by Dennis Crouch
In re NuVasive (Fed. Cir. 2016)
In an important obviousness decision, the Federal Circuit has reversed the PTAB IPR decision – holding that the PTAB failed to sufficiently explain its ruling that a person having ordinary skill in the art (PHOSITA) would have been motivated to combine the prior art teachings to create the patented invention. Although expressing its intent to follow KSR, the court here comes closer to trodding upon that (oft maligned) precedent.
The case involves an Inter Partes Review (IPR) challenge of NuVasive’s spinal fusion implant patent (U.S. Patent No. 8,361,156). The claims require that the implants include, inter alia, radiopaque markers on the medial plane. The PTAB found the claims invalid as obvious based upon a collection of prior art references related to spinal fusion.
Doctrine of Obviousness: A claim is invalid if the differences between the prior art and the claim (considered “as a whole”) would have been obvious to PHOSITA considering the issue at the time the invention was made. 35 U.S.C. § 103.
Motivation to Combine: In many US obviousness cases, each of the claim limitations are found in some form within the body of prior art imputed to PHOSITA and the obviousness question becomes whether it would have been obvious to combine those references to form the claimed invention. In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that the motivation to combine references need not be found expressly in the prior art itself but may be explained by the fact finder using common sense. Still, the KSR Court wrote that it “can be important to identify a reason that would have prompted [PHOSITA] to combine the elements in the way the claimed new invention does.” Extending that decion, the Federal Circuit ruled that the PTAB must (1) “articulate a reason why a PHOSITA would combine the prior art references”; (2) have an adequate evidentiary basis for that finding; and (3) provide a “satisfactory explanation” for the motivation finding that includes an express and “rational” connection with the evidence presented. See, In re Lee (conclusory statements are insufficient); Cutsforth v. MotivePower (must positively explain motivation – not just reject arguments against motivation); and Arendi v. Apple (PTAB “cannot rely solely on common knowledge or common sense to support its findings” of motivation).
Here, the basic question is whether it would have been obvious to combine prior art teaching the spinal fusion implant with references showing the use and importance of radiopaque markers in implants. However, according to the appellate panel, “the PTAB failed to explain the reason why a PHOSITA would have been motivated to modify [the prior art], to place radiopaque markers ‘proximate to said medial plane'” as required by the challenged claims.
After discrediting the PTAB decision, the court also looked at the evidence presented by the challenger Medtronic. Medtronic’s expert had explained that the motivation for adding the additional markers would be to provide surgens with “additional information” and that it would have been common sense to add the additional markers.
Medtronic’s arguments amount to nothing more than conclusory statements that a PHOSITA would have been motivated to combine the prior art references to obtain additional information. According to the court, these “arguments amount to nothing more than conclusory statements” and thus should not be credited. One key reference did explain that the medial markers were beneficial during the alignment process. However, the Federal Circuit rejected that reference because it was published after the patent-in-question’s priority date and not cited in the prior art references. Because they came after the priority date, the court found that the motivation “could not have been obtained . . . at the time of the invention.”
Another 8-0 or 9-0 beatdown on the way if this is granted cert next year. KSR said no mandatory TSM test, CAFC says yes there is, for the second time.
This is another on a plane, in a train, on a boat type claim. Radiopaque marking was well known, the idea to use it in this instance is new, but not inventive. That many things can be new but not inventive is the entire point of KSR.
How do you define inventive, Mr. Snyder?
“Inventive” is a noteworthy use of imagination and creativity.
It is not the generation of new and different patterns using tools and techniques well-known to produce similar patterns.
As finely stated in KSR:
“We build and create by bringing to the tangible and palpable reality around us new works based on instinct, simple logic, ordinary inferences, extraordinary ideas, and sometimes even genius. These advances, once part of our shared knowledge, define a new threshold from which innovation starts once more. And as progress beginning from higher levels of achievement is expected in the normal course, the results of ordinary innovation are not the subject of exclusive rights under the patent laws. Were it otherwise patents might stifle, rather than promote, the progress of useful arts. See U. S. Const., Art. I, §8, cl. 8”.
