In re Sullivan (Fed. Cir. 2007)
The Board of Patent Appeals (BPAI) found Sullivan’s rattlesnake antivenom immunoglobulins obvious in light of Sullivan’s own publications and another reference, “Coulter.” On appeal, the CAFC reversed – finding that the BPAI had improperly refused to consider Sullivan’s rebuttal evidence.
Once the PTO presents a prima facie case of obviousness, the patent applicant has a burden of presenting rebuttal evidence supporting the opposite conclusion. This rebuttal evidence may, for example, be evidence of unexpected results, teaching away from the invention, or secondary indicia of nonobviousness. The BPAI must consider rebuttal evidence that is presented.
Here, the BPAI had failed to consider three declarations that potentially provided evidence of unexpected results of the claimed compound.
Vacated and remanded.
If the Examiner can establish a prima facie case of obviousness without taking into consideration the functional language in the claim, such as for example intended use, then the court in In Re John B. Sullivan And Findlay E. Russell, Civ. Case 2006-1507 (Fed. Cir. August 29, 2007) would not have instructed the Board to consider the rebuttal evidence submitted by the applicant, since the aforementioned evidence comprised of declarations in support of an unexpected use, which was the aforementioned intended use, since consequentially the aforementioned evidence would be irrelevant. In Re John B. Sullivan And Findlay E. Russell the court first concluded that the Board decision not to consider the rebuttal evidence submitted by the applicant was wrong, and then later added that the aforementioned evidence is also an evidence of unexpected use, not just that it only describes the intended use. Therefore, the controlling issue based on which the court instructed the Board to consider the rebuttal evidence submitted by the applicant was not that the aforementioned evidence is also an evidence of unexpected use.
Sounds to me like someone isn’t having a problem with their examiner and is instead having a problem comprehending patent law.
One cannot ignore unexpected results in the obviousness analysis in so far as it might reverse the determination of obviousness and this is regardless of whether or not all limitations are met. Thus the court judged properly. There are situations where the unexpected result is not a result of the claim though, and is instead a result of something not in the claim. Then unexpected results might be “ignored”.
The above is a separate issue from “ignoring” intended use limitations. One can “ignore” intended use limitations regardless of whether or not they are unexpected results in so far as the decider(er) is establishing which limitations of the claim are met by the prior art. And when the term “ignored” is used that’s just shorthand for saying that the limitations of the claim are met by the prior art elements because they are capable of being used in the recited intended way. They are never really strictly “ignored”. They are taken into account, but are accounted for by the elements in the prior art because those elements are capable of being used in the recited manner.
Also, I’m not sure if an unexpected use is an unexpected result. I’m not even sure if you can have an unexpected use. You could have an unexpected result which was that a certain use was now made available which the combination of old elements would not have been able to perform. But again, that’s an unexpected result, not an unexpected use.
On the whole, it seems as if this guy might have an unexpected result which is only related to the claim by the portion in the claim which is the intended use. The intended use is not “ignored”, it is still a part of the claim. So, if the unexpected result comes from the intended use being performed, then it will need to be considered.
However, that doesn’t assure you that obviousness is still not found. I’ve found obviousness in cases that had inconsequential unexpected results, or where the combination is just too well supported by motivation and compatibility of the references, even though they had unexpected results. Then again, sometimes I’ve said that the unexpected results were sufficient to make a showing of non-obviousness.
Sounds like someone is having a problem with their examiner.
Functional language is not necessarily intended use.
Also it is not clear that intended use can be ignored in a 103 situation if the intended use defines who PHOSITA is, because obviousness is determined thru the eyes of PHOSITA
If the Examiner can establish a prima facie case of obviousness without taking into consideration the functional language in the claim, such as for example intended use, then the court in In Re John B. Sullivan And Findlay E. Russell, Civ. Case 2006-1507 (Fed. Cir. August 29, 2007) would not have instructed the Board to consider the rebuttal evidence submitted by the applicant, since the aforementioned evidence comprised of declarations in support of an unexpected use, which was the aforementioned intended use, since consequentially the aforementioned evidence would be irrelevant.
Stepback is right.
