By Dennis Crouch
Prometheus Labs v. Roxane Labs (Fed. Cir. 2015)
In this case, the Federal Circuit has affirmed the district court’s holding that that Prometheus’ asserted patent claims are invalid as obvious. The district court had also rejected the claims as invalid based upon the doctrine of obviousness-type double-patenting, however that issue was not reached in the appeal.
The patent at issue is U.S. Patent No. 6,284,770 and claims a method of treating “diarrhea-predominant female IBS” by giving the patient “an effective amount of alosetron or a pharmaceutically acceptable derivative thereof.”
At a bench trial, the district court held that the elements of the claim were found in the prior art – with “insubstantial” differences.” In particular, the prior art taught treating IBS using alosetron, but apparently not particularly treating “female IBS.”
In the appeal, the Federal Circuit recognized the starting-point rule in genus-species patenting – that a particular species (adding new limitations) may be patentable even if the broader genus is in the prior art. Eli Lilly & Co. v. Bd. of Regents of Univ. of Wash., 334 F.3d 1264 (Fed. Cir. 2003). And here, in the somewhat-personalized-medicine context, the court wrote that these additional limitations may be quite important because it represents focusing treatment on populations where it works best (and causes the least harm).
After reciting the potential for patentability, the court then found that the case at hand failed to present non-obvious subject matter. Notably, the court found that the “female” limitation was simply obvious since women represent half of the population and the majority of IBS patients, and the prior art taught differences in male/female reaction to the proposed treatment:
The first limitation of asserted claim 5 of the ‘770 patent pertains to treating women. Prometheus argues that the district court erred in framing its inquiry as whether alosetron was administered to women with IBS-D in the prior art, rather than as whether it was obvious to focus on treating women rather than men. It is not disputed that it was well known in 1997 that a majority of IBS patients were women. As the district court found, it was well known that “approximately 75% to 80% of IBS-D patients . . . have always been[] women.” For example, the 1992 Thompson article reported that female IBS patients predominate in Western countries. Even if the claims should be read as focusing treatment on women, as Prometheus urges, the district court found the prior art taught precisely that. The Hysu study (1995) taught that females taking alosetron “had higher concentrations of alosetron in their blood and total amount of the drug absorbed compared to [males taking alosetron]” and the district court found that “[t]his could reasonably suggest that women would have a greater response to the drug than men.” At the time of the ‘770 patent’s priority date, it would have been obvious to a person having ordinary skill in the art to treat women as a separate group of IBS patients.
With this reading of the prior art, it was an easy conclusion for the Federal Circuit that the patent was invalid.
Double Patenting: The patent at issue in this case (U.S. Patent No. 6,284,770) was originally owned by Glaxo as was the primary prior art reference (U.S. Patent No. 5,360,800). Because the ‘800 patent was public well before the priority filing of the ‘770 it was clearly prior art. The non-statutory obviousness type double patenting doctrine is generally designed for a different situation – one derived from a judicial pushback against the statutory limitation on counting certain actions of the patentee as prior art. Because OTDP is a non-statutory action by the courts, it was appropriate here for the Federal Circuit to focus on statutory obviousness as the issue and not reach the alternative non-statutory OTDB issues.
Of course, it remains to be seen whether OTDP remains in post-AIA world.
Slightly OT, but serving notice to those who wish to create a “logic,” but then need to simply apply that “logic” to its (logical) ends…
And guess what happens when an Art finally grows up from the “gee-we-don’t-know-what-will-happen” phase…
(from Greg A’s email today)
“But now, there is increasingly becoming automated. The most recent challenge hosted by the Cambridge Crystallographic Data Centre has resulted in a combination of two teams being able to completely automatically determine the 3D structure of complex chemicals – “… this blind test has shown that the problem of organic crystal structure prediction [note: KSR prediction?] has been solved.”
Yes “folks,” for those who believe 103 rules out anything predictable, you might as well close the patent doors for the chem (and bio-chem) arts.
for those who believe 103 rules out anything predictable, you might as well close the patent doors for the chem (and bio-chem) arts.
