[00:00:00] Speaker 03:
argument of 192194, NRA, Beacon Biomedical.

[00:00:07] Speaker 03:
Mr. Lockton, whenever you're ready.

[00:00:12] Speaker 00:
Good morning, Your Honors, and may it please the Court, Andrew Lockton from McHale & Slaven for Beacon Biomedical.

[00:00:18] Speaker 00:
Your Honors, we believe the Board legally erred in its application of this Court's precedent regarding satisfaction of the written description requirement of Section 112.

[00:00:27] Speaker 00:
This error resulted in a lack of substantial evidence regarding the four limitations at issue on this appeal.

[00:00:32] Speaker 00:
And further, the evidence demonstrates that at least with respect to Claim 1, the limitations were in fact reasonably conveyed to a skilled artisan.

[00:00:43] Speaker 00:
As addressed in our briefs, we believe the board's decision should be reversed, particularly with respect to Claim 1, but at least should be remanded for the board to apply the correct legal standard in analyzing the written efficiency of the written description.

[00:00:56] Speaker 03:
Let me just ask you a housekeeping question at the outset, which is if we were to hypothetically affirm the board in its conclusion that there's no written description support for the no bioactive glass in claim one, does that end the case before us?

[00:01:16] Speaker 00:
That would, Your Honor.

[00:01:18] Speaker 03:
Okay.

[00:01:18] Speaker 03:
Thank you.

[00:01:19] Speaker 03:
Please proceed.

[00:01:20] Speaker 03:
I'm sorry to interrupt.

[00:01:22] Speaker 00:
Oh, no.

[00:01:23] Speaker 00:
And I was going to say, because of that, because the first two limitations at issue are in independent claim one, I would like to focus my time on those.

[00:01:30] Speaker 00:
Because if either of those limitations aren't, if I'm not able to convince you with respect to both of those limitations, that would end this case.

[00:01:39] Speaker 03:
To either of those limitations?

[00:01:42] Speaker 00:
Yes, Your Honor.

[00:01:42] Speaker 00:
They're both in the only independent claim at issue here.

[00:01:51] Speaker 00:
The board provided no real explanation of its legal approach, other than to say that the limitations were not disclosed.

[00:01:58] Speaker 00:
It adopted the examiner's rejections, which stated much the same.

[00:02:02] Speaker 00:
The articulation of the rejection is not much more than simply, it's not there.

[00:02:07] Speaker 00:
Now in the red brief, my friend from the PTO argues that in support of such a summary declaration, citing to Knowles and Hyatt, but those cases actually contradict such a rejection.

[00:02:21] Speaker 00:
In the old case, Britton described solder pads and then in the claims attempted to claim something much more specific.

[00:02:31] Speaker 00:
Now, in that case, the court affirmed that it wasn't disclosed because only the general genus was disclosed and a much more specific species was claimed without any real indication that the inventor possessed such an invention.

[00:02:48] Speaker 00:
In contrast with that case, here,

[00:02:51] Speaker 00:
And the PTO concedes, we have disclosed many preferred embodiments.

[00:02:56] Speaker 00:
And the evidence shows those preferred embodiments, none of them are materials that contain bioactive glass.

[00:03:03] Speaker 03:
Yes, but isn't the case law fairly clear, even the Nike case, which I think you rely on?

[00:03:10] Speaker 03:
There's a negative limitation here, not containing bioactive glass.

[00:03:15] Speaker 03:
And the board found

[00:03:17] Speaker 03:
that the specification does not inherently or explicitly exclude materials that contain bioactive glass.

[00:03:27] Speaker 03:
That's correct, right?

[00:03:30] Speaker 03:
It does not inherently or explicitly exclude materials that contain bioactive glass, right?

[00:03:36] Speaker 00:
I would agree, Your Honor, that the Board made that finding adopting the examiner's position, but I would argue that that is not the correct standard of the law.

[00:03:45] Speaker 03:
Okay, well I just want to get, we can move on to that in a minute.

[00:03:50] Speaker 03:
And they also concluded that it doesn't provide any reason that the lack of bioactive glass is necessary or meaningful to the invention.

[00:03:59] Speaker 03:
Is that correct?

[00:04:03] Speaker 00:
It acknowledged that we have the argument and that there is evidence that there is a reason, but the board found it's an insufficient reason.

