Patently-O bits and bytes in its

USPTO's Deputy Director Sharon Barner has announced her resignation. Deputy Director Barner has been Director Kappos's second-in-command since October of 2009. Prior to joining the USPTO, Barner was a senior partner at the Foley law firm in Chicago. She has not announced publicly whether she will return to private practice. Barner is leaving government service with a number of important accomplishments in-hand and without any major scandal on her tail. She remains a likely candidate for a potential nomination to the Court of Appeals for the Federal Circuit if another opening arises during President Obama's time in office. Congratulations Deputy Director Barner!

Under the law, the USPTO Director David Kappos has the power to nominate a new Deputy, but the actual appointment is done by the Secretary of Commerce (Locke). 35 U.S.C. 3 requires that "The Deputy Director shall be a citizen of the United States who has a professional background and experience in patent or trademark law." Within current PTO inner circle, Chief Communication Officer Peter Pappas has been suggested for the position as has Patent Commissioner Bob Stoll. Traditionally, the Patent Commissioner serves as interim deputy director until the office is filled. However, Director Kappos has full control over the interim organization. Peggy Focarino is currently the Deputy Commissioner of Patents.

Patenting Methods of Treatment. After deciding Bilski, the Supreme Court asked Fed. Cir. to take a fresh look at the case of Prometheus v. Mayo. In Prometheus, the patent in question is directed toward an iterative method of determining the correct dosing of a drug by injecting a quantity of the drug and then measuring the level of the drug found in the body. The Mayo Clinic and its supporters argue that the patent should be held invalid under 35 U.S.C. 101 as lacking patentable subject matter. The Federal Circuit has now released its new opinion on the case, holding once again that the claims are patentable. More to come.

Silence Implies Consent. A reader sent me a copy of the recent BPAI rehearing decision ex parte Njo involving a Pitney Bowes patent application. In the original appeal, the patent applicant had not filed a reply brief to directly contest the examiners arguments. The BPAI made clear that failure to respond should be seen as acquiescence. "This absence does, in our view, also suggest that such inaction may constitute acquiescence in the Examiner's arguments. "Silence implies assent." Harper and Row Publishers Inc. v. Nation Enters., 471 U.S. 539, 572 (1985)." Consequently, the Board refused to allow the applicant to present new counter arguments that could have been raised in the reply brief.

Hands free typing. This week I had a successful shoulder surgery. The folks at Nuance were nice enough to give me a free copy of their voice transcription software known as Dragon NaturallySpeaking 11 (legal). I am now writing the blog hands free!

84 thoughts on “Patently-O bits and bytes in its

  1. 79

    Calling ME ignorant was the worst thing you could have said! My only ignorance was believing all you Lawyers one right after the other! and the most ignorant trick of all was abandoning the second only to trash it with more FRAUD!

  2. 74

    “Even though this is just a blog, you would do well to consider more carefully your writing.”

    Lighten up, Francis.

    “…he even entertains the poster herein known as ‘6’.”

    I admire and applaud David’s tenacity. He’s done more for the patent bar than anybody else I know. But personally, sometimes I get tired of banging my head against the brick wall of invincible ignorance of the likes of 6 and his ilk. At one point early in my career when I was frustrated with a particular examiner, a colleague told me, “This is your opportunity to educate them” and while I always keep that in mind, I also recognize that some of them are willfully, gleefully, and invincibly ignorant beyond any hope of redemption. So no, I’m not going to spend my client’s time and money, and my time, energy and sanity on those particular individuals. If I’ve disappointed you, well too bad.

    Just saying. 🙂

  3. 73

    A pity, Bob, that some are just too anti-patent to grasp your logic and are only too willing to kill patents “by any means possible”, including the reckless conflation of 101 with 102/103/112.

  4. 72

    Regarding preemption, the discussion above refers to but does not resolve the focus problem. Basically, nearly any claim that involves a natural phenomenon can be argued to preempt the natural phenomenon if you focus the analysis narrowly enough. In Prometheus, a specific drug is used to create/affect a natural phenomenon. If you focus on the “fact” that only this first drug is currently known to affect the natural phenomenon, then you can argue the claim preempts all uses of this natural phenomenon. On the other hand, if you imagine (as did the Federal Circuit panel in Prometheus) the claim is limited to the use of that one drug and that other drugs and means are possible for affecting the natural phenomenon then the claim should not be considered to preempt the natural phenomenon.

    Based on this, let’s consider to scenarios. In the first, assume a drug or means is known that affects the natural phenomenon. The inventor above then discovers that the drug above affects the natural phenomenon. A claim to using the drug clearly should not be held patent-ineligible for preempting the natural phenomenon. Hold that thought. In the second scenario, assume no prior drug or means to affect the natural phenomenon. The claim above is held to not be patent-eligible on the basis of preemption. Later, another inventor develops a second drug or means to affect the natural phenomenon. Clearly, the claim did not in fact preempt the natural phenomenon. Should the result of patent-eligibility depend on arbitrary conditions? I do not think so. This problem in focus is one of the reasons why preemption doctrine is a dangerous tool for assessing patent-eligibility.

    Related to this, inventors should be allowed patent claims to what they have invented and what they have contributed to the art. Here, the inventor provides (let us assume) the first drug or means for affecting a natural phenomenon. If the inventor claims this use limited to the drug or means invented (a result required by section 112), the patent grant comports with patent law (and preemption doctrine really should not disturb this). If instead the inventor attempts to claim every means of affecting the natural phenomenon, this might be considered to preempt the natural phenomenon (it also would likely violate 112—thus, this is another case where the other bases for patentability better solve the alleged problems that patent-eligibility is advocated to be needed to solve). Of course, the claims in Prometheus do not attempt to cover every means of affecting the natural phenomenon, so preemption is not a valid issue.

  5. 71

    Local–

    Who ever advocated “tilting at windmills to demonstrate mastery of procedure”?

    If you’re going to invoke MM-type criticisms, then, nice strawman.

    BTW, I responded to the content of your post, and actually assumed very little. Even though this is just a blog, you would do well to consider more carefully your writing.

    And Boundy’s choice of associate is no badge of credibility–he even entertains the poster herein known as “6”.

