GlaxoSmithKline vs. Dudas: An Attempt to Stop Implemention of PTO Prosecution Rules

The U.S. Patent Office does not have substantive rulemaking authority.  Thus, the office cannot change the meaning of “novelty” or “obviousness” even through a formal process of notice and comment rulemaking. The Office does, however, have the power to make rules that govern procedures within the office that are “not inconsistent with [the] law.” 35 USC 2.

GlaxoSmithKline has now sued the Patent Office to stop implementation of two new sets of PTO rules — arguing that the scope and effect of the new rules extend well beyond the PTO’s limited rulemaking authority. The main thrust of the rules is to limit the number of follow-on applications that can be filed that somehow relate to an original patent application and to limit the number of claims filed in each patent application.

Glaxo can easily show that these rule changes will harm its business — especially because the rules retroactively impact the UK company’s already pending patent applications.

The rules hit innovator pharmaceutical companies especially hard. Pharmaceutical companies typically file large original patent applications early in the drug development process. Those original applications typically disclose many variations of a class of drug along with various methods of manufacturing and using the drug. As development continues, follow on continuation applications are used to specify and claim particular subgroups. The continuations also typically include further information to prove utility and nonobviousness of the particular subgroups.  These rule changes will severely limit GSK’s ability to file these continuations and, as a consequence, will hurt its position.

GSK notes that the PTO’s exceptions to the rule is primarily mythical because it requires a strict “could not have” limitation.

  • Read the Complaint
  • The complaint was filed by my old firm of Kirkland & Ellis. This is perhaps odd since Kirkland does no patent prosecution.

111 thoughts on “GlaxoSmithKline vs. Dudas: An Attempt to Stop Implemention of PTO Prosecution Rules

  1. 111

    P.S.: If these rules are enjoined, heads should roll at the PTO, specifically the Chrome Dome of Doll, and his boss DudeArse. Instead, Bush will probably give them the Medal of Freedom– freedom from neverending-continuations, excessively-claimed, patentably-indistinct, and otherwise pesky patent applications. The pending IDS rules should also be the target of similar litigation.

    The PTO is the editor-in-chief and judge for a unique law quasi-judicial agency with exclusive jurisdiction over the most difficult type of legal writing, and it requires a patent attorney in that job. Lehman was a non-Registrant copyright attorney, and Dudas was counsel to some Committee on the Hill. In recent history, only Todd Dickinson fit the bill.

    Just my opinion.

  2. 110

    The Manbeck dec is not deficient for failure to explicitly state the usual language of “in my professional opinion as an expert”. The Court will not exalt form over substance, and no one is seriously in doubt about what his expert opinion is. With the AIPLA amicus entry, I see better than even odds for a PI.

  3. 109

    Okay Malcolm, you win. But I restricted a lot, which helped to narrow the search and possible issues. I had very few RCE’s near the end.

  4. 108

    “That is the excuse examiners use often. I was a primary examiner and I know a “better” reference when I see it. It is because I had read the specification and had that in mind while searching.”

    My specifications are loaded up with enough support to enable to me go in multiple directions, depending on what art the Examiner presents. In fact, if I can, I will often go down two paths simultaneously, in different claims, to make it even more difficult for the Examiner to figure out the nature of my game.

  5. 107

    MM:”Give me a break. How the frick is an Examiner supposed to find the “best art” to invalidate claims that have NOT YET BEEN PRESENTED? Is the Examiner supposed to read the Applicants mind to determine every possible amendment/argument that the Applicant could make?”

    That is the excuse examiners use often. I was a primary examiner and I know a “better” reference when I see it. It is because I had read the specification and had that in mind while searching. Also, much of what happens when making a rejection involves interpretation and stretching it to “make a referenct fit” into the terms of the claims. The better reference is usually spot on (i.e., no mincing of words).

    Some judge once said something like “it is hard to define pornography, but I know it when I see it.” The same is true when considering references. It is especially true when you consider that the better reference supplied with the sixth action could have been used to reject the originally filed claim.

  6. 106

    “If you want the best art in the case for what you REALLY INVENTED, make sure that at least a few of your claims are specific enough to actually read on what you invented. All too often, the original claims (as well as a few iterations) do not really recite what the invention is but some excessively broad version of the invention.”

    And why is that? Because the clients are told by VCs who are told by investors that the picture claims which cover the actual invention are not valuable.

    Isn’t that interesting?

    Here’s how this strange situation came about: the US patent office back in the “good old days” routinely issued stupidly absurdly broad claims. Patent prosecutors and the clients LOVED those claims. And the clients and their “investors” loved going around and whacking people over the head with those claims. In response, the people who got their heads whacked in decided to get their own bats, which were duly issued.

    Now the price of getting a bat has gone up. The bats are rare. All the bullies are crying and who wants to invest in a soaking wet bully holding a limp stick? Hardly anybody. So what is an investor to do? Why he’s going to put his money elsewhere! Where is he/she going to put it? In less risky ventures. What sort of less risky ventures? For starters, in ventures where the invention is much more likely to be valuable and has solid patent protection.

    Of course, that is a small fraction of all inventions. Only the smartest inventors and patent attorneys will survive.

    That’s really bad news for the bullies.

  7. 105

    “You are right that the examiner will often just use art that is “good enough” to reject the initially filed claims. While we instruct them to find “the best art” all too many and all too often examiners will stop the search when they find art that is good enough to reject the claims.”

    Give me a break. How the frick is an Examiner supposed to find the “best art” to invalidate claims that have NOT YET BEEN PRESENTED? Is the Examiner supposed to read the Applicants mind to determine every possible amendment/argument that the Applicant could make?

    Please, let’s try to keep it real. Applicants do play lawyerly games when they file applications. If an Examiner has art that anticipates the claims, then they should argue invalidity under that art.

    Of course it goes without saying that Applicants should be able to prosecute claims until allowance or rejection. The cost of doing so — whether it be through filing of RCEs or some other procedure — is a rather simple policy calculation. Denying applicants the opportunity to present claims describing their invention when they have prosecuted in good faith up to the point of final rejection is, simply, wrong.

  8. 104

    LL, we are now limited to 5/25 claims (and a limited number of continuations), making it even more difficult to compose claims as you suggest. With the RCE’s of the past, we complained a little (: , but we could live with the incremental rejections. Now, we are left to speculate and gamble, which is not good for our clients and dangerous for ourselves.

  9. 103

    Johng & Lionel Hutz,

    You are right that the examiner will often just use art that is “good enough” to reject the initially filed claims. While we instruct them to find “the best art” all too many and all too often examiners will stop the search when they find art that is good enough to reject the claims.
    Part of that is human nature. I am not trying to defend or justify it; just to explain it. If you have to get “X” many more cases done in a very limited amount of time, you need to cut some corners somewhere. Having art that is good enough to reject the (often way too broad) claims is often rationalized as a reason to stop the search, write it up & move on to a new case.
    Yes, you can (& should) complete the search & maybe find better art or art that “might” apply to some future amendment. And, in the long run you will be better off doing a complete search for the 1st action. However, if you need more counts for the PP/quarter/FY, self-interest (getting those counts & keeping your job) is a lot stronger incentive than what “might” make things easier in the future or doing things “by the book”.

    Now, who/what is to blame for this. Part is the production system & the way it is set up. Part is the hrs/bd. And a big part is the applicant/lawyer (sorry, guys). If you want the best art in the case for what you REALLY INVENTED, make sure that at least a few of your claims are specific enough to actually read on what you invented. All too often, the original claims (as well as a few iterations) do not really recite what the invention is but some excessively broad version of the invention. This contributes an awful lot to the issue of “close enough” art being applied & just incrementally better art being added thereafter.

    Doesn’t the MPEP still indicate (suggest?) that the applicant file claims that vary in scope from the “broadest they think that they are entitled to on to the most narrow that they are willing to accept” (paraphrase, not a direct quote). If you all actually did this, there would be a whole lot less of the problems you are talking about here. Why do you not file claims along these lines?

    thanks,

    LL

  10. 102

    Johng articulates my primary concern with the new rules.

    I have had to file 2 RCEs in cases where the Examiner started out with references that when combined could arguably (but laughably) cover theinitial claim language and then with each amendment, better art is produced. I should say that some Examiners have been good and issued multiple nonfinal actions, but most rely upon the Applicant’s amendment as an excuse to issue a final rejection with a new reference.

    An applicant should always have the right to an RCE or a Continuation where the Examiner introduces a new reference on final.

  11. 101

    I guess you’ve never been subjected to an “incremental” search, where the least relevant documents are cited first (just good enough to meet the claim features) and each action thereafter reveals prior art incrementally more relevant that follow the claim amendments.

    Finally, in the sixth or seventh action, you get the document that should have been cited in the first action. This is one of the chief problems causing churning and backlog.

  12. 100

    MM, for the first scenario, it would appear that you properly could with both the new and old rules. Thas is, as long as the claims are not simultaneously pending. But, the new rules will prevent you from doing it more than a predetermined amount.

    I think statutory DP would prevent you from having both claim sets pending at once in both scenarios, but the new rules would make you declare the other set. I guess this would prevent someone from shopping for a different examiner. I never considered doing something like this unless the examiner is nutz, and there are other remedies for that.

  13. 99

    I have a silly question.

    Let’s say we didn’t have the new rules.

    You file an application. The original claims are examined and rejected. You make some amendments. The Examiner rejects the amended claims as well. You amend some more. The Examiner rejects and you let the case go abandoned.

    Under the OLD RULES, are you allowed to refile and prosecute *the original claims* in a continuation? i.e., literally take another bite at the apple?

