Federal Circuit Finds Stent Patent Obvious by Combining Embodiments in a Single Prior Art Reference

Boston Scientific v. Cordis (Fed. Cir. 2009)

In 2003, Boston Scientific sued Cordis for infringement of its drug-eluting, non-thrombogenic, expandable stent. (Patent No. 6,120,536). The stent, thus has a metal core surrounded by a drugged layer that is then surrounded by a non-thrombogenic layer. A jury found the asserted claims infringed and not obvious. The district court accepted the jury verdict and denied the Cordis motions for JMOL and a new trial. On appeal, the Federal Circuit reversed – finding the patent obvious as a matter of law.

Cordis pointed to another Medtronic patent (“Wolff”) as prior art that – by itself – renders the claims invalid. Wolff discloses two separate embodiments: (Fig 4) a metallic core with a drug-eluting coating and (Fig 3B) a drug-eluting core with a non-thombogenic coating. Thus, Wolff “teaches all of the [claimed] limitations. . . . The only qualification to this statement of fact is that all of the limitations are found in two separate embodiments pictured side by side in the patent, not in one embodiment.”

Applying KSR, the Federal Circuit found that it would have been obvious to combine the two embodiments since the combination was simply a “predictable variation.”

“Combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness.”

Holding: The asserted claim “would have been obvious in view of Wolff.”

Note: The Cordis brief used a particularly effective strategy of including the two embodiments to be combined followed by a demonstrative drawing of how they would have been combined. Here, they used the same drawing style and also used the same figure numbering.

82 thoughts on “Federal Circuit Finds Stent Patent Obvious by Combining Embodiments in a Single Prior Art Reference

  1. 82

    “Did any of these cases involve invalidity decisions based solely on prior art considered by the US PTO examiner?”

    I don’t know, nor do I care. Here’s why: let’s say the reference was “considered” by the Examiner. Let’s say the reference anticipates the claimed invention.

    Now, what difference does it make whether the reference was previously considered? Answer: none.

    The same applies with respect to obviousness in nearly every case. I have already explained to you that there are close cases, but those are the exceptions. Most cases are not close. Most cases are slam dunks, with one side kicking up a lot of dust to give the impression that it’s close. Is there any doubt that’s what happened here?

  2. 81

    Sorry crumbs. Dividing my attention, between screen and desk, not a good idea. Now I see it, I concede that you are right. Probably any attempt to graft EPO-PSA onto the body of the US Patent Statute is doomed to fail. Me, I’m occupied with the idea that one day the US might tear up its patent statute and start afresh, as Europe did in the 1970’s. If that were to be the case, the EPC would be one benchmark. Then again, the EPC is formulated for growth in the civil law world, and I admit might not survive re-potting in common law soil.

  3. 80

    MaxDrei,

    That was not AllSeeingEye that proposed the question, and my “eye” was not all seeing – the analogy had me wearing glasses for seeing far.

    I see that you do not see the analogy.

  4. 79

    It is my answer to “everything” because every patent system in the world has non-obviousness as a condition of validity, to stop roadblocks that impede the Progress. Your all seeing eye and my European eye are both unique, not universal. Eye, just how many cases have you piloted through EPO opposition proceedings. When did you study for, and pass the European Patent Attorney Qualifying Examination. Can you tell me where EPO-PSA gets it wrong. I suspect not. Instead you just suppose that something so simple can’t possibly be anything but flawed. And yet. Aren’t the best scientific theories the most elegantly simple, once you’ve grasped them.

  5. 78

    “Either the subject matter of the claim is ob-Via “lying in the road” of progress; or it isn’t.”

    What if there isn’t any road? (I know, that’s an easy question).

    What if there are many roads, each with different potentials to progress? Does the road for ob-Via have to be the road for most progress? for any progress? Sometimes, the enemy of great is the merely good.

    What if there is an (or multiple) intersection(s) in the road? Is anything truly ob-Via when the way is indeterminate?

    Does the road have to have x and y coordinates, or would a scalar value be sufficient? Or is something only ob-Via when there is ONLY a scalar involved (and the scalar is small enough – whatever that means) – as perhaps illustrated by Basicly’s nose?
    link to patenthawk.com

    Is this ob-Via distinguished by the sections in 101 (…or ANY new and useful improvement thereof,) and 103 (Patentability shall NOT be negatived by the manner in which the invention was made.)? emphasis added.

    In hindsight, everything is obvious. It is an age-old question concerning how to un-ring a bell that the applicant’s own work rings.

    While a PHOSITA should have common sense, should a PHOSITA also have omniscience and total recall of all art in his field (and in any field that may pertain to the scope of the answer provided by the applicant’s work)?

