In re Theripion, Inc., 2022-1346 (Fed. Cir. Aug. 10, 2023) (nonprecedential) (Opinion by Judge Stark, joined by Judges Hughes and Cunningham).
ApoA1 is a key component of HDL, also known as “good cholesterol.” The founders of Therapin created a synthetic “fusion protean” of ApoA1 linked to the Fc portion of an antibody (the stem). That fusion extends the half-life of injected HDL and allows it to be a better potential drug treatment. The claims require a specific linker protein of 10-40 amino acids between the ApoA1 and Fc portions. Theripion discovered that this longer linker improved cholesterol efflux activity compared to fusion proteins having shorter 2 amino acid linkers or no linker. So the essence of the invention as claimed is an ApoA1-Fc fusion protein with an optimized 10-40 amino acid linker that enhances the fusion protein’s ability to remove cholesterol from cells as compared to a much shorter or absent amino acid linker. To be clear, the prior art (including some work by the inventors here) had created ApoA1-Fc fusions, but with a short linkage. And, various types of connectors of the claimed length were also known.
The crux of the obviousness case then is whether a person of skill in the art would expect that the use of a longer peptide linker in this situation would increase cholesterol efflux activity. The patent examiner rejected the claims as obvious and the PTAB affirmed despite evidence of unexpected results presented by Theripion.
On appeal, the Federal Circuit has vacated and remanded — holding that the PTAB did not sufficiently explain its decision.
It appears the Board was not persuaded by Theripion’s evidence of unexpected results. However, we cannot discern from its opinion the reasons for such a conclusion. Nor can we determine whether the Board adequately considered the totality of Theripion’s evidence.
Slip Op.
When making an obviousness determination, the Board must first articulate all necessary underlying findings, including establishing “an adequate evidentiary basis” and “a rational connection between the facts found and the [legal determination] made.” A written explanation is required, although the permits brief explanations in cases that are “simple and familiar” and where “the prior art is clear in its language and easily understood.” In re Nuvasive, Inc., 842 F.3d 1376, 1382 (Fed. Cir.
2016). Here, the PTAB failed to walk through its justification for finding no unexpected results — and for rejecting Theripion’s evidence. The court also found the Board’s explanation for motivation to combine references to be conclusory and lacking articulation of why a skilled artisan would have been motivated to combine the teachings.
PTAB Decision: 10780_1590931411-12-2021APDA
CAFC Decision: 22-1346.OPINION.8-10-2023_2171709
I should note the irony of this decision with the Federal Circuit requiring a clear explanation from the PTAB even though the Federal Circuit does not require the same of itself, despite statutory guidance to the contrary.
= = =
In this case, the Board first found the invention prima facie obvious before addressing any objective indicia of non-obviousness. On appeal, the Federal Circuit gave that approach a pass “So long as the Board considers all evidence before reaching an ultimate conclusion as to obviousness, there is nothing inherently wrong with proceeding in the order the Board did here.” See Adapt Pharma Ops. Ltd. v. Teva Pharms. USA, Inc., 25 F.4th 1354 (Fed. Cir. 2022).
From the CAFC opinion, it appears that the initial examination was also lacking (although the applicant did not bother to appeal all of the rejected claims). Had the initial Examination been more complete (with adequate explanations for obviousness in view of the cited art and allegedly unexpected results), my guess is the CAFC would not have administered this particular scolding. If a claim is obvious for the reasons given below and the unexpected results are not deemed sufficient to overcome 103 (for whatever reason is given) then there is no sense in requiring a reviewing body above to repeat the explanations (as opposed to simply adopting them) EXCEPT to make the public record less cumbersome.
Whiners about some alleged systematic lack of due process at the PTO can show they really care about fairness and integrity by advocating for Examiner Interviews to be recorded and published. Otherwise, well, they just come across like entitled crying babies most of the time.
There is nothing stopping you from recording and transcribing your examiner interviews.
That being said, it is (again) no surprise that you would denigrate that which you do not understand.
Most people actually work better without an authoritarian “every word will be captured.”
Further, the examination STILL proceeds based only on the written record (or at least it should, but we still have the many other ‘secret programs’ — of which SAWS was admitted to be but one of — that violate that).
Funny how you never seem upset about that end of the bargain.
Must be that infamous gaslighting-Malcolm-is-not-anti-patent side of you shining through.
“There is nothing stopping you from recording and transcribing your examiner interviews.”
For any purpose? Tell me more.
“Most people actually work better without an authoritarian “every word will be captured.””
White collar workers’ rights!
You are exceptionally thick this morning, aren’t you?
I will bet that the chances of YOU actually behaving how you would demand of others (record and transcribe every word and put that transcription into the written record), is exactly ZERO.
And then your fallback to divisive identity politics of the Sprint Left mentality intrudes with your attempted snide comment in the face of one side — unsurprisingly the anti-patent side — currently does not abide by the Rule as to prosecution ONLY to be on the written record.
Choosing to be snide here is an especially p00r choice.
“identity politics”
Another term whose use merely signals to the world that you are a low IQ inhaler and regurgitator of the most vapid scripts out there. Of course, we knew that about you already.
Are you really going to pretend that That term has no meaning?
“Signaling” indeed — just not how you pretend.
“ Are you really going to pretend that That term has no meaning?”
It means the person who uses it is a clueless dolt, and almost invariably a glibertarian or rightwing dolt.
