Unpredictable Arts Overcome KSR; Bonus: AND = OR

PatentLawPic256Ortho-McNeil Pharmaceutical v. Mylan Labs (Fed. Cir. 2008)

Ortho-McNeil’s anti-convulsant Topamax is expensive and brings in over $1,000,000,000.00 each year. Hoping to produce a generic version, Mylan Labs filed an Abbreviated New Drug Application (ANDA) with the FDA along with arguments that the Topamax patent is invalid and not infringed.

AND vs OR: Mylan’s primary argument relies on a specific construction of the word “AND.”  According to Mylan, AND should be construed logically as a conjunction. (i.e., AND = AND). Ortho, on the other hand, argues that its AND is not so restrictive. (I.e., AND = OR). 

As you might guess, according to the courts, AND does indeed mean OR.

The problem with Mylan’s argument is that it turns the claims into nonsense. In particular, a conjunctive AND would require the claimed R groups (above) to be both independent spurs and, at the same time, joined as ring groups.

In the 2004 Chef America case, the CAFC allowed such a non-sensical construction — holding that the claim should be interpreted “as written, not as the patentees wish they had written it.” Here, however, Judge Rader distinguished Chef America — noting that here, the claim intrinsic evidence points toward the “alternative” interpretation:

“In Chef America, the only possible interpretation of the claim led to a nonsensical result. This situation is distinguishable because claim 1 can and should be interpreted as the patentees intended, with the meaning of and connoting alternatives.”

Because AND means OR, the claim properly covers the active ingredient topiramate.

KSR and Unpredictable Arts: In what may become an oft-cited decision, Judge Rader outlines how the supreme court’s KSR decision should have little impact on the “unpredictable arts” such as the development of pharmaceuticals.

Apparently, the anti-convulsive properties of topiramate were discovered by a researcher (Maryanoff) looking searching for FBPase inhibitor for diabetes. Oddly, both Mylan and the Court focused on whether the actual decisions of the researcher were logical, blocked by obstacles, or helped by serendipity.

“In retrospect, Dr. Maryanoff’s pathway to the invention, of course, seems to follow the logical steps to produce these properties, but at the time of invention, the inventor’s insights, willingness to confront and overcome obstacles, and yes, even serendipity, cannot be discounted.”

Of course, under 35 U.S.C. 103 patentability is not to “be negatived by the manner in which the invention was made.”

A Flexible TSM Test: Focusing on KSR, the court promotes its new flexible TSM test:

“The TSM test, flexibly applied, merely assures that the obviousness test proceeds on the basis of evidence – teachings, suggestions (a tellingly broad term), or motivations (an equally broad term) – that arise before the time of invention as the statute requires. As KSR requires, those teachings, suggestions, or motivations need not always be written references but may be found within the knowledge and creativity of ordinarily skilled artisans.”

On the facts, the CAFC found agreed that the invention is clearly nonobvious.

“In this case, the record amply supports the district court’s finding of nonobviousness. . . . As noted above, the challenges of this inventive process would have prevented one of ordinary skill in this art from traversing the multiple obstacles to easily produce the invention in light of the evidence available at the time of invention. Of particular importance beyond the prima facie analysis, this court also detects evidence of objective criteria showing nonobviousness. Specifically, the record shows powerful unexpected results (anticonvulsive activity) for topiramate. The record also shows skepticism of experts and copying – other respected sources of objective evidence of nonobviousness – as well as commercial success. As this court has repeatedly explained, this evidence is not just a cumulative or confirmatory part of the obviousness calculus but constitutes independent evidence of nonobviousness.”

Notes:

  • Judge Rader wrote this opinion and was also a member of the 2004 Chef America panel

43 thoughts on “Unpredictable Arts Overcome KSR; Bonus: AND = OR

  1. curious,

    Perhaps the examiner is being cryptic by not relating to you that he means BP changes with pressure. Does the specification indicate that BP is determined at standard atmospheric pressure?

  2. having seen “or” twisted around too many times in litigation, i was taught to draft an “or” as “one of.” and/or becomes “at least one of.”

