[00:00:15] Speaker 02:
Okay, the next argued case is number 18-2031, Mayo Foundation against Yanku, Mr. Davis.

[00:00:27] Speaker 03:
Thank you, Your Honors.

[00:00:28] Speaker 03:
Good morning and may it please the court, Ahmed Davis from Fish & Richardson on behalf of Mayo.

[00:00:34] Speaker 03:
In this case, the continued examination that Mayo requested was complete

[00:00:39] Speaker 03:
when the examiner indicated that the claims were allowable and the Board of Interferences declared the interference in 2014.

[00:00:46] Speaker 03:
You asked for the interference, right?

[00:00:49] Speaker 03:
We did make the suggestion for the interference.

[00:00:51] Speaker 03:
That's correct, Judge Stein.

[00:00:53] Speaker 03:
At the point that the interference was declared consistent with the regulation at 37 TFR 41.102, examination had been completed in at least one claim

[00:01:06] Speaker 03:
had been found patentable but for the interference.

[00:01:09] Speaker 03:
The patent office here and the district court thereafter improperly charged the post-interference time to Mayo.

[00:01:16] Speaker 03:
And in so doing, they ignored the broader principles that was announced in Novartis, that after claims are deemed allowable, the additional time for B delay is chargeable to the PTO.

[00:01:30] Speaker 01:
But 703B1 talks about ending on the date of mailing of the notice of allowance.

[00:01:41] Speaker 01:
And that time was probably subtracted then.

[00:01:45] Speaker 03:
703B1 does, Judge Lurie, speak specifically to that time?

[00:01:52] Speaker 03:
That regulation was amended after this court's Novartis decision.

[00:02:00] Speaker 03:
And in pertinent part, during the rulemaking, there was a comment that was made.

[00:02:08] Speaker 03:
It was comment number two we cited in our brief, where the commenter noted

[00:02:13] Speaker 03:
that it would be unfair under that statute to count the time any time after the notice has issued if it is reopened for any reason that would be chargeable to the Patent and Trademark Office.

[00:02:24] Speaker 03:
The Patent and Trademark Office recognized that and clarified that any time that was reopened as a part of the process that was chargeable to the PTO still would not be counted towards the applicant's time.

[00:02:39] Speaker 03:
And I raise that point, Your Honor, just to note

[00:02:41] Speaker 03:
Although the regulation does say that, even the Patent Office itself has recognized that in certain circumstances, it would be appropriate after a notice of allowance has been issued to reopen and then charge that time back to the Patent Office.

[00:03:00] Speaker 03:
The district court here, in effect, in our view,

[00:03:04] Speaker 03:
engaged in an example of exalting form over substance as we read the Novartis decision that I recognize two of the three members of this panel were on that panel as well.

[00:03:19] Speaker 03:
The court determined that it was not when the patent issued, but when the notice of allowance was first mailed, that the time was cut off.

[00:03:31] Speaker 03:
And so we view this as a case in which merely there is an application of the broader principle of Novartis.

[00:03:38] Speaker 03:
And the analogies in this case mirror those in Novartis quite closely.

[00:03:46] Speaker 03:
The PTO regulations say again that examination is to be completed before the file goes to the Board of Patent Appeals and Interferences and an interference is declared.

[00:04:02] Speaker 03:
Once that interference is declared, the board takes over sole jurisdiction over the file and the examiner may not act unless specifically directed to

[00:04:14] Speaker 03:
by the board, the MPEP, which we recognize.

[00:04:18] Speaker 00:
So here the board did not, or the PTO did not charge you with the time between the notice of allowance and issuance, which would be contrary in Novartis, right?

[00:04:33] Speaker 00:
That's correct.

[00:04:33] Speaker 00:
It did not charge us for that time.

[00:04:36] Speaker 00:
So why doesn't Novartis stand for the proposition that you should be charged with the time before the notice of allowance, since that's what happened?

