing for and against injunctive relief in this situation. On appeal, however, the Federal Circuit vacated the infringement holding – leaving the discussion of injunctive relief for another day. The vacatur came from the district court’s pre-KSR strict requirement for a motivation to combine references.
Combining References For Novelty: On novelty, Buffalo asked the court to combine two references in its analysis because one of the reference cites the other in a footnote. The Federal Circuit rejected that argument — finding that the footnote discussion was insufficient to concatenate the two references. “In particular, the reference to Bingham does not ‘identify with detailed particularity what specific material it incorporates and clearly indicate where that material is found in the various documents.’ Advanced Display Systems, (Fed. Cir. 2000).”
New Matter: 35 USC 132 bars an applicant from presenting new matter once a patent application has been filed. In litigation, the written description requirement of Section 112 serves as the basis for invalidating patents with added new matter. The new matter limitation is not strict. Rather, when the claims are amended, the patent will only be invalidated if the original specification is not “sufficient to allow persons of ordinary skill in the art to recognize that the inventor invented the subject matter that is claimed in the asserted claims.” Further, the PTO’s decision to allow an amendment provides a patent with “an especially weighty presumption of correctness.”
Here, CSIRO changed its claim limitation from “frequencies in excess of 10 GHz” to simply “radio frequencies.” On appeal, the Federal Circuit affirmed the lower court’s factual finding that the amendment did not impermissibly add new matter. (No clear error). In particular, neither party suggested a technical distinction between handling lower frequencies. Further, the court found that the original specification was not limited to frequencies in excess of 10 GHz.
On remand, the lower court will reevaluate obviousness.
Secondary considerations are most often used by patentees as circumstantial evidence that an invention was nonobvious. “Negative” secondary considerations – those used as circumstantial evidence of obviousness – have received less attention and less support in the case law. However, Brent Yamashita discusses the potential use of one negative secondary consideration: the simultaneous invention factor. Brent gave his permission to publish this short article on the topic.
By Brent Yamashita*
Introduction: In nearly every patent litigation, the accused infringer will argue that the asserted patent claims are obvious (if not anticipated) by the prior art and therefore should be ruled invalid. The U.S. Supreme Court substantially altered the law of obviousness in KSR when it held that an accused infringer does not necessarily need to show “a teaching, suggestion, or motivation” (“TSM”) in the prior art to combine known elements in order to show that the combination was obvious. SeeKSR Int’l Co. v. Teleflex Inc., 550 U.S. ___, 127 S. Ct. 1727, 1741 (2007). Now that proving obviousness no longer requires establishing TSM, the secondary considerations of obviousness and nonobviousness have taken on greater importance in obviousness determinations, as KSR left that doctrine fully intact.
The concept of secondary considerations originated in Graham, where the Supreme Court stated that secondary considerations can serve as relevant “indicia of obviousness or nonobviousness” and might be utilized “to give light to the circumstances surrounding the origin of the subject matter to be patented.” See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966). The Court further stated that secondary considerations can include commercial success, long-felt but unsolved need, and the failure of others. See Id. Other factors recognized by the Federal Circuit after Graham include whether the prior art teaches away from the invention, whether others have copied the invention, and whether the invention has received industry acclamation. See, e.g., Ecolochem, Inc. v. Southern California Edison Co., 227 F.3d 1361 (Fed. Cir. 2000), cert. denied, 532 U.S. 974 (2001).
The Simultaneous Invention Factor: Another secondary consideration-and one which appears to have been discussed and applied much less frequently by the Federal Circuit than the other secondary considerations-is the simultaneous invention consideration. The Federal Circuit has stated that, “[T]he possibility of near simultaneous invention by two or more equally talented inventors working independently,… may or may not be an indication of obviousness when considered in light of all the circumstances.” Ecolochem, 227 F.3d at 1379 (quoting Lindemann Maschinenfabrik GMBH v. American Hoist and Derrick Co., 730 F.2d 1452, 1460 (Fed. Cir. 1984)). In other words, the fact that another person simultaneously and independently created the same invention claimed in the patent-in-suit can serve as an indication that the invention was obvious.