    In any event, it’s nice to know there’s at least one other person who cares about admin law in the PTO context.

  6. 69

    “Yours is exactly the attitude of which I speak–you discount the meaning and effectiveness of admin issues and arguments from the outset…”

    “Your inherent laziness creates your dismissive attitude. Wake up and smell the coffee, and be a real lawyer–you know, one who knows the law, and zealously advocates within the bounds therein to the best of his or her ability.”

    You made quite a few assumptions there. You know what they say about those who assume…

    “Which means that you must sometimes go the admin route, when appropriate.”

    I use whatever means necessary. But I use the most effective means. Tilting at windmills to demonstrate my mastery of the procedure doesn’t always serve my clients. When it does, I’ll use it. When it doesn’t I won’t use it.

    “You have the ability…”

    More than you know. Certainly more than you assume. 🙂

    “…maybe Boundy’s upcoming piece will be a good place for you to start.”

    David forwarded me a chapter from his upcoming book to read and comment on. I look forward to reading the whole thing when it comes out. He is the authority.

  7. 68

    Local–

    First, only myself and one other attendee has ever brought up an admin issue. They were both met with blank stares, immediately followed by requests for more information, as if it was the first time anybody had ever heard of such a thing, and found it absolutely fascinating.

    Second, “IF you can arrive at your destination”……you cannot always arrive there by “just going around”.

    Yours is exactly the attitude of which I speak–you discount the meaning and effectiveness of admin issues and arguments from the outset, by assuming that client interests can always be preserved by some other means. Not so.

    Like you said: “more often than not”. Which means that you must sometimes go the admin route, when appropriate.

    One time benefit? You could say that same about ANY action taken with the PTO. All actions relate directly to only one patent, or one family of patents, unless a precedential ruling comes out of it.

    And even then, there is no guarantee that the PTO will comply.

    Your inherent laziness creates your dismissive attitude. Wake up and smell the coffee, and be a real lawyer–you know, one who knows the law, and zealously advocates within the bounds therein to the best of his or her ability.

    You have the ability–maybe Boundy’s upcoming piece will be a good place for you to start.

  8. 67

    “Whatever the reason, the culture just is not there among the patent bar. Even at my local IP-law association meetings, admin law is ignored.”

    You could bring it up.

    Just a suggestion.

    “BECAUSE THEY ARE LAZY…”

    Not really. Unfortunately, arguing procedure to examiners, SPE’s, QAS’s, SPRE’s, TC Directors, etc. is pretty much tilting at windmills. As David points out, they don’t care. First, you’d have to get them to understand the importance of procedure, and then you’d have to get them to understand the procedure. That first mountain is nearly unscalable, so if you can arrive at your destination by just going around it, why wouldn’t you?

    I’m not advocating giving up the client’s rights, but more often than not, finding another path to allowance is in the client’s best interest.

    Besides, forcing anybody at the PTO to follow the procedure is a one time benefit. As soon as you’re done with them, they go right back to business as usual.

  9. 66

    I don’t think it matters exactly how one charaterizes the problem, Section 101 or Section 102

    cf

    How do you get to the right answer if you don’t ask the right questions?

    The difference is obvious

    Ned,

    W

    T

    F

  10. 65

    6 writes “It’s because not everyone cares as much as you do about procedural nonsense. Really, I promise they don’t. Most of them care about getting a patent, in as timely a fashion as possible, and that’s about it.”

    “Don’t care about procedure” is absolutely the case for most PTO employees, and exactly the problem. We in the bar care a lot, because procedure is the way that all legal inquiries get to the right substantive result efficiently. How do you get to the right answer if you don’t ask the right questions? And what is PTO procedure but specification of the right questions to be asked by the right person at the earliest practical time?

    Here’s what the Supreme Court has had to say about “procedural nonsense:”

    Procedural fairness, if not all that originally was meant by due process of law, is at least what it most uncompromisingly requires. Procedural due process is more elemental and less flexible than substantive due process. It yields less to the times, varies less with conditions, and defers much less to legislative judgment. Insofar as it is technical law, it must be a specialized responsibility [that does] not bend before political branches of the Government…

    If it be conceded that in some way [that the agency could take the action it did], does it matter what the procedure is? Only the untaught layman or the charlatan lawyer can answer that procedures matter not. Procedural fairness and regularity are of the indispensable essence of liberty. Severe substantive laws can be endured if they are fairly and impartially applied. Indeed, if put to the choice, one might well prefer to live under Soviet substantive law applied in good faith by our common-law procedures than under our substantive law enforced by Soviet procedural practices. Let it not be overlooked that due process of law is not for the sole benefit of an accused. It is the best insurance for the Government itself against those blunders which leave lasting stains on a system of justice but which are bound to occur on ex parte consideration.

    Failure to observe the fundamental requirements of due process has resulted in instances, which might have been avoided, of unfairness to individuals and inadequate or inaccurate findings of fact and unfortunate prescriptions of remedy. Due process of law is the primary and indispensable foundation of individual freedom. It is the basic and essential term in the social compact which defines the rights of the individual and delimits the powers which the state may exercise.

    Procedure is the means; full, equal and exact enforcement of substantive law is the end.

    The safeguards of “due process of law” and “the equal protection of the laws” summarize the history of freedom of English-speaking peoples running back to Magna Carta and reflected in the constitutional development of our people. The history of American freedom is, in no small measure, the history of procedure.

  11. 64

    Why isn’t there better advocacy by the patent bar, especially relating to admin law issues?

    Because the vast majority of their job relates to either substantive patent law or quibbling over examiners’ administrative deficiencies under the MPEP form paragraphs, so when it (comparatively rarely) comes to hardcore administrative law they’re simply out of their field of expertise.

    Maybe the patent bar is decidedly non-confrontational,

    Present company excluded, of course.

  12. 63

    Boundy–

    Why isn’t there better advocacy by the patent bar, especially relating to admin law issues?

    BECAUSE THEY ARE LAZY, AND GET LOCKED INTO THEIR “SPECIALTY”, SUBSTANTIVE PATENT LAW.