    In a related scenario, let’s see that instead of abandoning, you appeal all the way to the Supremes and lose. Are you allowed to refile the identical claims and prosecute them again (say, with “new” arguments for patentability)?

    I think the answer to both questions is HELL NO. But I’m curious what others think.

    The reason I ask is that some of the commentary about the new rules appears to imply that this sort of refiling and reprosecution of claims was kosher.

  14. 98

    “I hope it took him at least 20 hours of billable time to parrot the language of the complaint.”

    It’s likely that the complaint and the declaration were prepared in concert to ensure that the declaration supported each fact alleged in the complaint. It’s just that the complaint came first for obvious reasons.

  15. 97

    “Step Back” writes “IMHO, except for the last 2 paragraphs (Conclusion), Manbeck’s declaration is worthless because it does not set forth his professional opinion as a patent expert and more so as past commissioner who was charged with reading and interpreting the statutory code.”

    I disagree in that I thought that it was a very strong declaration. However, I agree that it could have been made stronger by setting forth his “professional opinion as a patent expert … ”

  16. 96

    OK. Just finished reading Manbeck’s 18 pager. (I hope it took him at least 20 hours of billable time to parrot the language of the complaint.)

    IMHO, except for the last 2 paragraphs (Conclusion), Manbeck’s declaration is worthless because it does not set forth his professional opinion as a patent expert and more so as past commissioner who was charged with reading and interpreting the statutory code.

    As to Manbeck’s para 47 about the “could have” language, it makes no sense to a new school practitioner such as myself. Manbeck must be so old school that he doesn’t understand how computer programming works. A computer of old, physically “could have” printed any document it was programmed to print (within the limitations of its daisy wheel or chain printer). But until it was programmed by thought process to print the document, it really could not have, because the semi-nonphysical software was not there. Manbeck’s (and GSK’s) approach to the “could have” language is definitely old school and predating the advent of computers into the human understanding of the universe. (Like the discovery of DNA, the proliferation of computer software has profoundly altered how we humans think about ourselves and what we “could have” or not could have done because the software was not in our heads. Example: before the software for Hiemlich maneuver was in my head, I personally could not and would not have saved your life with said maneuver.)

  17. 95

    Malcolm,
    Thanks for the tip.
    A summary of Manbeck’s Decl. is now posted here:
    link to patentdocs.net

    The actual declaration (18 pages PDF) is here:
    link to patentdocs.net

    So he bills at 7 benji’s per hour. Wow.
    I haven’t finished reading all 18 pages yet, but hooray to Manbeck’s Para 18 where he brings out something long forgotten by the USPTO, namely, the statutory law. Gee, no wonder he pulls in 7 benji’s per.

  18. 94

    Patent Leather –
    Are you suggesting that it will only take a few weeks for the PTO to act on/deny a petition?

    Which mail stop are you sending your petitions too?

    😛

  19. 93

    PatDocs reports

    “GSK has filed a declaration from none other than Harry F. Manbeck, Jr. (at left), former Patent Office Commissioner under President George H.W. Bush and now a member of the Rothwell Figg firm in Washington, D.C. In addition to his government service, Mr. Manbeck served as general patent counsel to the General Electric Company, which enhances the credibility of his testimony regarding the New Rules. The Patent Office has filed a motion to strike this declaration, which will come as no surprise once the declaration has been read and appreciated. …. It will be interesting to see how the Office attempts to rebut Mr. Manbeck’s informed opinion.”

    Who needs a rebuttal? Dudas can get Michelle Malkin on the phone and she can persuade her thugs to dig up some dirt on Manbeck and his immediate family. That’s the modern way of handling these controversies.

  20. 92

    “Does there exist an Ann Coulter of patent law?” Halloween’s just around the corner, and wouldn’t that be one grisly goitered ghoul to dump on Dudas’ rules?

  21. 91

    “Does there exist an Ann Coulter of patent law?” Halloween’s just around the corner, and wouldn’t that be one grisly goitered ghoul to dump on Dudas’ rules?

  22. 90

    Cool.
    Someone is promising to provide us with live updates:

    PLI to Cover GSK Injunction Hearing Live
    link to infringement.blogs.com

    “So stay tuned to the Patent Practice Center blog throughout the day on Wednesday, October 31, 2007. The hearing starts at 10:00 am and we plan to have a lot of undates as soon as anything worthy or reporting happens. ”

  23. 89

    “Rumor has it (as reported by Aharonian) that there is 3rd suit already in the works.”

    Can someone provide more info on this?

  24. 88

    I think the suit with the fact pattern most likely to prevail will be the following fact pattern: Application A already has two continuations filed on it pre Nov 1. On Nov. 1, the “one more” continuation is filed. On Nov. 2, yet another continuation is filed for a “legitimate” reason (such as to add unclaimed subject matter) with a petition (which will be denied). Now, the party files suit claiming a clear and concrete violation of 35 U.S.C. 120.

    I suspect some parties are waiting until Nov. 1 to take the above action so that they will have the best possible case. I suppose a few extra weeks of the new rules won’t kill anyone 😉

  25. 87

    RA,

    The rules are so complicated that it’s hard to remember who gets hit with what arbitrary part of all the new rules when.

    OK, so let’s say it’s your 4th continuation and it hasn’t issued yet. But you get your 4th “pending” continuation to issue after Nov. 1 while another person who files on Nov. 1 doesn’t get their “pending” 4th to also issue. And for what statutory reason? Because the Director “feels” that way?

  26. 86

    “So what happens to all app’s that are allowed, pending but do not issue until Tuesday Nov. 6th or Nov. 13th? Do they get pulled for violating the 5/25 rule and if not, why not? Isn’t there an equal protection violation at that point?”

    Stepback, am I missing something in your logic? If an app has had a FAOM before Nov. 1, 2007, it’s not subject to new rule 75, right? (FR, 46716)

  27. 85

    Does there exist an Ann Coulter of patent law . . . hmmm anyone who has written derogatory articles about the current practice?

  28. 84

    Stepback and Jones, I very recently became aware of a “fourth” one not related to the one discussed by Greg. I can’t divulge further information, other than they will be working to join GSK’s suit. There likely are more in the works.

  29. 83

    Jones,

    Rumor has it (as reported by Aharonian) that there is 3rd suit already in the works.

    Do realize however that all these pre-Nov. 1 suits are of speculative nature in that they are predicting damages but do not yet have actual damages from the supposedly-not-yet-in-effect rules.

    Let’s say that after Nov. 1, 2007 you are a party whose patent app has already been allowed and you paid the issue fee and suddenly you get a rescission notice from the PTO: We’re not going to grant your paid-for app because it violates the 5/25 rule. Now you’ve got real damages and a real taking by a Federal agency. That’s a different fact pattern from a pre-enforcement suit.

    An interesting problem for the USPTO is that of them not uniformly exercising the 5/25 rule against all “pending” applications. The next Tuesday after Nov. 1 is Nov. 6. So what happens to all app’s that are allowed, pending but do not issue until Tuesday Nov. 6th or Nov. 13th? Do they get pulled for violating the 5/25 rule and if not, why not? Isn’t there an equal protection violation at that point?

  30. 82

    Why have only 2 parties come forward after 2+ months to challenge these rules?

    A few more new actions filed in advance of the upcoming preliminary injunction motion hearing may help the atmospherics and increase pressure on PTO.

  31. 81

    Getting ahead of myself – but not too much – any speculation on whether either party will ask Moore to recuse herself if she’s assigned to the panel that hears this thing when it comes up for appeal? She was after all the one who (together with Lemley) as an academic wrote the bogus article about how continuation practice needs to be reigned in, and thus gave the PTO ostensibly objective evidence in support of their moves. (I say bogus because I found the article to be (a) tautological and (b) full of anecdotal, not statistical, evidence; and in her brief career in private practice she was a litigator, not a patent procurer.) That’s not to say she would necessarily be partial here to the USPTO – she might agree that proper procedures weren’t followed in implementing the rules – but it would sure look funny for her to hear an appeal of a case that she at least indirectly helped create.

  32. 80

    TJ

    New 37 CFR 1.75(b)(1) prevents an inventor from taking allowed dependent claims, if for example 3 independents and 17 direct dependents were originally filed (without an ESD, of course) and the independents are finally rejected and the dependents were all allowed.

    How is THAT a good thing? How does that forced dedication to the public or the forced filing of a Continuation and ESD for ALLOWED CLAIMS add to clarity and efficiency? What if the applicant has no continuations left? How is all that extra paperwork a good thing?

  33. 79

    If there was a line in Vegas on whether the PI would be granted, I would put it at 50/50. What does everyone else think?

  34. 78

    TJ, I really can’t understand your position. Speaking as an in-house attorney, when we want to enter a market, we look for issued patents and published applications. If the search returns something close, we further check (in no particular order): (1) the assignment database, to see if it’s owned by friend/neutral/foe; (2) the fee window, to see if it’s still in force; (3) the Continuity tab in PAIR, to see the other applications/patents in its family tree; and (4) the prosecution history of the reference at issue and any relatives that seem to matter.

    What we know at the outset is that we must avoid both the claims of the reference as well as the disclosed but as-yet unclaimed subject matter relevant to our intended market entry.

    You’d previously mentioned finding a continuation with a generic claim and a killer prior art reference (based on one species). When that happens to us, we just make sure our product fits within the “invalid” space, where the applicant’s claims (now and in the future) can’t reach us. Or we innovate and come up with our own solution.

    When we file on an invention, we expect to gain patent protection for as much of what we invented/disclosed as possible. I therefore don’t begrudge other applicants — even our competitors — that same legal right.