Every accused infringer should consider this often-overlooked secondary consideration in preparing its obviousness defense. This factor can be particularly useful in a situation where the simultaneous inventions occurred shortly after an enabling technology was introduced. Some inventions only become possible-or relevant-once a foundational technology becomes known. For example, tires could not have been invented before the wheel and would have been meaningless before the wheel. An enabling technology can serve as a chronological starting point for the simultaneous inventions that follow, which can be useful in gauging obviousness of the invention.
In this particular context, I propose that the simultaneous invention factor be modified as follows: Simultaneous invention by a first inventor and a second inventor is indicative of obviousness when the development by the two inventors occurred independent of one another in a simultaneous manner shortly after an enabling technology emerged and where there is a nexus between the enabling technology and the development by the two inventors. Applying the simultaneous invention factor in this manner would reflect the fact that if more than one person develops the claimed invention quickly once all of the necessary enabling technology becomes available, then the invention arguably was obvious.
As an example, imagine the following sequence of events:
March 1, 1925: Company A introduces the world’s first TV. The TV includes an antenna for receiving broadcast signals. (Admittedly, TV content is hard to come by at this time.)
May 1, 1925: Inventor B develops a TV antenna that improves the reception of Company A’s TV. Inventor B files a patent application on his invention and eventually obtains the patent.
May 15, 1925: Inventor C, independently of Inventor B, develops a TV antenna that improves the reception of Company A’s TV. Inventor C’s antenna practices the claims of Inventor B’s patent when it ultimately issues.
Under the simultaneous invention factor, an accused infringer in a lawsuit brought by the owner of Inventor B’s patent could argue that the fact that Inventor B and Inventor C each independently created a TV antenna shortly after an enabling technology (i.e., Company A’s TV) emerged suggests that the claimed invention was obvious once the enabling technology existed and that the invention would have been invented sooner had the enabling technology been available sooner. In addition, the simultaneous invention factor in this context would counteract the ability of the patent holder to argue that a long-felt but unsolved need for the claimed invention shows that the patent was nonobvious, since the “long” aspect of the long-felt need in this context was a result of the amount of time that elapsed before the TV emerged and was not a result of the amount of time taken to develop the invention once the enabling technology existed.
From a litigation strategy standpoint, in most instances the accused infringer under this proposed rule would do whatever it could to find technology that preceded the invention and argue that it was enabling and that the invention occurred only once that technology existed. The proposed modification of the simultaneous invention rule potentially could become a “knee-jerk” obviousness argument by every accused infringer, and courts therefore must be diligent about identifying and rejecting spurious arguments. In that regard, requiring litigants to establish a nexus between the simultaneous inventions and the enabling technology will help to prevent the abuse of this secondary consideration. The nexus will be most apparent if both inventors began their work only after the enabling technology emerged and if the inventions never could have been developed or built without that enabling technology in place. In this sense, the enabling technology must be a genuine prerequisite or foundation for the invention.
Conclusion: In appropriate circumstances, litigants should utilize the often-overlooked simultaneous invention factor in its obviousness defense. If applied in the manner proposed in this article, the simultaneous invention factor properly recognizes the fact that in some instances inventions do not occur after years and years of toiling in a laboratory, but rather, after a minimal effort (executed by others independently and simultaneously) after a breakthrough in an enabling technology that is not itself the subject of the invention.
Notes:
* Brent Yamashita is a partner in the patent litigation group of DLA Piper US LLP’s Silicon Valley, California office.
Any examples of how this section is being applied?:
Prior art is not limited just to the references being applied, but includes the understanding of one of ordinary skill in the art. The prior art reference (or references when combined) need not teach or suggest all the claim limitations, however, Office personnel must explain why the difference(s) between the prior art and the claimed invention would have been obvious to one of ordinary skill in the art. The “mere existence of differences between the prior art and an invention does not establish the invention’s nonobviousness.” Dann v. Johnston, 425 U.S. 219 (1976).