    I can’t think of any other reason. It would be good for clients, it would be good for jurisprudence, and it would be good for the administration of justice if any of the patent bar understood anything about administrative law enough to raise admin law issues.

    Maybe it’s something to do with personality type. Maybe the patent bar is decidedly non-confrontational, and prefers a conciliatory, or avoidance approach, and advocates the same to their clients. Maybe they are overly-introspective.

    Whatever the reason, the culture just is not there among the patent bar. Even at my local IP-law association meetings, admin law is ignored.

    It’s a shame, and a disservice.

  13. 61

    ” Most of them care about getting a patent, in as timely a fashion as possible, and that’s about it.”

    Given the shenanigans pulled by the examining corps and the useless “supervisors” and “managers” in the appeal-reopen-appeal-reopoen merry-go-round, by the time average fed up applicant finally does get their app in front of a panel of APJ’s they should care about every aspect of procedure and substance. The clear lack of understanding of both on the part of some APJ’s should be, but unfortunately is not, a point of major concern.

  14. 57

    The 6 mention of “procedural nonsense” set me thinking. The EPO version of the BPAI is DG3, which hears appeals in oppositions and decides (about 1000 times each year) whether the opposed European patent lives or dies. Advocates for the opposed parties can come from any one of the 38 Member States and can be attorneys at law or patent attorneys. The 3-member Board of Appeal invariably announces its collective Decision orally, straight after the advocates have finished their presentations.

    Prosecutors like me supposed at the start (1978) that litigators would inevitably get most of the opposition advocacy business. After 30 years of inter partes appeal hearings at the EPO, some parties still use litigators as their advocates. As the old saying goes “You pays your money and you takes your choice”. Good principle, no?

  15. 56

    “Why aren’t these raised? Because the “level of advocacy at the BPAI from the patent bar is rather poor.””

    Not really Boundy. I’ll tell you why. It’s because not everyone cares as much as you do about procedural nonsense. Really, I promise they don’t. Most of them care about getting a patent, in as timely a fashion as possible, and that’s about it.

  16. 54

    Dan Feigelson wrote: Another reason is b/c in order to argue before the BPAI, you need to have a USPTO registration number. Many of the really good litigators and many admin law specialists out there don’t have such a number. … And plenty of litigators who were English majors do just fine litigating patent cases. Maybe it’s time to take up Hal Wegner’s suggestion that we get rid of USPTO practitioner registration numbers and just let lawyers be subject to state bar discipline. It might shore up the level of argument in patent appeals – and lessen likelihood of someone not only losing before the BPAI but screwing it up so badly that the appeal is a lost cause too.

    The allegedly low level of advocacy won’t change if the USPTO allowed non-technical litigators to advocate. Why? Because the overwhelming number of applicants cannot afford to pay them to bill the sh*t out of the case.

  17. 53

    Proposed Rule 41.35(a) clearly states that jurisdiction passes to the Board upon the filing of the reply brief, or at the expiration of the period for filing the reply brief. Proposed Rule 41.41(a)(2) (or something) would prohibit new arguments in a Reply Brief.

    I would think that the proposed rule to prohibit new arguments in a reply brief is an acknowledgement that the current rules do not forbid new arguments in a reply brief. Yet I still see decisions where the APJ’s state they have not considered new arguments in a reply brief. Somebody needs to explain the law and the rules to these APJ’s.

  18. 51

    JustareadwhatIwrote lulz,

    Pay attention now. Iza left out the part about 37 CFR 41.41 and the part about the HMS Boundy reply on purpose. Iza only remarked on the “jurisdiction” clarification.

  19. 50

    As the application/appeal is not under the jurisdiction of the BPAI at the time of filing a Reply Brief, and as the BPAI’s role is to review the decision(s) of the examiner on the record before it, on what basis is the BPAI refusing to consider arguments presented in a reply brief, regardless of whether the arguments are in response to the examiner’s answer or presented for the first time?

    Perhaps I’ve lost track of the argument here, but in the present case, the new arguments were presented in a request for reconsideration, after the applicant lost. That’s a litle different, is it not?

  20. 49

    “Wasn’t this recently ‘clarified’, so thats this would be under the BPAI jurisdiction?”

    Not that I’m aware of. 37 CFR 41.41 doesn’t prohibit new arguments in a reply brief. And as David noted, the PTO’s “remedy” for new arguments in a Reply Brief is a supplemental answer, not ignoring the arguments.

  21. 48

    As the application/appeal is not under the jurisdiction of the BPAI at the time of filing a Reply Brief

    Wasn’t this recently “clarified”, so thats this would be under the BPAI jurisdiction?

  22. 47

    “37 CFR Part 41 is very clear that you can raise new arguments in a Reply Brief, and the remedy for the PTO is a Supplementary Answer.”

    Exactly. As the application/appeal is not under the jurisdiction of the BPAI at the time of filing a Reply Brief, and as the BPAI’s role is to review the decision(s) of the examiner on the record before it, on what basis is the BPAI refusing to consider arguments presented in a reply brief, regardless of whether the arguments are in response to the examiner’s answer or presented for the first time? If the BPAI wants the examiner’s response to arguments raised for the first time in a Reply Brief, it can remand the case back to the examiner. If you don’t want your appeal remanded and delayed, don’t make new arguments in a Reply Brief.

  23. 46

    I cannot image what it would be like if your technical background is limited.

    What if your technical background is completely unrelated, which would also entitle you to a registration number?

    As I understand it, the problem with letting lawyers represent applicants is that any old lawyer could do it, not just ones with relevant experience. But that’s true in every other field as well. Any lawyer could represent you in a child custody case, or a really complex administrative law matter. Two years and a room full of experts won’t make some random lawyer competent in those fields, much less proficient.

    Since lawyers are so good at self-policing themselves (I can’t imagine anyone else self-policing them nearly as well), can’t we trust that some small subset of the lawyer population (probably the ones with technical backgrounds) will develop some expertise in patent prosecution and appeals, and the others generally won’t touch the stuff?

    I guess the only question you’d be left with at that point is what to do with all those non-lawyer engineers and chemists who prosecute patents now. Grandfather the ones with numbers, obviously, but it’s a shame about the others.

