SkinMedica v. Histogen

By Jason Rantanen

SkinMedica Inc. v. Histogen Inc. (Fed. Cir. 2013) Download SkinMedica v Histogen
Panel: Rader (dissenting), Clevenger, Prost (author)

SkinMedica owns Patents No. 6,372,494 and 7,118,746, which relate to methods for producing pharmaceutical compositions containing "novel conditioned cell culture medium compositions,…[and] uses for the[m]."  A conditioned cell culture medium is an artificial environment that supplies the components necessary to meet the nutritional needs of the growing cells.  The conditioned medium at issue here also included extracellular proteins that, according to the patentees, may be useful for treating skin conditions such as wrinkles, frown lines, etc. 

The written descriptions of the '494 and '746 patents explain that a novel and important aspect of their invention is the difference between growing cells in two-dimensions and growing cells in three-dimensions. 

Claim 1 of the '494 patent:

1. A method of making a composition comprising:

(a) culturing fibroblast cells in three-dimensions in a cell culture medium sufficient to meet the nutritional needs required to grow the cells in vitro until the cell culture medium contains a desired level of extracellular products so that a conditioned medium is formed;

(b) removing the conditioned medium from the cultured cells; and

(c) combining the conditioned medium with a pharmaceutically acceptable carrier to form the composition.

(emphasis added by court).  At issue was the phrase "culturing…cells in three-dimensions."  The district court construed this phrase to mean "growing…cells in three dimensions (excluding growing in monolayers or on microcarrier beads."  Following claim construction, the district courted summary judgment of noninfringement for Histogen as it was undisputed that Histogen grew its cells on microcarrier beads. 

Limits on Ordinary Meaning: On appeal, the Federal Circuit affirmed the district court's claim construction. The court first agreed with SkinMedica that "the ordinary meaning of “culturing . . . cells in three-dimensions” would reach the use of beads."  However,

If the specification reveals “a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess[,] . . . the inventor’s lexicography governs.”…. And if the specification reveals “an intentional disclaimer, or disavowal, of claim scope by the inventor,” the scope of the claim, “as expressed in the specification, is regarded as dispositive.”
Slip Op. at 13 (citations omitted).  An  high hurdle applies when dealing with implied rather than express redefinition, as an "implied redefinition must be so clear that it equates to an explicit one."  Id. at 29, quoting Thorner v. Sony Computer, 669 F.3d 1362, 1368 (Fed. Cir. 2012).  Here, according to the majority, the inventors did precisely that for "culturing…cells in three dimenations":

In the written description, the patentees plainly and repeatedly distinguished culturing with beads from culturing in three-dimensions. They expressly defined the use of beads as culturing in two-dimensions. And they avoided anticipatory prior art during prosecution by asserting that the conditioned medium produced by two-dimensional cultures was inferior and chemically distinct from the conditioned medium produced by three-dimensional cultures. Because none of the evidence called to our attention by SkinMedica would reasonably lead to a different reading of the intrinsic evidence, we find that the inventors clearly redefined the scope of “culturing . . . cells in three dimensions” by disclaiming the use of beads—which would otherwise be included in the ordi- nary meaning of that phrase.

Id. at 15.  In support of this conclusion, the majority opinion walks through a lengthy discussion of the text of the specification and prosecution history, addressing language such as "beads, as opposed to cells grown in three dimensions and the use of "i.e."  The result was a disavowal of beads from the scope of the claim term at issue:

"In sum, although the inventors never explicitly redefined three-dimensional cultures to exclude the use of beads, their implicit disclaimer of culturing with beads here was even “so clear that it equates to an explicit one. Without fail, each time the inventors referenced culturing with beads in the specification, they unambiguously distinguished that culture method from culturing in three-dimensions."

Id. at 27. 