[00:04:43] Speaker 00:
I'm sorry, did you ask that again?

[00:04:45] Speaker 00:
Why doesn't Novartis stand for the proposition that you should be charged with the delay before the notice of allowance, which is what the Novartis allow?

[00:04:57] Speaker 03:
Your Honor, I think that Novartis stands for the proposition that the

[00:05:02] Speaker 03:
Applicant should not be charged for any time once it is clear that the application process is complete and In this particular instance the request for continued examination that was requested by the applicant has been completed Novartis talks about allowance and that occurs with a notice of allowance and

[00:05:27] Speaker 03:
That is correct.

[00:05:30] Speaker 03:
We would suggest, just Laurie, that a notice of allowance is a specific document that is issued by the patent office to indicate that the claims have been allowable.

[00:05:43] Speaker 01:
You're contesting now the period between the termination of the interference and the notice of allowance.

[00:05:50] Speaker 03:
That's correct.

[00:05:52] Speaker 01:
And that was a consequence of the continuation

[00:05:57] Speaker 01:
application examination that you requested?

[00:06:02] Speaker 03:
We did request a continuation examination.

[00:06:06] Speaker 03:
But we would suggest that the time up to the institution, the declaration of the interference, is in fact what it is that Mayo actually requested.

[00:06:18] Speaker 03:
Because at that point, pursuant to the patent office's own regulations, the claims that were at issue were deemed allowable.

[00:06:27] Speaker 03:
And the only issue that precluded those claims being allowed was the interference itself.

[00:06:34] Speaker 01:
And what about section of statute 151B1V, double I, talking about actually an interference?

[00:06:48] Speaker 01:
So that time had to have been deducted.

[00:06:51] Speaker 03:
It did.

[00:06:52] Speaker 03:
And that time, as I understand it, Your Honor, the time for the interference is

[00:06:57] Speaker 03:
itself is already deducted as a part of C delay.

[00:07:02] Speaker 03:
And I don't think there's any dispute between the parties at the time for the interference was to be deducted and properly so.

[00:07:09] Speaker 03:
But at the point that the interference ended,

[00:07:14] Speaker 03:
Having already concluded, as a necessary predicate to instituting the interference in the first place, that the claims were allowable.

[00:07:23] Speaker 00:
But your problem is that the PTO rules provide for continued examination after the termination of the interference and before the notice of allowance, right?

[00:07:33] Speaker 03:
Well, they do allow for the examiner to do something.

[00:07:40] Speaker 03:
In addition, I'm not sure I would say that it's continuing because

[00:07:46] Speaker 03:
That is a distinction between what the applicants requested and what the PTO on its own may agree to do.

[00:07:56] Speaker 03:
We don't take any issue with the fact that the examiner in this instance, after the board of patent appeals and interferences returned the file to the examiner, that the examiner decided to do another search.

[00:08:10] Speaker 03:
The examiner was perfectly entitled to do that.

[00:08:13] Speaker 01:
That was routine, right?

[00:08:14] Speaker 01:
That's routine post-interference.

[00:08:18] Speaker 03:
I understand that the government has said that in their brief, but we don't have any evidence that that is routine post-interference.

[00:08:25] Speaker 03:
And in fact, we think the facts of this case

[00:08:28] Speaker 03:
are a unique example of why the government's position is not routine at all.

[00:08:34] Speaker 03:
What happened here, Judge Lurie, is that earlier on in the application process for what ultimately became the 063 patent, the examiner at the time issued a restriction requirement.

[00:08:47] Speaker 03:
And Mayo, in response to that restriction requirement, elected certain claims.

[00:08:52] Speaker 03:
Those were the claims that ultimately ended up in the interference.

[00:08:58] Speaker 03:
Meanwhile, on a separate track, the very claims that the examiner had required Mayo to issue the restriction about were filed in a different application and ultimately issued as a patent, the 927 patent.