  24. 45

    “Maybe it’s time to take up Hal Wegner’s suggestion that we get rid of USPTO practitioner registration numbers and just let lawyers be subject to state bar discipline.”

    Interesting suggestion but ultimately not workable — if you want a single person to write the brief, which is needed for efficiency.

    What gets argued is the brief is highly fact dependent, and if you don’t understand the technology you are guaranteed to lose. Unless it is for a very simple technology, the person drafting the appeal brief had better be technically competent.

    “plenty of litigators who were English majors do just fine litigating patent cases”
    Prosecution and litigation are two totally different stories. As a litigator once put it to me, he’s got a couple of years to learn the technology, and he can bring in experts to help him learn it. However, if you prosecute patents, you maybe have 15-20 hours to understand the technology and draft a complete patent application, which means you had better understood it after the first 2 hours.

    Also, if you pick up the application after its been drafted to prepare an amendment or appeal brief, you have much less time to understand the technology. It is tough enough to do with a technical degree to fall back on, and I cannot image what it would be like if your technical background is limited.

    Still, a patent attorney should get some administrative law experience or engage someone that does have experience when preparing appeal briefs.

  25. 44

    “Is JDT” and David:

    Another reason is b/c in order to argue before the BPAI, you need to have a USPTO registration number. Many of the really good litigators and many admin law specialists out there don’t have such a number. The USPTO is the only federal agency where you need a test beyond your bar admission to represent someone, but strangely, representation before those other agencies seems to come off with few hitches – lawyers seem to adequately self-police themselves. And plenty of litigators who were English majors do just fine litigating patent cases. Maybe it’s time to take up Hal Wegner’s suggestion that we get rid of USPTO practitioner registration numbers and just let lawyers be subject to state bar discipline. It might shore up the level of argument in patent appeals – and lessen likelihood of someone not only losing before the BPAI but screwing it up so badly that the appeal is a lost cause too.

  26. 43

    Harmless Errors:

    The Board gets very high deference on findings of fact, Overton Park — standard of review determines reversal rate.

    However, most Board opinions have GLARING errors of administrative law, and could easily be at least vacated, and often reversed, on that ground alone. Why aren’t these raised? Because the “level of advocacy at the BPAI from the patent bar is rather poor.”

    There’s a lovely treatise on the intersection of patent law and administrative law coming to a bookshelf near you in a few months.

  27. 42

    Thresholding Units asks: is it proper for an appellant to raise new arguments in a request for rehearing, when those arguments were never raised in the appeal brief or a (non-filed) reply brief? And if it is proper, does the examiner get a chance to file an answer to those arguments?

    If a brief was filed before December 22, 2009, you can raise new arguments at any time, because the PTO had no clearance under the Paperwork Reduction Act for any brief filed before that date. See 44 U.S.C. § 3512 and 5 C.F.R. § 1320.6.

    For briefs filed after December 22, the White House told the PTO in no uncertain terms that the PTO was not to enforce rules above the text of 47 CFR part 41, 2004 version

    link to reginfo.gov

    37 CFR Part 41 is very clear that you can raise new arguments in a Reply Brief, and the remedy for the PTO is a Supplementary Answer.

    Law? Law? The PTO – including its “persons of competent legal knowledge” don’t give a rat’s ass for procedural law.

    Despite instructions from the Executive Office of the President not to do so, the Board insists on enforcing rules above those that have been validly promulgated. The Board has been fond of citing Federal Circuit cases and a few non-precedential informative Board opinions, but Federal Circuit opinions are inapplicable to Board procedure. The Board is not an Article III court. The Federal Circuit’s rules are not 37 CFR Part 41, the Board acts illegally when it cites non-precedential opinions (even “informative” opinions), 5 U.S.C. § 552(a).

    Scofflaws. Barbarians.

  28. 41

    “Considering that cases appealed to the Fed. Cir. tend to be closer cases, this shows some competency at the BPAI.”

    What cases appealed to the Federal Circuit from the BPAI reflect far more the cost of going to the Federal Circuit and the relelative importance a client places on an individual case than the actual merits of the decision itself.

    Going to the Federal Circuit just isn’t an option for most clients, no matter how bad the decision. The BPAI knows it, which is why they get away with what they do.

    I grant the observation that the level of advocacy by attorneys at the BPAI isn’t that high either. However, I think that this is reflective of most attorney’s experience with the process more than anything. An average attorney may write a handful of appeals a year. Given that it takes a couple years to get a decision, there is a long feedback lag, which further hampers an attorneys’ development. Like anything, the more you do it, the better at it you get. There just isn’t that many attorneys that have the experience to match the experience of the average BPAI APJ.

  29. 40

    “cleverness by the APJ rather than an actual cite to a legal authority –> such cleverness does not inspire faith in the integrity of the BPAI.”

    At least they moved past citing Johnny Depp movies.

  30. 38

    “Before we get carried away, I would just note that the BPAI is affirmed a strong majority of the time at the Fed. Cir. (including an opinion issued today). Considering that cases appealed to the Fed. Cir. tend to be closer cases, this shows some competency at the BPAI.”

    True dat. Generally speaking, the level of advocacy at the BPAI from the patent bar is rather poor. Everything from arguing claims as a group to failing to preserve issues for appeal, not shredding examiners’ reliance on inapposite, boilerplate case law, it runs the gamut. So yeah, the affirmance rate is pretty darn high, but if appeals to the BPAI got the effort they need, I daresay the rate would come down significantly.

  31. 37

    “the “facts” and “reasoning” affirmed by the BPAI amounts to no more than a steaming pile, but as long as the consequences are limited to those few, what’s the incentive for APJ’s to get it right”

    Before we get carried away, I would just note that the BPAI is affirmed a strong majority of the time at the Fed. Cir. (including an opinion issued today). Considering that cases appealed to the Fed. Cir. tend to be closer cases, this shows some competency at the BPAI.

  32. 36

    The “quality” of BPAI decisions is rather mixed right now. I frequently see issues framed as whether appellants have demonstrated that the examiner erred, or if there is reversible error. There is no requirement that appellants demonstrate errors in the examiner’s rejection. Appellant is only required to demonstrate that the examiner hasn’t made a sufficient prima facie case, or if the examiner has made a prima facie case, to submit evidence and/or arguments that rebut the prima facie case.