It is in the public interest for companies to research dosages, administration protocols, combinations of known active chemicals and new compositions. These types of inventions can easily be called obvious as we see from the above decision.
The people who call these inventions obvious are invariably people who did not study chemistry or biology, never saw the piles of rat carcasses behind pharma labs (all those obvious combinations) and who learned about labs from Dexter.
You can almost never find Malcolm’s “teaching away” for two simple reasons: 1) there are too many combinations to explicitly teach away from all of them and 2) no manager will approve research into something scientifically proven to be wrong.
So yes, to encourage innovation the measure of obviousness cannot be “teaching away” but must be “unexpected result” even if the unexpected result seems silly.
Malcolm’s example of an antivenom that tastes good to cats is excellent. House cats are a real industry (in the US about $5 billion spent annually on Purina cat food). Specific cat antivenom is an interesting product.
Now, there are many possible combinations of antivenoms. Someone wants to research and sell a specific combination AB for some reason. If any combination, including AB, is obvious then who cares that someone has a patent on AB? There are necessarily many other combinations that are apparently just as good. If AB has a “silly” advantage then no harm is done by issuing a patent. If, at the end, the “silly” advantage is important the inventor can recoup the expense of developing and testing AB.
This is exactly where the Apotex salt decision or Malcom’s cat venom crack are wrong.
stepback, Bayer did have some evidence of unexpected results in the specification (the comparative examples). Now, the Board did find some flaws in that evidence. However, the paragraph I quoted above essentially says that the Board would not have accepted ANY evidence of unexpected results which Bayer might have produced, no matter how compelling. That is simply wrong.
So the end result appears to be correct. However, this panel at the BPAI goes off the deep end in the process of reaching the right decision – and that could be problematic for some applicants in the future.
Malcolm, clearly you did not read the whole of the article you cite:
“In one of our studies, we found profound variations in the venoms of Acanthophis species (death adders) and and the efficacy of the antivenoms.”
“Skin testing with antivenom for allergy to antivenom is unreliable and waste of time.”
So if it’s you lying on the gurney and we administer 10 compounds instead of one or two, don’t we increase the chance you’ll die from an allergic reaction? What would a ***skilled*** artisan say?
Re the discussion above re the combo of snake venoms:
link to kingsnake.com
“In Victoria polyvalent antivenom is not required and a combination of tiger snake antivenom and brown snake antivenom can be employed when the identity of the snake has not been determined.”
That took me two seconds to find on Google (“snake anti-venom combination”). I suspect there’s loads more where that came from.
metoo,
I can’t say I followed your long-winded dissertation.
However, let’s cut to the chase. The most important question is how would have the ordinary artisan thought at the relevant time (what were his motivations)?
You say Bayer produced ZERO in the way of expert testimony as to that ultimate question of obviousness. On the other hand, no matter how poor it was, the BPAI produced its own finding of fact as to that ultimate question.
When we put the opposing weights on the scales of justice, it boils down to Bayer’s ZERO versus the BPAI’s something. BPAI automatically wins. That’s what the substantial evidence rule says. The Fed. Cir. must give deference to the BPAI finding of fact if the Applicant (Bayer) produced no contradictory evidence. Attorney arguments, by themselves, are usually worthless
“But for this panel of the BPAI, there was apparently NOTHING Bayer could have done to rebut the prima facie obviousness based on Horn.”
Hmm, that sounds familiar.
As further evidence that at least some members of the BPAI seem to misunderstand certain patent law principles, consider the Aug. 29 decision in Ex Parte Bayer (decision can be found here: link to des.uspto.gov).
Now, the BPAI may have indeed reached the correct conclusion in this case. But their reasoning is seriously flawed. The only claim at issue was a method of producing polyurethane integral skin foam by reacting component A with component B, wherein component B includes a zeolite (i.e., it is premixed with the other components of B).
The BPAI relied upon a single reference (Horn) to reject the claim as being obvious. Horn teaches essentially the same method, except that the zeolite is premixed with component A, rather than Component B as claimed. The BPAI clearly states in the opinion that Horn “does not teach adding zeolites to [Component B]. The BPAI goes on to state that Horn SUGGESTS adding zeolites to Component B for two reasons. First, Horn states that it was “expedient” to premix the zeolites with Component A, and therefore this suggests premixing the zeolites with Component B instead. Second, the background of Horn discusses prior art for producing a DIFFERENT kind of foam (i.e., not the claimed integral skin foam), and that prior art process described in Horn premixed zeolites with both Component A and Component B.