Beyond that it’s redundant with the term “politics.” Unless of course you believe that some “identities” are less legitimate than others, which is not an unusual belief for certain groups of white people who lack self-awareness.
It certainly is not redundant with the word “politics.”
That you think so (plus — again — your tendency of one-bucketing) only shows just how much Sprint Left you are, as politics is actually a spectrum. For you all of your ‘understanding’ of politics may be inseparable from politics, but that is definitely a YOU problem.
… should read “inseparable from identity politics”
Whiners about some alleged systematic lack of due process at the PTO can show they really care about fairness and integrity by advocating for Examiner Interviews to be recorded and published.
What do you imagine that such a policy will accomplish? I am hard pressed to see how this might improve due process, or fairness, or integrity to any material extent.
We already have a system in which the substantive meat of the discussion is recorded in writing by both the applicant and the examiner. The idea that a transcript will add much beyond what we already have seems implausible.
po”l”icy
(Behind a pay wall, but an article on Judge Newman’s side)
As for Malcolm’s aims, he imagines that every applicant is a Grifter, and the verbal exchange (somehow) must be illicit.
Of course, he is just projecting his own lack of ethics.
“ We already have a system in which the substantive meat of the discussion is recorded in writing by both the applicant and the examiner.”
Sometimes, sure. But not all the time. The fairness issue is about fairness to the public whose rights are diminished every time a patent is improvidently granted. Why are oral arguments at the CAFC recorded? Do they “add nothing”?
The resistance to this easy improvement that dramatically increases the transparency of interviews … pretty much gives the game away, don’t you think?
If you haven’t ever seen a file wrapper where the Examiner withdraws previously made rejections and the interview summaries from the parties seem … wanting …, well, maybe you haven’t looked at enough file wrappers.
What — precisely — do you believe to be the illicit content?
The far easier take-away is that the examiners are simply convinced that their original (and withdrawn) rejections were
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and it merely took the interview to move the examiner who has a level of ‘saving face’ with the mechanism.
But you be you and continue to 1g n0re the points put to you.
It’s well-known that many patent applicants are prone to making false or misleading statements ON THE RECORD so the idea that they aren’t doing that in Examiner Interviews is … naive. Beyond that, there are surely admissions being made that should narrow the scope of the patent claims but which aren’t being properly preserved for the record. Again, if you were an honest person who was familiar with oral arguments and how statements made in oral arguments are used by counsel, then you would just admit the truth and we could move on with recording the Interviews.
But instead you have to act like you were born yesterday. [shrugs]
Your assertion of, “It’s well-known that many patent applicants are prone to making false or misleading statements ON THE RECORD so the idea that they aren’t doing that in Examiner Interviews is … naive.” i simply not logically consistent.
IF — and that’s a might big if (and no doubt colored by our own anti-patent proclivities, which continue to cause you such extreme cognitive dissonance), such things are already – as you put it: “ON THE RECORD,” then there would NOT be any reason to add to the record with material that according to 37 CFR 1.2 (emphasis added):
“1.2 Business to be transacted in writing.
All business with the Patent and Trademark Office should be transacted in writing. The personal attendance of applicants or their attorneys or agents at the Patent and Trademark Office is unnecessary. The action of the Patent and Trademark Office will be based exclusively on the written record in the Office. No attention will be paid to any alleged oral promise, stipulation, or understanding in relation to which there is disagreement or doubt.”
You imagine the phantoms of Grift which are not there.
This is simply not something of a ‘born yesterday’ nature – unless YOU think that 37 CFR 1.2 has no force of the Rule of Law.
Granted – you do appear to condone the Patent Office violating this as a Means to the Ends of denying patent protection (as I noted in my comment above about the remaining programs that are SAWS-like — as admitted by the Office when they were caught red-handed with SAWS).
Again, you be you and continue to 1g n0re the points put to you.
I see you’ve been pushed way beyond your ability to write a coherent response so I’ll just slowly back away from the vehicle and have a laugh over this behind your back.
There you go again –
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¯\_(ツ)_/¯
“I should note the irony of this decision with the Federal Circuit requiring a clear explanation from the PTAB even though the Federal Circuit does not require the same of itself, despite statutory guidance to the contrary.”
Do as I say and not as I do . . . hypocrisy is alive and well at the CAFC.
I concur with Pro Say and Prof. Crouch. From the US Supreme Court to the CAFC, there is a clear need for a judicial code of conduct that is enforced by an independent agency to preserve Due Process rights for all US citizens.
“I should note the irony of this decision with the Federal Circuit requiring a clear explanation from the PTAB even though the Federal Circuit does not require the same of itself, despite statutory guidance to the contrary.”
Please clarify.
Do you mean the CAFC writ large? This panel (these particular judges)? Some subset of judges?
After all, with the internecine aiming at a particular judge (who is not the worst performing judge), should we wield these statements with a little more precision?
And yes, the peculiar habit of not listing judges of a tribunal also comes to mind.
Who is the “worst performing judge” on the CAFC and what are your criteria?
Forgot to add: nobody cares what you think, of course. I’m just asking for the Monday laughs.
Depends on the metrics, but Katznelson provided an objective analysis directly related to the current context.
Of course, it does not fit your desired narrative, so you have deigned to dismiss it.
“Katznelson provided an objective analysis”
Comedy gold.
Gold yes, but that laughter you hear is not laughter with you.
Lololol
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