    I also see decisions in which the APJ’s “adopt as their own” the examiner’s findings/reasoning with no analysis of those findings/reasoning that indicates the APJ’s did what was required: review them anew.

    I also see rejections affirmed on “amplified” finding(s)/reasoning(s) that are clearly new grounds of rejection, but not designated as such.

    There’s been a lot of improvement in the BPAI’s decisions in the past 2-3 years. Much more improvement is needed.

  33. 35

    “Put that identical citation in a brief to a Federal Judge and he or she will flay you alive.”

    Nope. Wish it were true that the CAFC judges really cared about such things, but it’s obvious that they don’t. Or maybe it’s just that most patent litigators don’t care if they are “flayed alive” or not as long as the client is happy with the way the argument looks on paper.

  34. 34

    “It is not cleverness — it is deceitful.”

    The cites to precedents in OA’s and BPAI decisions are generally atrocious. The examiners can be forgiven, I guess, as they haven’t a clue about relying on precedent, but for the APJ’s it’s simply unforgiveable. One case in particular, Ex parte Clapp, is repeatedly cited for a proposition that it isn’t even close to holding. It’s almost surreal.

    “Put that identical citation in a brief to a Federal Judge and he or she will flay you alive.”

    The problem is that very few people at the PTO ever have to face this consequence. I’ve read more than a few Fed. Cir. opinions in which some poor sap from the Solicitor’s office has to take a reaming because the “facts” and “reasoning” affirmed by the BPAI amounts to no more than a steaming pile, but as long as the consequences are limited to those few, what’s the incentive for APJ’s to get it right?

    If APJ’s want to be clever, let them go back to examining.

  35. 33

    “Ignoring the whole “silence implies assent” thing (which may have just been an attempt at cleverness by the APJ rather than an actual cite to a legal authority).”

    It was an actual cite to a legal authority (I reproduced it so there is no mistaking the intent), and there is no ignoring a blatant misrepresentation of the law. It is not cleverness — it is deceitful. Put that identical citation in a brief to a Federal Judge and he or she will flay you alive.

    “is it proper for an appellant to raise new arguments in a request for rehearing, when those arguments were never raised in the appeal brief or a (non-filed) reply brief?”
    It all depends, did the BPAI raise a new grounds of rejection? If they did, then no restrictions.

    Regardless, Ex parte Frye states that the BPAI is not to give deference to any positions taken by the Examiner. Therefore, the BPAI is to review all of the arguments and positions anew.

    I don’t know who is right or wrong with regard to the findings of fact and legal conclusions that were made, but I do know that what this APJ has done is reprehensible.

    “does the examiner get a chance to file an answer to those arguments”
    Only if the BPAI kicks it down to the Examiner with a remand or the Appellant takes it back down to the BPAI when faced with new grounds of rejection.

  36. 32

    sufficiently loose definition of “teaching”

    That would be proper, as we done use a sufficiently loose definition of “scholar” with the likes of Lemley.

  37. 30

    Were the “inventors” of claim 46 the first people to “discover” that if a person has no drug or drug metabolite in their bloodstream, then you may want to administer more drug?

    Does the prior art include homeopathic treatments where the drug is just getting started when you’re down to a 10^-20 chance of finding a single molecule of metabolite in the patient’s entire body?

    Presumably that’s a teaching away, if you have a sufficiently loose definition of “teaching”.

  38. 28

    Ignoring the whole “silence implies assent” thing (which may have just been an attempt at cleverness by the APJ rather than an actual cite to a legal authority), the question still remains: is it proper for an appellant to raise new arguments in a request for rehearing, when those arguments were never raised in the appeal brief or a (non-filed) reply brief? And if it is proper, does the examiner get a chance to file an answer to those arguments?

  39. 27

    The Constitution uses the term “Discoveries,” which means that discovering something (i.e., appreciating it for the first time) can be patentable.

    Were the “inventors” of claim 46 the first people to “discover” that if a person has no drug or drug metabolite in their bloodstream, then you may want to administer more drug? Because their claim reads on that.

    And that’s just the beginning of the problems with the claims at issue here.

    Anyone want to tell me where the “warning step” is in claim 1 or claim 46?

  40. 26

    BTW … if you want an example of an “appreciation” or “discovery” of something that ultimately became patentable,

    … look at anything. Just about every invention starts with the abstract realization or suspicion that a particular principle might prove useful in a particular application.

    Somehow I doubt that the claimed invention (“A velvet type fabric comprising …”) was discovered by the inventor growing on a tree. I would say that the Element 95 patent is closer to claiming a discovery; it was simply a matter of someone being there to construct that particular specimen and witness it before it decayed.

  41. 25

    BTW … if you want an example of an “appreciation” or “discovery” of something that ultimately became patentable, look up the history of Velcro.

    U.S. Patent No. 2,717,437

  42. 24

    The Constitution uses the term “Discoveries,” which means that discovering something (i.e., appreciating it for the first time) can be patentable.

    What about the person who first appreciated a law of nature or natural phenomena that occurred during a prior art process? Can I add an appreciation step to the prior art process and clear 102 and 103?

  43. 22

    I don’t have the full set of briefs on Njo to know who goofed, Pitney Bowes or the Board.

    If the Examiner’s Answer raised a new ground of rejection, then shame on Pitney Bowes for not responding.

    But if the Examiner’s Answer was a regurgitation of the last Action, then SHAME ON THE BOARD. Procedural law 101 – THE BURDEN OF PROOF IS *ALWAYS* ON THE PTO. Assent can be inferred from an examiner’s silence, not the other way ’round.

  44. 21

    The Constitution uses the term “Discoveries,” which means that discovering something (i.e., appreciating it for the first time) can be patentable.

    Ah, but the Constitution doesn’t use the term “Inventions”, so either “Discoveries” means what we now understand by “Inventions” (i.e., what “Inventors” do), or most of what we consider patentable is actually ultra vires – including all the stuff what wasn’t technically “discovered” like drugs and transistors and fuel injection.