Thanks Martin.
I have said that KSR is actually consistent with TSM, because it requires that the art have a known problem to be solved. This is, in my opinion, the same thing since the requirement to show some motivation to get from this known problem to the claimed solution is still there.
What the PTAB was doing for a long time after KSR, and might still be doing to some patent owners, is neither requiring the showing of a known problem, nor requiring proof of motivation. Rather the petitioner and the PTAB found it acceptable to locate the elements of the invention in the prior art from the claim (hindsight, of course), and then simply declare victory by further stating, without evidence in support, that the combination functions in a expected way.
Thus the claim to the Mona Lisa must be declared obvious because all its elements were known, and the paints, canvases and colors all worked in an expected way.
In other words, the PTAB used KSR in about as st 00pid a manner as one could devise.
You do realize of course the path of your logic inexplicably leads to Flash of Genius, eh Mr. Snyder?
Every slippery slope argument depends on the facts at hand. A flash of genius is not required. Because most people are honest and most believe in principle the social utility provided by patents, people in industry can judge quite well when an innovation is valuable and out of the ordinary. The distinction between junk and gem is distinguishable.
Maybe we should reform expert practice so the experts work for the court, with lists generated by conferring litigants, using larger numbers of expert participants with less- exacting qualifications, and only allowing written answers to court-approved and construed inquiries. Sort of a crowdsourced quasi-jury of experts to advise on the Gestalt of a purported invention and advise the factfinder as needed. We need a living stand-in for PHOSITA.
The alternative, of allowing patents on every variation of a theme, is a disastrous slope the other way.
Congress has spoken on your “gestalt”
Just in case you were wondering.
New and not obvious is sufficient. There is no requirement that the invention be “inventive,” what every your definition of that word might be (unless you mean not obvious).
It is important to note that Congress explicitly choose “non-obviousness” instead of “inventive” in the Act of 1952.
KSR is the controlling case. It says, plain as day, that “the results of ordinary innovation are not the subject of exclusive rights under the patent laws”
You parse that.
The words of Congress are where you should begin to understand what that case actually means, Mr. Snyder.
Not only was an RO marker old hat Martin, but also putting more than one RO marker on an implant.
One marker will reveal to you, in an X-ray image, where the thing actually is. Two markers though. How about that? That can tell you more, like how it is oriented.
Now with a stent, you need to know where it is. But with an inter-vertebral disc, wouldn’t it be nice to see, in an X-ray. how it is oriented relative the vertebral bodies above and below it? Concerned patients want to know.
And for how many years before the date of this claim have people been squinting at X-ray images of spines with implants in them, trying to see how the land lies?
Perhaps the CAFC panel was infuriated, that in such an open and shut case, the USPTO was still incapable of coming up with even a semblance of reasoning. Perhaps then it saw this case as an ideal one, with which to rap the Board on its knuckles.
“And for how many years before the date of this claim have people been squinting at X-ray images of spines with implants in them, trying to see how the land lies?”
How long indeed? And how many years must a man squint at an x-ray before an improvement no one implements is deemed not obvious?
The answer my friend….
Ah Les, there you go again with your argument: “If it were obvious, they would have already done it. And they didn’t until now and so, ergo, it’s not obvious”.
It’s not about the substance, it’s about the procedure. It’s about giving the patentee/applicant whose claims have been rejected/cancelled fair notice and ability evaluate the merits of the rejected/cancelled claims. It’s about fairness, not a particular outcome.
It’s like, it was conventional to put an RO marker on a stent. And then this guy claims a stent with an RO marker “at each end” of the stent. And the court then says that the petitioner has not made out its obviousness attack. All a bit silly really.
