Four Opinions Defining “a Patient” and Is a Natural Phenomena an Act of God?

By Dennis Crouch

Braintree Labs v Novel Labs (Fed. Cir. 2014)

I see this case as highlighting the most critical and problematic problem with our patent system – that patent claim scope is intentionally ambiguous and malleable. Consistent with the subject matter of the invention, this case may potentially serve as a trigger for cleaning-out the patent system.

Braintree’s U.S. Patent No. 6,946,149 (asserted claim 15) covers a “composition for inducing purgation of the colon of a patient” and is used to help prepare patients for colonoscopies. A major problem with colon cleansing is the risk of having a dramatic electrolyte shift in the body as a whole – leading to potential emergency health problems. Of course, colonoscopies have become very big business and this patent is potentially quite valuable.

Here, Braintree’s patent includes the clearly functional claim limitation of “wherein the composition does not produce any clinically significant electrolyte shifts.” The appeal is about the meaning of that the terms purgation, patient, and “clinically significant electrolyte shifts.” The panel here included Judges Dyk, Prost, and Moore. Each Judge had their own version of how the term should be construed and how that relates to infringement.

What is “a patient”: The preamble of asserted claim 15 indicates that that the invention covers a composition for inducting purgation of the colon of a patient. All parties agreed that the preamble term “a patient” should be seen as limiting since it is implicitly referenced by the later reference to electrolyte shifts. Here, both the district court and Judge Moore saw the “a patient” term as indicating “one or more patients” whereas Judges Dyk and Prost saw the term as meaning “a patient population.” This ends up being important since the plaintiffs provided evidence of a patient who had received the accused product and fit within the electrolyte shift limitation. However, the “general class of patients” interpretation would require evidence that the result is generally expected in all patients.

Judge Prost: Indeed, [the “one or more patients”] interpretation would allow a composition to meet the claims even if 99 patients out of 100 experienced clinically significant electrolyte shifts, as long as one patient did not. . . . [The] application of the claim terms “a patient” leads to the absurd result of infringement even if a composition causes clinically significant electrolyte shifts in a large percentage of patients

Judge Moore: The majority believes this to be an “absurd result” because it would allow “a composition to meet the claims even if 99 patients out of 100 experienced clinically significant electrolyte shifts, as long as one patient did not.” I understand the majority’s concern. But this is a question of damages, not infringement. . . . Infringement, whether on a large or small scale, is still infringement.

Judge Dyk: (Agreeing with Judge Prost) The sole evidence in the summary judgment record concerning the percentage of individuals experiencing such electrolyte shifts is data from two clinical studies … and those data are sufficient to show that the claim limitation was not met [since] a majority of patients experienced clinically significant electrolyte shifts.

In this case, the district court had awarded summary judgment of infringement to the patentee. On remand, the district court will need to revisit whether the patentee has proof that the patient population as a whole would react to the treatment as claimed. We’ll likely see this case again on revise-and-resubmit after the district court has redone its work. Of course, there is a chance that the Supreme Court may take this case – potentially seeing it as a subject matter sequel to Sakraida (“that cow shit case”).

= = = = =

This is a bit of an off-the-wall thought, but I might question whether an infringement finding is appropriate even under Judge Moore’s interpretation. Here, we basically have a setup where one claim limitation (no-electrolyte-shift) occurs in some patients and not in others – the cause of the difference is unknown but is likely a somewhat random operation of the laws of nature. What we know is that a particular treatment protocol will usually result in an electrolyte shift, but sometimes does not have such a result. Of course, for infringement to occur, the accused infringer must practice each and every step of the invention as claimed – here that includes the “no-electrolyte-shift” limitation. Now, although patent law does not require that the accused have intented to infringe the patent, the acts that eventually resulted in infringement must have been intentional.

My question on infringement, is whether performance of that no-electrolyte-shift element is properly attributable to a deliberate act by the accused or instead should it be seen simply as an occurrence of a natural phenomena – an Act of God as the old Lords might have said. See Tennent v. Earl of Glasgow (1864).

191 thoughts on “Four Opinions Defining “a Patient” and Is a Natural Phenomena an Act of God?

  1. unless there is an art-recognized or otherwise defined relationship between the effect and some objective physical descriptor corresponding to the stated effect.

    Worth repeating for a morning chuckle of Malcolm self-FAIL.

    art-recognized.

    (hint: software really does work – it really does make a difference if you are holding a Britney Spears cd and a Microsoft Operating disc)

    1. Gee, Tr0llb0y, there’s a bit more to my comment than the phrase “art-recognized.”

      Are you really that st00pit? Or are you just a path0l0gical liar who doesn’t care if people can see right through your pathetic attempts to lie about everything that everyone else says?

      Rhetorical question.

      1. Nothing of any of your words fit Malcolm.

        You did use the phrase “art-recognized.”

        You have previously provide your, um, ‘opinion’ of that art field, and without any law or fact to back you up, would seek to dismiss the entire art field – well recognized for extensive innovation touching almost every other art field as some base ‘grifting’ scheme.

        It is, as typical, ironic that you seek to accuse someone else of that which you are doing.

        C’est La Vie.

  2. Prof. Crouch’s statement of “Here, we basically have a setup where one claim limitation (no-electrolyte-shift) occurs in some patients and not in others – the cause of the difference is unknown but is likely a somewhat random operation of the laws of nature. What we know is that a particular treatment protocol will usually result in an electrolyte shift, but sometimes does not have such a result. Of course, for infringement to occur, the accused infringer must practice each and every step of the invention as claimed – here that includes the “no-electrolyte-shift” limitation.” prompted a new thought not advanced in any discussion I have seen on this case:

    Do we have a product-by-process here given that an interaction of one claim element is outside of the supposed ‘composition’ nature of statutory class involved? What merely appears at first blush to be a straight up composition actually relies for its patentability on an action (i.e. interaction) and result (result indicating process) of that interaction.

    This view may alliviate the good Professor’s ‘act of god’ notion, given that the purpose behind product-by-process claims was to protect patentees when they could not fully identify the product, but still presented something earning a patent.

