Therasense v. Becton Dickinson: A First Impression

by Jason Rantanen

I've got a new essay (with Lee Petherbridge) in which we provide an early analysis of what we think are substantial law and policy concerns raised by Therasense.  In the essay we argue that Therasense could have a much more significant, complex, and nuanced impact on the legal infrastructure of American innovation than the opinion for the court appears to appreciate.  In view of these complexities, we explain why the court may be too sanguine in its expectations for the instrumental effect of its decision.

In a nutshell, we consider the possible impact of Therasense on the efficiency of patent prosecution, on the amount of low quality patents, and on the cost of patent litigation.  In view of the significant impact that newly appointed judges had on the outcome of the appeal, we also consider what, if anything, Therasense may reveal about the characteristics of the new Federal Circuit. 

The essay is available here.  As this is a draft, we welcome any comments.  They can be provided in response to this post or sent to me at rantanen [at] uchastings [dot] edu.

63 thoughts on “Therasense v. Becton Dickinson: A First Impression

  1. 63

    What’s with the insults? Yes- the stress level has been high with the uncertainty in inequitable conduct. I fail to see the logic in your comments.

  2. 62

    The above post was brought to you by an automated post generator using the terms DOJ, Rocks, GOON, Post Office, Akin, Postman, Screen, GENO, Qui Tam, LOLOLOL, Supreme Court, Legal, Inventor.

    Thank you.

  3. 61

    Hard, nice speech.

    OK before I rub your face in it, you tell me what you dicta is?

    Could it possibly be something that is not necessary to the result?

  4. 60

    Man, you have NAL’s penchant for not being able to tell when to make a new paragraph ANL.

    Srsly tho NAL, do you still believe that the office would have an issue with res judicata if they tried to implement the same rules? I cited some cases a few weeks ago from the sixth circuit that said it was inapplicable to admin agencies.

    ” an examination only system would be a tremendous savings in cost, would have far greater promotion effects, and thus far greater sharing of knowledge and only those who want to spend the money in litigation would be faced with those costs, which affect less than 1% of all currently issued patents.”

    I agree, an examination only system probably would. Indeed, it may currently be doing that.

    “I have not seen any well-thought out rationale for not goign to such a system.”

    Maybe that’s because we already have an “examination only” system?

    “We tried that in a different area under vastly different considtions.”

    I agree, but the question is, what should we change to? We can’t do the registration only system, and we have the examination only system now, so what should we do? Maybe a mixed reg/exam system?

  5. 59

    Respectfully Ned, you are simply wrong. The Holding of the Case – what is the Holding of the Case.

    As in other discussions we have had, you seem to be deliberately obtuse at times, and I cannot figure out if you just have a hard time accepting logic that you yourself have not processed, be it from friendly folk, young strangers or people that you hardly ever agree with (yet hold respect for), or that you really do not understand law. Again, I mean no disrespect, but you tend to show a misunderstanding of how law works at times, or a lack of attention to facts that should be well known (the whole lack of knowing the Tafas history for example). Even how you come about your understanding of what a holding is and what dicta is – it seems like you are making things up, it seems like you expect people to accept what you say because it is you that is saying it.

    Ned, I really do feel sorry for you – but you are just completely off on this case.

  6. 58

    This is your problem, Hard, you have not been reading my posts or if you do, have not been understanding them.

    The court held the requirement to search to be ultra vires because of a prior Fed. Cir. case that held there is no requirement to search.

    This was a change in the law.

    That is the holding of the court.

    The court did not hold anything else.

    Everything else on this particular rule, the ESD, is dicta at best.

  7. 57

    I am left speechless by this comment.

    Anyone have any clue as to what Ned means?

  8. 54


    Maybe if you staart with the exact quotes, and carefully read those portions I put in bold for you.

    I am not sure if this will help, as those are the very portions that Light tried to get you to see.

    You do understand whose job it is to examine applications, right (I am not being condescending – at least, I am trying not to be condescending)? You do understand what the Judge actually said in the “rule of law” District result, fight?

    You seem to be ignoring the actual stated holding (which by the way recognizing when a holding is plainly stated should be your First) – you do not need to work backwards to try to guess what the holding is when the judge tells you what the holding is.

  9. 53


    It is only a joke that you cannot see your own typing.

    Seriously – it seems like everyone has no problem at all understanding the plain English.

    Maybe you are trying too hard to see something, perhaps squinting so hard that you think you see something.

    I really do not know how to help you.

  10. 52

    Hard, this is a joke, is it not?

    First, the quotes are exact.

    Second, the court established criteria for determining whether a rule is substantive.

    Third, it quotes the rule under consideration.

    Fourth, it applies the criteria to determine the result.

    Now, let’s work backwards to determine the holding of the court.

    What was the “criteria?” Could it happen be something to do with “change in the law?” What change in the law did the DC court cite?


    I cannot tell, help me. I am having trouble here, Hard. What did the court cite?


