Novartis Pharm. v. West-Ward Pharm.

Novartis Pharmaceuticals sued West-Ward Pharmaceuticals for patent infringement on  U.S. Patent 8,410,131 after Novartis filed its Abbreviated New Drug Application (ANDA), because West-Ward is seeking to make and sell a generic version of Novartis chemotherapy drug everolimus (a treatment method for solid tumors).

Novartis Pharm., Corp. V. West-Ward Pharm., Intl., Ltd. (Fed. Cir. 2019). Both the district court and the Federal Circuit found in favor of the patentee and adopted the “obviousness” test in this case.

The district court agreed that a person having ordinary skill in the art (PHOSITA) would have been motivated to pursue everolimus as a potential treatment for advanced solid tumors; however, this statement contradicted another district court statement “there was no motivation to combine the prior art.”

The Federal Circuit rejected the district court’s contradicted holding and agreed with the lack of “reasonable expectation of success” factor in the “obviousness” test.

Using the “obviousness” test, patent claims shall be invalid “if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made” to a person of ordinary skill in the art to which said subject matter pertains. 35 U.S.C. § 103(a).

Specifically, there are two factors to be considered: “Motivation to Combine” and “Reasonable Expectation of Success.” The Federal Circuit held that “Motivation to Combine” is not required for the obviousness test, and the district court erred in requiring the patentee to prove that a PHOSITA would have selected everolimus over any other prior art treatments.

In addition, the district court and the Federal Circuit both held that the claimed treatment method in this case would not have been obvious because the prior art did not appear to have sufficiently high “reasonable expectation of success,”; because these courts found that there was no clinical data on everolimus as an anti-cancer treatment and no completed trial for similar compounds.

Moreover, the district court found that there has been some promising attempts of finding a compound that may work as an anti-cancer treatment. Therefore, the Federal Circuit affirmed the district court’s decision for non-obviousness in this case.

Building on Abstract Ideas: Alice v CLS Bank

By Evan Jensen

In its much-anticipated Alice v CLS Bank decision the Supreme Court held that Alice’s software patent was patent-ineligible subject matter under §101. But in its decision the Supreme Court seems to have blended a §101 analysis with a §103 analysis. The Court seems to infer that well-known ideas, such as methods that are fundamental to modern economy, are abstract and therefore patent-ineligible under §101.

There is no debate that abstract ideas are not patentable subject matter. No one may claim exclusive rights to the idea of addition, or of binary-decimal conversion, or any other generic abstract mathematical or conceptual idea. To allow a patent on an abstract idea would preempt everyone else from using that idea, greatly discouraging innovation, which is contrary to the primary goals of the patent system. The issue is which software claims, or whether software claims in general, are made patent-ineligible by the Alice decision.

Continue reading Building on Abstract Ideas: Alice v CLS Bank

In re Hyon: Substantial Evidence Standard Helps Preserve Finding of Obviousness

By Chris Reaves

A recent appeal of a lengthy prosecution ended last week, when the Federal Circuit in In re Hyon, 102 USPQ2d 1889 (Fed. Cir. 2012) upheld the Board of Patent Appeals and Interferences (BPAI) findings that a person of ordinary skill would have reason to combine two references to create the invention at issue.  The Board’s decision, though possibly “flawed,” could not be found unreasonable under the applicable standard of review, emphasizing the challenge that patent prosecutors face in overcoming a factual finding.

Background

The applicants, Suong-Hyu Hyon and Masanori Oka, were granted U.S. Patent No. 6,168,626 on a specific type of “Ultra High Molecular Weight Polyethylene” (abbreviated throughout the patent and the opinion as “UHMWPE”), and on the method for creating these material.  The inventors intended the material to be used for artificial joints although the claims were not limited to this embodiment.  The patent had only eleven claims, with limitations such as thickness of the UHMWPE and orientation of the crystal planes within.

Deciding these limitations were unnecessary, the applicants filed a reissue application (No. 10/643,674) within the two-year window, cancelling the original claims and adding several dozen new claims.  These new claims generally consisted of a method of four steps:

(a) crosslinking an ultra high molecular weight polyethylene block having a molecular weight not less than 5 million by irradiating the block with a high energy radiation at a level of at least 1 MR;

(b) heating said crosslinked block up to a compression deformable temperature below the melting point of the UHMWPE;

(c) subjecting said heated block to pressure; and then

(d) cooling said block.