There’s a whole lot more to chem/bio than “crystals of previously existing compounds”. But you knew that already. Or maybe you didn’t.
Also, these “complex chemicals” are referred to by another name by the CCDC: “small organic molecules.” There’s a lot more to chem/bio than “small organic molecules.”
Lastly, if all of chem/bio has become “predictable”, that’s great news for chem/bio and … everyone else in the world. By all means let’s close the patent doors completely on chem/bio if the entirety of those fields are now “predictable”. After all, as most of us chem/bio patent attorneys know, the doors have been pretty firmly closed to patenting the predictable stuff in chem/bio for quite some time (in addition to a lot of other stuff). The world continues to turn — and even Greg A was capable of understanding — progress continues. Oh but wait! Without software patents, no biochemist would ever bother trying to improve the predictability of crystal structures. Riiiiiiiiiight.
And (yet again) you try to insert the canard of “but for”…
What is it with you and this need to think of the patent system as having this ONLY type of aspect to it?
You really should study the foundation of the country and of the patent system to better understand it.
The recent New Yorker article reminded me: has the PTO issued any “guidance” on all the obvious “edit this with CRISPR” claims that are surely pending right now?
“The non-statutory obviousness type double patenting doctrine is generally designed for a different situation – one derived from a judicial pushback against the statutory limitation on counting certain actions of the patentee as prior art.”
Isn’t the real problem the possibility of indefinite term if a single patentee can patent the same invention again, again and again? In other words, while congress can remove prior art, it cannot constitutionally allow indefinite term.
Ned,
I think “same invention” is covered by statute, 35 USC 101, viz. “may obtain a patent therefor” with emphasis on the article. I.e., one patent per invention, no more.
T, but, we get many patents on the same invention all the time. Small variations in continuations do not count as different inventions.
This is not a 101 concern. It is a term issue. I think that is 154.
Ned,
To do so, you are filing terminal disclaimers, correct?
T, the WE refers to the patent bar as a whole.
Of course we file terminal disclaimers when required.
“Small variations in continuations do not count as different inventions.”
That’s not exactly correct now is it Ned…?
I think “same invention” is covered by statute, 35 USC 101, viz. “may obtain a patent therefor” with emphasis on the article. I.e., one patent per invention, no more.
Statutory double patenting is when the claim is anticipated by another claim – i.e. they claim the exact same scope. Obviousness-type double patenting is not claiming the exact same scope, but the scope being claimed is not patentably distinct, which leads to people using the phrase “same invention” which, while useful in a 103 context is not useful here.
Non-novel claims can’t be re-claimed because you can only obtain a single patent for a claim. Patentably indistinct claims cannot be re-claimed because Congress set a time for a given exclusionary right, and to hold indistinct claims as having different exclusionary end dates would frustrate Congress’ command that patents are only good for a limited term.
Random, the original statutes provided that only the first and true inventor could obtain a patent. It was a defense. It was also the basis for a revocation action. Thus there is no 101 problem with double patenting unless a second inventor is not an inventor within the meaning of 101.
The Supreme Court identified extending term to be the problem when a single inventor receive two patents on the same invention. To keep things simple, if the claims are identical, the second to issue patent is simply invalid. If there are small variations that could have been claimed as dependent claims, they are allowed provided a terminal disclaimer.
Given first to file, I don’t see how two different inventors could get valid patents on the same invention, do you?
Given first to file, I don’t see how two different inventors could get valid patents on the same invention, do you?
Sure, they file on the same day or there is a lack of clarity over whether A derived from B.
“the original statutes provided that only the first and true inventor could obtain a patent.”
That only goes so far, Ned (didn’t you learn the lesson from Stadnyk’s F A I Led argument?)
“is not useful here.”
Ah yes, even Random picks up on that.
I don’t think that the problem is that there would be indefinite terms (though that certainly would result if taken to its logical conclusion) the problem is that Congress set a term for a given claim scope and indistinct scopes can’t have different timelines from that. I don’t necessarily view it as a Constitutional issue. It’s a statutory interpretation issue to effect whichever part of the statutory scheme sets the exclusionary period.
