Obvious to Try? BIO Challenges Ex Parte Kubin

In re Kubin (Fed. Cir. 2008)

Immunex (a subsidiary of Amgen) is hoping to patent its a DNA sequence coding for a NK (Natural Killer) cell regulator protein. The BPAI rejected the “nucleic acid molecule” claim — finding it obvious over the prior art. [BPAI Decision]. This decision is one of only three precedential BPAI decisions in 2007.

Just looking at the claimed sequence, it would not seem obvious — its structure is not overly similar to other regulator proteins, and the unpredictable nature of protein folding makes it virtually impossible to predict whether a particular sequence would code for an appropriate protein.

Despite the structural uniqueness, the BPAI found the claim obvious because it could have been isolated and verified simply by following conventional laboratory techniques — thus, making it obvious to try.

Although the CAFC has previously warned the BPAI away from using “obvious to try” analysis in its 1995 In re Deuel case. There, the appellate court held that obviousness analysis of a structure should focus on the structure itself as compared to prior art structures.

In Kubin, the BPAI rejected Deuel as limited by the Supreme Court’s KSR decision. That case focused on combination claims, but included the stray quote that “the fact that a combination was obvious to try might show that it was obvious under Section 103.”

Here, the BPAI argued, the inventor wanted to isolate the NK Regulator and simply used known methods to do so. “Thus, isolating NAIL cDNA was ‘the product not of innovation but of ordinary skill and common sense.’” (again quoting KSR).

The case is now on appeal at the the CAFC. On June 10, the Biotechnology Industry Organization filed an amicus brief asking the court to cabin in the scope of KSR and hold that its obvious to try dicta does not abrogate the Deuel standard. Briefing is ongoing and a decision is not expected until the end of the year.

  • Download kubin.amicus.pdf
  • The PTO’s Obviousness Guidelines have the following rules for making an obviousness rejection based on the obvious to try reasoning:
    • (1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem;
    • (2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;
    • (3) a finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success; and
    • (4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.The BPAI decision is notable for a few reasons, including the following two: (1) It was written by Nancy Linck, former PTO Solicitor, Newman law clerk, & PhD Chemist. Soon after authoring the decision, Linck left the firm to join the Rothwell Figg firm. (2) It is a unanimous opinion.
  • Thanks to Hal Wegner for providing a copy of the brief which his firm filed on behalf of BIO.
  • 71 thoughts on “Obvious to Try? BIO Challenges Ex Parte Kubin

    1. 71

      Thanks 3(d),

      I did in fact miss PLS’s posts, and I think we agree on more than we disagree (e.g., full use of the Law).

      I do think you seem too caught up in the invention/discovery semantics and thereby (I’m sure you don’t mean to) actaully lend credence to the notion that a significant difference exists solely between the two words as far as patentability goes. For me, the Law will sort it out. The Law does include discoveries as well as invention. I agree with you that obviousness must be overcome for what is claimed for the patent. There is room for discussion on non-obvious items being generated by an obvious process – I don’t have issues with that per se (i.e., the obvious “making” process is not what is being claimed).

      Your concern about scientists (rather non-scientists) and semantics was off-base. I would posit that semantics would actually affect scientists more than lawyers in the world of intellectual property, and thus the scope of the law, if left in scientists hands, would be in greater danger of being misapplied.

      I’m curious what you consider just what are the proper bounds of patent law.

    2. 69

      “crediting them for their isolation/purification of the substance” is indeed a far cry different than mere wandering around. While you may disagree with this isolation/purification-as-worthy-of-patent concept, it is bedrock law (after all, isn’t purifaction/isolation a form of “making”?).

      We seem to be in violent agreement. It is, indeed, a form of making. But it may be an obvious one, of PHOSITA could purify/isolate and expect similar results. Patent Law Student seemed to be pushing us away from this, which is what I was responding to.

      He/she/it said: “The fact that ordinary people of skill are apt enough to arrive at such discoveries should not negate patentability.” I disagree, I think that is exactly enough to negate patentability. That is the essence of obviousness. Like it or not.

      He/she/it went on to say: “KSR dealt with ‘inventions.’ In re Deuel dealt with ‘discoveries.’” This distinction is one I take issue with. Go back and read the comment — if we were to take it to its natural end, the 103 nonobviousness analysis would be rendered as irrelevant as the enabling analysis usually is.

      You are correct that the manner of “making” is not biased against… *Unless* PHOSITAs are using the same method and coming to the same conclusion. Or even doing so in their heads. That’s my understanding.

      Thanks for the discussion!

    3. 68

      “Discoveries are only patentable if they involve human intervention.”

      Your parsing of “invention” and “discovery” relies on your assumptions. One man’s invention may be another’s discovery. For the examples you provide (dustbunnies and snowflakes), other sections of the Statute and case law handle (e.g., laws of nature). Evidently we agree that the entire law is important.

      As you concede, “Discoveries are only patentable if they involve human intervention.” I concur and posit that all discoveries by their inherent nature MUST require human intervention (it is a human doing the discovering, or in the case of automated discovery, a human that progammed the purpose of discovery or set the terms of the automated search). I would further posit that mere human intervention MAY NOT be enough for a patent – the rest of the rules must be passed (and this applies to both discoveries and inventions). However, such as it is, a discovery does indeed (and should) merit review under the whole patent law. Dustbunnies and snowflakes will be denied patents under the appropriate sections.

      “crediting them for their isolation/purification of the substance” is indeed a far cry different than mere wandering around. While you may disagree with this isolation/purification-as-worthy-of-patent concept, it is bedrock law (after all, isn’t purifaction/isolation a form of “making”?).

      “I am concerned that the people making the distinctions are not scientists. The distinction between discovery and invention seems like a brilliant use of semantics that could expand patent law beyond its proper bounds.”

      Perhaps you mean “its proper bounds as I understand them to be”. I am merely indicating that the patent law (in its wholeness) trumps the semantics you are concerned about. Throw both discovery and invention (as you semantically understand those terms) into the law and the whole law will do what is right.

    4. 67

      Hi breadcrumbs. Please read the statute again:

      “Patentability shall not be negatived by the manner in which the *invention* was *made.*”

      There are two assumptions inherent to that language, that I was merely reflecting with my example. There needs to be a made invention. Discoveries are only patentable if they involve human intervention. This seems like a pretty safe assumption, seeing that it is reflected all over legal scholarship.

      The intent behind the statute in its entirety, which is drafted to reflect the intent of the drafters of the Constitution, would not be served by permitting patents on things I just found, like this dustbunny under my couch. Even if it is a completely nonobvious dustbunny. Or patenting each lovely nonobvious snowflake that falls on my arm. Even if humans have no way to calculate the myriad formations they can take.

      This seems to come back to the problem I was discussing before with not reading the whole statute — there are significant policy ramifications if we narrowly read line by line and don’t ever go back to “check our work” against the statute as a whole. Meaning: defining this as an obviousness problem, and therefore not looking at whether it meets the other basic criteria for patentability.