[00:04:14] Speaker ?:
Okay.

[00:04:14] Speaker 03:
So now you can tell me why that's not adequate under our review, the board's analysis and reasoning.

[00:04:23] Speaker 00:
Well, first, to go back to the legal standards that the court just articulated.

[00:04:27] Speaker 00:
The law is not whether it is explicitly or inherently disclosed.

[00:04:31] Speaker 00:
It must be, as the power oasis case stated, actually or inherently disclosed.

[00:04:37] Speaker 00:
We know from Ariadne and VASCAP that explicitly is not the standard.

[00:04:41] Speaker 00:
We don't have to have an if-is-verbal disclosure.

[00:04:44] Speaker 00:
And we know from the MC and Senteris cases that inherent disclosure is not the standard.

[00:04:50] Speaker 00:
Because if we disclose limitations and we cite, for example in this case, disclosing the implant and disclosing the bioactive glass being an additional feature, arguably we can say that, well under MC and Senteris, we can say that

[00:05:12] Speaker 00:
we don't have bioactive glass, or we could make the statement that the implant could positively recite an implant containing bioactive glass.

[00:05:21] Speaker 00:
That's not the invention here.

[00:05:23] Speaker 00:
The invention here is an implant that doesn't contain bioactive glass that has bioactive glass coating in order to aid in the bone fusion.

[00:05:37] Speaker 00:
The issue is whether or not the description will reasonably convey to a skilled artisan.

[00:05:43] Speaker 00:
that the inventor possessed the invention.

[00:05:45] Speaker 00:
That reasonably conveyed language that the court has expressly stated does not require that we expressly state the negative limitation.

[00:05:58] Speaker 00:
The specification that is issued here in paragraph 57 explains that, in effect, I think the easiest things, if I quote it,

[00:06:13] Speaker 00:
It teaches that while the basic preferred embodiment is preferably constructed of the, and I'm paraphrasing this part, the polyether ether ketone, polyaryl ether ketone, stainless steel, or titanium, or the like, the markers are preferably constructed from a bioactive glass having a composition such as.

[00:06:33] Speaker 00:
That language shows that there's a contrast between what the implant material is made of and what the markers there was bioactive glass coating is made of.

[00:06:43] Speaker 00:
it's drawing a distinction between these two materials.

[00:06:47] Speaker 00:
We also note from the record that polyether ether ketone, polyaryl ether ketone, stainless steel or titanium are materials that don't contain bioactive glass.

[00:06:58] Speaker 00:
And for the board and the examiner to require an explicit statement in the specification that those materials don't contain bioactive glass would be to completely read out what a person of ordinary skill in the arts reading the specification would understand.

[00:07:13] Speaker 00:
what would be reasonably conveyed.

[00:07:16] Speaker 01:
Can I ask you this question?

[00:07:17] Speaker 01:
Is it your position that the spec reasonably conveys that there shall not be bioactive glass in the internal part, or that it reasonably conveys there may or there may not, and since one of the possibilities is there may not, that's enough of a disclosure?

[00:07:44] Speaker 00:
My position is that under INSEE we know that such a specification would support both claiming it includes it or that it includes not including it.

[00:07:54] Speaker 00:
My argument to you right now is that this disclosure sufficiently or reasonably conveys to a person of ordinary skill in the arts that the inventor possessed an implant that didn't contain bioactive glass.

[00:08:07] Speaker 00:
For example, an implant such as stainless steel or titanium or peak or peak.

[00:08:14] Speaker 00:
all of which don't contain bioactive glass.

[00:08:19] Speaker 00:
And we know that it reasonably conveys that limitation to a skilled artisan because the examiner cited the Brosnahan reference and what I would term even more deficient, or a deficient, sorry, that's not the right word, a more broad disclosure as a sufficient disclosure of the claim limitation.

[00:08:41] Speaker 00:
In the Brosnahan reference,

[00:08:44] Speaker 00:
The examiner read the language that an insert could be made from a material such as metal, ceramic, polymer, or composites.

[00:08:52] Speaker 00:
And that was a sufficient disclosure, as the evidence shows, for an implant that doesn't contain bioactive glass.

[00:09:01] Speaker 00:
Now, stainless steel and titanium are metals.