I agree that if the scheme allowed for indefinite terms, the Court could not allow Congress to set an indefinite term. It’s likely similar to 101, where Congress is presumed to have written the scheme to avoid the Constitutional crisis.
“I agree that if the scheme allowed for indefinite terms, the Court could not allow Congress to set an indefinite term”
While admittedly different than “set,” terms currently are indefinite – leastwise when one considers that at any time during the set term, the patent owner can choose to dedicate the patent to the public, and (at other predetermined times), can also choose to not pay the maintenance fee.
THE MEDICINES COMPANY v. HOSPIRA, INC.
link to cafc.uscourts.gov
En Banc Order
(a) Do the circumstances presented here constitute a commercial sale under the on-sale bar of 35 U.S.C. § 102(b)?
(i) Was there a sale for the purposes of § 102(b) despite the absence of a transfer of title?
(ii) Was the sale commercial in nature for the purposes of § 102(b) or an experimental use?
(b) Should this court overrule or revise the principle in Special Devices, Inc. v. OEA, Inc., 270 F.3d 1353 (Fed. Cir. 2001), that there is no “supplier exception” to the on-sale bar of 35 U.S.C. § 102(b)?
These claims are terrible.
I see this “effective amount” language in chemical claims all the time, and yet it’s typically accepted without fanfare, because PHOSITA can determine experimentally how much is “effective.” Never mind the fact that pharmaceutical companies often require years of clinical trials to determine the “effective” dose of a certain drug in various populations.
And what does the specification have to say? “Somewhere in the range of 0.001 to 500 milligrams, administered between 1 and 4 times per day.”
So here’s a question: Where is the EFF on this entire class of cases? Shouldn’t they be broadcasting their displeasure with chemical patents that do this sort of thing all them time? Last I checked, not a peep.
Meanwhile, in Nautilus v. Biosig, reciting that two electrodes are “spaced apart” enough to detect a particular signal – as described in detail by both the specification, and expert testimony of the inventor. So you adjust the spacing of the electrodes along a single axis until you get a nice distinguished gain… pretty simple stuff. And that prompts the EFF to submit a 40-page amicus brief about how that’s “ambiguous.”
Meanwhile, not a word about the patent reciting nearly identical language that is owned and asserted by Mark Cuban, the namesake and primary benefactor of the EFF.
David, the specification in Nautilus was silent on spacing — or its relationship to detecting certain signals.
Thus, the claim claimed any spacing that worked.
But the prior art had the same mechanical and electrical setup with spaced electrodes for each hand. How can one practice this prior art and not infringe?
Ned, the key term is “undue.”
Laterally adjusting the position of a first electrode, relative to a second electrode, until a suitable signal is obtained, is straightforward. A child could do it.
Determining a “therapeutically effective amount” of a drug can take a decade of clinical trials costing millions of dollars.
No doubt, looking at 102(b) only from the point of view of clarity, you are right.
But there is something else in that statute too — an therein lies the problem.
I think the briefing on the issue could have been sharper.
When I said there is something else in THE statute, I was referencing the statute under discussion, not some different statute.
112(b) reads “The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.”
Distinctly claiming is only part of the requirement of the statute. The other part requires one to particularly point out. If the invention is the “adjusting” of the spacing of the grips to balance the signals from the two hands, one would think that the claim would actually say so.
But the claim did not say so. The claim itself merely distinguished the prior art by talking about some result of something that was not claimed. As discussed even before the Supreme Court, there was not even one hint in the specification of the need to adjust anything, let alone that being claimed. The specification assumed that the signals would be balanced coming from the electrodes. (Perhaps the original thinking on filing was that the circuitry was the invention?)
Moreover, the inventor in testimony said that they did quite a few things beyond adjusting spacing to balance the signals. He never said exactly what, but adjusting spacing was not suggested as being even sufficient for the purpose. What else has to be done was not specified.
