[00:00:53] Speaker 01: Okay, the next case is number 15-12-65, Pfizer Incorporated against Lee. [00:01:00] Speaker 01: Mr. Papakostis. [00:01:04] Speaker 03: Morning, Your Honors. [00:01:06] Speaker 03: May it please the Court. [00:01:08] Speaker 03: Your Honors, the question here is what is sufficient to qualify as a notice under the applicable statutes for patent term adjustment, such that the notice will stop the clock on the accrual of office delay [00:01:21] Speaker 03: And the type referred to here is the type we would commonly refer to as a delay. [00:01:26] Speaker 02: How do you draw the line? [00:01:27] Speaker 02: Because apparently you think that some deficiencies in the notice are tolerable and can still be a notice even though as a result of negotiation it's changed. [00:01:39] Speaker 02: And is it the clarity of the error that makes it not qualify as a notice? [00:01:46] Speaker 03: I think that's one way. [00:01:48] Speaker 03: I think that where we're actually drawing the line here, and to put things in context here, we're talking about the threshold sufficiency issue and not necessarily an issue where there's a legitimate dispute regarding the merits of an office action, whether that be a rejection or a restriction requirement. [00:02:09] Speaker 03: So for example, if a restriction requirement was issued that took into account all the claims [00:02:15] Speaker 03: and the parties then had a dispute over where those claims are grouped or there's a provisional election with Travers, and then the Patent Office ends up coming around to the applicants' arguments. [00:02:28] Speaker 03: That's part of the normal give and take process, and that's actually what happened later on in the prosecution. [00:02:33] Speaker 03: So the notice then would qualify? [00:02:35] Speaker 03: That's right. [00:02:36] Speaker 03: In this case, we had a notice that [00:02:39] Speaker 03: attempted to group 144 pending claims into 21 separate and distinct groups. [00:02:45] Speaker 03: Now, the grouping of the six omitted claims, so I guess backing up a second, six of the 144 pending claims were failed to place in any group. [00:02:57] Speaker 03: And it's not a simple sort of one-to-one. [00:03:00] Speaker 02: So you're saying it's an obvious error, and because it's an obvious error, it doesn't qualify as a notice? [00:03:08] Speaker 03: the omission of the claims you mean? [00:03:10] Speaker 03: Yeah. [00:03:11] Speaker 03: Yeah, and I would posit even further though that the grouping of the claims that were omitted wasn't necessarily with respect to each one of those claims clear as to one-to-one matching up a dependent claim with the group that had the corresponding independent claim, for instance. [00:03:26] Speaker 03: If we take just claim 106 as an example, that claim was [00:03:33] Speaker 03: dependent on claim 98, which the parties I think both incorrectly called that an independent claim in the briefing. [00:03:39] Speaker 03: Claim 98 depends off of a couple other claims for the purposes of today's discussion. [00:03:44] Speaker 03: The argument is the same. [00:03:45] Speaker 03: Claim 98 from which 106 depended on was placed into eight different groups. [00:03:50] Speaker 02: So would it be fair to say that you're saying that two things have to be present? [00:03:55] Speaker 02: One, an obvious error, and one made a difference in the way the applicant would have addressed the notice. [00:04:00] Speaker 03: I think that's exactly right, Your Honor, because if you look at the MPEP chapter on, for example, situations where a reply period is reset or restarted, that's chapter 710.06, that chapter actually calls out situations like that. [00:04:21] Speaker 03: And one of those situations is where an office action contains some other error that affects the applicant's ability to reply to the office action. [00:04:29] Speaker 03: And so the Patent Office in interpreting the statute has at least promulgated this instruction for its examiners in terms of when do we reset or restart a reply period. [00:04:42] Speaker 03: And the error has to be, according to the Patent Office, something that affects the applicant's ability to reply. [00:04:48] Speaker 05: Well, and the statute itself says that 132 requires an applicant at least be informed of the broad statutory basis for the rejection of [00:04:59] Speaker 05: his claim so that he may determine what the issues are on which he can or should produce evidence. [00:05:06] Speaker 05: Now, with Judge Dyke here, there's two extremes. [00:05:12] Speaker 05: I mean, if you read the district court opinion at its face value, it would seem to say all the PTO would have to do is send a piece of paper that reports to be under 132, and that would be the end of it. [00:05:24] Speaker 05: But it's unclear whether you made [00:05:28] Speaker 05: an alternative argument to the district court. [00:05:30] Speaker 05: But at the other end of the spectrum, I mean, just because there's some error doesn't mean that there isn't enough information for you to