  3. I don’t have much access to caselaw right now, and I could not find that In re Hutchinson via Google (hey, ya never know). But, you should be able to find all sorts of caselaw to refute the rejection. Also, unless you are claiming something which is intended to be used in a manner where a boiling point has some functional effect, you might even try common sense reasoning with her. For example, if you’re claiming a pharmaceutical composition which includes a component of a certain boiling pt range, how could boiling pt possibly relate to some “intended use” of what is being claimed? It’s still a very puzzling rejection.

  4. metoo — thanks for your response, and for what it is worth, the examiner cited In re Hutchinson, 154 F2d 135 (CCPA 1946) as support for her intended use rejection

  5. An “intended use” rejection? That makes no sense. If you’re claiming a composition that includes a alcohol of specified boiling pt, or even a method which uses an alcohol of specified boiling pt in one of the steps, the boiling pt has nothing to do with “intended use.” Rather, the boiling pt is simply a way to further define the claimed set of alcohols. And even if your claim is to a composition or compound and you specify that it has a certain boiling pt, that is merely a property which must be considered for patentability (unless you’re talking about a rejection for anticipation).

    I really do not understand how a boiling point in a claim could result in an “intended use” rejection.

  6. metoo — when I include a claim which has an element similar to “an alcohol having a boiling point between ___ and ___ degrees C”, I get an “intended use” rejection, i.e. “having a boiling point between __ and ___ degrees C” is an “intended use” and therefore is not accorded any patentable weight and therefore the claim is anticipated by prior art which shows everything but that boiling point

    comments?

  7. @anon: I can count the number of restrictions I’ve done on one hand; my art typically doesn’t get the kinds of applications that are, I suppose you would say, traditionally considered by the Office as restrictable. The majority of the applications fall into the 25~35 claim range, and it’s often far less actual claims than that since the 35 claims are divided between the method, the software comprising instructions for performing the method, and the computer system that executes the software to perform the method (reciting word-for-word identical substantive limitations, for the most part). Trying to show “undue burden” in those cases is pretty much impossible, nevermind distinctness or independence of invention.

    The few restrictions I’ve ever done all fall into the same category: claims directed to a method, or software, and then claims directed to a specific system (for instance, a software distribution network) that isn’t (inter-)dependant with the specific method. In other words, it would be like claiming software with a particular function, and then claiming a particular type of general-purpose computer. The inventions are independent and distinct in the sense that the software can be executed on any type of computer, and the special computer can be used to execute any type of software – there is nothing particular about the software or the computer that makes their combination ‘special’, if you will, and the software and the computer both have their own, separate points of supposed novelty.

    I (tentatively) concede that I cannot reconcile my argument above with the criteria for restriction in view of 802.01 cited above. However, in this case I would (again, tentatively) argue that the language in all of these instances is incorrect. Again, in a plain english sense, how do you read “A **is** X **and** Y” as being “A is X **or** Y”? Putting aside the implications of the case or whatnot – just stepping back and viewing the plain language as a fluent speaker of English, would you really think that “and” could be read as “or” in that situation?

  8. Malcolm, I’m not sure they had much of a choice. Based on the CAFC opinion, Mylan never attempted to argue that claim 1 was inoperable or indefinite. But, had they made that argument and won, I don’t think claim 5 would be inoperable or indefinite simply because it depends from an inoperable/indefinite claim. It seems to me that claim 5, even though dependent on claim 1, solves any problems in claim 1. Since claim 5 merely claims a single compound in clear and unequivocal language, why should it go down in flames with claim 1?

    Imagine an independent claim which includes as one element a “an alcohol having a low boiling point.” Such a claim could very well be deemed invalid due to indefiniteness – particularly if the specification says nothing about what is meant by “a low boiling point.” But, what about a dependent claim which adds “wherein said alcohol is ethanol”? Seems to me that such a dependent claim would not be invalid for indefiniteness, right?

  9. “At that point they simply rely on the principle that something which does not infringe an independent claim cannot infringe a claim which depends from that independent claim.”

    If that was the strategy, I don’t think it was a very well-considered one.

