“A single inartful statement in the prosecution history”

Genentech v. Iancu (Fed. Cir. 2020)

Hospira, Samsung Bioepis, Celltrion, and Pfizer each filed one or more inter partes review (IPR) petitions challenging Genentech breast-cancer slow-down patents: US7846441 and US7892549.  The patents recognize that some breast cancer patients make too much ErbB2 protein.  The offered solution is administration of an antiErbB2 antibody and “a taxoid, in the absence of an anthracycline derivative.”  The claims do not require a specific dosing except that it be adequate to do the job without causing major problems:

… in an amount effective to extend the time to disease progression in said human patient, without increase in overall severe adverse events.

‘441 patent, claim 1 (elsewhere claimed “effective amount”). The Board found a number of the claims invalid and Genentech appealed.  None of the petitioners participated in the appeal to defend the Board’s decision as part of a settlement with Genentech, but the USPTO intervened.

The question on appeal is the meaning of the claimed “amount effective to extend the time to disease progression.”  The problem for the patentee is that the specifications do not define the required comparisons. During prosecution the examiner originally rejected “extend the time to disease progression” as indefinite after explaining that the specification “never set[s] forth what the extension of time to disease progress is relative to.”

After receiving the indefiniteness rejection during prosecution, the patent applicant did not amend the claims but rather explained that “clearly” the effectiveness of the claimed combination should be compared with the baseline “relative to an untreated patient.”  Later, during the IPR, the Board used the statement to construe the claim term as stated and find the claim invalid as obvious.

Genentech argues that its claims should not be limited “Based on a single inartful statement in the prosecution history.” In particular, Genentech argues that the claimed improvement in disease progression should be compared to treatment with paclitaxel (the taxoid alone) – not with an untreated patient.  And, that in that framework the improvement in outcomes would have been nonobvious.

On appeal, the Federal Circuit has affirmed the PTAB claim construction and the obviousness determination.  The appellate panel noted that Genentech might have an argument except for the fact that “[t]he specification does not … expressly define the disputed terms.” In its indefininteness rejection, the examiner asked particularly — is the time “relative to untreated patients? Pateients who received antibody or taxoid alone? …”  The patentee then responded “untreated patients” and is now arguing that the correct answer should have been “taxoid alone.”

Genentech expressly rejected this comparator during prosecution and instead clearly stated that it was effectiveness relative to an untreated patient. Genentech provided an unequivocal, direct response to the examiner’s inquiry—that the term “extend the time to disease progression” was compared to an untreated patient.

Slip Op.  The response discussed above was provided in the ‘441 patent prosecution history.  In the appeal, the Federal Circuit also agreed that the same construction should apply in the ‘549 patent “which shares a specification and is in the same patent family.” “We see no error in the Board’s constructions.”


24 thoughts on ““A single inartful statement in the prosecution history”

  1. 6

    What I find surprising is that the Examiner did not require that the baseline comparison be added to the claim so that the relative nature of the language was resolved in the claim language alone. I’ve had that happen with Examiners on numerous occasions unless the definition in the specification was clear and unambiguous (and the Examiner didn’t see it during their examination).

    1. 6.1

      That is a good point. Given that the argument for 112 was that one skilled in the art would understand it as follows, it is fair for the examiner to require for allowance that that language be brought in.

  2. 5

    One thing is that “effectiveness relative to an untreated patient” is broader than “effectiveness relative to a treated patient.” So when I look at this I think in terms of scope of the claim. And given the prosecution history and the use of the broader term, I think it is fair to construe the claims to include the broader term.

    Going narrower to avoid obviousness is something that is hard to do in litigation and usually there are dependent claims to provide that ability.

  3. 4

    Off topic:

    I’ve long been familiar with MPEP 1214.04’s statement that “The examiner should never regard such a reversal as a challenge to make a new search to uncover other and better references.” I recently saw a PTAB decision citing MPEP 1213.02 which says “The Board’s reversal of a rejection should not be interpreted as an instruction to the Examiner to allow the claims so rejected.”

    I was just wondering if anyone here has a big enough sample of OPLA staff to say whether they’re hired for being weasels or whether they develop that after years of training?