    1. Anon, given the holding in the court that the patient population must be considered rather than the effect on individual patients, there may not be a problem if a particular formulation being sold by the defendant does not produce an electrolyte shift in all but a handful of outliers.

      However the way the claim is written, it does require that the particular formulation not produce an electrolyte shift in particular patients in order to infringe. Thus, the sale of the composition possibly could not infringe unless it was demonstrated that in no case would there be an electrolyte shift with the particular composition chosen. But Moore concluded the opposite, that if 99 out of 100 times there was an electrolyte shift, but in one case there was no shift, there would be infringement. But how can that be if the sale itself did not infringe?

      I don’t see how this changes if you construed a claim to be a product by process claim because the sale of the product would infringe unless it was shown that the formulation worked in every case.

      1. If you construe it as product-by-process, you would necessarily make the stated claim limitation an absolute requirement.

        Moore’s conclusion is a bit odd. I think that she is taking the “well, it is not necessarily always required” logic to its extreme. Since the word “substantially” or any other comparative word is not present, one is not necessarily constrained to view the limitation as a “most should,” but rather, the “at least one” thinking may be applicable.

        Of course, Moore’s way may be less and may not be so desired by the patentee – (think Chef America).

  3. TB: It is not considered infringement to make to see if the claim is actually reached.

    How fascinating, coming from the mouth of Mr. Strict Liability himself.

    As I said, I have all the recited salts in my garage and I already made a composition that lies just outside the scope of claim 16. Does my composition infringe claim 15? Yes or no?

    You seem to be suggesting that infringement of a composition claim depends on how I intend to use the composition. That’s an interesting legal theory — particularly from Mr. Strict Liability. Do you, uh, have a cite for this proposition?

    Let’s say I send you 250 mls of the solution and keep the rest here. You test half of it on a patient and you get a “positive” result. I test half of it on a patient and I get a “negative” result. So is your composition infringing but my identical composition is non-infringing?

    Spend some time thinking before you answer. Remember, folks: these are composition claims, not method claims.

    1. Do you, uh, have a cite for this proposition?

      You might try Justice Story in Whittemore v. Cutter: [I]t could never have been the intention of the legislature to punish a man who constructed such a machine merely for philosophical experiments, or for the purpose of ascertaining the sufficiency of the machine to produce it’s described effects.

      You can supply the next step, chump.

      1. You might try Justice Story in Whittemore v. Cutter: [I]t could never have been the intention of the legislature to punish a man who constructed such a machine merely for philosophical experiments, or for the purpose of ascertaining the sufficiency of the machine to produce it’s described effects.”

        Mr. Principle is going to rely on some extra-statutory “judical activism” now? And a total piece of shirt case from 1813 that addresses pretty much ever possible defect in a patent with petty one paragraph summations???? Too funny. What happened to your beloved Founders all of a sudden? Apparently you happily throw them under the bus when it suits you. Nobody could have predicted that.

        But more to the point: the passage you cited is not the holding of the case, but a description of the argument made before the lower court by the defendant. This is the holding:

        It is further argued, that the making of a machine cannot be an offence, because no action lies, except for actual damage, and there can be no actual damages, or even a rule for damages, for an infringement by making a machine. We are however of opinion, that where the law gives an action for a particular act, the doing of that act imports of itself a damage to the party. Every violation of a right imports some damage, and if none other be proved, the law allows a nominal damage.

        So pretty much the opposite of what you contended above. Nice try, though.

        In any event, I didn’t make the composition I described for the purposes discussed in Whittemore. I made it for completely different purposes. It’s a salt solution, after all. There’s lots of uses for sulfate salt solutions. I just made a bunch more by the way, and put it all in 500 milliliter bottles. I wonder if they each infringe? Each composition is the same, remember.

        So answer the question: Let’s say I send you 250 mls of the solution and keep the rest here. You test half of it on a patient and you get a “positive” result. I test half of it on a patient and I get a “negative” result [i.e., the limitation in the claim is not met]. So is your composition infringing but my identical composition is non-infringing?

        A simple yes or no followed by your explanation will suffice.

        It’s always an option, of course, to simply admit that relying on functional language for patentability creates all kinds of problems for the public.

        Going back to your assertion that “a philosophical experiment” is a defense to infringement: what’s a “philosophical experiment” exactly? Am I allowed just one experiment? How long can the experiment go on? Am I allowed multiple trials to determine if the results are reliable? What if the elements of the claim are each written in functional language (like typical computer implemented junk) and, according to you, the patentee, and all your bottom-feeding grifting friends, the claim is enabled upon description of the function? Exactly what sort of “philosophical experiments” can I perform without infringing your claim, according to your earlier espoused theory?

        1. You seem confused about the point I made (showing one of the experimental use defenses – in law) with a different argument that I was not ever making.

          Move the goalposts back and try again.

        2. So pretty much the opposite of what you contended above. Nice try, though.

          Are you saying that there are no defenses along the lines of experimental use, Malcolm?

          None?

          Are you really saying that?

          what’s a “philosophical experiment” exactly?

          Maybe you should read the Whittemore case with the intent to understand, instead of just looking for soundbytes.

        3. going to rely on some extra-statutory “judical activism” now? And a total piece of shirt case from 1813

          In case you missed the memo, in the time period of 1813, Congress has allowed the courts some nose of wax leeway.

          That leeway was removed in 1952.

          You might want to get these facts straight and not try to kick up so much dust.

        4. LOL! Tr0llb0y gets the holding of his case axx-backwards and calls me a chump. When he’s called on his error, he not only fails to acknowledge that he stuck his foot in his mouth but instead launches into further insults.

          Nobody could have predicted that a path0l0gical liar would behave this way.

          What a freakin t 0 0 l.

          1. Did I say my quote was the holding?

            That would be a NO.

            Pay attention – I gave you a cite for the proposition – which is what you asked for. Thus no error. No lie. no foot stuck in mouth. In fact, you are in the spotlight now to defend the notion that there are no defenses along the lines of experimental use – funny how you have not bothered to answer the question, and instead seek to kick up dust and proclaim yourself (red) Queen of the world…

            Try to contain your spin to just a little bit of accuracy, as I note that you have failed to answer my questions and requests for citations from you (instead giving the bland excuse of ‘I don’t need a cite for every legal proposition I make.’)

