by Dennis Crouch
This post gets into some weeds about obviousness type double patenting stemming from the Federal Circuit’s new decision in Institut Pasteur. Although non-precedential, the decision signals that the doctrine remains strong (and strict). The decision cements that for OTDP analysis, any comparison of unexpected results or long-felt need must be made to the applicant’s own earlier patent claims, not the closest “prior art.” The court also endorsed reliance on inherency to satisfy claim limitations not found in earlier claims.
I’ll note here en banc petition briefing continues in the OTDP/PTA case of In re: Cellect, LLC. Cellect’s petition has been supported by 10 amicus briefs. The PTO responsive brief is due December 14, 2023.
The Federal Circuit recently affirmed a PTAB rejecting claims in a patent application filed by Institut Pasteur on the ground of obviousness-type double patenting. In re: Institut Pasteur, No. 2022-1896 (Fed. Cir. Dec. 13, 2023) (non-precedential). This case provides additional insight into the doctrine of obviousness-type double patenting and the ongoing high bar set by the Federal Circuit for overcoming such rejections. Opinion by Judge Clevenger, joined by Judges Taranto and Stoll.
Obviousness-type double patenting is a judge-made doctrine designed to prevent applicants from extending patent rights first obtaining an earlier-expiring patent and then obtaining a later-expiring patent with claims that are obvious variants of those in the earlier patent. The policy goal is to prevent unjustified timewise extension of exclusive patent rights. The doctrine was particularly relevant for patent applications filed prior to 1995 because patent term was calculated at 17 years after patent issuance. Today, patent term starts ticking as soon as the patent application — making it much more difficult to stagger patent rights in order to evergreen protection. (Note that one way to differentiate patent timing is through PTA — and that is being challenged in the Cellect case discussed above.) In addition, the doctrine is designed to protect potential defendants from unfairly facing multiple infringement lawsuits.
The Gap in 102 for Self-Harming Prior Art: Everyone knows that you cannot obtain a patent that merely claims an obvious variant of the prior art. 35 U.S.C. 103. Section 102 of the Patent Act defines prior art, and includes an important exception that is incredibly relevant to the OTDP situation. In particular, we know that the first-inventor-to-file provision found in 102(a)(2) spells out, as the name suggests, that a prior-filed patent application (once it becomes public) will serve as prior art against a later filed patent application. The important exception for OTDP purposes is that Congress limited the first-to-file provision of 102(a)(2) to applies only in cases where the two competing patent applications name different inventors and are owned by different entities. In other words, Congress carved out an exception such that your own earlier-filed patent application does not qualify as prior art that could invalidate your later-filed application under 102(a)(2), even after the earlier application publishes. Although this analysis uses post-AIA statute, the limited protection for applicants against self-harming prior art also existed in the pre-AIA statute.
What we have here is a gap in the scope of prior art within the statute associated with the patentee’s own pre-filing activities. Courts have acknowledged that these filings by patent applicants are not prior art under the statute, but recognize policy concerns that justify limiting applicants’ rights anyway. Specifically, courts want to prevent applicants from unjustly extending patent protection with repetitive filings on obvious variants of their own inventions. Additionally, courts are concerned that separated patents (especially if ownership is separated) could put defendants at risk of facing multiple lawsuits asserting what is essentially the same invention.
The judge made solution then is to act in equity to bar an applicant from obtaining or enforcing to patents that are obvious variants to one another unless the patent applicant has filed what is known as a terminal disclaimer that disclaims any potential extra patent term in the later-issuing patent and that also promises to keep the two patents under the same ownership. Applicants who fail to file such a disclaimer can find their applications refused by the PTO or found unenforceable by the courts.
Ordinarily, obviousness analysis compares a claim against prior disclosures. OTDP is different. In OTDP, the policy concern is focused on obtaining two patents whose claims are too close to one another. Thus, the OTDP analysis compares the two sets of claims and asks whether one set is an obvious variant of the other.