  35. 77

    The docket yesterday shows that a hearing on the preliminary injunction motion will be held on Wednesday, October 31 at 10 AM before Judge Cacheris, and that Glaxo’s case has been consolidated with Dr. Tafas’. From my reading of the complaints, I’d at least grant a TRO.

  36. 76

    oops – typo. Last sentence should read:

    “Somehow I’m not surprised SHE voted for the patent reform act, even when most Republicans voted against it.”

  37. 75

    step back:
    “Art. I, Sect. 8, Clause 8: [Congress and the agencies shall have the following shared powers:] To promote the progressively advancing stranglehold of big business and the usual politics by securing to CEO’s and Two-party members for unlimited times (especially to CEO’s of Disney) the rights to the respective discoveries and writings of those who deserve to be less fortunate (although they are doing as best as they can for themselves, the poor dears).”

    This would make a great t-shirt.

    I am a bit surprised by the copyright protection views held by Congress, and the almost opposite view of patent protection by the same Congress. Then again, Mary Bono owns a lot of copyrights but likely doesn’t own any patents. Somehow I’m not surprised voted for the patent reform act, even if most Republicans voted against it.

  38. 74

    “As I read it, you are endorsing the proposition that the PTO is an awful bother and patentees shouldn’t need to write claims upfront, instead of offering a reason for the PTO and claims’ existence.”

    TJ, I think you misread my position.

    I complain about the combination of eliminating writing of claims up front and eliminating continuations. I think it’s intellectually dishonest to ignore the claim limits portion of the rules in the discussion, because the interaction between claim limits and continuations has particularly harsh results that cannot be justified even if the notice effects of claims is the paramount consideration.

    Under the rules, inventors are quite often proscribed from providing full notice of their claims in an application. Further, some aspects of the rules (for example the relaxing of claim limits for a continuation filed after allowance of the parent but before issue) make little sense (they don’t save the PTO any work) and actually compound the problem of notice.

    Why should there be limits on “voluntary divisional” applications. IMO those limits are not based on “notice” but rather on limiting issued patents and limiting work for the patent office.

  39. 73

    “Is the PTO … representing itself?”

    Well it certainly isn’t representing We the People.

    Here is the new new Constitution:

    Art. I, Sect. 8, Clause 8: [Congress and the agencies shall have the following shared powers:] To promote the progressively advancing stranglehold of big business and the usual politics by securing to CEO’s and Two-party members for unlimited times (especially to CEO’s of Disney) the rights to the respective discoveries and writings of those who deserve to be less fortunate (although they are doing as best as they can for themselves, the poor deers).

  40. 72

    “Is the PTO being represented by an outside firm, or is it representing itself?”

    I would highly recommend that the PTO keep it in-house and have Margaret Peterlin handle it.

  41. 71

    TJ: We disagree as to the practicality (if not possibility) of designing around disclosures prior to the chain of continuations ending. It’s too hard to agree on policy when we cannot agree to the underlying facts.

  42. 70

    It seems that we are the only people left in the conversation, but regardless:

    “pending continuation gives notice too” — a very different kind of notice. If we had an explicit rule that patentees can just rewrite claims for the first time in litigation, that would be “notice” that they could do that, too. A pending continuation is (a) not on the face of the patent, it needs to be dug up; and (b) indeterminate, compared to the clarity that claims are supposed to confer. In a world of unlimited continuations, the notice function of the claims, it seems, is reduced to an asterix, “*scope of property right to be determined later”.

    “the specification is only part of the analysis” — the other parts are (1) the prior art, which will be there no matter what, too; (2) the issued claims, which in your world isn’t worth the paper they are written on; and (3) the prosecution history of those issued claims. Thus, the only value of writing claims ex ante is that it generates a record of those claims being written. Is the PTO really there *just* to generate a paper trail for itself?

    “indeterminable” — talk about picking nits. As an economist, nothing is impossible with infinite resources, so yes indetermin”able” is overboard. To the extent that maximum potential patent scope can be determined under reasonable cost limits, it is cheaper for the patentee to do than for a potential competitor to do, because the patentee presumably knows what his OWN invention is. But in your world every fence still has an amorphous, invisible, indetermin*ate*, and retroactive nebula.

  43. 69

    The PTO probably anticipated a lawsuit over these rules and is prepared for a fight. This should not have been a surprise to the PTO.

    Is the PTO being represented by an outside firm, or is it representing itself?

  44. 68

    TJ wrote, “All I am saying is that if you believe that competitors are simply not entitled to rely on claims as written, then why bother write those claims? If claims can be changed ex post, why bother have them ex ante?”

    Issued claims give notice. But a pending continuation gives notice too: that the applicant has not yet dedicated the disclosed, but unclaimed subject matter.

    Thus, copyists (i.e., those wanted to *copy* disclosed, but unclaimed subject matter) can rely on the end of a chain of continuations to know that the applicant has decided what to dedicate and what not to dedicate. Until then, the copyist aware of pending application would be foolish not to consider the risk that the applicant may later draft claims that cover some the previously unclaimed subject matter.

    Why have claims ex ante? Because the issued claims, the prosecution history associated with those issued claims, the prior art, and the content of the specification collectively provide the copyists with sufficient information to assess that unclaimed subject matter may be properly claimed and then, either wait for the end of the continuation, or come up with a substantially different design.

    TJ wrote, “The patent specification will be there no matter what, which is apparently the only document you believe that a potential competitor (who you call a copyist) is entitled to rely on.”

    No, as mentioned in this post (and above), the specification is only part of the analysis. Your straw man (using the specification alone) wasn’t what anyone was suggesting.

    TJ wrote, “I am not saying that the risk of assessing a potential continuation claim is hopelessly difficult.”

    Actually, you did say that. (“To take an analogy, you would be untroubled by a amorphous, invisible, indeterminable, and retroactive nebula eminating from each and every fence surrounding real property; which neighbours cannot see but must not walk into.”) Or are you now admiting that “indeterminable” analogy is over the top?

  45. 67

    LL,

    To also quote that same president, I won’t hold your youth and inexperience against you. 🙂

    No offense, but I don’t care about getting support from examiners. My experience is that most of the senior examiners have the same line as POPA: more time should be given for every single app on every single examiner’s docket. Regardless of the actual time it would take to dispose of the case. That argument is so old and tired, and discredited, that I’m really disappointed that you would even bring it up in this forum.

    Like I said, any system premised on “the average case” can be disposed of in X hours is doomed. Doomed. Doomed. Doomed. Bumping the average up 1 hour, 2 hours, whatever, ain’t gonna save it.

    My proposal is for my client’s benefit, to ensure that they get what they pay for, extra claim fees for extra examining resources. As they pay my salary, I limit my advocacy to what is to their benefit. Nothing personal.

    The single most effective rule change PTO (mis)management could make is to forbid re-opening prosecution in response to an appeal brief and/or forbidding new grounds in an examiner’s answer (which they did for awhile, but stupidly reintroduced in September, 2004). Why would that be the most effective? Because it would put examiner’s on notice that if they are going to send out an FR, it better be good. No more of this, “Oh crap, these guys are serious!! They filed an appeal brief. I better actually read and search the case!!” There’s too much of that in the examining corps.

    I recently filed a brief against a 4 reference combination using the same “teaching away” arguments that had been presented before, even before KSR, and what I got was a re-opening of proseuction with a new, 2 reference combination, one of the references having been sitting in the case, unapplied for the past 3+ years, and a brand new reference that should have been found during the first, and theoretically updated, search. That examiner, and SPE, should be put in a stockade or pillory right out there on the “frisbee field” in front of the Madison building. And rotten tomatoes thrown at them.

    Is that examiner’s rating going to be negatively impacted by the lousy job that was done resulting in a complete waste of the applicant’s time and money? You and I both know the answer to that question is: NO.

    When it is, maybe we can discuss being “fair” to the examiners.

  46. 66

    “The whole point of unlimited continuation practice is that for the entire life of the patent, the claims are not set, because you can get additional claims (broader, narrower, different) through continuations for the entire life of the patent.”

    Isn’t this in direct conflict with 35 USC 120? I’m not sure what he’s talking about as “the entire life of the patent.” Once the patent issues, you can’t get any more CONs off it. Once an application has been published for over a year, it will anticipate any further claim to that application not claiming priority to that application.

  47. 65

    “The only reason patentees need the patent system is that otherwise they would be disadvantaged in the free marketplace.”

    TJ, it’s not patentees alone that need the patent system – don’t you see the societal need?* Or did you not see how fast science, technology, and creativity advanced in the Soviet Union, or has advanced in the Middle East? What’s the difference between here and there, sir? Check it out:

    link to corporate.britannica.com

    To be sure, Asian technology can advance in one sense to the extent that IP rights are ignored, but that advancing is only a “following” – until IP rights are fully respected, Chinese technology and creativity will never push the envelope, because it’s more profitable to follow. Why create when you can copy? (There’s considerable truth to that proposition – its the whole “public domain” concept.)

    And the Coalition for Patent Fairness (with the likes of Microsoft and RIM and the American Corn Growers Association) are perfectly content to follow (either because they have their market position secured by other means or because they cannot do the cutting edge research), and would have you believe that America can remain healthy and follow.

    After all, hasn’t Microsoft done just that with operating systems?

    [*Somehow, I think you and others now see patents as “evil” because the Office has been issuing bad patents at an incredible rate for the last 15 years (some of us have much more extensive data that blows the doors off what the USPTO would like you to believe about a 4% allowance error rate). The concept of “patents” is not evil; but the concept of socialism likely is. Why not address the cause of the issuance of bad patents, or do inventors now have to both invent and determine patentability? What on earth is the role of the USPTO? There certainly are problems with the patent system, but the problems that stem from the applicants are much smaller than the problems that stem with the Office. Perhaps you’re throwing up smoke so no one will look at the Office, or you think the Office’s self-made problems have become uncorrectable without cutting off patent applicants first. I believe you are wrong in both respects.]