On the whole, the inventors here got away with redrum.
Ned, the key term is “undue.”
The term “undue” is tied to enablement under 112a. Nautilus was a 112b case. There is no requirement that the imprecise language place an undue burden on the reader for something to fail 112b. The fact that one can experimentally move electrodes easily but not determine an effective amount easily is entirely irrelevant to a 112b determination; it is only relevant to a 112a determination. The fact that experimentation is required at all suggests there is a 112b issue, see THE INCANDESCENT LAMP PATENT, 159 US 465, 474-475.
By the way, Wood v. Underhill, cited there, is kind of directly on point that “effective amount” as you describe the claim and specification here, would be invalid under both 112a and b.
Serious deja vu – I’m certain that we’ve had this exact same exchange before, and you may remember my response – the MPEP’s definition of enablement:
I don’t understand why you have “(35 USC 112(b))” in there. MPEP 2164.01 has the phrase “the statute” there. MPEP 2164 is entitled “The Enablement Requirement” and only mentions 112 first or 112a. In re Wands only mentions 112, 1st and the direct holding is “Accordingly, the rejection of Wands’ claims for lack of enablement under 35 U.S.C. § 112, first paragraph, is reversed.” Telectronics had both 112 1st and 112 2nd issues, but it was clear that undue experimentation was tied to enablement and 112 first.
Nothing you cited appears to suggest that undue experimentation has anything to do with 112b, other than the fact that you wrote 112b in there. It seems to prove exactly what I say, which is undue experimentation has to deal with enablement under 112a.
I’m not suggesting the case doesn’t have an enablement issue. Nor am I suggesting that the case doesn’t have an indefiniteness issue. I think it has both. All I am saying is that your post at 2 talks about Nautilus but it talks about it in terms of enablement. Nautilus was an indefiniteness case. The EFF argued it was ambiguous, which is an indefiniteness issue. Ned’s response was directed to the vaguery of the spacing, which is an indefiniteness issue. Then when you responded to Ned at 2.1.1 you said the key term was “undue” (an enablement term) and tried to draw a distinction in enablement between the Nautilus facts and these facts.
A claim can fail enablement because of undue experimentation. That is a 112a issue. That has nothing to do with Nautilus, or EFF’s response to Nautilus, or Ned’s response to you. Nautilus was about indefiniteness. A claim scope can be indefinite SOLELY BECAUSE IT REQUIRES EXPERIMENTATION to determine if you are infringing, regardless of how easy that experimentation is to perform. Undueness goes to enablement, which is probably also in this case, but is wholly unconnected to Nautilus. You are jumping between enablement and indefiniteness language and cases like it’s all one thing.
“A claim scope can be indefinite SOLELY BECAUSE IT REQUIRES EXPERIMENTATION to determine if you are infringing, regardless of how easy that experimentation is to perform.”
That’s not even close to being correct.
Again, referring to the MPEP:
The Supreme Court’s Nautilus opinion also noted that 112(b) is determined in view of 112(a):
The scope of the “spacing” in the claims in Nautilus is defined by the entire rest of the claim. The arguments that have been presented here are not that the “spacing” was undefined (because it wasn’t), but that it required too much experimentation in order to find a “spacing” that would work.
I would be remiss if I did not add that the Act of Congress in 1952 enabled – in what is now 112(a) AND 112(b) the use of terms for claim elements (outside of single means claims – hint Ned) the LIBERAL use of terms sounding in function.
Some people still cannot grasp that the optional path of 112(f) is not the only portion of 112 that countenanced such use of such terms.
A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph with respect to the claimed invention.
The Supreme Court’s Nautilus opinion also noted that 112(b) is determined in view of 112(a)
No that’s backwards. You don’t define what is enabled and then construe the scope to be whatever is enabled. You construe the scope initially and then determine whether the full scope is enabled. That’s what the quoted section above is saying – you need a definite boundary so you can perform an intelligent 112a enablement analysis.
