Consumer Watchdog Argues That WARF Stem Cell Patent Is Invalid under § 101

By Donald Zuhn --

Last month, Consumer Watchdog filed its opening brief in an appeal of a Board decision affirming the patentability of U.S. Patent No. 7,029,913, arguing that the claims of the '913 patent are invalid because they cover ineligible subject matter and were anticipated and obvious.  The appeal arises from an inter partes reexamination of the '913 patent that Consumer Watchdog, which describes itself as a not-for-profit public charity dedicated to providing a voice for taxpayers and consumers in special interest-dominated public discourse, government and politics, filed in 2006.  The '913 patent, which is assigned to the Wisconsin Alumni Research Foundation (WARF), has three claims.  According to the Consumer Watchdog brief, independent claim 1 (as amended by WARF during the reexamination) recites:

1. (Amended) A replicating in vitro cell culture of pluripotent human embryonic stem cells derived from a pre-implantation embryo, wherein the stem cells (i) will proliferate in an in vitro culture for over one year in an undifferentiated state without the application of exogenous leukemia inhibitory factor, (ii) maintain a karyotype in which the chromosomes are euploid through prolonged culture, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) are inhibited from differentiation when cultured on a fibroblast feeder layer.

After the Patent Office granted Consumer Watchdog's request for an inter partes reexamination (Control No. 95/000,154), the Examiner determined that the pending claims were allowable, and Consumer Watchdog appealed to the Board.  The Board reversed, designating four news grounds of rejection (one anticipation rejection and three different obviousness rejections), and WARF responded by filing a request to reopen prosecution along with an amendment and a declaration.  The Examiner determined that the claims were patentable over the Board's rejections, and the Board affirmed.  Consumer Watchdog's appeal to the Federal Circuit followed.

In addition to arguing that the '913 patent is invalid as anticipated or obvious in view of the references on which the Board based its new grounds of rejection, Consumer Watchdog also argues that the claims of the '913 patent are invalid under § 101.  In particular, the brief states:

As a threshold matter, the claims of the '913 patent are invalid under 35 U.S.C. § 101 for claiming subject matter that is not patent eligible.  Specifically, the claimed hES [human embryonic stem] cell culture falls within the "product of nature" exception to statutory subject matter.  It is within the Court's discretion to address this issue despite the fact that the Board failed to address it below, and is especially appropriate in light of the recent Supreme Court ruling on Section 101 in Ass'n. for Molecular Pathology v. Myriad Genetics, Inc.. 2013 U.S. LEXIS 4540 (June 13, 2013).

Noting that "[t]he Supreme Court restated [in June] that discovery and isolation of a product that occurs in nature does not render that product patent eligible under Section 101," the brief attempts to draw analogies between its appeal and the Myriad case.  For example, the brief states that "[a]s in AMP, the '913 patent's claims are drawn to neither a method of preparation nor a scientific application of the claimed composition."  The brief also suggests that:

The '913 patent's requirement that the claimed culture of cells be in vitro is analogous to the claim limitation in AMP that the DNA be "isolated."  But here there is not even a chemical change between ES cells in an in vivo embryo and ES cells in an vitro culture as there is between human DNA in vivo and isolated DNA in vitro.

The brief also notes that "[t]he '913 patent does not in any way distinguish the claimed ES cells from those that exist in nature," adding that "if the claimed ES cells were not the same as natural ES cells, the claimed invention would offer very little benefit for medical research."  As the brief argues, "WARF did not create or alter the properties inherent in stem cells any more than Myriad created or altered the genetic information encoded in the DNA it claimed."

Although "[t]he Board never considered whether the claims to hES cells are patent eligible subject matter," the brief contends that "the Court may still consider whether the claims here are invalid under Section 101 because, 'a court may consider an issue antecedent to . . . and ultimately dispositive of the dispute before it, even an issue the parties fail to identify and brief,'" citing U.S. Nat'l Bank v. Indep. Ins. Agents, 508 U.S. 439, 447 (1993).  With respect to the issue of patent eligibility, the brief states that "[c]onsideration of the 101 question is especially appropriate in light of the fact that the Supreme Court's recent AMP decision came after the Board's decision here."