DC Medtronic’s arguments amount to nothing more than conclusory statements that a PHOSITA would have been motivated to combine the prior art references to obtain additional information. According to the court, these “arguments amount to nothing more than conclusory statements” and thus should not be credited.
Dennis, I think you copied a sentence from the CAFC’s opinion without quotes, and then you wrote your own summary where you quoted from the previous sentence. Kinda confusing.
One key reference did explain that the medial markers were beneficial during the alignment process. However, the Federal Circuit rejected that reference because it was published after the patent-in-question’s priority date and not cited in the prior art references. Because they came after the priority date, the court found that the motivation “could not have been obtained . . . at the time of the invention.”
On its face, this sounds like a giant heap of poor reasoning. If the authors of the reference were unaware of the disclosure in the specification (e.g., because the spec was unpublished), the motivation they provide is evidence that one skilled in the art could have been so motivated as of the critical date. In other words, it’s not “hindsight” to suggest that motivation. The motivation was, in fact, suggested by skilled artisans.
Also, let’s face it: markers are useful for marking stuff. Biomarkers are useful for marking biological stuff. Was there some teaching away from using these biomarkers to mark stuff “proximate to the medial plane” of the spine? I’m not the Director of HUD or anything but I’m guessing not.
OMG, you are so quick to say everything is obvious, you are making up subject matter. No one said anything about “biomarkers.” The controversy is over radio-opaque markers. That is, things that will show up in an xray to make it easier to tell where the implant is after the surgery……
” let’s face it: markers are useful for marking stuff. Biomarkers are useful for marking biological stuff.”
gimme a break.
biomarker: a measurable substance in an organism whose presence is indicative of some phenomenon
The controversy is over radio-opaque markers. That is, things that will show up in an xray to make it easier to tell where the implant is after the surgery
And when was that first disclosed? In this patent’s specification? Nope.
When was what disclosed? What radio-opaque means?…. I dunno…. fourth grade?
When was what disclosed? What radio-opaque means?
Please try harder.
The prior art disclosed generically the use of radio-opaque markers in the human body, for all kinds of reasons (more accurately: for any reason that you might want to use an x-ray detectable marker). If you want to claim a species, you better have some unexpected results or some teaching away. Otherwise, well, no patent. And, yes, that result is a feature of a functioning patent system.
Try harder to do what? My only point was you were rolling your eyes about bio-markers and this has nothing to do with bio-makers and you say everything is obvious.
If it was soooooo obvious to do what the inventor did, why didn’t anyone do it already?
You are a suuupper seerrrious person…. so, you must be able to explain that.
Les,
Hand over your car keys please. The “why did no one do it” (without more, like “long felt nead”) is an extremely weak argument for overcoming obviousness.
I’m not trying to overcome obviousness. I’m having a conversation with someone else.
Your conversation is about …
Hmm, the point that I added.
How nifty – and lucky for you.
“The “why did no one do it” (without more, like “long felt nead”) is an extremely weak argument for overcoming obviousness.”
Wrong. Wrong. And wrong. Unless you mean to exclude effective argumentation to juries of everyday people. Then you’re right.
My point requires the effective argumentation, Tourbillion (that would be the distinction with Les’s attempt without more).
Was the need not long felt here? Must every post be drafted like its a brief before the Supreme Court. Can nothing ever be implied? Go police there, their and they’re on twitter will you?
Les,
You simply try to imply too much with the question “Why has no one done this before?” when you ask that question without more.
The question on its own is simply a poor mechanism to establish non-obviousness.
One does not need anywhere near a brief drafted as if for the Supreme Court to get that simple principle.
imperious pompous pretentious smug assuming
conceited high and mighty insolent
Your feelings are noted Les.
Now focus on the fact that what I have posted is absolutely correct.
Here’s a hint: focus more on the content and less on your feelings.
Malcolm, you say it is not hindsight, but you also (only) use the applicant’s own application as that which is what provides the motivation.