(All claims to the UHMWPE material itself were eventually cancelled voluntarily.)

The examiner rejected all the reissue claims as obvious over two prior art patents, “Zachariades” and “Kitamaru” (Patent Nos. 5,030,402 and 3,886,056, respectively).  As the applicants acknowledged, Zachariades contained all the steps of the applicants’ claims, but in a different order – irradiation occurred after cooling.  (The exact radiation levels and molecular weights also varied, but not to a degree that the examiner thought relevant, and the applicants did not address this difference before either the Board or the Federal Circuit.)  Kitamaru, meanwhile, used a somewhat different method to prepare UHMWPE for use in films and sheets, but it began the process with an irradiation step.  The examiner found that it would be obvious to take the teaching of Kitamaru, to begin with the irradiation crosslinking, and apply it to Zachariades.

The applicants appealed to the Board of Patent Appeals and Interferences, arguing that there was no motivation to combine the references.  The Board, however, affirmed the rejection, and the applicants appealed again to the Federal Circuit.

Ruling: Board Had Substantial Evidence to Support Finding

The majority opinion, written by Judge Bryson and joined by District Judge Jeremy Fogel (N.D. Cal., sitting by designation), opened by recalling that “existence of a reason for a person of ordinary skill to combine references” is a factual finding, reviewed under the “substantial evidence” standard.

Examining the applicants’ arguments, the majority first rejected the suggestion that the prior art came from “fundamentally different material technologies.”  Both patents spoke to the preparation of UHMWPE products, and although each focused on different embodiments, “[n]either reference limits the structure of the UHMWPE product that can be made”.

The majority also found arguments that Zachariades taught against irradiating before molding, or that the examiner and Board had cherry-picked one aspect of Kitamaru to combine with Zachariades, unconvincing.  Although its claims were limited to irradiating after molding, nowhere had Zachariades stated that the opposite was unfeasible or inadvisable.  More importantly, Kitamaru had emphasized that irradiation before molding was the key to creating desired improvements in UHMWPE, namely “a higher melting or softening point, improved transparency, and excellent dimensional stability.”  Therefore, the suggestion to select that element from the reference was in the reference itself.

Judge Newman, in dissent, found it telling that Kitamaru predated Zachariades (indeed, the former issued over a decade before the latter was filed).  It was therefore “noteworthy that Zachariades, seeking mechanical strength and dimensional stability, did not follow the known Kitamaru processing sequence, but instead crosslinked the polyethylene after deformation”.  Newman found this sufficient to show that a person of ordinary skill would not find the results of the combination predictable; had it been obvious to combine, Zachariades would have already done it in his own patent.  The Board, she concluded, had engaged in impermissible hindsight analysis, “reasoning backward from” the patent at issue to see what Zachariades himself had not.

Analysis: Don’t Directly Challenge a “Reason to Combine” Finding

The majority emphasizes the standard of review in its decision.  “Substantial evidence,” a standard used in review of factual findings by both juries and quasi-judicial agency decisions, requires deference to the Board’s decision unless it was without “such relevant evidence as a reasonable mind might accept as adequate to support [the] conclusion” (Universal Camera Corp. v. NLRB, 340 U.S. 474).  In other words, unless no reasonable fact-finder could come to the same conclusion given the same evidence, the appellate court will affirm.

Given this emphasis, the standard was likely what tipped the court.  The applicants may have presented a sufficiently convincing case under a preponderance standard, but could not show that the Board’s decision was “unreasonable.”  (Notably, the dissent did not mention the standard of review once, merely calling the Board’s reasoning “flawed”.)

The substantial evidence standard reminds prosecutors that the Board hearing is the stage to win questions of obviousness.  A Circuit panel with a clear focus on this standard is highly unlikely to overturn such a finding, so prosecutors should treat the Board as their only chance.  Should that fail, however, a prosecutor can also focus more energy on the meaning of claims, both prior art and present, which are reviewed de novo.  Finally, although expensive, a § 145 civil action can reset the entire record and remove all deference (see the recent Kappos v. Hyatt, 132 S.Ct. 1690), should the applicant be in true need of a do-over.

