by Dennis Crouch
The Federal Circuit’s new decision in Rembrandt Diagnostics, LP v. Alere, Inc., 2021-1796 (Fed. Cir. Aug 11, 2023) complements the court’s recent decision in Axonics, Inc. v. Medtronic, Inc., 2022-1532 (Fed. Cir. Aug. 7, 2023). Ordinarily, an IPR petitioner must stick to the arguments and reasoning that it sets forth in the original petition. These two cases take a contrary position and permit the petitioner to shift as late as the final reply brief. The court permits these changes only if responsive to new arguments by the patentee and sufficiently linked to previously raised arguments.
This post focuses on Rembrandt. A prior post looked at Axonics.
Rembrandt was previously before the Federal Circuit on the full-institution issue that the Supreme Court addressed in SAS Institute. The PTAB had originally instituted Alere’s IPR petition on some but not all grounds presented. In its 2019 decision, the Federal Circuit affirmed the PTAB’s claim construction but remanded for the PTAB to consider non-instituted grounds. On remand, the PTAB instituted on all grounds and eventually concluded that additional claims were also unpatentable as obvious. On appeal this time, the Federal Circuit has affirmed — finding that the PTAB had properly found the claims obvious.
Rembrandt owns U.S. Patent No. 6,548,019 related to assay test strip devices for testing biological fluids. As the figure shows, the setup is quite simple and allows for multiple strips to be tested at once.
One of the key issues raised on appeal was the presentation of new theories mid-stream by the petitioner Alere. In particular, Rembrandt pointed to Alere’s reply brief as offering new theories.
Rembrandt argued Alere raised new theories about cost/time savings as a motivation to modify the MacKay reference to hold multiple test strips. However, the Federal Circuit found this was responsive to Rembrandt’s argument that there was no motivation to modify MacKay. Further, the cost/time savings was viewed as properly expanding on Alere’s previous “efficiency” argument.
Alere’s reply argument discussing cost and time savings has a nexus to Rembrandt’s prior argument and is responsive. It refutes Rembrandt’s assertions that there is no motivation to add multiple test strips or an expectation of success. And by discussing time and cost savings as a form of efficiency, it also properly expands on and is a fair extension of its previously raised efficiency argument.
Slip Op.
The Federal Circuit found an alternative reason to affirm — holding that forfeited its argument. Before the PTAB, Rembrandt had generally objected to new theories presented by Alere. However, the Federal Circuit concluded that generic objection was insufficient to timely assert its right. The Federal Circuit’s position was bolstered by the fact that Rembrandt had made a very specific objection regarding another new-theory issue that is not on appeal. “We hold that Rembrandt’s generic objection is insufficient to constitute a proper objection—especially because Rembrandt expressly objected to other allegedly new theories without doing so here.”
In addition to these procedural issue, the court also concluded that the Board’s conclusions were supported by substantial evidence. A key here is that Rembrandt did not provide expert testimony to rebut Alere’s expert. The prior art and expert testimony provide substantial evidence to support the PTAB’s findings on the teachings of the prior art and motivation to combine.
OT, but surprised Malcolm did not comment on this update:
link to wired.com
DC: “Ordinarily, an IPR petitioner must stick to the arguments and reasoning that it sets forth in the original petition. These two cases take a contrary position and permit the petitioner to shift as late as the final reply brief.”
Respectfully, that’s not what’s happening in either of the two cases. What’s happening is that the CAFC is allowing petitioners to (1) respond to new claim constructions that were not previously on the table; and (2) permit petitioners to flesh out previously made arguments (“improved efficiency”) when only general accusations (“no motivation to combine!”) are made in response.
Context is everything and the facts matter. Expecting petitioners to rebut in advance, in detail, all of the worst arguments a patentee will come up with is … silly. It should go without saying but this is why it’s ALWAYS useful (as long as we’ve had section 103) to consider whether filing a patent is the best approach to profiting from an “improvement”.
Well, Malcolm, do you feel the same way in the opposite direction:
“Expecting [patentees] to rebut in advance, in detail, all of the worst arguments a [petitioner] will come up with is … si11y“…?
After all, your animus is well-known (even as you ever attempt to gaslight that somehow you are not anti-patent).
As I recall, when an Examiner raises new arguments in an Examiner’s Answer during ex parte appeals before the PTAB, the applicant is allowed to address those arguments and present new evidence to rebut those arguments (on the basis that the Examiner opened the door). I don’t believe the applicant is allowed to present new evidence in the initial appeal brief that wasn’t before the Examiner (like an expert affidavit) but correct me if I’m wrong. These IPR-related decisions seem in line with that.