Incorporation by Reference: One of SkinMedica's counter arguments was that the written description incorporated a voluminous technical treatise, Cell & Tissue Culture: Laboratory Procedures ("Doyle") in its entirety and that Doyle describes three-dimensional culturing with beads.  Among the majority's bases for rejecting SkinMedica's argument was the lack of any specific reference to Doyle:

Third, even if we assume that the passage from Doyle discusses what one of ordinary skill in the art might understand to be three-dimensional culturing with beads, the inventors’ general citation of Doyle does not indicate any reliance on that particular passage to define “culturing in three-dimensions” and to abandon the otherwise clear disclaimer of beads in the specification. When discussing cell culture methods, the patentees make the following reference to Doyle:

The cells may be cultured in any manner known in the art including in monolayer, beads or in three-dimensions and by any means . . . . Methods of cell and tissue culturing are well known in the art, and are described, for example, in [Doyle], supra; Freshney (1987), Culture of Animal Cells: A Manual of Basic Techniques, infra.

’494 patent col. 10 ll. 2–6.

It is clear from that passage that the inventors did not refer to Doyle in order to define what they meant by “three-dimensional culturing” in their patent. They did not indicate their reference to Doyle was for that purpose; nor did they even refer with any detailed particularity to the passages in Doyle that, according to SkinMedica, may have discussed three-dimensional culturing with beads. When the inventors wanted to use Doyle to explain the potential scope of terms they used, they did so specifically….We see no reason for such a non-specific reference to trump the clear disclaimer in the specification of culturing with beads.

Slip Op. at 35-36. 

Judge Rader's Dissent: Writing in dissent, Judge Rader disagreed that the patentee had met the "heavy presumption" in favor of the ordinary meaning of claim language.  Central to Judge Rader's opinion was the distinction between growing cells "on beads" and growing cells in three-dimensions using beads.  

Deference battle? Judge Rader's dissent also relied on testimony by SkinMedica's technical expert, Dr. Salomon.  The majority agreed with district court's decision to give Dr. Salomon's testimony "no weight"; in Judge Rader's eyes, "Dr. Salomon's testimony, when viewed as a whole, deserves great weight and respect."  Slip Op. at 47. 

68 thoughts on “SkinMedica v. Histogen

  1. Even if they are not sure a compound will work, they file because the risk is to high not to.

    So, patent term wastes as one seeks a government license

    And once again Ned, you are being obtuse.

    Please stop calling it patent term waste. If – as you say – they are not sure, then they should not be filing.

    Plain.

    Simple.

    Direct.

    If they are still experimenting, then they should wait regardless of the other guy. The other guy has to experiment as well, right? The other guy has the exact same government license hoops to jump through, right? Stop pretending that that is a reason to obfuscate patent term. Just be honest about what is going on.

    If they want to file early (and the exact same applies to any competitor also wanting to file early), then either 1) their application should be rejected out of hand for lack of possession or enablement or both, or 2) LIKE EVERY SINGLE OTHER ART UNIT, they get the term that is coming to them.

    So sorry that the invention actually requires a ‘government license,’ as that is not the patent world concern. UNLESS you want to be intellectually honest and simply say, hey we are giving this art unit an extra added bonus.

    But for the love of G0D, be honest about it.

    And the added term history applied to all patents in all art units. Are you suggesting that all art unit patents could apply for bonus term? I would not have a problem with that approach, as that would be a more honest way of arriving at the pharma industry’s desired result (and many other art groups would simply not take advantage of that EQUALLY ALLOWED option).

  2. anon, historically pharma folks file as soon as possible because they are in a worldwide FTF regime. Even if they are not sure a compound will work, they file because the risk is to high not to.

    So, patent term wastes as one seeks a government license. Only 5 years of this can be recovered. I have no idea why congress is so ungenerous. But perhaps political contributions from generics might be clue.

    I seem to recall that when we first went to 20 years from filing patent term, we could get up to 10 more years term. Is my memory correct on this?

  3. It is irrelevant whether experimental use is public.

    Great. I never said otherwise. Now go back and read what I actually wrote.

  4. Or no problem at all with the patent term, Ned, but a problem with someone wanting both the patent term AND special treatment that no other art unit gets.

    That black figure in the deck of cards with the point on top is a spade.

  5. must be“?

    I chuckle as I remember MaxDrei’s own admonition against absolutes and immediately think: must not.

    Otherwise, I find the discussion exceptionally shallow, and wonder whether MaxDrei would be comfortable with an enablement standard of ‘plausible’ if that standard is applied to any other art unit (oh, for example software or business methods).