    Could it be this: “However, the Federal Circuit has stated that applicants have “no duty to conduct a prior art search” and “no duty to disclose art of which an applicant could have been aware.”

    I’m not sure. Please confirm, I really, really need help here.

  11. 51


    Not to be disrespectful at all, but did you cut and paste those quotes, or did you type them in?

    I have to ask, because if you typed them in, then you would not be asking “the offense, if there was one, was in the requirement for a search.” You would see that the point explicitly put forward in your earlier conversations is actually stated here: “demands that applicants…provide, among other things, a “detailed explanation: of “how each of the independent claims is patentable over the cited references.

    Wasn’t this the very thing – making the applicant examine their own application – that Light was arguing with you about? It certainly was not a mere “requirement for a search,” now was it? Your quoted section even explicitly states “[T]hese rules go far beyond merely requiring additional information.” I struggle to see how you can still seriously hold the stand that you are trying to hold. I truly am at a loss for words – even denigrating ones.

    It seems to me that if law students can clearly see the issues in this thread, and you do not (or cannot), you might want to take a step back and think about why this appears to be such a blind spot for you.

  12. 50

    Types of rules?

    OK, I’m game here. Please cite me chapter and verse. I read the DC decision, but did not recall this.

    Please tell me where to look in the District Court’s opinion. link to

    The district court said this:

    “While the APA does not define a “substantive rule,” any rule that “affect[s] individual rights and obligations” is substantive. Chrysler Corp. v. Brown, 441 U.S. 281, 302, 99 S.Ct. 1705, 60 L.Ed.2d 208 (1979); see also Animal Legal Def. Fund v. Quigg, 932 F.2d at 927 (stating that substantive rules are those that “effect[] a change in existing law or policy which affect[] individual rights and obligations”); Am. Hosp. Assoc. v. Bowen, 834 F.2d 1037, 1045 (D.C.Cir.1987) (defining substantive rules as those that “grant rights, impose obligations, or produce other significant effects on private interests… or which effect a change in existing law or policy”) (internal citations omitted). Despite the USPTO’s arguments, the Court finds that the Final Rules are neither procedural rules nor rules relating to application processing that have substantive collateral consequences, but substantive rules that change existing law and alter the rights of applicants such as GSK and Tafas under the Patent Act. The 2 + 1 Rule and the 5/25 Rule, which limit continuing applications, RCEs, and claims, and the ESD requirement, which shifts the examination burden onto applicants, constitute a drastic departure from the terms of the Patent Act as they are presently understood. By so departing, the Final Rules effect changes in GSK’s and Tafas’s existing rights and obligations. The Court will now explain why the provisions of the Patent Act compel this conclusion.”

    Now from this, I think the problem with ESD rules is the requirement for a search. (vis, change in existing law is the clue.)

    Let’s check further.

    “…[T]hese rules go far beyond merely requiring additional information. Instead, the ESD requirement changes existing law and alters the rights of applicants under the current statutory scheme by shifting the examination burden away from the USPTO and onto applicants. Final Rule 265 demands that applicants conduct a broad search of patents, patent applications, and literature, and provide, among other things, a “detailed explanation” of “how each of the independent claims is patentable over the cited references.” 72 Fed.Reg. at 46842; 37 C.F.R. § 1.265(a). However, the Federal Circuit has stated that applicants have “no duty to conduct a prior art search” and “no duty to disclose art of which an applicant could have been aware.”


    It does appear that the offense, if there was one, was in the requirement for a search. As noted by the court, it made a change in existing law.

    Do you disagree?

  13. 49

    I will overlook the error in your reading here (I am Even a 3L…),

    But only because it is even more scary that you quote as law that which you do not even know is not law. The Tafas episode is something I thought all patent attorneys would know inside and out.

    From 328 Fed. Appx. 658:

    (1) The petition for rehearing en banc is granted.

    (2) The court’s March 20, 2009 opinion, Tafas v. Doll, 559 F.3d 1345, is vacated and the appeal is reinstated.

    link to

    The Issue – not just the specific rules – was in the authority of the Office to set the types of rules under discussion between you and A New Light.

    Clearly, the Office does not have that authority.

    Your being wrong is not limited to the court history here – but extends to the law, your view of what makes the law, and the overarching discussion herein. I am not sure what can convince you, and frankly, it really isn’t up to me to convince you. As an attorney, don’t you have an obligation to know what the law is?

  14. 48

    New light, sorry, I was unaware that the Feds had vacated its panel decision on taking the case en banc. Can you provide a link?

    Regarding issue preclusion, the issues must be identical. Since we are talking about entirely different rules, they cannot be identical:

    Regarding the district court opinion itself, I do not recall that the issue of a requirement to comment on references was ever an issue by itself. It was part of the EDS rule, that required a search plus a lot of other stuff as well, such as pointing out where in the specification the claims are supported. Now just because the entire rule was found beyond the power of the PTO, it does not mean that every part of it in isolation is beyond its power.

