“Substantially Equivalent” Disclosure Satisfies Written Description

by Dennis Crouch

Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc. (Fed. Cir. 2019)

It is always surprising to see the Federal Circuit reverse a non-obviousness holding; However, the most important aspect of this decision is likely the written description discussion. 

This Hatch-Waxman litigation was triggered by the Abbreviated New Drug Application (ANDA) filed by Actavis — seeking permission from the FDA to begin marketing weight loss drugs naltrexone hydrochloride and bupropion hydrochloride extended-release tablets. Nalpropion is the branded distributor of the Contrave and owner of the Orange Book listed patents U.S. Patents 7,375,111, 7,462,626, and 8,916,195.  The lawsuit was started by Orexigen who held rights at the time. Nalproprion bought rights from Orexigen out of Bankruptcy in a $75 million asset purchase. (The problem is that the pills are not overly effective — ~10% weight loss, but only when combined with diet changes and exercise.)

The patentee won the district court litigation and obtained an injunction against generic entry by Actavis until expiration of the patents in suit. On appeal, the Federal Circuit has partially reversed — finding some of the asserted claims obvious.

The active ingredients were already known in the art, and so the claims at issue are directed toward (1) a method of treating obesity with naltrexone and bupropion and (2) a sustained release formulation of the two drugs in a single pill.

The key prior art taught use of the two drugs (in sustained release form) to avoid weight gain associated with smoking cessation (rather than losing weight for obese/overweight patients).  A second reference taught using bupropion for weight loss. Another reference taught the use of the two drugs as a treatment of depression and included case studies showing weight loss. The district court considered these references but found the weight loss effect were not clear enough and that there were too many potential side-effects to encourage experimentation.

On appeal, the Federal Circuit reversed — finding the claims obvious as a matter of law.

The prior art here discloses the claimed components of the composition claims and the steps of the method claims including the use claimed by the method. . . .

Given that both drugs had shown weight loss effects, we conclude that a person of ordinary skill would have been motivated to combine them. In fact, such persons did so [in the prior art]. O’Malley [the first reference] teaches a combination of effective amounts of sustained-release bupropion and naltrexone for minimizing weight gain. Likewise, Dante teaches use of an opioid antagonist, preferably naltrexone, and an antidepressant, including bupropion, for decreasing sugar cravings, noting that naltrexone administration alone led reduced sugar cravings and weight loss in two examples. A person of skill would have understood that a combination for reducing weight gain and decreasing carbohydrate  cravings may affect weight loss as well. . . .

The inescapable, real-world fact here is that people of skill in the art did combine bupropion and naltrexone for reductions in weight gain and reduced cravings—goals closely relevant to weight loss. Contrary to Nalpropion’s view, persons of skill did combine the two drugs even without understanding bupropion’s mechanism of action but with an understanding that bupropion was well-tolerated and safe as an antidepressant.

As a result here, the court held these claims obvious.

Power of a Portfolio: Important note here is that the the obviousness decision invalidated claims from only two of the three patents.  The claims in the third patent include more specific dosing and and extended release elements that were not found in the prior art. (E.g., 32 mg of naltrexone; 360 mg bupropion; release of 39-70% within one hour; …).  U.S. Patent No. 8,916,195.  End result appears likely the same — injunction to prevent generic entry.

Dissent on Written Description:  Chief Judge Prost wrote in dissent — arguing that the claims of the third ‘195 patent should also be found invalid as lacking written description.  The particular issue is that the patent claimed use of a particular standard (“USP 2”) for measuring the extended-release profile of the pills; but the specification apparently discloses a different standard (“USP 1”).   In the case the patentee’s expert testified that the two methods are “substantially equivalent,” and that was enough to satisfy both the district court and the majority here (Judges Lourie and Wallach). Chief Judge Prost disagreed — arguing that disclosure of a “substantial equivalent” of the claimed invention is not sufficient.

A substantially equivalent disclosure, even if it would render the claim limitation obvious, cannot satisfy the written description requirement. See Ariad (“[A] description that merely renders the invention obvious does not satisfy the requirement.”); Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (“The question is not whether a claimed invention is an obvious variant of that which is disclosed in the specification.”).

Chief Judge Prost went on to argue (1) that the claim element is certainly “limiting”; and (2) no evidence of record shows that the two methods produce the same results. For its part, the majority explains that “[i]t is not necessary that the exact terms of a claim be used in haec verba in the specification, and equivalent language may be sufficient.

I pulled up the prosecution history on this case using PAIR. Originally the claims did not mention any dissolution test at all for measuring the sustained release. Later, the patentee added that the test was a “standard” test.  The examiner rejected that amendment as failing the written description requirement and the patentee then changed the test to USP 2 (“a dissolution test of USP Apparatus 2 Paddle Method at 100 rpm in a dissolution medium of water at 37 deg C”). The office action response states that “there is sufficient disclosure in the specification to demonstrate possession of the claimed release profile” as amended. The examiner then allowed the case — mentioning the USP 2 profile in the reasons for allowance. All of this tends to favor Judge Prost’s analysis. On the other hand – when I read the patent document it actually discloses the use of USP 2 in the specification or “other test conditions substantially equivalent thereto.” However, the example given of actual dissolution measurements uses USP 1.

= = = =

Dominick Conde of Venable (NY) argued the case for Nalpropion; Jonathan Ball of Greenberg Traurig (NY) argued for Actavis assisted by Justin MacLean, et al.