respond. [00:05:41] Speaker 05: And so that's the real question. [00:05:43] Speaker 05: I mean, you knew that one of the problems here was that there were certain claims that were omitted. [00:05:48] Speaker 05: You could respond as to the other claims and you could also respond by saying, what about these omitted claims? [00:05:54] Speaker 05: I mean, wasn't there enough to give you something to respond to? [00:05:59] Speaker 03: Well, I think there's two answers to that. [00:06:01] Speaker 03: And so first of all, I think the language that you pulled was from one of the cases that looked at this, I think Chester V. Miller, talking about the fraud statutory basis. [00:06:13] Speaker 03: And in the statute, it says that the director shall [00:06:18] Speaker 03: notify the applicant, and I'm skipping over some of the stuff, the information and references as may be useful in judging of the propriety of continuing the prosecution of this application. [00:06:28] Speaker 03: So yes, we're not making a sort of foot fault argument where any clerical error in an office action automatically resets the reply period. [00:06:38] Speaker 03: What we're saying is that in this particular case, if you go and you look at the record, the applicants, when they [00:06:47] Speaker 03: noticed that there was a problem with the restriction requirement, that there were six admitted claims. [00:06:51] Speaker 03: Followed the steps outlined in the MPEP, section 710.06, they brought the deficiency to the examiner. [00:06:59] Speaker 03: And then the examiner told the applicant that they would redo and resend the restriction requirement. [00:07:09] Speaker 05: What if the examiner had simply said, let me send you some more information, let me amend the [00:07:15] Speaker 05: restriction requirement rather than pulling it. [00:07:18] Speaker 03: I think they could have done that, you know, in... Would that have changed things? [00:07:22] Speaker 03: I think that had... So, of course, examiners are able to make restriction requirements orally and applicants are able to elect groups orally over the phone based on the PTO's telephone practice. [00:07:37] Speaker 03: That just didn't happen in this case. [00:07:39] Speaker 03: And for whatever reason, [00:07:41] Speaker 03: The examiner took it upon themselves to say, you know what? [00:07:44] Speaker 03: I see we messed up this restriction requirement. [00:07:46] Speaker 03: We're going to redo it. [00:07:47] Speaker 02: What's the answer to the question? [00:07:48] Speaker 02: Would it have made a difference if there had been an amendment rather than a new notice? [00:07:54] Speaker 03: You mean an amendment by the examiner? [00:07:57] Speaker 03: Yeah. [00:07:59] Speaker 03: I'm not sure what the actual procedure to do so. [00:08:04] Speaker 03: Do you mean an amendment just right then over the phone? [00:08:09] Speaker 02: Well, no, the examiner sends out later a document which is titled amended notice so that there's no withdrawal of the original one and a substitute one. [00:08:20] Speaker 03: You know, without getting sort of tied into the nomenclature of whether something got vacated or withdrawn or rescinded, it may have made a difference, but I think that any time that if you follow the provisions in MPEP 710.06, I know I keep going back to this chapter, [00:08:39] Speaker 03: in the manual, I think anytime you follow those provisions, you go through it and the applicant brings a problem up with an office action to the examiner. [00:08:49] Speaker 03: The examiner, in that case, could do what they did in UMass, which is the case both parties briefed, and say, I don't think that affects your ability to reply. [00:08:58] Speaker 03: You guys need to still respond and then make your arguments and then [00:09:03] Speaker 03: will enter the normal give and take of patent prosecution. [00:09:06] Speaker 02: Let me tell you what my concern is here. [00:09:08] Speaker 02: I understand your argument, and I'm not unsympathetic to it, that in this case you had some difficulty in responding to it because it wasn't clear which way the dependent claims were going to be resolved. [00:09:22] Speaker 02: They didn't automatically follow the independent claims. [00:09:24] Speaker 02: I understand that. [00:09:25] Speaker 02: But what concerns me is the possibility of sandbagging. [00:09:29] Speaker 02: In other words, that the applicant [00:09:31] Speaker 02: notices this error, and then waits six months, which is pretty much what happened here, to raise it with the PTO, thereby earning six months of applicant delay, though actually in this case it only should have been three months. [00:09:47] Speaker 02: So what's the problem with that? [00:09:51] Speaker 02: I mean, if a claim is left out, that would seem to be something which was pretty obvious in the beginning. [00:09:57] Speaker 02: Why shouldn't the rule be, for example, that the applicant [00:10:01] Speaker 02: gets the amount of a delay that would give it an adequate amount of time to notice the error and then the