OK, sounds to me like a case or prima facie obviousness. I have no problem with that. But then the BPAI goes off on a bizarre tangent. The specification of Bayer’s application included three comparative examples of foams produced with (1) no zeolite, (2) zeolite premixed with Component A (i.e., Horn), and (3) zeolite premixed with Component B (i.e., the claimed invention). These results indicated a Shore D Hardness of 33, 38 and 44, respectively. So, Bayer argued that this was demonstrated an unexpected improvement in hardness as compared to the method taught by Horn.
First, the BPAI said this merely showed a 16% increase in hardness, and this difference was not a sufficiently significant difference. They even cite a CAFC case which apparently held that a 32-43% increase was not an unexpected result. First of all, that’s just plain silly to somehow draw any conclusion from the CAFC case. Second, it’s absurd to compare Shore D Hardness results in this manner (i.e.g, a simple % increase in hardness). But I will cut the BPAI some slack on this issue, since it sounds to me that Bayer really dropped the ball by not presenting ANY additional evidence on this “unexpected result” (e.g., an affidavit discussing the significance of a 6 point increase in Shore D) or further test results more closely comparing the claimed invention and what was taught by Horn.
But for this panel of the BPAI, there was apparently NOTHING Bayer could have done to rebut the prima facie obviousness based on Horn. In discussing the comparative results mentioned above, the BPAI states:
“In any case, the comparison is not representative of what those in the art would have expected. The closest prior art, Horn, suggests that the zeolite may be added to the polyol component, the polyisocyanate component, or both. Consequently, Bayer’s examples (2) and (3) are equally
representative of what the prior art teaches. Since they are equally representative of the prior art expectations, the comparison cannot establish unexpected results for the claimed invention compared to the prior art.”
So let me get this straight – Horn teaches premixing zeolite with Component A, and this corresponds with Bayer’s “example 2” in the specification. Horn fails to teach, but does SUGGEST premixing zeolite with Component B instead. This “suggestion” from Horn is what Bayer was trying to claim and corresponds to “example 3” in their specification. Yet, when Bayer tries to prove an unexpected result to overcome the obviousness rejection (i.e., example 3 is surprisingly better than example 2 in some meaningful way), the BPAI says they cannot do that because the prior art actually does teach both example 2 and example 3! Poppycock! Make up you mind – either Horn teaches adding zeolite to Component B or it does not. If the prior art does not teach what is being claimed, but merely suggests doing so, then comparative evidence of the type Bayer argued is absolutely appropriate and MUST be considered. The above quote from the BPAI is akin to saying that in order to be patentable, your claimed invention must be unobvious over what the prior art suggests, rather than what the prior art merely teaches. Good grief!
Again, by no means am I suggesting that the wrong conclusion was reached in this case. And the applicant certainly did not present decent evidence in support of patentability. But, the BPAI decision evidences a rather appalling lack of understanding some basic patent law. Hopefully this panel might have an opportunity to read this critique (and I was kind in not pointing out some of the other “problems” in this opinion).
“Larry Craig syndrome?”
Absolutely.
He was smitten by an administration in-stall-ed snake.
Aren’t the new continuation rules yet another in-stall-ment of the creeping paralysis that is overtaking our patent system?
Good insight.
Thank you Dr. Mooney.
“you feel the numbness creeping up ever assuredly from your ankles up towards higher functioning parts of your body.”
Larry Craig syndrome?
metoo(much),
So picture this.
You’re laying on a gurney in the Emergency Room (ER).
Your friends from an earlier adventure have lucky-for-you, found the shorter path to get you to the hospital quickly after you were bit by a poisonous snake.
(See this link for the tale of your trail:
link to patentu.blogspot.com )
Dr. Lunacy comes into the room.
“Ah my friend,” he begins, “I am not sure exactly what kind of snake has bitten you.”