The opinion is available at: http://www.cafc.uscourts.gov/images/stories/opinions-orders/11-1239.pdf

Oral arguments may be heard at: http://oralarguments.cafc.uscourts.gov/default.aspx?fl=2011-1239.mp3 (NOTE: the Federal Circuit’s oral argument database has been inconsistently accessible as of this article’s posting)

Federal Circuit Reaffirmed Lead Compound Analysis for Evaluating Obviousness of a New Chemical Compound

James Jang

In Otsuka Pharmaceutical Co. v. Sandoz, Inc., 678 F.3d 1280 (Fed. Cir. 2012), the Federal Circuit affirmed the decision of the district court that the patent was not obvious based on prior art evidence, nor the asserted claims were invalid for nonstatutory double patenting.

The Defendants are drug manufacturers who submitted ADNA filings to the Food and Drug Administration (FDA) for an approval to manufacture, use, or sale of generic aripiprazole products. Otsuka Pharmaceutical Corporation brought action against the drug manufacturers for infringement of patent on the compound claimed in Patent No. 5,006,528, aripiprazole, an atypical antipsychotic compound approved by the FDA for the treatment of schizophrenia. The Defendants counterclaimed that the patent was invalid for obviousness and nonstatutory double patenting. The Federal Circuit analyzed three ‘lead compounds’ asserted by the Defendants, unsubstituted butoxy compound, 2,3-dichloro propoxy compound, and OPC-4392 compound. A ‘lead compound’ means “a compound in the prior art that would be most promising to modify in order to improve upon its … activity and obtain a compound with better activity.” Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.d 1350, 1357 (Fed. Cir. 2007). The patents which disclosed the lead compounds, unsubstituted butoxy and 2,3-dichloro propoxy, also disclosed numerous examples of agents useful for the central nervous system, including an antischizophrenia agent.

In its ruling, the Federal Circuit reaffirmed the lead compound analysis, employed in Takeda Chemical Industries and Eisai Co. v. Dr. Reddy’s Labs, 533 F.3d 1354 (Fed. Cir. 2008) for evaluating obviousness of a new chemical compound, which were the first two lead compound cases decided post-KSR. The Federal Circuit explained that the lead compound analysis consists of a two-part inquiry:

First, the court determines whether a chemist of ordinary skill would have selected the asserted prior art compounds as lead compounds, or starting points, for further development efforts . . . . The second inquiry in the analysis is whether the prior art would have supplied one of ordinary skill in the art with a reason or motivation to modify a lead compound to make the claimed compound with a reasonable expectation of success.

The Federal Circuit also noted that for the lead compound selection, mere structural similarity between a prior art compound and the claimed compound is not enough, but it should be guided by the compound’s “pertinent properties.”

Applying this approach, the Federal Circuit rejected the Defendant’s argument that the lead compound analysis applied by the district court was a “rigid” obviousness analysis precluded by KSR because the court assumed that only the most obvious choice could serve as a lead. The Federal Circuit found that after evaluating all of the potential choices available to one of ordinary skill the district court correctly determined that the compounds asserted by the Defendants, unsubstituted butoxy, 2,3-dichloro propoxy, and OPC-4392, would not have been selected as lead compounds. Furthermore, focusing on the pertinent property of the new compound, rather than the structural similarity, Federal Circuit found that two other compounds — clozapine and risperidone — were viable lead compounds because these were the only capable antipsychotic compounds at the time of the invention. The Federal Circuit concluded that the Defendants failed to prove that the patent would have been obvious under 35 U.S.C. § 103.