amount of time that would have been taken to correct the error so that we don't have a situation where the applicant would say, well, I noticed this error. [00:10:22] Speaker 02: I'm going to wait till the last minute to raise this so I get a full 90 days or three months of PTO delay. [00:10:31] Speaker 03: Well, I think, and I appreciate the competing concerns here, and I think that there's two answers to that. [00:10:40] Speaker 03: Firstly, the reply periods have been set by statute and the potential extensions to those reply periods have been already considered and set. [00:10:50] Speaker 02: You didn't comply with the requirements. [00:10:53] Speaker 02: You should have replied in three months rather than six months. [00:10:56] Speaker 03: Well, there's the three-month statutory reply period, correct, and then there's the [00:11:01] Speaker 03: you can extend it out three more months. [00:11:04] Speaker 03: But they did, right? [00:11:05] Speaker 03: No, they did. [00:11:06] Speaker 00: They did. [00:11:06] Speaker 03: They paid for the extension under CFR, 37 CFR 1.1. [00:11:10] Speaker 03: So there's a formal extension of the three-month period? [00:11:12] Speaker 02: That's right. [00:11:13] Speaker 03: So it was within the time period to apply. [00:11:16] Speaker 03: Yeah. [00:11:18] Speaker 03: So there's actually two tiers of an answer here, and I apologize for going back to MPEP 710.06, which I'll do in a moment. [00:11:25] Speaker 03: But firstly, to the extent that a restriction requirement just doesn't meet [00:11:30] Speaker 03: the statutory requirements of section 132, then there's no reply period in the first place. [00:11:37] Speaker 03: So it's not like there's a time period within which to respond. [00:11:40] Speaker 03: In fact, judging from the PTO's briefing on this issue, they seem to have drawn a distinction between whether the PTO unilaterally decides to amend the office action or not should be one of the deciding factors. [00:11:56] Speaker 03: But assuming, even assuming that [00:12:00] Speaker 03: The time period to reply had started. [00:12:03] Speaker 03: The applicant had brought this question up. [00:12:08] Speaker 03: What about the delay? [00:12:09] Speaker 03: What about the fact that you waited until the very last minute to raise this? [00:12:13] Speaker 03: Under MPEP 710.06, the patent office has already considered what happens to your reply period based on when you bring the defect up to the office. [00:12:25] Speaker 03: For example, if you notice the defects within the first month of receiving an office action and you bring it up to the patent office within that first month, the office has decided in the MPEP that the office will restart the previously set reply period for reply to run from the date the error is corrected. [00:12:45] Speaker 03: So they just give you your same reply period and they reset it and they start it from the date your error is corrected. [00:12:51] Speaker 01: That's not really the issue, is it? [00:12:53] Speaker 01: I don't think the office is arguing that this particular applicant had an obligation to pick up this case and respond to the official action sooner than the statutory periods or an extended statutory period. [00:13:10] Speaker 01: But what I observe is that as soon as the applicant did in the normal course of business, so it appears, no one says otherwise. [00:13:19] Speaker 01: find the error, tells the examiner, the examiner says, oh, my goodness, I made a mistake and fixes it, almost immediately, within a couple of weeks, I think. [00:13:30] Speaker 00: Sure. [00:13:31] Speaker 01: That why would there should be, even on the most benevolent understanding, an entitlement to an extension for any longer than that period that it took the examiner to correct the admitted error? [00:13:46] Speaker 01: You're asking for months of extension, not a week or two. [00:13:49] Speaker 03: That's right, and I notice that I'm in my rebuttal time. [00:13:53] Speaker 01: How does that fit in with even your theory of the case? [00:13:56] Speaker 03: Well, I think, and I notice I'm in my rebuttal time. [00:13:59] Speaker 01: Yes, please answer. [00:14:00] Speaker 03: I can answer your question. [00:14:00] Speaker 03: Thank you. [00:14:01] Speaker 03: I have to bring it back to the office has decided that if you bring the error up to the office after the first month of receiving an office action, it has decided that the office will set a new period for apply that [00:14:20] Speaker 03: to substantially equal the time remaining in your reply period, but not less than one month. [00:14:26] Speaker 03: But nevertheless, that time period for reply does get reset, and that's just something the patent office has thought about and decided on. [00:14:33] Speaker 05: But in this particular case, you were able to completely reply. [00:14:37] Speaker 05: In fact, you even argued for recategorization of some of the omitted claims and without having to have a response or an amended [00:14:49] Speaker 05: classification of the