  48. 64

    Patent Leather:

    As you know, PIs are generally decided based upon the following criteria:

    A. Substantial likelihood of success on the merits by the movant.
    B. Substantial threat of irreparable damage or injury to the movant if a PI is not granted.
    C. Balance of harm weighs in favor of the movant.
    D. Its grant would not disserve the public interest.

    In this matter the linchpin issue seems to be A above. B appears to be satisfied since money damages cannot replace the loss of substantial rights. C appears to be subsumed within B. D would not appear to be an impediment since the current state of affairs does not disserve the public interest, so it is difficult to see how holding off on rule implementation would be a disservice to the public. Couple these with the observation that if the rules go into effect and are later overturned, there is no way to effectively and fairly “unring” the bell once it has been “rung”.

    It is with this backdrop that my concern is whether or not the GSK complaint presents a compelling argument with respect to A above. As I have stated before, the complaint appears to base the majority of the enumerated causes on what is asserted to be an ultra vires act by the PTO. It is predicated on Article 1, Section 8, Clause 8, Title 35 and PTO rulemaking authority versus the statutory language re continuations, the legislative history, and what is believed to be controlling case law. Retained counsel is no doubt adept at presenting arguments to the court, but to me it ultimately comes down to how adept is counsel at articulating the likelihood of success on the merits when the underlying facts are inexorably tied to the vagaries of prosecution practice. By no means will this be an easy task, and I would certainly hope that retained counsel is at this moment taking a detailed and comprehensive crash course on 37 CFR and the MPEP.

    While likely a tactical decision for which reasonable minds can differ, I would have been inclined to raise additional issues concerning the rulemaking process itself that was used by the PTO. I tend to believe that two strong arguments involving A above are better than just one.

    It would be nice to also know the name of the Judge assigned to the case in order to research how he/she has ruled in the past on requests for PIs, and just what type of showing re A yielding favorable results.

  49. 63

    So TJ, because the rules would prevent someone from filing an RCE to have a reference considered after allowance, a competitor has potential intervening rights that would not have occurred if the RCE were permitted? Just asking, don’t know.

    It seems that that threat should be reason enough to grant the petition?

  50. 62

    real anonymous:

    I am not a fan of reissues either, but in reissues at least you get equitable intervening rights, which can allow the competitor who relied on the defective claim to continue to infringe because of his detrimental reliance on the notice function of the claims. Ditto for reexam.

    I do not understand what you mean by business sense. The only reason patentees need the patent system is that otherwise they would be disadvantaged in the free marketplace. Nothing wrong with that–just means patentees have a comparative advantage in research. But to suggest that non-patent-holding competitors cannot compete in the market is backwards.

  51. 61

    I am curious what everyone’s opinion is here. Do people think the rules will go into effect on Nov. 1?

    My guess is yes. I don’t think there will be enough time for GSK to get the preliminary injunction. And since the USPTO demonstrated their extreme stubborness to enact illegal rules against the concerns of almost the entire patent bar, I doubt they will stop now. They probably don’t care about the future mess it will cause when GSK does ultimately prevail (I strongly believe they will– I don’t see how they can counter GSK’s solid complaint).

    So what does everyone else think? New rules on Nov. 1?

  52. 60

    Woops, I realize now I had a mix-up regarding topics. My last message should have been posted in the Moatz topic. Sorry about that.

  53. 59

    My original concern was that an IDS including a killer reference would not be considered after allowance. I guess reexamination, not reissue, would be the proper route to have the reference properly considered. This should cause a big spike in reexaminations.

    However, in theory, the error is really being caused by the PTO. Tyrants!

  54. 58

    “Back again to the competitor who sees an original issued patent with a claim, finds killer prior art that renders that claim dead-on invalid, invests millions to come out with a product, and then finds the original issued claim completely irrelevant as he gets nailed by the continuation.”

    Or the reissue? Sounds like he didn’t have good advice from someone who knew patents, or good business sense. Patents don’t issue in secret. In that case, shouldn’t we just let natural selection work its course then? Maybe the competitor would be more adept and valuable at teaching business in a university, or running a government agency rather than in business. Don’t kill the patent system just for him – redeploy his capital to an area where he may be more skillful, and produce more viable results.

    The economic argument for weakening the patent system to help those who are weak in business isn’t really compelling, and if you pursue such a course you will no doubt destroy our national economy (in the international market) in the process.

  55. 57

    I am concerned about the right of a competitor/copyist/whatever to use another’s disclosure because much scientific research builds off existing knowledge. I think even SF would concede that a substantial change from the patentee’s specification (which is nonetheless based off that specification) promotes the useful arts.

    My concern about ex post malleability is not limited to two years (I assume you are talking about broadening reissue). Unlimited continuations are not different from a broadening reissue in effect, except you don’t get an intervening rights defense and they are not limited to 2 years. The whole point of unlimited continuation practice is that for the entire life of the patent, the claims are not set, because you can get additional claims (broader, narrower, different) through continuations for the entire life of the patent. Back again to the competitor who sees an original issued patent with a claim, finds killer prior art that renders that claim dead-on invalid, invests millions to come out with a product, and then finds the original issued claim completely irrelevant as he gets nailed by the continuation.

  56. 56

    TJ – what do you call someone who relies upon and appropriates unclaimed subject matter, if not a copyist? Why are we concerned with this person’s rights to another’s disclosure if we want to advance the useful arts?

    Also, your concern about claims being ex post maleable is valid — for 2 years after issue, at most. That means for the majority of the life of the patent, the claims are set. …And for the entiretey of the period during which claims may be infringed, the claims are set (by definition). Why is this not enough notice to a “competitor”?

  57. 55

    SF: It is not a straw man. The patent specification will be there no matter what, which is apparently the only document you believe that a potential competitor (who you call a copyist) is entitled to rely on. All I am saying is that if you believe that competitors are simply not entitled to rely on claims as written, then why bother write those claims? If claims can be changed ex post, why bother have them ex ante?

    I am not saying that the risk of assessing a potential continuation claim is hopelessly difficult. I am saying that it is *more* difficult than the patentee assessing the risk of a competitor design-around. More fundamentally, I am saying that, if the “notice function of the claims” means anything, it means that the risk of ex post claim changing is one that competitors are not supposed to bear in our patent system.

  58. 54

    RE: JohnDarling | Oct 15, 2007 at 09:47 AM

    JD (quoting the 2nd best president of the last 40-some years; Nixon being the best 😉 ),

    “There you go again.”

    You once again just grabbed one line & skipped the rest. Hope you read rejections & references more closely. While, as one of a set of ideas, I did say to add a 3rd count to cases (for finals), I also said to give negative counts for finals that are withdrawn (quoting “However, if the examiner has to withdraw a final, the get a negative count. Maybe even a negative .5 count for each 2nd etc. non-final when it is the examiners fault”). You file an appeal (or pre-appeal) and the examiner re-opens, he looses the count. If anything, this is incentive to either make a better final or to allow the case, and quicker disposition of the case, not to make more bad finals.

    Further, I never said I was against giving less hours for easy cases. I said that your idea was an artificial evaluation of what was an easy or hard case. I also said that, from an examiner point of view your idea would not help any. From the applicant’s point of view, I agree that if they pay more money for something they should expect more services. Adding more time for longer cases & less for shorter makes sense from that view. Of course, do you really want to tell your applicant that since the claims were only 20 instead of 25 or the spec was only 15 pages instead of 40 (or whatever) the examiner is not going to take as much time to examine their case as their competitors which is longer? They’ll probably tell you to add some stuff to get up to the point were no hours are subtracted, anyhow.

    Now, as to why your idea will not make a difference to examiners (i.e., effectively a zero-sum game). Assuming that the current 20 hrs/bd is based on the average case (which it is supposed to represent, so a fair assumption) and assuming that average and “median” or “mean” are the same thing (yes, not necessarily true but probably close enough for now; at least until we get more data,anyhow), the following will occur:

    1/2 the cases will be “easier” than the average (median) case and thus get fewer hours by your formula;
    1/2 the cases will be “harder” than the average (median) case and thus get more hours.
    Total result – in the long run no real net change in the number of cases that need to be done for a given year. Just like in Vegas, in the short run things may go your way, in the long run the odds will come out to what the math says.

    So, unless the cumulative number of cases that would need to be worked on over a long period of time (e.g., a FY) would go down, why would the examiners support your idea? And, off-hand, without seeing exact numbers for claims, spec pages, etc & what the +/- numbers would be, it seems like it would be just “robbing Pete to pay Paul” in terms of hours. If you think my analysis is wrong, please explain it. As it is, an examiner would not benefit so why support it? Just like you wouldn’t support fewer claims, which is a big plus for examiners. There has to be something in it to get the examiner support.

    thanks,

    LL

  59. 53

    TJ:

    No one is responding to your straw man (abolishment of the USPTO with claiming in litigation) because it’s not remotely close to late claiming under the current continuation practice.

    Under current practice, a copyist is free to look at the pending patent disclosure, the prosecution history and the prior art to determine whether claims could be written to read on their proposed design around–which I don’t believe is as difficult as you characterize. If they determine claims can be drafted, they can either continue with their design and risk infringement of subsequently drafted claims or (God forbid) they can come up with a new, substantially different solution.

    You apparently believe that assesing the risk that an applicant could draft claims to read on the copyist’s “design-around” is hopelessly difficult. I disagree. But given your perception, it is no wonder that you suggest that litigation claim drafting and abolishment of the USPTO is somehow analogous to current continuation practice.