  6. I think that clinical trials may or may not be experimental.

    It depends on what you have – both product and knowledge of the product.

    Clinical trials may be a mere formality. Then again, if your item is more of a ‘best-guess,’ the trials may very much be experimental.

  7. A real problem? Ned would that be even with an SPC regime:

    link to en.wikipedia.org

    to give the inventor an extra five years after the end of the normal 21 years from the first filing date. Is 26 years still not enough to make out of a blockbuster invention enough money to tempt investors in?

  8. Well, it seems the application will normally be filed before the regulatory process begins. And, due to expense, perhaps firms will not even begin that process until after after a patent issues. If it takes 15 years for approval, then there is a real problem with patent term.

  9. Afterthought for Ned:

    On the issue what is experimental, Europe does of course have loads of caselaw. It occurs with blockbuster pharmaceuticals at the end of the 20 year (or SPC-extended) term though, when owner asserts against a generic who defends with the argument that the acts complained of are experimental and so not to be enjoined.

    But that can’t be helped, can it Ned? It is the unavoidable and irreducible minimum of litigation. So no harm done there then, eh?

  10. Ned I’m not pharma but, for any pharma person, your questions must be trivial to answer.

    Paul Cole might be able to help.

    In Europe, a valid claim is one directed to subject matter that was not earlier “made available” to “the public”. As I understand it, it is not difficult to perform trials before filing, without prejudice to validity.

    And how about enablement and utility as of the filing date?

    Well, according to the caselaw of Europe, you need to show in your filing documents that it is “plausible” that the claimed subject matter works and that it works plausibly over the width of the claim. You can do that long before you have data enough to satisfy the FDA.

    And besides, even Big Pharma doesn’t file on every new molecule it can conceive. Presumably there must be a sign of a possible therapeutic effect before the cost of a world-wide filing programme is underwritten? So, all in synch, no?

    Still a problem, Ned, under FtF? I suggest not.

  11. I assume the law of experimental use will continue post AIA.

    Does anyone disagree?

    On vaccines, if it takes X number of years to demonstrate utility in humans, just how can one file a valid application beforehand? I assume tests on certain animals is sufficient to show likelihood of success in humans, perhaps justifying an earlier filing.

    Continued testing has to be considered experimental use with so that a valid application could be filed after Phase III. See, e.g., Omeprazole, the subject of a discussion here in 2008: link to patentlyo.com

    Zak said in one comment:

    “Think the bigger questions is “If my Phase III FDA testing is an experimental use excusing 102(b) public use, then why do I need the term adjustment of the Hatch-Waxman Act?” Instead I could just file after my clinicals are complete.”

    But now we find ourselves in FTF, not FTI. The FTF gets the patent, or bars the second filer based on “prior art.” Can the first to file legitimately obtain a patent on a vaccine for human use if he has not completed his FDA testing on animals versus a second-filer, but the first to file after animal testing, is still in the field? How does this work?

    Any ideas?

    What is the law on this in Europe? Do they even require a demonstration of utility?

  12. Max, here too.

    But the problem seems to be that we must file to be first, but we still do not know if the vaccine works.

    There is something fundamentally wrong with this proposition.

  13. Obviously, and referencing my prior post, if clinical trials were deemed experimental use, we need some formal priority system back to when they began.

     
     
     

  14. anon, OK, when does one know that a vaccine is useful in humans?
     
    But you do raise a good point.  If clinical trials, even publicly conducted, were deemed experimental use, the filing could be deferred.
     
    We had a recent case that they remained confidential.  Do we have any cases that say that clinical trials are NOT experimental?

     
     

  15. You are being obtuse Ned.

    If someone wants to make a claim to something that is fit for humans, but does not actually know the item is fit for humans, then they are not ready to file.

    Being ready for humans carries the same hurdle for everyone, so there is no need for early filing and no need for extra bonus protection.

    Open your eyes and see that the extra protection is a gimme type of guarantee that no other art field gets. Period.

    It is one thing to acknowledge this fact and say that for policy reasons why are deciding to treat this art field special. It is quite another to clench tight your eyes and pretend that special treatment is not already in play.