claims. [00:14:50] Speaker 05: I mean, you knew what they were aiming for. [00:14:52] Speaker 05: You knew where those claims were going to fall. [00:14:54] Speaker 03: The applicants were only able to reply after receiving a corrected restriction requirement. [00:15:01] Speaker 03: So only after they received the February 23, 2006 restriction requirement did the applicants then engage in the normal give and take process of prosecution and look at the restriction requirement and say, for instance, we think claim 106, you've placed it in group 11. [00:15:18] Speaker 03: We think it also should be placed in group six, but that only happened after the office issued its corrective reply. [00:15:25] Speaker 02: Why should you get months and months of delay when it was your failure to raise the error promptly that caused the delay where you waited? [00:15:38] Speaker 02: You're getting the benefit of the fact that you waited six months to call this to the attention of the PTO, and you're saying that whole six months gets counted as a delay. [00:15:48] Speaker 03: I think we have to think about the policy then in terms of why these time periods are set, the time periods for reply. [00:15:57] Speaker 03: A patent examiner has many, many applications on their docket. [00:16:02] Speaker 03: A patent prosecution attorney at a place like Pfizer has hundreds of applications on their docket and they keep how they manage their time based off of these time periods for reply that they're automatically, these time periods for reply that they've been given [00:16:18] Speaker 03: by statute and by the patent office itself. [00:16:21] Speaker 03: So the fact that a patent prosecuting attorney may have turned to the application later on in the allowed time period for reply, I mean, that's just part of the time period for reply, so it's not really delaying. [00:16:36] Speaker 03: And again, the NPEP Chapter 7, 10.06 contemplates various reset reply periods and the length of those reply periods based on [00:16:48] Speaker 03: the timing of when one brings a defect or a deficiency in an office action to the attention of the patent office. [00:16:56] Speaker 03: And in fact, if you bring it up after your allowed time period for reply, MPEP 710.06 is clear and it says that if it's called to the attention of the office after the expiration period for reply, the period will not be restarted and any appropriate extensions be required to render a reply timely. [00:17:15] Speaker 03: So the patent office, [00:17:17] Speaker 03: back in the early 2000s, already thought about at least some of these issues and made the policy call to treat it the way it's treated in the MPEP. [00:17:26] Speaker 03: And I see that I'm well aware. [00:17:28] Speaker 01: Let's hear from the office. [00:17:29] Speaker 01: We'll save you rebuttal time. [00:17:30] Speaker 03: Thank you, Your Honor. [00:17:37] Speaker 01: Mr. Bargans. [00:17:39] Speaker 04: Thank you, Your Honor. [00:17:40] Speaker 04: Good morning, Your Honors, and may it please the Court, Dennis Bargan from the Department of Justice on behalf of the United States Patent and Trademark Office Director in this action. [00:17:48] Speaker 04: Section 154B is clear and unambiguous. [00:17:51] Speaker 04: Once the USPTO issues one of the notifications under Section 132, any additional patent term adjustment in the form of a delay ceases. [00:18:01] Speaker 05: You don't really argue that [00:18:04] Speaker 05: no inquiry should be made into whether or not what is issued actually qualifies under 132. [00:18:11] Speaker 04: No, we're not suggesting that at all. [00:18:13] Speaker 04: And I understand your honor's concern about the wording of the district court's opinion. [00:18:17] Speaker 04: I don't think that's what the district court was after there as well. [00:18:21] Speaker 02: Where would you draw the line? [00:18:23] Speaker 02: Excuse me, your honor. [00:18:23] Speaker 02: Where would you draw the line? [00:18:25] Speaker 04: I think that the statutory language is clear that the only inquiry is the minimal bar that section 132 places [00:18:32] Speaker 02: No, but there's some notices which in the patent office's view are not going to qualify, right? [00:18:38] Speaker 04: Absolutely. [00:18:39] Speaker 02: Absolutely. [00:18:41] Speaker 02: So how do we draw the line? [00:18:42] Speaker 02: Where's the line drawn? [00:18:43] Speaker 04: The line is drawn by both Section 132 in its language and this court's Decisional Authority interpreting that language. [00:18:50] Speaker 04: This is an admitted mistake. [00:18:52] Speaker 04: It is certainly a mistake, Your Honor. [00:18:54] Speaker 01: There's no argument about that. [00:18:55] Speaker 04: There's no argument that it is a mistake. [00:18:57] Speaker 04: The question is whether it is a mistake that renders the office action, here the restriction requirement, so uninformative, that's the words of Chester, that the applicant is unable to proceed with the application. [00:19:10] Speaker 01: But that wasn't really an