  60. 52

    ThePTO is supposed to make its annual presentation before the AIPLA Relations with the PTO Committee at the AIPLA annual meeting in DC on Friday.

    I expcet a packed house. Can’t wait for the answer to the questions “In view of the GSK litigation is the PTO sure that the rules will go into effect on November 1? And if not, what will be the result of a preliminary injunction?”

  61. 51

    JohnDarling, perhaps “unless otherwise indicated” at the end of 104(a) covers the matters of form that can be held in abeyance under 111(b)… I had wondered what that might mean. Anyway, I figure the affect of the “and other requirements” on Examiners’ morale won’t be good. I guess like the Deputy Director is reported to have said, “We’ll just have to wait and see.”

  62. 50

    real anonymous,

    Don’t forget that under Rule 111(b), applicant can request that matters of form be held in abeyance until allowable subject matter is indicated.

    If you find new Rule 104(a)(1) to be in direct conflict with existing Rule 111(b), that may suggest to you that the new rule package is half baked.

    Of course, this goes back to all these nonsensical drawing objections and this huffing and puffing by the examiners (via their form paragraphs) that the objections to the drawings “WILL NOT BE HELD IN ABEYANCE” and failure to provide corrected, formal drawings will result in the response being held non-responsive.

    Never let it be said that little things like 35 USC and 37 CFR slowed down PTO (mis)management in their efforts to 1) blame all the pendency and backlog problems on their “customers” and 2) write new rules to “solve” those problems that are so convoluted that 6 weeks after their issuance they’re still updating/clarifying/waiving certain provisions.

    The seeming discrepancy between new Rule 104(a)(1) and existing Rule 111(b) is not apparently big enough to get on PTO (mis)management’s radar screen.

    JD

  63. 49

    “Just Visiting”:

    As I read it, you are endorsing the proposition that the PTO is an awful bother and patentees shouldn’t need to write claims upfront, instead of offering a reason for the PTO and claims’ existence.

    It is an intellectually consistent position to argue that, instead of abolishing continuations, we should just abolish claims and the PTO. But I am still waiting for someone to articulate a reason why: (1) we should have claims (seperate from and in addition to the specification and the prior art) that supposedly provide notice to competitors, but (2) we should also allow those same claims to be changed without limit (subject to the specification and the prior art), ex post, through continuations.

  64. 48

    “You still have not addressed why, if continuations and unlimited claiming ex post is such a great thing, we shouldn’t just abolish the PTO and write claims for the first time in litigation.”

    The problem is that the PTO attempts to foreclose claiming an invention in an application using lots of claims, the filing of multiple initial applications holding the required claims, as well as filing continuations at some later point. There’s no way that “notice to the public” could be used to defend all of that.

    The rules affect those of us who know exactly what are inventions are but who can implement the invention in multiple embodiments all of which we consider to be valuable even when the PTO rightfully spends little extra effort evaluating the claims. At least the representative claims rules as initially proposed could reasonably accomodate the multiple embodiments that a communications application might need. Now you have the situations where those embodiments that are obvious in view of other embodimetns simply cannot be filed even though the form of the claim does matter during litigation.

  65. 47

    I recommend that all patent attys write to the USPTO asking clarification on various parts of the rules… with specific facts/problems and cc the counsel for GSK… to help give them evidence of being vague and unable to comply…

  66. 46

    SF: I think you and I are on the same page vis-a-vis the effect of continuations on patent notice function, but we just have such different views on whether this is a good thing that we cannot even agree on the label for it. To take an analogy, you would be untroubled by a amorphous, invisible, indeterminable, and retroactive nebula eminating from each and every fence surrounding real property; which neighbours cannot see but must not walk into. I think this is a really bad idea because: (1) a wasteland of uncertainty is bad for society–competitors can’t use this wasteland because of fear of infringement, patentee’s can’t use it because of fear of invalidity; and (2) it is cheaper for the patentee to state what he actually invented–by writing a one sentence claim–than for competitors to figure out what the patentee didn’t invent by reading the specification and then scouring the earth for prior art. The specification is supposed to, and always does, mix old and new elements. That is why we have claims.

    You still have not addressed why, if continuations and unlimited claiming ex post is such a great thing, we shouldn’t just abolish the PTO and write claims for the first time in litigation.

  67. 45

    “OK, examination based on the statutes and CFR, I see. But what the freak is this new “other requirements?” Look at FR 46737:col 1. Other requirements means anything the PTO throws into the MPEP.”

    Yep, that’s a biggie – all they added was that little phrase “and other requirements” so that the rules and their entourage would place a duty on the Examiners just like they do on the applicants.

    And “other requirements” (being vague) might apparently also mean anything they throw into the frequently-changing FAQs before they have time to update the MPEP (FR 46729).

  68. 44

    Does anyone know when GSK’s hearing for the preliminary injunction is? There are only two weeks left. Can they stop the rules in time?

  69. 43

    Anastasia: Another milton freedman approach would be to simply ramp up the cost of RCEs / continuations / divisionals using a model designed to deal w/ the backlog. This approach requires no new substantive rules, can easily be tweaked, and internalizes the office’s cost of “endless prosecution” within the Applicant.

    (1.5x, 2x) the cost of every cont. / divisional after a reasonable number has been filed. Conservative approach is to start w/ a linear model: every additional cont / div costs $1000 more than the previous. Take samples; if the linear model is not producing desired effects, make it more exponential.

    Right now the costs of filing are simply not an issue for many filers; a more thoughtful rate schedule could accomplish all objectives of the PTO, and is more clearly within their powers.

  70. 42

    In all of our collective hyperventilation over ESD’s and 5/25’s, I believe we are missing one of the most troubling rules in the whole mess. 104(a)(1) looks minor, but it’s potentially huge. It says that now examination is to be complete with respect to applicable statutes, rules, AND OTHER REQUIREMENTS.

    OK, examination based on the statutes and CFR, I see. But what the freak is this new “other requirements?” Look at FR 46737:col 1. Other requirements means anything the PTO throws into the MPEP.

    So they have, with this submarine, amended the CFR to allow them to avoid all the rule making safe-guards. This amendment elevates the MPEP to the status of the Code and the CFR. However, amending the MPEP is an internal process and does not include all the safeguards of proper rule making. Under the new Rule 104(a)(1) the PTO can enforce any rule it wants simply by adding the rule to the MPEP. This is a whole new rule-making paradigm.

    Babel Boy

  71. 41

    … Also, continuation practice allows the applicant to address non-infringement arguments barely permitted under Rule 11, which will likely lose in litigation. Why waste millions of dollars in litigation costs and fees (and the related judicial resources) when a continuation would quickly and easily resolve the matter? Continuation practice deters half-a**ed design around attempts and forces copyists [1] to wait for the applicant to stop filing continuations (or the end of the 20-year term, whichever comes first) or [2] to come up with a new, substantially different design. I’m not troubled by either.

  72. 40

    “You seem to concede that continuations basically destroy the notice function of claims that allow competitors to copy what is not claimed; you are just not troubled by the consequences for competitors.”

    No, I don’t concede destruction of the notice function because, if a continuation is pending, the competitors have notice that the applicant is unwilling to dedicate the unclaimed subject matter and that they should proceed with caution.

    Of course, copyists would love to leverage the disclosure-dedication rule so that they can use disclosed, but not claimed subject matter. And it’s much easier for copyists to design around claims than a specification because the relatively liberal written description requirement here in the United States makes it difficult to predict the precise bounds of what someone might claim.

    This difficulty in predicting the precise bounds of potential claims may unfairly benefit the applicant. In particular, some competitors may not pursue products because they are very similar to the disclosure and, while they believe the applicant has not enabled or described claims that could read on the products, they aren’t sure that the USPTO will have the same view.

    But, if I have to choose between an applicant that actually invented something and a copyist that is slightly disadvantaged, I’ll choose the applicant.

    In addition, copyists typically do not have to wait the full 20-year term to commence their copying. With each continuing application or RCE, applicants must weigh the cost of ongoing prosecution against the potential benefit of additional claim scope. As time passes, this cost-benefit analysis eventually persuades almost all applicants to voluntarily bring their applications to an early final resolution by not filing any continuing application or RCE. Of course, in a relatively small amount of cases, applicants may file several continuations where they see sufficient value in additional claim scope. But in each case, the value of exclusive right affects the chain’s length–leading to a fair result under the quid pro quo. Where inventions are highly valuable, the applicants will file several continuing applications. These several continuing applications create an increased burden on the public, but this increased burden is fair because the public will eventually benefit from these highly valuable inventions. In contrast, where inventions are less valuable, the applicants may file fewer continuing applications (or none at all), which is also fair because the public will be less burdened. Since economics are generally effective at limiting the length of application chains, the new rules are unnecessary.

  73. 39

    “I would also suggest incorporating the idea of adjustable hrs/bd similar to JD. But, I would made each case worth 3 (three) counts, with a final getting a count”

    Just what the examiners need, another incentive for writing an FR. (Insert sarcastic tone here.)

    Any system of examiner production/rating that relies on the premise of “well, we figure every case, on average, can be disposed of in 20 hours” is doomed to fail. Doomed.

    I understand LL’s opposition to my proposal to assign a unique hrs/BD to each case: he’d get more time for “longer” cases (and yes, I’m aware that a case with a 5 page spec can be a real dog), but less time for cherry picking the “easy ones.” And let’s admit what we all know is true, examiners cherry pick their dockets very adroitly.

    So what it boils down to is examiners are all in favor of more time for all of these tough, lengthy apps, but totally opposed to less time for the short, easy ones. Why am I not surprised by that?