    For example, the PTO requires you to show where the new claims one adds in a reissue or a reexamination are supported in the specification? E.g., 1.530(e) Is this rule ultra vires because the EDS rule was found ultra vires?

    Of course not.

    BTW, I think this rule, now limited to reexaminations and reissues, should be extended to original cases as well. You cannot believe how many flat out mistakes by applicants this will avoid when they have to find support in the specification for what they are now claiming.

    But, circling back to a requirement to explain the relevance of a reference submitted optionally in the face of a mandatory rule of non disclosure, I simply see nothing like this in the EDS rule. As such, this there is no issue preclusion at all.

    If, however, I am wrong in the assumption that a requirement to comment on art submitted in an IDS was not directly discussed, I remain open to be convinced.

  15. 47

    Jeff writes “materiality is not limited to “prior art,” but instead includes any information that a reasonable patent examiner would likely consider “important” in deciding whether to allow an application to issue as a patent.” To me, this statement has no bounds.

    To me, you’re like a four year old who needs to sit in a cage all day because “play with your toys” isn’t clear enough to keep you from sticking your tongue in the wall socket.

    When is a copending application sufficiently close that you have to submit copies of the office actions?

    You made me shxt my pants just thinking about how impossible that is to figure out!!!!!!!!!!!!

    Seriously, how have you survived the past decade or two prosecuting patents with all this “uncertainty”? You must have chewed your nails down to the knuckles.

  16. 46

    Ned Heller,

    Your tussle here shows clear error in your application of law.

    Your reliance on judicial opinion when that opinion has been vacated as part of the process, and your subsequent assertion that this vacated opinion actually represents the force of law strains credibility beyond all breaking points. To vacate a court order or judgment means to cancel it or render it null and void. (see link to ).

    When the en banc panel agreed to hear the case, they explicitly vacated the panel opinion. That action nullified the panel opinion’s force of law and thus there is no ability to quote anything from that panel opinion in a legal sense.

    Your position is thus shorn of any legal weight.

    You then posit that the District opinion is of little weight due to the parties involved. This is also incorrect. “ Issue estoppel (more commonly known as issue preclusion) prevents, in some cases, an issue that has already been litigated and decided on the merits from being re-litigated, even when the parties are different.” (see link to ) binds the Office even at the District level.

    Why do you think there was such import to the issue of vacatur after the Office terminated its proceedings before the en banc CAFC (for example, see link to )?

    The En Banc CAFC refused to grant vacatur.
    The En Banc CAFC vacated the panel decision.
    The Office is bound by the District Ruling. That ruling is law. A New Light is entirely correct and you are entirely incorrect.

    As a reader of this blog and an avid student of the law, I am aware that you are not bound by ethics in making arguments on this blog – (just as I am aware that you would probably be sanctioned in court if you attempted the same line of arguments in court as you have done here). However, I think it evident that any such attempt at arguing using false precepts of law is a sure loser even here on an unofficial forum. Surely you must realize that pinning your arguments to ungrounded (and legally false) positions weakens, rather than strengthens, the points you are trying to make.

  17. 45

    I have a comment . . . you should pick another topic to discuss. The flaws in your reasoning beguile the attempt by the Court to provide consistency and return the courts to their proper duty under the Constitution of the United States. Moreover, you lack any insight into the practice of patent prosecution. You simply fail to comprehend the United States economic system, which is the most troubling of your analysis. You speak of patents at hindering economic activity. At least the patent system is an open system of monopolistic venture in our society open to public scrutiny. I hardly think that hinders competition. Perhaps the better argument would be the monopolistic powers brought about with market power. If one really wants to spur the economy one should be discussing the strengthening of the Anti-trust division of the Department of Justice, as well as the trust of Goldman Sachs and its cohorts. These are monopolies that have virtually destroyed the culture. The patent system, however, it is, as I said, open and honest and does a great deal in moving innovation forward and to a small degree, provides an equalizer to unfair monopolicstic power wrought by market control. Your papers, in my opinion, lacks the proper breath of understanding of the greater problems that stifle competition in our economy, which starts at Washington DC. Vitiating the influence of the great cartels is what is needed to spur economic growth. The political cartel run by the Democratic/Republican Parties under guise of a two party system in competition, the oil cartel that pushes for importation of products so that greater amounts of energy is used to transport them, the financial cartel by just to name a few.

  18. 44

    A new light, the PTO is bound by the district court ruling regarding the particular party, but that ruling is not the LAW. No district court ruling is THE law, except in the case before it and perhaps in the particular jurisdiction, but even that is a stretch.

    The Federal Circuit decision in Tafas tells us what the law is even if the decision itself has been mooted by withdrawal of the rule.

    The notion that requiring an applicant to explain a reference if he optionally wishes to submit it (not required to submit it that is) is beyond the power of the PTO is a major major stretch. It is not illegal. Not at all.

    I expect the PTO could require optionally submitted art to be explained given there is NO FEDERAL CIRCUIT CASE that holds such a requirement is substantive.

  19. 43

    Ned Heller.