  45. 20

    Article I, Section 8, Clause 8 of the United States Constitution:

    “To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”

    The Constitution uses the term “Discoveries,” which means that discovering something (i.e., appreciating it for the first time) can be patentable.

  46. 19

    Given these facts and the admission above, it really boggles how the claims are not obvious in view of the prior art.

    Not only obvious, but possibly anticipated, given that the claimed indication was always there … it’s just that no one appreciated it (like sound made by the proverbial tree falling in the woods).

  47. 18

    IANAE: From the patent in question: “Previous studies suggested that measurement of 6-MP metabolite levels can be used to predict clinical efficacy and tolerance to azathioprine or 6-MP …”

    With respect to your question anon, the claims cover testing drug or drug metabolite levels in a patient being administered the drug and, if the level is zero, increasing the dose of the drug. Likewise, the claims cover the situation where, if the level of drug or metabolite is above the known level that is toxic to humans, the dose should be reduced. Given these facts and the admission above, it really boggles how the claims are not obvious in view of the prior art.

  48. 17

    anonymous: were there prior art tests that determined the level of 6-thioguanine and, if so, should the claimed indication be considered inherent in those prior art tests?

    From the patent in question: “Previous studies suggested that measurement of 6-MP metabolite levels can be used to predict clinical efficacy and tolerance to azathioprine or 6-MP …”

  49. 15

    Malcolm Mooney, were there prior art tests that determined the level of 6-thioguanine and, if so, should the claimed indication be considered inherent in those prior art tests?

  50. 12

    “Barner is leaving government service with a number of important accomplishments in-hand”

    . . . such as ? ? ?

    “She remains a likely candidate for a potential nomination to the Court of Appeals for the Federal Circuit”

    I agree. Without any prior judicial experience to speak of, she is a perfect candidate for a federal appellate position on the CAFC.

  51. 10

    In any case, I’m out biatches, got holidays to have and things of that nature. You guys have a merry one.

    I’ll try to stop by and stir some sht up but I’ve got lots to do.

  52. 7

    I take back what I said, according to the decision, nobody bothered to argue the actual cause of the 101 issue, i.e. the abstract idea that a level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject, where a level of 6-thioguanine greater
    than about 400 pmol per 8×108 red blood
    cells or a level of 6-methylmercaptopurine
    greater than about 7000 pmol per 8×108
    red blood cells indicates a need to decrease
    the amount of said drug suministered to said subject where said subject was administered a drug selected from the group consisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6- methyl-mercaptoriboside, said subject having said immune-mediated gastrointestinal disorder.

    If you can’t be bothered to make the correct argument you don’t deserve to win imo.

    But turning to what they did bother to argue…

    “Other drugs might be administered to optimize the therapeutic efficacy of the claimed treatment.”

    Well that is interesting. If correct then I must say that I agree with the Fed here about it not preempting all uses of a natural phenomena or natural law. They say what they say, but they provide no examples of what these other drugs may be or why they think future devised drugs would be useful in this way.

    However, all that said, I would remain unconvinced on the abstract idea analysis which apparently nobody bothered to argue before them. But I suppose if nobody wants to argue it then the claim may as well pass 101 np. I even held their hand right through the argument in another thread, if any of their lawyers bother to read the most popular patent blog and the comments on their own case then I’d think they saw it.

    Consider, for a moment MM, that they recite specific drugs in the claim, surely if that natural phenomena could be utilized in conjunction with other drugs in what is otherwise the same method recited in the claim then the natural phenomena is not preempt.

    “We similarly reaffirm that the treatment methods claimed in Prometheus’s patents in suit satisfy the trans-formation prong of the machine-or-transformation test, as they “transform an article into a different state or thing,” and this transformation is “central to the purpose of the claimed process.” See Bilski, 545 F.3d at 962. The trans-formation is of the human body and of its components following the administration of a specific class of drugs and the various chemical and physical changes of the drugs’ metabolites that enable their concentrations to be determined. We thus have no need to separately deter-mine whether the claims also satisfy the machine prong of the test.”

    Kind of irrelevant, but nice of the court to spend its time reciting it.

    ““It is virtually self-evident that a process for a chemical or physical transformation of physical objects or substances is patent-eligible subject matter.” Bilski, 545 F.3d at 962. The administering step, therefore,”

    Obviously, but if the method is not really “for” that, but is instead “for” determining something then I have to say that such a legal holding is kind of irrelevant. But again, nice for the court to spend its valuable time on things that don’t really matter rather than focusing like a laser on the things that do, these “other drugs” that supposedly could be used with the natural phenomena.

    “Not all of the asserted claims, however, contain the administering step. That omission, which occurs in claims 46 and 53 of the ’623 patent, does not diminish the patentability of the claimed methods because we also hold that the determining step, which is present in each of the asserted claims, is transformative and central to the claimed methods. Determining the levels of 6-TG or 6-MMP in a subject necessarily involves a transformation. Some form of manipulation, such as the high pressure liquid chromatography method specified in several of the asserted dependent claims or some other modification of the substances to be measured, is necessary to extract the metabolites from a bodily sample and determine their concentration. As stated by Prometheus’s expert, “at the end of the process, the human blood sample is no longer human blood; human tissue is no longer human tissue.” Decl. of Dr. Yves ThĂ©orĂŞt ¶ 6, Prometheus Labs., Inc. v. Mayo Collaborative Servs., No. 04-CV-1200 (S.D. Cal. Mar. 29, 2007) (Dkt. No. 528-3). That is clearly a trans-formation. In fact, Mayo does not dispute that determin-ing metabolite levels in the clinical samples taken from patients is transformative, but argues that this transfor-mation is merely a necessary data-gathering step for use of the correlations. On the contrary, this transformation is central to the purpose of the claims, since the determin-ing step is, like the administering step, a significant part of the claimed method. Measuring the levels of 6-TG and 6-MMP is what enables possible adjustments to thio-purine drug dosage to be detected for optimizing efficacy or reducing toxicity during a course of treatment. The determining step, by working a chemical and physical transformation on physical substances, likewise suffi-ciently confines the patent monopoly, as required by the machine-or-transformation test.”

