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Obviousness in the U.S. Patent System

Monday, June 04, 2012
By Andriy Lytvyn

THE OBVIOUSNESS STANDARD IN THE UNITED STATES PATENT SYSTEM
AN ANALYSIS OF THE EVOLUTION OF THE OBVIOUSNESS STANDARD IN LIGHT OF THE RECENT CASE LAW WITH A FOCUS ON IN RE KUBIN AND SUBSEQUENT CASES
 

INTRODUCTION

 

Obviousness is the heart of the United States patent system. It is a hurdle every prospective patentee must overcome to convince the Patent Office that the claimed invention is worthy of a patent. Obviousness is often an infringer’s best chance to invalidate the patent. Understanding the nuances of the obviousness standard and navigating through its complex labyrinths are difficult challenges patent prosecutors, patent examiners, and patent litigators must face.

 

Obviousness is an amorphous concept and, like most amorphous concepts, is not susceptible to a clear definition. The Patent Act of 1952 states that a patent claim must fall as obvious when “the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art.”1 This standard is inherently ambiguous, and the difficulty of satisfying it has been fluctuating over the years. 

 

The policy of granting and enforcing patents only when inventions are more than mere obvious improvements of existing technology has very strong roots. In light of the ultimate purpose of the patent system to incentivize innovation, patent protection is unnecessary for routine inventions that would likely occur as a result of mundane technological evolution even in the absence of a patent system. Moreover, if patents were granted on every improvement, regardless of how insignificant, technological progress could stall because when a particular field gets covered with patents like land mines, potential innovators may become reluctant to enter that field due to a fear of inadvertently stepping on a mine and exploding in a devastating infringement lawsuit. 

 

At the same time, innovation is an incremental process where each new invention builds on what is already known. The obviousness standard functions as filter that separates the unpatentable “work of the skillful mechanic” from patentable inventions that are conceived through a high degree of “skill and ingenuity.”2 Accordingly, the nonobviousness hurdle must be set at an appropriate height: if the hurdle is too high, deserving inventions will become unpatentable, and incentive to innovate may diminish. In contrast, if the hurdle is too low, a flood of junk patents may increase the likelihood of an inventor becoming an infringer and ultimately deter innovation. Therefore, it is crucial that the obviousness bar is set at an optimal height—a near impossible task to achieve considering that scholars, judges, legislators, inventors, patent attorneys, and patent examiners all have different ideas of what constitutes the ideal obviousness standard.

 

EVOLUTION OF OBVIOUSNESS: FROM HOTCHKISS TO KSR

 

The key milestones in the history of the obviousness standard continue to influence the current development of the patent law and, accordingly, deserve a brief overview. The Supreme Court first formulated the obviousness standard in Hotchkiss v. Greenwood in 1851.3 The case involved doorknobs: wooden and metal knobs were known in the art, and the patent at issue essentially claimed substituting porcelain or clay for wood or metal.4 The court held that “there was an absence of that degree of skill and ingenuity which constitute essential elements of every invention” and on this basis invalidated the claim.5 This holding laid the foundation for the obviousness standard and became monumental for the development of the United States patent system.

 

Congress codified the nonobviousness requirement for patentability in § 103 of the Patent Act of 1952. The statute provides:

 

A patent may not be obtained . . . if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.6

 

This formulation of the nonobviousness standard has remained unchanged since 1952. The America Invents Act will bring one amendment: “at the time the invention was made” will be replaced with “before the effective filing date of the claimed invention,” reflecting the switch of the U.S. patent system from the first-to-invent to the first-to-file.7  The substance of § 103 will remain unchanged.

 

The first Supreme Court decision to interpret § 103 was Graham v. John Deere Co.8 The claimed technology involved an improved plow: the improvement over the prior art consisted of relocating one of the components to increase plow’s durability. 9 The Supreme Court stated that although the ultimate determination of obviousness is a question of law, obviousness analysis under § 103 involves several factual inquires: determining the scope and content of prior art, ascertaining the differences between the prior art and the claims at issue, and resolving the level of ordinary skill in the pertinent art.10 These factual inquiries have become known as the “Graham factors” and still constitute a key part of the obviousness analysis. Graham also established several relevant secondary considerations that may suggest that a claim is nonobvious: the non-exhaustive list includes “commercial success, long felt but unsolved needs, failure of others.”11 As the case law indicates, these secondary considerations can play an important role in establishing nonobviousness.