    Quoting BAD caselaw I will not tolerate. The rule of law in the Tafas case it the District Court ruling – all of the CAFC decision after that point are null and void, thus is not quotable, because it is not law.

    You have gone too far – our discussion is over if you cannot act like a true attorney.

  20. 42

    A new light, from one commentator summary of the Fed’s opinion:

    “With respect to Rules 75 and 265, Judge Prost states that:

    Once a satisfactory ESD is submitted, examination will proceed in precisely the same manner as it would have in the absence of the rule. It is important to note that an examiner is not permitted to substantively reject claims on grounds that the ESD did not prove that the claims are patentable.
    As a result, Judge Prost finds these rules to also be procedural under a JEM analysis.”
    link to

    Dennis own summary is consistent.

    From the case itself:

    “We agree with the district court that the USPTO bears the initial burden of proving unpatentability, but disagree that the ESD requirement shifts that burden. Final Rules 75 and 265 do not require an applicant to make a prima facie case of patentability. While the rules require an applicant to conduct a prior art search and report his view of why the invention is patentable based on the results, the content of this disclosure does not change the standards by which the application is examined. An examiner cannot reject an application because he believes that the applicant failed to find the most material references or if he is otherwise not persuaded by the applicant’s view of the prior art. Even under the new rules, the examiner must examine the application in accordance with § 131 and the applicant will be “entitled to a patent unless” the examiner can make a prima facie case of unpatentability. 35 U.S.C. § 102. Thus, while creating an additional procedural step for the submission of applications, the ESD requirement does not alter the ultimate burdens of the examiner or applicant during examination.”

    It appears the Federal Circuit held exactly the opposite of what you contended they did.

  21. 41


    What you claim as “no vice” has been ruled illegal.

    It is as simple as that.

    Please re-read the Tafas case for an explanation that the Office cannot force the applicant to explain patentability over the art that the applicant submits. You have forced the applicant to become the examiner in the first instance.

    If you cannot see how this is illegal and if you cannot remember the furor caused during the Tafas case over this very topic, then we will simply be foreced to agree to disagree.

    A shame really that you cannot recognize something that galvanized the entired patent community not so long ago.

  22. 40

    New light, please.

    “I think that you are hung up on this rule 56, so much so that you are not seeing what I am saying about what you have explicitly said.

    Perhaps you need to realize the complication of your desire to have the PTO REQUIRE IT, and where the limits – by law – of just what the PTO may require intersect.

    What is required about

    1) Mandatory non submission of art except if the applicant KNOWS the art to be material (i.e.., his claims are unpatentable over the art and he knows it); and
    2) Art nonetheless may be submitted if the patentability of the claims over the art is explained.

    If art is submitted unexplained, it either is an admission that the claims are unpatentable over that art or it violates the rule. In either case, the examiner simply rejects the claims over the art without leave to provide a rebuttal. The applicant is HOSED big time.

    The applicant is offered the option to rebut the presumption on submission. There is no vice in that.

  23. 39


    I can only respond to what you actually post, not to what you are thinking about but not post.

    I do not believe that I am reading far more into what you have said because I am reading what you explicitly said.

    Here we go again keyed in on the idea – you did not correct him, so I can only assume that you agreed with that part of his post. I repeat that part here: “they [applicants] explain…why the claims are nevertheless patentable over the reference.

    I cannot imagine why you are not understanding the explicit nature of your own post. I cannot imagine that you cannot see that the explanation of patentability over a reference is examination. I cannot imagine how you forget that this was one of the most contested portions of the entire Tafas fight.

    I think that you are hung up on this rule 56, so much so that you are not seeing what I am saying about what you have explicitly said.

    Perhaps you need to realize the complication of your desire to have the PTO REQUIRE IT, and where the limits – by law – of just what the PTO may require intersect.

    I do not think that the intersection is so obtuse. The Tafas fight, in my opinion, should be so crystal clear that anyone suggesting a PTO mandated duty on the appllicant, as you have suggested, should immediately pause and consider what that recent battle left behind.

    I agree that deleting rule 56, by itself, may not stop the flood. That is why I also suggested that ALL submissions be stopped – I suggested that IDS’s not be required (thus additional rules 97-99 would be affected) – I certainly hope that you are taking my comments in their entirety and not cherry picking to suit your position. That was a move that IANAE did quite often and one I will not tolerate.

  24. 38

    New light, HUH?

    What in the world are you talking about? You are reading far more into what I said than I intended to say. I want the applicants neither to search nor to disclose any references. However, if they choose to disclose a reference for whatever reason they should explain it.

    Where, WHERE in the world do you get the remotest idea that I am the even suggesting, in the slightest, that the applicant do the work of the patent office for it. I am suggesting rather than applicants stop flooding the patent office with cumulative debris. The only way that this can be done, the ONLY way, is for the PTO to REQUIRE IT.

    Simply deleting rule 56 would not stop the flood by itself. This is completely obvious to anybody.