    MaxDrei, as you yourself indicated on The Patent Prospector, obviousness has its own fuzziness (at least in jury briefings). Offering the EP solution, as it appears to be your answer to everything, to the US body of laws is a bit like my offering you my glasses for seeing far to help with your inability to see close.

  6. 77

    Oh good. Thanks Mr Gur. In that case, would you like to add to my comment over on Prospector, on the Lichtman interview of Chief Judge Paul Michel, who (apparently) thinks that the present level of complexity and uncertainty in US patent law is already at an irreducible minimum.

  7. 76

    Dear Max,

    In my letter, I was referring to the USPTO. Malcolm Mooney noted that under current US law, there are no more patentable stent inventions, so people are dying in the US because novel life-saving stents are not profitable. I was trying to work together with Malcolm to find a solution for this undesirable situation.

    I have no real complaints with how the EPO applies the patentability tests as they are clear and objective. When a claim is rejected, one invariably understands why it was rejected, how to amend and what to argue. Importantly, EPO rules and laws themselves are in-line with public policy objectives, for example the recent simplification of language and broadened scope of allowable medical claims.

  8. 75

    Mr Gur, I’m disappointed that you draw this distinction between novelty and obviousness. EPO-PSA (here I go again) reduces obviousness to something every bit as B/W, Y/N, factual, as the novelty issue inherently is. There is more disagreement between the EPO and the German Supreme Court on “novelty” as defined in the EPC, than on the obviousness issue. Either the subject matter of the claim is ob-Via “lying in the road” of progress; or it isn’t. One or the other. Americans should not be so defeatist, negative, and hopelessly pessimistic, on the amount of subjectivity and legal uncertainty surrounding the issue of obviousness. Have any readers here actually observed how the EPO disposes of a thousand obviousness cases per year, all in short order, in inter Partes proceedings, at Appeal Board level, without any whingeing either from patent-owning community or the community of opposers?

  9. 74

    The purpose of patents is to encourage technological advancement by giving an innovator exclusivity for a limited time. This allows the innovator to raise the price for a product in order to recoup investments needed for developing the product.

    Patents are currently given for articles of manufacture that are novel and not obvious.

    Whereas novelty is a factual questions, obviousness is an artificial construct: an article may not be patented if its “wow”-factor is lower than a certain threshold.

    Malcolm Mooney states that in the field of stents, there are no longer any innovations that pass the current USPTO threshold for non-obviousness.

    Malcolm Mooney further states that people are dying because the stents that would save them are not profitable to make.

    It would seem that the conclusion is that 35 USC 103 should be scrapped, allowing companies to gain patents for obvious stents, allowing lives to be saved.

  10. 73

    Mr Mooney, reassuring while you are, I’m still a bit bothered by the effect of “clear and convincing” on the formulation of the model jury instructions on obviousness, in the Judicial Case Management 542 page tome referenced in a more recent posting by Dennis. I can imagine it saving a claim that would otherwise appear egregiously and embarrassingly obvious, even to an ordinary jury member after receiving what would otherwise be persuasive assistance at trial from the petitioner for revocation of that claim. Can you write something on that?

  11. 72

    Malcolm Mooney wrote, “I’ll repeat myself again, hoping against hope that it will sink through: the CAFC has on more than found patents invalid that were re-rexamined TWICE.”

    Malcolm, thanks for repeating this. When you wrote this before I asked the question set forth below, but you did not answer:
    Did any of these cases involve invalidity decisions based solely on prior art considered by the US PTO examiner?

         So, please answer now.

  12. 71

    ira “So Malcolm, how do you reconcile your interpretation of KSR with the following instructions which SCOTUS gave us in KSR: By direction of 35 U. S. C. §282, an issued patent is presumed valid.”

    I reconcile my interpretation of KSR by noting that patents are routinely invalidated, by noting that the USPTO continues to issue patents that are laughable crap, and noting that applicants continue to file claims that are laughable crap because they understand that the middle proposition is an exploitable fact. How about a difficult question, ira?

    As for this: “We nevertheless think it appropriate to note that the rationale underlying the presumption—that the PTO, in its expertise, has approved the claim—seems much diminished here”

    it goes precisely to my point upthread which is that your silly list is a stoopit waste of time. The “presumption” of validity is a thin one, particularly when the Examiner is clearly inept, blind or both (not an unusual situation).

    I’ll repeat myself again, hoping against hope that it will sink through: the CAFC has on more than found patents invalid that were re-rexamined TWICE. Did they do somersaults and cartwheels to reach their findings? Did they engage in endless apologies for their earthshaking findings? Did they pay paragraphs of lip service to this “presumption”? Nope. They just tossed the patent in the toilet and flushed with extreme prejudice.