issue. [00:19:13] Speaker 01: This was a much more open and casual interaction. [00:19:18] Speaker 01: Patent attorney getting ready to file the response to make the election sees out of these a hundred and some claims, there are seven that the examiner forgot about. [00:19:28] Speaker 01: So he tells the examiner. [00:19:30] Speaker 04: Correct. [00:19:30] Speaker 01: And the examiner says, my goodness, yes, fixes it immediately. [00:19:34] Speaker 04: Correct. [00:19:35] Speaker 01: So there isn't any issue of gaming the system or bad faith or anything else, an easy mistake to make, but needs to be corrected. [00:19:46] Speaker 01: Otherwise, as has been pointed out, there can down the road be curious consequences, but it was corrected right away. [00:19:55] Speaker 04: That is correct, Your Honor. [00:19:57] Speaker 01: But there was a delay, at least the delay that it took to correct the mistake. [00:20:04] Speaker 01: And it wasn't the applicant's fault. [00:20:06] Speaker 01: It was the Patent Office's fault. [00:20:08] Speaker 01: So where does this put us in terms of looking to see how to [00:20:15] Speaker 01: correct and compensate for office delay? [00:20:18] Speaker 04: Yes, Your Honor. [00:20:18] Speaker 04: A couple of responses to that. [00:20:20] Speaker 04: First, the question here isn't whether it is a delay in the abstract, whether it is a delay that is the fault of the Patent Office. [00:20:29] Speaker 01: The statutory language is clear that only certain delays... We know the mistake was the fault of the office. [00:20:35] Speaker 01: Correct. [00:20:35] Speaker 01: Not at the end of the world, but it was a mistake that had to be corrected. [00:20:40] Speaker 04: That is correct, Your Honor, but the statutory language only provides for patent term adjustment in the area of certain types of mistakes made by the Patent Office and certain delays that are attributable to the examiner. [00:20:53] Speaker 04: It is not simply that all delays that can be in one way, shape, or form attributable to the examiner [00:20:59] Speaker 04: are awarded with patent term adjustment. [00:21:01] Speaker 04: This takes us to Judge Dyck's question, where do you draw the line? [00:21:05] Speaker 04: And we draw the line at those office actions that are so uninformative that they fail the very minimal bar of section 132. [00:21:15] Speaker 04: And here we need to look only at the record to determine that this [00:21:20] Speaker 02: office action, this restriction requirement was sufficiently informative to allow... Why is that true? [00:21:26] Speaker 02: Because as I understand it, this is not a situation in which the dependent claims followed automatically the categorization of the independent claims. [00:21:36] Speaker 02: And so why didn't they need to know what the examiner was saying about the proper characterization [00:21:42] Speaker 02: of the dependent claims in order to respond. [00:21:45] Speaker 04: Well, there are two answers to that. [00:21:46] Speaker 04: First, I agree with Your Honor that the placement of the dependent claims did not perhaps automatically follow from their independent claims, but they are rather close. [00:22:01] Speaker 04: And I think a review of both the claim at issue, one of the main claims at issue here, claim 106, [00:22:07] Speaker 04: and its dependent claim, claim 98, when combined with the very detailed 21 categories of inventions that are found in the first restriction requirement, leave their little guesswork as to where the examiner would have placed claim 106. [00:22:21] Speaker 05: This is my problem, though. [00:22:23] Speaker 05: This is the work ability problem. [00:22:25] Speaker 05: I mean, you make a very good argument that you can figure all this stuff out and where those omitted claims would have ended up and their [00:22:35] Speaker 05: There wasn't actually a very dramatic change as it relates to anything in terms of where things fell out. [00:22:43] Speaker 05: But should we or should the lower court be getting into those weeds every time we have this debate? [00:22:50] Speaker 05: Or should it simply be a question of, if you're going to have to go through that analysis, then we ought to assume that if the error was that of the office, that the office should just be chargeable. [00:23:01] Speaker 04: I agree with Your Honor, and as our brief indicates, that we are concerned about the same thing, not only from an Article III court perspective, but also from [00:23:08] Speaker 04: an agency workability perspective. [00:23:10] Speaker 04: But I think that that only highlights the reason why the low bar of Section 132 is the proper touchstone. [00:23:19] Speaker 04: That this court, on a number of occasions, has construed Section 132 to place a very, very minimal hurdle in the path of the examiner, simply to provide the broad statutory basis for the rejection, or restriction in this case, of the claims at issue. [00:23:36] Speaker 04: That's in Ray Hughes. [00:23:38] Speaker 04: to make sure that the office action is sufficiently informative