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The U.S. Supreme Court’s ruling in KSR International Co. v. Teleflex, 127 S. Ct. 1727 (2007), has been called one of the most important patent cases in the last 30 years. Why all the hoopla? Most patent practitioners will tell you that the ruling is indeed a big deal and has shifted the landscape on patent validity and patentability to a degree that has altered and will continue to alter the way we practice. KSR is directed to invalidity issues (and, indirectly, unpatentability) based on obviousness under 35 U.S.C. 103(a). Although the case and its holding are likely to be familiar to the reader at this point, a brief summary is provided. The message of KSR is that the Supreme Court’s past rulings (even distant past) on obviousness remain the standard for patent validity determinations, but, as explained below, it appears that courts have been given greater flexibility in determining whether a claimed invention is obvious. KSR reaffirmed that Graham v. John Deere Co., 383 U.S. 1 (1966), remains the obviousness standard, requiring one to determine the scope and content of the prior art; determine the differences between the prior art and the claims; establish the level of ordinary skill in the art and determine obviousness against this background; and consider the established secondary considerations of nonobviousness such as commercial success, long felt and unresolved needs, failures of others, etc. KSR relates most specifically to combination patents and to the application of a teaching, suggestion and/or motivation (TSM) test for combining prior art elements to achieve the claimed subject matter. The thrust of the holding, reversing the U.S. Court of Appeals for the Federal Circuit, is that it is improper to rigidly apply a TSM test so as to require some overt or express motivation to combine prior art. The Supreme Court also identified four errors in Federal Circuit obviousness analysis and, in effect, broadened the ways to establish obviousness. The Supreme Court found that it was erroneous to look only to the problem addressed by the claimed invention when determining whether the prior art references could or should be combined; to look only for prior art references and elements thereof that actually address the problem solved by the claimed invention; to overlook that it may be obvious to try to make the claimed invention; and to foreclose the use of basic common sense as hindsight analysis. It is mainly in view of these findings of error that KSR has been predicted to change the patent world. KSR was predicted to increase the uncertainty in patent litigation and prosecution in the short term and to increase U.S. Patent and Trademark Office (PTO) rejections for obviousness and enable PTO patent examiners to insert their own “common sense” as “apparent reason to combine” references in an obviousness rejection. Also, as a result of KSR, patents would become more difficult and expensive to obtain and enforce and, ultimately, fewer patents would be issued. PTO rules changes The PTO has responded to KSR with its Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103 in View of the Supreme Court Decision in KSR International Co. v. Teleflex Inc., 72 Fed. Reg. 57,526 (Oct. 10, 2007). These guidelines went into effect on their publication date and appear to bring all fears of patent applicants regarding KSR to fruition. The guidelines empower examiners as Graham fact finders and encourage using “common sense.” They instruct examiners to determine obviousness from the perspective of the person of ordinary skill in the art, which is also to be determined by the examiner and can be expressed in a rejection either “explicitly or implicitly.” Finally, examiners are instructed to rely on their own technical expertise to define this level of skill in the art. It now appears that if an examiner thinks something is obvious, it is obvious, unless the applicant can rebut the allegation with evidence of secondary considerations. The examiners’ practice of combining many references is being affirmed at an alarming rate by the Board of Patent Appeals and Interferences. Additionally, the PTO has effected changes for prosecution practice in general. A summary can be found at www.dicksteinshapiro.com/publications/newsletters/. While these changes are not the subject of this article, they will combine with KSR to make prosecution very different from what the patent bar has become accustomed to. While only months have passed since the decision, the effects of KSR are being felt. KSR already has been cited in numerous Federal Circuit decisions, of which the following provide a good overview of that court’s stance: Leapfrog Enters. Inc. v. Fisher-Price Inc., 485 F.3d 1157 (Fed. Cir. 2007); Syngenta Seeds Inc. v. Monsanto Co., nos. 2006-1203, 2006-1204, 2006-1205, 2007 WL 1295028 (Fed. Cir. May 3, 2007) (nonprecedential); Takeda Chem. Indus. Ltd. v. Alphapharm Pty. Ltd., 492 F.3d 1350 (Fed. Cir. 2007); Pharmastem Therapeutics Inc. v. ViaCell Inc., 491 F.3d 1342 (Fed. Cir. 2007); Omegaflex Inc. v. Parker-Hannifin Corp., No. 2007-1044, 2007 WL 1733228 (Fed. Cir. June 18, 2007) (not for publication); and Pfizer Inc. v. Apotex Inc., 488 F.3d 1377 (Fed. Cir. 2007). It is safe to say that the TSM test still has some life in it. While KSR was pending before the Supreme Court, the Federal Circuit itself emphasized the flexibility of the TSM analysis in DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356 (Fed. Cir. 2006). The court held that the “suggestion test is in actuality quite flexible and not only permits, but requires, consideration of common knowledge and common sense.” Id. at 1368. In a decision addressing obviousness shortly after KSR, the Federal Circuit indicated that it will continue to look for a motivation to combine prior art references in obviousness determinations. See Omegaflex, 2007 WL 1733228, at *2. In Takeda, the Federal Circuit explained that KSR rejects rigid application of the TSM test; it maintained that there is “no necessary inconsistency between the idea underlying the TSM test and the Graham analysis” and that the test can provide “helpful insight” to an obviousness inquiry. 