The gap between the prior art and the claimed invention may not be “so great as to render the [claim] nonobvious to one reasonably skilled in the art.” Id. In determining obviousness, neither the particular motivation to make the claimed invention nor the problem the inventor is solving controls. The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts. Factors other than the disclosures of the cited prior art may provide a basis for concluding that it would have been obvious to one of ordinary skill in the art to bridge the gap.
Because of the expected increase of appeals to the Board of Patent Appeals and Interferences (the “Board”), the Patent Office has proposed a new set of rules governing practice before the Board. [Proposed Rules]. The PTO received over fifty comments from the public — mostly negative. As it turns out, the rules appear to primarily serve as a roadblock to appeals — either by raising costs or creating procedural stumbling blocks. The extra rules are especially shocking when you consider that the vast majority of appeals filed never reach the BPAI. Rather, even after the applicant files an appeal brief, most cases are re-opened by the Examiner who either allows the case or re-opens prosection. [cite]
In its letter to the PTO, the AIPLA noted problems with the new rules:
Some of these new requirements … do not appear to address any specific problem being experienced by the Board, and would simply add additional formal requirements that would increase the burden and costs of preparing an appeal brief, and lead to even more disputes over compliance of an appeal brief with the many formalities already required.
Intellectual Ventures said it more forcefully:
The proposed new rules are onesided and will serve as a significant hurdle to a patent applicant in pursuing their statutory right of an appeal to the BPAI. Many of the proposed changes run counter to the patent statute and improperly attempt to transfer responsibilities and shift burdens of proof from the USPTO to applicants. … Since the agency is forcing more appeals, the appeal process should be reformed to make appeals easier and less expensive to prepare rather than make appeals more expensive and burdensome as in the proposal.
Some Examples:
Proposed Rule 41.37(q) and (r): would require applicants to identify for every argued claim where every claim limitation finds support in the specification and is illustrated in the drawings — even where a claim limitation is not at issue in the appeal. This requirement only raises the cost of preparing an appeal brief.
Proposed Rule 41.37(o)(7): Would require applicant to provide an explanation of patentability when obviousness is asserted. There may be some policy reasons for requiring this. However, under current law, the applicant is not required to prove patentability — rather, the applicant only needs to poke holes in the Examiner’s prima facie case of obviousness.
In its comments, the Adams law firm of New Mexico noted a recent Patently-O posting on BPAI delay — and suggested that briefs should be submitted directly to the BPAI — not to examiners for their initial review.
David Boundy – writing for CantorFitz – debated whether these rules are actually ‘procedural.’
When combined, the various limits imposed in the propped Appeal Rule accumulate to a substantive denial of an applicant’s right to a fair and efficient appellate review. Increased fonts [14 point], decreased page limits [25 pages], added material that must be included, no limits on the amount of material that an Examiner can present, and a draconian remedy for failing to address every point raised by an Examiner – all make one question the motivation for these proposed changes. At some point, a collection of “procedural” limits becomes so stringent that they amount to a “substantive” limit on the ability to prosecute an application.
A. Intellectual Property Organizations and Government Agencies
Earlier this week, a Texas jury determined that Forgent’s patent claims against EchoStar were all invalid as anticipated, obvious, and lacking proper written description. Although the one-sided decision probably did not receive a boost from the recent decision of KSR v. Teleflex, it is interesting to note that the jury instructions on obviousness-by-combination closely follow DyStar and other new CAFC obviousness cases.
Jury Instructions:
One way to decide whether one of ordinary skill in the art would combine what is described in various items of prior art, is whether there is some teaching, suggestion, or motivation in the prior art for a skilled person to make the combination covered by the patent claims. Motivation can be implicit. In other words, motivation need not be explicit.
It is common sense that familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle. Multiple references in the prior art can be combined to show that a claim is obvious. Any need or problem known in the field and addressed by the patent can provide a reason for combining the elements in the manner claimed. To determine whether there was an apparent reason to combine the known elements in the way a patent claims, you can look to interrelated teachings of multiple patents, to the effects of demands known to the design community or present in the marketplace, and to the background knowledge possessed by a person of ordinary skill in the art. Neither the particular motivation nor the alleged purpose of the patentee controls. One of ordinary skill in the art is not confined only to prior art that attempts to solve the same problem as the patent claim.