      My comment, in context, was critiquing PLS’s distinction between discovery and invention, because I do not understand the reasoning that we should somehow give discoverers *more* leeway than inventors, that somehow the realm of existing biological organisms and combinations/adaptations thereof is more vast than the human imagination as applied to chemistry, mathematics, and physics. It seems ridiculous to me, based on my experience in the lab as a researcher/technician (in genetic and protein research, at two major teaching hospitals), and as a computer coder who has worked with massive databases and interactive systems (which are notoriously unpredictable, due to human incapacity to manage and adapt such systems without error, as we tweak and add on and cut away – we have no actual idea how it will work!).

      I am concerned that the people making the distinctions are not scientists. The distinction between discovery and invention seems like a brilliant use of semantics that could expand patent law beyond its proper bounds.

      I hope this was more clear.

    5. 66

      “Patent law is specifically not supposed to credit someone for their work wandering around to find something.”

      Compare to this part of the Statute at 35 USC 103(a):
      “Patentability shall not be negatived by the manner in which the invention was made.”

      Assumption check time.

    6. 65

      I know I’m late on this (new ’round these parts), but isn’t the question really “W.W.PHOSITA.D.?” not whether the claimed invention is “among a finite number of… solutions… IDENTIFIED IN THE FREAKIN’ PRIOR ART”?

      Combinations that are not documented in the prior art, but are obvious to PHOSITA *based on* those ID’ed in the prior art, apply, no?

      Sorry to stir up the s**tstorm, all these months later…

      Further, PLS, why are we giving special treatment to discoverers instead of inventors? The only reason discoverers get anything outta patent law is that the law basically pretends they are inventors, crediting them for their isolation/purification of the substance. Patent law is specifically not supposed to credit someone for their work wandering around to find something. That is meant to be left to the public domain, so we can all wander around and find things, when those things are on public property. Using the property metaphor, something like a nucleotide sequence is in the public domain (I can look at my blood, given the right tool), and so the work being credited, the nonobvious work, is my making that into a useful product.

      “Einstein could not patent his celebrated law that E=mc2 ; nor could Newton have patented the law of gravity. Such discoveries are manifestation of nature, free to all men and reserved exclusively to none…. …[R]espondent’s micro-organism plainly qualifies as patentable subject matter. His discovery is not nature’s handicraft, but his own.” (Diamond v. Chakrabarty, 447 U.S. 303 (1980))

      So what he is discovering is his own work. It’s kinda deep.

      Finally, on this thread, I am noticing that people on this board are so eager to break apart 102 and various parts of 103, but they exist together for a reason. For example, utility is part of a nonobviousness analysis – it comes in as we analyze for secondary factors (as part of motivation – a market for the product – remember, it’s all about money, here, really). It seems to me that compartmentalizing the separate sections of the statute and not doing the complete analysis leads us down strange roads.

      Anyway, hi. I expect to be flamed, so have fun.

    7. 62

      I think the KSR decision stands for “obvious to combine” not “obvious to try.”

    8. 60

      Mooney thinks everything is obvious because he can personally “fold proteins” and write lengthy, edgy treatises about it. He is the Truman Capote of patent law.

    9. 59

      You’re a little quick on the trigger Monkey, er, I mean Mooney. Unlike you, with your nauseatingly endless, glib, yet authoritatively delivered drivel on signals, I rarely try to go outside my area.

      In fact I was actually impressed that you could do all of that “protein folding” with one hand while you type away, there in the dark.

      As for your dissembling on my accurate quote of your take on KSR, you have only solidified my observation. There was no talk of “hapazard” application of TSM, strict or otherwise. The problem was not haphazard application, but systematic, predictable (regular) application of the strict TSM test.

      Maybe somewhere in that protein mess you can find a clue.

    10. 58

      Let’s put it this way. Let’s say I find a protein that hasn’t been sequenced. I publish a paper and say “Here’s this protein. Contact me and I’ll send you a bunch of it, plus a monoclonal antibody, and a cDNA library derived from the cells expressing the protein. I have no intention of sequencing the protein or determining the coding sequence for the protein but here’s how I would do it, step a, step b, step c.”

      26 people (Ms. A through Mr. Z) write to me and I send them the materials. They each follow the steps I indicated. Mr. T is the first to sequence and he files an application on the isolated cDNA and amino acid sequence of the protein. Within two weeks of Mr. T’s filing, 22 of the other people obtained the same sequences.

      Question 1: Should Mr. T get a patent on the specific sequences? Why?

      Question 2: Should Mr. T get a patent on all functional homologues of those sequences with 80% identity to the “discovered” sequences? Why?

      Good luck.

    11. 57

      Babel Boy wrote

      “Wrong again. The fact that PA teaches how to make an invention does not necessarily make the invention obvious, unless that invention is the only thing that can be made by the PA process, in which case it’s likely a 102 anticipation issue because the product has already been made. In the present case the PA process was a textbook describing a process that is used to make any number of DNA sequences.”

      BB, the process is only half the story. If the process is well known AND the product that comes out is entirely predictable, then it is obvious. If the nature of what comes out has to be studied and observed or is otherwise unobvious, then the product would be nonobvious, regardless of how well-known the process was.

    12. 56

      “Either way, please rewrite this so the technology and the issues make sense.”

      Don’t be lazy, herg. That’s what comments are for. I already addressed some of the issues upthread.

      What’s interesting about the first paragraph you quoted is that it reiterates the reasoning behind the Board’s devastating 112 rejection. The claims at issue do not cover an isolated nucleotide “sequence” but rather (hundreds of?) millions of sequences encoding proteins whose structures and activities are unknown. Kubin tries desperately to avoid the problem by inserting functional language but it is then forced to argue that the same highly skilled artisans that find the claim non-obvious would be easily able to identify which of the millions of sequences are the ones that Kubin actually “invented.”

      It’s a python squeeze. The Board has a guaranteed win in terms of squashing the claims. All that’s left to fight over is the impact of its dicta on future cases. One could read Kubin to stand for the proposition that, in the case of a claim to a nucleotide sequence, if a single prior art reference discloses the protein and the method and desirability of obtaining its natural cDNA, then that cDNA sequence is obvious ***UNLESS*** there is some evidence that, following the prior art publication, skilled artisans were confounded and met with unexpected difficulties, i.e., it was not amenable to sequencing by conventional methods.

      I’m not sure why the biotechnology field couldn’t live with that. On the flip side, one wonders where all the biotech handwringers were when the CAFC held that merely possessing an *unsequenced plasmid* put one “in possession” of the nucleotide sequence (In re Crish, 393 F.3d 1253, 1258 (Fed. Cir. 2004)). That was the writing on the wall for folks like Kubin because it was an acknowledgement that the field — like all fields — had continued to progress. Sequencing a cDNA is like breathing air for molecular biologists. Sequencing a protein is like breathing air on top of a short mountain. Have you ever gone skiing?

    13. 55

      “Just looking at the claimed sequence, it would not seem obvious — its structure is not overly similar to other regulator proteins, and the unpredictable nature of protein folding makes it virtually impossible to predict whether a particular sequence would code for an appropriate protein.