    Mylan’s interpretation of claim 1 makes the claim inoperable and/or indefinite. But is claim 5 necessarily inoperable or indefinite, by virtue of its dependency? I guess it must be or this case couldn’t have been appealed…?

  10. Just Visiting – are you asking if the word “may” in the claim raises an issue of indefiniteness? Terms such as “may contain”, “optionally”, etc. are often acceptable in the chemical/pharma arts (although it depends on the circumstances). But I do find it odd that the opinion did not mention the word “may” in claim 1. It seems to me that the word “may” lends support to the claim interpretation of the court.

    The other issue that no one has addressed here is the dependent claims. In particular, claim 4 of the patent states:

    4. The sulfamate of claim 1, wherein said sulfamate of formula (I) is selected from the group consisting of:
    (tetrahydro-2H-pyran-2-yl)methane sulfamate;
    2,3:4,5-bis-O-(1-methylethylidene)-.beta.-D-fructopyranose sulfamate;
    2,3:4,5-bis-O-(1-methylethylidene)-.beta.-D-fructopyranose methylsulfamate.

    And claim 5 states:
    5. The sulfamate of claim 4, wherein said sulfamate is 2,3:4,5-bis-O-(1-methylethylidene)-.beta.-D-fructopyranose sulfamate.

    In other words, claim 5 simply claims the compound 2,3:4,5-bis-O-(1-methylethylidene)-.beta.-D-fructopyranose sulfamate.

    Mylan’s product at issue in this case (Topiramate) is this very compound.

    Mylan’s proposed construction for claim 1 would render the claim inoperable. But, wouldn’t claim 5 still survive? After all, it is clearly and unequivocally claiming one specific compound – nothing more, nothing less.

    What Mylan was attempting to do in this case is establish that claim 1, by its explicit language, requires that R2, R3, R4 and R5 are independently hydrogen or lower alkyl AND that R2 and R3 and/or R4 and R5 together are formula (II). If they get that claim interpretation, their product cannot infringe claim 1. At that point they simply rely on the principle that something which does not infringe an independent claim cannot infringe a claim which depends from that independent claim. Never mind the fact that claim 5 clearly claims Topiramate and nothing else.

  11. Just visiting wrote: “When you require restriction, don’t you interpret the “and” in “two or more independent and distinct inventions” to mean “or”?”
    examiner wrote: “@Just: No, I don’t.”

    So does that mean that you don’t require restrictions at all? Because I have yet to have seen claims that actually contain independent inventions. All the restrictions I’ve seen in my lifetime were based on related (i.e., not independent) but distinct inventions.

    According to the MPEP 802.01(II), “Two or more inventions are related (i.e., not independent) if they are disclosed as connected in at least one of design (e.g., structure or method of manufacture), operation (e.g., function or method of use), or effect. Examples of related inventions include combination and part (subcombination) thereof, process and apparatus for its practice, process and product made, etc. In this definition the term related is used as an alternative for dependent in referring to inventions other than independent inventions.”

    Thus, all the restrictions I’ve ever seen are based on interpreting the “and” in “two or more independent and distinct inventions” to mean “or”, as suggested by Just Visiting. Honestly, this always was puzzling to me.

  12. Not mentioned by anyone, but what was with that “may” language in the claim. That bothered me a lot more than the “and” vs “or” stuff.

  13. But it was big of Mr. examiner to do so.

    Some other posters should take heed: when the shoe fits, put it on.

  14. @metoo: You’re remarkably sensitive to insults for someone who posts on this blog. From what I’ve seen, a disproportionate number of posters here are assholes and/or raving egomaniacs; excuse me if I expect the population here to be a bit thick-skinned. But honestly, if I offended you, I’m sorry.

  15. um, examiner, did you notice the little :P at the end of my post? apparently not…so let me be more direct….my post you were responding to was not intended to be taken seriously. That :p was a person’s face with their tongue sticking out. And if you want a credible response from me, then don’t insult me.

  16. The more I stew on this case the more pixxed off I get. Perhaps the real difference between Chef America and this case is that the panel had pity on the patentee or the patentee’s lawyer had better hair.