  16. link to en.wikipedia.org

    Ned, did you know about the European system of SPC’s that yields up to 5 more years on the patent term when regulatory approval is late? What’s to stop the USA (the land of the strong patent system)enacting something analogous?

    Pity the authors at Slate did not pick up on it. After all, one of them is a patent attorney.

  17. anon, this a slightly different problem that FTF v. FTI. If I understand the problem, it takes most of the patent term to get FDA approval. So there simply is not enough patent term to justify the investment.

  18. To MM: thanks for your analysis -

    “…. there was just an incredible amount of jujitsu during prosecution to avoid the prior art and come up with something “worthwhile” that you could sue someone with. The majority on the Federal Circuit recognized the game-playing and dust-kicking and made an appropriate call in the defendant’s favor. Rader seemed to want to reward the prosecuting attorneys for being “clever.” Thankfully Rader was in the minority here.”

    which I found plausible, and shrewd.

  19. Nothing Ned. Why? Do you think filing for a patent before you are ready is ok? Do you think that then wanting more is ok?

    Replace the medical nature here with a business nature, or a software nature. Would you be singing the same tune?

  20. Ned, we’re on the same page, literally. This is exactly the passage I was referring to in my Aug 23 comment re “the patentee’s wishy washy attempt to distinguish their 3-D scaffold culturing method from the prior art”.

  21. MM, check the discussion of the ‘508 patent at from the pages 7-8 of the opinion.  The applicant is quoted as distinguishing the ‘508 by saying,
     
    “…nowhere
    in Naughton et al., is there a teaching or suggestion that
    sustained proliferation of the cells in culture is a result of
    factors or components of the conditioned medium.”
     
    Naughton is the inventor on both the patent and the reference, the ‘508. The ‘508 disclosed a 3D matrix and 3D culture.  The ‘508 however did not disclose a property of the process described. 
     
    As we know, an inherent property of the prior art cannot serve to distinguish the art even if claimed.  But the claim did not even claim “sustained proliferation”  or how it relates to the conditioned medium.  The claim simply claimed 3D culturing which was disclosed in the ‘508.
     
    The Feds clearly were not amused by this patent.
     

     
     
     

  22. Ned The claims read on the prior art, pure and simple, and as admitted by the applicant, because the point of departure is not in the claims.

    Unless I’m missing something that wasn’t discussed by the Federal Circuit, I think that’s a reasonable conclusion.

    I don’t understand how such claims can be issued given such arguments.

    And they usually aren’t, at least not in this art unit. Another scenario that comes up is the Applicant getting the broad claim in the earlier case (“hooray!”) and then the Examiner realizing the error he/she made while Examining a continuation (aw crrrrap”). Sometimes that realization can occur during an Interview that isn’t on the record (“hooray!”) but then the Examiner puts some text in the Reasons for Allowance that gives away “the game” (“aw crrrrap”).

  23. If even this case was hard for them, how do they ever master the technical content of cases where the science or the engineering really is esoteric? Answer: they don’t (of course).

    One way is to take a scientific adviser, as the UK Supreme Court did here

    Advisers (or a panel of them) would probably be helpful in many cases. I’m not so sure that the “technology” was what made this case more difficult for the judges but rather the facts of how the case was drafted and prosecuted and, legally, how those facts affect the construction of the claims. It seems to me that there was just an incredible amount of jujitsu during prosecution to avoid the prior art and come up with something “worthwhile” that you could sue someone with. The majority on the Federal Circuit recognized the game-playing and dust-kicking and made an appropriate call in the defendant’s favor. Rader seemed to want to reward the prosecuting attorneys for being “clever.” Thankfully Rader was in the minority here.

  24. Rinse. Recycle. Repeat

    LOL – more of the accuse-others-of-that-which-you-do.

    But in your case, you actually post CRP, ignore the valid counter points raised against the CRP you post, and post again.

    Maybe if you posted on another blog under an ever-changing pseudonym basis, the stench of burnt ‘theory’ wouldn’t be so strong.