The ruling in Otsuka Pharmaceutical Co. might be seen as the Federal Circuit’s return to the “rigid” motivation rules precluded by KSR.1 However, It appears that the Federal Circuit attempted to avoid this concern by addressing that to keep with the “flexible” nature of the obviousness inquiry, “the reason or motivation for modifying a lead compound may come from any number of sources and need not necessarily be explicit in the prior art.” This is consistent with the rulings in the previous chemical compound cases after KSR, such as Eisai Co. v. Dr. Reddy’s Labs, where Judge Rader found that the decision in KSR for flexibility would not preclude the Federal Circuit from assessing motivation in the case. Thus, the post-KSR chemical compound cases may imply that the flexible motivation test is still viable.2

“Laundry List” of potential effects is not sufficient to prove the obviousness

The Federal Circuit also rejected the Defendants’ argument that the three lead compounds asserted by the Defendants were known to have antipsychotic activity so that the claimed compound, aripiprazole, would have been obvious to one of ordinary skill. The Federal Circuit found that the patents’ “laundry list” of the potential central nervous system controlling effects, would not have informed one of ordinary skill in the art that the three compounds would have antipsychotic activity.

Nonstatutory Double Patenting

The double patenting doctrine is a judicially created doctrine “precluding one person from obtaining more than one valid patent for either (a) the ‘same invention,’ or (b) an ‘obvious’ modification of the same invention.” In re Longi, 759 F.2d 887, 892. The latter is referred to as the obviousness-type double patenting. The Federal Circuit differentiated obviousness-type double patenting from obviousness under § 103 by addressing that when examining the obviousness-type double patenting in chemical compound cases, the earlier-filed application need not qualify as prior art and “the issue is not whether a skilled artisan would have selected the earlier compound as a lead compound.” However, the Federal circuit rejected the Defendants’ argument that the double patenting never requires identifying the motivation to modify the earlier claimed compound. The Federal Circuit noted that the identification of the reason for modification is an essential part of the question whether the two claimed compounds are “patentably distinct” in the obviousness-type double patenting analysis.

In concluding that the asserted claims were not invalid for obviousness-type double patenting, the Federal Circuit also noted that predictability is an important element to consider in the obviousness analysis. The Federal Circuit held that given the high degree of unpredictability in antipsychotic drug discovery at the time of the invention, “the prior art would not have provided a skilled artisan with a reason to make the necessary structural changes.”


1. Mark D. Janisal, Tuning the Obviousness Inquiry After KSR, 7 Wash. J. L. Tech. & Arts 335 at 344-45 (2012), available at http://digital.law.washington.edu/dspace-law/bitstream/handle/1773.1/1125/7WJLTA335.pdf?sequence=4.

2. Id. at 342-44.

Board of Patent Appeals and Interferences Rules on Indefiniteness of the Term “Substantially Filled,” Prima Facie Obviousness in an Engine Cooling Method

By Charles Pierce

In Ex Parte Evans et al. (Appeal 2011-004119; Application serial no. 11/823,993), the Board of Patent Appeals and Interferences reversed examiner rejections under 35 U.S.C. § 112 for indefiniteness, and 35 U.S.C. § 103(a) for obviousness.

Claim 1 of the patent states:

A method for cooling an internal combustion engine using a reduced toxicity, ethylene glycol and water based heat transfer fluid, said method comprising the steps of:

(a) formulating a heat transfer fluid comprising (1) a glycol component consisting of ethylene glycol and propylene glycol, wherein the weight of the propylene glycol is between 5% less to less than 30% of the total weight of the glycol component and wherein the glycol component is less toxic than 10,000 mg/kg on an acute LD50(rat) oral toxicity basis, and (2) water, wherein the water comprises between 40% and 70% by weight of the total weight of the heat transfer fluid; and

(b) substantially filling the cooling system of the internal combustion engine with the heat transfer fluid such that the heat transfer fluid absorbs heat that is produced by the internal combustion engine and releases the absorbed heat to the atmosphere. (emphasis added).

The examiner rejected this claim reasoning that because the term “substantially” is not defined, the specification does not sufficiently describe the invention such that a person of ordinary skill in the art would be reasonably apprised of its scope.  The board disagreed.  They noted that “substantially” was used to describe how much a cooling system should be filled, and any person skilled in the art would know what can be considered substantially filled.  The term “substantially” was used to avoid a strict measurement,  because slight variations in the amount of fluid may still be considered to have filled a cooling system.  The board decided that the claim was sufficiently definite.