56 thoughts on ““Substantially Equivalent” Disclosure Satisfies Written Description

  1. 5

    “— ~10% weight loss, but only when combined with diet changes and exercise”

    What are they arguing over? How much have the parties needlessly blown fighting over virtually placebo-like patents of such limited real world value to humans?

    So how much of the weight loss is attributed to the drug; how much to the diet changes and exercise?

    Indeed, diet changes and exercise alone will produce such 10%+/- weight loss … to say nothing of their numerous other wonderful health and longevity benefits … and with no drug side effects.

    Sheesh.

    1. 5.1

      To answer your question, re patenting “virtually placebo-like [products] of such limited real world value. ” They [and even numerous fully quack nostrums] are a multi-billion dollar a year industry in the U.S. Many are even protected from FDA review or evaluation by special interest federal legislation passed years ago. Patents are well worth obtaining if they help such highly lucrative marketing by miss-representing a government approval to the gullible public.

      1. 5.1.1

        Good observation Paul. I can see the great value in being able to shout to the marketplace (including doctors):

        “What a great patented medicine … that’s just perfect for you!”

        … and in small print:

        “When combined with materially changing your eating and (no or little) exercise habits.”

    2. 5.2

      @ Pro Say –

      Just for clarity, I believe the 10% figure is from testing that shows that the drug, in combination with dieting and exercise, provides 10% more weight loss than a placebo in combination with the same dieting and exercise. The drug without dieting and exercise shows no effect on weight loss.

      But to your point, although statistically significant, a 10% increase in weight loss is unlikely to be clinically significant and the noise level in any individual weight loss program is at least an order of magnitude higher. When the side effect profile is added, I personally think the risks are too high for a negligible benefit. But people read the 10% weight loss statements as saying “lose 10% of your weight just by taking this pill!” which is totally ridiculous. You would have to lose 100% of your weight to be able to claim 10% was due to the pill.

      1. 5.2.1

        Good points Mike — thanks.

        “But people read the 10% weight loss statements as saying ‘lose 10% of your weight just by taking this pill!'”

        Yup.

        “Work,” after all, is a 4-letter word to many.

  2. 4

    I actually agree (gasp) with the majority here that “substantially equivalent” should be the standard for written description. There has to be some characterization of what scope is supported by the disclosure of an embodiment, and I believe it should be the means-plus standard (equivalent means to achieve an equivalent result) is the only one consistent with prior caselaw.

    This has the proper effect of rendering most non-means-plus functional claims invalid as overly broad under 112(a). Because the structure in the specification performs the function in a particular way, a claim limited only to the functional result, without reference to the particular structural mechanism to achieve the result, is not substantially equivalent to the disclosed apparatus and thus not fully supported by it.

    Now all they need to do rule that pointing to a specification that fails to foreclose non-substantially equivalent embodiments from a scope is sufficient to shift the 112(a) burden to the patentee, and they will have solved much of the problem that the supreme court sought to solve in Alice. i.e. When your specification is the first to teach a bow, but your claim is limited to a machine that fires a projectile, merely pointing to the fact that the specification fails to prove that “the bow and its substantial equivalents are the only way to fire a projectile” shifts the burden to the patentee to prove the proposition or be found invalid under 112(a). The burden of foreclosing other means always lies with the person who claims to have invented all the means that achieve a result.

    1. 4.1

      This has the proper effect of rendering most non-means-plus functional claims invalid as overly broad under 112(a).

      This statement cannot be supported with any reasonable view of the law.

      1. 4.1.1

        A very apt quote from the movie “Enemy of the State” was (all too sadly) deleted.

        FAR more direct and offensive language may be found on this site.

        1. 4.1.1.1

          Admiral Shaffer:

          I want the entire history of this device, from birth to abortion on my desk in 2 hours. I want the name of the tech who made it. I want to know who authorized its use, who checked it out from inventory,
          [slams table]
          and for what purpose. And most important, how in G0d’s green earth it got into Congressman Albert’s hotel room.

          Listen people, everyone know where this is going. If this was a legit op, and I can’t imagine how it could be, then so be it. But if this was someone’s unilateral [deemed offensive], then that someone is going to prison.

          Here, the audacity of Random to pass off his wild musings as if they reflected law is on the order of something to which the admiral (in the movie) was expressing himself.

    2. 4.2

      [R]endering most non-means-plus functional claims invalid as overly broad under 112(a).

      I understand what you mean to say here and largely agree with it, but just to be strictly accurate, means+function claims are only pseudo-functional. They are not really functional claims at all.

  3. 3

    Two thoughts:

    (1) The obviousness conclusion does not cite In re Kerkhoven, 626 F.2d 846, 850 (C.C.P.A. 1980) (“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose”), but this holding is just the ordinary application of that long-standing precedent.

    (2) I think that the majority has the better argument than C.J. Prost’s dissent here. In particular, I think that the Chief’s long discussion of whether or not the USP2 limitation is limiting shows that she really fundamentally misunderstands what the majority concluded here. The majority never said (as C.J. Prost takes them to have said) that the USP2 limitation is not limiting. Rather, the majority concludes (rightly, on this record) that the USP2 dissolution characteristics claimed are inherent in the disclosed invention. The trial court found as much as a fact, and the appeals court had no reason to upset that finding.