    As it should be. The only tangible benefit of the presumption relates to who has the burden of proof. In the very rare close case when the evidence isn’t “clear”, it might also make a difference, but the difference between a close case and a not-so-close case is more often decided by whether one side more faithfully adheres to the judge’s requirements re page limits etc that it is by the silly presumption (not that the presumption won’t be presented as “the reason”).

  13. 70

    Malcolm Mooney wrote,
    “Dude, it’s you and others who are begging for the assumption, i.e., that if some combination has not been expressly described or suggested in the prior art, then it must be non-obvious.

    “The whole point of KSR was to squash such rudimentary, crap-patent-proliferatin’ assumptions out of existence.”

         So Malcolm, how do you reconcile your interpretation of KSR with the following instructions which SCOTUS gave us in KSR:

    “By direction of 35 U. S. C. §282, an issued patent is presumed valid.”

    “We need not reach the question whether the failure to disclose Asano [prior art apparently known to the applicant but not disclosed to or considered by the examiner] during the prosecution of Engelgau [the patent in suit] voids the presumption of validity given to issued patents, for claim 4 is obvious despite the presumption. We nevertheless think it appropriate to note that the rationale underlying the presumption—that the PTO, in its expertise, has approved the claim—seems much diminished here.”

  14. 69

    “We need to focus on getting rid of the amorphous mess that determines the abilities of the PHOSIA … and replace it with a standard that creates “predictable results””

    Here we go again. You want predictability? Fix the case law re preambles so preambles are always limiting. Fix the case law re means-plus-fxn claims so that 112P6 is only invoked when the applicant expressly asks for it to be invoked. Get rid of product-by-process claims once and for all. And get rid of Beauregard claims, once and for all.

    There’s a lot of predictability right there and very very few people would complain. No doubt those who would complain would complain loudly, but those people will NEVER stop complaining because for those people any time a patent is invalidated its a worse crime than executing an innocent person.

    It’s not predictability that the pro-patent whiners want: it’s more patents, period. The less predictable a patent’s validity is, the better, as long as the CAFC upholds the validity or reverses findings of invalidity more often than not (and ideally, 100% of the time). If it was predictability that the pro-patent whiners want, they’d be loving KSR all the time because KSR makes it much easier to predict whether a patent is invalid or not.

    Did anyone think the CAFC would uphold this case on appeal? Did anyone go on the record saying that they thought so? I’d love to see the reasoning behind that call, if so. Please share.

  15. 68

    ira “KSR does NOT instruct anyone to assume facts, such as WHY others in a particular art not have made a particular combination.”

    Dude, it’s you and others who are begging for the assumption, i.e., that if some combination has not been expressly described or suggested in the prior art, then it must be non-obvious.

    The whole point of KSR was to squash such rudimentary, crap-patent-proliferatin’ assumptions out of existence. The ‘536 patent discussed above is exactly the sort of crap that KSR was intended to crush.

    So by all means, create your little list and wave it around. If you’re lucky, you’ll find some dumbaxx judge who finds such garbage persuasive. You can bet your life that the CAFC won’t give a crap.

  16. 67

    Malcolm Mooney wrote, “Maybe you should read KSR again. You seem rather clueless.”
         KSR requires examiners and judges to apply common sense to known facts. KSR does NOT instruct anyone to assume facts, such as WHY others in a particular art not have made a particular combination. Of course, IF such facts are known, they may inform the application of common sense.

    Malcolm Mooney wrote, with respect to the list of cases in which the Federal Circuit issued (or confirmed a lower court) ruling of obviousness based solely on prior art that had been considered by the US PTO examiner that I am trying to compile, that it is a “*pointless* list of cases.”
          I look forward to having the opportunity to litigate against Malcolm Mooney some day.

  17. 66

    Wow! the randomness of the abilities of the PHOSIA never ceases to amaze me. We all know every patent argument has a 50% chance of sticking any way (and we know this when we file the complaint/response).

    We need to focus on getting rid of the amorphous mess that determines the abilities of the PHOSIA … and replace it with a standard that creates “predictable results”

  18. 65

    renter: “Isn’t the fact that the inventors of Medtronic patent (“Wolff”) – the PHOSITAs – failed to propose the variation evidence that PHOSITA would not have predicted the variation?”

    LOL. This one has the depth of insight I’d expect to see in the comment section of a Fox News article about this case, not here. Wow.

  19. 64

    ira: “Neither we nor a US PTO examiner should presume any reason for why those of ORDINARY SKILL IN THE ART have not done something if that presumption would weigh against non-obviousness.”

    Maybe you should read KSR again. You seem rather clueless.

    “So, my “little list” of cases”

    Correction: little *pointless* list of cases.