David, if you are going to edit a direct quote, use [], not ().
brosef that is a misquote. It should be 35 U.S.C 112 (a) not (b).
6, we know it was wrong, 6. But we do not know if it was intentionally wrong.
Ned – the King of “intentionally wrong” …
How about this Ned: I would be remiss if I did not add that the Act of Congress in 1952 enabled – in what is now 112(a) AND 112(b) the use of terms for claim elements (outside of single means claims – hint Ned) the LIBERAL use of terms sounding in function.
Some people still cannot grasp that the optional path of 112(f) is not the only portion of 112 that countenanced such use of such terms.
Oh, and as for the “same circuit” argument – this is from our earlier Nautilus discussion:
Fujisaki is certainly a much better reference – and, yes, it does teach a differential amplifier.
However, in response to Fujisaki, the applicant submitted arguments (without amendment). The examiner agreed and issued a reexam certificate.
How is that possible if Fujisaki teaches “the same circuit?” Because it doesn’t. Here is the applicant’s argument, which the examiner found persuasive:
So, this raises the question: What’s in the patent, and the disclosure, that achieves this result?
Well… that’s where your argument starts to gain some traction, Ned, because the disclosure is pretty weak about this. There is some further explanation in the reply to the non-final office action:
It is submitted that claim 1 distinguishes from the teachings of the Cutter patent by defining the electrode arrangements (the first live electrode and the first common electrode; the second live electrode and the second common electrode) on either half of the elongate member. … Only with such electronic connections is it possible to eliminate noise, which includes signals of substantial equal amplitude and equal phase on each set of electrodes, and the effects on muscle artifact, which also have equal magnitude and equal phase signals on both sets of electrode.
If that were the end of it, I’d say that your arguments have some validity, Ned.
However, there is one additional key difference between Fujisaki’s circuit and Biosig’s circuit – one that reflects both a structural difference, and a difference in the inventive concept (again citing the applicant’s argument that prompted a reexam certificate):
So, that’s the difference – structural and functional. Fujisaki uses a differencing amplifier to amplify the ECG difference and a band-pass filter to reduce noise, but this configuration has the side-effect of also capturing and amplifying noise caused by the EMG signal. Biosig’s inventor appreciated the effect of EMG, and therefore not only adjusted the positioning of the electrodes, but also relied on amplification by the differencing amplifier to cancel out the EMG.
Put another way: Fujisaki’s circuit amplifies the entire signal – both the EMG and ECG components – and then tries to filter out the ECG component, but this is futile because the EMG component already overwhelms the ECG component. In Biosig’s circuit, the differencing amplifier simultaneously cancels the EMG (same-phase, opposite-polarity) contribution of each signal and amplifies the ECG component.
David, the asserted invention was providing equal and opposite EMG signals to a differential amplifier so that the differential amplifier could completely filter out the EMG signals. Both the invention and the prior art use differential amplifiers. So there was no difference in circuits. The difference was in that the signals provided to the differential amplifier were different.
But there is nothing in the specification that said that anybody how to make the signals equal and opposite. That one could adjust the spacing on the grips seems self-evident. But that was not taught in the specification. There seems to be some lack of written description support here at a minimum.
But in addition, if the invention was adjusting the spacing, that was not in the claim.
Ned, these two circuits are different:
Fujisaki: A two-stage filter comprising (1) a differencing amplifier that determines a difference between the inputs, and (2) a band-pass filter that filters out unwanted frequencies from the signal produced by the differencing amplifier; and
(Biosig) a one-stage filter comprising a differencing amplifier that provides amplification that removes the unwanted signals while also outputting the difference between the inputs.
And the structural difference is significant: it leads to a functional improvement due to a cleaner output – based on the analysis by Biosig’s inventor. The inventor had the “abstract idea” of performing the filter differently, and then produced a structurally different circuit that implements the improved filtering, as compared with Fujisaki’s circuit.
These don’t involve computers, therefore they are by definition “definite”. Or, for Ned, they don’t involve “means” at the point of novelty, therefore no one cares about them.