A look of concern crosses your face. He pays no attention. The poison is already working its magic and you feel the numbness creeping up ever assuredly from your ankles up towards higher functioning parts of your body.
“Normally what we do my friend,” the good Dr. Lunacy continues, “is to follow protocol and give this one proven antivenom drug. However in your case, because we are not sure exactly what snake bit you, I find it ‘obvious’ to try two antivenoms at once because some very wise scientist once said:
“Combining two known antivenoms is obvious unless there is clear teaching away.”
“In fact,” the doctor reasons out loud, “if combining two chemicals whose interactions with each other are unknown is ‘obvious’; it is even more obvious to combine ten, yes ten so-called antivenoms whose interactions with each other are unknown. So that’s what I’ll do in your case. I’ll randomly pick 10 chemical compounds which somebody or other said works as an “antivenom”. I’ll pick random dosage amounts for each. And I’ll squirt the cocktail into your blood stream. It is obvious to me, the great Dr. Lunacy that mixing known elements for their known functions is obvious. Here we go. Let’s all hope my mental gymnastics are correct.”
Gentlemen, many thanks for this debate. It has been for me a puzzle for many years how the chemists argue obviousness. and not just for me. There is a world-wide debate about the correctness of “absolute Stoffschutz” (protecting not just the method but wider, the composition itself, when the contribution to the art is actually a method that delivers a surprising result). Years of accumulated caselaw is always what the chemists cite in defence of the current position but, in these exciting times in which we live, that’s not conclusive.
“Obvious compositions aren’t patentable. Combining two known antivenoms is obvious unless there is clear teaching away. Assertions of ‘unexpected properties’ of the composition should not work to rebut the obviousness of a composition claim such as that described in my hypo. I’m not seeing a whole lot of inconsistency here, my friend.”
The inconsistency is that what you are saying is simply not correct, at least in so far as the relevant caselaw is concerned. THAT is the problem. Feel free to argue what you think the law SHOULD be, but please don’t continue to incorrectly suggest that your views comport with the applicable caselaw.
“Well, your argument as to what the law should be is absurd and goes against decades of patent law.”
So does KSR. [shrugs]
“if you were waiting for that shoe to drop, then why did your previous post assert that your “reading of the case law is that absent a clear teaching away of combining those two antivenoms for any purpose such a composition is UNPATENTABLE”?”
Obvious compositions aren’t patentable. Combining two known antivenoms is obvious unless there is clear teaching away. Assertions of “unexpected properties” of the composition should not work to rebut the obviousness of a composition claim such as that described in my hypo. I’m not seeing a whole lot of inconsistency here, my friend.
Let’s try to be clear. Compositions and apparatuses don’t “give unexpected results.” They have unexpected properties.
Methods give results. Evidence of an “unexpected use” is relevant only for method claims. Such evidence has no bearing on the obviousness of a composition per se. Any composition or apparatus can be used in an “unexpected” way. So what?
“what if the composition in your hypothetical gave an amazing tenfold increase in efficacy for snakebites. Would that be a different situation since it’s an unexpected result?”
It would be a different situation if we are talking about a method claim, of course. That’s perfectly clear and reasonable.
“Why on earth would that be a different situation?”
It’s a different situation because a method claim and a composition claim are as different as two claims can possibly be. That’s why.
“And what other secondary considerations would you like to do away with? Commercial success?”
Hell yes. I can’t think of anything less relevant to obviousness than that. Enablement? Sure. Utility? No doubt. Obviousness? No way.
If you were waiting for that shoe to drop, then why did your previous post assert that your “reading of the case law is that absent a clear teaching away of combining those two antivenoms for any purpose such a composition is UNPATENTABLE”? Your reading of the case law was wrong, so now you are trying to argue what the law should be in your mind. Well, your argument as to what the law should be is absurd and goes against decades of patent law.
Why should composition claims be treated any differently than other types of claims (e.g., apparatus claims) when it comes to obviousness? If an apparatus or other type of claim is prima facie obvious, do you think that unexpected results should ever be considered? If unexpected properties should not be available to rebut a prima facie obviousness for a composition claim, then there is no good reason why unexpected results should work for any other type of claim. There is nothing special about composition claims, and the fact that they can usually be claimed as methods is irrelevant. A composition claim can be far more valuable to a patent owner than a method claim in many instances.