    I loled. So irrelevant it probably made several patent attorneys wet their pants from loling. “the determining step incidentally involves a transformation, therefor there is a transformation and we base our holding partially on this irrelevant test in light of this irrelevant factor”

    lulz.

    “While it is true that the administering and determining steps gather useful data, it is also clear that the presence of those two steps in the claimed processes is not “merely” for the purpose of gathering data. Instead, the administering and determining steps are part of a treatment protocol, and they are transformative. As explained above, the administering step provides thiopurine drugs for the purpose of treating disease, and the determining step measures the drugs’ metabolite levels for the purpose of assessing the drugs’ dosage during the course of treat-ment.”

    How, prey tell, does whether or not administering and determining steps are part of a treatment protocol affect anything regarding whether, for the purpose of the claim, rather than for actual steps being carried out, they are merely data-gathering? Of course you wouldn’t want to go into this or anything mr. court man, because that wasn’t the chief error that the DC made. The only error they made was focusing on the natural phenomena, when other drugs can apparently be used with it, rather than focusing on an abstract idea caught up in the claims.

    “We found that this process was not drawn to patentable subject matter because the essence of the claimed process was the mathematical algorithm, rather than any transformation of the tested individuals. 888 F.2d at 839-41.”

    A wise decision they made in Grams. However, making the claim turn essentially on form as they appear to be doing here, is a doosey.

    “More specifically, the Grams process was unpatentable because “it was merely an algorithm com-bined with a data-gathering step,” i.e., performing a clinical test. Bilski, 545 F.3d at 963.”

    Clinical tests don’t involve a transformation like you just loled into the current decision for the instant claim? I’m not familiar with clinical tests, but under this court’s standard I would imagine that someone must have at least sneezed during the clinical trial and therefor there was a transformation.

    “The claims did not require the performing of clinical tests on individuals that were transformative—and thus rendering the entire process patentable subject matter—because the tests were just to “obtain data.” Grams, 888 F.2d at 840.”

    So what they really needed was to adjust their form? Good call Fed.

    “Therefore, con-trary to Mayo’s assertions, a physician who only evaluates the result of the claimed methods, without carrying out the administering and/or determining steps that are present in all the claims, cannot infringe any claim that requires such steps.”

    Isn’t there such a thing as contributory infringement? Would that not apply in substantially all cases surrounding this? I really don’t know.

    On the whole, great lolz.

  53. 6

    I take back what I said, according to the decision, nobody bothered to argue the actual cause of the 101 issue, i.e. the abstract idea that a level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject, where a level of 6-thioguanine greater
    than about 400 pmol per 8×108 red blood
    cells or a level of 6-methylmercaptopurine
    greater than about 7000 pmol per 8×108
    red blood cells indicates a need to decrease
    the amount of said drug suministered to said subject where said subject was administered a drug selected from the group consisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6- methyl-mercaptoriboside, said subject having said immune-mediated gastrointestinal disorder.

    If you can’t be bothered to make the correct argument you don’t deserve to win imo.

    But turning to what they did bother to argue…

    “Other drugs might be administered to optimize the therapeutic efficacy of the claimed treatment.”

    Well that is interesting. If correct then I must say that I agree with the Fed here about it not preempting all uses of a natural phenomena or natural law. They say what they say, but they provide no examples of what these other drugs may be or why they think future devised drugs would be useful in this way.

    However, all that said, I would remain unconvinced on the abstract idea analysis which apparently nobody bothered to argue before them. But I suppose if nobody wants to argue it then the claim may as well pass 101 np. I even held their hand right through the argument in another thread, if any of their lawyers bother to read the most popular patent blog and the comments on their own case then I’d think they saw it.

    Consider, for a moment MM, that they recite specific drugs in the claim, surely if that natural phenomena could be utilized in conjunction with other drugs in what is otherwise the same method recited in the claim then the natural phenomena is not preempt.

  54. 5

    Malcolm, I agree.

    Given that the panel has now thrown its finger at the Supreme Court and in particular Breyer who thought the “test” to be immaterial in Lab. Corp., I think the Feds should hear this en banc to reconsider. They really gave short shrift to preemption and in distinguishing material data gatering steps from the immaterial.

  55. 4

    “Patenting Methods of Treatment. After deciding Bilski, the Supreme Court asked Fed. Cir. to take a fresh look at the case of Prometheus v. Mayo. In Prometheus, the patent in question is directed toward an iterative method of determining the correct dosing of a drug by injecting a quantity of the drug and then measuring the level of the drug found in the body. The Mayo Clinic and its supporters argue that the patent should be held invalid under 35 U.S.C. 101 as lacking patentable subject matter. The Federal Circuit has now released its new opinion on the case, holding once again that the claims are patentable. More to come. ”

    I lulzed. Fed. Circ. cruisin’ for a bruisin’. Rader leading the charge.

    /media/docs/2010/12/08-1403.pdf

    As a side note I don’t know why your everyday internet tard will nearly always provide a link to whatever it is of note that he is talking about, yet you high-priced lawlyers elect instead to not provide one so that everyone gets to have as much fun as you did looking it up. For being over-priced scribes you guys really should consider best practices.

  56. 3

    CAFC (Rader, Lourie, Bryson – Lourie writing):

    We do not think that either the Supreme Court’s GVR Order or the Court’s Bilski decision dictates a wholly different analysis or a different result on remand…The Supreme Court’s decision in Bilski did not undermine our preemption analysis of Prometheus’s claims and it rejected the machine-or-transformation test only as a definitive test…Thus, the Court did not disavow the machine-or-transformation test. And, as applied to the present claims, the “useful and important clue, an investigative tool,” leads to a clear and compelling conclusion, viz., that the present claims pass muster under § 101. They do not encompass laws of nature or preempt natural correlations.

