In re Kubin (Fed. Cir. 2009)

    By Kevin E. Noonan --

The sky isn't falling.  But it's becoming increasingly clear that when the Supreme Court sneezes, the Federal Circuit gets a cold (if not pneumonia).  And the questions continue about whether the Federal Circuit as currently constituted has the institutional fortitude to exercise its Congressional mandate to harmonize patent law in this country.

The case, of course, raising these issues anew is In re Kubin, decided on Friday.  In its decision, the Federal Circuit not only affirmed the finding by the Board of Patent Appeals and Interferences that Kubin's invention was obvious, but in the process decided that the Supreme Court had overturned the Federal Circuit's In re Deuel decision.  This outcome is sufficiently disappointing in itself; the reasoning is all the more so.  But there are lessons to be learned, and some glimmer of hope that this decision has come just too late to make much difference (i.e., harm innovation) for biotechnology patents.

As Patent Docs readers will remember, this case involves a rejection on obviousness grounds for claims to cDNA encoding human NAIL protein, in which the U.S. Patent and Trademark Office asserted two relevant prior art documents:  a reference disclosing the existence of a protein, p38, later found to be encoded by the NAIL cDNA invented by Kubin; and Sambrook et al. (aka: the Maniatis cloning manual), that old standby of what was routine in the art.  (There was another reference to Matthew regarding cloning of the mouse gene homolog, but while this reference certainly informed the Office's thinking -- and, it appears, Judge Rader's -- it was not cited in support of the obviousness determination.)  In making its obviousness determination, the Patent Office raised a host of factual distinctions between the technology extant when In re Deuel was decided and the technology available today.  Of course, the Office is well aware that its best chances for affirmance lay in these factual questions, because the Federal Circuit is bound to give deference to the Office's determination on fact issues (Dickinson v. Zurko; In re Gartside) while it reviews obviousness and other questions of law de novo.

The Office's reliance on these factual issues was prescient, since in many ways the Federal Circuit's decision was based on its misunderstanding of the crucial factual distinctions between the cited art (and even more importantly, the Matthew reference) and Kubin's invention.  The Court's opinion, written by Judge Rader in which Judges Linn and Friedman joined, set out the "factual" bases upon which the Board, and the Court, relied in deciding Kubin's claimed cDNA was obvious.  The opinion notes that:

This emphasis on similarities or differences in methods of deriving the NAIL DNA misses the main point of this obviousness question.  Of note, the record nowhere suggests that the technique in Valiante's Example 12 for isolating NAIL (p38) DNA, even if slightly different than the technique disclosed in the claimed invention, would not yield the same polynucleotide claimed in claim 73.  Stated directly, the record shows repeatedly that Valiante's Example 12 produces for any person of ordinary skill in this art the claimed polynucleotide.

This was the Court's first mistake, evidencing that they were not listening (or did not understand, or were too focused on the outcome to be deterred by inconvenient facts) when Kubin's counsel brought up that critical distinction:

Judge Rader (at right):  No, it tells one of skill in the art how to produce those libraries, and when you [have] the probe it's not so hard to do.

Rudolph:  It does not tell one with skill in the art how to produce a NK cell library, and if you look at the methodology that's recited in the specification, what they [Kubin] used was a specific mixture of resting cells, resting NK cells and NK cells stimulated with a very specific cocktail of activators.  That's not disclosed in Sambrook.  That's not disclosed in Valiante.  That's not disclosed anywhere[.]

The Court then turns the rationale of In re Deuel on it head:

More to the point, however, any putative difference in Valiante's/Sambrook's and appellants' processes does not directly address the obviousness of representative claim 73, which claims a genus of polynucleotides.  The difference between Valiante's and the application's techniques might be directly relevant to obviousness in this case if Kubin and Goodwin had claimed a method of DNA cloning or isolation.  But they did not.  Appellants claim a gene sequence.  Accordingly, the obviousness inquiry requires this court to review the Board's decision that the claimed sequence, not appellants' unclaimed cloning technique, is obvious in light of the abundant prior art.

This statement misses, or simply ignores, the evidence that performing the methods of the prior art would not have resulted in production of the claimed genus of polynucleotides.

The point, eloquently made in Deuel (and recognized by Judge Rader in oral argument as the Court's emphasis on "structure, structure, structure" for chemical obviousness) has always been:

The PTO's focus on known methods for potentially isolating the claimed DNA molecules is also misplaced because the claims at issue define compounds, not methods.  See In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993).  In Bell, the PTO asserted a rejection based upon the combination of a primary reference disclosing a protein (and its complete amino acid sequence) with a secondary reference describing a general method of gene cloning.  We reversed the rejection, holding in part that "the PTO's focus on Bell's method is misplaced.  Bell does not claim a method.  Bell claims compositions, and the issue is the obviousness of the claimed compositions, not of the method by which they are made."  Id.

We today reaffirm the principle, stated in Bell, that the existence of a general method of isolating cDNA or DNA molecules is essentially irrelevant to the question whether the specific molecules themselves would have been obvious, in the absence of other prior art that suggests the claimed DNAs.  . . .  There must, however, still be prior art that suggests the claimed compound in order for a prima facie case of obviousness to be made out; as we have already indicated, that prior art was lacking here with respect to claims 5 and 7.  Thus, even if, as the examiner stated, the existence of general cloning techniques, coupled with knowledge of a protein's structure, might have provided motivation to prepare a cDNA or made it obvious to prepare a cDNA, that does not necessarily make obvious a particular claimed cDNA.  "Obvious to try" has long been held not to constitute obviousness.  In re O'Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1680-81 (Fed. Cir. 1988).  A general incentive does not make obvious a particular result, nor does the existence of techniques by which those efforts can be carried out.  Thus, Maniatis's teachings, even in combination with Bohlen, fail to suggest the claimed invention.

Unfortunately, the panel was able to extract disclosure that supported their hindsight reconstructions of the inventive event:

In particular, appellants' arguments that Valiante and Sambrook are deficient because they do not provide "any guidance for the preparation of cell culture that will serve as a useful source of mRNA for the preparation of a cDNA library," Appellants' Br. 34, are diminished by appellants' own disclosure:

A "nucleotide sequence" refers to a polynucleotide molecule in the form of a separate fragment or as a component of a larger nucleic acid construct.  The nucleic acid molecule has been derived from DNA or RNA isolated at least once in substantially pure form and in a quantity or concentration enabling identification, manipulation, and recovery of its component nucleotide sequences by standard biochemical methods (such as those outlined in Sambrook et al., Molecular Cloning: A Laboratory Manual, 2nd ed., Cold Spring Harbor Laboratory, Cold Spring Harbor, NY (1989)).

'859 Application at 16-17 (emphasis added).  Thus, Kubin and Goodwin cannot represent to the public that their claimed gene sequence can be derived and isolated by "standard biochemical methods" discussed in a well-known manual on cloning techniques, while at the same time discounting the relevance of that very manual to the obviousness of their claims.

From this, it became a simple matter for the Court to have the question devolve into a factual one, so that the Court can defer to the Board's determination on the facts instead of deciding the issue (as it should) as a matter of law:

For this reason as well, substantial evidence supports the Board's factual finding that "[a]ppellants employed conventional methods, 'such as those outlined in Sambrook,' to isolate a cDNA encoding NAIL and determine the cDNA's full nucleotide sequence (SEQ NOS: 1 & 3)."  Board Decision at 5.