😉
Plus, if you start complaining about these types of cases, you’re going to butt heads with the big boys. Drugs make billions of dollars per year. Keep complaining, and you will be crushed or silenced.
Patent Bob, MM, who is from the inventions-that-count industry, has, I believe, expressed concern over functional claiming in bio and pharma.
Also, consider Myriad that was decided the way it was because the structure was functionally claimed.
“from the inventions-that-count industry”
You need to hold up that sarcasm sign a little higher…
David,
The “E” in “EFF” stands for Electronic. I think chemical patents are likely out of scope for their efforts.
First – not quite:
Myriad’s Dangerous Patents and their Negative Impact on Women’s Health
The Supreme Court Gets it Right: No Patents on Laws of Nature
Appeals Court Hears Argument in the “Breast Cancer Gene” Case
Second – the EFF’s rhetoric is built on this cornerstone that problems such as ambiguity and abstractness are “particularly” and “especially” present in software patents. For example:
Yet, the type of language present in this case – “therapeutically effective amount” – is not only absurdly bad, it is abundant in chemical patents.
The EFF has never provided an argument for why electronics and software patents “especially” have this problem: it just keeps saying so.
Why is that? Well… mainly to reflect Mark Cuban just doesn’t like them.
First – not quite:
Second – the EFF’s rhetoric is built on this cornerstone that problems such as ambiguity and abstractness are “particularly” and “especially” present in software patents. For example:
Yet, the type of language present in this case – “therapeutically effective amount” – is not only terrible; it is abundant in chemical patents.
The EFF has never provided an argument for why electronics and software patents “especially” have this problem: it just keeps saying so.
Why is that? Well… mainly to reflect Mark Cuban just doesn’t like them.
The EFF has never provided an argument for why electronics and software patents “especially” have this problem: it just keeps saying so.
One could craft a range of the drug that would be effective for most people and would have commercial value. Certainly they would lose out on treating the fringe cases, but with a bell curve you can capture most of the people.
With computer software there is no bell curve and there are so many competing means of achievement that any one algorithm would have virtually no commercial value – there is no commercially valuable “range.” You either settle on a scope that is commercially worthless or you assert a scope that covers every means of achievement (which is certainly valuable but not patentable under the law).
It IS worse in software. That doesn’t mean this isn’t a good indefiniteness case for them to crow about.
So in your view all claims to “computer software” are either commercially worthless or not patentable?
So in your view all claims to “computer software” are either commercially worthless or not patentable?
No, you could have software that drives machinery in the real world, where you care about a specific algorithm that enables movement of the machine, and that would be commercially valuable and allowable because it enables your machine.
Similarly, you could have a specific protocol that might be useful – if you find a better way of compressing files your particular compression algorithm might be valuable because it is effective. If people cared about the compression difference between your algorithm and general algorithms I suppose it might have commercial value.
The thing that makes compression valuable is coming up with a good compression algorithm is truly hard, so limiting yourself to one algorithm is possibly valuable. Most software patents specifically argue that their functional results are so easily achieved (and equivalent to each other) that they barely need to give an example to teach them. When that is factually true the claim is worthless, because a claim to the function is a claim to the abstract idea, and a claim to the algorithm is useless because you just admitted its easily designed around.
…”movement of the machine”….?
and what exactly is this “general algorithm”…?
(and you STILL do not grasp the equivalencies courtesy of the philosophy of MathS)
“ a range of the drug”
Tell me again what the exacting physical structure is for a “range”…
Wait – you want more than one physical structure for a single patent….?
/off sardonic bemusement
Yeah I’d like something a little more clear than .0001 to 2 grams a day. When your range is exponential in nature you probably need a little more detail.
Not just probably – and the point in the comment that you did not address: what is the SINGULAR (objective) structure?
“any one algorithm”
You STILL have not checked out Slashdot and Techdirt for articles written by POiR (concerning that double edged sword of equivalencies under the philosophy of MathS), have you?
You really should if you want to try to keep on using an argument that does not work as you think it does.