    C.J. Prost says (dissent slip op. at 4) that ” during litigation, neither party identified any evidence that a 32 mg dose of any sustained-release naltrexone formulation necessarily contains an amount of sustained-release carrier that inherently generates the claimed USP 2 dissolution profile measurement.” This is just wrong. The patentee had expert testimony that the USP1 and USP2 protocols are substantially identical in their outcomes. Expert testimony is evidence, and that is enough evidence to constitute a substantial basis for the district court’s fact finding.

    C.J. Prost also contends (dissent slip op. at 5) that “the original patent disclosure fails to literally or inherently disclose [the USP2 clause]… .” This is begging the question. For the reasons noted above, the district court concluded that the original disclosure does inherently disclose the USP2 clause. This is a fact finding, and I cannot see how (on the basis of the facts that we have in the opinion) one can conclude that such a fact finding is clearly erroneous.

    The majority got this one correct, on both the written description and obviousness grounds.

    1. 3.1

      Prepare for the good ‘ol “one-bucket” treatment, Greg.

    2. 3.2

      GDL: C.J. Prost also contends (dissent slip op. at 5) that “the original patent disclosure fails to literally or inherently disclose [the USP2 clause]… .” This is begging the question.

      LOL No, it’s definitely not “begging the question.” Either USP2 and USP1 are the same thing, or they aren’t. The patentee’s expert testified that they are not the same thing (a fact that is consistent with — get ready for this! — the different names given to the two tests).

      “Inherency” in patent law is short-hand for the necessary and objectively cognizable structural identity between something that is taught in the prior art and something that is claimed, where there are elements that are unrecited in either the prior art or the claim. It isn’t a means for running an end-around the written description requirement (?!) so the patent applicant can reach into to the ether and insert specific technical terms into the claims that appear nowhere in the specification but which “arguably” are “substantially equivalent” to what was actually taught in the specification (in which case … why not just go with the language in the specification???).

      This is a very very unfortunate road for the CAFC to head down. Trainwreck at the PTO coming soon.

      1. 3.2.1

        You do realize (since you self-profess to be an expert) that equivalency does NOT mean “exactly the same thing,” eh?

        1. 3.2.1.1

          equivalency does NOT mean “exactly the same thing

          …. particularly when the “equivalence” is further qualified as merely “substantial”.

          Thank your for implicitly admitting that everything I wrote in my comment is correct. As noted above, creating a massive loophole in the written description requirement so that “substantially equivalent” but admittedly non-identical and admittedly non-disclosed elements can be added to claims years after filing is a disaster for everyone participating in the system. No good can come of this.

          1. 3.2.1.1.1

            Thank your for implicitly admitting that everything I wrote in my comment is correct.

            Except for the fact that you were were explicitly NOT correct for the reason I added, you just may have been onto something.

            As it is, no, you are not onto anything at all.

            So much then for your vaunted self-professed “expert” status….

          2. 3.2.1.1.2

            admittedly non-disclosed elements can be added to claims years after filing is a disaster for everyone participating in the system.

            No, you’re wrong, the same scope would be valid under current law. If the patentee simply removed the structural element from the claim and replaced it with means for [performing the function of the element], the scope of the claim would reach the structure in the spec and equivalents that are not in the specification and be valid.

            This decision is simply a recognition that a disclosed structural embodiment has always supported a scope drawn to equivalent means. The scope of Written Description does not vary with whether 112(f) is invoked or not. It was always possible to write an application which only textually includes the word “nail,” modify a claim years after the filing date during examination to substitute in “means for fastening,” and have that scope validly cover screws (so long as screws are equivalent in context) despite the word “screw” not having appeared anywhere in the specification.

            1. 3.2.1.1.2.1

              Oh Random, I must thank you for this:

              “It was always possible to write an application which only textually includes the word “nail,” modify a claim years after the filing date during examination to substitute in “means for fastening,” and have that scope validly cover screws (so long as screws are equivalent in context) despite the word “screw” not having appeared anywhere in the specification.”

              because of its relevance to prosecution amendment practice in First to File jurisdictions. A hypo might help.

              Suppose you are Julio Palmaz and you just invented the stainless steel radially expandable metal cage that today we call the stent. Safe, long-lived in the body, fatigue resistant. You draft and file an application on your invention.

              During its prosecution, the first inklings of something very surprising emerge, namely the possibility of a safe alternative to stainless steel, namely NITINOL. Your patent attorney realises that your claim needs to be amended, by removing from it the words “stainless steel”, so as to do what you say, namely “have that scope validly cover” (no if’s, no but’s) stents made of NITINOL.

              In a First to file jurisdiction, such a prosecution amendment would be problematic. How about at the EPO?

              1. 3.2.1.1.2.1.1

                Oops. Sorry, readers. Amend (of course) that last word “EPO” to read “USPTO”. No idea (ha ha) how I came to type “EPO” when I intended “USPTO”.

              2. 3.2.1.1.2.1.2

                During its prosecution, the first inklings of something very surprising emerge, namely the possibility of a safe alternative to stainless steel, namely NITINOL. Your patent attorney realises that your claim needs to be amended, by removing from it the words “stainless steel”, so as to do what you say, namely “have that scope validly cover” (no if’s, no but’s) stents made of NITINOL.