  25. 37

    Good Morning Ned,

    As on the other threads, I find myself with the need to remind you that what you rpopose is illegal per the Tafas case.

    f you think it through, it would be best to change the logic of rule 56 from a requirement of disclosure to a requirement of nondisclosure – but permit references to be disclosed if the applicant explains why the claims are patentable over the reference.

    The minute you step over the line and have the applicant do the work of the Office by examining references and determining patentability of the application over those references you have gone too far.

    I am sorry but the thinking that “it would be best” does not change the fact that the Office simply cannot do as you suggest.

    Would you agree that if we are to take a middle step between the current situation and the correct end change, one possible way that might be satisfacotry to all would be the simple elimination of rule 56? I have been thinking about what other posters have said (I think MaxDrei leads in this area), and that step may be a worthwhile consideration.

  26. 36

    I recommend that you read the Eli Lilly brief. That brief pointed out that one of the purposes for the 1977 amendment to rule 56, and as well as the 1991 amendment, was to “limit” the amount of information the Office was to receive. Even at that time it was receiving far more information than what it considered to be “material.” It was being flooded with references which were immaterial. Obviously the flood of immaterial references was not stemmed by the change in the rule, if anything the flood was accelerated as the Federal Circuit did provided no sanctions for disclosing mountains of irrelevant or cumulative material.

    If you think it through, it would be best to change the logic of rule 56 from a requirement of disclosure to a requirement of nondisclosure – but permit references to be disclosed if the applicant explains why the claims are patentable over the reference. The combination would keep almost all irrelevant references from being disclosed at all, which is the primary purpose for majority holding in Therasense. It would still allow close references to be cited and distinguished. But most importantly, it would almost entirely spike the unholy practice of defense counsel of raising the question of inequitable conduct (and withstanding a motion to dismiss) simply by the fact that a reference was not disclosed – without regard to whether the reference was more material than a reference before the examiner. On this latter point, I have seen Judge Newman recently argue, vainly, that the Federal Circuit had affirmed the finding of inequitable conduct without having determined that the withheld reference was more material that a reference before the examiner when she had painstakingly pointed out that the reference was merely cumulative.

    In sum, change rule 56 from a requirement of the disclosure to a requirement of nondisclosure.

  27. 35

    You know if the DOJ speaks to the one with Rocks in his head.. They will find that the GOON at the Post Office was Akin to not be a real Postman. They will get a lot of valuable info, lots of it. After all he was a Screen with rocks in his head. And he is going to realize just how rocky things are going to get.
    PS let my last entry out.. and GENO you too.. Qui Tam is the only way the others could have any control.. and that was after they told me to let it go LOLOLOL. But I am sure the Supreme Court will see that the Qui Tam is taking away the Legal rights that should belong only to the Inventor, or those he assigns too. How that whole Qui Tam thing was EVER considered legal is beyond me.

  28. 33

    Here we go,

    That is a little difficult to read.

    Are you saying that because the ESD program was not mandatory and only affected “timing” and not any substantive rights that that program was allowed to have rules that were otherwise considered illegal in the Tafas case?

    What if the IDS rules were also changed along with rule 56? What if the Law was changed, rather than merely the rules? The only difficulty I see with merely additional rule changes is that is my belief that the Microsoft v i4i case did not completely resolve the matter of what it means for the Office to “consider” something. In a sense, by so overwhelmingly finding for the clear and convincing standard of the presumption of validity, even to the point of expressly noting that the Office does not (or must not) currently even note of record all prior art considered, the avenue created by Congress for dealing with bad patents (reexamination) is still unsettled in this un-noted area because the reexamination request of a SNQ practically assumes that all actual art considered is of record – and as I pointed out in a discussion with Ned, it is not. Someone has posted that this was something that Ping stated – if he did, then he took my idea, as I was the one that pointed out the several sections that explain examiner behavior and the direction by the Office not to have full documentation – including sections not covered in the Supreme Court’s decision, that indicate this lack of full record in the Office.

    If the collection of rules dealing with the applicant’s ability to make something of record and force consideration by the examiner without endangering estoppel effects is negative to applicants substantive rights, then I agree such would be illegal under the Tafas‘ case. But as I indicate, I think that the Government – as incomplete in its reexam formulation as it was, should now take the opportunity to rethink this whole “consideration” thing.

    As I see it, there are two logical paths – The first path is eliminate not only the “consideration” of supplied references, but also all “consideration” – the path of the registration only system. The second path is to force a detailed and complete examination, including having the Office not only list all references “considered,” but state (after doing) a full legal examination on all aspects of patentability over each and every reference considered – to put actual teeth into this word, and not a waive of some magical wand. The problem with the second path is clear: cost prhibitive and time prohibitive. But if you choose neither path one nor path two than you will always have the problem of patents being granted that shouldn’t be granted and patents denied that shouldn’t be denied. You will always have what you have now – and that includes the entire attached machine of special interest pandering, of a too-bloated (for some) and too expensive (for some) examining corp that provides too little benefit (for many) with always a call (by some) that patents are granted too easily. Likewise, you will always have the machine of the applicants, the attorneys who (for some) complaign too much that patents are stymied and the economy held in check by an Office that just says “No.”