 

Graham also gave guidance as to what policy considerations must be taken into account regarding the obviousness standard. The Supreme Court stated that the obviousness analysis must be flexible and “should be amenable to a case-by-case development.”12 The Court recognized that there will be difficulties in applying the obviousness test, but nonetheless, expressed its belief that if lower courts follow the guidance laid down in Graham, their holdings will demonstrate “uniformity and definiteness which Congress called for in the 1952 Act.”13 It is noteworthy that the Supreme Court explicitly articulated its concern that there is a “notorious difference between the standards applied by the Patent Office and by the courts” and called on the PTO to restrict the “free rein often exercised by Examiners.” 14 The Court instructed the PTO to strictly adhere to the Graham’s interpretation of §103 of the Patent Act.

 

The Court of Customs and Patent Appeals, the predecessor of the Federal Circuit, set out to create a bright-line obviousness test to provide clear guidance to patent examiners. This rule became known as the teaching-suggestion-motivation (“TSM”) test and traces its origins to In re Moreton and Application of Bergel, which were both decided in 1961. The court used the following language to formulate the test: “[w]here  . . . knowledge of the art clearly suggests a [combination of known prior art elements to achieve the claimed invention], the mere possibility of failure does not render the claim unobvious.”15 

In the years that followed, the TSM test continued gaining importance and achieved the status of practically the exclusive test for obviousness. The Patent Office fully embraced the TSM test and incorporated it into section 2143 of the Manual of Patent Examining Procedure (“MPEP”).16

 

The MPEP instructed patent examiners that to establish prima facie case of obviousness three requirements must be met: 

 

First, there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings. Second, there must be a reasonable expectation of success. Finally, the prior art reference (or references when combined) must teach or suggest all the claim limitations.17 

 

 

Many prosecuting patent attorneys supported the TSM test as it provided a bright-line rule that placed clear boundaries on patent examiners’ discretion and precluded hindsight. 

 

In 2007, the Supreme Court sent an earth-shattering wave though the patent system when it decided KSR v. Tleleflex.18 The patent at issue was in the field of mechanical arts, and the claimed invention was a combination of two prior art elements: a position-adjustable accelerator pedal and an electronic position sensor attached to the pedal assembly.19 The district court invalidated the claim as obvious, but the Federal Circuit reversed on the ground that there was no specific reference teaching or suggesting the claimed combination, and therefore, the claim was nonobvious because it passed the TSM test.20 

The Supreme Court reversed, denouncing the Federal Circuit’s application of the TSM as too rigid and formalistic.21 The Supreme Court criticized the Federal Circuit for limiting the obviousness analysis to an impermissibly narrow inquiry by placing an “overemphasis on the importance of published articles and the explicit content of issued patents.”22 The Court noted that although the TSM test is not necessarily inconsistent with the Graham analysis, the Federal Circuit and the PTO have been applying the TSM test in a way that departs from the Graham obviousness framework.23 KSR, however, did not completely reject the TSM test, only its status as an exclusive test for obviousness.24  

 

KSR resurrected a different obviousness standard—the “obvious to try” test.25 The test has three prongs: first, there must be a design need or market pressure to solve a problem; second, there must be a “finite number of identified, predictable solutions;” third, PHOSITA must have a good reason to pursue a solution that would lead to anticipated success.26 In light of KSR, the “obvious to try” standard has become the cornerstone of the modern obviousness analysis.

 

THE OBVIOUSNESS STANDARD AT THE USPTO

 

The United States Patent and Trademark Office (“PTO”) is bound by the statutory and case law. Accordingly, when the Supreme Court denounced the TSM test as the sole criterion for establishing obviousness, the PTO responded by amending the MPEP. The PTO expanded the list of appropriate bases for an obviousness rejection from a single three-prong TSM test to a non-exhaustive list of seven broad rationales, demoting the TSM test to the very end of the list.27 This expansion placed an enormous amount of discretion in the hands of the patent examiners, and many patent attorneys are concerned.