                Removing language has no bearing on anything except the claim scope. It’s not like the rules are different if you start with elements ABCD and turn it into elements ACD as opposed to if you started with means-plus language. Either the spec supports scope ACD or it does not. If ACD could be achieved through distinct means B, E, or F, and the spec only discloses B, then a claim to ACD is invalid because it covers ACD through B, ACD through E, and ACD through F, and the spec only posits B and its equivalents.

                Consequently, the patentee has the same two choices they always have – limit to B (claim ABCD) or convince the fact finder that E, F, and any other possible elements are equivalents of B. Because the latter as a general matter can rarely be done, the vast majority of the time option one (limit to ABCD) must be selected.

                If one of skill would find NITINOL to be distinct (i.e. not substantially similar in all of function, means or effect) then no amount of fancy scrivening will allow someone who only teaches stainless steel means to validly reach a NITINOL-encompassing scope. You seem to have concluded that NITINOL and stainless steel are distinct, so it doesn’t matter whether you try and use means plus or try and remove elements or even if you rewrote it using broad marginally-indefinite language, there is no valid scope that both (1) covers NITINOL and (2) is enabled and possessed.

                1. Either the spec supports scope ACD or it does not.

                  If the spec supports ACD, then it just does not matter if that ACD can be achieved through B, E, or F, because at that point one is only claiming ACD.

                  Your view of this matter simply is untethered to actual patent law.

                  One may claim a “hammer,” and need NOT show each and every way of making a hammer in order to have a valid claim to a hammer.

                2. Random, while I appreciate your reply, I feel that you are making things unnecessarily complicated. Dr Palmaz invented the metal stent concept. That’s what his patent attorney should have claimed, with ample support from his successful embodiment of the concept, made of stainless steel. You don’t have to include embodiments for every metal under the sun, do you. Just at least one that works, no?

                  My hypo is that the patent attorney claims that concept, but, unfortunately, all the claims are limited to “stainless steel”.

                  Belatedly, that attorney sees his error, and amends the claims, perhaps in a continuation, to recite “metal” or even “biologically compatible metal” instead of “stainless steel”, with ss re-appearing in dependent claims.

                  Putting aside any considerations of the special properties of nitinol, you seem to be suggesting that such a broadening amendment is legitimate and unproblematic. Right?

                3. MaxDrei,

                  Your hypo is not as clear as you may think (and thus, you may be projecting a “you are making things complicated” when in fact, that is not the case).

                  For example, and to equate your additional comments to the example provided by Random, you appear to want to have the application discuss (and per Random then, “the spec supports scope ACD” and yet you ALSO appear to want it that the spec does NOT support scope ACD (insinuating that new matter in the form of a specific TYPE of biologically compatible metal” is only later being inserted into a claim, without CLEAR basis for that type of metal, and possibly (merely) as a result of someone else noting a particular patentable advance WITH that specific type of metal.

                  In other words, Random reverse his usual course of ramblings and APPEARS to note that subsequent improvement patents are possible (note his comment of “If one of skill would find NITINOL to be distinct“).

                  HOWEVER, he remains inconsistent in that — solely based on his stated views — the LATER discovery of the distinctiveness of NITINAOL necessarily makes the larger genus-type patent VOID (Random’s penchant for jumping to a two-step ladder).

                  For argument’s sake, let’s switch the hypo and have the applicant note (as you suggest), a bio-compatible metal, such as stainless steel or titanium.

                  Would the later improvement over base titanium then — as Random’s position necessitate – make the earlier genus claim INvalid?

                  This is but one aspect of the ramblings of Random simply do not (and cannot) accommodate.

                  I do find it interesting in your attempt to provide a “trap” (for a new matter aspect), actually has some inadvertent value for exposing one of Random’s weaknesses.

                4. My hypo is that the patent attorney claims that concept, but, unfortunately, all the claims are limited to “stainless steel.” Belatedly, that attorney sees his error, and amends the claims, perhaps in a continuation, to recite “metal” or even “biologically compatible metal” instead of “stainless steel,” with ss re-appearing in dependent claims… [S]uch a broadening amendment is legitimate and unproblematic. Right?

                  Broadly speaking, I think that this must be correct. Stainless steel is not really an essential aspect of the invention, so it should not require that the invention be actually reduced to practice with (e.g.) copper in order to claim the copper stent based on the reduction to practice with stainless steel.

                  Still and all, there is a sort of scope of enablement issue here that sits uneasily with the doctrine. Strictly speaking, if you do not specify a material for the stent in the claim, then the claim reads on stents made with any material (e.g., lead, uranium, diamond, etc). Naturally, however, a stent made of uranium would not function for its intended purpose, so if you leave the material unspecified, then the claim reads on a non-trivial amount of non-enabled subject matter.

                  I think that it practice the way that the courts deal with this is to say “well, ‘everyone’ knows that we do not mean the claim to be understood as reading on uranium.” This is not a very satisfactory answer, however, because that leaves open the possibility of someone making an argument that “‘everyone’ knows that we do not mean the claim to be understood to read on nitinol,” and who is to say that this is wrong?

                5. One may claim a “hammer,” and need NOT show each and every way of making a hammer in order to have a valid claim to a hammer.

                  A plainly incorrect statement. That is the whole point of the Morse case. Morse invented a machine that prints at a distance, and by your logic he was the inventor of a networked printer or a modern day fax machine, something he blatantly was never in possession of. Similarly, the person who invented the first car did not invent all cars for all time. The only thing they invented was *their* *structure* and equivalents thereof. As I’ve repeatedly pointed out, attempting to broaden the invention to everything that has the same utility or performs the same function is just overclaiming.