In its consideration of the Matthew reference, which the Court characterizes as showing "the relative ease of deriving the claimed sequence following the teachings of the prior art," the Court follows the Board's lead in focusing on whether the reference taught that there would be a human homolog for the 2B4 (mouse) gene.  The evidence of Matthew could have strongly supported the Court's reasoning, except for the fact that the gene identified in the Matthew reference was recognized as being the mouse homolog for human NAIL only after Kubin's filing date (which is why the Board found it to be cumulative -- it wasn't properly prior art at all).  If the evidence established that Kubin had done nothing more that rote recapitulation of Matthew's methods, then the Court's conclusions might have some logical merit.  In fact, the evidence was that Kubin (and the worker of ordinary skill in the art) would have been unsuccessful had they merely performed what Matthew (and Valiente and Sambrook) informed them to do.  The Court did not seem to appreciate this distinction.

One distinction raised in oral argument that was unavailing was Kubin's emphasis on CD48 binding and the portion of human NAIL involved in this binding.  While agreeing that the prior art was silent on these aspects of NAIL biology, it was "a distinction without a difference" to the panel -- "the Kubin-Goodwin application itself instructs that CD48 binding is not an additional requirement imposed by the claims on the NAIL protein, but rather a property necessarily present in NAIL."  Finding that there was substantial evidence that Valiante's p38 was identical to the NAIL protein encoded by Kubin's disclosed cDNA, the Court found substantial evidence that the CD48 binding properties were inherent (citing, appropriately, the Supreme Court's decision in General Electric Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249 (1945), that "It is not invention to perceive that the product which others had discovered had qualities they failed to detect").

Turning to In re Deuel, the Court focused on its reliance on when "obvious to try" can rise to the level of obviousness; as a starting point, the Court cited this portion of the Deuel decision:

[T]he existence of a general method of isolating cDNA or DNA molecules is essentially irrelevant to the question whether the specific molecules themselves would have been obvious, in the absence of other prior art that suggests the claimed DNAs.  . . .  "Obvious to try" has long been held not to constitute obviousness.  A general incentive does not make obvious a particular result, nor does the existence of techniques by which those efforts can be carried out.

In doing so, the Court expressly followed the Board's lead:  in its Ex parte Kubin decision, the Board said:

To the extent Deuel is considered relevant to this case, we note the Supreme Court recently cast doubt on the viability of Deuel to the extent the Federal Circuit rejected an '"obvious to try" test.  See KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, __, 82 U.S.P.Q. 2d 1385, 1394, 1396 (2007) (citing Deuel, 51, F.3d at 1559).  Under KSR, it's now apparent "obvious to try" may be an appropriate test in more situations than we previously contemplated.  Board Decision at 8.

Ironically, the Patent Office capitulated during oral argument regarding their long-expressed desire for the Court to overturn Deuel.  Rather, Janet Gongola, arguing for the Office, distinguished Deuel, citing that portion of the decision that stated "[a] prior art disclosure of the process reciting a particular compound is another matter raising issues of anticipation and obviousness" and saying "[w]e are that other matter."  In its decision, however, the Court went much further than the Board, or the Supreme Court, had gone:

Insofar as Deuel implies the obviousness inquiry cannot consider that the combination of the claim's constituent elements was "obvious to try," the Supreme Court in KSR unambiguously discredited that holding.

The key, of course, is in the "insofar":  while the Deuel opinion can fairly be interpreted as overstating the principle, that decision did not (and could not) overturn the holding in In re O'Farrell that while sometimes what is obvious to try is also obvious, it is not the case that just because something is obvious to try that it must be obvious (which in fairness was the Patent Office's position in Deuel).

The Court arrived at its misinterpretation of Deuel by equally overestimating the Supreme Court's sneeze in its direction:

In fact, the Supreme Court expressly invoked Deuel as a source of the discredited "obvious to try" doctrine.  The KSR Court reviewed this court's rejection, based on Deuel, of evidence showing that a particular combination of prior art elements was obvious because it would have been obvious to one of ordinary skill in the art to attempt such a combination:

The only declaration offered by KSR -- a declaration by its Vice President of Design Engineering, Larry Willemsen -- did not go to the ultimate issue of motivation to combine prior art, i.e. whether one of ordinary skill in the art would have been motivated to attach an electronic control to the support bracket of the assembly disclosed by Asano.  Mr. Willemsen did state that an electronic control "could have been" mounted on the support bracket of a pedal assembly.  (Willemsen Decl. at P33, 36, 39.)  Such testimony is not sufficient to support a finding of obviousness, however.  See, e.g., In re Deuel, 51 F.3d 1552, 1559 (Fed. Cir. 1995) ("'Obvious to try' has long been held not to constitute obviousness.").

Ironically, the Supreme Court illuminated the proper analysis for distinguishing when something is obvious to try is also obvious by restating the standards enunciated (in slightly different form) in O'Farrell:

When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.  If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.  In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.

i.e., sometimes, but not all the time, something that is obvious to try is also obvious.  Whatever effects the Supreme Court's KSR decision has had on patent law, this statement does not represent a major change.

But it certainly had an effect on this panel's judgment.  While recognizing the consonance between O'Farrell's teachings on the obvious to try standard and that set forth in KSR, the panel focused on the following statement of the proper analysis under O'Farrell:

Specifically, this court observed that an obviousness finding was appropriate where the prior art "contained detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful."  853 F.2d at 902 (emphasis added).  Responding to concerns about uncertainty in the prior art influencing the purported success of the claimed combination, this court stated:  "[o]bviousness does not require absolute predictability of success . . . all that is required is a reasonable expectation of success."  Id. at 903-04 (emphasis added).  The Supreme Court in KSR reinvigorated this perceptive analysis.

The panel then found that Kubin's claims fell within this class of situations when something that is obvious to try is also obvious.  The Court enumerated the factual predicates for applying this O'Farrell standard to Kubin's claim 73:

[T]he Valiante reference discloses the very protein of appellants' interest -- "p38" as per Valiante.  Board Decision at 4.  Valiante discloses a monoclonal antibody mAb C1.7 that is specific for p38/NAIL, and further teaches a five-step protocol for cloning nucleic acid molecules encoding p38/NAIL using mAb C1.7.  Id.  In fact, while stating that "[t]he DNA and protein sequences for the receptor p38 may be obtained by resort to conventional methodologies known to one of skill in the art," '690 Patent at col.7 ll.49-51, Valiante cites to the very same cloning manual, Sambrook, cited by Kubin and Goodwin for their proposition that the gene sequence is identified and recovered "by standard biochemical methods."  '859 Application at 16.  Moreover, the record strongly reinforces (and appellants apparently find no room to dispute) the Board's factual finding that one of ordinary skill would have been motivated to isolate NAIL cDNA, given Valiante's teaching that p38 is "expressed by virtually all human NK cells and thus plays a role in the immune response."  Board Decision at 6.  The record shows that the prior art teaches a protein of interest, a motivation to isolate the gene coding for that protein, and illustrative instructions to use a monoclonal antibody specific to the protein for cloning this gene.  Therefore, the claimed invention is "the product not of innovation but of ordinary skill and common sense."  KSR, 550 U.S. at 421.  Or stated in the familiar terms of this court's longstanding case law, the record shows that a skilled artisan would have had a resoundingly "reasonable expectation of success" in deriving the claimed invention in light of the teachings of the prior art.  See O'Farrell, 853 F.2d at 904.