    The best result for everyone would have been to follow Chef America, interpret the claims as they were plainly written, and chuck Ortho’s patent in the garbage where it belongs. Chef America, after all, represents the CAFC’s elusive backbone where judicial realism gets thrown off the bus. The Court Without Pity. It stands for the proposition that claim drafting (and prosecution) isn’t something that should be treated lightly and done in a half-axxed way with the expectation that “everyone knows what it’s supposed to mean” and “the court will fix this.”

    Maybe Rader is getting soft in his old age. I’d like to see this one get re-heard en banc.

  17. @Just: No, I don’t.

    @metoo: Your lack of credible response doesn’t surprise me at all, given the caliber of reasoning in your original reply.

  18. The word that bothered me about the claim was “may”. Why on earth was that word in there?

  19. ROFL – Just Visiting, that was absolutely priceless!

    And Examiner, all I have to say in response is this: /).(\

  20. Examiner,

    When you require restriction, don’t you interpret the “and” in “two or more independent and distinct inventions” to mean “or”?

  21. @metoo
    see: “Appeal to Authority”. You should know better than that.

    Frankly, this comes down to a matter of the English language, so if you’re going to cite authority, an English professor would actually be more appropriate than a circuit judge, as esteemable as they are. Again, the opinion’s rationale is that Chef America doesn’t apply because there the claim could only be read one way, and here the claim can be read in multiple ways (i.e., ‘and’ = ‘and’ vs. ‘and’ = ‘or’).

    While I have no problem with the opinion if we can assume the above premise to be true, there is no basis for that assumption. The opinion cites the dictionary as evidence that “and” can be used to link alternatives, but completely ignores the conditions under which this reading of “and” is appropriate. I’m not an English professor, but I’ve never seen “and” read as “or” in that context – I’d call such a reading outrageous, actually.

    What some of you are basically arguing here is that the language of the claim doesn’t matter if we can show that “well, we all knew what they meant” – a dangerous argument, frankly, and plainly incorrect in view of Chef America.

  22. Seems to me that if three of the most experienced judges at the CAFC, including Chief Judge Michel, interpret the claim as Ortho intended/desired, then the chosen claim language was just fine. :p

  23. Mooney, as a prep/proc person, I share your sentiment – why are companies willing to spend millions in litigation fixing a mistake that they could have fixed for a few thou during prosecution – but at the time Ortho was prosecuting, did they know it was going to be a $1B/year drug? The Pfizer patent I mentioned in my previous post wasn’t even filed in most countries because at the time Warner-Lambert (Pfizer’s predecessor in interest) had no idea that atorvastatin would become an $11B/year drug and management decided the patent budget would be better spent elsewhere.

  24. @defender:
    “We all know what they meant”. Huh. So how do you reconcile that with Chef America? We all know what they meant there also – unless you really want to argue that somebody actually thought the dough itself had to reach temperatures of 400~850 F.

    We claim that this case is distinguished from Chef America because the language in Chef had only one possible interpretation, and the language here has many. I don’t buy that, because the language here does ***not*** have many interpretations. The claims are in the form: “wherein A is X and Y”. You don’t get to read that as “wherein A is X **or** Y”. Plain english doesn’t allow an alternative reading here. In fact, aside from situations like the aforementioned “choosing between X and Y”, in what other situations is “and” properly given an alternative reading? Do you ever read “A is X and Y” as “A is X or Y”? I sure as hell don’t.

    And there’s also the use of “and/or” and “may be”. Perhaps it’s different for biochem, but in the electrical arts, we treat “A and/or B” or “A may be B” as likely being indefinite under 112 2nd.

  25. What’s mindblowing is that Ortho evidently couldn’t be bothered to find better prosecution attorneys to draft claims to cover a $1 billion/year drug. Was the prosecution handled in-house or what?

  26. As Mal Moon suggested, the proper equation is not AND = OR.

    The proper equation is AND = AND or OR, depending on context. Which is, substituting for the “depending on context” — AND = AND and/or OR.

    So, rearranging: OR = AND or/and AND (??) Or is it OR = OR and/or AND? Which is to say: OR = ([AND or/and AND] or [OR and/or AND]).