                  If I assume that every car travels at 15mph, and the art can use GPS to estimate the distance between two points, I can achieve the function of estimating trip travel time by simply taking the distance and dividing it by 15mph. The estimate would be terrible, as it ignores that roads, rather than how the crow flies, controls the distance required, and that 15mph is both too low (for highway travel) and too high (for city travel) an assumption. The notion that flight distance / 15 is the same invention as, e.g. google maps driving directions is ridiculous, and the idea that you can capture the former by using broad, vague or functional language when you inventor only posited the former ignores the entire point of patent law – to promote the arts. The bad algorithm only allows for a claim to reach the good algorithm if one can conclude that they are equivalents, and they are not. Consequently, any claim by the first inventor which purports to cover the second algorithm (“I claim a method comprising: determining the GPS of two points; determining a distance between the two points; and using the determined distance to estimate a travel time”, which would cover both the bad algorithm and google’s excellent one) fails 112(a) because the applicant does not posit or possess the full scope of the claimed invention.

                  Dr Palmaz invented the metal stent concept. That’s what his patent attorney should have claimed, with ample support from his successful embodiment of the concept, made of stainless steel. You don’t have to include embodiments for every metal under the sun, do you. Just at least one that works, no?

                  You are likely incorrect. Your argument seems to be that disclosing a stainless steel stent supports all metal stents. But by the same logic, disclosing a stainless steel stent supports all stents regardless of substance. To pull back even farther, your logic would be that disclosing a stainless steel stent, being a subset of medical devices, supports all medical devices.

                  The last statement is obviously absurd, but is used to illustrate the point: Disclosing an embodiment and then *applying inductive reasoning* to reason that it is representative of all similar devices and to state that the embodiment inherently supports any level of abstraction is simply insufficient.

                  Disclosing a stainless steel stent supports other metal stents when it can be shown that the other types of metal are equivalent to stainless steel, just like it would support a claim to all stents when it can be shown that, e.g. a wooden stent is equivalent to stainless steel (I think its clear the answer to that would be no) and it supports a claim to all medical devices when it can be shown that all medical devices are equivalent to a stainless steel stent (patently absurd).

                  So the answer is that you have to include embodiments for all metals that are not equivalents of each other. You determine whether metals are equivalent by (now here’s a shocking suggestion about inventing something) testing the metals in context. You can’t make a stainless steel stent, *assume* that the stainless steel feature is irrelevant to the functioning of the device, and then simply claim metal stents. The type of metal becomes irrelevant when you can provide an evidence-based reason that the type of metal is irrelevant. If it turns out that your assumption was incorrect, your claim to a metal stent (as opposed to a stainless steel one) is going to be invalidly overbroad.

                  Since you later bring up “biologically compatible metal” I can only assume that some metal, just as a posited wood stent would be, would not actually perform as a stent. Let’s put written description to the side for a second (though the same argument will also apply to that) and simply ask how you’ve enabled the full scope of the claim if you’re specifically noting that in order to make and use a stent, it must be placed in the body, and that there exists metal that is not compatible?

                  Again, to use my old analogy – Inventing the bow does not let you later capture the gun, because the gun is not an equivalent device, even if you have language in your spec that says “The bow is but one particular embodiment of the invention, which is a machine that fires projectiles.” A claim to a machine that fires projectiles is overbroad of the bow disclosure, and a claim to the bow does not reach the gun. The gun inventor takes free of the bow inventor, despite their distinct inventions achieving the same function if the function is described in a broad and vague manner. By the same standard – a specification that discloses a stainless steel stent, even if the stent could be made with any metal, only reaches some other particular metal if that metal is equivalent to stainless steel.

                  In other words, Random reverse his usual course of ramblings and APPEARS to note that subsequent improvement patents are possible

                  Subsequent improvement patents are always possible when non-obvious. The question is whether the original patent is overbroad. When the original patent claims by function, the vast majority of the time the same embodiment that would allow for an improvement patent proves the overbreadth of the original claim, because the fact that the improvement was non-obvious over the original shows that the original failed to possess the full scope of the function they claimed. That’s the danger in functional claiming – you’re asserting you possess all manners of achieving the function. There’s nothing suprising about this at all – the first inventor should be compensated for their invention, and the second inventor should be compensated for improving on it. If the first inventor’s scope would cover the improvement, there would be no compensation (and thus no incentive) for disclosing the improvement.

                  Would the later improvement over base titanium then — as Random’s position necessitate – make the earlier genus claim INvalid?

                  To genericize this argument, anon asks “Would disclosure of something lying within the claim scope that the inventor did not posit or possess make the earlier claim invalid?”

                  That is the very definition of a written description violation. What anon is so increduluous about is the exact fact pattern of Lizardtech – the defendant later came up with something that fit within the claim scope, but achieved the results using distinct means. According to anon, the fact that it fit within the claim scope would be no evidence of invalidity of the genus. Instead, the defendant’s embodiment proved the overbreadth in that case.

                6. This is turning out to be a useful exploration of the differences of mindset, between the USA and Europe, when it comes to drafting an independent claim. In Europe, one is supposed, from the get go, to say what the invention is. Describe it. Define it.

                  Not so, it seems, in the USA.