  20. 63

    I hope the PTO does not encourage examiners to use this case to justify a 103 in every instance in which some elements are disclosed in one embodiment in a prior patent reference and others are disclosed in another embodiment in the reference. I have seen instances in which an examiner pointed to an element disclosed in one part of a prior patent reference and another element disclosed in a totally unrelated part of the reference, and issuing a 103 if not a 102!

  21. 62

    “for Ira” gave me this link:
    link to stlr.stanford.edu
    Thanks. While it isn’t exactly what I wanted, the article provides helpful insights. It also reminded me that the Brown and Tyler Refrigeration cases I mentioned in an earlier comment are ANTICIPATION cases and not obviousness cases. So, my “little list” of cases in which the Federal Circuit issued (or confirmed a lower court) ruling of obviousness based solely on prior art that had been considered by the US PTO examiner is now down to just the Boston Scientific v. Cordis case which is the main subject of this thread.

  22. 61

    Renter, reading your effort just above, I am forced to the conclusion that you have read neither Wolff nor my interpretation of it upthread (contrast with gearboxes). Do you want to tell me you have already read Wolff?

  23. 60

    The combination was simply a “predictable variation?” Predictable by who? Certainly not the inventors of Medtronic patent (“Wolff”), who had the materials before them and failed to make the connection or see the variation. Why would it be predictable? Isn’t the fact that the inventors of Medtronic patent (“Wolff”) – the PHOSITAs – failed to propose the variation evidence that PHOSITA would not have predicted the variation? There is no motivation to make the combination other than to reject the pending claims.

    Also, even if “Combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness.” how can the court say that “Combining two embodiments disclosed adjacent to each other in a prior art patent to teach the claimed invention does not require a leap of inventiveness.”

    The court fails to define a variation. Apparently a “variation” is any conbination needed to teach the claimed invention. So using the pending claims as a road map, the examiner need only propose a “variation” to match the claims and say it is obvious. Of course it is obvious if you have the pending claims as a road map. Under the present patent legal theory, E = mC**2 was obvious when Einstein wrote it ’cause E, =, m, C, and **2 were in the same book prior to Einstein making his obvious variation.

  24. 59

    Well Mr Spevacek, if you look at the “patent family” members, related to the patent in suit, you will see about 20 in the USPTO and about 10 in the EPO. This case has the legs to run indefinitely, or at least for as long as the patent has any of its 20 year term left in it. And anyway, only three of the many claims of the suit patent were invoked, right? Hydra-headed, or what?

  25. 58

    As a PHOSITA and not an attorney or PE, can someone tell me what happens now to the Boston Sci patent? Is the whole thing invalid, now and forever? Is this recorded somewhere? (Assuming the SCOTUS denies cert or hears it and concurs.)

  26. 57

    Ira,

    I ran across a journal article discussing cases where the Fed Cit invalidated claims as anticipated by previously considered art. The cite is 2006 Stan. Tech. L. Rev 2 and appears to be available at

    link to stlr.stanford.edu

    Not exactly what you were looking for, but still interesting.

  27. 55

    The last time I looked, insufficiency and obviousness are not mutually exclusive but, often, there’s a squeeze on the petitioner for revocation: argue it’s insufficient and you hurt your own obviousness attack. When the paclitaxel-coated stent was to be litigated in London, an insufficiency attack would have been exhausively considered, of course. But, in the end, they didn’t run it. As to obviousness, on its special facts it was in Europe a textbook 50:50 case. What happened in the USA, by the way?

  28. 54

    “the PTO makes mistakes. Examiners make mistakes.” I make a LOT of mistakes.

    And BTW, I really really dislike “old people.” Which is a shame, because as much as I dislike myself now, I’m in for a big surprise in the form of vicious self loathing a year or two down the pike.

  29. 53

    Malcolm wrote, “I think you would be suprised how many of those experts dismissed the idea for reasons that had nothing to do with whether such a stent would be useful or not and everything to do with whether it could be cheaply made. Did you know that experts sometimes decide not to pursue a particular combination because one of the elements in the combination is patented by a litigious entity?”
         Neither we nor a US PTO examiner should presume any reason for why those of ORDINARY SKILL IN THE ART have not done something if that presumption would weigh against non-obviousness.

  30. 52

    Hi Ivanator,
    If Claim 8 is invalid for obviousness, the broader claims from which it depends would also be invalid for obviousness.

  31. 51

    The punters never fail to miss the point:

    “I suspect that few of our European colleagues have ever tried to coat a bare metal stent with a material such as paclitaxol”

    Again, if it’s extremely difficult and everyone knows it, then you might be able to rebut a prima facie case. Hell, if it’s so difficult, you might be entitled to a method claim as well. But my proposition stands: if a bunch of doctors say that a stent coated with paclitaxol would be awesome, then a claim to a stent with paclitaxol is prima facie obvious, unless you’ve got unexpected results (highly unlikely given that the doctors in my hypo seem to expect it would be awesome).