      Despite the structural uniqueness, the BPAI found the claim obvious because it could have been isolated and verified simply by following conventional laboratory techniques — thus, making it obvious to try.”

      WHAT??? Dennis, I know you have some molecular bio people at MBHB. Why oh why do you not have them help you here? If the firm had hired me I would have helped… Either way, please rewrite this so the technology and the issues make sense. It is quite a big blemish on your usually top-notch blog.

    14. 54

      I take it that neither Cave nor PLS has a credible rebuttal to Mooney’s post. Still, I must commend you all for actually addressing the points like reasonable adults instead of engaging in worthless mudslinging.

      Oh wait.

    15. 53

      Does this Malcolm Looney character ever do some billing?

      It’s probably another of Looney’s theories: Less attorney work = less filings = less patents.

      After all, according to Looney, any patentability test is workable, as long as it ultimately results in fewer patents. Looney, I guess, thought up his own neat little way of helping bring about that goal.

      Dudas extends his personal thanks.

      Malcolm Looney is a real hero.

    16. 52

      CaveMan: “did I hear Mooney say that TSM was being “haphazardly” applied? …one of the main points the Supreme Court made in KSR was that the TSM was being applied too rigidly, meaning it was applied fairly regularly.”

      I can always count on CaveMan for the sloppy quotemine, followed by the halfaxxed “analysis”.

      What I actually wrote was “In part (but not solely) because of the haphazard way the “strict TSM” test was applied in the past, there was no more “predictability” in the patent universe as a whole before KSR compared to its wake. The major difference, as you noted, is that it is now less likely that a filed claim will issue.”

      You also got the take-home message wrong, Cavey. The “strict TSM” test need not have been “regularly” applied in its most rigid fashion to garner the Supreme’s attention. One clear-cut case of strict TSM overboard was enough to provide grounds for an appeal.

      By the way, if I were to engage in one of your typical rhetorical slimefests, I might mention that you have zero expertise in the technological area relating to Kubin so you should simply shove off. But I’m not going to do that.

    17. 51

      “The point is that if you give me a 38 kD protein and an antibody there is ZERO uncertainty that I’ll be able to hand you ONE coding sequence in a very short time with very little effort. Hell, I don’t even need the antibody to come with a sequence of the breadth of those encompassed by Kubin’s claims.”

      Its amazing that Mooney can do all that and type with the other hand, AND all with the lights off.

    18. 49

      I’m sorry, did I hear Mooney say that TSM was being “haphazardly” applied? What a load of “gobbledygook” One of the main points the Supreme Court made in KSR was that the TSM was being applied too rigidly, meaning it was applied fairly regularly.

      Man, I go away for a little while and Mooney is dirtying up the sandbox – again.

    19. 48

      Moving right along to Babel Boy’s commment I’ll note first that it unfortunately lacks any attempt at a response to my comments of June 13.

      “The KSR standard to obviousness is not whether there are a finite number of solutions, it’s whether the claimed invention is among a finite number of IDENTIFIED solutions. That is — IDENTIFIED IN THE FREAKIN’ PRIOR ART. Not in some examiner’s mind.”

      I respectfully submit that this is a (bizarre) distinction without a difference and that Babel Boy’s “expertise” lies elsewhere. As every skilled molecular biologist knows (or more accurately, as a great deal of high school graduates know) and as both the author of the Board’s opinion and Kubin certainly know, the genetic code is a redundant code wherein 64 nucleotide triplets (all triplet combinations of A, T, G and C) are translated into (roughly) 20 amino acids. The basic code is ancient scientific history. What this means is if you tell me that a protein has an asparagine at position 100, I can assure you that the nucleotide triplet at the corresponding position in the coding DNA (i.e., cDNA) is either AAT or AAC. NOTE: I can be *certain* that the first two nucleotides are AA.

      What this means is that if you provide me a protein sequence — such as the 200 amino acid p38/NAIL protein — I can immediately provide you with all possible coding sequences. Moreover, it is well known prior to Kubin’s filing date that certain codons are more likely to be used in humans versus say bacteria, so I can truncate the list of possibilities further.

      In other words, with a short (e.g., 200 amino acid) protein sequence in hand, I can immediately conceive of many thousands of isolated cDNAs that are *at least* 60% identical to the natural coding sequence. Synthesing them is trivial.

      Now look again at Kubin’s claim to understand how ridiculous it is (and yes the claim is garbage mainly due to written description issues but the obviousness problem is very real). Kubin does *not* claim “a nucleotide sequence with 80% identity to a nucleotide sequence encoding SEQ ID2.” Rather, Kubin claims a nucleotide sequence CODING FOR a protein that is 80% identical to that in SEQ ID2. Given the redundancy in the genetic code, Kubin’s claim literally captures nucleotide sequences that have as little as 50% identity (66% x 80%) to the nucleotide sequence they actually discovered! A patent of that breadth should appall any educated person. (does anybody know why Matthews sequencing of the homologous mouse cDNA wouldn’t preclude patentability as a prior invention under 102(g)?)

      Kubin’s only hook to non-obviousness is that the amino acid sequence of their protein was not known, but the protein itself had been identified as a 38 kD protein of interest. Moreover, the same prior art (“Valiente”) disclosed an antibody against the protein ***in addition to the method of isolating the nucleotide sequence from a cDNA libary using the antibody***. As set forth in the Board’s findings of fact, Kubin “isolated from [a] cDNA library . . . using the commercial monoclonal antibody C1.7 . . . disclosed by Valiante.”

      Now, I will grant you that the specific amino acid sequence of the protein of interest (i.e., p38) was not known nor could it have been predicted based on the published art. But that specific sequence was NOT claimed (at least, not in the claims at issue here). As dicussed above, what was claimed was

      “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.”

      And we can translate this as follows: “An isolated nucleic acid molecule comprising a polynucleotide encoding a polypeptide at least 50% identical to amino acids 22-221 of SEQ ID NO:2, wherein the polypeptide binds CD48.”

      One skilled in the art can tell you that because there are only 4 nucleotides, a nucleotide sequence with 50% identity over 200 nucleotides to a sequence of interest does not impress. And that is where KSR comes in. Kubin’s claim includes sequences that bear no useful relation to the natural coding sequence of p38. Given that Kubin did little more than follow the teaching in the prior art, what is “non-obvious” about their claimed invention”? The motivation to find *the exact sequence* of p38 was present in the prior art, as were the conventional methods of finding that **exact** sequence. One needn’t even be “highly skilled” to reasonably expect success at finding the **exact** sequence because the claim allows for half of the cDNA sequences to to have been incorrectly identified.

      BIO and other chicken littles are wasting their time. In 1990 Deuel was arguably the most useful legal precedent for pushing the biotech boom and contributing to the bubble economy. But it also contributed to the patent bubble and Kubin’s claims are quintessential examples of the madness. Granting claims like Kubin’s doesn’t help biotechnology as a field of endeavor, nor does it benefit the public. It just helps Kubin and Kubin’s employer and Kubin’s attorneys and other attorneys who make money by catering the greediness of others.