The board also disagreed with the examiner’s obviousness rejections.  The examiner’s rejection was that the claims were prima facie obvious.  The board noted that no reference disclosed the weight range of the propylene glycol in the glycerol component, or the weight range of the glycerol in the polyhydric alcohol component.  Because the references also disclosed only the components of the invention, the board ruled that they were not enough for a person of ordinary skill in the art to create the claimed cooling method.

Federal Circuit finds Patent Obvious in view of Common Sense despite Objective Evidence

In Wyers v. Master Lock Co., 95 USPQ2d 1525 (Fed. Cir. 2010), plaintiff Philip W. Wyers (Wyers) sued defendant Master Lock Company (Master) for infringement of its patents for hitch pin locks.  Hitch pin locks are typically used to secure draw bars or tow-ball mount to a hitch receiver attached to a motor vehicle.  Wyers’ patents describe a barbell-shaped lock with a stop portion on one end, a locking head on the other end, and a shank portion which passes through the aligned apertures of the hitch receiver and the tow-ball mount.

The use of barbell-shaped locks and locks on trailer hitch receivers was well known in prior art.  Specifically, the prior art had examples of locks with a lock head, a shackle having a stop member, a shank, and a latch.  Moreover, the prior art also had examples of barbell-shaped locks being used as a trailer hitch receiver lock.

Wyers’ patents claim improvements to the prior art locks; mainly a removable sleeve to increase the shank’s diameter.  The removable sleeve allows adjusting the diameter of the shank which can be used with trailer hitch receivers of different apertures sizes.  The patent claims also include an external seal designed to protect the locking mechanism from contaminants.

At the trial level, the two main questions the court asked were “whether the use of the removable sleeve to adjust the operative thickness of a shank would have been obvious;” and “whether Master Lock presented clear and convincing evidence that the use of the external flat flange seal would have been obvious.” JMOL Order, 2009 WL 1309774 at 3 and 5.  The district court found held that plaintiff’s patents were not obvious and awarded $5.35 million in damages, $1.1 million in interest, and a 24% royalty for any infringing products Master sold based on Wyers’ patent.

On appeal, the parties agreed that the case turned on whether the claims were obvious based on prior art.  The court said that the issues in dispute were, “(1) whether the prior art references are in the same field of endeavor as the patented invention; (2) whether there was sufficient motivation to combine the references; (3) the existence and significance of pertinent secondary considerations.”

In reviewing the first question, the Federal Circuit noted that the test of whether the art is from the same field of endeavor is “(1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Comaper Corp. v. Antec, Inc., 596 F.3d 1343, 1351 (Fed. Cir. 2010) (quoting In re Clay, 966 F.2d 656, 658-59 (Fed. Cir. 1992)).”  The Federal Circuit noted that the jury at the trial court applied the wrong standard.  The correct standard is whether a person of ordinary skill in the field of locksmithing would find this improvement to be obvious, not the standard of a layman on a jury.  The appellate court, also said the prior art was relevant because the prior art was within the “same field of endeavor.”  The prior art was directed towards trailer-towing applications, as were most of Wyers’ patents.

On the second question as to whether there was motivation to combine the adjustable sleeve with the prior art barbell locks and whether there was motivation to combine the prior art locks with an external sealing mechanism, the Federal Circuit noted that the test is no longer strictly one of express motivations to combine.  KSR International Co. v. Teleflex, Inc., 550 U.S. 398 (2007).  “Common sense” is one standard when looking for a reason to combine references.  Moreover, the Federal Circuit noted that, while the facts supporting obviousness are to be determined by a jury, the ultimate question of whether the facts support “common sense” or reasons to make combinations are susceptible to resolution at summary judgment and motions JMOL.

In applying this standard, the Federal Circuit said that sleeves were used in prior art in a towing arrangement similar to a hitch receiver/tow bar arrangement, and could be combined with a barbell-shaped hitch pin lock in order to address different aperture sizes in standard hitch receivers.  In addition, the Federal Circuit noted prior art in the Down patent that “sleeves of different external diameter may be provided for the attachment of trailer towing eyes of different internal diameter.  When the sleeve is used, the pin accommodates larger diameter towing eyes; without the sleeve, the pin fits smaller ones.”    Thus, a person of ordinary skill in the art of locksmithing would have been likely put these two designs together.