    (and your recucled “you don’t know what a strawman” line is more than a bit trite. You have tried that repeatedly in the past – yes, see the archives – and stop when I post definitions and hold your hand. H311, even your cheerleader Leopold has had to hold your hand when you lost the ability to understand what the word ‘effectively’ meant.

    LOL – here’s a hint – it was in our discussion of the Myriad case, before the Supreme Court came out and said you-know-who was right – and right for the reasons stated.

    LOL – as they say, svcks to be you.

  25. Fish, if I understand the point of the article, vaccines take about 20 years to get approved, and even with a 5-year extension, this is not enough time to recover one’s investment let alone make a buck. The reason treatment drugs are approved faster is that they show immediate results.

    So, what we need to do is simply guarantee more than 5 years effective patent term in all cases.

    (I was just reading 35 USC 156. Now that statute is a mess. The bulk of it should have been promulgated by “rules.” For example, if a patented drug is approved by the FDA, the FDA could give the patentee a ticket for patent extension that might cash at the PTO. I don’t quite understand why all the bother about applicant “delay.”)

  26. Many thanks MM. The aeration point I had not thought of, but the rest strikes me as unsurprising, as I imagined, and not difficult to grasp, even for an appeal court judge. The mind boggles. If even this case was hard for them, how do they ever master the technical content of cases where the science or the engineering really is esoteric? Answer: they don’t (of course).

    One way is to take a scientific adviser, as the UK Supreme Court did here:

    link to bailii.org

    One can skip to the end of the speeches (para 134-5)to read the tributes to the adviser, Prof. Yudkin.

  27. MM, but note that the “framework” is probably the same framework as in the prior art ’508 patent as the inventor of the reference was the same inventor as in the patent in suit. The ’508 was distinguished only in its lack of disclosure of the “importance” of “sustained proliferation” that, it was argued, would lead one to actively remove monolayers growing on adjacent walls.

    But none of that is in the claims. The claims read on the prior art, pure and simple, and as admitted by the applicant, because the point of departure is not in the claims.

    Moreover, this is a classic Perkins Glue case where the claim was to result without specifying any inventive step or ingredient in the claim. Perkins Glue held the claims indefinite for not including in the claims the subject matter that departed from the art. That is equally as true here.

    I don’t understand how such claims can be issued given such arguments. Examiners I have encountered are quite to point out if I begin to argue the spec and not the claims, which I did at time did early in my career. But litigators should quick to point this out to the court and not that the alleged departure over the prior art is not claimed.

  28. not actually saying anything

    I asked you a question, Tr0 llb0y. Exactly what “!i es” were you referring to?

  29. Ned: The specification made it clear that beads were considered a form of two dimensional culture. The three dimensional structures shown in Rader’s dissent were not clearly disclaimed.

    The problem, Ned, is that beads themselves are very much 3-dimensional and completely different from the 2D surface on the inside surface of a flask. And the applicant knew this. The applicant made a desperate and hand-wavey attempt in its specification and during prosecution to distinguish its very limited and narrow (and probably non-existent) 3-D scaffold “invention” from prior art 3-D surfaces (such as beads). The Federal Circuit majority recognized that the attempt was a failure. Quite frankly, by construing claim 1 of the ’494 patent narrowly they threw the applicants a bone they really don’t deserve. In this circumstance (where the bone represents a patentee loss — the correct result in this particular dispute), it’s probably not something to get too terribly upset over. When Skinmedia chooses to use these patents to pursue someone using a 3-D scaffold perhaps we’ll see these other issues fleshed out. Or maybe one of their competitors will see a chance to make trouble for Skinmedia in the form of a re-exam request. That would be fun, too.

  30. That’s rather strong language to describe a paper that, at most, seems to recommend strengthening a small corner of patent protection for the public good.

  31. MD, the key fact to start with is that fibroblasts require a surface on which to proliferate. So “3-D” doesn’t certainly mean “freely floating around in 3-D space in a test tube”. What it means, then (and this was driven home by the patentees) is “not a monolayer on a 2-D surface”. It also doesn’t mean (again, repeated ad nausem by the patentee) “a monolayer of cells surrounding a bead that is freely floating around in 3-D space in a test tube.” Note that the “bead” in these cases is quite a bit larger than the cell (at least hundreds of times larger, I believe). The purpose of the beads is to create a larger surface area than you would have with, say, the interior walls of a glass culture flask.