    “I think you would be surprised in how many experts in the field had either never thought of using the material in the product or had thought of it briefly before outright dismissing the idea.”

    I think you would be suprised how many of those experts dismissed the idea for reasons that had nothing to do with whether such a stent would be useful or not and everything to do with whether it could be cheaply made. Did you know that experts sometimes decide not to pursue a particular combination because one of the elements in the combination is patented by a litigious entity? Chew on that for a while.

  32. 50

    I don’t get it. Claim 8 is the only claim at issue in this appeal. Claim 8 depends on claim 6, which depends on claim 1.

    Even if claim 8 is invalid, wouldn’t the defendent still infringe claim 1 & 6 anyway?

    What then is the point to appeal claim 8 alone?

  33. 48

    “The idea of importing it into the stent field is mundane, the idea of filing a patent on that combination is (in nearly every instance) worthy of scorn.”

    Mooney, just about all of your posts are mundane, without any substance and worth of scorn.

  34. 47

    “Candy bars and intercourse…”

    Yes, my bedroom is a sad and joyless place.

  35. 46

    Malcom Mooney wrote, “I think the stent application modus operandi for many years is to wait for a new material to be developed or discovered by a third party, then either make a stent out of that or coat a stent with it. The new material itself is likely patentabile in many cases. The idea of importing it into the stent field is mundane, the idea of filing a patent on that combination is (in nearly every instance) worthy of scorn.”

         Many years ago I litigated a case involving trade secrets and knowhow regarding the importing a particular material (whether or not it existed in nature or was developed by some third party does not matter) into a product to improve the product in a certain respect. (Sorry for all the generalities; the litigation was settled with the usual confidentiality restrictions.) In getting into the history of the development of the improved product, I think you would be surprised in how many experts in the field had either never thought of using the material in the product or had thought of it briefly before outright dismissing the idea. So, without much more information in addition to the existence of a material and its known properties, I think that we cannot generally presume that importing a material into any product is mundane.

  36. 45

    Macolm Mooney wrote, “If the case was issued prior to KSR, then KSR should give the judge all the confidence the judge needs [to rule that a claim is invalid for obviousness solely in view of prior art considered by the US PTO examiner}, at least in the utterly predictable mechanical and computer arts. Did you see the recent Federal Circuit decision upholding Judge Schwarzer’s summary judgment opinion
    link to legalpad.typepad.com .”

    Thanks, Malcom. The Frisket case to which the link ultimately led is very interesting.

    However, both KSR and Frisket seem to rely on prior art NOT cited by the examiner. In KSR, SCOTUS says so explicitly. In Frisket the CAFC relies on prior art referred to as “IUMA Radio,” and I could not find in the Frisket patents any mention of that prior art. So, with respect to my concern about giving district court (and even Federal Circuit) judges confidence to rule on the obviousness of claims solely in view of already cited art, I’m still looking for cases to add to my list.

  37. 44

    I refuse to flame any individual on the web.

    Therefore, in regards to the simplistic comments above regarding the application of various coatings on various stent substrates, I’d merely point out that in general the comments display a remarkable ignorance about an art which can in fact be quite complex. I’m fairly certain that on this blog I couldn’t get away with such ignorance of, oh, say, ME/EE.

    I suspect that few of our European colleagues have ever tried to coat a bare metal stent with a material such as paclitaxol, or ever attempted to develop a drug-eluting product which met the US FDA requirements for predictable drug dosing patterns. (Yes, children, some of it really is rocket science.)

    At the same time, IMHO the panel blew it on this one. A more reasonable holding of invalidity would have noted that the specific chemical nature and physical arrangement of layers may well be critical to the performance drug-eluting stents, such that the broad claims identified in the opinion were not adequately supported in the specification; valid claims would have to be much more limited in scope.

    This would avoid the need for the CAFC to do what it really should have done if its reasoning was valid — remand the case to permit the assignee to present specific evidence why it would have been unobvious for the elements of the reference to have been combined in the manner suggested by the appellate court. By the court’s own rules the appelate court is not the venue in which evidence is presented.

  38. 43

    I’m disappointed, Mr Mooney. I thought we were debating ME/EE and yet you seem to have slipped into chemistry, and unexpected results, and the selection of the one coating (TAXOL?) that works, out of the multitude proposed for fighting restenosis. Not sure about stent coatings being new,as such, just new for restenosis (etc). But what about, say, a new system of lacing a soft boot for a particular sport. Improved performance “obvious”, once your sportsman claps eyes on the new boot. New, predictable, no effects unexpected, but yet not legally obvious.

  39. 42

    “”It wasn’t obvious to [inventor of issued patent] when he told me to do it.””