In Institut Pasteur, the patent applicant filed a patent application in 2015 directed to methods of treating pain by administering opiorphin. The examiner rejected the pending claims as obvious over the claims of a different Pasteur patent directed to similar methods of pain treatment using the same peptides, and that had been filed the year before, in 2014.
Before the Board, Pasteur argued that OTDP should not apply — arguing that its 2015 applicant claimed claimed methods that were significantly different from those in the 2014 patent. In particular, the 2015 applicant required administration of the peptides for seven days without inducing drug dependence or tolerance, whereas the 2014 patent did not specify any particular duration of treatment or recite the lack of dependence/tolerance. The PTAB rejected that distinction and instead affirmed the examiner’s rejection, finding that the 2014 patent embraced treatment of chronic pain, so it would have been obvious to administer the therapy for over seven days. The Board also found that avoiding dependence/tolerance would be an inherent result of carrying out the methods of Pasteur’s earlier 2014 patent.
On appeal, the Federal Circuit affirmed the Board’s decision strictly applying obviousness-type double patenting. The court reiterated that when unexpected results are used to rebut a prima facie case of obviousness, those results must be shown to be unexpected compared to the closest prior art (here, Pasteur’s 2014 patent). In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Pasteur failed to make that comparison. The court also endorsed the Board’s use of inherency to fill in the missing claim limitation of dependence/tolerance as part of the obviousness analysis. The trick here that the court played, is that this “closest prior art” precedent comes from ordinary obviousness cases, not OTDP cases. See Baxter. And, as you recall, Pasteur’s 2014 patent is not prior art. Here, the court made the leap that it should effectively be treated as prior art for all aspects of the OTDP obviousness analysis, including both evidence of unexpected results and secondary considerations of nonobviousness.
Regarding secondary considerations, the Federal Circuit affirmed the Board’s dismissal of Pasteur’s long-felt need evidence. Pasteur had argued there was a long-felt need for pain medication that avoids issues of drug tolerance and dependence. However, the court endorsed the Board’s finding that any such need was already satisfied by Pasteur’s 2014 patent claims. In other words, in obviousness-type double patenting, where reference claims satisfy a long-felt need, that need does not constitute objective evidence for a later patent’s claims of non-obviousness over the reference claims.
During oral arguments, Salvatore Arrigo argued on behalf of Institut Pasteur before the panel of Judges Taranto, Clevenger, and Stoll. Arrigo emphasized that unexpected results are an “integral part” of determining obviousness under Graham v. John Deere. He argued that the unexpected lack of tolerance and dependence when administering the claimed peptide for 7 days should be considered in the prima facie obviousness analysis, before reaching a conclusion on obviousness:
You have to look at the unexpected results first to figure out if it’s obvious. If you don’t, it’s always an expected results are always going to be inherent 100 percent of the time because you’ve already reached obviousness before considering. It’s part of the obvious analysis to get there.
The judges questioned whether the proper comparison should be to morphine or to the closest prior art, the claims of the ‘871 patent. Mr. Arrigo maintained morphine was the appropriate comparison “because the prior art is just this giant genus and no one within that genus ever did anything that would have shown this unexpected result.” In its decision, however, the Federal Circuit rejected this analysis — holding that for OTDP analysis, any unexpected results must be in comparison to the company’s other patent being analyzed.
“Despite having had thirty-six years …, the Federal Circuit has yet to settle on even the basic standard for double patenting.” (R Street Institute, Amicus brief in support of Mylan’s petition for cert, 2018)
How many years did that “marking statute” run before the courts finally realized what the law meant? 55, 56 or so?
You have to look at the unexpected results first to figure out if it’s obvious. If you don’t, it’s always an expected results are always going to be inherent 100 percent of the time because you’ve already reached obviousness before considering. It’s part of the obvious analysis to get there.