to allow the applicant an idea or an ability to move the application forward and make a decision as to A, how to traverse that application, and B, whether to traverse it at all. [00:23:54] Speaker 02: There is another bright line approach to this, which is what Judge Newman suggested, and that is to give them the amount of delay between [00:24:03] Speaker 02: the withdrawal of the original application or the recognition of the error by the examiner and the issuance of the new notice. [00:24:13] Speaker 02: So that would be easy enough to calculate. [00:24:16] Speaker 02: It doesn't get into all the weeds and difficult issues that we've been talking about. [00:24:22] Speaker 02: So why not at least give them that amount of thought? [00:24:27] Speaker 04: even if I were to agree with your honor's analysis about the workability and the equities involved, unfortunately it doesn't flow from the statutory language because the statutory language is clear that a delay ceases at the moment that an initial notification under section 132 is issued and that if there is a time period between the 14 month mark after the application's filing [00:24:54] Speaker 04: And the filing of that notification, one day of patent term adjustment is provided for each of those days. [00:25:00] Speaker 04: So there is simply no statutory hook, if you will, to provide the type of calculation that Judge Newman has articulated. [00:25:09] Speaker 05: What if one of the claims that was omitted in the restriction requirements was an independent claim? [00:25:15] Speaker 05: Would that change things? [00:25:16] Speaker 04: I don't think that it would, Your Honor. [00:25:17] Speaker 04: I think it would certainly make it a closer call. [00:25:20] Speaker 04: But I don't think that it would make a difference here. [00:25:24] Speaker 04: Because what this restriction requirement did was provide A, that all 144 claims were subject to restriction, B, provided 21 extremely detailed categorizations of separate and distinct inventions. [00:25:39] Speaker 04: The remaining aspects of this portion of the very elongated examination that led to this patent [00:25:46] Speaker 04: is a matter of advocacy. [00:25:48] Speaker 04: Pfizer's attorneys could very simply have looked at those 21 separate and independent claims and made an argument about where the omitted claims belong in their own interest. [00:26:01] Speaker 01: And the examiner would have considered that and made a decision about whether he or she... No, the examiner is just as likely to say this is non-responsive, schools out, case abandoned. [00:26:12] Speaker 04: I doubt that the examiner that would see a traverse that read, as I just stated, would say that this is not responsive, especially in the face of seeing that he or she made the type of error that we're talking about here. [00:26:27] Speaker 01: Well, exactly. [00:26:28] Speaker 01: Openly in an open exchange, obviously there wasn't any adversarial situation. [00:26:34] Speaker 01: The mistake was corrected. [00:26:36] Speaker 01: However, it did set back the examination. [00:26:40] Speaker 04: I think that you certainly could argue that it set back the examination. [00:26:43] Speaker 01: We don't have to argue. [00:26:44] Speaker 01: We just look at the record. [00:26:45] Speaker 01: Then they had to go back and make their election and proceed having had this lapse of time because of the office mistake. [00:26:55] Speaker 04: But I think we could also make the argument, your honor, that Pfizer having had six months to look at the initial restriction requirement and then seeing the- You know very well it doesn't work that way. [00:27:07] Speaker 01: You can have a six month period to respond to an office action and in a timely manner, you look to see what you have to do. [00:27:16] Speaker 01: If the rule is going to change, to change the entire practice of patent prosecution in the nation, that you must [00:27:26] Speaker 01: immediately take up every office action that you get to see if there's something you want to grumble about. [00:27:32] Speaker 01: All you do is increase the costs for the client and add to an already heavily bureaucratized system that's extremely difficult to cope with. [00:27:45] Speaker 04: But again, your honor, even accepting everything that you've just said, I think that that's only highlights the reason for a bright line rule about what types of delays and what types of errors in office actions allow for additional- Why shouldn't the bright line be error? [00:28:01] Speaker 01: Clear error. [00:28:02] Speaker 01: It's clear error. [00:28:03] Speaker 01: But that's because- A minor error, but clear error. [00:28:06] Speaker 04: But that minor error does not render the office action in question void or viable. [00:28:13] Speaker 01: They don't say anything that was void. [00:28:14] Speaker 01: They just say that it just took them longer. [00:28:16] Speaker 01: It added to the period of prosecution because the error had to be corrected. [00:28:21] Speaker 04: But under section 