[00:09:04] Speaker 00:
Polyether ether ketone and polyaryl ether ketone are polymers.

[00:09:11] Speaker 00:
Under the examiner's fact-finding,

[00:09:13] Speaker 00:
That's a sufficient disclosure.

[00:09:24] Speaker 00:
We look at that and we can see that the board's analysis and the examiner's 112 analysis was simply a matter of, was there an explicit disclosure?

[00:09:37] Speaker 00:
But we see from the examiner's fact finding in the 103 rejection, which was reversed because of a different reason,

[00:09:43] Speaker 00:
that a disclosure such as what's made in paragraph 57 of the specification is a sufficient disclosure in order to claim an implant that doesn't contain bioactive glass.

[00:09:57] Speaker 00:
Now with regard to the second limitation of claim one, the wrap removal, we can also look to the examiner's finding with regard to using a wrap.

[00:10:08] Speaker 00:
The examiner rejected in the 103 rejection argued that

[00:10:13] Speaker 00:
Removing a wrap prior to the installation is an inherent feature of using a wrap.

[00:10:18] Speaker 00:
It's part of its necessary function.

[00:10:20] Speaker 00:
It has to be removed.

[00:10:25] Speaker 00:
Because that limitation would be inherent in the claim including a wrap, then that limitation should also be found to satisfy the requirements of Section 112.

[00:10:44] Speaker 00:
An issue here is that we don't have much to go on from what the board of the examiner said, but what they did say, the requirement for explicit or inherent disclosure is not the law.

[00:11:06] Speaker 00:
We would ask that this court reverse the board's decision with regard to claim one, because

[00:11:14] Speaker 00:
the first limitation at issue, not containing bioactive glass, is adequately supported, is reasonably conveyed based on the examiner's fact-finding, and that the second claim limitation of claim one, that the wrap is removed just prior to installation, is an inherent feature as conceded by the examiner.

[00:11:33] Speaker 00:
With regard to claim eight and nine, we don't have the board's analysis or their reasoning more than to simply say it's not there, and therefore we would ask that

[00:11:44] Speaker 00:
if the court is not inclined to reverse those rejections, that they be at least remanded.

[00:11:53] Speaker 00:
Since I find out I'm repeating myself, I would like to reserve the rest of my time.

[00:11:57] Speaker 03:
Thank you very much.

[00:11:58] Speaker 03:
Let's hear from the government, the PTO.

[00:12:03] Speaker 02:
Thank you.

[00:12:03] Speaker 02:
May it please the court?

[00:12:05] Speaker 02:
The new claim limitations in claims 1, 8, and 9 were added during prosecution in order to overcome prior art.

[00:12:15] Speaker 03:
Can I just ask you the same housekeeping question I asked your friend at the outset, which is if we were to hypothetically agree with the board with respect to the no bioactive glass limitation, does that end this appeal?

[00:12:31] Speaker 02:
Yes, so actually if you agree with either limitation, the RAP removal limitation or the no bioactive RAP limitation, if you believe that either of those do not have proper written description support, then you can affirm the board's decision because then claim one and claims eight and nine do not meet the written description requirement.

[00:12:57] Speaker 03:
Okay, I'm sorry to interrupt.

[00:13:00] Speaker 02:
So, when Beacon Biomedical added those claim limitations in order to overcome the prior ART, they did not point to the specification as the MPEG recommends and therefore, the board and examiner pointed out that those claim limitations as a public counsel

[00:13:21] Speaker 02:
admitted to you that those are not explicitly in the specification.

[00:13:24] Speaker 02:
So then it was on Beacon Biomedical, it was their burden to explain and show how one of ordinary scleromy art would understand the facts to find those claim limitations.

[00:13:34] Speaker 02:
And they didn't come forth with any objective evidence, they didn't talk about what the level of a person of ordinary scleromy art would be, an explanation of how a person in the ordinary scleromy art would understand

[00:13:45] Speaker 02:
based on the four corners of the specification, how you would get from the disclosure in the specification to that newly added claim limitation and what would be understood.

[00:13:57] Speaker 02:
Based on that, the board findings were sufficient.

[00:14:01] Speaker 02:
You know, the board said as is allowable in the law that these are limitations that are not in the specification and addressed by biomedical

[00:14:11] Speaker 02:
Therefore, we think that substantial evidence supports the board's determination that the claims didn't meet the written description requirement and we ask the support to affirm.