    I’ve been listening to some comedy this week, but that is by FAR that funniest sht I’ve heard all week.

  40. 41

    “Companies and doctors will come to you and describe a problem. Since you are the only ones who know that every solution has been already made or is obvious, you guys will be very rich very quickly.”

    The difficulty with providing doctors with the stents they want is not a question of human ingenuity, it’s a question of human will. If a particular stent will cure Steve Jobs and Steve Jobs wants to be cured, trust me, that stent will be made.

    Can a profit be made from the stent? Different question. Crucial for practical purposes but utterly irrelevant for 103 purposes.

  41. 40

    Max “That’s not enough though, is it, to make that particular combination of technical features legally “obvious”?”

    Again: coated stents are old. Coating stents with an ancient material is old. Coating stents with a newly discovered material is old. The idea of coating a stent with any PARTICULAR material, whether that material is newly discovered or ancient, is prima facie obvious. That is the proper application of the law. The law also provides a means for rebutting the prima facie case but, in the case of coated stents, I would guess that the appropriate facts are present 1% of the time, max (no pun intended).

  42. 39

    “Every year there are a number of stent conferences where the ultimate stent experts (far beyond PHOSITA level) discuss what is missing in the world of stents to save the lives of thousands of people.”

    Do they keep transcripts? That would be some sweet prior art.

    ” If I paint my car a new colour, have I made a patentable invention?.”

    I think the stent application modus operandi for many years is to wait for a new material to be developed or discovered by a third party, then either make a stent out of that or coat a stent with it. The new material itself is likely patentabile in many cases. The idea of importing it into the stent field is mundane, the idea of filing a patent on that combination is (in nearly every instance) worthy of scorn.

  43. 38

    Spot on, Mr Gur. Mr Mooney, can you comment on “predictable=unpatentable”? After the event, with the benefit of hindsight, ie when the PTO looks at it, everything in ME/EE is “predictable”, by which I mean that the results delivered by a novel combination of technical features could have been predicted. That’s not enough though, is it, to make that particular combination of technical features legally “obvious”?

    Since the dawn of time, (or was it John Milton?) it has been recognised that “predictable”, as a hindsight test of obviousness, is unfair. Where’s the forward-looking, fair to the inventor ME/EE test in the USA, corresponding to PSA at the EPO (which works exclusively from sources prior to the date of the claim)?

  44. 37

    Malcolm Mooney = Commissioner of the U.S. Patent and Trademark Office, one Charles H. Duell reincarnated? cloned?

  45. 36

    Malcolm, your comment at 6:10 is painful to read.

    You are sitting in the USPTO and say that everything that can be invented in the field of stents has been invented.

    Every year there are a number of stent conferences where the ultimate stent experts (far beyond PHOSITA level) discuss what is missing in the world of stents to save the lives of thousands of people.

    I have two suggestions:

    The first, give a plenary lecture at a stent conference (there is one in Hawaii February 16-20) where you will be able to tell how to solve every single stent challenge that exists. You will be a shoo-in for the Nobel prize.

    The second, leave the USPTO with some stent Examiners and set up a company called “Stent Solutions”. Companies and doctors will come to you and describe a problem. Since you are the only ones who know that every solution has been already made or is obvious, you guys will be very rich very quickly.

  46. 35

    I’s worth looking at Wolff, through the eyes of a stent builder. We are not here in the area of combining bits of a first embodiment (a Medtronic “carotid” stent say) with bits of a second embodiment (a “coronary” stent maybe). It might not be “obvious” in, say, a gearbox to combine a “Jaguar” third gear with a “BMW” first and third because both the Jag and the BMW embodiments are already best mode optimalised. But Wolff is saying no more than “Hey, if you want, in coating your metal stent (of whatever design that stent happens to be), you can put a barrier layer on top of your drug-eluting polymer coating, and you’ll get the effect that barrier layers routinely provide”. Whether or not that’s an anticipatory teaching is perhaps just about worth arguing. If I paint my car a new colour, have I made a patentable invention?.

  47. 34

    “Michael Barclay, can you cite the previous case you claim the Fed circ says that you cannot combine two embodiments to anticipate?”

    There is no case that makes any such blanket proposition. For example, if one embodiment in reference A shows X, and another embodiment in reference A shows that Y is inherent to X, then the two embodiments can be combined to show anticipation.

    The proposition you’re thinking of is merely the old saw that anticipation requires that the reference describe not only the elements in the invention, but also the claimed arrangement of those elements, i.e., it’s not sufficient for the reference merely to contain within its four corners all of the terms recited in the claim (of course, it’s also not necessary …).

    “Did any of these cases [where The Fed Circuit has found a number of patents invalid that were re-examined TWICE] involve invalidity decisions based solely on prior art considered by the US PTO examiner?”