Now that the Supreme Court has issued its opinion in KSR v. Teleflex, the first reaction is what took it so long? During the past six months since oral arguments in late November, I was expecting that the Court was taking its time crafting a historical opinion that delved into the genesis and evolution of the nonobviousness doctrine since the Hotchkiss decision in 1851. The Court does mention the Hotchkiss decision and a few others, but the six month gestation has yielded a compact, thirty page decision that can be summarized with three simple F-words: formalism, functionality, and flexibility.
Though the Supreme Court’s unanimous reversal in KSR v. Teleflex, No. 04-1350, 550 U.S. ___ (2007), contains some harsh words for the Federal Circuit’s teaching, suggestion, or motivation (TSM) test, the decision itself appears to leave the TSM requirement roughly intact. Justice Kennedy’s opinion emphatically rejects an ‘explicit’ TSM test—one that would require explicit prior art teachings in order to combine given references in the obviousness analysis. At the same time, the decision appears to essentially recreate the ‘implicit’ or ‘flexible’ TSM test—one that would allow implicit suggestions, such as the nature of the problem, to provide the requisite motivation to combine. It is this implicit TSM requirement that represented current Federal Circuit doctrine, pursuant to several decisions published after certiorari was granted in KSR (e.g., In re Kahn, DyStar, & Alza). In fact, the Supreme Court even indicates that the Federal Circuit may have gotten it right in these post-cert cases. The KSR opinion is more a critique of the Circuit’s application of the obviousness (and TSM) standard to the specific facts in KSR than a critique of the need to rigorously (and expansively) evaluate what would lead a PHOSITA to combine certain references in the obviousness analysis.
Under KSR, in order to evaluate whether a given combination was obvious, the factfinder must "determine whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue." The Supreme Court’s "reason to combine" sounds significantly like "suggestion, teaching, or motivation to combine." It is interesting that the Court used a term as loose as “reason,” given concerns raised during oral argument about the indefiniteness of the term “motivation.” In addition, the Court requires that, "[t]o facilitate review, the analysis should be made explicit," a proposition for which the Court cites Kahn, warning that conclusory statements are not sufficient. The Court goes on to criticize rigid application of TSM, particularly relying solely on published articles and explicit content of issued patents. But, the Court notes, "In the years since the Court of Customs and Patent Appeals set forth the essence of the TSM test, the Court of Appeals no doubt has applied the test in accord with these principles in many cases. There is no necessary inconsistency between the idea underlying the TSM test and the Graham analysis." And, the Court explicitly notes that the post-cert Circuit cases were not before it: "The extent to which [DyStar and Alza] may describe an analysis more consistent with our earlier precedents and our decision here is a matter for the Court of Appeals to consider in its future cases." The opinion also clearly (appropriately in my opinion) invites greater analysis of the PHOSITA and the circumstances surrounding the PHOSITA and the pertinent technology than the Circuit has engaged in in some of its decisions.
By Professor Joshua Sarnoff, Assistant Director of the Glushko-Samuelson Intellectual Property Law Clinic and a Practitioner-in-Residence at the Washington College of Law, American University. Professor Sarnoff filed an amicus brief in support of Petitioner KSR.
In its unanimous decision in KSR Int’l. Co v. Teleflex Inc., No. 04-1350 (April 30, 2007), the Supreme Court expressly overruled the Court of Appeals for the Federal Circuit’s “teaching-suggestion-motivation” (“TSM”) test for finding a claimed invention obvious and reaffirmed the Court’s precedents (in light of the 1952 enactment of Section 103 and its holding in Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966)) regarding the obviousness of patents “based on the combination of elements found in the prior art” where there the combination “does no more than yield predictable results.” Slip op. at 11-12. The Court’s decision has therefore called into question the validity of hundreds of thousands of claims in issued patents, and will likely lead to a dramatic change to the method by which the Patent Office, the courts, and the bar conduct their obviousness analyses.