The Federal Circuit concluded that “it was a mater of common sense to combine the Down patent with the prior art barbell locks in order to arrive at the invention claimed in the [Wyers’ patents], and that one of ordinary skill in the art would have had a reasonable expectation of success in doing so.”

Furthermore, the Federal Circuit noted that “it is a matter of common sense that a flat external seal used in the prior art padlocks could be combined with a barbell-shaped hitch pin lock.”  This is because prior to Wyers’ filing, the concept of using external or internal seals to protect a lock’s head from contaminants, was widely known.

Lastly, in evaluating the effect of secondary considerations, the Federal Circuit noted that for objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention. In re Huang, 100 F.3d 135 (Fed. Cir. 1996); In re GPAC Inc., 57 F.3d 1573 (Fed. Cir. 1995).  Here, plaintiff could not prove that Master’s $20 million in sales of the accused product were the result of any of the supposed features of Wyers’ patents.  Further, there was no evidence of copying of Wyers’ design.  Thus, any secondary considerations here can not overcome a strong prima facie case of obviousness, as was the case here.

Significance for Patent Applicants and Owners

Rejections under 35 U.S.C. §103 using common sense as a basis are particularly perplexing for patent practitioners as what constitutes common sense appears to be a subjective test.  As is evident from the Federal Circuit’s analysis, the use of common sense is based upon an analysis of prior art within the record.  While such a robust record is expected in inter partes proceedings, however, it is unclear as to how Patent Examiners performing examination in an ex parte process would be able to develop a sufficient record to substantiate a prima facie burden.  Moreover, the United States Patent and Trademark Office has not provided examples of how such a conclusion would be made in its proposed Examination Guidelines Update: Developments in the Obviousness Inquiry After KSR v.Teleflex, Fed. Reg. Vol. 75, No. 169, pp. 53643 (September 1, 2010).  Thus, patent applicants should be mindful that, when faced with a rejection based upon common sense, the Examiner must still provide evidence supporting this conclusion and require this evidence as grounds of traversing the rejection.

 

Federal Circuit Finds Well Known But Undefined Claim Element Definite and Evidence of Copying a Secondary Consideration for Non-obviousness

Power-One, Inc. v. Artesyn Technologies, Inc., Docket No. 08-1501 & -1507 (Fed. Cir. March 30, 2010), Power-One, Inc. (“Power-One”) owns U.S. Patent No. 7,000,125 (the ‘125 patent).  The ‘125 patent relates to power supply systems which control, program and monitor point-of-load (POL) regulators. Each of the claims recites the use of POL regulators, but the specification does not specifically define the term “POL regulator”.

Artesyn Technologies, Inc. (“Artesyn”) sells a competing power control system, which Power-One asserts infringes the ‘125 patent.  At trial, the District Court defined the term “POL regulator” to be a “dc/dc switching voltage regulator designed to receive power from a voltage bus on a printed circuit board and adapted to power a portion of the devices on the board and to be placed near the one or more devices being powered as part of a distributed board-level power system.”  Based upon this definition, the jury found that the ‘125 patent was a valid patent, and that Artesyn infringed the ‘125 patent.

On appeal, Artesyn contended that the District Court’s definition of the POL regulator was unduly broad and that the term is indefinite.  Moreover, Artesyn appealed the District Court’s decision that the ‘125 was non-obvious.

Undue Breadth of District Court Definition

On the issue of whether the District Court’s definition was unduly broad, the Federal Circuit first cited to Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) for the rule that claim terms are “generally given their ordinary and customary meaning,” which is the meaning “a person of ordinary skill in the art . . . at the time of the invention” would give to a particular claim term.  In reviewing the specification, the Federal Circuit noted that the definition of POL regulator was supported by the intrinsic record.  Importantly, the Federal Circuit found that the definition adopted by the District Court provided sufficient meaningful guidance to the jury as to be definite and not unduly broad.  Specifically, the Federal Circuit has found that the terms “adapted to” and “near” can be definite, and the District Court was entitled to utilize these terms without rendering the resulting definition unduly broad as these terms are understandable in light of the ‘125 patent specification.  As noted by the Federal Circuit, “[t]he fact that the claim is not defined using a precise numerical measurement does not render it incapable of providing meaningful guidance to the jury because the claim language, when taken in context of the entire patent, provides a sufficiently reasonable meaning to one skilled in the art of distributed power systems.”