154B, the only types of errors and delays on the part of the patent office that are rewarded or awarded, for lack of a better term, with additional a delay are those that violate section 132 that are so uninformative, that do not allow the applicant the understanding of what [00:28:42] Speaker 04: the basis of the rejections are, or the restriction requirement, and prevents them from making an argument going forward. [00:28:49] Speaker 04: I respectfully submit to Your Honor to the statute. [00:28:52] Speaker 05: You made an argument in your brief that I found to be a little troubling. [00:28:57] Speaker 05: And I'm going to challenge you to tell me you don't really mean it, hopefully. [00:29:02] Speaker 05: And that is that you made the argument that, well, if we caught it ourselves and corrected it, then you could get a delay for that. [00:29:11] Speaker 05: But if you have to point it out, [00:29:13] Speaker 05: to us and we correct it, then by definition, you were able to respond. [00:29:18] Speaker 05: That's not really your position. [00:29:20] Speaker 04: That's certainly not the underpinnings of what we're suggesting, Your Honor. [00:29:24] Speaker 04: We do, in the two administrative decisions that have not been subjected to judicial review in any way, that are cited by my opponents, Oncolytics and Janssen. [00:29:35] Speaker 04: Part of the difficulty in those cases, the difference between this case and that, [00:29:41] Speaker 04: is that the examiner unilaterally took action. [00:29:45] Speaker 04: Now, obviously, there was more going on in those cases. [00:29:48] Speaker 02: You're saying now that shouldn't be a factor. [00:29:50] Speaker 04: I don't know that that shouldn't be any factor, Your Honor. [00:29:55] Speaker 04: And the reason for that is this. [00:29:57] Speaker 04: When the examiner takes you. [00:29:59] Speaker 02: In those cases, it seemed to cut the other way. [00:30:01] Speaker 02: Because the examiner made the correction, that gave them the aid alike. [00:30:08] Speaker 04: Correct. [00:30:09] Speaker 04: And there is a rationale for that. [00:30:12] Speaker 04: And the rationale for that is where the examiner unilaterally takes action. [00:30:17] Speaker 04: It takes the examination away from the applicant. [00:30:21] Speaker 04: It presupposes that the applicant believes that the restriction requirement or the office action is so uninformative that they can't make an argument. [00:30:30] Speaker 05: But in this case, the examiner quickly said, oh, yeah, you're right. [00:30:34] Speaker 05: This is wrong. [00:30:35] Speaker 05: I got to fix it. [00:30:36] Speaker 05: I'm going to withdraw it, start over. [00:30:37] Speaker 05: I mean, if the examiner had just happened to look at the file during that six-month period, the examiner might well have pulled it himself, right, or herself. [00:30:46] Speaker 04: I would hesitate to say it would be likely that an examiner would, in looking at the file, notice such a... Let's assume that that happens. [00:30:56] Speaker 04: Yes, if that were the case, and it was this type of error [00:31:01] Speaker 04: I don't want to speak for the office and how it would decide that case, but I'm not sure that that in and of itself would warrant additional patent term adjustment. [00:31:12] Speaker 04: But again, unilateral action on the part of the examiner is different than part of the give and take of patent prosecution. [00:31:20] Speaker 04: We need to interpret statutes so as also not to lead to absurd result. [00:31:25] Speaker 04: And if we were not to award PTA in the instance of an [00:31:29] Speaker 04: unilateral action on the part of an examiner that would allow an examiner to continue to revise office actions over and over and over again unilaterally, kicking the examination can down the road without any additional a delay patent term adjustment. [00:31:49] Speaker 04: And the office is simply unwilling to allow that type of interpretation to stand. [00:31:55] Speaker 02: Just one last question here. [00:31:57] Speaker 02: Do you agree that they were entitled to six months to reply? [00:32:03] Speaker 04: Yes, we do. [00:32:04] Speaker 04: Under the MPEP provisions, yes, they were. [00:32:08] Speaker 04: I will note, though, that in that regard, that nothing in section 154b or section 132 imports the minutiae, if you will, of the MPEP into the question of whether this is the type of error that would give rise to more aid delay. [00:32:24] Speaker 04: And I thank the court for its time this morning. [00:32:26] Speaker 01: Okay. [00:32:28] Speaker 01: Good. [00:32:29] Speaker 01: All right. [00:32:29] Speaker 01: Thank you, Mr. Byron. [00:32:31] Speaker 01: Mr. Papakostis. [00:32:36] Speaker 03: Your Honor, one point on the Oncolytics case. [00:32:39] Speaker 03: It wasn't unilateral action by the examiner. [00:32:41] Speaker 03: There was actually an interview between the applicants, between the contested and office action. [00:32:47] Speaker 03: In that case, it was a rejection. [00:32:49] Speaker 03: and then