    So, to return to your questions:

    How many cells are there in a coat covering a single bead? A: very very many

    If you grow cells on the surface of one isolated bead, is it a monolayer? A: generally speaking yes but strictly speaking it’s impossible to guarantee that

    If you grow cells on a plurality of beads that are touching each other, the beads arranged as a single layer, do the cell monolayers fuse and, if so, does that fusion thereby create an array of cells that is in reality a three-dimensional array (scaffold) of cells? A: as the majority discusses, it seems that something like this can and does occur in bead culture methods

    Can you also grow a scaffold of cells on a close-packed multi-layer array of beads? A: don’t see why not — but there may be problems with aeration of the cells in the interior if fresh media doesn’t come into contact with them during culturing

  32. Ned: Notably, nothing in the claim talks about “sustained proliferation” or “the factors or components necessary for sustained proliferation.” The claim as written reads 100% on the prior art without those limitations as admitted by the applicant whose arguments regarding these points of distinction did not appear in the claims in the form of any limitation as noted by MM.

    As they say, something stinks in the State of Denmark.

    That’s the part I alluded to upthread, Ned. The granting of this patent (or the above claim, at least) was a fairly spectacular fail. What always amazes, then, is when the patentee goes ahead and manages to press that claim all the way to the Federal Circuit in an infringement case against someone practicing art that was repeatedly disclaimed by the specification and prosecution history.

    I’ve been curious about the dependent claims as well. There are no informative dependent claims in the ’494 but there is a second independent claim with a clause (a) that is more informative and accurate than the corresponding clause that appears in claim 1:

    (a) culturing fibroblast cells in three-dimensions on a framework composed of a biocompatible, non-living material formed into a three-dimensional structure in a cell culture medium sufficient to meet the nutritional needs required to grow the cells into a stromal tissue, said stromal tissue comprising fibroblast cells and connective tissue proteins naturally secreted by the cells attached to and substantially enveloping the framework, and culturing the cells until the medium contains a desired level of extracellular products so that a conditioned medium is formed

  33. “They don’t care about the veracity to the extent they don’t get caught.”

    They don’t care even then, if they have enough lemmings to repeat the !i es.

    Exactly what “!i es” are you gentlemen referring to?

    Also, pretty funny listening to you two patent t–bgers mock academia (!) for “repeating !i es” and creating “lemmings.” Too funny. Whatever happened to “every patent creates a job”? Or “It’s patentable because it’s a process”? Or “refusing to grant patents on a mental step preceded by an old non-mental step is an abomination?”. Or “dissection isn’t allowed except under 103 but we can’t talk about that” ?

    LOL.

  34. the law of obviousness continues to favor

    LOL – nice strawman, and quite kicks up the dust over what I am clearly saying.

    and no, you do not get to do anything over what Congress explicitly said – that’s called ‘illegal.’

  35. LOL – I am not having an imaginary argument. You said I was incorrect. I was not.

    I pointed out why I was not, showing your proffered reasons to be in error.

    You are getting huffy (and not responding to my corrections of your errors).

    Your errors stand as noted (and corrected). Maybe you should have thought a little more before charging at the red cape of ‘anon said.’

  36. You asked whether you had paraphrased me correctly. I told you that you hadn’t. But go ahead, have your imaginary argument – you obviously don’t need me.

  37. To paraphrase then, “it’s hard to do” means that they want more coddling than the patent system already provides, right?

    Wrong. First, nothing I said can be paraphrased as “it’s hard to do.” Second, who is this “they” that you’re talking about? The article we’re talking about is written by a business school professor who is reporting on a study undertaken by two economists. None of these people is asking to be “coddled.”

  38. To paraphrase then, “it’s hard to do” means that they want more coddling than the patent system already provides, right?

    /off half-sardonicism

    The (obvious) flipside of that particular coin is that anything that is ‘easy’ deserves less then what the patent system provides.

    Funny on that point, it smells an awfully lot like the Flash of Genius position that was explicitly rejected by Congress in 1952.