Nevertheless, the Supreme Court’s opinion appears self-consciously narrow and provides little additional guidance for how to apply the Graham approach. The Court’s decision leaves unclear whether the party with the burden of proving obviousness must demonstrate that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue,” or only that the claim at issue if patented would reflect an “advance[] that would occur in the ordinary course without real innovation[, which] retards progress and may, in the case of patents combining previously known elements, deprive inventions of their value or utility.” Slip op. at 14, 15. As the Court noted, “as progress beginning from higher levels of achievement is expected in the normal course, the results of ordinary innovation are not the subject of exclusive rights under the patent laws. Were it otherwise patents might stifle, rather than promote, the progress of useful arts.” Slip op. at 24. Although the Court recited the Constitutional language, it did not expressly hold that obviousness is a constitutional requirement. Further, the Court left to later case law any consideration of the extent to which the Court of Appeals’ more recent statements regarding the flexibility of its TSM test is consistent with Graham and the Supreme Court’s earlier precedents. Slip op. at 18.
Optivus and Loma Linda v. Ion Beam Apps. (Fed. Cir. 2006).
Focused proton beam therapy offers real promise to cancer victims. Optivus and Loma Linda control rights to several relevant patents including a multi-room proton therapy apparatus. The pair sued IBA for patent infringement as well as various business torts (unfair competition) based on IBA’s marketing of its devices without FDA approval.
The district court granted summary judgment in the defendant IBA’s favor on invalidity, noninfringement, and unfair competition. Optivus and Loma Linda appealed.
Appellate Practice Waiver of Arguments: In their opening brief, appellants argued a lack of motivation to combine various pieces of prior art, but did not raise an argument as to whether the prior art contained all of the claim elements. They then attempted to raise that issue in their reply brief. The CAFC, however, dismissed that issue as a matter of procedure — holding that the argument was “waived because it was not raised in Loma Linda’s opening brief.”
Death Ray: On motivation to combine prior art, Loma Linda argued that modifying a UW Neutron therapy center by sending protons to the patient would create a “death ray” that would kill the patient. After defining “skill in the art” as familiarity with particle beam technology uses in medical treatment, the CAFC dismissed this “teaching-away” because our PHOSITA would know to turn down the intensity.
Unfair Competition: Marketing Non-Approved Device: The CAFC reversed the dismissal of the California unfair competition claims — holding that California law provides a right of action on unfair competition even where the claim is based on violation of a law and the law does not provide for a private right of action.
DyStar’s patent discloses a process for dyeing textiles with catalytically hydrogenated leuco indigo. After a trial, the jury found that Patrick infringed claims 1–4, that the patent was not invalid, and that $90,000 of damages should be awarded.
Patrick appealed the lower court’s denial of a new trial on obviousness grounds. A new trial should not awarded when “a jury, viewing the evidence in the light most favorable to [DyStar], could have properly reached [its validity] conclusion.” The CAFC reviewed the denial for abuse of discretion. (Level of review based on Fourth Circuit law).
As is often the case, all the elements of DyStar’s invention were already known in the art — the question was whether there was some obvious motivation to combine the prior art together.
Suggestion to Combine: In recent weeks, we have seen a common thread in CAFC jurisprudence indicating that “the suggestion test is not a rigid categorical rule.” Rather, the suggestion to combine references can be found from “any number of sources, including common knowledge, the prior art as a whole, or the nature of the problem itself.”
It is difficult to see how our suggestion test could be seen as rigid and categorical given the myriad cases over several decades in which panels of this court have applied the suggestion test flexibly. Obviousness is a complicated subject requiring sophisticated analysis, and no single case lays out all facets of the legal test. DyStar’s argument and the above-cited commentary highlight the danger inherent in focusing on isolated dicta rather than gleaning the law of a particular area from careful reading of the full text of a group of related precedents for all they say that is dispositive and for what they hold. When parties like Dystar do not engage in such careful, candid, and complete legal analysis, much confusion about the law arises and, through time, can be compounded.
Holding: Claims are obvious
In a footnote, the Court defends its KSR decision — a decision currently being briefed at the Supreme Court.