The PTO has limited resources and is overburdened with work. Bright-line rules facilitate uniformity and predictability. They also streamline the patent prosecution process and reduce the costs to inventors and backlogs at the Patent Office. Moreover, even the Supreme Court has recognized that “the free rein often exercised by Examiners” is undesirable and problematic.28  These concerns point to a need for reforming the obviousness standard, at least at the PTO level. Perhaps having two separate standards—a rigid one for the patent examiners and a flexible one for the courts—could be a possible solution. Admittedly, such a solution could lead to a hoist of potential problems, but it would also put a number of issues to rest. This would be an interesting topic for legal research, but it is beyond the scope of this paper

 

THE ”OBVIOUS TO TRY TEST AFTER KSR AND IN RE KUBIN

 

KSR brought some major changes to the obviousness analysis. However, KSR left answered a question of how these changes would affect patentability of inventions in the fields of unpredictable arts. The Federal Circuit addressed this issue head on in In re Kubin.29 

 

Kubin involved a “classic biotechnology invention—the isolation and sequencing of a human gene that encodes a particular domain of a protein.”30 The protein was known in the art, and so were the methods for isolating and sequencing polynucleotides. The patent examiner rejected Kubin’s claims as obvious, and the Board of Patent Appeals affirmed the rejection. Kubin appealed to the Federal Circuit. 

 

The issue of applicability of the “obvious to try” test to the unpredictable arts laid at the heart of Kubin. The Federal Circuit revisited its holding in In re Deuel, a case involving an isolated DNA encoding a known protein, which explicitly rejected the “obvious to try” test.31 The Federal Circuit overturned Deuel and reaffirmed the resurrection of the “obvious to try” standard, stating that the “obvious to try” test is indeed a proper obviousness standard, albeit with two important exceptions.32

 

The Federal Circuit referred to its decision in In re O’Farrell, a case predating Deuel, to explain these exceptions. First, the “obvious to try” test is inapplicable to cases where numerous possible solutions exist, and the prior art provides no guidance as to which solution is likely to be successful.33  Second, the “obvious to try” test is improper when the prior art gives only general guidance to explore a new technology or a promising field of experimentation but does not contain “detailed enabling methodology.”34

Kubin has several important implications for patent prosecution. The Federal Circuit refused to limit KSR to predictable arts and extended the “obvious to try” test to the unpredictable arts.35 Accordingly, Kubin provided patent examiners with bases for obviousness rejections that were previously foreclosed to them, and good patent attorneys should be prepared to make persuasive arguments traversing these rejections. Kubin established two platforms for such arguments: (1) numerous possible solutions and no guidance as to which one might work, and (2) experimentation in a promising field when prior art provides only general guidance. These platforms are quite broad and may serve as a solid foundation for building a convincing response to a § 103 rejection.

 

At a first glance, Kubin seems to erase all distinctions between predictable and unpredictable arts for the context of the obviousness analysis. However, a subsequent case involving a pharmaceutical patent, Eisai Co. v. Dr. Reddy’s Labs., reasserted this distinction.36 The second prong of the “obvious to try” test requires that there is a “finite number of identified, predictable solutions,” and in Eisai, the Federal Circuit stated that for the unpredictable arts, “potential solutions are less likely to be genuinely predictable” and therefore, may present a “difficult hurdle” for patent examiners.37 In light of this language, “obvious to try” test has had “less practical impact on the pharmaceutical industry, in which patents often involve the generally unpredictable interactions of various chemicals.”38 

 

In Ortho-McNeil Pharm. v. Mylan Labs., a case involving a successful epilepsy drug unexpectedly discovered during a search for new anti-diabetic drugs, the Federal Circuit stated that obviousness is found only when there is “a finite, and in the context of the art, small or easily traversed, number of options.”39 This language has a dual significance for patent prosecution. First, the issue of whether the number of possible identified solutions is finite must be addressed in the context of the relevant art. Second, the Federal Circuit shines light on the meaning of the term “finite number” by defining the term as a “small, or easily traversed number.”40 Both of these ramifications of Ortho-McNeil lower the nonobviousness hurdle in favor of patentability, especially for arts where potential combinations are numerous and the art is “unpredictable.”

In re Brimonidine Patent Litigation provides an excellent insight into how the Federal Circuit perceives the resurrected “obvious to try” test.41 The facts of the case were as follows: the appellee, Allergan, had several patents covering its glaucoma drug Alphagan P, which was an improved version of the original drug Alphagan. Essentially, the improved version had a higher pH, lower concentration of the active ingredient brimonidine, and contained a preservative SCD and a solubility-enhancing component CMC. Both SCD and CMC were components of an existing artificial tears solution, Refresh Tears, also owned by Allergan. The main benefits of Alphagan P were reduced risk of allergic reactions to brimonidine and decreased discomfort of the eyes. 