Stated this way, and disregarding the factual distinctions to the contrary, it is not hard to see how the panel arrived at its conclusion.  And in some ways, this is actually good news for biotechnology inventions:  the bases for the Court's decision was not a generic "DNA is obvious" position that the Patent Office has long sought.  Instead, the Court set forth a plethora of factual grounds unlikely to be identically (or even substantially) encountered for other genes.

Elsewhere in the opinion is evidence that biotechnology has become the victim of its own success.  In discussing whether the skilled worker would have had a reasonable expectation of success in cloning Kubin's cDNA in view of the cited art, the Court opined:

In fact, this record shows that one of skill in this advanced art would find these claimed "results" profoundly "predictable."  The record shows the well-known and reliable nature of the cloning and sequencing techniques in the prior art, not to mention the readily knowable and obtainable structure of an identified protein.  Therefore this court cannot deem irrelevant the ease and predictability of cloning the gene that codes for that protein.  . . .

The record in this case shows that Valiante did not explicitly supply an amino acid sequence for NAIL or a polynucleotide sequence for the NAIL gene.  In that sense, Kubin and Goodwin's disclosure represents some minor advance in the art.

The Court may be right, but it would take an attitude studiously ignorant of history not to consider that the promise of biotechnology and its fulfillment was precisely in providing genes that made it possible to produce useful quantities of erythropoietin, tissue plasminogen activator, human insulin, interferon, blood clotting factor VIII, and several other otherwise unavailable proteins.  But today, in this panel's perspective, this is but "some minor advance in the art."  In the Court's view, this is the equivalent of an electronic accelerator pedal or children's game.

Because the panel was able to affirm the Board's decision of unpatentability on obviousness, it declined to address the rejection based on written description.  While consistent with the principle that the Court need not address secondary grounds for invalidity or unpatentability when it has reason to affirm others, the Court also sidestepped an important question on how the Office is applying the Court's rather convoluted written description jurisprudence (wherein certain members of the Court think the time ripe to consider the question en banc).  It is particularly puzzling because the panel mentioned its suspicions about how the Office had changed its policies in view of Kubin (see "Kubin Panel Questions Motivation behind Reversal in New Written Description Training Materials"):

Court:  I'm quoting almost out of PTO's manual on written description -- verbatim -- when I give my example there, am I not?  The variations plus the activity Y -- protein having activity Y -- isn't that exactly the PTO's manual on written description?

Gongola:  Are you referring to the training materials?

Court:  Yes, I am.

Gongola:  That language may be found in the training materials, but it is not -- it's guidance.  It's -- each case of written description has to be decided on its own facts.

Court:  The Patent Office is guiding applicants on how to do things wrong?

Gongola:  No, your Honor, but guidance provided in a training document cannot be taken and applied to each case.  Each case has to be decided on its own facts.

Court:  So it's just guidance to examiners on how to do it wrong?

Gongola:  No, your Honor -- respectfully -- it is guidance to the public as well, but . . .

Court:  But if we take that guidance, we don't get to your result, do we?

Gongola:  No, your Honor, I respectfully disagree; we do.  In Carnegie Mellon, this Court has explained that when there's substantial variation within a genus, an applicant has to describe a sufficient number of species to reflect the variation.  Kubin has not done that here.  Kubin hasn't described any variation.  If we want to look at the training materials, the Board only . . .

Court:  It's interesting that this was revised immediately after Kubin -- the Kubin result -- wasn't it?

Gongola:  That . . .

Court:  Which is kind of an admission that the example did track Kubin and was detrimental to your position, wasn't it?

Gongola:  No, your Honor.

Court:  So, despite your smiling defense, the facts tend to give us a different conclusion.

Gongola:  No, your Honor, that's not correct.  The training materials were not revised post-Kubin to somehow capture Kubin.  The revisions have been in the works for a very long time.

Court:  I see, okay.

Gongola:  So it's just coincidence that Example 11 may seem to look like the Kubin fact pattern. . . .

The Court's decision in In re Kubin reinforces the impression that, after KSR, what will be dispositive is evidence, not argument.  KSR increases the tendency and risk of subjective hindsight reconstruction of an invention, based on a "totality of the circumstances" approach ("I may not know how to define what's obvious but I know it when I see it," to paraphrase Justice Potter Stewart in another context).  This "gut reaction" obviousness can be defeated only by evidence refuting the construction that hindsight informs.  While there was some such evidence here, the Court did not give it sufficient credence or weight, or simply chose to ignore it altogether.  But the outcome here illustrates the importance of pressing these kinds of factual distinctions.

Another reason the sky will not be falling on biotechnology patenting arises from the time in the history of biotechnology in which the decision was handed down.  Many (if not most) of the "known" genes in the art have been cloned and patented (or not) over the past 30 years of gene patenting, and many of these patents have expired or are nearing the ends of their terms.  In addition, many of these genes were isolated at a time when the technology was much less well developed and when there are sound factual bases for concluding that there was not a reasonable expectation of successfully cloning a cognate gene even for proteins that were well known and well characterized.  Turning to the present day, many (if not most) of the genes patented or that have been attempted to be patented were not known prior to their discovery (usually through homology comparisons) as a result of the Human Genome Project (HGP).  A fundamental pillar of the Court's decision in Kubin was that p38 was known; that will not be the case for most of the genes identified since the late 1990's.

This leaves a class of genes and gene patents "in the middle" -- granted since (and perhaps because of) the Court's decision in Deuel but prior to identification during the HGP effort.  Some of these, no doubt, have been made more open to an obviousness challenge since the Court's decision in this case.  However, many (if not most) of these genes will be lacking some if not several of the factual underpinnings of the Kubin decision:  the existence of the protein encoded therein was not known, or there was not a commercially-available monoclonal antibody specific for the protein, or expression cloning was ineffective or unpredictable for that gene, or there was no express description in the art on how to isolate the gene, or there did not exist a cell or tissue source reliably expressing the protein.  In these and perhaps other ways, the Kubin decision is sufficiently narrow that it should not provoke a sea change in the fortunes of such gene claims.  Insofar as it has a tendency to have this effect in the Patent Office, factual challenges, particularly supported by expert declarations, should have the greatest persuasive punch.

As for what this decision says about the current state of the institutional integrity and fortitude at the Federal Circuit, the Court (or at least this panel) clearly believes that the Supreme Court has spoken clearly that their jurisprudence has gone severely awry.  There are, no doubt, instances where the Court has struggled (no more mightily than the Supreme Court) in applying patent law principles to ever-changing subject matter.  In this, the Court has (as it was intended to have) a unique position in the American federal judicial framework.  That makes it all the more important that the Court make its decisions based on direction from the Supreme Court filtered through its own expertise.  Indeed, even the Supreme Court, in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., recognized that the Federal Circuit was the best place for the consistent development of patent law in the first instance (subject, of course, to Supreme Court correction).  But an uncritical application of Supreme Court precedent, particularly where the Court has not mandated a change (as it did, for example, in eBay Inc. v. MercExchange, L.L.C.) fails to fulfill the Federal Circuit's Congressional mandate and its responsibility to harmonize patent law in this country.  In Kubin, once again, the Federal Circuit appears to have reacted to Supreme Court guidance more with what it perceived as strict compliance than with flexibility in applying the Supreme Court's broad principles to particular cases.  And in doing so, it took the occasion to unnecessarily overturn a decision that has been the basis for countless decisions made by applicants, investors, and the companies that have developed biotechnology from the laboratory bench to an industry in which America is competitive throughout the world.  It is not the Federal Circuit's brief to make decisions based on these considerations, of course.  But it would be consistent with their harmonization mandate (as much as it is inconsistent with some of their current jurisprudence, see, e.g., In re Bilski) if the Federal Circuit would keep such considerations in mind.