there were numerous problems. [00:32:51] Speaker 03: I'll just give you the Joint Appendix site for the response to the petition decision that describes the interview that happened, intervening that caused the examiner to then issue a corrected office action. [00:33:02] Speaker 03: That's at Joint Appendix 2161 to 2165 and the relevant part of the interview summary is at 2162 to 63. [00:33:11] Speaker 03: Now, to the question of where do we draw the line, as Judge Newman just pointed out, [00:33:18] Speaker 03: We look at the record in this case. [00:33:20] Speaker 03: We're not here, you know, the examiner already told us where they drew the line when the examiner heard the applicant's concern and decided to redo and resend the restriction requirement. [00:33:31] Speaker 03: This case came to us under the APA. [00:33:34] Speaker 03: The parties agreed that the case was amenable to summary judgment at the district court based on the record. [00:33:39] Speaker 03: And so the case isn't here to discuss what Pfizer could have done or what the examiner could have done or what Pfizer should have done [00:33:46] Speaker 03: way back in 2005 and 2006. [00:33:49] Speaker 03: The examiner, acting on behalf of the patent office at the time in 2006, has decided where to draw the line, at least in this case. [00:33:58] Speaker 03: If the question is where do we draw the line, I think [00:34:06] Speaker 03: the type of error in this case, the record bears out that it affected Pfizer's ability to reply and that the examiner took it upon himself to reissue and redo the restriction requirement. [00:34:19] Speaker 03: So with regards to the last point about the PTO's distinction that if it's unilateral examiner action versus an applicant actually following the procedures outlined in the NPEP and bringing the mistake to the attention of the office, [00:34:35] Speaker 03: I would assume based on the PTO's arguments that this would be treated as a nullity if the examiner had just looked at it as Judge O'Malley hypothesized just now. [00:34:46] Speaker 03: And that seems somehow to punish the applicant for bringing mistakes to the office's attention. [00:34:51] Speaker 03: And that seems to be contrary to the whole idea of the traditional process of prosecution where I think when we talk about Judge Dyke's concern as well of people maybe sandbagging, [00:35:05] Speaker 03: That posits that the applicants are more interested in getting patent term adjustment rather than just having their patent. [00:35:12] Speaker 02: Well, to some extent that's true, isn't it? [00:35:15] Speaker 02: Particularly in the pharma area where you may have to wait to market the thing until you get regulatory approval. [00:35:21] Speaker 02: So if you can get an extension rather than early issuance of the patent, that can be beneficial. [00:35:27] Speaker 03: That's right. [00:35:28] Speaker 03: But that's also why Section 154B was changed and why [00:35:35] Speaker 03: the pre-GAT era of basing your patent term off of the issue date surely greatly incentivized people to push their issue date as far as possible. [00:35:47] Speaker 03: But the way the patent term adjustment statute and the applicable regulations and provisions of the MPEP are designed is that there is a given thing. [00:35:57] Speaker 03: There's not just office delay. [00:36:00] Speaker 03: You're running a risk if you're an applicant [00:36:02] Speaker 03: and you're trying to game the system to get office delay because after a certain point, you're also going to be assessed with applicant delay. [00:36:09] Speaker 03: And so it's not, in the post-GAP world where we're pegging your patent term ultimately off of your filing date and you're making certain adjustments, that's something that Congress has decided and that the PTO has interpreted in terms of what are the specific instances that will allow you to get [00:36:31] Speaker 03: additional patent term based on delays on the part of either the office or the applicant. [00:36:36] Speaker 03: And those are things that are just decided and in the statute. [00:36:38] Speaker 03: And all we're asking in this case is for the PTO to apply the practices that it applied in Oncolytics and in Janssen and in its regulations and in its own manual of how it instructs examiners to treat restriction requirements. [00:36:52] Speaker 02: What was the site to the one-month provision that you mentioned in your opening argument? [00:36:57] Speaker 02: You said in the MPEP there's a one-month [00:37:01] Speaker 02: that an applicant raises something within a one month period. [00:37:04] Speaker 03: What is that? [00:37:05] Speaker 03: That's MPEP chapter 710.06 and that's entitled situations where I believe situations where a reply period is reset or restarted. [00:37:17] Speaker 03: 710.06, okay, thank you. [00:37:21] Speaker 01: Okay, any more questions? [00:37:22] Speaker 01: Any more questions? [00:37:24] Speaker 01: Okay, thank you both. [00:37:25] Speaker 01: The case is taken under submission and that concludes the argument.