    As I have postulated, an examination only system would be a tremendous savings in cost, would have far greater promotion effects, and thus far greater sharing of knowledge and only those who want to spend the money in litigation would be faced with those costs, which affect less than 1% of all currently issued patents.

    I have not seen any well-thought out rationale for not goign to such a system. I have only seen nay-saying and “we tried that before.” We tried that in a different area under vastly different considtions. It is time to try it again. Tell me what we have to lose – the current gridlock with neither side satisfied?

  29. 32

    What a friggin’ stretch.

    I propose a new rule 56 that flatly prohibits submission of prior unless the applicant knows it will render his claims invalid, and you do not object to that.

    I give the applicant a single out: he can submit art, but if he does he have to explain it (per the draft rule) and you say THIS is substantive!!!!!!????

    Here we go, you are friggen ….

  30. 31


    The part I highlighted is beyond mere ESDs. The allowance of impacting mere ESDs were allowed as it was a volunteer program that only impacted timing and did not impact any substantive right.

    If you attempt to tie substantive rights – and references made of record through an IDS submission still have effect on substantive rights – you violate Tafas.

    Your attempt here at changing rule 56 necessarily impacts the IDS rule and the applicants’ substantive rights. You are attempting to be coy with form and you impact substance. You cannot decree what an applicant cannot disclose if there is another rule which allows the applicant to disclose and you now add an additional duty that belongs to the Office – any time you ask the applicant to determine patentability over a reference you have violated Tafas. When I say “illegal,” I mean illegal. Just don’t go there.

    The phrase “too clever by half” comes to mind.

  31. 30

    Help me here, please. I thought the Feds held that the Section 120-related rules were beyond the power of the PTO; but that the rules regarding ESDs were otherwise within the rule-making authority.

    When you say “illegal,” do you mean, “beyond the power?” What are you saying precisely?

  32. 27

    they explain the materiality of the reference and why the claims are nevertheless patentable over the reference.

    Illegal per Tafas

  33. 26

    How’s this for new rule 56?

    1.56 Applicants have a duty not to disclose art that the applicant does not know to be material to the patentability of at least one claim. Applicant, may submit art without violating this duty of non disclosure provided that they explain the materiality of the reference and why the claims are nevertheless patentable over the reference.

  34. 25

    Andrew, I still haven’t fully thought it through myself as to how I am going to change my own IDS practice, but at a mininum I would agree that citing art from related cases is one of the things the Feds wanted to stop.

    Now, to go full circle, we need the PTO to actually issue a clear rule to this effect. The PTO has to go out of its way to implement the holding of Therasense to bring in fruition the benefits it was intended to obtain. They have to be clear that it does not want art, office actions, or amendments from related cases, and that in submitting an IDS one will have to affirm that none of the art was from a related case, unless the particular art is sumbitted with an explanation as to its materiality.

    You know, we need an entire post on this topic. What does the PTO need to do to carry into effect the holding of Therasense?

  35. 24

    Amen. There are difference between those that do and those that teach. It is quite apparent in this article which is way, way off base for this reason.

  36. 23

    Jeff, you seem to be relying on current Rule 1.56. I think the PTO is going to revise it by removing any definition of materiality.

    If they do not, then the PTO is going to cause a lot of confusion.

  37. 22

    I wrote me a country Song.

    I waited and waited for you to correct,
    all the wrongs that have been done to me.
    But instead you went on and on as you do,
    This is for all the years that you hurt me.

    I’ll give you your due. I’ll now take the lead,
    and let you see how you hurt me.
    And then with the facts you’ll have to concede,
    your done now, you’ve lost Tripoli.

    Repeat Stanza

    And then while you sit you’ll always remember,
    your Job was to protect me,
    You’ve now lost respect, no longer a member,
    just in time for a Fata Complete.

    Repeat Stanza

  38. 21

    Hi Andrew, I would not assume all patent attorneys do not prepare or read the references in IDS’s they file. I prepare my own IDS’s and I do read the references (I believe you are required to do so.) When questioned in a deposition, I would rather answer that I prepared the IDS and read all of the references, rather than stating I merely signed an IDS prepared by a non-registered assistant.

    As far as patent quality goes, my two cents is that the more aware of the meets and bounds of the prior art you are, the better the claims will be drafted.

    In short, I do not consider IDS a racket and I believe we should continue to cite “relevant” prior art. However, there needs to be a better line drawn in the sand as to the standard used to determine inequitable conduct, and this case goes in the right direction.

  39. 19

    The IDS practice has nothing to do with patent quality. For some it may be about liability, but for many filing IDSs is a racket. IDSs are really easy money when all you do is cite everything. It takes 5 minutes to review an IDS prepared by your assistant and most people charge a flat fee of hundreds of dollars. Think about it…..the retail price of an iPod Touch is less than what it costs your client when an office action issues in a case that you deem is “related”.