In re Kubin (Fed. Cir. 2009)
Panel: Circuit Judges Rader, Friedman, and Linn
Opinion by Circuit Judge Rader

Comments

[EG]

Kevin,

Nice post, and especially commentary on the opinion and what it means. What really bothers me here is this panel's astounding ignorance of important underlying biotech facts necessary to render this decision. (That this panel chose to basically overrule standing precedent, such as Deuel, when not compelled to do so by SCOTUS's KSR opinion is also very bothersome.) Dealing with a technologically-challenged SCOTUS is bad enough. But having the Federal Circuit be almost clueless about certain aspects of the technology involved in a given case is very discomforting. This suggests that the Federal Circuit needs at least a judge or with the appropriate technical backgrounds for the newer technologies like biotech and computer science. What we're seeing now is starting to get embarrassing.

[Kevin E. Noonan]

Dear EG:

I considered, but did not include in the post, some comments along the lines you suggest. Actually, I would go further than you did - if the CAFC is going to truly be a patent court, then there should be some number of the court that must have a technical background. I know federal court judges are intelligent, but it is easier for a non-technically trained judge to lose the details at the margins, and to not recognize the significance of technical facts having great bearing on the outcome (as here).

The alternative viewpoint, of course, is that the judges are deciding questions of law, and thus a generalist judge is fine. And I have seen judges vastly over-estimate their grasp of technical facts (I've seen lawyers do it, too) so perhaps there is no perfect solution. It will be interesting to see whether Kubin asks for rehearing based on the failure to properly consider the facts.

Thanks for the comment.

[FH]

I still think a distinction between genus claims and species claims is relevant. While application of Kubin to Deuel would have led to a different outcome for genus claims 4 and 6, it is not clear to me that species claims 5 and 7, reciting a single nucleotide sequence, would now be found obvious. No species claim was discussed in Kubin. Perhaps this is an unimportant distinction since species claims in biotechnology have little force (except under the doctrine of equivalents?)
Also, I was disappointed that the Kubin court did not address the statement in Deuel that "what cannot be contemplated or conceived cannot be obvious."

[EG]

Kevin,

I concur your comment that a certain number or proportion of the Federal Circuit should be judges with a technical background (including backgroungs relevant to biotech and computer science which are the "hot spots" now). For example, I know some will point to Judge Moore as having a "patent background" but the fact is, she doesn't have an underlying technical background (and it shows unfortunately in her opinions, along with a lack of understanding of the "realities" of the patent prosecution process in the USPTO). To say that a Federal Circuit bench can be comprised almost exclusively of "generalist" judges who can't even understand or grasp the basic technical facts necessary to render a reasoned opinion based on the patent law is oxymoronic in the extreme.

[Kevin E. Noonan]

Dear EG:

But that is what we have, isn't it? And since the trend seems to be that facts are more and more important, it will be generalist district court judges who will be making findings of fact.

Thanks for the comment.

[Kevin E. Noonan]

Dear FH:

The Deuel court did not reach the genus claims, except for the tantalizing hint (fulfilled in California v. Lilly) that there could be written description issues with broad genus claims.

In Kubin, the genus claims were even broader, and that might have been another basis for the CAFC to have decided the case on 112 grounds, avoiding the obviousness question entirely.

Thanks for the comment.

[EG]

Kevin,

Sorry, I misunderstood your comment. Yes, we've got "generalists" at the district court level, although, as you know, part of the so-called "patent law reform" package is funding for district court training in patent matters. Changing the "generalist" district court judges isn't likely to happen, and probably requires enabling legislation (unlikely with this Congress). But if the Federal Circuit is predominated by judges with a "generalist" background (and no technical background, especially in the "hot" areas of biotech and computer science), we truly will have the "blind leading the blind." At least there's some ability for us in the patent bar to push for getting more judges on the Federal Circuit bench who have the appropriate technical background (although given Judge Moore as the more recent selection, that too may be a "pipe dream").

[Prediction: FAIL]

Just as predicted. Chalk one up (more than that, actually) for yours truly.

http://www.patentdocs.org/2009/01/in-re-kubin-the-obviousness-of-dna.html

A lot of verbiage upthread is wasted on the applicant's arguments. Not sure why anybody should/would care. In any event, Kevin, based on this paragraph it seems that you have finally come to the light:

"Stated this way, and disregarding the factual distinctions to the contrary, it is not hard to see how the panel arrived at its conclusion. And in some ways, this is actually good news for biotechnology inventions: the bases for the Court's decision was not a generic "DNA is obvious" position that the Patent Office has long sought."

I take minor issue with this statement, however: "the Court set forth a plethora of factual grounds unlikely to be identically (or even substantially) encountered for other genes."

I think that the sort of teaching found in the art here is very common. You underestimate the extent to which applicants file and pursue unreasonably broad claims in the face of such teaching. If you are saying that it is unlikely that another case with similar facts will be appealed to the CAFC, I think you are correct. But I expect that the PTO will be using this case (appropriately and succesfully) to blow up a fair number of pending isolated gene-encoding nucleic acid claims.

[CNS]

Kevin states: "the bases for the Court's decision was not a generic "DNA is obvious" position that the Patent Office has long sought." While this may be true, I strongly suspect the PTO will not see it the same way. Any guesses on how long it takes PTO mgmt to circulate a directive to the TC1600 examiners that essentially says "DNA is obvious, absent compelling evidence to the contrary?"

[Kevin E. Noonan]

Dear PF:

Still not with you, and I'll tell you why.

First, insofar as the genus/species/overbroad claiming issue was important to the decision, the place to address that was the 112 issue. There the PTO may have a point, in view of the unpredictability of changing up to 15 amino acids out of 100, and the Office's interpretation of the written description requirement per Example 11 of the training materials published last spring.

But it is likely that Judge Linn stopped that approach in its tracks, given his concurring opinion in the Ariad case regarding the way the court has handled the written description requirement.

You missed the irony of the portion of the post you cited. Like Kevin Kline in "A Fish Called Wanda," you can reach any conclusion if you aren't bothered by the facts. And the facts pretty clearly indicated that the court was wrong that the human NAIL cDNA could be obtained by following Valiante/Sambrook/Matthew. Which is why I mentioned how important facts have become to the entire analysis.

As for pending applications, I think the obviousness question should be an easy one to answer. Was the protein known in the prior art? No, then Kubin is distinguished. Was there an available monoclonal antibody to the protein? No, then Kubin is distinguished. Was the protein able to be expressed on a phage expression library? No, then Kubin is distinguished. Did the art provide the explicit roadmap for cloning the gene, and an example of a third party using the method to clone an ortholog? No, then Kubin is distinguished. Is there a known, reliable cell or tissue source that expresses the protein? No, then Kubin is distinguished.