WARF now has until August 12 to file its opening brief in the appeal.

Comments

[Igor Faynshteyn, Esq.]

It seems to me that the decision in Myriad was limited to isolation of DNA, and it's doubtful that CAFC will broaden the reasoning to apply to isolation of ES cells.

It's also interesting to note that the appellant argues in the brief that if the cells as isolated are different from ES cells as exist in nature, then it would make the claim ineligible on utility ground, because they would be of no use to medical researchers. I think that is a bad argument, because medical researchers may find multiple uses for altered ES cells.

Of course the patent eligibility question under 101 is confusing to begin with. And the legal history of it is not as clear cut either as many authorities, including textbooks, claim. See http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2152105.

The argument in the brief is certainly plausible, and it would be interesting to see how CAFC will interpret Myriad.

[Skeptical]

Igor,

Sorry, but I fell strongly compelled to disabuse you of your notion of how limited the decision in Myriad was.

The Court in Myriad applied a (universal) concept (the product of nature exclusion based on the judicial exception to patent elligibility under 35 USC 101) to the particular facts of that case.

It is quite baseless to say that the Court will not apply that universal concept to facts of another case because (if I read into your post) the facts are different.

Notwithstanding the linked paper, the Court has FIRMLY come out in support of their judicial exception (and this should be no surprise given the 9-0 Prometheus decision and how strongly they indicated that their exceptions would not be made into dead letters).

I also think you are misapplying the 'no-change' argument. It is not an argument that 'change' is useless, per se. It is an argument that 'change' in this instance would not be useful because it is the desired 'no-change' that is being pursued. And the desired pursuit of 'no-change' is fatal given the Myriad decision. 'No-change' simply cannot give you the necessary change-in-kind that is needed for patent eligibility.

And quite the contrary to your post, this patent eligibility question under 101 is not confusing at all.

[Moocow]

Well... the Supreme Court DID call it, verbatim, "the rule against patents on naturally occurring things." They didn't call it "the rule against patents on genes that were isolated from the surrounding genetic material." That doesn't make the opinion clear or well-reasoned, but it does say something about how narrow it is, or isn't.

[anne brown]

Just how does one determine the characteristics of a cell as it occurs in vivo if one cannot isolate sufficient quantitie of it directly from a tissue, ie, without expanding it in culture? With a DNA, a sequence is a sequence. With a cell??

[Igor Faynshteyn, Esq.]

Skeptical,

I have no desire to get into a long debate about this, because while you seem very confident in the implication of the Myriad decision, and the consequences it carries, I am less confident in this regard and more unsure about it.

My interpretation of the case is a bit different from what yours seems to be. Let me explain. The decision, it seems to me, is not about whether a material isolated from its native state may be patented. It is about whether DNA in particular may be patented.

The primary reason for my interpretation is the Court's words themselves: the Court stressed that the problem is that Myriad didn't claim chemical changes to the DNA molecule (during the isolation, purification process) as the basis for the patent. Rather, what Myriad really claimed is the genetic information DNA carries. See pg. 14-15 of the opinion.
At the very end of the opinion, the Court said:
"We merely hold that genes and the information they encode are not patent eligible... simply because they have been isolated from the surrounding genetic material".
See generally http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1747191 for an extensive discussion of this distinction.

Thus put, it seems to me that isolation, purification of cells, molecules and other materials in biology is still patentable, so long as even minor changes are made to the isolated material (which almost by definition is almost invariably the case). However, DNA is not, despite the changes, because its value lies in its genetic information, rather than its chemical composition.

[Igor Faynshteyn, Esq.]

On a side note:
I wanted to say that I started reading this blog regularly only recently (less than a month ago). It is one of the best, if not the best, blog around to my knowledge. It is prudent, thoughtful, and sophisticated, and it should be a model for all legal, and other blogs.

As an aspiring patent attorney, and as someone studying for the patent bar exam at the moment, this blog has further increased my interest in patent law, and deepened my knowledge about it.

Please keep the great work!

[Skeptical]

Igor,

I agree this is a great patent blog, and generally speaking I think this reflects directly on those running the blog.