And are you suggesting that, if instead of an unexpected property or use, the claimed composition gives an unexpected result then that situation is different? For example, what if the composition in your hypothetical gave an amazing tenfold increase in efficacy for snakebites. Would that be a different situation since it’s an unexpected result? After all, in that scenario, the method claim would be no more patentable than the composition claim since that method claim would be the expected use of such a composition. Why on earth would that be a different situation?
And what other secondary considerations would you like to do away with? Commercial success? Boy, that one’s sometimes kind of hard to figure out. ANY secondary considerations of obviousness (including teaching away) must be weighed against the evidence supporting the underlying determination of prima facie obviousness. If it’s too hard or too subjective of a test, then by golly lets get rid of the lot in favor of more certainty.
“must be weighed against the facts underlying the prima facie obviousness determination”
I was waiting for that shoe to drop. 😉
This is my point. A composition claim to a combination of two known snake anti-venoms is (or should be) de facto irrebuttably obvious absent any clear teaching away in the art. Any other outcome based on “weighing” is arbitrary. How does one “weigh” these things?
The method claim to treating leukemia in my hypo is low hanging fruit if you’ve got the data. Grab it. Get the method claims. Be proud. Assert them. Reap your just rewards.
Any other outcome opens the door to applicants’ asserting all kinds of “unexpected properties” for the obvious combination. How would such showings be “weighed” against the prima facie obviousness argument? What is the nature of such showings that tip the scale? Maybe to someone the fact that the combined anti-venoms taste better to house cats than a single anti-venom or are more easily formulated into a spreadable paste is really really really important! Why should that matter less?
If consistency and predictability and clarity is the goal (and that seems to be the hugest gripe out there) then the best rule is that **for composition claims** these “unexpected properties” are irrelevant for rebutting a prima facie showing of obviousness.
And let me clarify something in that last post – evidence of some unexpected use/property must still be commensurate with the scope of the claims, and must be weighed against the facts underlying the prima facie obviousness determination.
Malcolm, I disagree. In your example, even though the combination of two known antivenom immunoglobulins in a single composition would be prima facie obvious, that composition still can be patentable if there is sufficient evidence of an unexpected property or use. In your example, unless there is something in the prior art to suggest that antivenom immunoglobulins would be useful in treating leukemia, the composition itself would likely be considered patentable due to the unexpected use/property. Now, merely coming up with some property of the composition which is undisclosed in the prior art is not enough. But, certainly an extraordinarily unexpected use/property such as treating leukemia (assuming no suggestion of such a use or property in the prior art) would likely be sufficient to overcome a case of prima facie obviousness.
Similarly, if instead the unexpected property was that the particular combination of immunoglobulins was much more effective at treating snakebites than one would normally expect based upon the teachings of the prior art (e.g., it works 10 times faster, or it can be taken orally instead of having to be administered intravenously), that too would likely overcome the prima facie obviousness of the composition.
“As for the difference between the claim at issue in this case and a method claim (i.e., a method of using the composition), I don’t think the issue of patentability would be different.”
A method of using the compound for treating a particular snakebite could be patentable where the compound itself would be obvious.
Consider: a pharmaceutical composition comprising two well-known antivenom immunoglobulins is prima facie obvious in view of art stating that combining two antivenoms is useful for making treatment of snakebites easier. My reading of the case law is that absent a clear teaching away of combining those two antivenoms for any purpose such a composition is UNPATENTABLE. No other secondary factors should render the composition patentable. Put simply: it’s an obvious composition.
A method of using that composition for treating leukemia: non-obvious.
Now some folks will whine that it is “unfair” to deny the discoverer of the utility of that combination a claim to the composition.
My reply is: it is not unfair. On the contrary, it is quite reasonable. And the discoverer of the utility of that combination for treating leukemia is entitled to a method claim that is perfectly adequate to prevent others from using the combo to treat leukemia and to prevent others from selling the combo for that purpose.