      Deuel has been knee-capped and, frankly, it’s about time. Obtaining the coding sequence of an identified protein where an antibody to the protein is disclosed as well as a method itself is simply too trivial a procedure to allow the first party to the finish line a 20 year monopoly on the sequence, simply because “the sequence” is “unpredictable.” The point is that if you give me a 38 kD protein and an antibody there is ZERO uncertainty that I’ll be able to hand you ONE coding sequence in a very short time with very little effort. Hell, I don’t even need the antibody to come with a sequence of the breadth of those encompassed by Kubin’s claims.

    20. 47

      In response to Lior’s question, let’s get back to the claim at issue here:

      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.

      The simplest answer to your question is that the claimed nucleic acid molecule is “isolated”. This is why certain DNA molecules are patentable over the sequences found in chromosomes in nature.

    21. 46

      “Mooney” said:

      “That would be “nucleotide structureS”, Babel Boy. Plural. The claim encompasses vast numbers of sequences, not a single non-obvious sequence.”

      Right you are, “Mooney.” With from 1 – 3 possible codons for each amino acid, the number of possible combinations are pretty huge. What does the number of species have to do with obviousness?

      Go back and read KSR. The phrase is “a finite number of identified, predictable solutions . . .” It doesn’t say “identifiable” it says “identified.” Past tense, as in done. And it doesn’t say “identified OR predictable.” If Kubin’s vast number of molecules all fall within what has been identified, KSR applies.

      How many of Kubin’s combinations of nucleotides have been previously identified? Probably 3 or so. The rest do not fall under KSR obviousness.

      The Board is pushing the point that if only one species has been identified, all species in the genus are obvious because they are all made in the same manner. And I’m saying I don’t think so. Doesn’t matter how they are made because the invention is not negatived by the manner in which it is made.

      e6k
      I have a couple of responses, all in the form of queries. 1. What are you talking about? 2. What is AI? 3. Don’t you see what you’ve done? The problem you started with was how to produce a trilaminar composite material — which was really ill-defined because you apparently don’t even know what the three layers are made of: “perhaps another ceramic.” Are you saying there is only one solution to making tri-laminar composite materials?

      No, of course not — you shift the problem, and your view, to a narrower problem: how to get the third layer to adhere. And, apparently, you are arguing that there is only one solution to this problem. As long as you live in the box, you are probably right. The “box” being the PTO.

      And then, to avoid being labeled dull, you appear to take the contrary position — my position — that no problem has just one solution and that you can think of many:

      “I could give you a million outlandish solutions that could possibly result in the desired outcome. If any of those million actually work then we’re talking patentable subject matter. Bottom line is, without resorting to magic there are finite ways of approaching certain tech problems.”

      Please read my response to “Mooney” above. The KSR standard to obviousness is not whether there are a finite number of solutions, it’s whether the claimed invention is among a finite number of IDENTIFIED solutions. That is — IDENTIFIED IN THE FREAKIN’ PRIOR ART. Not in some examiner’s mind.

      Lior
      No, what is at issue is not a claim for a process of making the DNA molecule. It is to the structure of (as “Mooney” points out) a large group of DNA molecules that would all code the same (known) protein.

      But your point is interesting. One can take the DNA to amino acid translation table and apply it backwards to get each one of the claimed DNA sequences. Which is exactly what Kubin has done. That is not quite the same as claiming a physical konstant like you suggest, but it’s getting close.

      I think your way of looking at it is much, much closer to the law than what the pumpkin heads on the Board are doing. They are saying that the textbook, physical steps to be performed to synthesize the molecules make the all of the structures of the molecules obvious.

    22. 45

      Could someone help a non-lawyer and explain why this is not a patent for a fact of nature? Obviousness shouldn’t be the issue here — it’s the patenting of a protein that is “80% similar to the sequenced one”. Can a physicist patent a constant of nature (say, the speed of light)? Perhaps I’m confused, and the patent is for a new method for making proteins, or for an entirely new protein that does not occur is nature (at least, for a purposeful modification of the natural protein)?

    23. 44

      Oh, and babel, don’t try and pin me as being unimaginative, I’m the sort of flighty person who does consider creating a whole new deposition process. Maybe my deposition process for the second ceramic involves causing the ceramic to form as a reaction product between two other materials and the Al resulting in perhaps a ceramic of imperfect purity. I could give you a million outlandish solutions that could possibly result in the desired outcome. If any of those million actually work then we’re talking patentable subject matter. Bottom line is, without resorting to magic there are finite ways of approaching certain tech problems.

      I mean sht, I could put the Al on the first ceramic, put a unicorn in the room and the top ceramic might form.

    24. 43

      Yes babel I will give you an example of a tech problem with only one even remotely possible solution. The solution also happens to be predictable.

      Let’s assume you’d like to make a composite material. Three layers. A ceramic, a metal, and perhaps another ceramic. Now, besides the fact that you might have adhesion problems putting a certain metal on a certain ceramic or vice versa let’s assume you are able to get Al on the first ceramic with sufficient adhesion. Now let’s say you performed that process at a certain temperature. 300C. Let’s then say that you proceed to the problem of getting your top ceramic layer on the Al. This particular ceramic can be applied in two different manners, both well known in the art. One allows you to do the process at 400C min and the other allows you to do it at 800C min. Now, it just so happens that when you apply the 800C process the adhesion between the Al and the first ceramic goes out the window and the Al comes right off. Then, when you try the process that allows you to deposit at 400C the Al/first ceramic adhesion is not ruined. Bingo. A technical problem (deposition of second ceramic) with a finite number of solutions (two deposition methods are all that are currently technologically conceivable) and another technical problem (how to deposit second ceramic without the first two layers coming apart) with only one solution.

      Now, you can possibly assert that you’re the greatest inventor of all time and have discovered a completely new way to deposit the second ceramic that operates at room temp. In that case, you my friend get a patent. Also in that case I would recommend patenting the deposition method rather than merely the deposition of the certain materials (or do both). All your buddies that stuck with “hur, let’s use the standard bs to solve a technical problem with 2 known solutions that has only one realist solution to anyone who is familiar with the adhesion properties of Al on the first ceramic” do not get a patent.

      This is but one of MANY, MANY MANY MANY MANY MANYxinf problems with only “one solution”.

    25. 42

      “The only issue is whether Kubin’s polynucleotide structure is obvious given the known structure of the protein.”

      That would be “nucleotide structureS”, Babel Boy. Plural. The claim encompasses vast numbers of sequences, not a single non-obvious sequence. If Kubin had claimed a single defined sequence, we would probably not be having this discussion.

    26. 41

      What does “cabin in” mean? I have a cabin but I have never heard that expression. Google it and you get “Cabin in the sky”, a 1940s musical. How would one “cabin in” a Kubin or the scope of KSR?

    27. 40

      What does “cabin in” mean? I have a cabin but I have never heard that expression. Google it and you get “Cabin in the sky”, a 1940s musical. How would one “cabin in” a Kubin or the scope of KSR?

    28. 39

      1600exam said:

      “112/1 = make and use
      To render a claim obvious, the prior art must teach one of ordinary skill in the art how to make and use the obvious invention (and of course need motivation to combine and reasonable expectation of success).”