            1. LOL – gee, did you use the wrong word again and get all excited for nothing, while still avoiding providing any answers that were asked of you?

              (and yes, that is a rhetorical question)

            2. When he’s called on his error, he not only fails to acknowledge that he stuck his foot in his mouth but instead launches into further insults.

              LOL – a lovely bunch of AOOTWMD.

            3. “Good lord what a freaking psycho.”

              Actually I think that the need to be right was more a symptom of OCPD wasn’t it? The psychopathy might be indicated by the lying before that, but the declaration of “no error” is more simple need to be right.

              “Friends and family are often under serious strain because the OCPD individual must be in charge and the only one who knows what is right”

              Yep.

            4. “For a person with fully-developed OCPD, actions and beliefs are either completely right or completely wrong, and they are always right. Because of this, interpersonal relationships are difficult as the person demands too much of their friends, partners and children. ”

              And yep again.

            5. I see the Chump Malcolm has run away from the conversation.

              Again.

              Stooping to spread his lies on “holding” in another thread, yet refusing to answer the points put to him.

              So typical of the coward.

    2. btw, love the spotlight of your self- FAIL by posting this right up on top – mighty considerate of you to supply the laughter (at you, not with you) with such easy access.

    3. further, it’s called a defense – there a few limited ones and they do not take away from the context in patent law known as ‘strict liability.’

      Why don’t you know these things?

  4. “wherein the composition does not produce any clinically significant electrolyte shifts”

    So, scope of enablement. Which compositions are enabled by the specification by a PHOSITA? And throw in there the doctrine of equivalents and you have the scope of the claims. Look at the accused composition. Would it take more than routine application of known techniques to invent the accused composition? If yes, then no infringement and the claims are too broad.

    LazardTech is the proper way to police claim scope. It is fair and logical. You are entitled to what you have enabled. If you claim scope is too broad, then you end up with invalidated claims.

    Please, try to apply real patent law. Try to be real patent attorneys and agents and not a Lembot.

    1. Night, if the claimed subject matter is not enabled, then certainly too the claim is indefinite because it does not particular point out and distinctly claim the invention. The Supreme Court has indicated that when claims are overbroad, they have both problems.

      But the Supreme Court has made a stand – that when a composition is claimed in terms of the results it achieves, rather than in terms of what it is, the claim is inherently indefinite. It makes no difference whether one of ordinary skill in the art would know how to construct the claimed invention and test it to see if it has the claimed result. The claim must specify the structure or steps that will yield the claimed result.

      In the present case, the claim compositions ranges were not effective to achieve the claimed the result in all cases. Once this was made clear, the claim was invalid under both 112(a) and (b).

      But the patent office never should allowed the applicant to distinguish the prior art based upon the claimed result when the claimed compositions themselves were disclosed or obvious over the prior art.

      1. Ned,

        Your over reading habits are suspect.

        I do not question the Supreme Court (well, I do, but in a different manner) – I question your version of the Supreme Court.

    2. NWPA Would it take more than routine application of known techniques to invent [sic] the accused composition? If yes, then no infringement and the claims are too broad.

      What your analysis fails to acknowledge is that the typical claims that present problems are claims such as the one at issue in this case which, absent the functional limitation, cover a gazillion different compositions and, with the functional limitation, still cover few zillion compositions. Each one of those compositions may be trivially easy to make (I just made one right now, using readily purchased salts, for an entirely different purpose than that described in the claim) but it’s absurd to require me to perform the applicant’s arbitrary clinical test on the “effectiveness” of the solution to discover if my solution infringes the applicant’s composition claim. The act of preparing the solution for testing is itself an infringement, unless I can show it’s reasonably related to some future FDA submission. So I have to risk infringement in order to determine if I infringe? That seems a bit unfair, to put it mildly.

      Note that this is a different problem than that which plagues so much of the computer-implemented junk that’s out there. All of the structures in the typical computer-implemented junk claim are old — the computers, the processors, the transmitters, the receivers, etc — including their connectivities. All that’s “new” is the information that is being received, “processed” and spat out. To the extent there is any objective physical structure that is novel, it’s described nowhere. Such claims do not protect or promote any new technology; they simply limit what the public can freely do with existing technology, in exchange for the mere identification of that specific potentiality (where the generic information processing functionality of computers has been understood for eons, in patent terms).

      1. The act of preparing the solution for testing is itself an infringement, unless I can show it’s reasonably related to some future FDA submission

        Not true. It is not considered infringement to make to see if the claim is actually reached.

        And this is not the only reason either.

        Why don’t you know this?

      2. MM, still the specification enables a PHOSITA to make the compound. I have a reverse question for you: if the claims are not valid, then what claims would be? Are you saying this is simply not the type of invention that can be eligible for patentability?

          1. LOL – just a funny feeling?

            When (if ever**) has Malcolm provided a straight-up, intellectually honest answer to anything?

            **-without torching one of his agendas, as in when he volunteered the admission as to knowing the controlling law of the exceptions to the judicial doctrine of printed matter.

        1. if the claims are not valid, then what claims would be

          Claims that describe the composition in objective physical terms. As was already pointed out, the claims granted in the EP are much more sensible (they look a lot like claim 16 in the corresponding US case).

          1. in objective physical terms

            Do you feel that Orthokinetics is described in “objective physical terms?”

            What are “objective physical terms?

            Do you recognize that your “absence of functional terms” simply does not accord with US law?

            Further, are these US-law-acceptable terms in relation to the person having ordinary skill in the art to which the invention pertains?

            (did you notice the almost prescient emphasis I had been giving that part of the law prior to this decision coming out?)

            granted in the EP” – LOL refresh for yourself the importance of actually applying US law, my friend.

      3. absent the functional limitation, cover a gazillion different compositions and, with the functional limitation, still cover few zillion compositions.