You may be correct Malcolm with respect to patentability. I had the same reaction upon reading the case, since the evidence of unexpected use/property doesn’t seem all that unexpected. On the other hand, that does not mean that the Board can refuse to consider evidence of unexpected properties. The ultimate question is whether or not that evidence is sufficient to rebut the prima facie obviousness.
As for the difference between the claim at issue in this case and a method claim (i.e., a method of using the composition), I don’t think the issue of patentability would be different. Since the claim is written as a pharmaceutical composition (i.e., active + carrier) and it is not a situation of a prior known medical use of the same active, the question of obviousness would likely be the same even if the claim were written as a method of use (i.e., to treat a snakebite victim).
“Rather, EVIDENCE of an unexpected use/property (i.e., the declarations) may be used to rebut a prima facie case of obviousness.”
I would think that work for a method claim but don’t see why it should work for a claimed composition whose properties are otherwise obvious and reasonably expected by those of skill in the are.
These claims are going nowhere, for more or less the reasons that Judge Lourie articulated.
Good luck, kcb – that’s all I have to say, good luck.
An unexpected use/property, even if recited in a composition claim as an intended use, is not a distinguishing characteristic of the composition. Rather, EVIDENCE of an unexpected use/property (i.e., the declarations) may be used to rebut a prima facie case of obviousness. So, the declarations concerning an unexpected use/property are indeed relevant to the obviousness inquiry – good grief, they would be one of the secondary considerations of nonobviousness which the PTO MUST consider! That is ALL this case stands for.
And by the way use and functional language ARE the same.
A funcitonal limitation is an attempt to defin something by what it does, rather than by what it is. See MPEP 2173.05(g); In re Swinehart, 169 USPQ 226 (CCPA 1971)
I find a non-sequitor in your reasoning. If the intended use cannot be the distinguishing characteristic of the composition, then I side with the BPAI, because the declarations were directed to intend use evidence which, in your world, would be irrelevant since it cannot be a distinguishing characteristic, i.e., cannot be considered as part of the invention as a whole. So which is your position?: The BPAI must consider irrelevant evidence; or, The intended use language is a distinguishing characteristic?
And if this case really stood for the proposition that an unexpected use, when recited in a claim, is functional language which must be considered if it is the distinguishing characteristic of the invention as a whole, then the Fed Cir clearly would not have agreed that he examiner had established a prima facie case of obviousness. If, as you suggest, the Examiner improperly failed to consider the “functional language” in the claim, then the examiner has not established a prima facie case of obviousness. Yet, the Fed Cir did not reach that conclusion – in fact, just the opposite. And they clearly instructed the Board to consider the rebuttal evidence submitted by the applicant – evidence which comprised declarations in support of an unexpected use/property. They did not instruct the Board to consider the “functional language” in the claim itself, since that would be tantamount to revisiting the issue of whether or not a prima facie case had been established.
An intended use recited in a claimm is NOT functional language – and an intended use recited in a claim to a composition is CANNOT be a distinguishing characteristic of the claim in question (at least not in this case). The claim was to a composition, that’s all – nothing more. The intended use cannot be a distinguishing characteristic of that composition. And I am not adding language to the case – quite the contrary, I am reading what the case actually says. Unexpected use, unexpected property, unexpected result – it’s all THE SAME THING. And if the Applicant in this case had not submitted evidence that the property of the composition was unexpected, the mere recitation of an intended use in the claim would have been of absolutely no significance.
You are flat wrong.
Metoo:
Look my statement involved a new unexpected use not merely a new use. By the way I am certain that the judge knew what he was doing when he wrote the opinion. If he meant unexpected results, he would have said so. But please don’t confuse the In re Antonie unexpected result line of cases with this one. It is a completely different issue. This case states that functional language must be considered in a structure claim if it is the distinguishing characteristic of the invention as a whole. Christ quit trying to add language to the case and just read it for what it states, .e.g, read the court’s holding.
Did you catch Lourie’s KSR slight-of-hand? He dashed right past the argument that there was no prima facie case of obviousness with this gem:
“It was not unreasonable for one skilled in the art of snake venom to consider that a Fab fragment of a whole antibody that neutralizes one type of venom might be used to neutralize the venom of another species. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. __, 2007 WL 1237837, at *13 (2007) (stating that “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill”).”