    Solely, not solely, the issue remains the same: the PTO makes mistakes. Examiners make mistakes. Prior to KSR, the PTO issued patents for the dumbest reasons that any intelligent human could imagine: because the PTO couldn’t produce a prior art reference “expressly suggesting” a claimed combination of old stuff that yielded nothing more than what anyone would expect the combination to yield. How could there be a presumption of validity post-KSR for a patent that was examined according to the insanely patent-friendly strict TSM standard?!?

    “I think having a list of such cases would give a judge more confidence”

    If the case was issued prior to KSR, then KSR should give the judge all the confidence the judge needs, at least in the utterly predictable mechanical and computer arts. Did you see the recent Federal Circuit decision upholding Judge Schwarzer’s summary judgment opinion?

    link to legalpad.typepad.com

    Schwarzer is 80+ years old. He kept the dust out of his eyes out without any problem whatsoever. There’s your “confidence builder.” If a judge has his head up his axx, it shouldn’t take a rocket science to pull it out. Unless the judge is from Texas or some Appalachian cesspool.

  48. 31

    So here the Federal Circuit rules that one reference renders a patent invalid due to obviousness. Why didn’t the Fed Circ rule that the patent was invalid due to anticipation? Michael Barclay, can you cite the previous case you claim the Fed circ says that you cannot combine two embodiments to anticipate?

    When drafting a patent, a statement is usually put at the end of the spec that the inventor contemplates any combination of the embodiments. The Wolff reference in this case did NOT have such a statement. Maybe that is the distinguishing factor.

  49. 30

    “why not just identify the mistakes made by the Examiner thereby flushing the presumption of validity down the toilet.”
         Were it just that simple to get a district judge to avoid taking the easy path of deferring to the examiner. I think having a list of such cases would give a judge more confidence (and perhaps the feeling of obligation) to actually rule on the merits of an obviousness argument based solely on prior art considered by the examiner.

    “The Fed Circuit has found a number of patents invalid that were re-examined TWICE.”
         Did any of these cases involve invalidity decisions based solely on prior art considered by the US PTO examiner?

  50. 29

    “wouldn’t this finding by the court assist BS in now asserting their Wolff against Cordis under DoE; since the Cordis stent has in effect been found to be using an obvious variation of the Wolff stent?”

    Rather, it works against BS because they could have claimed it but didn’t. The most equitable result is that the patentee is hosed.

    But more importantly, the admissions and arguments made by BS during prosecution of the ‘536 patent and their defense of the validity of that patent will surely screw any attempts to claim infringement of the Wolff patent under DoE.

    News flash: sometimes a mini-field like “stents” does get used up, patentwise. Like candy bars and intercourse, at some point all the innovation gets used up.

  51. 28

    So then; wouldn’t this finding by the court assist BS in now asserting their Wolff against Cordis under DoE; since the Cordis stent has in effect been found to be using an obvious variation of the Wolff stent?

    Is this obvious variation also an equivalent?

  52. 27

    Yo, ira, instead of playing stoopit games with your opposing counsel (Them: “This has never happened before.” You: “Yes it has! HAHAH!” Them: “The facts here are totally different.”) why not just identify the mistakes made by the Examiner thereby flushing the presumption of validity down the toilet.

    The Fed Circuit has found a number of patents invalid that were re-examined TWICE.

    Does anyone really believe that the particular reference discussed in this case was necessary to find these crap claims valid? My god.

  53. 26

    All I have so far are the Boston Scientific v. Cordis case which is the subject of this thread (before my attempt at steering it in a new direction) and Brown v. 3M Co. 265 F.3d 1349, 60 USPQ2d 1377 (Fed.Cir. 2001) (see dissent, 265 F.3d at 1354, explaining that the prior art relied on by the court was cited to the PTO examiner), and Tyler Refrigeration v. Kysor Industrial Corp., 777 F.2d 687, 227 USPQ 845, 847 (Fed.Cir. 1985).

  54. 23

    Well Ira, this one can certainly take pride of place, in your little list, because it’s more up to date than any of the others. Do you think it might be a straw in the wind?

  55. 22

    “So freaking what?”
    Thanks for your return query.
    I am trying to put together a list of cases in which the Federal Circuit issues (or confirms a lower court) ruling of obviousness based solely on prior art that had been considered by the US PTO examiner.

  56. 21

    “Don’t we have a case here of the Federal Circuit concluding that a claim is invalid for obviousness over a prior art reference that had been considered by the US PTO examiner?”

    So freaking what?

  57. 20

    Don’t we have a case here of the Federal Circuit concluding that a claim is invalid for obviousness over a prior art reference that had been considered by the US PTO examiner?