What you did IS a classic sign of hindsight.
The end of the article misquotes and misrepresents the conclusion of the court. First, there was no “one key reference” that the CAFC referred to. It was testimony of an expert. Second, the last line which is a mangled quote, is missing a key negative. The last line of the article should have stated: Because it came after the priority date, the court found that NEITHER the benefits nor the motivation “could have been obtained…at the time of the invention.”
OT, but for all those pendulum watchers out there:
The ineligibility of MacroPoints junky freight tracking claims was affirmed today by the CAFC in another Rule 36 decision. Is it the second or third ineligibility decision affirmed this week?
A very good guess for the next Rule 36 decision upholding an ineligibility finding would be SmartFlash v. Apple, argued yesterday — and argued very well by Apple’s attorney, with the usual caveat that the attorney’s hands are tied and so he can’t touch the elephant in the room.
Good quotes from Apple: “These claims were killed by Bilski, buried by Alice, and the nails were put in the coffin by PTAB.”
“There is a relation between [101 and 112] and this case is an excellent illustration. This kind of functional claiming where the patentee/applicant claimed only the result … raises a serious indefinite problem. … The inventive concept claimed by [the patentee] … is [b l a b l a h b l ah functions]. This function is not defined by structure … but rather repeated references to means. We have functional claims and a functional specification. …”
Judge Lourie asks a question which proves that at least some CAFC judges are thinking ahead: “Is the computer modified in a physical way or is this … just … mental steps written down and getting the computer programmed?”
I strongly recommend listening to the oral argument. It’s one of the best argued 101 cases I’ve listened to in quite a while, at least from the defense perspective:
link to courtlistener.com
Anthropomorphication.
Computers do not – and cannot – have mental steps.
(and yet another reason for a detailed expose of the history of the mental steps doctrine to help ward off the zombification of that relic in the name of the anti-software curse-ade – from a source that Malcolm instantly won’t reject)
“Pencils held in a hand do not — and cannot — have mental steps.”
Deep and compelling stuff.
Pencils in the hand….
Another false equivalency attempted.
There’s no “false equivalency.”
Computers are old tools used for carrying out logic. Pencils are old tools for carrying out logic.
Arguing that “computers don’t think” or “pencils don’t think” completely misses the point that, at the end of the day, what is being protected when those tools are used are mental steps (i.e., logic).
This isn’t even controversial. The logical result is controversial because it will make you and your patent maximalist c0horts cry a river full of alligator tears. Your plate of quail will get all soggy! Boo hoo hoo.
“Computers are old tools used for carrying out logic.”
Your [Old Box] fallacy rears its head – your [Old Box] simply does not have all future improvements “already in there” – improvements that come from the design choice of “wares” (hard, firm, or soft).
Anthropomorphication does NOT miss the point – it nails the point.
And again – this is why a more detailed expose of the mental steps doctrine would be very useful. And even more useful coming from someone whom Malcolm won’t reject out of hand (if Malcolm could ever get out of his own way of the his way against everyone else in a single bucket mentality).
your [Old Box] simply does not have all future improvements “already in there” –
“Your [Old Recipe Book] simply does not have all future improvements ‘already in there’.”
So. What.
Double down with a book fallacy…?
How quaint.
Especially as you have volunteered an admission against your interests with knowing and understanding controlling law when it comes to the exceptions to the judicial doctrine of printed matter.
Not sure why you want to gift me with another white horse on this topic….
a more detailed expose of the mental steps doctrine would be very useful.
Go right ahead! You’re the expert. The floor is all yours.
Try starting from the beginning.
Lol – you need to read ALL of what I wrote.
(and yes, I would be considered an expert on the topic, thank you)
🙂
Has anyone ever seen the mythical examiner affidavit required when requested under 37 C.F.R. 1.104(d)(2)? If so, could you point me to the file history so that I can see such a rarity.