The language is KSR is that the skilled bloke must RECOGNIZE. The CAFC has now lowered the bar even further to what the skilled bloke would CONSIDER. “Recognize” at least includes a bare residual hint of inventive cerebral processing — as he recognizes that A can be combined with B. But “consider” smacks more of hindsight analysis, as in he considers — or gives consideration to — the argument that A could be combined with B.
IOW, you can “recognize,” sua sponte, a combination could exist from merely seeing the elements in an uncombined state. You can only “consider” the likelihood of making a combination once the combination has been presented to you.
Is the analysis on appeal now what an examiner considered a skilled bloke would consider? The ole’ double-consideration standard? Was that in KSR???
Babel Boy
KCB, it is you who have completely misconstrued the meaning of this opinion. As the Fed Cir stated, “[w]hile a statement of intended use may not render a known composition patentable, the claimed composition was not known, and whether it would have been obvious depends upon consideration of the rebuttal evidence.” In other words, the statement of intended use in the claim is really not at all dispositive. As the Fed Cir further stated, “[t]he issue here is not whether a claim recites a new use, but whether the subject matter of the claim possesses an unexpected use. That unexpected property is relevant, and thus the declarations describing it should have been considered by the Board.”
To me (someone intimately familiar with pharmaceutical patent prosecution), this case is not at all surprising. The BPAI went off on a tagent and simply got confused by a claimed “intended use” when the real issue was unexpected results (i.e., an “unexpected use”). And the end result should be the same whether or not the claim itself recites that unexpected use.
Any bets on the outcome when the BPAI considers these declarations?
I’m not serious, of course.
This all goes back to a point I tried to make at my own offbeat blog:
link to patentu.blogspot.com
Before going up on appeal in front of the BPAI, it is the case 9 out of 10 times that you must first file a rebuttal declaration (or two or three).
The number of times that we see Applicants get KO’d for the full count on the mat because they had no “evidence” are too numerous to be funny anymore.
If you have no evidence on the record, then the substantial evidence rule (In re Gartside) works against you.
Sullivan had “evidence” on the record. Thus pursuant to 5 USC 706, the CAFC had to set aside the agency finding because it was not in accordance with that part of the law that requires the Board to consider all evidence in the record when evaluating obviousness.
Hey, who ever wrote the by-line totally missed the import of this case. It stands for the proposition that an articulated new unexpected use recited in a claim to a structure (composition in this case) must be given weight as to patentability. This is pretty monumental considering that functional language is typically ignored during examination of a non-method claim. For this reason, the declarations were found to be relevant and must be considered. To the author of the by-line I give you the grade of C on this case analysis.
Hey John Darling:
I am just happy when these examiners consider the subject matter, let alone the subject matter as a whole 🙂
The case just emphasizes the importance of holding the PTO’s feet to the fire regarding the evidentiary findings required to present a prima facie case. Some evidence (e.g. the applicant’s 3 declarations) always trumps ZERO evidence (or the arrogant approach of some examiners and APJ’s that they’re not required to consider the FACTS on their way to a determination that a certain application is not deemed worthy of a patent in their considered opinion).
It is also rather disconcerting to find out that some APJ’s apparently don’t understand the concept of considering “the subject matter as a whole.”
SF – an appeal to the Federal Circuit may soon be the least expensive part of prosecution!
“BPAI Must Consider Evidence Rebutting Obviousness” … *if* the Applicant can afford to appeal to the Federal Circuit.
“Will this really be true come November 1, 2007 for applications containing more than 5/25 claims?”
There will be applications containing more than 5/25 claims after November 1?
Get these mxxxxxfxxxxx examiners off my mxxxxxfxxxxx case!
/Samual Jackson off
“Once the PTO presents a prima facie case of obviousness, the patent applicant has a burden of presenting rebuttal evidence supporting the opposite conclusion.”
Will this really be true come November 1, 2007 for applications containing more than 5/25 claims? It seems the statutory burden-of-proof will be shifting from the USPTO having to the reject the claims to the applicant having to file an ESD proving patentability in order to avoid abandonment.
Statistics Since KSR
BPAI- 999999999999 Applicants – 1
OOOOOO they are shakin’ now at the PTO
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