I mean this is clearly wrong, both in terms of secondary considerations and practically since it suggests that in a situation with no evidence of results that the claim would inherently be allowable. Just as a practical matter the office could not generate results and wouldn’t be able to reject anything unless applicant’s were stu/pid enough to write them in.
That being said I do think that unexpected results are the lynchpin of nonobviousness, and the supreme court has said as much. If you’re just using a bunch of known things to do what they’ve been known to do you’re not doing anything unobvious. Nothing is more detrimental to our system than the office generally allowing claims when 4-5 references are needed to teach all the limitations rather than asking if any part of the system is doing something unexpected. Of course, if you applied the actual standard you’d have a lot fewer computer software patents and we can’t have that now, can we?
Nobody could have predicted that my toothbrush with a bone saw attached would help reduce the bad breath that is associated with amputating your own foot.
That comment about “unexpected results” to me flags up the differences between claims in the “unpredictable” arts as opposed to claims in the engineering space. Has the degree of unexpectedness any relevance for the patentability of engineering inventions? If so, how shall it be measured? I don’t know: perhaps by a TSM enquiry?
MD: “ Has the degree of unexpectedness any relevance for the patentability of engineering inventions?”
Of course it does. It’s “measured” by comparing the actual result/benefit with what the art predicted, as filtered through the testimony of an expert (either “on the stand” or under oath, or as evinced in the published prior art).
I read that “unexpected results” are the lynchpin of non-obviousness. OK, let’s apply that to the invention of the first toothbrush (in its modern configuration), or mousetrap. What is the “result” in each case, that can legitimately be deemed to be “unexpected”? That a brush works? That one can trap mice? I’m still having difficulty applying to simple mechanical contrivance inventions (such as a stent for trans-luminal cardio-vascular insertion) the notion of what the art predicted or did not and whether the results were expected or not.
MaxDrei – consider the source, as Random is an examiner and simply has a very p00r grasp of the legal concepts that he is supposed to be examining to (he has often cried that he is not an attorney, and it is somehow ‘unfair’ that he has to deal with attorneys that DO know the law).
What you are seeing is the vestiges of the Flash of Genius that Congress had to actually explicitly quash from a bygone (and since people do not learn from history, being repeated) era in which the Supreme Court self-labeled itself with the phrase, “The only valid patent is one that has not yet appeared before us.“
Yup, it is never ending. Alice is a flash of genius holding.
I see it more and more in my practice with examiners wanting a flash of genius justification for an allowance.
I’ve been told recently that the Director (anti-patent judicial activist) has been telling examiners that they must not allow claims unless they are clearly non-obvious. I recently had a patent pulled back from allowance by the Director’s office (and then reallowed.)
Do any of these horror stories ever end with the patent not being issued?
They didn’t explicitly quash it. They added “obviousness” to the statute to anchor a previously ill-defined inquiry around where they thought the average standard was (e.g., to “minimize departures” or something).
As the Court noted in Graham, the “flash of creative genius” flourish in Cuno had a long pedigree going back to the 19th century, but “genius” began to take on a different connotation in the 20th century, of super-intelligence, rather than its older meaning of “a peculiar or identifying character” of something.
Kyle – twice you choose to speak and both times you are in error.
Obviousness was chosen — precisely — instead of ‘inventiveness,’ ‘gist of the invention,’ or any of the other twenty or so terms that the Supreme Court NEVER could settle upon.
ANY dicta in Graham as to ‘pedigree’ or their attempt to claw back what Congress had removed from that is exactly that: dicta.
This is what Congress said in the Senate Report on the 1952 Act about why obviousness was codified in statute. It was intended to anchor the inquiry around a less vague criterion than “invention” or “patentable novelty” or “genius”. It seems to cast doubt on Cuno and the “genius” language–because Congress and presumably Giles Rich were unaware of the archaic origins of that phrase and therefore alarmed by what they feared it meant–but it ultimately just codified the judicial requirement, as happened with 102(b), 102(e), etc.