      Let’s stay with the program, guys. We’re not talking 112/1 here. 112/1 sets minimal criteria for the spec. Obviousness goes to the claims. Try to keep this straight. Have a look at 103, which is what we’re discussing, and then get back to us on this.

      112 and the manner of making has nothing to do with the obviousness of Kubin’s claim 73. The claim is to a structure — a DNA structure. Any examiner who can’t grasp the distinction between structure and process should go out and get a job where they won’t be harming a lot of innocent inventors.

      1600examiner said:

      “The prior art taught how to make the invention and how to use it and motivation and expectation of succes [sic], thus the prior art was enabling to make and use the invention.”

      Wrong again. The fact that PA teaches how to make an invention does not necessarily make the invention obvious, unless that invention is the only thing that can be made by the PA process, in which case it’s likely a 102 anticipation issue because the product has already been made. In the present case the PA process was a textbook describing a process that is used to make any number of DNA sequences.

      1600exam said:

      “If applicant had to carry out any “inventive” steps in the isolation that were not obvious in view of the art this could potentially KO the 103.”

      Wrong again. The only possible relevance of this case to anyone’s inventive steps would be if a process or a product by process were claimed. Kubin’s claim was to protein structure itself. The process of making the structure was irrelevant regardless of how inventive.

      Here’s how the pumpkins on the Board framed the question — as a total non sequitor:

      “We frame the § 103(a) issue: Would Appellants’ claimed nucleotide sequence have been obvious to one of ordinary skill in the art, based on Valiante’s disclosure of p38 [OK up to here] and his express teachings how to isolate its cDNA by conventional techniques?” [totally irrelevant]

      The only issue is whether Kubin’s polynucleotide structure is obvious given the known structure of the protein. Whether the synthesis steps are known is a red herring.

      Unfortunately, Kubin will probably go down on appeal because the DNA sequence was likely obvious given the known amino acid sequence (unless there is something unexpected in Kubin’s particular sequence). So the CAFC won’t pick out all of the logic-maggots and non sequitors embedded in this decision — like the following gem:

      “A single, obvious species within a claimed genus renders the claimed genus unpatentable under § 103. [Here it comes . . .] Thus, an obvious method of obtaining a single nucleic acid molecule encoding NAIL may be all that is required to show that the presently claimed genus of nucleic acid molecules is unpatentable under § 103.”

      Dumb, dumb, dumb . . .

    29. 38

      “Looney Mooney”

      Wow, it can rhyme, too! Maybe next we’ll see some alliteration or maybe even a metaphor.

      “Narcissistic Personality Disorder”

      Trolls and their attempts at armchair psychology never cease to amuse. You should join up with one of the other name-callers around here, PLS. What you need to do is find someone who is modestly clever to complement your awesome writing and legal skills (not to mention your psychoanalytical powers). Then, when you two touch your activation rings, everyone will be at your mercy.

    30. 37

      Looney Mooney: Please check this post every five minutes for the next four hours. You will be rewarded with a one sentence response to your previous post.

      BTW, how about using a dictionary to look up the term Narcissistic Personality Disorder?

    31. 35

      Mr. Mooney writes: “the “predictability” aspect of an obviousness determiation does not relate to the motivation to combine but to the reasonable expectation of success. KSR did not obviate that requirement but merely noted in dicta that in cases where success is virtually guaranteed and the motivation to make the claimed invention is plain to everyone and his mother, then it is not a violation of the law to find that claimed invention obvious.”

      No question, the guy is a pure mess – all confused. With this latest pure-nonsense post of his, he has finally proven that reading his posts is a pure waste of time.

    32. 34

      Thank you anon1600exam for your straightforward analysis.

      When we focus on the claims (where we should be focusing) we seem to reach different conclusions than the cheerleaders for this particular patent. Perhaps you can visit PatentDocs and offer your insights over there where comments are few, but always appreciated.

    33. 33

      112/1 = make and use
      To render a claim obvious, the prior art must teach one of ordinary skill in the art how to make and use the obvious invention (and of course need motivation to combine and reasonable expectation of success).

      The prior art taught how to make the invention and how to use it and motivation and expectation of succes, thus the prior art was enabling to make and use the invention.

      Therefore the prior art renders the claimed invention obvious.

      If applicant had to carry out any “inventive” steps in the isolation that were not obvious in view of the art this could potentially KO the 103. This type of evidence could be established in a 1.132 and would naturally require a demonstraton that following the prior art teachings without this added insight would not yield the claimed sequence.

      Alternatively, had Kubin made a single change anywhere but the termini of the protein and demonstrated the mutant still had 101 utility then claimed the mutant protein and 80% + function I think they would only have the wd rejection to deal with. (or for that matter had they done a substantive mutant/fuction analysis they could have potentially established possession of the broad genus).

      However, to have done this latter sort of thing would not have been because applicant thought this is just too obvious so we need a backup plan but rather now that we have the natural sequence lets start to see what makes this tick and we’ll just throw all that into our application.

    34. 32

      “Whether or not the process of making the invention is obvious has nothing to do with whether the invention is obvious.”

      Huh. So when I’m evaluating whether one of skill had a reasonable expectation of making the invention successfully, I can’t look at how one of skill would have made the invention?

      I don’t think so.

      “But to make or uphold an obviousness rejection against a machine or manufacture or even a protein, totally on the grounds that manner of making the claimed invention was obvious”

      That’s never happened so I wonder why you appear so excited.

    35. 31

      Lionel, here is how I argue with it: I read the statute.

      “Patentability shall not be negatived by the manner in which the invention was made.”

      It don’t get any clearer than that, unless you’re like me and have to pause on “negatived.” Whether or not the process of making the invention is obvious has nothing to do with whether the invention is obvious.

      The issue is not how obvious the process of making the invention is. The issue is how obvious the invention is once it’s made. Who cares how obvious it is to make — UNLESS the claim is to the way of making it, in which case we are in agreement. But to make or uphold an obviousness rejection against a machine or manufacture or even a protein, totally on the grounds that manner of making the claimed invention was obvious is contrary to the clear language of the law. How can reject a manufacture on the basis that a process is obvious? Unless there is a methods claim, the manner of making anything’s got nothin’ to do with nothin’.

      ptomonger

      I take your point that you were speaking from the point of view of the PHOSITA-head. Let me amend my kevetch, see upper case.

      Whether or not the invention has any benefit, or whether the inventor OR THE EXAMINER OR PHOSITA OR GOD can perceive any benefit, is relevant to the question of utility. Only. And the inventor’s AND PHOSITA’S AND GOD’S perception of utility ARE not even relevant to the 101 determination. (At least I do not believe utility is judged on the basis of PHOSITA. Please correct me if I’m wrong on that.)

      [Actually, I’m beginning to realize more and more that PHOSITA is God. I think it’s one of those trinity things: examiner = PHOSITA = God. Pass the plate, brother.]

      Amen.

    36. 30

      Babel Boy,

      If the process of making a claimed invention is obvious to try and the results of that process are predictable, then the invention is obvious. I do not see how you could argue with that.