In KSR, we vacated a district court’s grant of summary judgment of invalidity for obviousness. The district court found a motivation to combine not in the references but “largely on the nature of the problem to be solved”, which we did not deem erroneous. Teleflex, Inc. v. KSR Int’l Co., 119 Fed. App’x 282, 287 (Fed. Cir. 2005) (unpublished). Rather, we vacated because the court did not explain sufficiently its rationale, and failed to make “findings as to the specific understanding or principle within the knowledge of a skilled artisan that would have motivated one with no knowledge of [the] invention to make the combination in the manner claimed.” Id. at 288 (citation omitted).
In an impressive history (that is begging for a full analysis), the CAFC sets out the full scope of the flexibility of the suggestion test and notes how the test is well grounded in Supreme Court jurisprudence and has always been flexible. This is one for the casebooks.
Alza holds the patent on a once-daily controlled release oxybutynin formulation used to treat urinary incontinence. (U.S. Patent No. 6,124,355). Alza’s formulation is sold as Ditropan XL®. Mylan wants to sell a generic version and challenged the patent, and the district court obliged by finding the patent invalid as obvious.
In affirming the obviousness finding, a unanimous decision penned by Judge Gajarsa presents its defense of the much criticized teaching/suggestion/motivation test (TSM Test) for obviousness that is currently on review before the Supreme Court in the Teleflexcase.
The meat of the opinion begins with a reminder that the motivation test did not arise with Federal Circuit, but rather that the making of the CCPA. The 1943 case of Fridolph, for instance, instructs that when “considering more than one reference, the question always is: does such art suggest doing the thing the [inventor] did.”
Next, the opinion explains that the TSM test “has been developed consistent with the Supreme Court’s obviousness jurisprudence as expressed in Graham and the text of [Section 103(a)].” The court explains that the purpose of the proof portion of the TSM test test is to avoid the problem associated with hindsight. The theory is that obviousness “should be based on evidence rather than on mere speculation or conjecture.”
Many of the briefs in Teleflex argue that the TSM test is “rigid.” In Alza, the court disagreed, arguing that the test is flexible “because a motivation may be found implicitly in the prior art.” (emphasis in original).
We do not have a rigid test that requires an actual teaching to combine before concluding that one of ordinary skill in the art would know to combine references. This approach, moreover, does not exist merely in theory but in practice, as well. Our recent decisions in Kahn and in Cross Medical Products amply illustrate the current state of this court’s views.
In Kahn, the court emphasized the availability of implicit proof of a motivation to combine references, and in Cross Medical, the court found that motivation could come from “general knowledge.”
In this case, the patent holder Alza argued that back in 1995, there was no suggestion to try (or likelihood of success of) using controlled release pills because nobody thought that the formulation could be absorbed in the colon. Defendant Mylan relied on an expert witness who testified that back in 1995 there would have been a reasonable likelihood that a controlled release pill would work – and thus that there was a motivation to try it. Alza presented some references that suggested that controlled-release pills might not work, but those did not specifically discuss absorption of the type of molecule contained in Ditropan.
Based on the expert testimony, the lower court agreed that the TSM test had been satisfied and that the patent was invalid as obvious. The appellate panel affirmed on a clear error standard, finding that:
we cannot perceive clear error in the district court’s factual findings that while colonic absorption was not guaranteed, the evidence, viewed as a whole, is clear and convincing that a person of ordinary skill in the art would nonetheless have perceived a reasonable likelihood of success and that she would have been motivated to combine prior art references to make the claimed invention.
Doesn’t anyone think that debates over “combinations of references” are outdated? I usually only use one reference — Google. Occasionally I combine Google with a directed PTO search — although even that will likely become more rare as Google continues to digest and index the history of written word. We are information rich, and arguments that exclude certain bits of knowledge from “prior art” based on inaccessibility do not make sense when that information was freely available online and indexed by Google.
On another note, in the current regime, where the Internet is not a single reference, couldn’t a showing that two references would have both been retrieved with a single Google search serve as evidence of a motivation to combine the two?