    Eventually, we should be able to derive the Theory of Everything.

  27. Defender, I agree with you. But I should point out that simply changing the AND to an OR would not have solved the problem (not sure if that was what you were suggesting).

    If the clause of claim 1 in question had read “R2, R3, R4 and R5 are independently hydrogen or
    lower alkyl OR R2 and R3 and/or R4 and R5 together may be a group of the following formula (II):”, what would R4 and R5 be if only R2/R3 had the formula (II) structure? Perhaps the way the clause was drafted is not as bad as some people seem to believe.

  28. 70 yr old pat atty,

    Judge Moore is indeed from a different mold than Judge Newman.

    Moreover, the first is young while the latter is ancient & up for senior status (retirement).

    The first appears to be very much anti-patent while the latter is experienced as a real scientist (chemistry) and understands the travails of inventors as they weave their way through the system only to emerge at the end of the cattle chute under the gaze of the first as hapless pests.

  29. examiner wrote, “Applicants should not be getting away with this kind of irresponsible writing”.

    “Getting away with”?! “irresponsible writing”?! They didn’t have a disgustingly broad claim (like a claim for a jpeg on a website), just a poorly drafted one, and we all agree it should have said “or”; but the fact that we all agree on this shows that we all know what they meant, hence the meaning of the claim was clear. They weren’t trying to “get away with” anything, and they weren’t irresponsible, just sloppy. The fact that neither they nor the PTO caught this minor error during prosecution shouldn’t have deterred the CAFC from upholding the claim – as demonstrated by the evidence, they had a novel, non-obvious invention, and it’s refreshing to see the court correctly uphold a patent as valid and infringed instead of tossing it on a technicality (compare to claim 6 of Pfizer’s atorvastatin patent that got tossed for allegedly improper dependency).

  30. I can’t agree here. It’s possible that my English is poor, but using ‘AND’ in the alternative requires additional language, such as “choosing between X and Y”. If I just say, “X and Y”, I don’t get to interpret that as “X or Y”. The language of the claim at issue states:

    wherein
    X is oxygen;
    R1 is hydrogen or alkyl; and
    R2, R3, R4 and R5 are independently hydrogen or
    lower alkyl and R2 and R3 and/or R4 and R5 to-
    gether may be a group of the following formula (II):

    There is no basis for interpreting AND in the alternative here. The claim uses “wherein” and “R2, R3, R4, and R5 ***ARE*** …”. If I say “A is B and C”, that doesn’t mean “A is B OR C”. That doesn’t make any sense in plain english. The fact that the specification states the same thing means the specification doesn’t make any sense either.

    These issues should have been raised in prosecution, the claims being rejected as inoperable as claimed. Applicants should not be getting away with this kind of irresponsible writing.

  31. As a matter of physics, if you put dough in a cavity filled with air at 400, the dough molecules on the skin of the loaf must inevitably be at 400 too, no? Or, put another way, the addressee is a baking technology person, and what does such a reader directly and unambiguously derive from the text of the patent, including the claim. Patents are to be read by technical wallahs, no, not fancy lawyers. The fancy lawyers just argue about what the tech reader would have derived from the thing, no? For the feet on the ground common sense bakery technologist, only one meaning makes sense, and it’s not the one the CAFC discovered.

  32. Paul, I think the two cases are easily distinguished.

    In Chef America, the claim phrase at issue was “heating the resulting batter-coated dough to a temperature in the range of about 400° F. to 850° F. for a period of time ranging from about 10 seconds to 5 minutes to first set said batter and then subsequently melt said shortening flakes, whereby air cells are formed in said batter and the surface of said dough”. According to the patentee’s proposed construction, the limitation referred to the temperature in the oven; the dough didn’t actually get that hot. I wouldn’t characterize this claim construction per se as non-sensical. Implausible, maybe, but not non-sensical. The problem in Chef America was that this isn’t what the claim plainly says, and there wasn’t any support in the claim itself or in the specification for the patentee’s construction. Thus the court said that, in accordance with the plain language, the claim must mean heating the dough so that the dough itself reaches these temperatures, even though the *result* of the claimed process under this construction was non-sensical, since by heating the dough to these temperatures, one would wind up with a hockey puck.