These are not fanciful considerations. There were patents to proteins like clotting Factor VIII that were invalidated because the mRNA was much larger than what was predicted by the coding sequence/size of the protein. The EPO gene has been attacked in litigation because the actual EPO protein is 1 amino acid shorter than the predicted sequence. There is a pre-Deuel patent to a brain receptor that was a member of a multigene family, where the receptor was so much smaller than the other family members that it would have been (and was, as I recall) overlooked by others trying to find it.

So, instead of "structure, structure, structure" we now have "fact, fact, fact." That benefits the Office, based on Zurko/Gartside deference, but it also helps applicants, under In re Sullivan. Many predicted that after KSR declaration evidence would become more important, and now it has (peruse the Cabilly reexam file if you don' believe me).

Thanks for the comments.

[Kevin E. Noonan]

Dear CNS:

They already have, actually. The Guidelines for implementing KSR, published in November 2007, substantially say that. In Example E, Kubin is used as an example of obviousness due to "obvious to try." So I expect a bright line rule to be imposed.

Why I am hopeful is that there are so many ways to distinguish Kubin. One of the difficulties encountered by Kubin in this case is that they were sucker punched by the PTO. Prosecution counsel pointed out that the Examiner was wrong under In re Deuel, and the Office was not forthcoming about its "new" determination that KSR had somehow "overruled" Deuel. It didn't; Deuel was consistent with O'Farrell, and KSR merely reiterated the O'Farrell standard. So the court's reasoning that somehow Deuel was another case in its precedent where the court improperly imposed a rigid non-obviousness standard is, frankly, nonsense.

Let us know if you (any of you) receive the kind of "Kubin says these claims are prima facie obvious" rejections. It might be fun punching holes in their logical balloon.

Thanks for the comment.

[Prediction: FAIL]

"You missed the irony of the portion of the post you cited. Like Kevin Kline in "A Fish Called Wanda," you can reach any conclusion if you aren't bothered by the facts."

There are two sides to every story, Kevin. Or, more to the point, there are two stories to be told given any set of existing "facts." The PTO's story was much more compelling. Was it the fault of the applicants' hired storytellers? I don't think so.

It was the premise. Hence my prediction: that Kubin would fail.

"So, instead of "structure, structure, structure" we now have "fact, fact, fact."

The structure of the claimed invention is also a "fact" so I think your distinction here is not terribly helpful.

"Why I am hopeful is that there are so many ways to distinguish Kubin."

Here's one great way: don't claim a gigantic genus of molecules that you haven't discovered when you have prior art telling you how to identify the single sequence that you did discover.

[Prediction: FAIL]

Kevin: "Which is why I mentioned how important facts have become to the entire analysis."

C'mon, Kevin. Facts have always been important. They are no more or less important now than they were before.

Just for the record, I'll say it again: I predicted this result, based on facts available to everyone. And based on those same facts, I have been prosecuting cases assuming the result that was just handed down. Now I am ahead of the game. I don't have to tell my clients that we need to change strategy based on this decision. We adapted and moved forward because we saw the writing on the wall. No time to whine.

[RM]

Kevin,

You make the point that the decision is not a blanket "DNA is obvious" holding, but that it relies on specific facts that narrow its impact. But the Court sweeps aside the main thrust of Kubin's argument concerning the cDNA libraries and the absence of any specific teaching ("enabling methodology" in the O'Farrell parlance) regarding their preparation. Doesn't this amount to an ominous endorsement of, and reliance on, the general methods references embodied by the likes of Sambrook/Maniatis?

[Kevin E. Noonan]

Dear PF:

I don't disagree with the last thing you said: don't claim a huge genus of molecules when you have just discovered one.

Except: if you file a claim such as:

An isolated nucleic acid encoding an amino acid sequence identified by SEQ ID NO: X"

you have written a claim encompassing a huge genus of (synonymous) molecules. I think that claim should be allowed, and in fact so does (did) the court.

I also agree that there can be trouble when you try to claim the genus of "substitution, deletion or insertion" variants.

But not because they are obvious, because you are overclaiming and have not described the variants (in most, although not all, cases).

No whining, and glad you predicted it. But no matter how clever you are, if you want to claim a nucleic acid you'd better be able to distinguish your claim as I set forth in my post or you won't be able to, no matter how narrow you make it scope.

(Although I suppose you could, and maybe you have, just recite the nucleotide sequence in the claim as in Bell.)

And for the record, my analogy to Kevin Kline was not directed at you. We don't to the "ad hominem" routine here; it just gets in the way.

Thanks for the comments.

[Kevin E. Noonan]

Dear RM:

This panel seemed to be disinterested in the facts, it's true. But if you are arguing obviousness, under the hindsight-prone prism of "obvious to try," the only way to overcome the prima facie case is to undercut the factual bases for the determination.

The portion of the decision I quoted is the roadmap for distinguishing Kubin. I think many genes will be distinguishable; anyone game to review granted or pending claims to see if I'm right is welcome to do it. Just let me know what you find.

Thanks for the comment.

[Prediction: FAIL]

Kevin: "Insofar as it has a tendency to have this effect in the Patent Office, factual challenges, particularly supported by expert declarations, should have the greatest persuasive punch."

You are far, far better off building the necessary facts into your application and getting the information before the prosecutor WITHOUT relying on declarations. Expert declarations are chum for defense attorneys, and for good reason.

[Prediction: FAIL]

Kevin: "if you file a claim such as:

An isolated nucleic acid encoding an amino acid sequence identified by SEQ ID NO: X"

you have written a claim encompassing a huge genus of (synonymous) molecules."

I disagree. I would call that a "limited set" of molecules. Under Gleave (at least), if a reference provided the amino acid sequence and a suggestion to prepare a nucleotide sequence encoding the gene, all of those nucleotide sequences would be anticipated.

[Kevin E. Noonan]

Dear PF:

The difference between expert declarations and putting the evidence into the spec (although always a good idea) is that the expert may well be someone with sufficient credentials to overcome hindsight (again, read the Cabilly reexam record). Things written in the specification are written by lawyers, and what we think is given no weight.

I don't think Gleave said that, but it is the logical extension of the Gleave opinion. And it has been the PTO position from the start.

Thanks for the comments.

[Brian]

It's time to pull the plug on the Federal Circuit as a failed experiment and let the existing circuits handle patent cases. It was a good idea at the time, but history has proven that a court of specialized jurisdiction can be just as ignorant about the subject matter of that jurisdiction as any regular circuit in the federal judiciary.

[moondoggie]

Dear Brian:

The problem with regional circuits is inconsistency. Now, I realize that consistently bad may be worse than inconsistency, and that inconsistency has been more of a hallmark of the CAFC than not, but the Supreme Court has done a good job (maybe too good) of focusing the court recently (for better or worse).

What we need is to have some requirement that a sufficient number of CAFC judges have some relevant background or experience in technology, patent law or both. This is not a problem in the regional circuits, where generalist judges treat general questions. The problem has been Congress treating nominees to the CAFC like any other circuit judge, forgetting the role they will have to play once they get on the bench.

But you are not the first to question whether the Federal Circuit experiment is working.