        So you seem to be saying that the same problem would exist without functional language…

        Each one of those compositions may be trivially easy to make

        You want what? you want it to take a flash of genius? What part of the last sentence of 35 USC 103 do you not understand?

        they simply limit what the public can freely do with existing technology

        LOL – like what people could freely do with electrons, protons and neutrons….?

        What is the difference again between three resistors in series and the same resistors switched to be in parallel…? Something witty about a car seat…?

        What is it that you mean by “specific potentiality“…? Sounds like gobbledygook and dust-kicking to me.

  5. While I would personally prefer to see a knife fight, the CAFC could probable get better results if they just arm wrestled or flipped a coin.

        1. Wow – Cliven again pulls a Malcolm…

          (note that only two people ever have been chastised and had posts pulled for N word usage – guess which two)

  6. For the record, the reexamination, 90/010316, was owner initiated. Claims 1 and 6 were amended to add the limitations about electrolytic shift, and specific ranges of solutions. Here are the reasons for “allowance” in the NIRC:

    “the prior art of record, namely Morishita, Russell, Nissho, Giuliani, and Martindale, fail to teach or fairly suggest a composition comprising from about 100 ml to about 500 ml of an aqueous hypertonic solution, wherein the solution comprises an effective amount ofNa2S04, an effective amount of MgS04, an effective amount of K2S04, wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.” (emphasis in original)

  7. This case was already decided in the much more interesting context of glue, see Holland Furniture v. Perkins Glue 277 US 245 @ 257.

    “One attempting to use or avoid the use of Perkins’ discovery as so claimed and described functionally could do so only after elaborate experimentation. Respondents say that laboratory tests would be insufficient and that “the best and probably the only satisfactory test is to try it out on a large scale in a furniture or veneering gluing factory.” A claim so broad, if allowed, would operate to enable the inventor who has discovered that a defined type of starch answers the required purpose to exclude others from all other types of starch and so foreclose efforts to discover other and better types. The patent monopoly would thus be extended beyond the discovery and would discourage rather than promote invention. The Incandescent Lamp Patent, supra, 476. That the patentee may not by claiming a patent on the result or function of a machine extend his patent to devices or mechanisms not described in the patent is well understood.”

    When one has to submit studies for a fact finder to determine if they are infringing, the underlying patent is invalid.

    1. What about Funk Bros. as well?

      All three salts of the composition were known laxatives. Effective amounts of each were known. Combining them in a solution is not invention per Funk.

      The invention, if any, lay not in the combination, but in such combinations and that were both effective for purging and for not inducing electrolytic shift.

      The defendants proved that there were many combinations in the claimed ranges that were effective for purging but that induced electrolytic shifts. Thus either the claim is way overbroad — it claimed an invention not enabled.

      This cannot be that hard to figure out. Why in the world the defendants did not make the argument is a wonder.

      1. You’re correct, but it’s important to understand I’m going down a different road than you.

        There are case-specific facts which would find this claim invalid. What I am saying (and apparently what Prof. Crouch is saying) is that this entire type of claim is always invalid.

        The statutes require the patentee to inform the public of what is his invention. When the invention turns on an effect or result and the effect is not readily apparent at the time of making, it creates a negative effect on the public because it chills valid competition. Nautilus (which is argued next week) has the same problem: Post facto it’s entirely possible to determine whether an article infringes or not, but nobody could know at the time of making whether it infringed.

        The CAFC’s current test, which simply requires that the scope be ascertainable and if the accused product fits within the scope, is insufficient in giving effect to the full requirement of the law. The patentee must inform the public of what structures are foreclosed from them, so that the public need not brave infringement to find a noninfringing alternative. That’s the essence of pointing out and particularly claiming.

        Its not hard to figure out how it came to be either – In Wabash the court said that limited use of functional language to describe inherent properties is okay (see @ 371-372) but that was in the context of well-known functional properties of old things. Over time, the CAFC has drifted so far from that that we have this case here, where it’s the distinguishing characteristic from the prior art, that the entire point of the Supreme’s words is lost.

        It ties in greatly with the general prohibition on functional claiming. It’s not just that in this case it’s unenabled and undescribed, it’s that in virtually all cases it’s unenabled, undescribed and indefinite.

        1. The patentee must inform the public of what structures are foreclosed from them, so that the public need not brave infringement to find a noninfringing alternative. That’s the essence of pointing out and particularly claiming.

          Um, “structure’ is not your magic elixir (one way or the other).

          And lose the Latin – it paints you as a 1 L.

          1. Not understanding that strict liability is only a characterization of the required mental state paints you as a dropout. Was your school accredited?

            But I’ll explain using smaller words: If one of skill in the art reads your patent and still doesn’t know what things they can and can’t make, you’ve got an invalid patent. The idea that once something is made you can test it and see if it falls into a class is not an acceptable standard for determining definiteness.

            Let’s say the defendant instead came to the court in a declaratory action: “I intend to make a compound comprising 100mL of X, 200mL of Y and 200mL of Z, decide if I infringe these claims.” A resolution would be utterly impossible. The case necessarily turns on dueling expensive studies of a compound the court would have to essentially immunize someone to allow them to make. The law doesn’t tolerate that disincentive on the public, it just declares the patent indefinite and moves on.

            1. Not understanding the context of the use of the term “strict liability” in the patent setting – and then lecturing others on an incorrect understanding paints you as an @$$.

              You are trying too hard to sound impressive in an area of law that you really just do not know.

              If one of skill in the art reads your patent and still doesn’t know what things they can and can’t make, you’ve got an invalid patent.

              Nice strawman. You might though want to emphasize that “one of skill in the art”portion though. You know, for others that also seem not to recognize what that means.

              The idea that once something is made you can test it and see if it falls into a class is not an acceptable standard for determining definiteness.

              More than a slight problem with that is the notion of inherency – you might want to think about that. Your simply assuming the conclusion that you want to have (not acceptable) does not make it so.

              the court would have to essentially immunize someone to allow them to make” LOL – actually you are wrong on this as well. You probably have not gotten to the point in your 1L studies yet on the possible non-infringing ability to “make” to verify that the invention does what it claims to do.