    The Therasense court couldn’t have been any more clear about its intent to stop this practice and convince practitioners that they won’t be liable. Rather than breath a sigh of relief all I hear coming from the patent community is that this doesn’t change anything. Our firm of 70 patent attorneys did a CLE on this case and I took a poll to see how many people thought they would stop citing “related cases”. Not a single person (except me). Either the patent community doesn’t know how to read, or they have other motives that don’t align with the public policy concerns plainly explained by the Court.

  40. 18

    Therasense has nothing to do with the art generated by the inventors. Jason doesn’t understand where the prior art is coming from that bogs down the patent office. It isn’t coming from the inventors. It comes from patent attorneys that blindly cite references in allegedly “related cases.”

    Here’s why those references are not relevant: Those reference were identified by a USPTO Examiner searching a presumably different invention. Unless the patentee has run afoul of double patenting, the claims in the alleged “related case” are necessarily different. Consequently you don’t know if the art cited in that case is relevant to another case. No one, including the patent attorney, the Examiner that found the reference in the “related case”, or the Examiner signing the IDS actually reads the references in the context of the invention for which it is being cited. These patents are being cited and checked off and no one has any idea whether they are relevant to “claimed invention.”

  41. 17

    “False”??? 🙂

    Malcom- Please explain your position:

    What does the following mean to you “materiality is not limited to “prior art,” but instead includes any information that a reasonable patent examiner would likely consider “important” in deciding whether to allow an application to issue as a patent.” To me, this statement has no bounds.

    When is a copending application sufficiently close that you have to submit copies of the office actions?

    The USPTO a while back issued a draft form for information on applications that were commonly owned and having a common inventor. Since the USPTO thought that information is “important” to an Examiner at that time, why is it now not important so we no longer have to submit it?

    I could go on with numerous more examples.

    Please provide an example where I do not have to cite an article, brochure, prior patent, or other written documents, that have the slightest connection to the application.

  42. 16


    Why are you avoiding answering my question and resolving the dichotomy you created?

    Let’s resolve your self-made dichotomy first, then we can move on to your questions.

    Can we agree to this?

  43. 15

    I think Jason’s predictions of gloom and doom are greatly exaggerated. Also, I think Jason tries to climb into the mind of the inventor and ascribe intent where none may be present. Issues of intent must be objectively shown and not assumed like, say, Mooney would do.

    Come to think of it, you never see Jason and Mooney in the same room do you…. hmmmmm.

  44. 14

    Hard, so if you choose to be willfuly blind to what the BRI is, you can escape your duty of disclosure?

    Actually Hard, do you have a plan yourself for witholding references you do not know are material, or will you simply disclose them as we all have in the past just to avoid the issue arising in litigation?

  45. 13

    Huh? Too bad that the non-sequitur of the day award was already handed out.

  46. 12

    Now Ned, you are altering the substance of your position here.

    one knows about – the knowing we are talking about is known materiality, not known as in awareness of existence.

    You are the one that created this dichotomy – all I am doing is asking you to resolve your very own dichotomy.

    You cannot have it both ways.

  47. 11

    Hard, I am not convinced that one can simply not disclose a reference one knows about on the excuse that one doesn’t know the BRI. If that were legitimate, no reference would ever have to be disclosed.

  48. 10

    How about increasing the penalties on both litigators and prosecutors?

    As has been kindly pointed out to you Malcolm, “Trolls” do not prosecute patents.

  49. 9

    we can never be sure about BRI


    Once again you circle back to comething that you left hanging on a previous thread.

    Please now finalize the opposite pointing results of the “knowing” factor of materiality and this “never be sure” factor of BRI – how do you propose to have it both ways, when those ways point in opposite directions? Either an applicant knows, or an applicant does not know.

  50. 8

    w about addressing the problems associated with litigating “low quality” patents (patent trolls ring a bell?) by increasing the penalties on the litigating attorneys instead of the patent prosecutors?

    How about increasing the penalties on both litigators and prosecutors?

    How many patent prosecutors were sanctioned or disciplined by the USPTO over the last five years? And I’m not talking about sternly worded letters.

  51. 7

    fore the Therasense case, there was no end to the amount of information required to meet the duty of disclosure.


  52. 6

    “Does not go far enough” is an understatement. Many, if not most, who advocated a “but for” standard had in mind validity, not patentability. In order to even get to IC, these advocates would have required a verdict of invalidity over the withheld reference or statement. Had the court adopted this approach, it would have brought the US substantially in line with the rest of the world.

    This decision helps, no doubt, but given that the standard for materiality is patentability and BRI, and not validity, we are still going to have to disclose all references that are potentially relevant because we can never be sure about BRI. The overdisclosure problem has not been cured, not at all.

    Now we add to litigation a second claim construction requirement. That is really going to complicate litigation and drive up costs.