    In the meantime, applicants continue to pay extra claim fees on the old tried and true mantra of PTO (mis)management that: extra claims require extra examining resources. Yet they’ve never given any examiner so much as one single extra minute of time to examine an application, regardless of the number of claims. So for 20+ years they’ve been ripping off applicants and examiners. And getting away with it. Who’s going to stop them?

    And see 72 FR 46815 (first column, about 2/3 down) where PTO (mis)management states that “The Office, however, considers it appropriate for applicants who place a disproportionate burden on examination by presenting more than 5/25 to bear these additional costs to facilitate effective examination of the application.” Huh? Haven’t applicants who present claims in excess of 3/20 been “bearing the additional costs” to facilitate effective examination by paying extra claim fees for the past 20+ years? What has PTO (mis)management done? Nothing. They took the extra claims fees and spent them. On what? Giving examiners more time to examine the extra claims? (Insert laughter here.) When you’re done laughing, go ask PTO (mis)management where the money went. Seriously, go ask them.

    Ms. Beaverhausen, please go read the 129 page FR notice and tell me where, with some particularity, PTO (mis)management takes any responsibility, no matter how small, for the backlog and pendency. I’m on about page 110 and I haven’t found it yet.

    There were many proposals made to PTO (mis)management in the 500+ comments that would have made examination more efficient. They ignored them all.

  74. 36

    PDS: “As such, I’m sure that the next president will likely want her own man”

    I have attended several functions where past Commissioners speak and mingle, and it has always been a pleasure and an honor. However, for some reason, I don’t think Mr. Doll will have much of a speaking career upon his removal from the Office. And maybe Dudas will start his own law firm. But I wouldn’t recommend sending him any constitutional law cases.

  75. 35

    I can see the point in limiting the number of CIPs, and even limiting the claim numbers. What I am having trouble with is the limiting of RCEs. Sure RCEs increase pendency, but the applicant pays for that with a reduced patent term. Limiting RCEs can only increase the number of appeals, thereby creating more pressure and a greater workload for USPTO staff. At least with RCEs, the examiner and the applicant get repeated chances to work things out, at applicant’s voluntary expense.

    My point applies to continuations as well since under the new definition, it appears continuations are essentially the same as RCEs since the claims must be within the same restriction group as the parent.

    I agree with the posters above who suggested that the changes should be rolled out incrementally. As it is, it’s going to be a mess for everyone: applicants, attorneys and the USPTO staff.

    I wish GSK the best of luck in their suit.

  76. 34

    “Does anyone know, can the newly elected president remove the Commissioner or is he guaranteed to serve out his five year term?”

    I’m no constitutional lawyer, but the USPTO is part of the executive branch and is an appointed position, and they all serve at the President’s pleasure. As such, I’m sure that the next president will likely want her own man (oops … did I just write “her”?) in that position.

    However, I doubt Dudas would want to stick around. He is likely to find some lucrative position on the outside. But where would he go? hmmmmmm

    Perhaps he could find a law firm with attorneys that hate inventors, hate small-time inventors, hate software inventions, think all inventions are obvious, dislike the profession and the professionals in the profession, have a spotty understanding of some of the law and have an unusually high (yet unwarranted) opinion of themselves and their wit. This would seem like a perfect fit for Dudas … but where would he find such a law firm in which a person with such characteristics would be welcome?

    Wait …. it just came to me, we have someone who posts (like no one else) on this board that might be able to lead him in the right direction.

    Then again, could a law firm survive having two individuals with these “talents?”

    I guess we’ll find out in a little over a year.

  77. 33

    “I really hope those over at the PTO are monitoring this post to see some of the said ‘other ways to skin this cat.'”

    Don’t count on it. They are operating to reach a goal different from pendancy reduction, just like WMDs in Iraq. Ha ha. We can’t right your boat. Put your money/hopes on GSK.

    The complaining here is justified on many levels, and alternatives were pointed out here and elsewhere for months, in fact years. You accuse people of simply complaining and not providing ideas. That was a baseless accusation. I am wasting too much time on here, as I have in the past. My time, my money.

    “sic” ’em GSK!

  78. 32

    SF: You seem to concede that continuations basically destroy the notice function of claims that allow competitors to copy what is not claimed; you are just not troubled by the consequences for competitors. We will not reach agreement on this, then. I fully believe in giving patentees the statutory term, for what he distinctly points out and *claims* as his invention. Otherwise, what is the point of having claims at all? Just abolish the PTO write claims for the first time in litigation.

    I have not addressed the ESD requirement for 25+ claims, because I am not sure it is a good idea. If it is an administrative aid like the duty of candor, I would have little problem with it. If it becomes functionally an absolute bar to having more than 25 claims, it would be problematic. A little early to tell which.

  79. 31

    “just change 101 and remove software and biz methods” – Why do this? Some of us in the software industry rely on patents to protect their technology, just as people in your industry (whatever it is) do.

    “The biggest problem now is what do we do when these are institutes if we think they are going to be changing soon afterward.” – Yes, the word from many big firm lawyers who have reviewed the GSK complaint is that GSK is likely to ultimately prevail (it is not clear if they will obtain the preliminary injunction though). This is going to be a huge mess at the PTO!! And a big embarrassment to them as well when the rules are reversed.

    Does anyone know, can the newly elected president remove the Commissioner or is he guaranteed to serve out his five year term?

  80. 30

    Unlimited CONs are a problem, but lets fix that problem first and THEN institute the rest of this crap. Alternatively, lets just change 101 and remove software and biz methods and move forward. Finally – simply increasing the cost greatly after your third RCE/CON would have likely stopped most of them, and without the uproar.

    The biggest problem now is what do we do when these are institutes if we think they are going to be changing soon afterward.

    Lets take some incremental steps and not do it all at once folks!!!!!

  81. 29

    Unlimited CONs are a problem, but lets fix that problem first and THEN institute the rest of this crap. Alternatively, lets just change 101 and remove software and biz methods and move forward. Finally – simply increasing the cost greatly after your third RCE/CON would have likely stopped most of them, and without the uproar.

    The biggest problem now is what do we do when these are institutes if we think they are going to be changing soon afterward.

    Lets take some incremental steps and not do it all at once folks!!!!!

  82. 28

    “At the end of the day, wishfull (sic) thinking and accusations of BS will get you nowhere.”

    johng, I don’t know what “accusations and BS” you are referring to. I was merely trying to stir more debate on this issue and it seems that it worked.

    Also, thanks for offering to send me a copy of your plan but it’s probably not worth it since I’m not a PTO insider and have absolutely no sway with the PTO powers that be. I’m just someone with an interest in this area.

    I am glad to see that others have ideas though. I particularly like LL’s idea of letting $$$$ dictate the number of claims that ultimately get filed, but I’m sure it wouldn’t do much to deter the likes of Exxon or Shell or similarly situated companies that seem to have endless resources to spend on patent prosecution.

    I really hope those over at the PTO are monitoring this post to see some of the said “other ways to skin this cat.”

  83. 27

    TJ wrote, “This foolish competitor is then nailed by the continuation into forfeiting his investment.”

    TJ is one of a vocal group who believe that its unfair for a copyist to wait the full 20-year term of a patent to be able to copy inventions disclosed therein. If the public gets the full benefit of a patent application’s disclosure, the applicant should get the full benefit of the 20-year term. The best way to allow the applicant to get its full benefit is continuation practice. If 20 years is too long to wait, invent it first.

  84. 26

    TJ says “…society and the PTO has no reason to go along.” How harmoniously lined up everyone’s interests are in your bureaucratic world!

    A most abominable aspect of this mess is PTO’s hypocrisy. They clearly care only about their own backlog. If they happen to harm some industries, they just don’t care. Think what their 15/75 numbers in the FR mean with respect to forced continuations, and you find out just how deeply concerned they are about closure and the notice function of claims.

    Thank you GSK for stepping up to the plate.

  85. 25

    LL, I said “adjusted.” Obviously, certain situations must be reflected in the formula for the actions per disposal. Think out of the box man.

    Regarding POPA, all I can say is that there must be trust on both sides before attempting negotiation. I know that the fruit is spoiled on both sides. This is another issue that must be tackled. Speaking of tackling, got to go now. Go Skins!

  86. 24

    You see Anastasia, there are many ways to skin this cat. As another example, John Darling presented (over at JPE) another approach (dealing with associating $$$ paid for claims #’s to an adjustment to a BD for an application). These various ideas can be integrated into a single comprehensive plan.

    I would like to forward a copy of my plan to you if you believe it may help (not sure how to do this here). At the end of the day, wishfull thinking and accusations of BS will get you nowhere.

  87. 23

    JohnG, etc.
    A rewriting of the PAP is something that would have to be negotiated with POPA about. And I doubt they would go for a change like that. Further, other things would need to be changed if the rating was primarily based on act/disp. E.g., advisories count as “actions”. Express abandonments (like with an RCE) count as “actions”. No response abandonments do not count as actions. These are just small things, but are things that would need to be taken into account for your change.

    An even bigger issue is the difference in act/disp over different arts. Some arts historically have very low rates and others high. Also, allowance rates (which would factor into this also vary greatly throughout the office). As an example, is an examiner makes a rejection, final, advisory & then the RCE abandonment, that is 4 (FOUR) actions for one disposal! They would be clearly unacceptable and they are (probably) doing a good job.

    While I do think that act/disp needs to be looked at in the evaluation of examiners, it needs to be looked at in context and not as an absolute. That is the problem with so many peoples “solutions”. They think that they can make a small change and all will then be perfect. (The same applies to JD’s idea of making every case have it’s own hrs/bd – sounds good in theory, but not in practice. For that, assuming that we already have the hrs/bd for an “average” case, increasing some & lowering others with, in the long run, result in no perceptible change in the hrs/bd for an examiner. It’s a zero-sum.)