We can agree to disagree on the Myriad case. I think that has you develop your patent-sense, you will come to understand why I am so confident as to the Rule of Law/Application to Specific Facts split I use to bolster my view of the Myriad (and any) case decision.

While the Supreme Court tends away from bright-line rules, they also tend to want to make sure that the CAFC understands 'who is boss.' In the 101 cases especially, this tends towards an overly strong view if their own implicit reading of 101 (the judicial exceptions), and tends to counter-intuitively create a type of bright line (albeit broad) and simple reading of the rule of law. Just take any facts specific to a case and distill them out from the Rule applied by the Court.

[Igor Faynshteyn, Esq.]

Skeptical,

I don't dispute that the Court sometimes desires to rein in CAFC (although CAFC judges are much more qualified in judging patent cases than Scalias and Alitos on the SC).

But I also think that there is a reason why SC does not want to create very bright-line rules. Like any other court, they want to make sure that they allow the law and the given field to which the law applies, to develop. But these are generalities.

I don't doubt that 101 exceptions are here to stay. I doubt we will go back to the days when patentability questions were judged by subjecting them solely to obviousness and novelty inquiries. However, I am also skeptical that the SC in the Myriad ruling was hoping to halt all biological isolation/purification patenting. If they did, they could have said so.

I will be very curious to see what CAFC does with this particular appeal. And if they distinguish it from Myriad, will SC inject itself again into the fray?

On a slightly different note, I think this case was overtly quasi-political to begin with. This case heavily implicates public health costs. That is also the reason why Obama admin. got involved as well. I surmise that behind the veil of the court's opinion, lied more external motivations.

The liberal side of the court probably considered the public health costs; while the conservatives were happy enough to go along with the decision because they probably didn't grasp the scientific issues, and because it may have seemed nefarious to them to patent genes (Scalia even wrote that he could not comment on the scientific issues).

However, I think when CAFC takes another look at it, they will distinguish Myriad from all other isolation/purification cases (not involving DNA and genetic information) and SC will probably stay out of it. I would consider this decision another Bush v. Gore - basically non-precedential. At the very least, I would bet on that.

I guess we agree to disagree. :)

[Skeptical]

Igor,

There is a clear and easy distinction you are missing from the product of nature doctrine: "different in kind." When you state "halt all biological isolation/purification patenting" you indicate a lack of appreciation of this facet. Mere isolation is doubtful to induce patent eligibility without more. Purification on the other hand may easily present that aspect of more.

Revisit Prometheus and refresh on the 'more is needed' line of thought.

As to your views on distinguishing, we will maintain our disagreement - not (from me) on the policy front, but rather on the rule of law front. As I indicated, the rule of law here is broad and purposefully so. Most definitely not limited to the biological arts - revisit Chakrabarty and see that the indications there ran from the simple (crystal structure) to the complex (living matter) and that the bio part was not chosen as indicating a specific art field, but rather a complexity level.

(we will have to disagree as to precedent as well - but again based on the broad rule of law angle)

[Igor Faynshteyn, Esq.]

Skeptical,

When one isolates a particular material (DNA, RNA, protein, etc.) he/she purifies it. Thus, I put the two words together, precisely not to draw distinctions between them. Because to my knowledge, there are none.

I also think this: if the Court was really trying to not only rein in CAFC, but also to make a broad rule of law on the issue of biological isolation, then why was the Court 9-0, and CAFC 2-1 the other way?

My view is that if this was truly a case that involved broad implications, then it wouldn't be a unanimous ruling. I think it's precisely because the issue was narrow that the Court ruled 9-0.

To reiterate, we simply disagree. :)

Have a good weekend!

Igor

[Skeptical]

Sorry Igor, your statement of "When one isolates a particular material (DNA, RNA, protein, etc.) he/she purifies it." is simply not true in the patent sense. You want to run the two words together even though they simply do not mean the same thing. Also, you are still not getting the difference in kind distinction (and that distinction is one aspect that makes the two words quite possibly different). In other words, NEITHER an act of isolation (alone) NOR an act of purification (alone) may be enough to effect a difference in kind that would breach the product of nature exception and bring you into a patent eligible zone. Quite in fact, it is possible to do BOTH and still not be different enough.