[00:14:22] Speaker 03:
Let me tell you, there's only one thing that happens to be bothering me personally about this case and that's with respect to the second question, which we don't necessarily even have to reach, but the remove just prior to installation.

[00:14:39] Speaker 03:
Because there's a lot of backstory here and your friend is arguing about obviousness, you know, the standard for obviousness versus written description.

[00:14:47] Speaker 03:
And frankly, I'm not necessarily buying it.

[00:14:50] Speaker 03:
But with respect to this particular limitation, I am troubled that the examiner really used the word inherently when he was dealing with the obviousness.

[00:15:02] Speaker 03:
He didn't just say it was obvious.

[00:15:05] Speaker 03:
He used the word the wrap is inherently removed prior to installation.

[00:15:10] Speaker 03:
So I'm having a little trouble not transferring that conclusion by the examiner about inherently removed to allow this limitation to stand here because of the inherence.

[00:15:25] Speaker 03:
Do you understand my question?

[00:15:27] Speaker 02:
I do.

[00:15:27] Speaker 02:
I do.

[00:15:28] Speaker 02:
And I think I can help you.

[00:15:29] Speaker 02:
I have two responses.

[00:15:31] Speaker 02:
A, as we pointed out in our brief, that obviousness and written description and disclosure are two separate inquiries.

[00:15:38] Speaker 02:
But also, I would have us turn to the appendix of 403, what the examiner found.

[00:15:45] Speaker 02:
And the examiner did say, and I would actually say 403 and then 408, there's more explanation.

[00:15:52] Speaker 02:
So, the examiner did say that yes.

[00:15:54] Speaker 02:
In order for the RAP to function, it has to be removed, but the just prior part was intended use, and then the examiner relied on the fact that, okay, well, if you have the structural limitations, you would have that intended use, and then as the examiner said on 408, you could remove it just after, or you could let it biodegrade, so it could be removed.

[00:16:19] Speaker 02:
But it's not necessarily removed just prior to installation.

[00:16:22] Speaker 02:
And that is a claim limitation that they decided to add that there's absolutely zero support for in the specification.

[00:16:31] Speaker 02:
Does that answer your question?

[00:16:33] Speaker 03:
Well, it tries to answer the question.

[00:16:35] Speaker 03:
I'm still looking at 402 and 403.

[00:16:38] Speaker 03:
And the quote seems pretty clear to me that this is a quoting the examiner's language, that the wrap is inherently removed prior to installation of said implant.

[00:16:49] Speaker 02:
Right, I guess I was trying 403 and 13 where it talks about the intended use and then on 408 where the examiner does explain that the different times of removal that could be possible.

[00:17:06] Speaker 02:
That's it, yes.

[00:17:08] Speaker 01:
Okay, I take your point.

[00:17:09] Speaker 01:
Can I ask you the same question I asked earlier?

[00:17:14] Speaker 01:
I'll try to do it in a concrete term.

[00:17:20] Speaker 01:
The spec talks about the stainless steel.

[00:17:25] Speaker 01:
Would it suppose, and you may want to contest the assumption, but suppose a skilled artisan would read that and say,

[00:17:34] Speaker 01:
Huh, there might be bioactive glass or there might not.

[00:17:38] Speaker 01:
I certainly could understand either way.

[00:17:41] Speaker 01:
Would that be enough written description support for a limitation that said no bioactive glass?

[00:17:51] Speaker 02:
I don't believe so.

[00:17:52] Speaker 02:
I know that the NC case that the Poison Council mentioned talks about alternatives.

[00:17:59] Speaker 02:
So, I think if you give specific alternatives and, you know, if there was more explanation of we can't use bio-glass for these reasons or we cannot use bio-glass for these reasons, but one of our nerds still in the art, I mean, reading this staff which talks about using bio-active glass for markers and

[00:18:21] Speaker 02:
talks about, you know, even does mention using glass and pieced together, I don't think one of ordinary people in the art would clearly understand that the inventor was the criticality of using or not using bioactive glass.

[00:18:39] Speaker 02:
So I do not think either way is sufficient written description.

[00:18:45] Speaker 01:
But not because as a legal matter, if a skilled artisan

[00:18:49] Speaker 01:
would understand that both alternatives would immediately envision both alternatives upon reading it.