    Changes (and probably drastic ones) need to be made. And act/disp, in context, should be a factor looked at. So should hrs/bd. Personally, I think instead of a limit on claims, they should have stuck with representative claims (maybe 10, maybe 15 or 20). Maybe the idea of a drastically increasing scale for additional claims would work (after the 1st 20, maybe the next 5 would be $100 each, the next 5 $200 each, next 5 $400 each and so on. Maybe higher. Maybe exponential?) That way the applicant would need to determine is it is financially worth it to file 500+ claims. As it is now, there is no real downside to filing a ton of claims. It often becomes like buying a lot of lottery tickets. The more you buy the better chance of winning. And it’s cheap!

    Limiting the # of CON/CIP/RCE is not something I have a problem with. I might even make it a little more restricitve in the # automatically given. BUT for additional CON/CIP/RCE, the reasons for accepting the petition should be more lenient then in the new rules (allow for new art from foreign searches; for new art in the final; new declarations/affidavits that could not have been presented earlier; etc.) Maybe making the reasons for granting each successive CON… more stringent. Also, each CON… should increase in cost (maybe double?).

    I would also suggest incorporating the idea of adjustable hrs/bd similar to JD. But, I would made each case worth 3 (three) counts, with a final getting a count (if it goes from 1st action to allowance, the allowance gets 2 counts to still get a total of 3; 1st action allow gets 3). However, if the examiner has to withdraw a final, the get a negative count. Maybe even a negative .5 count for each 2nd etc. non-final when it is the examiners fault (i.e., a bad 1st action). But no negative if it is not their “fault” (e.g., the applicant swears behind a reference or perfects foreign priority). Of course, the total hours/bd for each art would need to be recalculated to account for the new # of counts for each application. (Hopefully not just a straight increase of 50% to account for the increase in counts/case. A chance for a full reevaluation of the hrs/bd for ALL arts.)

    Externally, I would like to see ALL cases be reviewed & proofed (e.g., typos cleared up, claims written in proper form and made as clear as possible, etc.) by the applicant’s representative prior to examination (e.g., w/in 6 months from filing) and a statement filed that this function has been performed. This will particularly help with cases based on foreign applications. Will save examiners a lot of time & “wasted” effort, as well as limit the amount of 112 rejections we all have to deal with.

    This is just some things off the top of my head here on a sunny Sunday morning that I think will help improve the system. Probably a lot of other things, as well as probably a lot of issues with things I suggest that won’t work or could be better, but it is a start.

    Thanks,

    LL

  88. 22

    Anastasia, many other countries have a system where they can file an application and later on request examination (and pay an additional fee) if they want an examination. I don’t know the stats, but I think something like 20% of applications in these countries don’t get examined (the applicants eventually realize that the invention isn’t commercially viable). This approach was mentioned many times in the public comments to the new rules, but of course it fell on deaf ears.

    And as johng says above, the examiner production metrics need to be re-evaluated. It is funny that the USPTO is only NOW studying this. They claimed the new rules would help reduce examiner attrition, but this is BS. EVERY examiner I spoke to (I’ve asked every examiner I speak to what they think of the new rules) says they hate the new rules because they love RCEs and CONs since they are very easy to examine (the case has already been read and searched). Thus, the new rules are actually going to cause increased examiner attrition.

    And there was talk once about opening a branch office of the USPTO (perhaps in California). There is a huge hi-tech workforce in CA. Why not start with just a few art units with the highest pendency and over time the branch office could become the savior to our patent system. And how to pay for it? Simply raise filing fees. I doubt anyone would complain about filing fees being raised a few hundred dollars.

    But instead, the USPTO’s solution was to propose illegal rules, then ignore the overwhelming negative feedback about them, then spread false rumors that they were dead, then suddenly spring a “modified” version of the illegal rules that are even more capricious and undecipherable than before. Making them retroactive and thus requiring everyone (patent owners, attorneys) to spend large amounts of time and money to address the rules for already pending applications is just criminal.

    How would Dudas feel if suddenly new housing codes were introduced in Va (or wherever he lives) requiring Dudas to spend $$$ to make his house comply? He might then suddenly remember what the constitution is.

  89. 21

    Anastasia, I met with Dudas and Lois Boland a few years ago. I gave them a high level comprehensive plan to reduce backlog. It involved, among other things, rewriting the PAP so that actions per disposal was the most important reviewed statistic (adjusted, and set to about 2.0 for satisfactory rating), and an intensive review and upgrade of the classification system. “Smart” docketing of cases also was tied to the classification effort to ensure examiners received applications for examination that they were best able to examine in the limited amount of time.

    If you would like a copy of the brief I gave Dudas and Boland, let me know. Having had only 24 hours to produce it, I spend the wee hours putting it together, so obviously it could have been more complete.

    In short, it did not require ANY new rules!

  90. 20

    “There are much better approaches to address the pendency issue that a good bunch of leaders would explore.”

    Really?? Then I’m dying to hear your suggestions . . . . . I’m no fan of the new rules either but I think the overall point of the new rules package is a good one, i.e. there needs to be some sort of “finality” in the patenting process. Allowing companies to file unlimited numbers of continuations and RCEs is not good for the system, and results in prolonged prosecution that may continue for years and years. This practice obviously has some bearing on overall pendency at the PTO.

    I just think that it’s amusing how people will slam the PTO over the pendency issue and then turn around and be up in arms again after the PTO makes an attempt at addressing the pendency issue with changes in the rules!!!

    So what’s the other option?? The status quo?? Maybe, but people here on this board will still be complaining about the pendency issue.

    So yes, please let us hear your many ingenious suggestions for the PTO.

  91. 19

    “Furthermore, in contrast to what some other posters have said, divs and cons won’t be treated equally. We won’t be allowed to file CIPs on divs. ”

    Kinda sorta. It is my understanding that you can file CIPs if they do not expand beyond the original claims in that DIV, plus in the first prosecuted DIV (e.g. the original case) you can file true CIPs which claim new matter but they “waste” of your CONs you might like to use in prosecution. They are pushing you to file a new case, in which the original case will be prior art (see rules and Patent Reform).

    Welcome to the new rules, where a voluntary DIV is a CON, and a CON may only be a CIP in certain situations – I think, unless it changes next week, or the rules are held in abeyance, and a PI is granted, or Dudas wakes up and tries to prosecute a patent, any patent.

  92. 17

    I think we appeal everything – even out of the PTO, and go to the Fed Cir of DC courts on every taking under these new rules.

  93. 16

    1) File a huge number of apps to cover each ompound separately, it is really the only answer to the new rules in light of the new Markush rules. 500 applications anyone? I hope this is what Doll wanted, because the rules will not only increase pendancy but also the number of apps he has to deal with.

    2) As for the new rules, make sure you read them in light of the changes that will be posted to the OG Nov. 6 (changes signed Oct. 10) – this changes many answers regarding the “two RCES from two cons” question. It also waives the 60 day reporting requirement for patentably indistinct claims for aps filed before Nov. 1. Dennis – have you posted on this?

    3) What does it mean for the rules to go into effect Nov. 1 and then be modified -including reporting dates that presumable were Nov. 1 (for the CIP reporting requirements) – on Nov. 6. This should be strong argument for the PTO not understanding their own rules, and hopefully will make it into the GSK case.

  94. 15

    And while it may be true we could file additional applications, how the hell does this reduce the backlog? These rules were designed to attack the backlog, but will only increase it! Those in charge at the PTO are either idi@ts, or they are politically motivated. I think it is a combination of the two.

  95. 14

    Hey TJ, forgetting for the moment that an ESD provision exists, what about the limitations on the number of claims? You talk about multiple dependents like that way of claiming is an actual option under the new rules, but when doing so, the 25 claim limit would quickly be exceeded.

    I’m not a bio guy. I write and prosecute mostly inventions related to communication systems. It is difficult, if not impossible, to capture all the aspects properly. Believe me, I am writing claims now and I’m pulling my hair out about this sht.

  96. 13

    Sorry, I forgot to address the cost point. First, I think the situations described by others would call for Markush and multiple dependent claims. More fundamentally, however, cost goes to the incentive to invent and disclose a particular invention, and each potential dependent claim, of course, is a seperate invention. If the patentee is not willing to pony up the $50 for dependent claim no. 1324, that just means that the invention in dependent claim no. 1324 has a marginal expected present value of less than $50 at the time of filing, which is the time to assess patent incentives. If the patent system is only providing the patentee with $50 of marginal expected benefit to create invention no. 1324, frankly that is a drop in the bucket. To take a more literal example, can anyone imagine a conversation like this:

    GSK: We have dicovered the cure for cancer! And here are all the other variations we can do with this invention. Patent it immediately.

    Attorney: It will cost you $50 to make a claim for variation no. 1324.

    GSK: The extra $50 completely blows our budget and variation no. 1324 is so important to us that, without patent protection for it, it doesn’t make sense to file the patent. We are just going to abandon this project.

    If this never happens, then the cost factor doesn’t come in. And even if it somehow happened in a blue moon; that is a critique of the amount of PTO fees, not a justification for unlimited continuations.

  97. 12

    The difference between claiming all 500 in the original patent and claiming 50 at a time in ten continuations is the same reason EVERY smart patentee chooses to do the latter and not the former (and, why patent prosecutors are screaming bloody murder that they favorite toy is being taken away): (1) cost, (2) capturing later innovations and avoiding later-discovered prior art, and (3) submarining competitors. The policy reason for claims is to state what the patentee’s invention is, out of a garble of mixing old and new in the specifcation. If you have a distinct claim for each of 500 compounds in the original application and a competitor walks into the claim, that competitor gets what he deserves.