    37. 29

      ptomonger, I agree with the gist of your comment but I take issue with this:

      “Toss the TSM standard out as the Supreme Court has done and we wind up with unpredictability.”

      In part (but not solely) because of the haphazard way the “strict TSM” test was applied in the past, there was no more “predictability” in the patent universe as a whole before KSR compared to its wake. The major difference, as you noted, is that it is now less likely that a filed claim will issue.

      And THAT fact is why certain people are whining. Take a baby’s bottle away and you can observe the same phenomenon.

    38. 28

      “Mr. Mooney, not surprisingly, misses the point once again.”

      You mean like the previous time I “missed the point” and showed everyone that your understanding of the doctrine of construing claims to preserve their validity was based on 1972 case law? LOL.

      “Obvious to try/discover/experiment does not equate predictability or likelihood-of-trying.”

      Likihood-of-trying? That’s the lamest strawman I’ve heard in quite some time. Is that a phrase you made up all by your wittle self? The thing is, Patent Law Trooll, when you wish to rebut someone’s comment it helps to actually quote what the person said. Try it sometime. It takes a bit more effort but it’s worth it because it avoids time-wasting silliness along the lines of your name-calling foolishness.

      In any event, as was perfectly clear from my comment(s), the “predictability” aspect of an obviousness determiation does not relate to the motivation to combine but to the reasonable expectation of success. KSR did not obviate that requirement but merely noted in dicta that in cases where success is virtually guaranteed and the motivation to make the claimed invention is plain to everyone and his mother, then it is not a violation of the law to find that claimed invention obvious.

    39. 27

      “There are certainly cases where valine to alanine substitutions unexpectedly alter function and structure.”

      I’m aware of that and I was careful not to state otherwise in my comment. That fact changes nothing because I’m not proposing that such substitutions be found obvious as a matter of law. Thanks for playing.

    40. 26

      I said if the PHOSITA says: “I forsee (or foresee, if you prefer) a benefit to making the claimed invention and I expect to be succcessful if I try.” indicates obviousness. I was not talking about the inventor who is filing the application, but the person having skill in the art, to whom the statute refers.

      If you introduce the word “insight” and degrees of insight then you are muddying the waters even more, since it is hard to imagine a more subjective (in the sense that everyone differs in their assessment of it) standard.

      Would it help if I recast the formulation this way: Assume the claimed invention is a combination of a widget and a dohicky. Then the standard of obviousness is if the PHOSITA says: “I forsee (or foresee, if you prefer) a benefit to combining a widget with a dohicky and I expect to be succcessful if I try.” indicates obviousness.

    41. 25

      ptomonger says”

      “I forsee [sic] a benefit to making the claimed invention and I expect to be succcessful[sic]if I try.” If that condition exists, then he claimed invention is obvious.

      What are you talking about? What is Justice Kennedy talking about? Somebody must be operating with a burst aneurysm here.

      To see a benefit in making a claimed invention and to expect success equates to obviousness???? What in the blinkin’ blue blazes can that possibly mean?

      To see a benefit in an invention means you must already have had the insight of what the invention is. It is the magnitude of that insight that is at issue in an obviousness determination, assuming the invention is novel. And that’s all that is at issue regardless of whether one calls it “obviousness” or “inventive step.”

      Whether or not the invention has any benefit, or whether the inventor can perceive any benefit, is relevant to the question of utility. Only. And the inventor’s perception of utility is not even relevant to the 101 determination.

      Did Bell see a benefit in making a long-range talking device? Did he expect to succeed? You bet your bippee he did. According to your analysis, that would be enough to find obviousness. What dolt would start off on an expensive and time-consuming endeavor to develop and reduce an invention to practice, literally or constructively, who does not expect to succeed?

      Please clarify your position.

    42. 24

      ptomonger,

      Not just factories; many products are developed here and constructed overseas. Why do development here when you can get the same size markets and better protection for less money in other countries?

      Our established, (somewhat) predictable legal framework is what keeps our markets strong and keeps companies and rich people (who spend lots of money in the areas they live in) located here. Beyond those protections, there’s not much reason to live here.

    43. 23

      This whole debate illuminates the wisdom of the Fed. Cir’s TSM test. It provided some predictability. The wildly divergent theories and positions taken in the posts above demonstrate that we now cannot reach a consensus as to what is or is not non-obvious.

      The FedCir went too far in dictum when it handled KSR by saying the references themselves must provide the motivation. But the PHOSITA must be able to say, based upon his knowledge of the art and the teaching of the references and before being exposed to the teachings of the inventor, something like: “I forsee a benefit to making the claimed invention and I expect to be succcessful if I try.” If that condition exists, then he claimed invention is obvious. If not, it is not. At least under a proper TSM analysis. Toss the TSM standard out as the Supreme Court has done and we wind up with unpredictability.

      In the PTO, that unpredictability leads to fear of granting a patent that somebody will criticize, so they go overboard in locking up the patent granting stamp.

      Once patents are issued, second-guessing goes on and infringers with enough at stake can choose to litigate on the hopes that they can knock out the patent based upon fancy lawyering.

      This is not good for the US economy, especially at a time when US producers face unprecedented competitive pressure from overseas. If our innovations are not protectable by patents, we may as well close up all the factories.

    44. 22

      Mr. Mooney, not surprisingly, misses the point once again.

      Obvious to try/discover/experiment does not equate predictability or likelihood-of-trying.

      Whether the chances of success are 90% or .00009%; both are from terminology perspective equally “obvious to try”. Whether or not scientists ultimately pursue what is obvious-to-try, ultimately depends on what’s at stake. with stakes high enough, people will be pursuing endeavors with even remote chances of success.

      Is buying a lottery ticket for $2 with a 1 out of 7000000 chance of success NOT “obvious to try?” If that were the case, then I suppose our country is blessed with tens of millions of outright geniuses.

      So should patentability therefore be limited to only purely “accidental” discoveries? Clearly, from a policy perspective it makes little sense to so limit patentability. The patent system is geared for encouraging innovation – not accidents. The patent system encourages people to either use their mental facilities to arrive at “inventions”, or engage in laborious experimentations to arrive at “discoveries”. The fact that ordinary people of skill are apt enough to arrive at such discoveries should not negate patentability.

      The second sentence of Section 103(a) is expressly intended to convey just that. The “manner” in which an invention is made is not a determinative factor for patentability. Whether, it is a mentally produced “flash of genius” or a physically produced “discovery”; whether the discovery is accidental or the result of a chain of laborious experimentations; does not make a difference from a policy perspective, and are therefore equally afforded patentability.

      KSR dealt with “inventions”. In re Duell dealt with “discoveries”.

    45. 21

      Malcolm Moody –

      There are certainly cases where valine to alanine substitutions unexpectedly alter function and structure. In fact, such a simple change may be the basis of your hindsight “problem”.

      Samuel Clemens
      President of Society Against Informed Peons

    46. 20

      Patent Law Student: “Obvious-to-try”, i.e., obvious-to-discover, is expressly rejected as a standard of obviousness under the second sentence of 103(a) for discoveries.”