“Section 103, for the first time in our statute, provides a condition which exists in the law and has existed for more
than 100 years, but only by reason of decisions of the courts. An invention which has been made, and which is new in the sense that the same thing has not been made before, may still not be patentable if the difference between the new thing and what was known before is not considered sufficiently great to warrant a patent. That has been expressed in a large variety of ways in decisions of the courts and in writings. Section 103 states this requirement in the title. It refers to the difference between the subject matter sought to be patented and the prior art, meaning what was known before as described in section 102. If this difference is such that the subject matter as a whole would have been obvious at the time to a person skilled in the art, then the subject matter cannot be patented.
That provision paraphrases language which has often been used in decisions of the courts, and the section is added to the statute for uniformity and definiteness. This section should have a stabilizing effect and minimize great departures which have appeared in some cases.
I am well familiar with all of what Congress, and the writers of what Congress have said.
It is just not what you think it to be.
With your comment of “blizzard of patents” below, you clearly are not familiar with why we have a patent system in the first place.
Slashdot guy? Techdirt? Something else?
Kyle,
That includes Spatulas vs Tool Patent. So how could it be allowed? Could it be because my patent was secretly in the Tool Patent File Design Patent D 416,453
Come Kyle, you can share just where your perspective is coming from without outing yourself.
Why so shy?
And Patrick Egan is my cousin along with all the other Egans.Even Cardinal Edward Egan.
Kyle,
You know about Catholic University & USPTO Examiners?
To be clear, most new creations in the so-called “unpredictable arts” also yield expected results. That’s why most valid and eligible claims in those arts are narrowly structurally defined. Note also that the “unpredictable” aspect has sharp teeth in the enablement and written description area which also forces claims into narrower scope.
No, wait:
Malcolm and his worthless exacting picture claim mentality of “narrow structure.”
Must be that oh-so-‘grown-up’ UNPREDICTABLE arts ‘thinking’ and Malcolm’s one-bucket tendencies that dictate that anything outside of what Malcolm likes is
(gasp)
B
A
D
“Nothing is more detrimental to our system than the office generally allowing claims when 4-5 references are needed to teach all the limitations rather than asking if any part of the system is doing something unexpected.”
You DO know that 103 art is NOT piecemeal 102 art, right?
I mean, it is YOUR JOB to know this, eh?
References don’t have to explicitly recite all the elements of a claim, and it’s silly to make examiners go find extra art just so they have something that reads on every stray limitation nearly verbatim.
Oh, how I would enjoy talking to your SPE if you attempted to reject one of my client’s claims with handwaving and NOT treating every single element of a claim.
If someone knows Kyle in the Office – do him a favor and have him sign up for understanding his job.
Not an examiner, but USPTO management not following the Federal Circuit’s case law–let alone the Supreme Court’s–might be why we have such a blizzard of patents.
Not an examiner, clearly not a registered patent attorney.
Without outing yourself, what exactly do you do (here)?
link to youtube.com
There is some very strange rhetorical game-playing going on here. It is correctly observed that:
“ In OTDP, the policy concern is focused on obtaining two patents whose claims are too close to one another. Thus, the OTDP analysis compares the two sets of claims and asks whether one set is an obvious variant of the other.”
In that regard, it makes no sense whatsoever to block off consideration of the first filed patent when looking at unexpected results, long felt-need or any other aspect of obviousness when performing the OTDP analysis. The so-called “prior art exception” in 102(a)(2) is not nullified by this approach. The second patent is not invalidated by the first. If OTDP is found to apply, only the term of the second patent is limited.
Re: “If OTDP is found to apply, only the term of the second patent is limited.”
There is a far more serious consequence if OTDP is found to apply after patents are issued without an adequate terminal disclaimer and are in litigation.
The consequence should be to limit the term of the later expiring one, force the patentee to file a terminal disclaimer during litigation.
Yup.
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