37 C.F.R. 1.104(d)(2):
“(2) When a rejection in an application is based on facts within the personal knowledge of an employee of the Office, the data shall be as specific as possible, and the reference must be supported, when called for by the applicant, by the affidavit of such employee, and such affidavit shall be subject to contradiction or explanation by the affidavits of the applicant and other persons.”
It’s a rarity that such a request be appropriate. ‘Personal knowledge’ does not include common-knowledge or common-sense. The request is appropriate when an examiner is arguing something like “based on my experience as a X engineer, I know that Y has been used for…”.
Interesting assertion. One would think that an Examiner’s assertion about what he knows to be true from personal knowledge would be more reliable than what an Examiner believes an entire group of people knew as common knowledge at the time of the invention.
You mean “In[correct] assertion.” When Examiner asserts that something is common knowledge, that assertion is predicated upon the Examiner’s personal knowledge of the knowledge of others or upon some reference that could establish the truth of the assertion (and if there were a reference, surely that reference would have been provided). Thus, this assertion is still predicated on personal knowledge, just one layer removed.
Ben’s response is typical of USPTO bureaucracy, in that it entirely misses the forest for the trees by ignoring the fundamental inequity that the rule is intended to address (and quite clearly does adderss) and resting on a procedural interpretation that contorts the intent of the rule severely.
Using Ben’s example, if the Examiner made the identical statement “I know that Y has been used for…”, but simply removed the one aspect of the assertion that has some circumstantial weight (the clause “based on my experience as a X engineer”), Ben would ostensibly say that the assertion is simply “common knowledge” that can rest on its own. Silliness.
When you’re done with that strawman you might take a moment to note that I never said anything about the common knowlede resting on its own. If applicant adequately traverses the noticed fact, the examiner has to either shut up or put up evidence.
“If there were a reference, surely that reference would have been provided.”
One would only say this if they didn’t actully understand what official notice is for.
“One would only say this if they didn’t actully understand what official notice is for.”
What is if for?
“If applicant adequately traverses the noticed fact…”
The problem with this is the bullsh!t in MPEP 2144.03, which has no legal authority, or basis whatsoever, but that examiners seem to think is actually the law. It’s not.
Here’s a tip: If you’re taking Official Notice, you’re doing your job wrong. Stop it. Find a reference. If the “noticed fact” (lulzapalooza) is actually “capable of instant and unquestionable demonstration as being well-known,” then spend an “instant” and find a reference.
Respectfully disagree. How does one know what is “common-knowledge”? Must a fact asserted as CK be accepted as true just because the Examiner says it is? What is or isn’t CK is itself a factual issue. An examiner’s assertion that X is CK is a form of personal knowledge; not of the underlying fact X, but rather of the fact that _X s common knowledge_.
The Supreme Court caused this confusion by extolling the role of common knowledge. I think the Court’s purpose in bringing it up was to emphasize that the potential sources of information relevant to obviousness analysis should not be constrained.
But they must be constrained – in at least the point that some factual predicate must be established.
The times that I have challenged such “official notice” rejections, the Examiner has either dropped the allegation, or cited a document to support the assertion. I have never seen an example of the affidavit to which you refer.
Thanks, Les. Neither have I.
Have never seen this happen, though I have seen a case history that had one … sorry I can’t recall it. Have challenged personal-knowledge assertions many times. They always either go away or are replaced with real art, which is good for the Applicant, since how do you disprove personal knowledge? Modern 103 rejections usually blur the line between fact and reasoning. Teasing out the facts (including implicit assumptions) can help identify facts that are “personal knowledge”.
As an examiner with prior prosecution experience, I hope this decision is integrated into the examining corps. There have been times when I allowed an application and was questioned why I didn’t make a 103. My response was that I couldn’t come up with a reason to combine them. To me, that means allow the application. To too many examiners, that means make up a rationale and hope it sticks.