  39. None of which addresses the primary thrust of the article, which is that the longer development times associated with vaccines mean that patents on vaccines are less useful/valuable, which in turn means that investing in vaccine development is that much less attractive than other drug development, which in turn means that less of it is happening than we might like.

  40. Also ignores the impact of data exclusivity and pretends that having a patent gives the patentee the right to exploit the invention

    Good points. Especially the ‘use’ aspect, as the nature of patents being a ‘negative’ right is so often misunderstood in the common press (and unfortunately, even in the Whitehouse).

  41. LOL – which happens occasionally? You allowing something, or an ignorant attorney arguing nonsense?

    As we see Ned arguing nonsense all the time here, I would tend to place the emphasis on you allowing something.

  42. I would not use the term “the claim was functional” to describe a claim that merely claims a result.

    If as you say growing in 3D itself was old, then even your so-called mislabeling would not suffice.

    The ‘so?’ is to point out that (yet again), reason is made subordinate to agenda seeking. You are kicking up dust over functional claiming, when functional claiming in itself is perfectly valid.

    It is only too easy to see your next step of the misuse of the canard of Point of Novelty in the crusade to limit patent eligibility from certain types of innovation.

    The merry-go-round needs a rest, Ned. Give it one.

  43. “The claim was allowed over the ’508″

    Is that what the reasons for allowance said or just what they argued? Be clear, I sometimes allow things based on something other than whatever nonsense the attorney is arguing, especially if they are an ignorant attorney. That does happen occasionally.

  44. The academics win by publishing the paper. They don’t care about the veracity to the extent they don’t get caught.

  45. OK, anon.

    Culturing 3D was old. Using a 3D matrix was old. See, the cited ’508 reference. The claim was allowed over the ’508 because the applicant argued that the ’508 did show the importance of “sustained proliferation”:

      “nowhere in Naughton et al., is there a teaching or suggestion that sustained proliferation of the cells in culture is a result of factors or components of the conditioned medium.”

    Notably, nothing in the claim talks about “sustained proliferation” or “the factors or components necessary for sustained proliferation.” The claim as written reads 100% on the prior art without those limitations as admitted by the applicant whose arguments regarding these points of distinction did not appear in the claims in the form of any limitation as noted by MM.

    As they say, something stinks in the State of Denmark.

    Perhaps they have dependent claims with the details on what they did differently from the ’508 that caused “sustained proliferation.”

  46. Also ignores the impact of data exclusivity and pretends that having a patent gives the patentee the right to exploit the invention.

    Also, author Fisman is just raring to get his daughter the HPV vax as soon as she turns 11. I hope he takes some time to investigate more numbers and cost/benefit information than the “70 percent reduction!” touted in the popular press.

    For example, assuming the 70 percent reduction is correct, that means a woman goes from a 0.008% chance down to a 0.0024% chance.[1]

    If I had a daughter, would that benefit be worth the ~ $500 cost of getting her the HPV vax? Probably so – it’s kind of like a 1-time insurance policy.

    Is that benefit (reducing the 0.008% risk to 0.0024%) worth the potential side effect? Dunno – but that’s what I’d be investigating.

    [1] These numbers are from CDC 2009 annual prevalence rates (i.e. approx 8 persons per 100,000), so it’s not really proper to use them as “risk” rates, which should be spread over a lifetime. Presumably both numbers should be higher (but still proportionate to each other) if I could find them presented as “risk” on a per-person basis…

  47. Anon, so? 
     
    From my understanding, growing in 3D itself was old.  The only thing new in the claim was the result.  How the claim achieved that result was not stated in the claim.
     
    The claim is functional.

     
    Sent from Windows Mail
     

  48. From the article:

      All drug innovations get patented at the time of discovery

    What? before the claims are even proven to work? They then get extra protection as well? What kind of coddling is this?

    /off half-sardonicism

    Also:

      After a patent expires, other innovators can build on earlier breakthroughs and competitors can market similar products without worrying about licensing contracts, patent litigation, or other headaches

    .Half correct. The moment the patent application is published, the information is avaialable for all to see, and work-arounds and other design activity can commence at that point in time, well before the period of exclusivity is up.

