August 14, 2008
Whalen et al faced PTO patent board appeal on a chemical composition for embolizing an aneurysm. In a precedential opinion, the BPAI clarified the boundaries of inherency, and reinvigorated the seemingly orphaned stepchild of Queen KSR, grande dame TSM.
In re Thomas J. Whalen II, Chinh N. Tran, Noah M. Roth and Rich, and Richard J. Greff (BPAI 2007-4423)
Inherency must have a scintilla of evidence.
"Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient." In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). See also Ex parte Skinner, 2 USPQ2d 1788, 1789 (BPAI 1986) ("[T]he examiner must provide some evidence or scientific reasoning to establish the reasonableness of the examiner's belief that the functional limitation is an inherent characteristic of the prior art" before the burden is shifted to the applicant to disprove the inherency.).
The Examiner has not provided evidence or scientific reasoning to show that any specific composition disclosed by Evans is within the scope of the instant claims, and therefore has not made out a case of inherent anticipation by Evans.
While "the discovery of an optimum value of a variable in a known process is normally obvious," In re Antonie, 559 F.2d 618, 620 (CCPA 1977), this is not always the case. One exception to the rule is where the parameter optimized was not recognized in the prior art as one that would affect the results. Id.
Here, the Examiner has not pointed to any teaching in the cited references, or provided any explanation based on scientific reasoning, that would support the conclusion that those skilled in the art would have considered it obvious to "optimize" the prior art compositions by increasing their viscosity to the level recited in the claims. No reason to have done so is apparent to us based on the record. On the contrary, the references all suggest that low viscosity was a desired property in embolic compositions.
TSM still stalks the halls of the patent office.
The U.S. Supreme Court recently held that rigid and mandatory application of the "teaching-suggestion-motivation," or TSM, test is incompatible with its precedents. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1741 (2007). The Court did not, however, discard the TSM test completely; it noted that its precedents show that an invention "composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art." Id.
The Court held that the TSM test must be applied flexibly, and take into account a number of factors "in order to determine whether there was an apparent reason to combine the known elements in the fashion claimed." Id. at 1740-41. Despite this flexibility, however, the Court stated that "it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the [prior art] elements in the way the claimed new invention does." Id. "To facilitate review, this analysis should be made explicit." Id.
The obviousness rationale addressed in KSR was premised on combining elements known in the prior art. Id. at 1738-39. A parallel analysis applies, however, to a rejection premised on the obviousness of modifying a known composition to change its properties.
The KSR Court noted that obviousness cannot be proven merely by showing that the elements of a claimed device were known in the prior art; it must be shown that those of ordinary skill in the art would have had some "apparent reason to combine the known elements in the fashion claimed." Id. at 1741.
In the same way, when the prior art teaches away from the claimed solution as presented here (FF12, FF20, FF22 and FF 24), obviousness cannot be proven merely by showing that a known composition could have been modified by routine experimentation or solely on the expectation of success; it must be shown that those of ordinary skill in the art would have had some apparent reason to modify the known composition in a way that would result in the claimed composition.
The Examiner has not persuasively explained why a person of ordinary skill in the art would have had a reason to modify the compositions taught by Evans, Greff '767, or Taki in a way that would result in the compositions defined by the claims on appeal. Therefore, the Examiner has not made out a prima facie case of obviousness under 35 U.S.C. § 103.
Posted by Patent Hawk at August 14, 2008 11:57 AM | Prior Art
The IFW of the application includes the oral hearing transcript. It is 10 pages long. Given the Fed. Cir.'s use of PHE to kill the DOE, one wonders if conducting oral hearings makes any sense any more.
Posted by: JD at August 14, 2008 1:34 PM
This decision seems to me to be an eminently sensible application of the (much criticised) reasoning in KSR. Obviousness can be a subtle and slippery fellow, and the PTO must be dissuaded from its apparent desire to use KSR simply as blunt intrument to "reject, reject, reject".
"it must be shown that those of ordinary skill in the art would have had some apparent reason to modify the known composition in a way that would result in the claimed composition."
This suggests a degree of convergence with the EPO Problem-Solution-Approach. No-one ever said TSM was dead. KSR, like PSA, recognises that the "M" might come from the common general knowledge of the PHOSITA, and that it is not necessary for "T" or "S" to be explicit in the prior art.
Posted by: Eurodisnae at August 15, 2008 12:26 AM
Whelan is a God-send for those of us trying to reign in Examiners who refuse to support rejections with evidence, or even logic. The Board has made clear that rejections must be supported by evidence or at least "scientific reasoning."
Posted by: EG at August 15, 2008 4:05 AM
Of -- "No-one ever said TSM was dead" --, note
Michael Barclay (of Wilson Sonsini) at scotusblog, who stated
-->At the outset, the Court’s unanimous opinion abolished the CAFC’s imposition of a “teaching, suggestion, motivation” (TSM) test for obviousness. Slip Opn. at 11.
Having abolished the TSM test, the Court had to figure out what to replace TSM with.
How quickly we forget the "prior art." And, no, Gary Boone did not invent the integrated circuit, no matter what one finds in the Stanford Law Review.
Posted by: Lawrence B. Ebert at August 15, 2008 7:03 AM
Barclay isn't the only one who hastily and incorrectly sounded the "death knell" of TSM. (This brings to mind Mark Twain's statement that "the rumors of my death are greatly exaggerated") All you have to do is read SCOTUS's opinion in KSR International to realize that TSM hadn't been killed, just the "rigid application" of it. And the Federal Circuit made clear during and after KSR Interational that they're not going to bury TSM, but instead apply it "flexibly" as SCOTUS said was OK. And now the Board of Appeals and Interferences in Ex parte Whelan appears to have caught on that TSM is still "alive and well."
Posted by: EG at August 15, 2008 7:38 AM
My reference to the words of Michael Barclay was merely to give one example to negate the statement "No-one ever said TSM was dead".
Further discussion is on the IPBiz post titled
The TSM test after KSR v. Teleflex, dated May 5, 2007.
Posted by: Lawrence B. Ebert at August 15, 2008 9:03 AM
I don't see this decision changing the way I examine.
Don't rely on inherency unless you can prove it (duh)
"Optimization of results" is a bullshit motivation. I'm not a chemical examiner, so I've never had reason to use it anyway.
Posted by: 2600examiner at August 16, 2008 8:14 AM
I don't see how anyone could read KSR and declare TSM dead. Explicit TSM in the prior art will usually kill a claim, and that is still true. KSR said that lack of explicit TSM does not necessarily mean that the claim is non-obvious.
Posted by: Eurodisnae at August 19, 2008 1:38 AM