You can disagree with me all you want on that, but you would only be wrong.

You are also not getting the 'rule of law/application of that rule' bit here. I am not sure how to explain this to you as I am not sure why you are not understanding the rule/application dichotomy. The rule is broad. The specific facts that the rule was applied to IN THIS PARTICULAR CASE were narrow. This single narrow application simply does not change the rule of law. There was nothing in this case that would drive the rule of law to be narrowed in any subsequent case. The rule remains broad.
This too, you can disagree, but that only leaves you incorrect.

Have a great weekend.

[Igor Faynshteyn]

Skeptical,

It appears to me that your way of arguing is through assertions, followed by unjustified conclusions.
Let me clarify:
1. You say that there is a distinction between isolation and purification for "patent sense". You then proceed to say that even when isolation and purification are combined, it may be still be insufficient for patent eligibility. That may or may not be true, and it would certainly depend on the facts of a given case. However, you failed to actually explain what the difference is between isolation and purification for so-called "patent sense".
Neither, I might add, have you even attempted to explain the "in kind" distinction, other than to tell me that I just don't get it. But seemingly, neither do you.

2. Frankly, there is not much to say about your second point - law vs. facts. I graduated law school, I know what the difference is (lol).
The issue is not to distinguish between law and facts, but rather to determine whether and what the rule actually was in Myriad.
The Court didn't actually state anything new. It's well established through judicial precedent that you cannot patent nature, such as laws of nature, or other discoveries. Nevertheless, the PTO has allowed the patenting of DNA over the years and the Court reined it in in the Myriad case.
The question, then, is to determine exactly what the Court did. Did the Court provide a new rule/principle, or did it simply reaffirm it, and then applied it to DNA patents.

Your interpretation seems to be a rather simplistic one: you think that the Court in Myriad made a new rule. If they made a new rule, then I didn't notice it. If they simply reaffirmed it, then the question is whether it would be applicable to isolation of stem cells, proteins, etc.

You seem to be confident in that the rule applies to isolation of anything from nature. And I disagree. I think the court was concerned about the genetic information encoded in DNA molecule, rather than the molecule itself. And the opinion pretty much says that much, albeit in a muddled way.

The real question here is what does "product of nature" really mean? If the product of nature is the molecule itself, then the mere act of isolation (and therefore also purification) of it from the native state wouldn't pass the muster of 101. However, if the product of nature refers to its native state, the way a given molecule is actually found in nature (bound to other molecular complexes), then isolation of it would make the molecule itself patent eligible under 101.

When you say that isolation and purification of a molecule is not patent eligible, understand that the analysis you are referring to now is not under 101 anymore, but rather 102 and 103 - novelty and obviousness. But you seem to mix it all together under 101 analysis.

On a final note: "You can disagree with me all you want on that, but you would only be wrong", is hardly a way to argue. If you are so sure of yourself, then I am not sure why you are still debating with me on this.

Igor

[Skeptical]

Igor,

You really must stop trying to turn things all around.

You state “It appears to me that your way of arguing is through assertions, followed by unjustified conclusions.” And yet, you are doing that very thing.

We are both making assertions. Whether or not the conclusions are justified or not is the key. My conclusions follow from basic understanding of law and how law is applied.

You can assert that my conclusions are unjustified, but that assertion itself is rather meaningless because my conclusions follow from the (unchanged) law and you simply fail to understand the very simplicity I put forth.

When you state that I fail to actually explain what the difference is between isolation and purification is for the so-called “patent sense,” you seem to expect that YOUR assertion that the words do in fact mean the same has been already solidly established.

That is simply not so - and I do not need to explain the difference for there to be a difference.

On the other hand, you have the obligation to establish that the words actually do mean the same thing.

The plain fact is that the words do not mean the same thing, and I need only point this out.

The unjustified position is yours, not mine.

Likewise, I do not have to attempt to explain what the “in kind” distinction is.

The fact is that there is such a distinction.

Whether you understand it or not is the point that I am making.

Clearly, you do not understand it. You do not even seem to understand that it exists.

It does.

The first step is for you to recognize that the concept exists. Once you take that step, then we can discuss.