Thanks for the comment.

[Kevin E. Noonan]

Good points, moondoggie.

[Bean head]

As a public sector biotechnologist, I have to say that the court's conclusions appear obvious. The kind of claim in this application are not inventions, and issuing these patents stifles discovery and innovation.

[Kevin E. Noonan]

Dear Bean head:

I am curious why you think a claim like Kubin's stifles discovery (innovation is a harder matter, but we have something to say about that, too).

In the first place, recognize that the sequence is not what is patented, the nucleic acid is. So disclosure of the sequence and patenting the gene does not prevent you, public sector biotechnologist, from using all that information disclosed by private sector biotechnologist to use the sequence to hunt for related sequences in public databases. Or looking for orthologs in other species. This information is at no cost to you and it is the incentive of patenting that encourages it (instead of the information being withheld by the private sector biotechnology company). How many traditional pharmaceutical companies disclose the underlying science behind their products?

In addition, one of the reasons why we have public databases of sequence information is due to the private sector, specifically Craig Venter's companies. His competition, fueled by the fire of his interest in obtaining patent rights, is what got the HGP to complete its government-funded work as quickly as it did. So there is an incredible amount of information that has been available for the past 10 years, maybe 10 years earlier than it would have been. Considering that patents filed by 2000 will expire permanently and forever no later than 2020, the consequence is that the public got the information in 2000 and many of these patents have not been granted yet. Seems like a deal, especially when you take the long view that the info and the nucleic acids will be perpetually in the public domain after 2020, that info became public earlier than it might have otherwise, and the info was produced using private money.

And, by the way, the Patent Office has (reasonably) decided that nucleic acids are not patentable unless the applicant can show an activity for the encoded protein. So no one is giving away the store to private biotechnology companies on these claims.

The question of whether Kubin's claims are patentable, or obvious, is a legal one and the Federal Circuit has held they are not. Whether right or wrong, this decision is based on a specific set of circumstances unlikely to be satisfied by many other genes. Gene patenting, and the investment it attracts, will continue to support development of diagnostic and therapeutic products. And public sector biotechnologists will be able to pursue their research unfettered by these patents (unless they try to commercialize them, which takes out the public sector part). Sounds like innovation to me.

Thanks for the comment.

[6]

"This statement misses, or simply ignores, the evidence that performing the methods of the prior art would not have resulted in production of the claimed genus of polynucleotides."

Um, what evidence? There was none. Just because Kubin did a nice way of producing the genus doesn't mean the prior art method would not have. And in fact, it was found that they would. There was no evidence showing that they would not. At least that I've seen, and that you've put forward.

"fact, the evidence was that Kubin (and the worker of ordinary skill in the art) would have been unsuccessful had they merely performed what Matthew (and Valiente and Sambrook) informed them to do. "

What evidence tends to show this? Which? Be specific please.

"The record shows that the prior art teaches a protein of interest, a motivation to isolate the gene coding for that protein, and illustrative instructions to use a monoclonal antibody specific to the protein for cloning this gene. Therefore, the claimed invention is "the product not of innovation but of ordinary skill and common sense." "

There is hardly any better way to put it.

Score: Rader 1
Noonan 0

"Stated this way, and disregarding the factual distinctions to the contrary, it is not hard to see how the panel arrived at its conclusion. "

WHAT FACTUAL DISTINCTIONS?

Your post reminds me of attorney arguments I recieve. A lot of jibbering and jabbering about facts and etc, when all you need to do is point out specifically what the facts are and why they lead to a different conclusion or do not support the conclusion made and would thus leave the conclusion still hanging to be made with no evidence either way. If you can simply do that, wallah, you win.

[Kevin E. Noonan]

6, 6, 6:

OK, here goes, one more time. Kubin's counsel told the court (as cited in my post, and my post on the oral argument, and in the briefs, etc.):

Unlike mouse NK cells, human NK cells do not make the NAIL protein in sufficient quantities for the skilled worker to identify/clone/obtain its cDNA by following the prior art. This one of those unpredictabilities about biotechnology that are not only very real but trump ignorant statements like "Sambrook gives you the library." As someone said on another blog, "Farming looks mighty easy when your plow is a pencil and you’re a thousand miles from the corn field" D.D. Eisenhower, 1956.

Back to biotechnology, in order to obtain the NAIL cDNA Kubin had to treat the human NK cells in ways that were not taught in the art. So the factual predicate of the decision was that the Valiante reference provided an antibody and a scheme for cloning the gene encoding the p38, Sambrook provided the routine methods for cloning, and Matthew showed that by following the art you reliably (predictably) obtained a cDNA (for 2B4, of course, the mouse protein). And this was wrong.

Once again, the specific factual distinction is that you cannot obtain Kubin's cDNA by practicing the combination of the prior art relied upon by the examiner, the Board and the court.

I am not in competition with Judge Rader (he holds the gavel, after all). But I don't think it too much to ask that he (or anyone else) get the facts right when making a decision based on those facts. Or in pointing it out when they make a mistake. Maybe (maybe) showing you the facts will result in a "win" but it didn't work here.

Thanks for the comment.

[6]

Here we are three days later and you still have delivered no beef, either here or on PO. I've agreed to your terms, surely the beef is easily found right?

Wait for it ...

l o l

[Donald Zuhn]

6:

Kevin responded to your challenge on April 8 at 4:50 PM, so the ball has been back in your court for almost two days.

Don

[Kevin E. Noonan]

Sorry, 6, I got sidetracked by our discussion on Dennis's blog.

Here's the deal. The patent explains in Example 1 that the library was made from NK cells that had been stimulated with a specific cocktail of activator molecules (IL-2, IL-12, IL-15, IFN-gamma and anti-CD-16 antibody); this treatment, and the necessity of this treatment is not found in Valiante, Sambrook or Matthew.

Score: 1 for me

In their Appeal Brief to the Board, Kubin argued that there was no guidance on how to "prepare" human NK cells so that they would produce sufficient NAIL mRNA to be detectable in a cDNA library.

Score: 2 for me

In their brief to the CAFC, Kubin argued that the prior art did not teach stimulating human NK cells with "certain activators."

Score: 3 for me

Further in their brief, Kubin argued that the evidence of record showed that Applicants did not use conventional methods to clone NAIL.

Score: 4 for me

Finally, at oral argument Kubin's counsel said: It does not tell one with skill in the art how to produce a NK cell library, and if you look at the methodology that's recited in the specification, what they [Kubin] used was a specific mixture of resting cells, resting NK cells and NK cells stimulated with a very specific cocktail of activators. That's not disclosed in Sambrook. That's not disclosed in Valiante. That's not disclosed anywhere[.]

Score: 5 for me

Not directly related to the point I have been making, but relevant to the point in general, Kubin argued that Matthew did not teach that 2B4 was conserved between mouse and human (and indeed it was not, sharing only 69% sequence homology) AND that Matthew reported that 2B4 expression could NOT be detected in human NK cells.

Score: 6 for me

6, I understand that, from reading the decision is sounds logical and correct. Upthread I invoked Kevin Kline in "A Fish Called Wanda." Everything he said sounded logical and correct, too. It is unreasonable to think that Judge Rader would right an opinion that sounded any other way. But when the fundamental facts are missed or ignored, you get these types of errors.