David,
Regarding “First“: The EFF blog entries you picked from 3 or 4 years ago include an admission by the author of all three entries (Julie Samuels) that she’s going off-topic for EFF fare:
Regarding “Second“: Your quote doesn’t really support your stance. The way I read it, the “particularly true with software patents” assertion is in regards to “The result: a flood of bad patents . . . .”, and not that vagueness, etc. are particularly applicable to software patents.
Of course, you could still disagree about software patents being preeminent among the “flood of bad patents”, but there are too many ways to weasel around the definitions of “software patent” and “bad patent” for a meaningful discussion to occur.
It would be entirely legitimate for the EFF to say: “The focus of our organization is electronics and software, so we are focusing on patent reform in this area.”
It is not doing that:
1) As noted above, the EFF dabbles in other areas – so its arguments should apply consistently to all areas.
2) The EFF argues not that its focus is limited, but that the problems that the EFF wants to tackle are particular to software and electronics (without any evidence of this position). This position is flat-out wrong: functional claiming is pervasive in all fields of technology – in fact, the problems are much worse outside of electronics and software.
Exhibit A: the patent in this case. Exhibits B through (some really, really big number): many other patents in non-EE/CS fields.
There are dozens of other EFF quotes on this same topic. Just a few from its brief in Nautilus:
Bonus: Nautilus wasn’t even a case about a software patent: the claimed invention was a circuit comprising a differencing amplifier. The EFF just can’t resist bashing software as presenting a “particular” problem at every opportunity.
It really is worse than that David.
If one takes a look at the anti-software arguments, and one critically evaluates those arguments, you end up with just anti-patent arguments.
…and since you note that the EFF brings up the (fake) “Tr011” argument,…
Have you heard any word from the Executive in response to the (March 30…?) request from Ron Katznelson to stop and come clean concerning that selfsame “Tr011” propaganda?
Me neither.
I agree that the term “effective amount” has always seemed like an issue and now after Nautilus should definitely be challenged in the pharma market. Kudos!
Under the specification you disclosed, I also think it is subject to a written description and enablement rejection.
David: Somewhere in the range of 0.001 to 500 milligrams, administered between 1 and 4 times per day.”
In case you hadn’t noticed, that’s an infinitely more objective and physical limitation than the functional limitations that show up in logic patents.
Never mind the fact that pharmaceutical companies often require years of clinical trials to determine the “effective” dose of a certain drug in various populations.
There’s a big difference between “safe enough to satisfy the FDA” and “effective”. Note that the PTO and the FDA are distinct entities with different purposes and they work together to benefit the public. Note also that a well-drafted drug patent will include nested ranges and the strongest one will always recite a narrower range than this one in the claims. Note also the lack of anything remotedly resembling an FDA that vets crappy bug and virus-ridden software before it’s presented to consumers.
Setting aside all that, the claim is junk. You and I and two courts all agree. It’s gone. The system works and nobody — not even Kevin Noonan — is going to hold this case up and complain that the courts are turning the US into a third world country.
“infinitely more objective and physical limitation”
Tell me again how a range is a single (the objective part) physical structure…?
Oops.
I don’t think that you understand what your own tired and trite mantra entails.
Tell me how many drugs F A I L out of the FDA program and show that they never did have the utility claimed…
Even with the non-grown-up wiggle room of “effective,” what percentage F A I L ?
“vets crappy bug and virus-ridden software before it’s presented to consumers.”
well, with that “logic,” there goes the “predictable” argument…
Ooops.
The case is unremarkable except for “Costs to appellees.” Usually, I see “No costs.”
Dennis,
You said: “The non-statutory obviousness type double patenting doctrine is generally designed for a different situation – one derived from a judicial pushback against the statutory limitation on counting certain actions of the patentee as prior art.”
But, from form paragraph 8.33 in MPEP section 804:
“The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees.”
And,
“Although nonstatutory double patenting is sometimes called obviousness-type double patenting (“ODP”) …”
I am confused.
T, I just said the same thing about prior art as you did.
Comments are closed.