 

Four of the five patents covering Alphagan P essentially claimed the combination of original drug Alphagan and Refresh Tears. With respect to those patents, appellant argued that the combination would have been obvious to try, and therefore, claims reciting the combination are invalid for obviousness.42 In supports of its position, appellant relied on evidence showing that Aphagan and Refresh Tears were often prescribed together. Furthermore, there was a strong market pressure to reduce the brimonidine concentration of Aphagen to lower the risk of allergic reactions, and increasing pH was a known way of accomplishing that.43 

 

The Federal Circuit did not directly address these arguments; instead, the court explicitly stated that “obvious to try arguments, based on KSR, are unavailing” when there is no “anticipated success.”44 Skepticism of experts may create “roadblocks” that would deter PHOSITA from trying the combination, thus favoring a finding of nonobviousness.45 The Federal Circuit stated that the fact that two drugs were commonly prescribed together is insufficient to establish that their combination in a single formulation would have been obvious under the “obvious to try” test.46 The Federal Circuit focused on the “anticipated  success” language of KSR, and concluded that a possibility that the combination of two drugs may be incompatible or infective buttressed by an expert testimony that PHOSITA would be hesitant to try the combination warranted a finding of nonobviousness.47

 

This opinion of the Federal Circuit may be interpreted as stating that a combination of known elements is not necessarily obvious when some doubt is cast upon the “anticipated success” by a mere possibility of failure. As Judge Dyk argued in his dissent, the “anticipated success” standard lowers the threshold for nonobviousness from the one stated in O’Farrell and Kubin and departs from the “reasonable expectation of success” standard embodied in MPEP 2143.48 As stated in O’Farrell and reiterated in Kubin, the “obvious to try” standard “does not require absolute predictability of success . . . all that is required is a reasonable expectation of success.”49 Judge Dyk criticized the majority for deviating from O’Farrell and Kubin by shifting the third prong of the “obvious to try” test from a “reasonable expectation of success” to the “anticipated success.”50 

 

This shift, however, is not unprecedented. In Rolls-Royce v. United Technologies, the Federal Circuit emphasized that “[t]he important question is whether the invention is . . . an “anticipated success.””51 This seemingly subtle dissonance between the “reasonable expectation of success” language adopted by the PTO and the “anticipated success” standard applied by the Federal Circuit may turn into a powerful weapon in the hands of a good patent attorney.

 

What are the ramifications of In re Brimonidine Patent Litigation for the patent prosecution? The Federal Circuit lowered the obviousness hurdle for patent applicants and gave patent attorneys a basis for an argument to traverse obviousness rejections when the probability of success of a claimed combination does not rise to a level of an “anticipated success.”  Even when an examiner can point to a strong market pressure or other motivation for trying the claimed combination, references teaching away from the combination or expressing some skepticism may be sufficient to establish nonobviousness. The Federal Circuit places much emphasis on keeping the hindsight out of the obviousness analysis, and skepticism of experts is a strong indication that the invention would not have been obvious to PHOSITA at the time the invention was conceived.

 

Summarizing the above analysis, as embodied in the MPEP 2143, the “obvious to try” test has three prongs: (1) a recognized problem, (2) a finite number of identified, predictable solutions, and (3) a reasonable expectation of success.52 The first prong is fairly straightforward and does not avail itself to many challenges at the patent prosecution stage. The second prong, as interpreted by the Federal Circuit, may be a weak spot of an “obvious to try” rejection, especially for the inventions in the field of the unpredictable arts. With respect to the third prong, the standards applied by the PTO and the Federal Circuit appear to diverge. Based on the case law, the heightened “anticipated success” standard may cause some “obvious to try” rejections to crumble under the weight of a reference teaching away from the invention even when the first two prongs of the test are satisfied. Finally, as the case law continues to develop, patent attorneys should remain vigilant as seemingly subtle developments may become major game changers.  

 

THE TSM TEST IN THE POST-KSR ERA

 

Even after the criticism the Supreme Court unleashed upon the TSM test in KSR, the Federal Circuit is unwilling to denounce this test. Although KSR significantly diminished the significance of the TSM test, the Supreme Court left a string of hope by stating that there is “no necessary inconsistency between the idea underlying the TSM test and the Graham analysis.”53 The Federal Circuit has latched on to this string and with a skill of a spider has been pulling the TSM back into the spotlight. 