    In contrast, here one claim construction itself – the defendant’s – made no sense, since a molecule can’t satisfy both recited conditions if “and” is construed as conjunctive, whereas the construction that says that in this claim, “and” means “or” made sense. So the court went with the only construction that made sense. I think the court got it right in both cases.

  33. With regard to the Chef America decision, it is worthwhile remembering that judges are human beings not machines, and have ordinary motivations including a desire to clear unmeritorious cases from their docket.

    So if we look at the Chef America case, the CAFC obviously could have construed the claim to make sense rather than nonsense out of it. There is, I believe, plenty of black letter law that would have enabled them to do so. But they did not avail themselves of that opportunity.

    Why not? Possibly because they had become convinced that the patent was unmeritorious or that the infringement case was unmeritorious. Clearly they felt that this was a case that should be cleared from their docket and they used the patentee’s inept claim language to do that.

    So what do we learn from Chef America? Certainly to avoid claim language that gives wriggle-room towards a narrow construction of the claim. Probably not much more than that – it requires much faith to view Chef America as providing a rule that narrow and absurd claim constructions must be adopted if tghe claims can be read that way.

    It seems that in the present case the court has viewed the situation otherwise, which is a good but not unexpected development.

  34. March 31 IPO Daily News reports an interesting 3 star case for legal scholars to consider:
    Rat Trap That Combined Elements From Prior Art Was Obvious Despite Objective Evidence of Nonobviousness — Agrizap, Inc. v. Woodstream Corp. 2007-1415, -1421 — On March 28 in an opinion by Judge Moore, the Federal Circuit overturned a jury verdict that Agrizap’s patent claims were not obvious over the prior art. The patented invention, sold as the “Rat Zapper,” killed rats by electrocution. The difference between the prior art and the asserted claims was the type of switch claimed. Another prior art patent showed the switch used by Agrizap in a device akin to a cattle prod. The court said, “. . . this is a textbook case of when the asserted claims involve a combination of familiar elements according to known methods that does no more than yield predictable results.” Objective evidence of nonobviousness — commercial success, copying, and a long felt need in the market for electronic rat traps — could not overcome “such a strong prima facie case of obviousness.”
    (1 to 4 stars rate impact of opinion on patent & trademark law)
    The CAFC observed that:
    “However, as the ultimate conclusion of obviousness is a question of law, it remains our duty as the appellate court to ensure that the law has been correctly applied to the facts. Structural Rubber Prods., 749 F.2d at 719. In other words, we review de novo the conclusion on obviousness. Though we are fully cognizant of the hindsight bias that often plagues determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1, 36 (1966), we are also mindful that “[the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results,” KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1739 (2007).”
    So with that observation, we know where this is leading.
    But whoa — the CAFC recognizes its got an obstacle in front of it when it goes on to further observe “… we effectively find ourselves in the curious position of reviewing the same prior art that the PTO relied upon to reject the asserted claims.”
    But that’s an easy obstacle for the CAFC to jump over as it says “This is a textbook case of when the asserted claims involve a combination of familiar elements according to known methods that does no more than yield predictable results. KSR, 127 S. Ct. at 1739″ — all this leading to a conclusion of obviousness with a closing comment that “In this case, the objective evidence of nonobviousness simply cannot overcome such a strong prima facie case of obviousness.” QED.
    So what happened to the presumed validity of issued patents and what happened to the existence of a clear and convincing standard to negative an issued patent, especially, where the art in question was already considered by the examiner before the examiner allowed the application to pass to issue???
    Could it be that Judge Moore is from a different mold and has a different thought process than that of Judge Neuman??? Like in saying we are cognizant of the hindsight bias, but acting as though we still believe in Monday morning quarterbacking?
    A challenge lies ahead.

  35. “under 35 U.S.C. 103 patentability is not to “be negatived by the manner in which the invention was made.”

    This provision was intended to overrule the “flash of genius” test the courts sometimes employed. Graham says this explicitly” “It also seems apparent that Congress intended by the last sentence of § 103 to abolish the test it believed this Court announced in the controversial phrase “flash of genius,” used in Cuno Corp. v. Automatic Devices Corp., 314 U.S. 84, 51 USPQ 272 (1941).”