Again, it is you with the unjustified position (seemingly) that you are taking in ignoring the existence of the concept.

To your comments of
- 2. Frankly, there is not much to say about your second point - law vs. facts. I graduated law school, I know what the difference is (lol).

And

- The Court didn't actually state anything new.

You quite appear to miss the point of my posts.

It is both odd and confusing that you state “Your interpretation seems to be a rather simplistic one: you think that the Court in Myriad made a new rule.” Because it is simple and I am NOT AT ALL l thinking that the Court made a new rule.

Quite in fact, the situation between you and I is the exact opposite. It is you that appears to think that that the Court in Myriad made a new rule by limiting the broad existing rule ONLY to the application for the facts of the Myriad case.

You miss the simple fact that the Court did NOT make a new rule and it is YOU that appear to think that the Court made a new rule, somehow constraining the existing rule to ONLY apply to the facts as discussed in the Myriad case.

It is YOU that for some unstated reason want to change the existing rule of law.

Yet, you simply do not establish why this would be so. You simply draw an unjustified conclusion that the rule of law has been narrowed because it was applied in a certain manner to the facts of the Myriad case.

It really is that simple and yes, the simplicity of the existing, unchanged and broad rule will apply to any set of facts in which mere isolation takes place – without more. For the very reason that without more, isolation enough simply does not and cannot provide the difference in kind that would distinguish the item from the item covered by the judicial exception.

You seem to think this overly simplistic, yet you do not explain why this simplicity does not accord with the existing rule of law. I can only take it that you disagree with the existing rule of law (which is my position), but YOU cannot explain why my position is incorrect from a legal standpoint.

Thus. It is your position that is the unjustified and unexplained position. I have advocated NO change to the Rule of Law, NO narrowing.

You want to bank on the Court being concerned about genetic information encoded in the DNA molecule. That belongs to the APPLICATION of the rule to the facts of the Myriad case, and NOT to the rule itself. You lol at knowing the difference, and then you misstep at that very difference. I would kindly put to you that you should not LOL at something and then make a rather simple mistake in legal logic concerning that very point.

The only ‘muddling’ going on is how you are treating the case. You ask “The real question here is what does "product of nature" really mean?” as if you don’t know what that means. What you then posit as my position is in fact yours: “When you say that isolation and purification of a molecule is not patent eligible, understand that the analysis you are referring to now is not under 101 anymore, but rather 102 and 103 - novelty and obviousness. But you seem to mix it all together under 101 analysis.” Quite in fact, I am not at all mixing in 102 and 103 legal positions. I am in fact trying very hard to keep you from doing so. Again it is you that is mixing up the words and trying to make isolation and purification the same word. You cannot do so. The words simply are different words.

It is you that takes this unjustified beginning position and then it is you that seems to want to mix in some type of 102/103 analysis – my position has had absolutely no such dependency at all – and I cannot even begin to see why you would think my position would have such dependency. As I indicate – it is you that is muddling things here.

Finally, on your final note of “On a final note: "You can disagree with me all you want on that, but you would only be wrong", is hardly a way to argue. If you are so sure of yourself, then I am not sure why you are still debating with me on this.” You once again engage in the very tactic you seem to want to pin on me.

You seem to want to argue about the way of arguing.

This circles back to whom has taken unjustified positions – you want to claim that I have. In fact, it is you that has done so.

You want to turn my assuredness into a weakness. You have provided no basis for doing so.

My assuredness comes from the proper Law/Application knowledge and use. My assuredness comes from the simplicity of the rule (as it is and not how YOU want to change it – and the fact that I am not at all seeking to change it – quite in opposition to your claim of what I am doing).

Purely and simply, my assuredness comes from being correct and knowing that I am correct. Legally and logically. I grant you that it comes across a bit cocky and that THAT might rub you the wrong way, but you will have to actually show where what I have said is in error, and where your errors are not in fact in error to begin change the what is from what is.

You may not like the way that I have argued, but I am completely correct in what I have argued. The debate still exists because your flaws are evident, the law remains the law, and if you want to take a different position, then you need to do more than what you have done.