 

§ 103 requires that obviousness is evaluated at the time of the invention, which means that hindsight is impermissible in the obviousness analysis. Not falling victim to hindsight is no easy  task for the patent examiners, and insisting on a showing of a teaching, suggestion, or motivation that existed prior to the date of the invention is an effective method for curtailing the hindsight. However, the Supreme Court left little room for a rigid pre-KSR TSM test, and, accordingly, the Federal Circuit responded by injecting some flexibility into the TSM analysis.54  

 

Ortho-McNeil, a case discussed in the previous section, contains important language regarding the TSM test. In Ortho-McNeil, the Federal Circuit made the following statement: “a flexible TSM test remains the primary guarantor against a non-statutory hindsight analysis.”55 The court elaborated that “[t]he TSM test, flexibly applied merely assures that the obviousness test proceeds on the basis of evidence—teachings, suggestions (a tellingly broad term), or motivations (an equally broad term)—that arise before the time of invention as the statute requires.”56

 

The Federal Circuit continued developing the flexible TSM test in Rolls-Royce, PLC v. United Technologies Corp., a case involving an invention in mechanical arts—an improved fan blade that increased the efficiency of an airplane engine.57  The key issue of the case was determining whether Rolls-Royce’s claims were obvious in light of UTC’s claims. When addressing the issue, the Federal Circuit reiterated that even after KSR, the TSM test remains quite important because it precludes hindsight in the obviousness analysis.58 Just as in Ortho-McNeil, the Federal Circuit emphasized that “[the] court flexibly seeks evidence . . . in the form of some teaching, suggestion, or even mere motivation (conceivably found within the knowledge of an ordinarily skilled artisan).”59 

 

This flexible formulation of the TSM test departs significantly from its pre-KSR version. In response to the Supreme Court’s criticism that the TSM analysis has become too formalistic, the Federal Circuit has showed willingness to apply the TSM test flexibly to avoid complete abandonment of this test. In the post-KSR era, as evidenced by the language in Ortho-McNeil and Rolls-Royce, the terms “teaching, suggestion, or motivation” are given much broader scope, and a showing of a general knowledge in the art may be sufficient to support a finding of obviousness, while identifying  a specific prior art reference containing an explicit teaching or suggestion is no longer required. Although the flexible TSM standard raises the nonobviousness hurdle for prospective patentees, the TSM test may still pose a less difficult obstacle for a patent applicant than the “obvious to try” test. Based on the language Federal Circuit choose to apply in Ortho-McNeil and Rolls-Royce, the TSM test is unlikely to disappear any time soon, and its importance will likely make a comeback in a not-so-distant future.

 

Furthermore, in Rolls-Royce, the Federal Circuit did something very curious: it imported the language of the TSM test into the “obvious to try” test. The court stated that an invention “is not obvious to try unless some design need or market pressure or other motivation would suggest to one of ordinary skill to pursue the claimed course or selection.”60 The court proceeded to analyze the prior art in a TSM-like manner looking for a reference containing a reason for PHOSITA to adopt a fan blade design covered by Rolls-Royce’s claims.61 The court did not find such reference and, therefore, held the claims nonobvious.

In light of Rolls-Royce, the “obvious to try” standard appears to begin merging with the TSM test. This may not be as radical and unexpected as some may think because the Federal Circuit is notorious for heavily emphasizing the importance of eliminating the hindsight from the obviousness analysis. Prior to KSR, the TSM test functioned as a fairly effective gatekeeper for keeping the hindsight out, so perhaps the Federal Circuit may try to incorporate those gatekeeping aspects of the TSM test into an “obvious to try” rationale. At this point, however, this is a mere theoretical speculation based on one sentence of the court’s opinion. Nevertheless, it will be interesting to see how the obviousness standard develops in the future.

 

Finally, the Federal Circuit continues to emphasize the significance of secondary consideration as evidence of nonobviousness.62 A long-felt but unresolved need, commercial success, and praise of experts in the field are all excellent indicators that the claimed invention is nonobvious.63 Accordingly, patent practitioners must pay close attention to these secondary factors. These factors are supported by factual evidence and are often easy to establish. Any time a patent attorney faces a difficult obviousness rejection, she should look for evidence of the aforementioned secondary considerations as they may lead to some very persuasive arguments capable to traverse obviousness rejections regardless of the underlying obviousness rationale.