    But if you don’t claim everything in the first patent, and instead file a string of continuations, competitors may (and would be entitled to) rely on the original issued claim to come out with a product that is not infringing but is disclosed in the patent specification; either because the first issued claim is dead-on invalid or has a limitation that excludes the competitor product. This foolish competitor is then nailed by the continuation into forfeiting his investment. Classic submarining. In short, unlimited continuations mean that patentees do not really have to articulate what their invention is until *after* a competitor enters the market. In this world, pray tell, what is the point of having claims at all? Competitors would be foolish to rely on them. If you really think we should allow unlimited continuations to claim ex post, the logical endpoint is to abolish the PTO and have the patentee write claims for the first time in litigation.

    To SD: your statement that “the applicant has no way of knowing which of these claims will be held valid, and has no way of knowing which of these claims competitors will choose to appropriate” is an accurate description of continuation practice, but is what is WRONG with the practice. If the patentee doesn’t know what his own invention is nor whether it is new, and is essentially playing lottery, how much incentive to actually invent new stuff does the patent system create? Not very much. Essentially, the current system rewards speculative patent filing, listing 500, 1000, or many thousands of compounds to stake your territory (but in secret, of course), and then wait for OTHER PEOPLE to test them and figure out which one is commercially valuable. In Edison’s day, he did his own testing of the thousands of potential filaments, and found that carbonized bamboo was the one that actually worked well before patenting it. The difference between you and me is that you apparently believe that allowing patentees to file speculative theories and later appropriate other people’s later commercial insights is a good thing. I disagree.

  98. 11

    “We’ve also shown how to make the compounds, and how to use them, so presumably we’ve met the requirements of 112. But it won’t be for another several years before we know which if any of these are likely to get FDA approval”

    A claim to a use of those compounds to treat a patient would presumably include within its scope methods of treating a patient without serious deleterious side effects.

    I humbly suggest that, per Leibel-Flarsheim and other cases, such a claim is not enabled until you do your FDA testing.

    Is this a “bad result” for pharma? Sure. Then pharma should pony up some fraction of its multibillion dollar profits to lobby Congress and convince the American people that it needs (more) special favors from the patent laws.

    Judges and rule makers should not simply look the other way and treat pharma differently because pharma will cry if it doesn’t get continuations ad nauseum.

    The fact of the matter is, pharma companies use those continuations as shields AND swords. Anybody who pretends otherwise is being disengenuous, to say the least.

  99. 10

    “For once, take responsibility for your actions and withdraw the regulations package.”

    Save your breath. The leaders at the USPTO are too arrogant and clueless to even realize the gravity of their stupidity of the rule package and the future harm it will cause. So I don’t expect them to withdraw it, but the rules will eventually be overturned by the smart folks at Kirkland & Ellis.

    Once the rules are overturned, something needs to be done about removing the current “leaders” at the USPTO and replacing them with leaders who will actually promote our patent system. And new leaders that will not engage in illegal actions to boot. There are much better approaches to address the pendency issue that a good bunch of leaders would explore.

  100. 9

    By the way, if you read my posts you will see that I told you so. Dudas your sorry carreer as a politician is finished. Your ignorance of the Constitution is exposed.

  101. 7

    Should the new rules tank, can my firm get the nonbillable ~100k back it’s spent prepping for them?

  102. 6

    To GSK,

    Thank you! Thank you! Thank you!

    To the USPTO,

    For once, take responsibility for your actions and withdraw the regulations package.

  103. 5

    TJ, you say that “If you had the knowledge in the original filing date, you would have put it in the original claim.” Applicants can’t be expected to claim everything that’s disclosed. It’s impossible.

    Here’s why: Suppose you have an application that discloses a single basic invention that might be claimed with a single broad independent claim. Suppose also that the application discloses 10 refinements of the basic invention — 10 dependent claim type limitations. If every possible combination of these ten dependent claim limitations is claimed as a dependent claim, the applicant would have to draft >1000 dependent claims (the math is 2^10). For a more complicated disclosure, with 20 dependent claim type limitations, it would require >1,000,000 claims (same math, it’s 2^20). The applicant simply cannot claim everything to which he or she is entitled. And the applicant has no way of knowing which of these claims will be held valid, and has no way of knowing which of these claims competitors will choose to appropriate. So continuations are necessary to ensure that the applicant gets the benefit of his disclosure.

  104. 4

    “The whole point of a continuation is to import ex post knowledge into the claims, when it wasn’t present in the original application.”

    You’ve got to be kidding me.

    So, apparently you think it would be OK (i.e., not an abuse of the notice function of claims) to claim all 500 compounds in independent claims in a single parent application. If that’s OK, then why not claim 50 at a time in a string of 10 continuations? I don’t see the difference.

    Under the new rules, neither option is available.

  105. 3

    “Ruling the Rules”

    Too easy. What is your “invention” here? If it is the genus of 500 hundred compounds, nothing stops you from filing one single claim, which you presumably have done. If it is each of the 500 species, then you haven’t identified the specific species. Allowing you to later pick and choose *any* of those species to specifically claim is problematic because:

    1. You are going to have a potential written description problem even if you get unlimited continuations. The “path in a forest test” may or may not be met here.

    2. The whole point of you wanting to have a continuation here is to capture post-filing innovation. To wit, a competitor discovering that particular species — not the genus — is particularly valuable. If it is some special property of the genus then it is already covered by the genus claim.

    3. If your concern is that the genus really isn’t patentable because of some unknown prior art out there, then you haven’t made a real “invention.” Suppose that one of your 500 species is already in the prior art. Right now, you neither know think there is a significant difference between that 1 and the other 499, nor appreciate that difference as material to patentability. Your invention is the whole genus. The whole point of a continuation is to import ex post knowledge into the claims, when it wasn’t present in the original application.

    4. Easiest way is to imagine a competitor, say Teva. If I am counsel to Teva, about to start manufacturing compound A (one of the 500), see your genus claim of 500 compounds, and find a dead on killer prior art reference for a compound B (another of the 500), what am I to advise Teva? “Rely on the claim as written, it is dead-on invalid”? Or “you would be crazy to go in because they will file a continuation on compound A after finding out it is commercially valuable, ex post”? Patentees effectively get each and every species even though they filed only a genus claim. Pray tell, what happens to the “notice function of the claims”?

    Everything about your justification for a continuation here is that you can import knowledge that you gain *after* filing back to the original filing date. If you had the knowledge in the original filing date, you would have put it in the original claim. While I certainly understand why patent owners like retroactive capture of later developments; society and the PTO has no reason to go along.

  106. 2

    NIPRA has a new preliminary report on the possibility of obtaining extra RCEs in divisional families under 37 CFR 1.114(f)(3) (similar in some respects to our earlier report describing the possibility of obtaining two RCEs from parallel continuations). Comments, especially from those who feel comfortable sifting though the rules, would be *very* much appreciated before we make this page final. Thank you.

    link to nipra.org

    Earlier report:

    link to nipra.org

  107. 1

    Thanks you, Hecky’s, for your post (under the tidbits thread). Again, three cheers for GSK!

    To respond to Mooney et al.: I recently filed a chem app that contained over 500 examples of novel compounds that were active on our structure-activity relationship screen. As best we can determine on the basis of database searches, every one of the compounds is novel. Moreover, we’ve written our genus to exclude all the compounds we tested that we know are inactive on the SAR. So presumably, at this stage, we’ve demonstrated utility, and we’ve got novelty. We’ve also shown how to make the compounds, and how to use them, so presumably we’ve met the requirements of 112. But it won’t be for another several years before we know which if any of these are likely to get FDA approval.

    If I file a single dependent claim that lists all 500+ compounds, and it turns out one of the compounds – even the one that doesn’t prove to be commercially important – is found to be known, out goes the whole claim, as well as the genus claims. So we want many dependent claims, one to each promising compound (well over 25 of those), and we’re willing to pay for them. But under the new rules, if we file that many dependent claims, one to each compound, we’re way over the 5/25 limit, and we’ve got to file a document of death. Ignoring the cost for the moment of the DOD – and I don’t understand why we should be saddled with extra cost just because we worked hard and came up with over 500 compounds – why should we be required to go on record and make statements that might be adverse to our interests in an ESD, just because we worked hard, and b/c the nature of the beast here is such that we won’t know for several years which particular embodiment(s) of our invention will be the commercially important one(s)?

    Furthermore, in contrast to what some other posters have said, divs and cons won’t be treated equally. We won’t be allowed to file CIPs on divs. But suppose early on we get hit with an RR, and wind up dividing. Then we keep working and come up with some new compounds that fall within our (now divided) genus. We want to protect those too. We can file a CIP in the parent case to add the new compounds, but not in any of the divs. So if we guess wrong at the outset about the commercially important embodiment, we lose (unless, by chance, there are so few new compounds for the divs, and they are so superior to the compounds we already disclosed, that we can file them in a new app and argue that they’re a non-obvious selection over the disclosure of the parent app).

    So yeah, I’d say we know what our invention is, and we’ve met all the substantive requirements for patentability. But if the new rules stick around, we may not be able to get optimal patent protection for what turns out to be our our lead compound, which means we may not be able to get someone to help us do the necessary FDA approval work to get that compound to market (we’re smaller than GSK and need a big partner in this). As someone who thinks new medicines are a good thing, I’m rooting for GSK on this one, and I’m grateful they’re taking the lead. (Frankly, I’m kinda surprised Pfizer hasn’t entered the fray yet, but maybe it’s just a matter of time.)

    And Perry Saidman, I’d sure join a class action for damages.

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