      I don’t see the term “obvious-to-try” or “obvious-to-discover” in the second sentence of 103(a).

      Perhaps the term “expressly” has been redefined since I attended law school.

    47. 19

      “The BPAI decision is notable for a few reasons, including the following two: (1) It was written by Nancy Linck, former PTO Solicitor, Newman law clerk, & PhD Chemist.”

      Again, people skilled in the art understand that when the PTO says that the “chemical arts” are “unpredictable,” it only means that they are “unpredictable” relative to the clothespin arts, the board game arts, and the doing math to save money arts.

      If you sequence Protein X and it has a valine at position 123, it’s almost certainly not going to “unexpectedly” fold in a completely different manner when I change the valine to an alanine.

      The only person who would ever argue otherwise is a patent attorney, paid to do so by a client desperate to grab a piece of the action. I know the pro-patent biotech pundits out there do not like to hear this but: informed people are often disturbed by what lawyers manage to claim.

      Not always, of course, but often enough. There’s nothing wrong with admitting this. But certain folks really, really dislike to see it discussed publicly. Just watch.

    48. 18

      “the unpredictable nature of protein folding makes it virtually impossible to predict whether a particular sequence would code for an appropriate protein.”

      I’m sorry, Dennis, but that’s a pile of bullcrxp.

      Protein folding is “unpredictable” at some level, like the the weather in your neighborhood two weeks from now is somewhat “unpredictable.”

      But it is very much “possible” to predict whether “a particular sequence” will code for an “appropriate protein.” In fact, open up just about any patent on a protein filed in the last twenty or thirty years and you will find long sections of boilerplate explaining how the invention in those patents includes “conservative substitutions”. The better examples of these patents will define “conservative substitutions” in a way that demonstrates quite clearly that PHOSITAs of protein engineering are quite comfortable “predicting” what will work and what won’t.

      And of course, since those patents were filed twenty years ago, PHOSITAs are better than ever before at making such predictions.

      The Supremes will not overturn KSR. The CAFC put the nail in the Kubin’s coffin (and it’s going to stay there) when they correctly pointed out in Pfizer v. Apotex that the standard for obviousness is that the probability of success must be *reasonable*. When someone like Kubin is presented with a “problem” of “discovering” a fact, and that “discovery” is easily made and does not contain any demonstrated “unexpected results” then the “discovery” is, well, more or less predictable.

      Put it this way: nobody knows “exactly” what is in my sock drawer. If it turns out to contain fifteen pairs of socks, is that “non-obvious”? Because, like, nobody knew FOR SURE? The answer (thankfully) is “no.”

      The PTO’s prior lax and generous standard for biotechnology “discoveries” was that basically any previously unsequenced biomolecule was per se non-obvious because “nobody could have predicted it.” That quantum mechanical approach to biological sequences was surely helpful to the silicon valley boomers and those early venture capitalists. Everybody gets a patent, everybody gets some money, and everybody’s happy. But let’s not forget that it also led to the attempt to patent sequences without utility (wasn’t that fun?) and it also led to the issuance of claims of such absurd breadth that they make a sincere PHOSITA sick to his or her stomach.

      Kubin is a classic example of the applicant wanting to have his cake and eat it too. The claims are drawn to cover sequences of a particular percent identity to a disclosed sequence. What are the sequences of the undisclosed claims that Kubin seeks patent rights to? Kubin will say that you can figure those sequences out without “undue experimentation.”

      Yes, we know.

    49. 17

      “(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;”

      The applicant used well-known laboratory techniques, but the solution itself was completely unpredictable. The case turns on whether “potential solutions” encompasses “all solutions that might be found using conventional ways of searching for solutions.” How many patents could possibly survive if this is the standard?

    50. 16

      e6k

      There are problems with only 1 solution?

      Name one. Ok, ok, . . . you’re going to say how to spell “fourth” correctly. But even that one has multiple solutions: 1. crack a dictionary, 2. boot a spell checker, 3. ask mom, . . .

      But give us an example of a technical issue(suffice it to say we aren’t talking mathematical theorems here). By declaring that there are technical problems in the universe with not just a finite number of solutions, but with just one solution, you risk positioning yourself right in the midst of the unimaginative herd I was referring to, hence proving my point.

      Nor do I buy your tautological waffle: “to perceivably overcome.” Does a problem that can’t perceivably be overcome have a solution? Can you hear my one hand clapping, Cricket?

    51. 15

      “If the accepted wisdom is that there are only 3 ways to solve a problem and the claimed combination is a forth way, then the (erroneous)perception that there was a limited number of solutions is not evidence of obviousness of the claimed combination, it is evidence of non-obviusness. Yet the PTO is trying to sell the point that any finding of a finite number of perceived solutions to the problem solved by the invention is grounds for rejection, regardless of whether the invention is one of those solutions.

      I agree w/ Cro-mag, the word “finite” doesn’t belong in a discussion of obviousness.

      Finite does belong because instead of getting an application claiming a fourth way we get applications claiming the 3 ways that conventional wisdom dictates. If we get that fourth way then it often issues.

      None the less, there are a VAST number of problems in this universe that there are in fact only one way (let’s not even get into 2, 3, 4 etc) for humans to perceivably overcome.

    52. 14

      Deferred, you misunderstand and misstate your own example. In your example the “problem” is the efficiency of the vehicle, not the $ per g. If you then solve the “problem” of efficiency by creating an engine that merely trades off power for fuel consumption at a certain ratio that has hitherto not been disclosed as being used then yes, it would seem to me to be an obvious “invention” in view of the market forces and the recognized problem. The industry is already aware that such vehicles can be manufactured. You could put a go cart engine in a car, but it probably wouldn’t go very fast now would it?

      Bottom line is, SCOTUS in KSR seems to say you need to “invent” something (whatever that means) rather than just doing something “new”. It’s a hard pill to swallow from SCOTUS, and I haven’t broken away from the old ways yet myself. None the less that is the way it seems it is.

    53. 13

      Dangerously misguided: “(1) a finding that at the time of the invention, there had been a recognized problem or need in the art, which may include a design need or market pressure to solve a problem”

      So, gas is $4 a gallon, and I invent some type of new gasoline engine that is twice as efficient. Voila! There need was a need, so it was obvious.

      The more “useful” an invention is, the more obvious it is?

      Phooey.

    54. 12

      “One (of the many) things that I thought the Supreme Court fell down on in KSR was a textual analysis of the actual language of 35 USC 103(a) …”

      PDS,

      You’re very astute in your analysis of how SCOTUS spouts “patent doctrine” without ever considering the statutes. And this isn’t the first time either. Witness Anderson’s-Black Rock and Sakraida, and the SCOTUS’ “synergy” nonsense which may, unfortunately, have been resurrected by KSR International. Frankly, I grow weary of SCOTUS’ rhetorical nonsense in our area of the law. As even SCOTUS has said, it is infallible only because it’s final, and that is certainly true of patent law.

    55. 11

      PTO is contorting KSR just like they consistently contort the USC and CFR. That second criterion is a misrepresentation of Kennedy’s point.