Of course, these teasers suggest a new business model: Archiving of Google search results for later use during litigation.
Abbott Labs v. Andrx Pharma (Fed. Cir. 2006, 05–1433).
Abbot was awarded a preliminary injunction (PI) against Teva to stop alleged infringement of its patents relating to extended release clarithromycin. The CAFC reviewed that holding for abuse of discretion or clear error.
Looking at the prior art, the lower court found no motivation to combine several prior art references that discussed azithromycin rather than clarithromycin. On appeal, the CAFC found the motivation in the form of an implicit admission made by Abbott in one of its prior patents. In that prior patent, the specification discussed only clarithromycin, but the claims were directed at both azithromycin and clarithromycin.
Because the [earlier Abbott] patent explicitly discloses only clarithromycin controlled release compositions, yet claims azithromycin compositions, we conclude that Abbott has represented to the U.S. Patent and Trademark Office ("PTO") that the differences between clarithromycin and azithromycin were such that azithromycin could be substituted into a controlled release clarithromycin composition by a person of ordinary skill in the art without undue experimentation.
Based on the earlier Abbott patent, the CAFC found a substantial argument that a jury could find a motivation to combine the references with a reasonable expectation of success.
Regarding potential irreparable harm, the CAFC held that direct competition “alone does not establish that Abbott’s harm will be irreparable.”
And, on the question of public interest, the appellate panel “agree[d] with the district court that the public is best served by enforcing patents that are likely valid and infringed.” But, because of the chance that Abbott’s patents are invalid, the panel concluded “that the public interest is best served by denying the preliminary injunction.”
In dissent, Judge Newman argued that the majority opinion constituted de novo rule and did not give significant deference to the lower court — as is required by law.
My colleagues do not discuss the trial judge’s careful explanations, but, upon finding that Teva has raised a "substantial question" about patent validity, they hold that Teva should be permitted to practice the Abbott invention before patent validity is decided. With all respect to my colleagues’ concerns, they misapply not only the criteria of the preliminary injunction but also the standard of appellate review.
Newman argues that the criteria used by the majority for determining likelihood of success on the merits were not correct:
Thus my colleagues conclude that claim 4 of the ‘718 patent is "vulnerable to allegations of invalidity," and find "a substantial argument" as to other claims. These are not the criteria of likelihood of success.
Lawman Armor v. Winner Int’l (Fed. Cir. 2006, en banc).
In February 2006, the Federal Circuit decided Lawman Armor in a way that utterly devalued design patents. The decision appeared to read a design patent would never be enforceable if the patent was simply a novel combination of known elements. Essentially, the decision held that, for the point of novelty test, multiple prior art references could be combined without any prior suggestion or motivation for doing so. As noted in the AIPLA’s amicus brief requesting rehearing, if this result were true, there would be very few enforceable design patents because most (if not all) designs are combinations of old forms.
On motion for rehearing and rehearing en banc, the original CAFC panel issued a new opinion intended to “clarify” the original:
In our [original] decision, we did not intend to cast any doubt upon our prior decisions indicating that in appropriate circumstances a combination of design elements itself may constitute a ‘point of novelty.’ Such a combination is a different concept than the overall appearance of a design which, as indicated, our cases have recognized cannot be a point of novelty.
Thus, the result:
A unique combination of known elements may be a “point of novelty” for design patent infringement analysis; but
The “overall appearance” of a design cannot serve as such a “point of novelty.”
As one of the attorneys of record pointed out to me in a post-decision conversation, this distinction does not make sense for this case because the Appellant never argued that the point of novelty was simply the “overall appearance.” Rather, the Applicant set forth eight constituent elements and also argued that the combination of those elements was a ninth point of novelty.
Judge Newman, joined by Judges Rader and Gajarsa would have heard the case in an en banc panel. In a dissenting opinion, those judges argue that the overall appearance of a design should be sufficient to constitute patentable novelty:
The patentability of a design is determined on statutory criteria, as for all patents. The protocol called "point of novelty" has often aided the analysis of the application of these criteria to designs, but it is not a different concept from patentability based on the invention — the design — as a whole, and has not replaced the statutory provisions. Contrary to the panel’s view, the overall appearance of a design can indeed be novel, and can indeed constitute the patentable novelty.