    It’s good to know that the claims don’t “preempt natural correlations”. Here’s claim 46:

    46. A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising:

    (a) determining the level of 6-thioguanine or 6-
    methylmercaptopurine in a subject admin-
    istered a drug selected from the group con-
    sisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6- methyl-mercaptoriboside, said subject having said immune-mediated gastrointestinal
    disorder,

    wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells
    indicates a need to increase the[] amount of
    said drug subsequently administered to
    said subject, and

    wherein the level of 6-thioguanine greater
    than about 400 pmol per 8×108 red blood
    cells or a level of 6-methylmercaptopurine
    greater than about 7000 pmol per 8×108
    red blood cells indicates a need to decrease
    the amount of said drug suministered to said subject.

    Just to be clear: if I can’t simply look at data and make a determination as to what is the most reasonable treatment, or if I can’t follow an instruction to do what is old in the art (test levels of thioguanine in a subject), then in fact a “natural correlation” (i.e., between drug metabolism rates and drug toxicity) has been preempted.

    Can someone remind me: did any party in this case ever bother to address the question as to whether steps of measuring post-administration thioguanine levels in a patient (for whatever reason) were old in the art? It always seemed unlikely to me that the levels couldn’t have been measured in patients well before these particular numbers were “discovered”.

    Also interesting how the Federal Circuit ends its decision with a real whopper:

    Viewing the treatment methods as a whole, Prometheus has claimed therapeutic methods that determine the optimal dosage level for a course of treatment. In other words, when asked the
    critical question, “What did the applicant invent?,” Grams, 888 F.2d at 839 (citation omitted), the answer is a series of transformative steps that optimizes efficacy and reduces toxicity of a method of treatment for particular
    diseases using particular drugs.

    Except that neither claim 1 (which includes an earlier step of administering a drug) or claim 46 actually reduces the toxicity of anything. One could argue that the methods in those claims yield information that can be used for achieving this goal, but the claims themselves do not achieve this goal. In fact, it’s really the information provided by the description section of the patent (i.e., the specific threshold levels of drug and/or metabolites in the blood) that are allegedy new and non-obvious for the stated purpose, not the information provided by the old “transformative” step of checking the level of a drug in a patients blood (I say “allegedly” because certainly if you are attempting to treat a patient with thioguanine and he is not responding at all and you check the level of thioguanine in his/her blood and it’s zero you may want to increase the dose. Seems a bit obvious, to say the least?)

    In the instant case, the presence of mental steps similarly does not detract from the patentability of the administering and determining steps.

    A very strange statement. Did Mayo argue that any claim that recites a mental step is patent ineligible? I was not aware of such an argument being made.

    Although a physician is not required to make any upward or downward adjustment in dosage during the “warning” step, the prior steps provide useful information for possible dosage adjustments to the method of treatment using thiopurine drugs for a particular subject.

    First off, there is no step in claims 1 or 46 that requires anyone to “warn” anyone about anything. Reading non-existent steps into a claim and then referring to those steps using quotation marks is a good sign of a Federal Circuit decision that has gone off the deep end.

    Ignoring the absence of any “warning” step, Judge Lourie seems to be suggesting that claims 1 and 46 should be patentable (and not just patent eligible) even *without* the “wherein” clauses. Were any such claims prosecuted by Prometheus to allowance at the same time that they filed the application that led to the patent at issue? i.e., claims to a method of administering thioguanine and then testing the levels of thioguanine in the patient *or* claims to merely testing the level of thioguanine in a previously treated subject, period (without the “wherein” clauses)? Because Lourie sure makes it sound like it’s *those* steps (really, just the latter step) that’s new and non-obvious and patent-worthy here. What do the “wherein” clauses add to these claims if the methods are deemed useful even where no action is taken? Did the Examiner ignore them as well?

    contrary to Mayo’s assertions, a physician who only evaluates the result of the claimed methods, without carrying out the administering and/or determining steps that are present in all the claims, cannot infringe any claim that
    requires such steps.

    Great to know. So if Joe is getting treated by his doctor with thioguanine for his gastrointestinal disorder, can he ask some third party lab to merely measure his thioguanine levels (old in the prior art) without anyone infringing the claim? Surely neither Joe nor the lab infringes by simply determining his thioguanine levels (there’s no “warning” step…). But what if Joe’s doctor advises him to take this step? Assuming Joe doesn’t know what the data means, does Joe infringe only after he tells his doctor the result? What if Joe goes instead to a second doctor with the result? According to the case, the second doctor isn’t infringing by analyzing the data if the second doctor doesn’t make or order the determination. What if the first doctor advises Joe “Get your thioguanine levels tested by this lab and take the results to a second doctor who can treat you accordingly”? Seems to me that there’s no inducement because, according to Lourie’s decision, there’s no direct infringement by anyone (assume neither I nor the lab looks at the results and/or we do not know what they mean). Would it matter if the doctors work at the same hospital? Seems like it wouldn’t matter because (again): no direct infringement by anybody according to Lourie’s holding.

  57. 2

    “Silence implies assent.” Harper and Row Publishers Inc. v. Nation Enters., 471 U.S. 539, 572 (1985).”

    Did anybody read the Supreme Court decision? This case dealt with the publishing of Gerald Ford’s memoirs. It was a copyright issue.

    The phrase “Silence implies assent” is taken from the Court’s discussion of the transcript. Importantly, the phrase “Silence implies assent” is found within the transcript of the memoirs. The following is the paragraph from the memoirs:

    “It’s my understanding from a White House lawyer,” Haig replied, “that a President does have authority to grant a pardon even before criminal action has been taken against an individual.” But because Ford had neglected to tell Haig he thought the idea of a resignation conditioned on a pardon was improper, his press aide, Bob Hartmann, suggested that Haig might well have returned to the White House and told President Nixon that he had mentioned the idea and Ford seemed comfortable with it. “Silence implies assent.”

    This particular APJ, James D Thomas (JDT), who wrote the decision is known for his bad decisions and playing fast and loose with the patent office’s rules. However, this citation sinks to levels that would get him sanctioned in any court of law. This is how JDT used the above citation within Ex parte Njo (Appeal No. 2009-004173):

    This absence does, in our view, also suggest that such inaction may constitute acquiescence in the Examiner’s arguments. “Silence implies assent.” Harper and Row Publishers Inc. v. Nation Enters., 471 U.S. 539, 572 (1985).

    If Sharon does anything before she leaves, giving this APJ the boot is high on my list.

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