                  If I have invented the concept of a stent, in Europe I am expected to claim the stent concept, and to not include in the claim inessential limitations like “stainless steel”. If I do, the presumption in Europe is that the drafter was deliberate, in choosing to limit to stainless steel. In the USA, the presumption seems to be that the intention lying behind the originally filed claims was to confine the USPTO search to stainless steel, then amend to a wider claim, say to “biologically compatible metal”, i) to finesse out of a thorough search that is commensurate with the scope of the subject matter being protected by the patent and ii) to lull readers into a false sense of security.

                  First to File thinking requires that one announces, in the application as filed, what is the inventive concept that is the subject matter of the patent application.

                  Amending out during prosecution at the PTO, from stainless steel to “biologically compatible metal” adds matter in that it is the first intimation (or teaching) to the reader, wholly absent from the application as originally filed, that the invention is anything other than an expandable cage made of stainless steel.

                  As to claims that embrace embodiments that don’t work, this is a total red herring. Just because a claim is expressed in terms wide enough to embrace non-functional embodiments (eg “uranium) is not enough to destroy the validity of a claim. You can always come up with an embodiment that doesn’t work but nevertheless falls within the strict wording of the claim. If that alone is enough to invalidate a claim, no claim ever granted is valid.

                7. If I have invented the concept of a stent, in Europe I am expected to claim the stent concept, and to not include in the claim inessential limitations like “stainless steel”.

                  Would a wooden stent perform a useful function in the body or not? I would assume putting wood into the body would be a bad thing. So why is what the stent is made out of an inessential limitation?

                8. A plainly incorrect statement. That is the whole point of the Morse case.

                  You clearly do not understand the Morse case.

                  Try reading the case again, paying attention to what was allowed, what was not allowed, and what the statutory categories involved were for each.

                9. I’m grateful to Random for writing at such length, in reply to my question about WD and how to claim the ground-breaking invention of the trans-luminal metal stent, in the patent application exemplified by an illustrated embodiment made of stainless steel.

                  There are several biologically-compatible metals with which one can make a safe implant. It’s common general knowledge amongst those skilled in this field. Titanium, for example. Random seems to be saying that I cannot claim a stent of metal until I include in my patent application examples of them all. I say that ss ought to be enough. I dislike the myriad ways in which the superfluous concept of “equivalency” obfuscates patent law.

                  As ever though, I think Random and I would agree with each other, if we were to debate face to face. But here, it’s more problematic.

                10. As ever though, I think Random and I would agree with each other, if we were to debate face to face. But here, it’s more problematic.

                  Wow.

                  Simply wow.

                  You too CLEARLY do not agree on a direct point, and YET, some Frickin desire to “be polite” wants to make it out that you “would agree face to face.”

                  Such slavish adoration of “politeness” is NOT HELPFUL.

                  Quite in fact, such is eminently UNHELPFUL.

                  There is a very real difference in viewpoints here, and underlying that difference is a fundamental NON-understanding of critical patent law foundations by Random (mostly), and some (enduring) desire by MaxDrei to proselytize the “EPO Way.”

                  Trying to dress this up with a cloak of civility is absolutely the wrong thing to do. This is exactly the point at which the use of strong words as an assault on the unthinking is called for.

            2. 3.2.1.1.2.2

              Your last paragraph is the closest that you have ever come to indicating that understand the law that you are charged to examine under.

              Now if you could only grasp the fact that the Ladders of Abstraction always have more than two rungs.

              1. 3.2.1.1.2.2.1

                Now if you could only grasp the fact that the Ladders of Abstraction always have more than two rungs.

                I do, it simply is the fact that virtually every applicant and most patents we see discussed on this site are hanging on to the top rung. Stating a generic or conventional context (“on a computer”) followed by a function (perform this computer function) will naturally encompass non-substantially-similar means.

                Indeed the goal of the drafter is to cover non-substantially-similar means, the very thing the law prevents him from doing. In fact, in many examples at the office level there isn’t even a disclosed means for achieving the function at all (e.g. the function is described in the spec by stating that there is code for performing the function, as if that is any description at all), so the equivalency analysis could not even be performed at all.

                In these all-too-common and all-too-easy-to-analyze situations the result is routine – it’s invalid under 112(a) (and would, under Alice, also likely end up abstract). Of course other rungs exist, it doesn’t change the fact that what one sees, time and again, is the invalid only-limited-by-functional-result approach.

                Would that more applicants could disclose sufficient structure to even make a definite means-plus disclosure, let alone draw their claims to a scope that only encompasses 112(a) described subject matter, rather that coming up with a (bad) solution to a problem and claiming all possible solutions to a problem.

                1. tl;dr – The problem is not when someone uses the word nail and the question is whether they can reach a screw, they can. The problem is when someone says “I’ve got this novel black box that does [useful function F]” and since I posit that there’s multiple ways of achieving F and I don’t seek to limit myself to any particular manner of achieving F, I claim all the ways of achieving F.”

                  This is 99% of computer software claims, as rearranging parts does not render something non-obvious, so using known code is obvious, and the only possible inventive act is new code. When new code is defined by the functional result of running it (function), rather than what the code actually is (means) the claim is overbroad of the disclosure and invalid, and that is assuming that the spec even bothers to disclose at least one means for achieving the function. Many specs simultaneously claim they have novel, non-obvious functions but provide no teaching on how to achieve them, which itself is a laugh, but renders a substantially similar analysis impossible.

                2. Indeed the goal of the drafter is to cover non-substantially-similar means, the very thing the law prevents him from doing.