    1. 4.1

      It has nothing to do with “OPLA staff,” which is separate from the PTAB. Even though the rules allow new grounds of rejection, in view of the backlog the PTAB management years ago decided entry of new grounds must be unanimous as to the panel (and still discouraged). When the backlog goes away and APJs have not so much to do, that directive will be changed.


          The editor of the MPEP has lately been under OPLA. I thought you were lamenting the PTAB decision. The panel citing that very old MPEP language, put in place before most of the present OPLA staff was born, was (1) lazy or (2) because the panel could not agree on entering new grounds of rejection.


            The editor of the MPEP has lately been under OPLA.

            In what line of work is this important to know on such a casual basis?

      1. 4.1.2

        More ‘inside’ stuff from my pal with the penchant for shifting historical pseudonyms.

        It’s clear what his line of work was, once upon a time.

    2. 4.3

      I was unaware of this sentiment toward OPLA in the examining corps. Is it just your personal feeling or is it more widespread?

      1. 4.3.1

        I am under the impression that it is not widespread. Perhaps other examiners dream of one day joining OPLA, and never having to work again.

      2. 4.3.2

        You’re the guy who complains about worthless QASs, right? Those are cushy, makework jobs, but they’re usually filled by genuinely helpful people who’ll really try to be of assistance to their internal customers. The OPLA people in contrast are probably beyond the General Schedule pay scale, and haven’t managed to release a MPEP update since January 2018 despite a rather significant change in Office policy 15 months ago. And they don’t have to deal with examiners calling to pester them examining issues. That is the good life.


          QAS’s are useless at best. And a hindrance at worst. At least to those of us on the outside. YMMV.

          I have two former law firm colleagues who are in OPLA. I’m sure they would agree it’s an easier gig than either private or in-house practice. That’s why they’re there.

          They do have “customers” calling and pestering them. Me included. They’ve always been helpful from my experience. Are examiners not allowed to call them? I can’t imagine any of them refusing to answer a question from an examiner.

          There is a separate MPEP staff who are responsible for editing the MPEP. The PTO employee locator shows five employees (and a detailee and/or intern) in that group. If that’s not the easiest gig in the federal government it’s running a very close second.

          The folks in OPLA write the FR notices and respond to the public comments on the proposed new rules and changes to the existing rules. That’s certainly more demanding than editing the MPEP.

  4. 3

    I’m looking forward to the day when I ask a question in an interview and the only thing the representative will concede is that his client has a application before the office.

    1. 3.1

      Sometimes, reticence may be driven by client or partner dictates. I have known attorneys that I would not even trust to make prepared statements, let alone off the cuff statements, so I understand the reasoning.

    2. 3.2

      I am looking forward to a return to TSM so that examiners don’t feel like they are sovereigns that can allow or reject claim ’cause of their feelings.

      The way it was when I started in this business before KSR.

  5. 2

    In litigation, how would you prove that an accused compound actually “extends the time to disease progression in said human patient”?

    1. 2.1

      Assuming these are FDA approved drugs, would not those comparative test data normally be available from FDA required tests by the time of infringement suits?

      Some clients do not seem to understand that the attorneys they hired to prosecute their patent applications are their legal agents, and whatever they say on the record will normally have the same effect as if they said it themselves. A file history assertion to obtain allowance is not a “nose of wax” without a timely express disclaimer during prosecution before issuance.
      Clients buying their prep and prosecution on a low bid and/or low cost caps these days have even less grounds for litigation problem complaints.

      1. 2.1.1

        That would prove that the patentees commercial embodiment extended the time via some benchmark expressed to the FDA, but it wouldn’t prove that the accused compound extended time compared to the benchmark. I would argue that the patentee would have to do studies co-extensive with the original studies to show that the accused compound had the same effect vis-a-vis the same benchmark. I have only dealt with this issue once, in a case involving synergistic combination of compounds, and (1) the evidence of synergism was baloney and (2) we never got any evidence that the accused compound had the same synergistic effect and (3) subsequent randomized studies by NIH proved that the combination made the condition worse. I never got a handle on how other attorneys handle this problem.

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