Over at the Shape Blog, Boston attorney John Welch has been writing about the fallout after the Federal Circuit’s design patent decision in Lawman Armor v. Winner International. In that case, the appellate panel determined that the “point of novelty” test for design patent infringement is focused entirely on individual points of novelty, gives no weight to the resulting novelty-by-combination, and requires no suggestion or motivation to combine prior art references.
The technology-at-issue here is a steering wheel lock design similar to “The Club”
Lawman recently filed a petition for rehearing, and, in addition, Nike and the Industrial Design Society of America (IDSA) have each filed an amicus brief in support of a rehearing. The AIPLA is reportedly planning to file as well. This CAFC decision takes the wind out of design patents and leaves them quite weak. The petition for rehearing hopes to change that outlook. Winner’s responsive brief is due April 3, 2006.
Kahn’s voice synthesizer patent application was rejected by patent office as obvious over a group of four references. Kahn appealed:
Motivation to Combine: Most inventions involve “a combination of old elements” where each element is found somewhere in the prior art. However, the combination can be patentable as a whole if the combination creates something new and nonobvious. When rejecting a patent application as obvious based on multiple prior art references, the PTO must articulate the motivations for selecting references and combining them together. This has come to be known as the “motivation-suggestion-teaching” test.
[T]he “motivation-suggestion-teaching” test asks not merely what the references disclose, but whether a person of ordinary skill in the art, possessed with the understandings and knowledge reflected in the prior art, and motivated by the general problem facing the inventor, would have been led to make the combination recited in the claims.
Here, the CAFC found that the board had ‘substantial evidence’ to conclude that the asserted references could be combined because they were all directed to some form of word localization for the blind.
Although a reasonable person might reach the opposite conclusion, there is far more than a “mere scintilla” of evidence present from which a reasonable mind could find a motivation to combine.
Long-Felt but Unresolved Need: Kahn requested that the CAFC take ‘official notice’ of a long-felt but unresolved need for his invention as a way to overcome the obviousness rejection. The court, however, refused because “precedent requires that the applicant submit actual evidence of long-felt need, as opposed to argument.”
Lawman Armor v. Winner Int’l (Fed. Cir. 2006, 05–1253).
To show infringement, a design patent holder must satisfy two separate tests: (a) the ‘ordinary observer’ test and (b) the ‘point of novelty’ test.
The “ordinary observer” test requires comparison of the two designs from the viewpoint of the ordinary observer to “determine whether the patented design as a whole is substantially the same as the accused design.”
Under the “point of novelty” test, a court must determine whether “the accused device . . . appropriate[s] the novelty in the patented device which distinguishes it from the prior art.”
Regarding points of novelty — Lawman pointed to eight specific points of novelty of its patented design for the sliding hook portion of a vehicle lock. On summary judgment, the district court found that all eight points of novelty could be found in a combination of prior art references. As a consequence, the lower court ruled that the patent was not infringed.
Lawman appealed, arguing that there was no suggestion to combine the references in the art. The CAFC, however, affirmed, finding that, for the point of novelty test, multiple references can be combined without any prior suggestion or motivation for doing so.
What Lawman’s contention comes down to is that the D’621 patent contains a ninth “point of novelty,” namely, the combination in a single design of the eight non-novel “points of novelty” it embodies. This argument is inconsistent with, and would seriously undermine, the rationale of the “points of novelty” test.
By Brent Yamashita* 
As an example, imagine the following sequence of events: 
By Professor 
KSR than a critique of the need to rigorously (and expansively) evaluate what would lead a PHOSITA to combine certain references in the obviousness analysis. 
DyStar v. Patrick Co. (
Alza v. Mylan (Fed. Cir. 2006, 
Abbott Labs v. Andrx Pharma (Fed. Cir. 2006, 
Lawman Armor v. Winner Int’l (Fed. Cir. 2006, en banc). 
In re Kahn (Fed. Cir. 2006, 
”