    Minor nit: their term calculations
    need to be adjusted for filing dates, rather than grant dates.

    Lastly, the article falters on how the patent term (arguably applying to any and all medical cure efforts) actually skews anything.

  49. “Maybe the reason we have so few cancer vaccines is that they’re harder to develop than treatments for patients who already have cancer, which are more common. But in an as yet unpublished study, economists Eric Budish and Heidi Williams teamed up with patent lawyer Ben Roin to argue that the scarcity of preventive measures and relative abundance of late stage cancer treatments can also be blamed on the distorting effects that the U.S. patent system has on medical research.”

    link to slate.com

  50. It seems structure of some sort was functionally claimed

    Ned, the claim shown here is a method claim. Your propensity for j1hads is showing.

    “ready, fire, aim” is not a great rhetorical tool.

  51. It seems structure of some sort was functionally claimed

    Ned, the claim listed here is a method claim.

    Your propensity for jihads is showing.

  52. MM, scaffold?

    You might be right. The claim merely claims a result that it argued the prior art structures could not achieve. It seems structure of some sort was functionally claimed, but the issue of whether the claim was functional was not raised, it seems. The defense focused on “beads” and the Feds affirmed, in part, I think, because of this prior art/functional claiming issue. The court may have been convinced that the patentee was not entitled to broad scope.

  53. 6, the issue of two or three dimensional beads never came up during prosecution. The examiner did not cite any bead reference, let alone a bead reference like the those illustrated in Rader’s dissent.

    The specification made it clear that beads were considered a form of two dimensional culture. The three dimensional structures shown in Rader’s dissent were not clearly disclaimed.

  54. From the above synopsis, the posture of this case is appeal from summary judgment. To find in favor of the moving party, the district court must necessarily say the expert witness Solomon is entitled to NO weight, and can ignore the testimony of the non-moving party’s expert. Without that, the District Court must consider the evidence in a light most favorable to the non-moving party and accept the expert testimony. No splitting the baby here.

  55. This is one of those cases where it is difficult to comment uefully until one has read all the material. I don’t know, for example:

    How many cells are there in a coat covering a single bead?

    If you grow cells on the surface of one isolated bead, is it a monolayer?

    If you grow cells on a plurality of beads that are touching each other, the beads arranged as a single layer, do the cell monolayers fuse and, if so, does that fusion thereby create an array of cells that is in reality a three-dimensional array (scaffold) of cells?

    Can you also grow a scaffold of cells on a close-packed multi-layer array of beads? I envisage a lattice of connected cells with the beads trapped within, like a fly in amber.

    MM (or somebody else who is au fait with the technology of the case and has the inclination to write something useful), perhaps you can put me straight? Would be grateful.

  56. This is an odd case because the patentee really seems to be trying to thread a needle between capturing the alleged infringer, on one hand, and avoiding the very close prior art which includes a prior patent by a shared inventor.

    It would have taken all of 10 seconds for someone involved in the drafting of the specification or claims to simply write “wherein culturing of cells in three dimensions includes culturing cells in three dimensions using beads or any other substrate, but does not include culturing cells using a monolayer of cells or a monolayer of beads.”

    Instead, they wrote “Cell lines grown as a monolayer or on beads, as opposed to cells grown in three dimensions, lack the cell-cell and cell-matrix interactions characteristic of whole tissue in vivo.”

    What’s really strange is that the patent ever granted in the first place given the patentee’s wishy washy attempt to distinguish their 3-D scaffold culturing method from the prior art. And it’s odd that “scaffold” (or some similar term) doesn’t appear in the claim or in the district court’s construction, as that is surely what is meant by “3-D” in this context.

  57. “f the issue never came up during prosecution, two vs. three in connection with beads, then just how can one say that three were disclaimed?”

    Did you read the majority? Or are you requesting someone hold your hand through it?

  58. Beads can grow cells in both two and three dimensions. I agree with Rader that the patentee only clearly disclaimed beads with two dimensional growth, never having considered that beads can also grow cells in three dimensions.

    If the issue never came up during prosecution, two vs. three in connection with beads, then just how can one say that three were disclaimed?

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