              You keep on wanting to sound impressive and all that you are doing is highlighting that you really do not know patent law.

              You are pathetically wrong and doubly so for bragging about it.

            2. You keep on wanting to sound impressive and all that you are doing is highlighting that you really do not know patent law.

              He makes way more sense than you do, nutcase.

            3. Anon, “The idea that once something is made you can test it and see if it falls into a class is not an acceptable standard for determining definiteness.” [Quoting RandomGuy]
              More than a slight problem with that is the notion of inherency – you might want to think about that. Your simply assuming the conclusion that you want to have (not acceptable) does not make it so.

              Actually anon, it is the holding the Supreme Court in Perkins Glue – which makes Dennis’s opening post exactly on point. Defining a claim in terms of an effective result without the details in the claim that ineluctably achieve that result is indefinite.

              It is not simply a matter of whether you can construed a claim to determine whether a claim is indefinite, but whether one of ordinary skill in the art would know whether they infringed before they constructed and tested the product. RandomGuy is exactly on point.

              To the extent that the Federal Circuit is not enforcing Perkins Glue, then the matter should be taken up to the Supreme Court.

            4. thout the details in the claim that ineluctably achieve

              You over-read the case (again) Ned.

              It is black letter patent law that the fact that some experimentation may be required does not mean a claim is indefinite.

              Your over-reading would change that completely.

            5. anon, that is why ranges and things like “substantially” can be placed into claims. The Supreme Court is also said that in the nature of the case if one cannot precisely define the scope of the claim, one can add in the skill in the art such that the person of the ordinary skill in the art would appreciate what he has to do to achieve the result.

              Thus an effective dose is probably not indefinite because doctors know what that is.

            6. Ned,

              Do you realize that your post at 11.1.1.1.1.6 directly contradicts your post at 11.1.1.1.1.4?

              In other words, your last post affirms that I am correct.

              Thanks.

          2. To respond to 11.1.1.1.1.1 – There is no inherency. It is subject to effects upon a particular patient or a group of patients (depending upon the construction). As I pointed out in my example, it’s entirely possible that a mixture is effective on one person and the very same mixture is ineffective on another person. It has a fixed (inherent) structure, but that structure does not have an inherent effect. This isn’t even a situation where a machine sometimes works and sometimes doesn’t (and thus sometimes infringes, making it an infringing article) as the dissent argues, because every particular article is different and is consumed upon a single use. So it doesn’t even meet the wrong standard that the CAFC uses.

            Nautilus will again show this quite soon for you. If you were right, Nautilus would infringe because one can post-facto determine if a structure inherently substantially cancels out the EMG (even though there was little to no guidance as to what structures actually achieve that effect in the patent). We’ll see if the Supreme Court finds that to be the proper test, won’t we?

            “You probably have not gotten to the point in your 1L studies yet on the possible non-infringing ability to “make” to verify that the invention does what it claims to do.”

            That exception goes to experimentation for further development and it isn’t in play here. Even if it were, you’re suggesting that the public pay a tax (the cost of the experimentation) to determine whether the scope of the invention reaches their action, but that’s a burden the law specifically forces the patentee to bear before the patent issues. The patentee must make clear what is protected or there simply is no protection.

            What I am talking about the commercial making, using and selling of a product where it is impossible to determine if there is infringement on that particular article until the use is exhausted and the product ceases to exist. You make a mixture, you administer the mixture, it will either shift electrolytes in the patient or it won’t, and infringement turns upon that. If your argument that the exception applied was accurate there would be no case here, as the infringer would be immunized under the experimentation doctrine because the experimentation is necessarily patient-specific (i.e. every commercial use would also be an experimental use, and infringement could never be found). Obviously that isn’t the law.

            1. It has a fixed (inherent) structure, but that structure does not have an inherent effect.

              You are not talking about what is actually claimed though.

              Move the goalposts back.

            2. What I am talking about the commercial making, using and selling of a product where it is impossible to determine if there is infringement on that particular article until the use is exhausted and the product ceases to exist

              Nice goalposts moving. Can we move it back now?

        2. Random, describing well know properties of the prior art is totally acceptable — it is the novelty of the thing that cannot be claimed in terms of its properties or results or functions.

          Rich and crew really screwed the pouch in Swinehart and Donaldson.

          Just one more time: Halliburton not only condemned functionally claiming the point of novelty. That case also demanded that old elements as well be claimed structurally. While this is just dicta, it is an important reason the patent bar went into a panic, in addition to the open question of whether a novel combination could be functionally claimed.

          The language of the current statute did not start out that way. It first was proposed as a modification to 103, and without any construction clause. This suggestion was not received well on the Hill, nor in the patent bar as a whole. The modification where means plus function was permissible was added to 112, but no one at the time thought it was in any way a derogation on 112(2) that excluded claiming the novel feature in terms other than its properties or functions or results. No one intended to overturn not only Halliburton, but Wabash Appliance, United Carbon and Perkins Glue. The only way to reconcile this is to observe that MPF are allowed, but not at the point of novelty.

          This is entirely consistent with the Supreme Court cases, consistent with Halliburton’s holding, but with not its dicta. The clause clearly was intended to allow claiming of old elements functionally, and no more.

            1. anon I will bet you that Halliburton will be spoken or cited approvingly with respect to its functional claiming logic in Nautilus.

              The abrogated part of Halliburton is only the claim construction part with respect to 112, 6th, and you cannot cite any statute passed by Congress that states otherwise. Congress has endorsed the Halliburton (large prohibition on) functional claiming logic.

            2. “The abrogated part of Halliburton is only the claim construction part with respect to 112, 6th, and you cannot cite any statute passed by Congress that states otherwise. Congress has endorsed the Halliburton (large prohibition on) functional claiming logic.”

              Nah bro, that’s just the way it looks to the everyday bystander who is not a federal circuit judge with a pro-patent agenda.

            1. Correction:

              Not all [ ] functional language is within 112, 6th

              And that is the key.

              112(f) is STILL not written in mandatory language.

              And that my random examiner friend is the law as written by Congress. While you struggle to seek out and find some endorsement, I will use the very words of Congress.