Why on earth would an examiner *want* to make up a rationale in the first place? I’ve been puzzled by this for a long time.
If they themselves have ostensibly determined non-obviousness because there is no reason to combine the prior art, why on earth do they not *want* to assert their own rationally based finding of patentability?
“Why on earth would an examiner *want* to make up a rationale in the first place? I’ve been puzzled by this for a long time.”
A first class ticket on the RCE gravy train is one reason.
Do you need more?
If your examiner is a junior examiner, they are most likely just trying to reach the conclusion that the know they are expected to reach by the person who is actually signing the action.
If your examiner is not a junior, they are likely trying to reach the conclusion that they sincerely feel is right. (Though that sincerity may be due to an anti-patent attitude).
“If your examiner is a junior examiner, they are most likely just trying to reach the conclusion that the know they are expected to reach by the person who is actually signing the action.”
And therein lies the problem. As I posted in the next topic, objectively is a skill that can be taught, and learned. When the junior examiner is examining the application and the mindset is, “I need to get this counted, and it’s easier to just reject everything because I know it will get signed no problem, so even though I think the claims are allowable, I’m just gonna write it up as a rejection” then the whole exercise is pointless. Literally every second you’ve spent on the case has been a waste of time. Your time. The applicants time. Everybody’s time. Stop it.
Examine the application objectively. In other words, consider all of the evidence in favor of unpatentability, and all of the evidence in favor of patentability. If the objective analysis leads you to conclude that the claims, or some of the claims, are allowable, then “advocate” that position to whoever it is that has the authority to sign your action.
Question for all of the examiners: If you’ve ever argued for the allowability of a claim and had some SPE, QAS, or other useless, know-nothing, do-nothing brain dead GS-15 say, “That’s obvious. Just cite In re Boilerplate” how many times have you ever pointed out that In re Boilerplate is not applicable to the claim, or at least asked “How is that case applicable?”?
If the answer to that question is NEVER, you’re not doing your job. You may be gittin’ yo’ counters, but you’re not doing your job.
Start doing your job.
One (not small) problem:
Examiners confuse their job with the metrics of their job.
“You get what you measure.”
Under the EPC, there are claims which easily shrug off novelty attacks but which cannot withstand simple obviousness attacks under the EPO-PSA TSM regime. But there are others that struggle mightily with novelty but, once through that, have no difficulty whatsoever with any obviousness attacks one can put together. Every case depends on ist unique facts.
Some patent systems encourage the false assumption that, if it’s barely novel, it must be obvious. Their statutory provisions and caselaw fail to flag up and cherish the very different (but complementary) functions of the novelty and obviousness provisions of the statute.
As I often point out, the winning line in a lottery differs from the next non-winning line by a single digit. Small differences can be all important.
Absolutely – especially when those small differences seem so very easy after the fact.
I agree heartily with MaxDrei here.
A running complaint here in the States is the anti-patent fervor that among other things spawned the “Reject-Reject-Reject” era and certainly flavors the star chamber antics such as the (once publicized quickly shut down) SAWS program – of which, the Office admitted to having several such clandestine programs.
A mind like yours, MaxDrei, being open to understanding, surely must have picked up that understanding about the US system…
the anti-patent fervor
Such fervor! And the result of all this alleged “anti-patent” fervor? More patents being granted than ever before in the history of civilization.
But, oh, the fervor!
Talk about your false equivalencies…
Many thanks for your honest and helpful intervention.
As a European, the first question is whether the claimed features lead to a new or improved result from which a technical problem is derived. If not, then simply finding the claimed features in the prior art suffices. If so, then you need a reason to combine, and should show a healthy respect for the “entropy” of invention. Once you know the answer, you can dismiss all the mass of failed alternative proposals and concentrate on the 2 or 3 proposals that could have led to the invention. But the inconvenient truth is that they are assembled with hindsight and do not represent what the skilled person really knew before the invention was made.