I don't think it's too much to ask that a decision having the consequences we can expect this one to have (the sky is not falling but it isn't trivial, either) should be based on the facts. My point.

Thanks for the discussion.

[Kevin E. Noonan]

That should be "write" an opinion.

[CNS]

The above dialog between Kevin and 6 has an all too familiar ring to it: technically knowledgeable attorney makes clear, cogent, fact-based arguments to the PTO as to why claims are allowable over cited art; technically naive (but too self-important to admit it) examiner ignores attorney's convincing argument and responds with final rejection consisting of boilerplate and misapprehension of relevant technology.

[Kevin E. Noonan]

Dear CNS:

To be fair, I don't think this is 6's technical area.

[CNS]

True, but that's my point, or at least part of it. Technical (in)competence is increasingly rarely stopping examiners from rejecting what they don't understand.

[6]

"Here's the deal. The patent explains in Example 1 that the library was made from NK cells that had been stimulated with a specific cocktail of activator molecules (IL-2, IL-12, IL-15, IFN-gamma and anti-CD-16 antibody); this treatment, and the NECESSITY (THERE IS NO NECESSITY RECITED IN THE APP because this treatment is not necesary!!1111!!!!! a million times over) of this treatment is not found in Valiante, Sambrook or Matthew."

Their patent app never states that it was NECESSARY to perform that treatment to obtain the library. How can you be missing this Noonan? I see patent apps like this all the time. The applicant performed x method, but could have performed m method instead where m was a well known non-exotic method compared to x. The fact that the applicant choose to use x is not material unless it is in the claim or unless it was REQUIRED to have the overall method achieve success. Neither of these circumstances arise in the present application. I thought I'd been over this already. Either show me the beef, aka where in the patent app that they discuss the NECESSITY of using Kubin's exotic method of achieving what the standard method for obtaining libraries fails to achieve, or you have NO FACTUAL SUPPORT to back your supposition.

I'm subracting a point. Now you're back at 0.

"In their Appeal Brief to the Board, Kubin argued that there was no guidance on how to "prepare" human NK cells so that they would produce sufficient NAIL mRNA to be detectable in a cDNA library."

What do you not understand about repeating example 12 ad infinitum until you have literally a hundred tons of NAIL? There being (maybe, maybe not, the argument doesn't address this) enough NAIL in one batch produced by example 12 is irrelevant. If you need more of it, then MAKE A NEW BATCH until you have enough. Rader saw this, and thus addressed Kubin's argument about this point. You act as if Kubin merely arguing something makes it a fact, and makes it have relevancy other than what they specifically explain. News for you, arguments do not have that effect.

I'm subtracting this point as well, you still stand at 0.

"In their brief to the CAFC, Kubin argued that the prior art did not teach stimulating human NK cells with "certain activators."

RELEVANCE IS WHAT??!?! Dear jebus, I'm left hanging here wondering what relevance this statement, and Kubin's argument had. I do suppose that you're implying that human NK cells needed to be stimulated with "certain activators" in order to produce the structure claimed. I'm pretty sure Rader addressed this by stating that the prior art did give an activator (I can't recall what it was off hand) and thus couldn't see the relevance of Kubin's argument. As I cannot see the relevance of your point/argument.

I'm subtracting you that point as well, again you're at 0.

"It does not tell one with skill in the art how to produce a NK cell library, and if you look at the methodology that's recited in the specification, what they [Kubin] used was a specific mixture of resting cells, resting NK cells and NK cells stimulated with a very specific cocktail of activators. That's not disclosed in Sambrook. That's not disclosed in Valiante. That's not disclosed anywhere[.]"

You're not getting it chief. Their using a specific mixture of resting cells, resting NK cells and NK cells activated IS IRRELEVANT if POSHITA could have simply used the Sambrook methodology instead. Which POSHITA could have, and Kubin DOES NOT ARGUE THAT POSHIT COULD NOT HAVE. Kubin merely states that they did something different in their method to obtain the structure. WHO GIVES A SHT? NOBODY! NOT RADER, NOT ME, NOT YOU! We MIGHT give a small sht IF the Sambrook method WOULD NOT HAVE WORKED. Kubin FAILS to argue such a thing. Why does Kubin fail to argue such a thing? Because Kubin knows that it would be a lie. The Sambrook method does just a good of a job as Kubin's method. Why then do you keep relying on this argument to say more than it actually does? Perchance are you not aware that this is not a product by process claim, or a process claim, but is rather solely a STRUCTURE claim, aka composition?

Again, this point has to go. Sitting at 0.

"Not directly related to the point I have been making, but relevant to the point in general, Kubin argued that Matthew did not teach that 2B4 was conserved between mouse and human (and indeed it was not, sharing only 69% sequence homology) AND that Matthew reported that 2B4 expression could NOT be detected in human NK cells."

You're going to have to explain to me how 2B4 being conserved between mouse and human and it not being detectable in human NK cells is relevant before I give you a point. Further, if you could explain what 2B4 is precisely it would help. I found out that it is a receptor (I think) but how this would possibly be relevant to the discussion I cannot fathom.

So you stand at one possible point. If you can explain it. Although we both know that the last point you made was the weakest, because Mathew could just be dismissed as being irrelevant to the present case since it was done in a mouse.

And yes, you're right, this isn't my area of expertise. All that I can see is this. As to the fundamental facts being ignored, well yes, because they were irrelevant, and as to the facts being overlooked, nah, they were addressed, one by one in turn.

There is a structure claim:

73. An isolated nucleic acid molecule comprising a polynucleotide encoding a polypeptide at least 80% identical to amino acids 22-221 of SEQ ID NO:2, wherein the polypeptide binds CD48.

Which basically says: a genus of isolated polynucleotides encoding a protein that binds CD48 and is at least 80% identical to amino acids 22-221 of SEQ ID NO:2 – the disclosed amino acid sequence for the CD48-binding region of NAIL.

What relevance does Kubin's method of obtaining the library have on this claim? (this is really your only realistic leg to hypothetically stand on) None. Why? Because the prior art method arrives at this claimed structure just as well as Kubin's specific method and Kubin does not argue otherwise. You're reading things into his arguments that are not present if you believe otherwise. He would not contest this point precisely because he would have to lie to do so. He is, in effect, trying to divert attention to irrelevant facts that do not fully support his arguments. I see this every day, I know when it is occuring.

Kevin look man, I've asked you several times now, I would like the beef, that is, the complete facts. The only facts (if they are actually facts instead of merely repackaged arguments) you provide me with are the following:

1. Kubin performed a special method for apparently no reason since he could have just used the nice conventional prior art method.
2. Valiante MIGHT not make NAIL in sufficient quantities IF one only performs example 12 a single time. (there are no facts that suggest that Valiante indeed did not make enough NAIL in one execution of example 12 and there is no reason to believe that a POSHITA would run example 12 enough times to make lots of NAIL as Rader suggests that POSHITA would know to do).
3. That Kubin did not use conventional methods to clone NAIL (but there is no discussion of who gives a sht if Kubin went out of his way to use something exotic rather than the common or why anyone should give such a sht).
4. That "it" aka Valiante by itself, doesn't show the specific mixture that Kubin dreamed up to replace the prior art method's stuff it uses and that nobody tells about the specific mixture that Kubin dreamed up. (there is again no discussion as to why Kubin didn't just use Sambrook's method thus making the whole argument irrelevant).
5. etc.