Definiteness of Undefined, Well-known Claim Term

Consistent with this holding, the Federal Circuit also found that the term “POL regulator” was definite for purposes of 35 U.S.C. §112, paragraph 2.  In making this determination, the Federal Circuit outlined the test for definiteness as being whether the claim boundaries are discernible to a skilled artisan based on the language of the claim, the specification, and the prosecution history, as well as the artisan’s knowledge of the relevant field of art. See Halliburton Energy Servs., Inc. v. M-1 LLC, 514 F.3d 1244, 1249-51 (Fed. Cir. 2008).”  The mere fact that the claim term may be difficult to understand or subject to some disagreement is not enough to find a claim indefinite.  Exxon Research & Eng’g Co. v. United States, 265 F.3d 1371, 1373 (Fed. Cir. 2001) (“if the meaning of the claim is discernible, even though the task may be formidable and the conclusions may be one over which reasonable persons will disagree, we have held the claim sufficiently clear to avoid invalidity on indefiniteness grounds.”).

In applying this standard, the Federal Circuit found that the intrinsic record did support the recited term “POL regulator”.  Specifically, the Federal Circuit found that the intrinsic record showed that POL regulators are well known devices in the field.  Since one of ordinary skill in the art would understand what a POL regulator does and how it operates, the Federal Circuit upheld the District Court’s decision that the term “POL regulator” is definite despite any express definition in the specification.

Nonobviousness of claims

On the issue of obviousness, the Federal Circuit upheld the District Court’s decision that the ‘125 patent was nonobviousness.  During trial, Artesyn asserted that the ‘125 patent was obvious based upon seven pieces of prior art, and testimony of its expert.   Power-One provided its own expert, as well as secondary considerations of non-obviousness.  The Federal Circuit found that the jury was entitled to credit Power-One’s expert at the expense of Artesyn’s expert on the issue of obviousness.

Further, the Federal Circuit noted that Artesyn’s primary argument was that each of the recited elements were known in the prior art.  In rejecting this argument, the Federal Circuit quoted the Supreme Court for the proposition that “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements is, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).  As such, to show obviousness, there needs to be evidence as to why the known arguments would have been combined.

Lastly, the Federal Circuit noted that the jury was entitled to take into account secondary considerations.  Specifically, Power-One put into evidence that Artesyn had copied Power-One’s patented design, which Artesyn then touted as an advancement in the industry on introduction of its copied product.  According to the Federal Circuit, “Artesyn’s contemporaneous reaction to Power-One’s invention, and the industry’s reaction, demonstrate the unobviousness of the invention disclosed in the ’125 patent.”  See Allen Archery, Inc. v. Browning Mfg. Co., 819 F.2d 1087, 1092 (Fed. Cir. 1987) (praise in the industry for a patented invention, and specifically praise from a competitor tends to “indicat[e] that the invention was not obvious”).  As such, the evidence of copying, as well as Artesyn’s own advertising represented an admission usable as a secondary consideration of nonobviousness.

Significance for Patent Owners and Applicants

In Power-One, the Federal Circuit provides a reminder that tests such as definiteness under 35 U.S.C. §112 and obviousness under 35 U.S.C. §103 are primarily factual inquiries to be based upon evidence, not formulaic rules.  Thus, claim terms are not rendered indefinite merely because they are undefined specifically in the specification so long as there is evidence that one skilled in the art would understand the meaning of the term.  Moreover, merely because each claim element is known does not render a claim obvious without evidence as to why the particular recited combination would be made.  Lastly, it is interesting to note that the Federal Circuit based its nonobviousness ruling, at least in part, on the fact that the infringer had copied the patented design as evidence of copying is not classically considered a secondary consideration.