[00:18:57] Speaker 01:
You're not saying that as a legal matter that would be insufficient to claim either one of the alternatives, but simply that there wasn't enough evidence for the board to have to find that a skilled artisan would envision both alternatives.

[00:19:15] Speaker 02:
I think certainly substantial evidence, the latter is through legally.

[00:19:22] Speaker 02:
I guess I don't think it meets the legal test yet because you do have to clearly lay out those alternatives.

[00:19:28] Speaker 02:
And so I think if there are clear alternatives laid out legally, you could have support for a negative limitation.

[00:19:41] Speaker 02:
Are there any further questions?

[00:19:46] Speaker 03:
I do not think so.

[00:19:48] Speaker 02:
I will yield the rest of my time.

[00:19:50] Speaker 02:
Thank you.

[00:19:51] Speaker 03:
Thank you.

[00:19:53] Speaker 03:
Mr. Lockton, you've got some time left on rebuttal.

[00:20:05] Speaker 03:
Mr. Lockton?

[00:20:07] Speaker 00:
Oh, my apologies, Your Honor.

[00:20:08] Speaker 00:
I was still muted.

[00:20:13] Speaker 00:
Thank you.

[00:20:14] Speaker 00:
It sounded like

[00:20:15] Speaker 00:
My friend from the PCO was arguing that the board's analysis of simply saying it's not there is sufficient because when the claim limitation was added during prosecution, the specification wasn't clearly pointed out.

[00:20:33] Speaker 00:
But the specification was clearly pointed out when we were arguing on the 103 issues.

[00:20:39] Speaker 00:
And the majority of the prosecution dealt with the 103 issues.

[00:20:43] Speaker 00:
The original plane was an implant, and it was rejected based on a prior art reference that was an implant that had bioactive glass.

[00:20:51] Speaker 00:
It was teaching a method of actually making a composite structure that included bioactive glass, which actually evidence is showing that most of these materials don't contain bioactive glass.

[00:21:02] Speaker 00:
It was added as clarifying the distinction, and it was addressed in that clarification of the 103 rejection.

[00:21:09] Speaker 00:
But what we did when adding the language and when arguing during prosecution is we specifically pointed out to the specification that there are preferred embodiment materials and those materials are understood by a skilled artisan as not containing bioactive glass.

[00:21:27] Speaker 00:
It's a pretty straightforward manner in material science that if we're talking about stainless steel, if we're talking about titanium, if we're talking about peak or peak polymers,

[00:21:40] Speaker 00:
these are materials that have a certain structure.

[00:21:43] Speaker 00:
They have a certain composition.

[00:21:45] Speaker 00:
And there is nothing about those compositions which would inherently or even suggest that they are materials that contain bioactive glass within them.

[00:21:55] Speaker 00:
And so by citing to the specifications showing that there are materials that are understood because they're objectively materials that don't contain bioactive glass within them,

[00:22:06] Speaker 00:
We have adequately conveyed to a skilled artisan that the inventor is in possession of an implant that doesn't contain bioactive glass.

[00:22:17] Speaker 00:
To go back to Judge Toronto's question regarding the sufficiency of the disclosure, I believe that the MC case presents actually a good inverse of the position that we're arguing here.

[00:22:29] Speaker 00:
It quotes the Sam Harris case, where in that case,

[00:22:36] Speaker 00:
If we're disclosing a material and an additional material, for example in this case, we're disclosing the implant and it is being coated with bioactive glass, then what that case tells us is that that's a sufficient disclosure for adding the material or taking the material away.

[00:22:56] Speaker 00:
Now, since we're talking about adding bioactive glass to the implant material itself,

[00:23:03] Speaker 00:
coating it onto it, putting it into crevices of that material.

[00:23:07] Speaker 00:
Under that law, that should be sufficient to disclose to a skilled artisan and under this court's precedent that the implant itself is sufficiently described as not containing bioactive glass in order to satisfy the 112 requirement for its description.

[00:23:32] Speaker 00:
But if there are no further questions from the court.

[00:23:36] Speaker 00:
Thank you.

[00:23:38] Speaker 03:
We thank both sides and the case is submitted.

[00:23:40] Speaker 00:
The Honorable Court is adjourned until tomorrow morning at 10 a.m.