These are all in effect facts, and are used to support arguments which do not completely follow from the facts stated. Here, let's play fill in the blanks since you have a hard time understanding what I'm asking for.

1. Kubin performed a special method that makes a cell library from NAIL and POSHITA could not have accomplished this from using Sambrook's method because of x.

2. Valiante's example 12 doesn't make enough NAIL for the procedure to work because it only makes x amount and y amount is needed. One of ordinary skill would not know to repeat example 12 until they got x amount because of z.

3. The prior art does not teach stimulating human NK cells with "certain activators" and you need "certain activators" as opposed to what the prior art would use because of x.

I would go on, but you get the picture. Repaeat that for all your "facts" supplied above.

Simply fill in x, y and z with the rest of the relevant fact, or provide a reasonable explanation in leiu thereof, and you have sufficient facts to make this case patentable. Simple as that. But you can't. Why can't you? Because the facts you have are insufficient to support the arguments on which you are relying.

What CNS meant to say was: The above dialog between Kevin and 6 has an all too familiar ring to it: technically knowledgeable attorney makes clear, cogent arguments, without any facts that are demonstrated to be relevant to back them up, to the PTO as to why claims are allowable over cited art; technically naive (who has already admitted it at PO) examiner ignores attorney's argument that lacks any cited facts that are demonstrated to be relevant and responds with final rejection consisting of "show me the FACTS and tell me how they are relevant, and I will consider them, until then here is why your facts are irrelevant: "blah etc."."

"Technical (in)competence is increasingly rarely stopping examiners from rejecting what they don't understand."

If you don't understand it, how then are you to always know that what limited understanding you do have is insufficient if the applicant doesn't TELL YOU SPECIFICALLY WHAT IT IS THAT YOU'RE MISSING WHEN YOU ASK THEM WHAT YOU'RE MISSING?

Sorry for the bold guys, but this is just ridiculous. I've asked Kevin to give me the full support for the things that were alleged, and he just recites the allegations back to me. Even the attorneys that practice before me do not entirely ignore what I'm asking for. They either drop the argument because they realize they don't have complete support, or they provide the support. Usually they go with the former because they realize they don't have enough facts to back them.

Incidentally I guess this is why attorneys try to argue law more often than facts. Because they are apparently horrible at fact finding and the application of facts.

[Kevin E. Noonan]

Dear 6,

You should entertain the possibility that there is actually an argument that either you don't get or you don't agree with, AND STOP WITH THE SHOUTING ALREADY - after all, you have Dennis's blog to shout all you want. Please, not here.

You have hit on the central issue here - was the treatment necessary to obtain the NAIL cDNA? You want an affirmative statement of that in Kubin's specification, which in retrospect (could we say hindsight?) would have made the point so that even you (someone admittedly outside their area) could understand it.

I think the treatment was necessary, for two reasons. First, this was a very specific group of molecules, which are not the ones and only ones that you would pull off the shelf to treat cells to stimulate mRNA synthesis generally. It is also not something Kubin would have done routinely (we've already agreed, I hope, that the art didn't teach the skilled worker that it was necessary). Since research scientists don't do things for the fun of it, the inclusion of this treatment in the Example indicates to me that it was necessary for them to obtain the NAIL cDNA.

Second, I don't know how many applications you've seen that recite in the specification a litany of what doesn't work, but besides being outside the statutory requirements (you don't have to teach someone how to disable the invention) it is a waste of time and raises all sorts of issues - if you include some things that don't work, how do you draw the line of what not to include?

So our basic difference is that you think Kubin was under an obligation to recite expressly that the cytokine mixture treatment was necessary, and I don't think so. Kubin provided an enabling disclosure by including the treatment in the example, and consistently argued that this treatment was not in the prior art. They may not have said it in a way that you understand, but you are not the standard - the person of ordinary skill is. One of the problems I have with the decision is that it seems the CAFC thinks they are in a position to make the determination of what facts to consider and that facts to ignore. Why don't you put the question to one of your colleagues in Group 1600 and see if what I am saying makes sense (I don't require that they agree with me, just that they can see the basis for my argument)?

I understand that you don't understand, and part of this dialog is to use it to "get to the point" - in this case, whether the treatment was necessary. I think we've gotten there.

Thanks for the discussion.

[6]

"I think the treatment was necessary, for two reasons. First, this was a very specific group of molecules, which are not the ones and only ones that you would pull off the shelf to treat cells to stimulate mRNA synthesis generally. It is also not something Kubin would have done routinely (we've already agreed, I hope, that the art didn't teach the skilled worker that it was necessary). Since research scientists don't do things for the fun of it, the inclusion of this treatment in the Example indicates to me that it was necessary for them to obtain the NAIL cDNA."

Well that's a beautiful indication, but it isn't a fact, and it doesn't tell me why it was so important. If this were a real case, then I would tell you to go ask the applicant why it was so important and then we could proceed. Or not proceed if it turns out he was drunk in the lab one day and used that to impress his girl co-worker with his Leet skillzors.

"Second, I don't know how many applications you've seen that recite in the specification a litany of what doesn't work, but besides being outside the statutory requirements (you don't have to teach someone how to disable the invention) it is a waste of time and raises all sorts of issues - if you include some things that don't work, how do you draw the line of what not to include?"

Generally speaking I don't require them to put it in the spec, I require them to make their case to my satisfaction. My satisfaction usually involves them explaning the situation to me. Invariably every time they've tried, they've failed. Because they either 1. didn't have a good reason to do what they did, 2. don't have facts to back up what they say (though I'm pretty lenient on this one) or 3. don't want to tell me about it (they don't want to disclose it) sometimes 4. the attorney can't even talk to the inventor (lol bigcorp). Fine with me, keep your secrets, but you won't get a patent.

"One of the problems I have with the decision is that it seems the CAFC thinks they are in a position to make the determination of what facts to consider and that facts to ignore."

I think in the end the only problem you actually have with the case is that you weren't the lawyer and their lawyer failed to make their case. Miserably. I told you already Kubin should have gotten a gruff man instead of that girly girl. You're gruff right?

I'll look over your technical post later on, but it is going to take awhile for me to brush up on prot n accel n blah blah from bio (probably upper lvl bio I never had lol).

[Kevin E. Noonan]

Dear 6:

Well, we can't redo the prosecution, so I guess we're stuck with where we are now.

There's actually another point I didn't make (I may do another post on it tonight): if the NAIL cDNA was obvious because the art provided routine methods for making the cDNA and motivation in the form of the Valiante reference, is the next PTO assertion going to be that antibodies are obvious over the combination of an antigen (say, influenza) + routine methods of making them? The (il)logic of the Kubin decision if taken to its logical conclusion is stunning.

Let me know if you need help brushing up on that bio. Thanks for the continuing discussion.

[Tamsen Valoir, PhD]

Re: "What do you not understand about repeating example 12 ad infinitum until you have literally a hundred tons of NAIL?"

It's not relevant how many tons of NAIL there is, what matters is the percentage of NAIL in the population. If there is only 1 in 10^24 molucules that correspond to NAIL sequence, you'll have to screen and screen and screen and screen... until you find it. It's simply not practical, and enrichment or otherwise increasing the percentage of NAIL mRNA is very important to success.