[00:09:13] Speaker 03:
And it was those claims, that patent, which a new examiner, after the interference had concluded and Mayo was declared to have prevailed,

[00:09:24] Speaker 03:
Those were the claims that were ultimately subject to the double patenting rejection and so the board itself could have instructed the examiner to reopen not continue but reopen in the words of the MPP.

[00:09:40] Speaker 03:
examination, but it did not do that.

[00:09:43] Speaker 03:
The MPEP says that the examiner may reopen until that was a decision that the examiner made on her own, the new examiner.

[00:09:51] Speaker 03:
She rejected the claims on a double patenting rejection based.

[00:09:56] Speaker 01:
In any event, all of this was before the notice of allowance.

[00:09:59] Speaker 01:
which was the key date.

[00:10:01] Speaker 03:
It is absolutely correct that it was before the notice of allowance.

[00:10:04] Speaker 03:
We want to suggest that the notice of allowance is a key date.

[00:10:09] Speaker 01:
You're saying there was in effect an allowance before the grant of the notice of allowance.

[00:10:14] Speaker 03:
Saying that the claims were deemed allowable and that the declaration of... Which is different from Novartis.

[00:10:21] Speaker 03:
It is different from Novartis on Novartis's facts, but we believe that Novartis expressed a broader principle that Novartis, as we see it, wasn't definitively saying that it is the notice of allowance and only the notice of allowance

[00:10:37] Speaker 03:
that determines when prosecution has closed.

[00:10:40] Speaker 03:
And the language of Novartis itself, Judge Lurie even says that it's the presumptive end.

[00:10:46] Speaker 03:
We would suggest that in this case, the presumptive end of prosecution in this matter was earlier.

[00:10:55] Speaker 03:
That in effect, what happened here was at the close of the interference

[00:11:00] Speaker 03:
The examiner opted to reopen examination, conduct an additional search, issued the double patenting rejection, and then when Mayo responded, the double patenting rejection was withdrawn.

[00:11:15] Speaker 03:
I'll note also that there's no dispute between the government and Mayo that during that time period, Mayo did ask for a one-month extension to respond, and that time was counted towards applicant delay.

[00:11:32] Speaker 03:
And so there was nothing that occurred after the

[00:11:36] Speaker 03:
interference was completed that was duly chargeable to Mayo in its activities.

[00:11:43] Speaker 03:
And one additional point that I would make that I think the government took issue with in its brief is that we find ourselves in a position here where, but for the request for continuing examination, the outcome would have been different.

[00:12:01] Speaker 03:
And I think even the government agrees with that, and that is that

[00:12:05] Speaker 03:
Had the suggestion for an interference taken place during the initial application and pendency of the prosecution before the request for continued examination was made and then everything else occurred exactly the same and that the that ultimately the interference had been found in Mayo's favor the time after that interference and

[00:12:33] Speaker 03:
under the regulations would have been counted towards the government.

[00:12:37] Speaker 03:
And I don't think there's a dispute that Mayo would be entitled to PTA in that instance.

[00:12:43] Speaker 03:
And so the fact here that Mayo made a request for a continued examination.

[00:12:48] Speaker 00:
Does it make a difference that it resulted from a request for continued examination?

[00:12:52] Speaker 00:
That would seem to be contrary to statute, though.

[00:12:55] Speaker 03:
Well, I do think it makes a difference only in the sense that the statute itself and the implementing regulations say that the time that is counted against Mayo is only the time related to the request that Mayo made.

[00:13:10] Speaker 03:
In this instance, the request that Mayo made for continuing examination was that the patent be determined to be allowable.

[00:13:18] Speaker 03:
That happened when the board issued the Declaration of Interference.

[00:13:24] Speaker 02:
Okay.

[00:13:25] Speaker 02:
Let's hear from the Director.

[00:13:26] Speaker 02:
Thank you, Mr. Davis.

[00:13:31] Speaker 02:
Mr. McCotter.

[00:13:32] Speaker 04:
Thank you, Your Honor.