[Igor Faynshteyn]

Skeptical,

I have no desire to continue debating with you anymore about this. You spent about 80% of the above post talking about literally nothing. You still didn't even make an attempt to explain what I asked you. Instead, you say that you don't have to do it... for reasons I cannot understand.

Frankly, it appears to me that your knowledge of the law is very thin at best. I therefore lost interest in debating you about this.

Igor

[Skeptical]

That you have lost interest without recognizing the existence of the concepts involved is your loss.

That you think this means that I have a thin level of knowledge of the law is bewildering.

That you lose interest in a debate so quickly, without you recognizing and confronting the weakness of your position then is not that surprising.

I hope you do better in your practice.

[Igor Faynshteyn]

Maybe if you said something substantive about the actual issues, instead of fluff about nothing, then I would still retain some interest. Instead, you elected to dismiss my questions to you.

Your previous post took up 3 full pages in MS Word. And yet, there was literally 0 of substance. All fluff about nothing.
Below are some excerpts:

1. "I do not need to explain the difference for there to be a difference"
2. "I do not have to attempt to explain what the “in kind” distinction is. The fact is that there is such a distinction."
3. "The plain fact is that the words do not mean the same thing, and I need only point this out.

When you are clueless with regard to the subject, the answer that follows is typically like the fluff above.

You wasted so much time and electronic writing space on nothing.

Thanks for the "debate".

[Skeptical]

Funny Igor, I was thinking the same of you.

You took a position that is not supported in current law, and then posted as if the concepts I shared have no meaning (when in fact they do).

Your lack of understanding of the concepts is not for me to change. You need to get up to speed on your own dime. When you do, then you will recognize that what you attempt to call fluff controls.

You not agreeing is rather immaterial. You are always welcome to maintain a state of ignorance.

The key point is not related to the three excerpts you list. The key point is that you are attempting (without rhyme or reason) to limit a rule of law based on one case's particular details. You say you graduated law school, and yet you insist on not understanding the law/application dichotomy.

The excerpts you post are simply my way of saying that your ignorance is not my problem. That you insist on taking this as me being ignorant is just like you insisting on me being the one trying to change the rule of law. It is prima facie wrong. There is no debate about such points when you are simply wrong on the face of what is already present.

Still your move.

[Igor Faynshteyn]

I'll say no more to you about this, or other topics. However, I noticed that you have this incredible tendency to use unnecessary words and twisted sentences to say something plain and simple. In addition to dodging the analysis of the actual issue.

You spent about 4.5 MS Word pages now to basically tell me how elevated your knowledge and understanding is, and how ignorant mine is. And not a single sentence towards the analysis or explanation of the issue(s). All fluff.

I often find people who tend to dodge issues, use fancy words and twisted sentences to say something that is straight forward, illustrative of one's clutter and triviality of one's mind.

I don't know who you are or what you do, Skeptical, but it's obvious that you are not a lawyer.

Take care.

[Skeptical]

Funny Igor, I was thinking the same of you.

You still call fluff the very items that control. Just because I do not hold your hand and take you and a guided tour does not make the law fluff.

Still your move (you might try investigating and acknowledging the 'difference in kind' doctrine, or even more basic showing you understand the law/application dichotomy by retracting your baseless accusation that it was I that was attempting to change the products of nature exception by somehow NOT limiting it to the application of the Myriad case that started this entire exchange.

You want simplicity? Try the first and last points I have shared.

Full circle, and still your move.

[Igor Faynshteyn, Esq.]

Dear Skeptical,

I apologize for this misunderstanding. I actually thought you were human. But after reading some of your comments in other posts, especially on this very topic, I realized that you are actually an automated troll.

Sorry again for this confusion.

[Skeptical]

It's nice that you actually thought I was human.

I am.

Funny how we have the same thoughts...

And yet, my view, understanding and application of law accords with the results, while yours does not, and cannot. Further, your decision to not recognize this, and kick up a lot of dust all the while you stand there and accuse me of things you are doing is very interesting. I notice that you choose not to address the simplicity of the law/application dichotomy. Probably a smart choice by you, as any further digging only makes the hole you stand in that much deeper.

You should be sorry, but not for the reasons you think.

Have a good week.