For anon:
“Nonsense – I have commented at least twice that that “big report” is self-serving
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put out by the perps themselves.”
Yeah, that’s “avoiding” the obvious disordering of people’s lives around her bro, as reported in the report.
No.
No it is not.
Last I checked, your ability to render a medical opinion has ZERO consequence, and plainly is not how reality works. The only actual doctor involved to this point has rendered an actual medical opinion that you do not get to simply dismiss out of hand.
Wake up son.
“medical opinion ”
Simple observation of disordering of the lived life experiences of people around an individual doesn’t require a “medical opinion” or a “medical degree”. All it requires is half a brain, and understanding what the word “disorder” is referring to. Bur burp pa derp derp. The actual diagnosis (schizophrenia etc) is what the bet is about, not the observation of disordering of people’s lived life experiences. And those are entirely separate things.
“The only actual doctor involved to this point has rendered an actual medical opinion”
Dollars to doughnuts they didn’t deliver the report to the doc just yet (I think they mentioned that they didn’t even get to discuss with the doc). If they had, it would at least raise an eyebrow, as the docs are usually not entirely incompetent at detecting disorderings in the lives of those around their patients like the avg joe anon is. Like I reported previously, both people with schizophenia, and especially with delusional disorder, the patient is largely unaffected in many areas of life and simply doing a few kindergarten mental tests will of course be ez (barring alzheimers or dementia etc). And that’s especially the case if they are sub-clinical.
You are confusing your opinion with “simple observation” (of such observation, YOU have none), with the level required for the accusers to prevail in the given context.
Again, wake up son.
As for your further musings, you contradict yourself (giving yourself – a non-physician to Divine something from (for you, absent) mere observation, but somehow a doctor engaged directly on point to the present context, somehow lacks the ability to “observe.”
Not just wake up — pull your head out.
Hilarious that Billy is obsessed with bias and conspiracies in all other aspects of Newman’s meltdown but when it comes to testimony from Newman’s personal physician (! LOL) and a selectively performed test omitting key sections, suddenly Billy is “derp derp bow down before the expert derp”!
Give us all a break already.
You must be exhausted from moving all of those goalposts Malcolm.
Clearly, I am being merely on topic and there is NO such ‘0bsess10n’ with “bias and conspiracies in all other aspects” – due in critical part to the fact that there is NO “Newman’s meltdown.”
But your accusation of being one-sided is exactly what YOU are doing – shockers:
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Bro you obviously are not understanding how the word “disorder” is being used here. When someone is having super huge bad feelings, or is at risk of getting fired, or is having to spend hours of their day tracking down some supposedly missing computer, or any other large life disruption to the day to day, their life is being “disordered” in the jargon being used. This is not an opinion. This is the definition that fancy pants people came up with. And that is what we see here. Again, this no more of an “opinion” than any of the thousands of fact findings or observations being made in the gov or a science experiment.
“with the level required for the accusers to prevail in the given context.”
I don’t care whether “accuserslol” lol “prevail” or not. Who cares about that?
“but somehow a doctor engaged directly on point to the present context, somehow lacks the ability to “observe.””
Um no, as explained to you, if that report was given to the doctors they also would “observe it”. The situation is that judge newman didn’t go on and on about her missing computer while at the doc, she didn’t note that “no other judge had been treated so badly as her, ever” while at the doc, or threaten to fire a 100% trustworthy employee for supposed “not being trustworthy” (after she herself hired him no doubt lol) while at the doc. And that is the reason why the doc is not a bit clued in. Along with the people at the court not being allowed to discuss things with her doc iirc. She didn’t do any shinanigans listed above, or any other crazy shinanigans she’s been getting up to, at the doc. If she had got up to them in the doc office, they’d be clued in very well. Or if they had the report. Or the people at the court could discuss things with the doc.
Again, this is not about muh accusations, nobody at the court cares about muh accusations, they care about resolving the disturbances to people’s lives at the court and getting work done. If getting that done was on the table, then they may well just drop the whole matter tomorrow. Note this is fair common in disorderings. This is real life, this is what happens with disorders.
I FULLY get what you are trying to say, 6 – you are simply incredibly wrong on the merits.
Man I can’t even post on the last thread.
For ben tho:
“Why would you even bother posting such absurd conditions?”
Because it would be a little bit more generous to me since we’d have such a hard time getting the truth out of the feds and the high odds I already face 1/100 (lelz). As I already discussed.
“Vidal’s pay raise is vaporware”
Vidal was going to pay raise? I didn’t even hear about it.
“it would be a little bit more generous to me”
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