[00:13:33] Speaker 04:
And may it please the Court, Trent McCotter, Assistant United States Attorney on behalf of the PTO Director.

[00:13:38] Speaker 04:
In our view, the Brightline Rule established by Novartis controls here.

[00:13:42] Speaker 04:
The Court and Novartis held that continued examination requested by the applicant is the time up until the mailing of the Notice of Allowance on page 602 of that opinion.

[00:13:52] Speaker 04:
Twice, it uses the phrase mailing of the allowance, and there's no dispute between the parties.

[00:13:57] Speaker 04:
That's what the PTO did here.

[00:13:59] Speaker 04:
That, in our view, should end the case.

[00:14:01] Speaker 04:
Now, Mayo claims that Novartis announced a broader principle.

[00:14:05] Speaker 04:
There's no evidence of that in Novartis itself.

[00:14:07] Speaker 04:
But even if there were, the principle of Novartis would be that continued examination requested by the applicant ends when the application

[00:14:16] Speaker 04:
Permanently moves from a substantive review to a more ministerial clerical review like the publication office as was the case in Novartis Here that certainly did not happen when the interference when the notice of allowance That's when the notice of allowance is mailed John it's exactly what Novartis said that certainly did not happen at the time the interference was declared there were another two and a half years or so of substantive review after that period and as Judge Helen Judge Ellis held below it's quite common that

[00:14:43] Speaker 04:
for this examination to continue after the interference.

[00:14:46] Speaker 04:
It's essentially required.

[00:14:48] Speaker 04:
Mayo is not entitled to a patent as soon as the interference ends.

[00:14:52] Speaker 04:
The examiner has to look at the state of the art at the time the interference has ended to determine whether a patent should issue.

[00:14:59] Speaker 04:
And Mayo, I think, acknowledges several times in their brief that, in fact, examination did occur well after the declaration of interference.

[00:15:08] Speaker 04:
Mayo pivots by arguing that that time was not actually requested by Mayo, but, of course,

[00:15:13] Speaker 04:
The only reason we had an interference in the attenuating examination afterwards was because Mayo filed an RCE asking for an interference.

[00:15:24] Speaker 04:
And further, that RCE remained pending this entire time, all the way through interference, all the way through the examination afterwards, up until the allowance was mailed.

[00:15:33] Speaker 04:
There are only two ways to end an RCE.

[00:15:35] Speaker 04:
Either the notice of allowance gets mailed or the application is rejected finally and abandoned.

[00:15:42] Speaker 04:
Obviously, neither of those happened during the relevant time period.

[00:15:46] Speaker 04:
I think, in a way, even Mayo agrees.

[00:15:48] Speaker 04:
Its opening brief at page 15 when it's describing the court's decision in Novartis said, quote, the applicant's continued examination request is responsible for all the time up until allowance, end quote.

[00:16:01] Speaker 04:
And so in our view, that shows that entire time period up until the mailing was, in fact, Mayo's responsibility.

[00:16:06] Speaker 01:
They're just disagreeing as to what allowance means.

[00:16:09] Speaker 04:
But again, as we said, Novartis doesn't have any indication of that.

[00:16:13] Speaker 04:
And Novartis expressly referred to the mailing of the allowance.

[00:16:16] Speaker 04:
And there are key distinctions between mere allowability solely for purposes of kicking the application into the interference process, which is what happened here and under the reg that Mr. Davis cites, as opposed to actual allowance.

[00:16:28] Speaker 04:
And those key differences are ones that Novartis itself addressed, i.e., whether examination is likely to continue after that point, Your Honor.

[00:16:36] Speaker 04:
And I do think, finally, it's worth pointing out

[00:16:39] Speaker 04:
that for purposes of a delay, time running against the PTO for responding, Mayo agreed that the RC was pending well after the interference itself ended.

[00:16:49] Speaker 04:
So Mayo seems to be arguing that the RC was pending for purposes of a delay, but yet it wasn't pending for purposes of b delay.