    In the end, we may actually need legislation to slay this dragon. Thanks Federal Circuit. What a hash you have made of things.

  53. 5

    This comment is in response to the draft article by Jason, not the case facts.

    Inequitable conduct has grown into an overburdensome nightmare, ie. we are now citing office actions from other pending applications to the Examiner (even the USPTO is already aware of them), citing every document we are aware of no matter how relevant (the opposing counsel will surely argue that the one document you thought was immaterial is the most important document ever written), advising the Examiner of every other copending application with common ownership and at least one common inventor (the USPTO thought this was sufficiently important to issue a draft form), etc. Before the Therasense case, there was no end to the amount of information required to meet the duty of disclosure. To top it all off, when inequitable conduct is alleged in a patent case, the prosecuting attorney often does not even have the right to defend his/her position, i.e. no right to confront the accussor. The Therasense case is a godsend, and does not go far enough.

    Correct me if I am wrong, but Jason seems to generalize that by trying to give a prosecutor a more defined course of action in regards to the duty of disclosure, that this somehow will result in an increase of “low quality patents.” First, I do not agree that the majority of patents are of low quality. I do agree that the few low quality patents that have issued seem to be the ones that end up in major decisions. It is frustrating to see courts base significant changes in the law on such low quality patents.

    No other country on the planet has the duty of disclosure. I Jason suggesting that the patents of all these other countries are of “low quality” for this reason alone?

    I do not fully comprehend Jason’s position on how closing the door on the majority of inequitable conduct allegations will increase litigation. Furthermore, Jason appears to be laying the blame for increased litigation on patent prosecutors. In other words, he appears to be arguing that it is not the thieves fault they are stealing, but rather the owners problem for not securing their goods properly. How about addressing the problems associated with litigating “low quality” patents (patent trolls ring a bell?) by increasing the penalties on the litigating attorneys instead of the patent prosecutors?

  54. 4

    It occurs to me that even a slimeball has rights. If he or she has made an invention, it is novel and unobvious and it is disclosed so as to comply with enablement and written description, why should the patent not be asserted? How many of Edison’s inventions would have survived the currently fashionable inquisition into inequitable conduct, especially given the sometimes less than straightforward side of his character? But he is acknowledged as perhaps the greatest inventor ever, and to have advanced electrcal technology by a generation by his efforts.

    One answer would be to have a straightforward action on the merits i.e dealing with validity and infringement only with (if supported by what emerges at trial) the possibility of a post-trial motion for attorney fees on the ground of inequitable conduct. If the patent were held valid, then there would be no need for an enquiry, and the enquiry would only be needed in that minority of cases where it was truly needed.

  55. 3

    Jason, I disagree that practitioners will fail to disclose the best art. Generally they want the best available art listed on the face of the patent to enhance the presumption of validity. Secondly, if the best available art is actually discussed by the examiner, is not available to form a basis for re-examination.

    You do raise the issue of broadest reasonable interpretation. This probably will require the courts to have two claim constructions in virtually every case. That has to increase costs. But it also further increases the likelihood of reversal by the Federal Circuit, who are highly prone to reverse claim constructions on appeal.

    Finally, you failed to mention that broadest reasonable interpretation is vague and indefinite. Practitioners cannot know what this is because its rules have never been defined with clarity. For example, in the case of In re Morris, it is quite apparent that the claim construction affirmed by the court did not cover any of the disclosed embodiments. Now I ask you, honestly, how can any practitioner predict what the broadest reasonable interpretation is in light of cases such as In re Morris?

    Given the vagueness of broadest regional interpretation, the standard for materiality is extremely vague. I suggest that this will result in findings of actual knowledge of materiality in many cases where the practitioner could not have reasonably known that a reference was material. So where does this leave us in fact? What is the practitioner’s duty when he has to guess at whether the reference is material or not?

  56. 1

    This is an interesting and timely essay, but I fear I am on the opposing side.

    The defendants in Therasense were able to locate the allegedly inconsistent statements without difficulty as they formed part of a relevant published EPO file wrapper. Is the lumbering and expensive mechanism of inequitable conduct really necessary when the straightforward position was that the patent was invalid because the arguments for patentability collapsed on closer examination? Is it really necessary to blow a straightforward cross-examination point up into this whole inequitable conduct scenario with no less than two hearings before the CAFC and a highly likely further appeal to the Supremes?

    In the UK we have considered the options for a slimeball with a partially invalid patent being allowed to amend to cover only the valid subject matter. After decades of lengthy and costly investigations into the conduct of patentees we decided that it is wasteful, and that all we need to think about was whether the patent contains valid subject matter and can be amended, not whether or not the patentee is a slimeball. From its inception the EPO was of the same view.

    As I have pointed out in previous postings there appears to be no studies of the cost-effectiveness of the disclosure program in the US, of what prior art is helpful to an examiner, and of what the USPTO needs to receive in order to do its job, as opposed to being distracted from its job. But it is a pretty fair bet that if less material was submitted to the USPTO, the backlog would become reduced.

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