              (I like my position way more than yours)

            2. At 11.1.1.2.3.18-19 AAA JJ nails the critical weakness in the Ned/6/Malcolm Mooney,

              LOL! Patent Jeebus has spoken.

              Bow down, everybody.

              As if I’m going to scroll around to find out what Mr. Impeachment has to say today. LOL!

            3. “As if I’m going to scroll around to find out what Mr. Impeachment has to say today. LOL!”

              Except that you did exactly that. And then when I schooled your sorry examiner a$$ you ran away and hid. Like you always do.

              LOL!

          1. The point made in 11.1.1.2 is supported and amplified in Frederico’s comments, where he said about 112(f):

            “The language does not go so far as to permit a so-called single means claim, that is a claim which recites merely one means plus a statement of function and nothing else. Attempts to evade this by adding purely nominal elements to such a claim will undoubtedly be condemned. The paragraph ends by stating that such a claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. This relates primarily to the construction of such claims for the purpose of determining when the claim is infringed (note the use of the word “cover”), and would not appear to have much, if any, applicability in determining the patentability of such claims over the prior art, that is, the Patent Office is not authorized to allow a claim which “reads on” the prior art.”

            Note here that Frederico recognizes that claims nominally could appear to be combinations. His formulation clearly excludes claims where novelty is in the one element.

            Second, he states flatly that the novelty cannot be in the functional expression.

            THIS was the intent and understanding of Congress, and it is flatly inconsistent with the CCPA’s and the Federal Circuit rewriting of the intent of congress to allows claims to be functional at the point of novelty. NOTHING could be further from the truth.

            1. His formulation clearly excludes claims where novelty is in the one element.

              ONLY in the context that he is discussing: single means claims.

              Your over reading needs to be corrected.

            2. And this is why I poke you in the eye with your PON and the Diehr case.

              You want to scramble in the Diehr case to stutter out that there is no PON or that the PON is the claim as a whole – which is basically saying that PON is a canard.

              You do this because the obvious “Point of Novelty” (as you would use the term) is a computer program – the very thing that you have a crusade against. To adhere to your own consistent views, you then must admit that either PON is a canard or that computer programs are perfectly patent eligible.

              Either way, you die at Diehr.

              This too is something that I strive for you to be consistent at – on the record – before the decision in Alice comes out.

            3. anon, claims where novelty is in the one element is effectively a single means claim. That is why Frederico was talking about nominal elements.

            4. anon, PON is a concept developed especially for functional claims.

              Diehr had no PON, so talking about claims as a whole in that case made no sense. The math itself was, in fact, OLD — one of the old elements.

              However, novelty is essential when determining eligible subject matter. Consider the book (a manufacture) with a new recipe. The book is old, the recipe is new and non obvious over other recipes. Here, 101 looks at the novel subject matter, the recipe, and finds it ineligible. Thus, such cannot be used to distinguish over the prior art.

              Another way of putting this, Mayo, is that the added subject matter, the book, is conventional. Ditto the computer in Benson.

              Diehr suggested the novelty of the ineligible subject matter is irrelevant. Indeed, this is true, lest the discovery of a unknown product of nature could by that discovery render the claim eligible. But, when the only thing that distinguishes the claim from the prior art is ineligible, it makes no difference whether the ineligible is known or unknown.

            5. claims where novelty is in the one element is effectively a single means claim

              LOL – you die at Diehr with that statement. In Diehr, the only ‘novelty’ was the computer program. The only thing is what you (and you outside of the Supreme Court case – do you need my quotes to you from Benson and Flook – try to paint as ineligible. Repeat after me” We do not so hold.

              Once again Ned – read my post at 11.1.1.2.2.3.

              Read it slowly if you must, but you are hung on your own petard here. You must choose to be consistent. You cannot NOT have PON in Diehr just because it is not convenient for you.

              Further, your book example violates the exceptions to the judicial doctrine of printed matter. It is a no-go and you already know this because I have already pointed this out to you. It is rather intellectually dishonest of you to attempt (yet again) a known fallacy.

              Face it Ned – your position cannot be maintained in any intellectually honest manner.

            6. A further problem with your incorrect “effectively statement is that it is YOU now attempting to create a bastardized and particularized patent law.

              To wit: a perfectly eligible claim can be comprised entirely of NO novel elements.

              None.

              Your attempt to create some dependency on a particular novel element and claim that if there is a single novel element, then THAT is the critical point, cannot wash with the fact that NO critical point is required at all.

              PON is a canard in how you are attempting to use it.

            7. I am sorry anon, you try too hard.

              PON was raised in cases like Wabash Appliance. It has to do with functional claiming.

              Faulkner v. Gibbs recognized that a combination claim where novelty was in the combination did not violate the rule. I have never said otherwise.

              If the novel subject matter in a claim is ineligible, however, the claim as a whole is not eligible if the ineligible subject is not applied to produce a new or improved result. See, Benson, Flook, Diehr, Myriad, Mayo, et al. They are all consistent on this point.

            8. It is not I that tries too hard Ned – all that I am doing is pointing out to you the logical contradiction that your own views create.

              You need to square your own views – and you cannot do so by wishful thinking and closing your eyes to your very own PON 101 discussions just because the Diehr case places you on the horns of a dilemma between choosing to maintain your “PON” view and admitting that a PON of software is plainly patent eligible or fully admitting that PON is a canard.

              Those are your only intellectually honest choices my friend.

              The only thing novel in Diehr was the thing that your crusade impales itself upon.

              I offer you this chance to contemplate your own logical contradiction in advance of the Alice decision. Remember what is on record in that decision and remember what was stipulated. I am not looking for an immediate reply from you Ned – take in our recent 101 conversations fully. Realize why you have switched your views in those conversations. Then slowly step through why your views here on 101 result in your contradictions. It will be when you open your own eyes and realize why I have been right, then you will be able to set your crusade aside.

            9. Lol finally! After many years I’m finally able to pinpoint the source of anons tardation rearding “point of novelty” and why he always starts sht with people about it. In this thread it has become clear how normal people use the term and how anon uses it and why that leads to conflict between views stemming from application of pon.