                  You are simply delusional.

                  Whatever it is that you do in your recreational time, stop.

                3. Your “understanding” of code is NOT an understanding of either code, nor the requirements under the law.

                  I really cannot believe that you yourself truly believe what you write, and assuredly, your do not examine as you postulate.

                4. That you merely THINK that you understand the Ladders of Abstraction remains one of your most egregious weaknesses.

                5. so using known code is obvious

                  – can you fall any MORE heavily into the canard of the Big Box of Protons, Neutrons, and Electrons?

                  It is NOT merely “using known code,” JUST AS MUCH as it is not merely “using protons, neutrons, and electrons.”

            3. 3.2.1.1.2.3

              [A] disclosed structural embodiment has always supported a scope drawn to equivalent means.

              Maybe I am just misunderstanding you, but this looks like an assertion that a disclosure of that which makes X obvious is an adequate written description of X, which is definitely not the law (Univ. of Cal. v. Eli Lilly & Co., 119 F. 3d 1559, 1567, “[A] description which renders obvious a claimed invention is not sufficient to satisfy the written description requirement of that invention”). I agree with you that “most non-means-plus functional claims [are] invalid as overly broad under 112(a),” but that is not at all the same thing as saying that disclosing an equivalent of X is enough to support a claim to X.

              What the court concluded here is that the patentee did disclose a composition having these USP2 dissolution properties, even though the data disclosed in the app concerned tests run under the USP1 protocol. In other words, the court did not conclude that the patentee had disclosed an equivalent of the claimed invention. Rather, the court concluded that the patentee had disclosed exactly the claimed invention, even if the words used to disclose it were not the same as the words used to claim it. If the court had merely concluded that the patentee had only disclosed an equivalent of the claimed invention, presumably it would have gone the other way on the validity judgment, because merely disclosing that which makes X obvious is not enough to support the claim to X.

              1. 3.2.1.1.2.3.1

                Just to offer a concrete example that I hope will clarify what the court did here, imagine that the compound “teranofanox” has a density of 25 g/mm^3, but this density information is not actually disclosed in the application. The application as filed discloses pharmaceutical formulations comprising between 1 mm^3 and 5 mm^3 per liter of total formulation volume. The patentee then goes on to claim compositions comprising between 25 g and 125 g teranofanox per liter of total formulation volume.

                When this claim is later challenged as lacking adequate written description, it is fine for the patentee to bring an expert to testify that the density of teranofanox is 25 g/mm^3. If the trial court believes the expert (a question of fact, to which an appeals court owes deference), then it follows that the disclosure of the 1 mm^3 and 5 mm^3 range is inherently a disclosure of the claimed 25 g and 125 g range.

                Similarly here, the patentee disclosed a formulation having certain dissolution properties when measured by the USP1 protocol. The patentee provided an expert (whom the trial court credited) to testify that the results for this composition measured by USP1 are essentially the same as the results would have been if the measurement had been done using USP2 protocols. Therefore, the disclosure according to the USP1 protocol inherently discloses a composition having the dissolution characteristics claimed in terms of the USP2 protocol.

                This is not a conclusion that the one composition is “equivalent” to a different composition. Rather, it is a conclusion that the composition disclosed is exactly the same as the composition claimed, even though the composition is described in the written description according to USP1 measurements, and then claimed according to USP2 measurements. It is exactly analogous to disclosing the volume and then claiming the mass, when there is a known (but not explicitly mentioned in the patent text) density.

              2. 3.2.1.1.2.3.2

                Maybe I am just misunderstanding you, but this looks like an assertion that a disclosure of that which makes X obvious is an adequate written description of X, which is definitely not the law

                I agree it is not the law, and that is not the assertion. The assertion is that if 112(a) exists for a particular element (i.e. I claim a system comprising elements ABCD and a nail, where a nail meets 112(a)) then 112(a) exists for equivalent means, since one can always rearrange the claim to remove the element and replace it with means for performing the functionality. (i.e. I claim a system comprising elements ABCD and means for fastening). The scope of the means-plus claim will, by order of statute, be drawn to the structure disclosed for performing the function (nail) plus equivalents (screw). As we can see by removing the word “nail” and replacing it with a generic “element X”, disclosure of the structure of X consistent with 112(a) always allows for a valid scope to be drawn that covers equivalents of X.

                Therefore the generic rule is always that meeting 112(a) for a particular means always allows for a granted scope that covers equivalent means. Equivalent is defined under the means plus equivalency test – the same functional result through substantially similar means to achieve substantially similar results.

                This is not to be confused with non-112(f) functional claiming (claiming novel functions outside of means-plus), which are typically invalid for the same reason as above – they only properly bound one of the requirements for equivalency rather than all of them – they require the same result, but not via substantially similar means nor for a substantially similar result. Consequently, they generate scopes that include unposited non-substantially-similar means, and therefore will generally fail 112(a).

                In other words, the court did not conclude that the patentee had disclosed an equivalent of the claimed invention. Rather, the court concluded that the patentee had disclosed exactly the claimed invention, even if the words used to disclose it were not the same as the words used to claim it.

                I’m not very good at bio chem and do not attempt to consider the fact finding in any manner. Obviously, there need be no debate that if it is the same scope it would meet 112(a). I simply was responding to MM’s statement that it would destroy the system to disclose an element, but then, years later, achieve a scope outside of that element – a clearly erroneous statement. Amending to include means-plus language proves that wrong, and the reason is because disclosure of the element has always supported a scope drawn to means-plus equivalents of the element.