      Kennedy did not say that a mere finding that there is a finite number of predictable solutions is sufficient for a finding of obviousness. He said that in certain market situations if a combination is one of a limited number of “predictable,” solutions to a recognized problem, THEN there is grounds for obviousness.

      If the accepted wisdom is that there are only 3 ways to solve a problem and the claimed combination is a forth way, then the (erroneous)perception that there was a limited number of solutions is not evidence of obviousness of the claimed combination, it is evidence of non-obviusness. Yet the PTO is trying to sell the point that any finding of a finite number of perceived solutions to the problem solved by the invention is grounds for rejection, regardless of whether the invention is one of those solutions.

      I agree w/ Cro-mag, the word “finite” doesn’t belong in a discussion of obviousness. There is never a finite number of solutions to any problem. That is just the way the dim herd of non-creative jurists and examiners (and, yes, prosecutors and other non-inventors) view the world. That’s why they don’t have any patents of their own.

    56. 10

      “I fear we are headed towards infinite monkeys on infinite typewriters making everything obvious.”

      Cro-magnon, please amend the above-identified paragraph to state –6000 Examiners– in place of the current statement of “infinite monkeys,” to state –6000 computers– in place of the current statement of “infinite typewriters,” and to state –indicating– in place of the current statement of “making.”

    57. 9

      “Obvious to try” coupled with a reasonable expectation of success would indicate unpatentability.

      But if it is obvious to PHOSITA to try but PHOSITA does not have confidence that success is likely from such trying, that should not negative patentability.

    58. 8

      “Obvious to try” coupled with a reasonable expectation of success would indicate unpatentability.

      But if it is obvious to PHOSITA to try but PHOSITA does not have confidence that success is likely from such trying, that should not negative patentability.

    59. 7

      In my mind, the error with this obviousness determination rest with this section:

      “(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem;”

      Although we have made advancements in modeling protein folding, it is still not predictable.

      Furthermore, I have a problem with the word finite. Of course if I can say there are a billion and 48 substituants that could be bonded at that point in the AA chain, then that would be finite. Who is going to test all those possibilities? I fear we are headed towards infinite monkeys on infinite typewriters making everything obvious.

      The inventiveness here is cutting through the large number of possibilities and figuring out how make something useful without all those monkeys.

    60. 6

      One (of the many) things that I thought the Supreme Court fell down on in KSR was a textual analysis of the actual language of 35 USC 103(a) …
      A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.

      For example, some of the key language is “at the time the invention was made” and “Patentability shall not be negatived by the manner in which the invention was made.”

      SCOTUS gave short shrift to improper hindsight reconstruction of the claimed invention, but this is part of the statutory language. Also, as been already noted above the “obvious to try,” appears to be at conflict with the “Patentability shall not be negatived by the manner in which the invention was made.”

      The Constitution refers to giving “Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” Thus, discoveries should also be patentable.

      Another court-recognized indicia of non-obviousness is recognition and solving of a problem. In many instances, once the problem is recognized, the solution to the problem is easy to formulate. However, the “discovery” occurs, not during the creation of the device/method/etc, but by dicovering the problem (or perhaps the source of a recognized problem).

    61. 5

      CaveMan, I agree with the invention/discovery distinction and suggested treatment. As to the statement, “…hard work and toil eventually leads to discoveries, and is thus obvious to try. The second sentence of 103(a) was meant to clarify just that”, I disagree. Congress added the line “Patentability shall not be negatived by the manner in which the invention was made to override the Supreme’s previous “flash of genious” test. See link to en.wikipedia.org.

    62. 4

      Well, at least on the bright side for Dennis, if the PTO, courts, congress, and special interest groups (e.g., CPF) manage to finally reduce the patent system to next-to-nothing, there will be alot less patents filed for, and thus less cases appealed and litigated to have to report about on this blog, not to mention alot fewer blog readers to care about since there will be only a handful of patent practitioners left, and therefore Dennis will be able to focus much more time on preparing for the next class.

    63. 3

      The BIO amicus brief makes a strong point that an “obvious to try” doctrine is at odds with the second sentence of Sec. 103(a) which provides: “patentability shall not be negatived by the manner in which the invention was made”.

      However, the problem with the BIO brief is that it is quite tenuous in explaining away the KSR dicta. After all, KSR clearly accepts “obvious to try” as a valid showing of obviousness under 103(a). The BIO brief is simply deficient in clarifying the tenuous distinction it proffers, between “obvious to try a combination of known elements,” as in KSR, and “obvious to try the synthesis of a new chemical entity when there is motivation to try such synthesis,” as in In re Kubin. I cannot see how the CAFC is likely to accept such distinction without additional elaboration.

      Perhaps the following may be helpful in explaining the distinction proffered by BIO:

      First, we should understand that there are “inventions” and “discoveries”. The two terms are not necessarily synonymous. There is, and always has been, a real difference in meaning for these terms. “Invention” involves the conception in one’s mind of a novel idea of a new structure or method. Although, the invention may require further reduction-to-practice and testing to ensure its utility, nevertheless the conception largely occurs in the inventor’s mind.

      “Discovery” on the other hand is the result of hard work and experimentations using various methods and processes to arrive at a discovery. The “discovery” is the result of hard work, not a mere formulation occurring in the inventor’s mind.

      It is why novel chemical entities and their uses are generally characterized as “discoveries,” while new electronic or mechanical contraptions and the like are generally characterized as “inventions.”

      Having said the foregoing, I think it is self-explanatory why the “obvious to try” doctrine should be treated differently in relation with “discoveries” as opposed to “inventions.” When the invention at issue is the combination of two known elements to arrive at a new electronic/mechanical device, then “obvious to try” is applicable. Although, it may be unknown whether the combination will work for its intended purpose, the conception of the invention “in one’s mind” is obvious, because it would be obvious to combine and then try/test the utility of such combination.

      But when it comes to “discoveries,” the approach should be quite different. In the context of discoveries, “obvious to try” equates “obvious to discover”. It is in the context of discoveries, where the second sentence of 103(a) becomes relevant. A discovery is not negatived from patentability simply because it was obvious to work hard to arrive at such discovery. If we were to accept such obviousness standard for “discoveries”, we would effectively be disavowing all discoveries from patentability. Common sense is that hard work and toil eventually leads to discoveries, and is thus obvious to try. The second sentence of 103(a) was meant to clarify just that.

      I think this is the crux here. KSR involved an “invention”. The obvious-to-try inquiry was in relation to its usefulness for its intended purpose. The Supreme Court rightfully held obvious-to-try to be applicable in this context. On the other hand, In re Duell, and similarly In re Kubin, involve “discoveries”. Obvious-to-try”, i.e., obvious-to-discover, is expressly rejected as a standard of obviousness under the second sentence of 103(a) for discoveries.

    64. 2

      I guess what you’re saying anon is that three judge panels (which BPAI usually consists of), by definition, are either 2-1 or 3-0…

    65. 1

      Since when is a unanimous BPAI decision “notable” for the sake of it being unanimous????

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