492 F.3d 1350-57. The Federal Circuit addressed the Supreme Court’s comments on “obvious to try” in multiple cases with different outcomes. In Takeda, the Federal Circuit explained that when the prior art does not “identify predictable solutions” and instead discloses a “broad selection” of solutions, some of which may actually lead away from the patented invention, the resulting invention is not obvious to try. Id. at 1359. In Pharmastem, the Federal Circuit held that “[s]cientific confirmation of what was already believed to be true may be a valuable contribution, but it does not give rise to a patentable invention,” in ruling the invention was obvious to try. 491 F.3d 1342-64. As evidenced by the multiple dissents in Pfizer, the “obvious to try” doctrine will have significant implications for the pharmaceutical and chemical industries going forward. 488 F.3d 1377 (denying rehearing en banc). Before this case, practitioners may have thought the chemical arts too unpredictable to fall under KSR control, which specifically dealt with predictable technology, but this is not so. In Leapfrog, the Federal Circuit affirmed an obviousness finding because it believed the invention to be “the adaptation of an old idea or invention . . . using newer technology that is commonly available and understood in the art.” 485 F.3d at 1157-62. Citing KSR, the court opined that “[t]he common sense of those skilled in the art demonstrates why some combinations would have been obvious where others were not.” Id. at 1161. For purposes of client counseling regarding patent prosecution, the most important and immediate consideration should be how the Board of Patent Appeals and Interferences interprets KSR. Board decisions, post- KSR, show a very disturbing trend, from the point of view of patent applicants. KSR, in a sense, may be considered a “magic bullet.” A review and unscientific comparison of board cases over the course of the year shows that before KSR, an appellant had fairly even odds of prevailing, i.e., a roughly 40% chance of a reversal or reversal-in-part of an obviousness rejection. Since KSR has become precedent, those odds drop severely, to about 23%, if the case is cited. Since KSR, the board of appeals has issued the following three important opinions: Ex parte Kubin, No. 2007-0819, 2007 WL 2070495 (BPAI May 31, 2007) (precedential); Ex parte Smith, No. 2007-1925, 2007 WL 1813761 (BPAI June 25, 2007) (not for publication); and Ex parte Catan, No. 2007-0820, 2007 WL 1934867 (BPAI July 3, 2007) (not for publication). Each of these decisions establishes an attack point for the board of appeals, and for patent examiners, based on obviousness. Per Ex Parte Kubin, once a problem is solved, every method that could be used to solve it becomes obvious to try, as the act of solving a problem provides sufficient motivation to combine prior art. 2007 WL 2070495, at *5. The board quoted KSR, stating, “when there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.” Id. at *9. Success in such is not innovation, but ordinary skill and common sense, and would be obvious to try. Id. Based on Ex Parte Smith, claimed combinations must be beyond the skill of one of skill in the art, and if prior art does not explicitly teach away from the invention, one of ordinary skill in the art can “put the pieces together” to render it obvious. 2007 WL 1813761, at *23. Because “[a] person of ordinary skill is also a person of ordinary creativity, not an automaton,” the board held that it takes no more than ordinary creativity to adapt “familiar items with obvious uses” (the teachings of multiple patents) together like “pieces of a puzzle.” Id. at *20. Based on Ex Parte Catan, there is generally sufficient motivation to combine any number of same-field prior art references and, as a result, claimed combinations of known elements will likely be nearly impossible to prosecute going forward. In that case, the invention was found obvious as an “adaptation of an old invention . . . using newer technology that is commonly available and understood in the art.” 2007 WL 1934867, at *18. “[T]he mere existence of differences between the prior art and an invention does not establish the invention’s nonobviousness.” Id. Effect on client counseling Now that the patent bar has had time to live with KSR and see how the courts and the PTO are using the new precedent, how should client counseling change? It is clear that more preapplication-filing counseling is needed. Patentability opinions are a good idea, whether made formally or informally. Such efforts, while increasing client costs initially, will serve to decrease futile filings and hone claim language, ultimately resulting in saved costs. Prosecution will be far different, since applicants cannot rely on appealing with any confidence. Stronger and better reasoned arguments must be made during prosecution (early in prosecution in view of the new rules, if they become permanent). Applicants will be required to show that prior art combinations would have been beyond ordinary skill, which could cause other validity problems later should the patent be litigated. It’s worth remembering that an examiner’s reasoning for obviousness when combining references must be rationally articulated per KSR and PTO guidelines. Counsel should watch for examiner arguments unsupported by facts, but beware that examiners can now use “common sense.” Arguments that should be emphasized are the interdependency of recited claim features and the overt or implicit teaching away by cited references. Inventors must be more involved in preparing and prosecuting applications. Because secondary considerations have become more important post- KSR, inventor declarations on the skill level in the art, unexpected results, long felt needs, etc., could be used to further prosecution in light of prior art combinations by newly empowered examiners. Furthermore, an inventor’s input on what is not predictable or what is likely to succeed can be evidence of nonobviousness in rebuttal of obviousness arguments. Finally, attorneys and clients must realize that it may be more difficult to obtain patents. A well-crafted patent will cost more, but will likewise be worth more because it will be well reasoned at the PTO and will more likely withstand invalidity attacks in subsequent litigation. Ryan H. Flax is an associate in the Washington office of Dickstein Shapiro and can be contacted at [email protected].

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