                1. with non-112(f) functional claiming… , and therefore will generally fail 112(a).

                  No matter how many times you say this, this is simply not the law.

                  You clearly do not understand the Act of 1952 and the opening of use of terms of function (outside of the optional claim format of 112(f)). The use of terms of function is simply NOT the same as your “two-step only” ladders and the mistaken notion that somehow any term of function necessarily creates an invalid claim.

                  Yet again, I really do have to wonder if you actually examine as you like to postulate here. If so, I would have to imagine that you are likely the most-overturned examiner in the entire patent office.

      2. 3.2.2

        Malcolm’s cognitive dissonance is on blazing display (yet again), as he attempts to spin a pro-patent term into something decidedly anti-patent:

        ’Inherency’ in patent law is short-hand for the necessary and objectively cognizable structural identity between something that is taught in the prior art and something that is claimed,

        Are ANY of your so-called clients informed of your blatantly anti-patent (and flat out wrong) feelings?

    3. 3.3

      The patentee had expert testimony that the USP1 and USP2 protocols are substantially identical

      Did you mean to say “substantially inherent”?

      LOL

      Rhetorical question.

    4. 3.4

      There is also a Fed. Cir. decision they could have cited holding that a claim to a combination of two known laxatives for a laxative [presumably with no unexpectedly different result from the combination] was not unobvious.

      Also, this kind of patent has been called patent “ever-greening” and has been the subject of the recent House hearings and proposed patent or other legislation re drug prices.

  4. 2

    It’s amazing how dumb a PHOSITA can be made.

    1. 2.1

      A second reference taught using bupropion for weight loss. Another reference taught the use of the two drugs as a treatment of depression and included case studies showing weight loss. The district court considered these references but found the weight loss effect were not clear enough

      LOL Because the claims recited a “clear weight loss” resulting just from the two drugs. Oh wait … no, they didn’t. Because you still have to exercise and change your diet if you want to lose weight while taking the drugs.

      Good grief. Losing weight, not gaining weight … how does it work? It’s a total mystery in the 21st century. I’m going to lay on the couch with a huge bag of potato chips and a case of beer and see if I can solve this super complex problem.

    2. 2.2

      Indeed, which is maybe why the Sup. Ct. felt the need to note several times in KSR that the POSITA has common sense.

      1. 2.2.1

        … and yet, “common sense” often is neither as common … nor as sensible … as some folks believe.

        1. 2.2.1.1

          As in the terms of art for the legal world, in the non-legal world people often confuse common sense and hindsight.

    3. 2.3

      Is it “amazing”? It should not be amazing, to one with a familiarity with the common law of patents. As the Canadian Federal Court of Appeals admirably expostulated,
      The classical touchstone for obviousness is the technician skilled in the art but having no scintilla of inventiveness or imagination; a paragon of deduction and dexterity, wholly devoid of intuition; a triumph of the left hemisphere over the right. The question to be asked is whether this mythical creature (the man in the Clapham omnibus of patent law) would, in the light of the state of the art and of common general knowledge as at the claimed date of invention, have come directly and without difficulty to the solution taught by the patent. It is a very difficult test to satisfy.

      Along one dimension, the PHOSITA is a genius (she has read literally every published work in the field, in every language in the world). Along another dimension, she is an idiot (she is not capable of even the least creativity in combining insights from other fields with her extensive knowledge of her own field). That is just the nature of the beast.

      1. 2.3.1

        … except when the Supreme Court wants it otherwise (and if you pay careful attention, you can smell the “Flash of Genius” being snuck in).

  5. 1

    Chief Judge Prost wrote in dissent — arguing that the claims of the third ‘195 patent should also be found invalid as lacking written description. The particular issue is that the patent claimed use of a particular standard (“USP 2”) for measuring the extended-release profile of the pills; but the specification discloses a different standard (“USP 1”). In the case the patentee’s expert testified that the two methods are “substantially equivalent,”

    En banc reversal of the majority’s ridiculous new written description test, please. This isn’t “using two different words” to describe the same thing. This is using two different terms to describe two different things, where the different meaning term in the claim isn’t used at all in the specification as filed. That’s just a straightforward written description FAIL. Could this problem be rescued by application of the DOE? Possibly (especially given the CAFC’s recent resuscitation efforts) … but it’s a different analysis and it isn’t clear (based on the summary of the case, at least) that the DOE would work in this instance.

    I assume the usual folks who reflexively screech about “confusion” and “unpredictability” when it comes to subject matter eligibility (one of the easiest things in the patent law to understand and analyze, in fact) will be here in just a moment to complain about this transparent and ruinous example of “judicial activism”.

    [crickets]

    1. 1.1

      Maybe our pal Shifty could supply some good Wikipedia quotes for this notion of DOE that you hint at…

      As for your “unclear” supposition, yet again I find this odd coming from you, seeing as you declared yourself to be an expert — and that this stuff was NOT hard or confusing.

      Were you prevaricating then or now (or both)…?

    2. 1.2

      — subject matter eligibility (one of the easiest things in the patent law to understand and analyze, in fact) —

      21 Things That Are “So Easy” For Trump (According To Trump):

      link to youtu.be

      1. 1.2.1

        Hilarious – Malcolm IS the Trump of these boards.

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