 

CONCLUSION

 

The case law governing the obviousness standard in the United States patent system is developing dynamically. The Supreme Court, the Federal Circuit, and the USPTO continuously stir the murky waters of the obviousness analysis in search for the ideal obviousness standard. Good patent attorneys will remain alert and pay careful attention to the future evolution of the obviousness standard because a minor policy shift of tectonic plates underlying the patent system may result in a major earth quake leading to drastic practical implications.

 

 

References:

 

1 See 35 U.S.C. § 103(a) (2006).

2 See Hotchkiss v. Greenwood, 52 U.S. 248, 267 (1851).

3 See id.

4 See id. at 249-50.

5 See id. at 267.

6 35 U.S.C. § 103(a) (2006).

7 See 35 U.S.C. § 103 (2006), amended by Leahy-Smith America Invents Act (AIA), Pub. L. No. 112-29 , § 3(c), 125 Stat. 284, 287 (2011).

8 Graham v. John Deere Co., 383 U.S. 1 (1966).

9 See id. at 4.

10 See id.

11 See id. at 17-18.

12 See id. at 18.

13 See id. 

14 See id.

15 See Carl B. Wischhusen, Obviousness in the USPTO After KSR v. Teleflex, Prior Art & Obviousness 2011: Current Trends in Sections 102 & 103, 1051 PLI/PAT 93, 97 (2011) (quoting In re Moreton, 288 F.2d 940, 943-44 (C.C.P.A. 1961)).

16 M.P.E.P. § 2143 (7th Ed., July 1998).

17 See id.

18 KSR Intern. Co. v. Teleflex Inc., 550 U.S. 398 (2007).

19 See id. at 410.

20 See id. at 400. 

21 See id. at 419.

22 See id.

23 See id.

24 See id.

25 See id. at 402.

26 See id.

27 Jake Ward, The Evolution of MPEP 2143 – Prima Facie Case of Obviousness, Anticipate This! Patent and Trademark Law Blog (February 23, 2008), http://anticipatethis.wordpress.com/2008/02/23/the-evolution-of-mpep-2143-prima-facie-case-of-obviousness/.

28 See supra note 14 and accompanying test.

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

30 See id. at 1352.

31 In re Deuel, 51 F.3d 1552 (Fed.Cir.1995).

32 See id. at 1358.

33 See id. at 1359 (citing In re O'Farrell, 853 F.2d 894, 903 (Fed.Cir.1988)).

34 See id. at 1359-60 (citing In re O'Farrell, 853 F.2d 894, 903 (Fed.Cir.1988)).

35 See id. at 1360 (“This court also declines to cabin KSR to the ‘‘predictable arts’’ (as opposed to the ‘‘unpredictable art’’ of biotechnology).”).

36 Eisai Co. V. Dr. Reddy’s Labs., Ltd, 533 F.3d1353 (Fed. Cir. 2008).

37 See id. at 1359.

38 See Robert Merges & John Duffy, Patent Law and Policy: Cases and Materials 701 (5th ed. 2011).

39 Ortho–McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1364 (Fed.Cir.2008) (emphasis added).

40 See Justin L. Krieger, Effectively Traversing “Obvious to Try” Arguments in the Wake of KSR v. Teleflex 3 (Aspatore 2011).

41 In re Brimonidine Patent Litigation, 643 F.3d 1366 (Fed. Cir. 2011).

42 See id. at 1372-73.

43 See id. 1376

44 See id. at 1376.

45 See id.

46 See id. at1374

47 See id.

48 See id at 1378 (Dyk, J., dissenting).

49 See id. (Dyk, J., dissenting) (emphasis in original) (quoting In re Kubin, 561F.3d 1351, 1360 (Fed. Cir. 2009)).

50 See id.

51 Rolls-Royce, PLC v. United Technologies Corp., 603 F.3d 1325, 1339 (Fed. Cir. 2010).

52 See M.P.E.P. § 2143 (8th Ed., Rev.8, July 2010).

53 See KSR Intern. Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007).

54 See Merges & Duffy, supra note 38, at 699.

55 Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1365 (Fed. Cir. 2008) (emphasis added).

56 See Merges & Duffy, supra note 38, at 699 (quoting Ortho-McNeil Pharm. v. Mylan Labs, 520 F.3d at 1365).

57 Rolls-Royce, 603 F.3d at 1327.

58 See id. at 1338.

59 See id.

60 See id. at 1339 (emphasis added) (citing KSR, 550 U.S. at 421)

61 See id.

62 See id.

63 See id.

 




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