  58. 19

    Interestingly, in a case in 2008, the Federal Circuit said that if a reference had two separate and discrete embodiments, the reference couldn’t prove anticipation. This newer opinion explains the other half of the equation.

  59. 18

    …maybe, but let’s not look at what Wolff does not disclose, and look instead at what it really did disclose, namely:

    1. That my drug-eluting stents have a metal matrix,

    2. I include the Fig 3B detail, to show readers how to put a polymer barrier layer on top of a drug-containing polymer.

    Those facts are responsible for not one, not two but a succession of three incredible events before breakfast, namely:

    1. That the claim issued

    2. That its owner deliberately asserted it, and

    3. That the jury swallowed the owner’s line.

    The rest of the world looks on, gob-smacked.

    For any useful response from Sheep’s, I will be thankful.

  60. 17

    If Wolff had taught that the embodiments were mutually exclusive because of serious problems that were later overcome by Cordis, this case would have come out quite differently and Mooney would have to whine about something else – like software patents.

  61. 16

    Yes, as I learned from years of observation in my kitchen, Mooney knows all to well about the “twinkie” defense. Not that there’s anything wrong with that…

  62. 15

    “surely had a fun time irritating Cordis with this garbage over the past several years”

    Mooney you’re such a cynical idi0t. Pretty much all of your posts are glib garbage. Yes, everyone with a patent is only out to irritate someone.

    I’m guessing the only one they are trying to irritate is you; and it looks like its working…

  63. 13

    Painfully obvious. This is the medical equivalent of a patent for a vehicle with both an accelerator and a brake.

  64. 12

    Steve Zweig, I think we can distinguish this case over the unreasoned cherry-picked element assemblages… …except where the cherries are side-by-side in the ref. as in this case.

  65. 11

    All examiners have a couple of patents in their fields that they keep in their desks with extensive and broad disclosures that they can use over and over in their art as base or sole references in 103 rejections. This has been going on forever.

  66. 10

    I’m starting to get some extremely long (100,000 word plus) patent applications cited against my applications, where the examiner essentially uses the application as a convenient “parts catalog” to mine terms to combine in what are essentially “single reference” obviousness arguments. This decision isn’t going to help any.

  67. 9

    112, good point, understanding enablement. Is that Liebel-Flarsheim? That sort of thing. At least that theory does have some logic.

  68. 8

    Back when I was an examiner (25+ years ago), I had a mechanical application in which I cited a patent owned by the same assignee as the application but naming a different inventor. I said it would be ovbious to combine Figures 5 and 6 to come up with the claimed invention.

    In an interview with the attorney and the named “inventor” of the pending application I asked why it would not be obvious to combine these embodiments and was told:

    “It wasn’t obvious to [inventor of issued patent] when he told me to do it.”

    The application went abandoned.

  69. 7

    I guarantee you this: right now at the PTO dozens of response are pending where attorneys are arguing about equally crappy sets of claims, e.g., “But … but … my stent has THREE coatings and has surface-enhancing dimples!!!”

    This garbage has nothing to do with innovation. It’s just business, as Tony Soprano would say.

  70. 6

    “Oh, lack of enablement? Too bad.”

    Moocow – I suspect you would have much bigger problems with written description / new matter.

    And as for “chain of logic” – I see where you’re going, but understand that the enablement standard for a 102 reference is different than the enablement requirement under 112 (112 requires more)

  71. 5

    I hope Cordis has a pending continuation open … they should stick the Boston Scientific claims into their pending continuation and see what happens. Oh, lack of enablement? Too bad.

    Something is broken in the chain of logic here.

  72. 4

    “A jury found the asserted claims infringed and not obvious.”

    It’s always hard to tell in these cases who “won.” Yes, Boston Scientific lost their patent. But they surely had a fun time irritating Cordis with this garbage over the past several years.

    I wonder … all these litigation costs over this crap patent … would Cordis try to recoup the money they spent by raising the price that sick people must pay for their product?

  73. 3

    When the two embodiments that are combined are in the same reference (what I call a “102.5”), it’s pretty hard to argue against obviousness under 103.

  74. 2

    But if a reference discloses a structural diagram of R1-A compound right next to a structural diagram of A-R2 compound, then a patent on R1-A-R2 is probably not obvious, particularly if it’s a pharmaceutical. We need more chemists on the court.

  75. 1

    How to explain the opinion the jury reached? Fooled by the line of argument that “non-thrombogenic” (in a vascular prosthesis) is something inventive? After all, it’s not a word one comes across very often, down the pub or while out shopping. Deference to the Government experts at the USPTO, reinforced by the Presumption of Validity and the need for the evidence of obviousness to be clear and convincing and, in particular, good enough to overturn the “evidence” of secondary indications of non-obviousness. Do juries often get fooled in this way?

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