  36. no idea, Dan. I suspect that they did not, else the issue would have been addressed. They certainly would not want to argue that their proposed claim interpretation (conjunctive AND) was indefinite – that would be foolish. And an inoperable claim is not necessarily indefinite – most of the time, an inoperable claim is not indefinite. Mylan probably made the decision that arguing the claim was indefinite because you could not determine what the AND meant might lessen the impact of their argument for the plain meaning of AND.

  37. Metoo, do you know if Mylan argued indefiniteness on this basis? It appears from the decision that they didn’t present this argument. Not that it seems the CAFC would have bought the argument even if it had been made.

  38. Titlebaumdde, I don’t think that’s what the court said at all. Rather, the court basically said that the claim encompasses four scenarios:

    (1) R2, R3, R4 and R5 are independently hydrogen or lower alkyl (i.e., all can be hydrogen, all can be lower alkyl or some can be hydrogen and some lower alkyl)

    (2) R2/R3 together are formula (II), and R4 and R5 are independently hydrogen or lower alkyl

    (3) R4/R5 together are formula (II), and R2 and R3 are independently hydrogen or lower alkyl

    (4) R2/R3 together are formula (II) and R4/R5 together are formula (II)

    Now, one thing I find odd about the opinion is that the court ignores the fact that Mylan’s proposed claim construction would render claim 1 meaningless. While the court said that Mylan’s proposed construction would render some of the dependent claims meaningless, it would also do that to claim 1 – it would simply be impossible for R2, R3, R4 and R5 to be independently hydrogen or lower, while at the same time R2 and R3 and/or R4 and R5 together are formula (II).

  39. The court seems to have read the claim language

    “R2, R3, R4 and R5 are independently hydrogen or
    lower alkyl AND R2 and R3 and/or R4 and R5 to-
    gether may be a group of the following formula (II)”

    to read

    where at least one of the following is a group of the formula (II): (A) “R2, R3, R4 and R5 are independently hydrogen or lower alkyl AND (B) R2 and R3 and/or (C) R4 and R5.

    Spins the head.

  40. > *per se* findings of obviousness
    >of compositions based on the amount of time it took to generate them, i.e., >can’t argue that “if a child could make it, it’s prima facie obviousness”.

    Of course all pharmaceutical patents are obvious. There are only so many atoms and molecules, so adding a few new atoms(when anyone can make them) is obvious. And it is obvious to modify a known compound with the finite number of new atoms and try it to see if it has any utility. Mooney, your entire field should be stricken from 101. Further, since anyone can make a molecule now based on the specification or formula, the formula is really just an idea.

  41. I’m happy that Chef America has come up again, and intrigued that Judge Rader writes of it “In Chef America, the only possible interpretation of the claim led to a nonsensical result”. Not how I remember it. He’s on a mission to “Airbrush out”, isn’t he?

  42. Because it is the most righteous of all CAFC cases, it pains me every time that Chef America is distinguished. I read the case last night with trepidation.

    Dennis writes, “according to the courts, AND does indeed mean OR”

    But reading the discussion, it seemed to me that AND was construed to mean either AND or OR, depending on the context. For example, Wasn’t the court’s argument that one skilled in the art would understand which definition was applicable in the different passages in the claims at issue? e.g., “choose from A and Z” versus “choose from A or Z” … it seems that AND or OR can be used in that context without changing the meaning.

    In Chef America, on the other hand, the claimed method was simply *wrong* as written.

    “under 35 U.S.C. 103 patentability is not to “be negatived by the manner in which the invention was made.”

    What does the legislative history of that passage say about its intended effect? I thought its purpose was to preclude *per se* findings of obviousness of compositions based on the amount of time it took to generate them, i.e., you can’t argue that “if a child could make it, it’s prima facie obviousness”.

    I never understood it to mean that no evidence of predictability or ease of manufacture could be introduced in the context of an obviousness argument. Certainly such considerations are used to argue non-obviousness all the time.

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