[00:16:58] Speaker 04:
And so both of the statutory requirements are met here.

[00:17:01] Speaker 04:
There was, in fact, continued examination well after the declaration of interference.

[00:17:06] Speaker 04:
And all of that time is attributable

[00:17:08] Speaker 04:
to Mayo's RCE, and that's why the time can't count as B2A, Your Honors.

[00:17:18] Speaker 04:
As Judge Ellis addressed in his decision, if the court were to adopt Mayo's position, there would be absurd results.

[00:17:24] Speaker 04:
There would be very difficult, pragmatic results.

[00:17:27] Speaker 04:
I won't go into all of them.

[00:17:28] Speaker 04:
Our brief lays out several.

[00:17:29] Speaker 04:
Judge Ellis himself laid out several.

[00:17:31] Speaker 04:
And again, that's why we think that the Bright Line rule established by Novartis was so important.

[00:17:35] Speaker 04:
And it makes perfect sense, both in Novartis

[00:17:37] Speaker 04:
And in this case, Your Honor, to draw that line when the notice of allowance was mailed and not before.

[00:17:44] Speaker 04:
If the Court has no further questions.

[00:17:47] Speaker 04:
We respectfully request the Court affirm.

[00:17:49] Speaker 02:
Thank you.

[00:17:50] Speaker 04:
Thank you, Your Honor.

[00:17:54] Speaker 02:
Mr. Davis.

[00:17:55] Speaker 03:
Yes, just briefly in response, Mr. Mercado said that it's clear that Mayo is not entitled to a patent after

[00:18:05] Speaker 03:
the Declaration of Interference, it is also true that Mayo is not necessarily entitled to a patent merely when the Notice of Allowance issues.

[00:18:14] Speaker 03:
That is a point in time in which the file moves to another area of the Patent Office, but the Notice of Allowance itself on its face says that the Patent Office on its own or in response to a request from the applicant can reopen prosecution, and if it does so, that is time that is not chartable to

[00:18:35] Speaker 03:
the applicant.

[00:18:38] Speaker 03:
Judge Ellis and again in the government's brief argues that what is proposed by Mayo in this place would lead to observed results but the example that I believe Judge Ellis gave that the government repeats in its brief is an example where an examiner indicates that claims are allowable over the phone and so there's no written record

[00:18:59] Speaker 03:
And that could lead to all kinds of difficult and challenging results.

[00:19:04] Speaker 03:
And that's not Mayo's position here.

[00:19:06] Speaker 03:
Mayo's position here is there needs to be some sort of clear written indication that as far as the Patent Office is concerned, that the claims are effectively deemed allowable.

[00:19:18] Speaker 03:
And our position is that here in this case, that is when the Declaration for Interference was served on the parties.

[00:19:29] Speaker 03:
Just very briefly, the MPEP itself says that if there's a recommendation for further action after the interference in the examiner must reopen prosecution, but if not, such is the case here, the examiner may reopen prosecution.

[00:19:44] Speaker 03:
The PTO itself recognized that prosecution and examination had closed on those claims before the interference, but allows that prosecution to be reopened after the interference, much in the same way that the PTO on its own can reopen prosecution after the notice of allowance.

[00:20:03] Speaker 03:
And so in the end, we would say that there's no doubt

[00:20:07] Speaker 03:
that the notice of allowance itself is one period at which a bright line can be drawn, but that is not the only bright line that can be drawn, and that there are particular instances of which this is one where it's clear from the PTO's regulations and its implementing practices that an earlier date is appropriate.

[00:20:25] Speaker 03:
So we would ask this court respectfully to reverse the decision of the district court.

[00:20:30] Speaker 02:
Thank you.

[00:20:30] Speaker 02:
Thank you.

[00:20:31] Speaker 02:
Thank you both.

[00:20:32] Speaker 02:
The case is taken under submission.