              Anon uses pon to mean “the point at which the claim introduces something altogether novel, never before seen or described in the world.” Thus anon likewise thinks the only pon in diehr is the comp program.

              However, ned and the rest of the world instead use pon to mean “the point at which the claim diverges from that which was shown in specific reference x (or specific references x1, x2,x3 etc.). So, to ned and the rest of the world,diehr has a pon for each reference of record. And they may be different for all the different refs. Though in common use ned and everyone usually simply mean the pon from the closest ref since there is usually one ref ( or an assortment of refs all showing the same thing) that is closest.

              As per usual, the vast majority of his conflicts he creates regarding pon can be boiled down to nothing more than anon having made up his own special definition for the phrase.

              Only took five years or so to identify your tardation on this subject anon, but I’m glad its finally out so that perhaps you and others can stop fighting about sht simply because you’re using different language. You and ned can try your discussion using those more precise definitinos of what pon may mean and you’ll likely be at least closer to agreement.

            10. LOL – “finally”…?

              Um, 6, this has been my consistent stand over these lo many years.

              And they may be different for all the different refs.” – truly bizarre 6 – far too shallow. PON as a legal concept is not so limited as to being the difference between any one reference and the claim under consideration. That is merely the starting point.

              That you only now have this dawn of revelation is more a factor of you finally waking up (at least in some small way).

            11. 6, I really do not know what anon is talking about half the time.

              I reference the Supreme Court cases in Perkins Glue, Wabash Appliance, Halliburton, etc. I say, THAT is what I am talking about when I refer to PON.

              Then he says that Diehr has a PON when not a single soul anywhere else agrees with that. Just take a look at the claim and see just how many novel elements there are over the prior art. A lot. But one of the few claim elements that is not new is the math, not even when computed with a computer. That is old. But that appears to be what anon says is new, when it was not new.

              Conversing with anon at times is borderline ins*ne.

            12. Anon,

              Can I talk you into sharing your views on why the thermocouples described in Diehr would not be considered a point-of-novelty?

              For reference:
              constantly determining the temperature (Z) of the mold at a location closely adjacent to the mold cavity in the press during molding,

              Thanks in advance,

              Dobu

              Opinions are not [necessarily] facts.

            13. Just take a look at the claim and see just how many novel elements there are over the prior art. A lot

              Name them.

              Each individual item you list was individually old in the art.

            14. Dobu,

              Thermocouples were old in the art.

              Not sure what you are looking for beyond that.

              What a thermocouple does is constantly provide a signal.

              The placement of thermocouples was also old in the art.

              (btw, the “not necessarily” in your byline is cute – ambiguous as to what point you might want to be making, but cute)

            15. Anon,

              My understanding is that embedding thermocouples in the molds to monitor the temperature of the curing rubber was not “old in the art”, and that Diehr‘s computer was for processing the data resulting from the thermocouples via A-to-D converters.

              I don’t have a cite, but I’m pretty confident computers have been used to monitor chemical processes prior to the Diehr patent.

              I was looking for your take on why the addition of the thermocouples to the rubber molds could not be considered a point-of-novelty. If you assert that that would be “old art”, well, then, question answered.

              [And the “not necessarily” in the byline is there because some posters on this blog are extremely contentious. Not pointing any fingers, though.]

              Thanks for the response.

              Dobu

              Opinions are not [necessarily] facts.

            16. Thermocouples were old in the art.Not sure what you are looking for beyond that.What a thermocouple does is constantly provide a signal. The placement of thermocouples was also old in the art.

              Looks like Tr0llb0y is finally getting close to admitting that Diehr’s claim was, and is, a complete piece of junk.

              That’s an important step towards understanding why Diehr is ultimately a sideshow of little lasting importance to the question of the eligiblity of computer-implemented claims, except for the trivial proposition that the mere presence of ineligible subject matter in a claim does not render the claim per se ineligible.

            17. “However, ned and the rest of the world instead use pon to mean ‘the point at which the claim diverges from that which was shown in specific reference x (or specific references x1, x2,x3 etc.).’ So, to ned and the rest of the world,diehr has a pon for each reference of record. And they may be different for all the different refs. Though in common use ned and everyone usually simply mean the pon from the closest ref since there is usually one ref ( or an assortment of refs all showing the same thing) that is closest.”

              So if I have a claim to an apparatus comprising A, B, C, D, and E, and prior art reference 1 shows an apparatus comprising A, C, D, and E and prior art reference 2 shows an apparatus comprising A, B, C, and D, what is the “point of novelty” of the claim?

            18. Dobu, your understanding is wrong.

              LOL on the contentious – is that another way of saying that you were wrong on certain facts in certain contexts, and decided that being overly pedantic was not a winning strategy….? ;-)

              Malcolm, your “claim is CRP” mantra is wrong.

              why Diehr is ultimately a sideshow of little lasting importance to the question of the eligiblity of computer-implemented claims

              LOL – the return of the pre-Bilski, the death of Diehrbots mantra from Malcolm. Funny how even Malcolm’s dance-a-jig-9-0-Prometheus case lauded Diehr as the case most on point and not changing any of that case’s holdings….

            19. 9-0-Prometheus case lauded Diehr as the case most on point and not changing any of that case’s holdings….

              Right, dipshirt, but that’s because the Supreme’s cite Diehr for its trivial, non-controversial holding and not for your Dierhbot fantasy that the mere recitation of an eligible element means the entire claim is therefore eligible.

              Here’s the Supreme’s citing to Diehr in Prometheus: “(“[T]he prohibition against patenting abstract ideas‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant postsolution activity’” (quoting Diehr, supra, at 191–192)). (cited three times)

              (“[A] new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made”). <–note: "may be patentable", not "is patentable" or "is eligible." Again, trivial stuff.

              And lastly they rejected the government's position that claim limitations can be ignored in an 102/103 analysis. They quoted Diehr, but Diehr was simply quoting from 35 USC 103. In other words, they flushed your beloved "printed matter doctrine" down the toilet. Non-structural limitations reciting "information" are not to be ignored under 103, but examined under 101 for eligibility (where secondary factors are irrelevant). Did the Federal Circuit and the PTO get the memo?

            20. So if I have a claim to an apparatus comprising A, B, C, D, and E, and prior art reference 1 shows an apparatus comprising A, C, D, and E and prior art reference 2 shows an apparatus comprising A, B, C, and D, what is the “point of novelty” of the claim?

              Failure to identify the elements makes the analysis somewhat difficult. Let’s try the following. Here’s the elements in your claim:

              A: plug
              B: “new” instructions on side of apparatus
              C: motor
              D: on/off button
              E: wherein machine creates bubble-free hard candy from peanuts

              You’ve got prior art teaching ACDE? Your claim is ineligible because your element B is the point of novelty and it’s ineligible subject matter (alternately, it’s obvious by reliance on the Fed Cirs printed matter doctrine).

              You’ve got prior art teaching A,B,C,D? Your claim is an ineligible attempt to claim a function because it fails to recite corresponding new structure. Or its invalid under 112.

              It’s pretty straightforward stuff, folks. We all know why the patent teabaggers want to pretend that it’s somehow unworkable. But it’s not. Dont worry though: you’ll eventually be forced to “get it.” And then you’ll cry about the “gestapo.” LOL!

            21. Per Wikipedia (yeah, I know . .. “consider the source”) on Diamond vs. Diehr:

              The problem was that there was, at the time the invention was made, no disclosed way to obtain an accurate measure of the temperature without opening the press.

              In any event, it seems to this layman (with an interest in patent law) that a claim’s PoN can, in some cases, require considering the entire claim before it becomes novel.

              Regarding “… you [Dobu] were wrong on certain facts in certain contexts …
              That wasn’t really the intent. I was intimating the possiblity that some contributors who hold their opinions as incontrovertibly established facts might, hope springing eternal, form an opinion that coincides with reality. (Note: I freely admit I make at least my share of mistakes, which might include the just-mentioned intimation.)

              Kindest Regards,

              Dobu

              Opinions are not [necessarily] facts.

              P.S.: I’ve been reading up on the Printed Matter Doctrine. So, software is ineligible until it’s in machine-readable/machine-processable, “functional” form? Geez. Loopyness epitomized.

            22. Ned:

              “6, I really do not know what anon is talking about half the time.”

              I totally know what you mean. It’s because he makes up bizarro terms and bizarro definitions for normal everyday terms. I mean, he’s a whiz at computers (at least from his bio), but as to language, the man is just … I don’t even know how to say it. There is certainly no word for his bizarre mix of tardation/lack of basic education/lack of experience/lack of ability to understand what others are trying to convey to him/desire to control what others are trying to convey to him to make whatever they’re trying to convey fit in with whatever he wants them to be saying. It’s just a big bunch of crazy mixed into one big cluster f.

              I hate to sit around and talk about him when he’s like right there, but I’m currently letting him take a break.

              Dobu:

              “Can I talk you into sharing your views on why the thermocouples described in Diehr would not be considered a point-of-novelty?”

              “Thermocouples were old in the art.”

              See? He wants the PON to be what I’ve stated he wants it to be. To anon, a PON cannot be something that was old, at all. Of course in reality, the PON for each claim is a novel feature over each given reference, considered by each one after another. And of course this can also include novel never before seen things wholly unknown before the application. And this is a routine occurrence for all properly issued claims, even if, as in some rare cases, the PON is the claim as a whole and nothing else.

              Maybe if people other than anon just started calling the PON the “point from which the claims diverge from each individual reference” on PO then anon would calm the f down and stop starting fights about this all the time and instead address what the speaker is trying to tell him.

            23. “Geez. Loopyness epitomized.”

              What you’re talking about is called the “draftsman’s art” and the USSC is finally catching on that it has taken a death grip on patent law and needs to be broken up.

            24. “So if I have a claim to an apparatus comprising A, B, C, D, and E, and prior art reference 1 shows an apparatus comprising A, C, D, and E and prior art reference 2 shows an apparatus comprising A, B, C, and D, what is the “point of novelty” of the claim?”

              There are technically two PON’s. For ref 1 it is B. For ref 2 it is E. But generally whoever is speaking will simply refer to one of them, (also generally speaking you won’t typically have a lot of refs one element away from the claims where the elements away differ from ref to ref, but it does happen) whichever they feel is associated with whichever reference they subjectively feel is the “closest prior art” even though both refs are technically one element away from anticipating. So in everyday language you’ll most likely just see someone say it’s E since the second reference follows right along ABCD and just lacks E.

            25. “You’ve got prior art teaching ACDE? Your claim is ineligible because your element B is the point of novelty and it’s ineligible subject matter…”

              and

              “You’ve got prior art teaching A,B,C,D? Your claim is an ineligible attempt to claim a function because it fails to recite corresponding new structure.”

              You got a cite to support any of those incredible feats of analysis? (Really hard to believe that you svck at this even more than we all imagined.)

              Let’s make it real simple, so simple that even you should be able to understand it, although the hypothetical unfortunately won’t include any protein bits or DNA fragments, but try to follow along as best you can.

              Here’s the elements of my claim:

              A: plug
              B: rectifier
              C: motor
              D: on/off button
              E: inverter

              So using the “explanation” from examinertard 6 the “point of novelty” of the claim with respect to prior art reference 1 is the rectifier (element B), and the “point of novelty” of the claim with respect to prior art reference 2 is the inverter (element E).

              Examiner Mooney, rectifiers and inverters are well known structures as would be understood by anybody who didn’t/doesn’t spend their life in their mommy’s basement “cloning isolated DNA strands” or whatever it is you did/do or claim to have done or do now.

              So the question for Ned, or anybody else, is: what if I write the claims so that element B (the rectifier) and/or element E (the inverter) are recited as mpf terms (e.g. means for converting AC to DC and/or means for converting DC to AC)? Is the claim indefinite under 112, 6th (or f or whatever subsection it is now)? If so, why?

            26. AAA JJ, the claim is indefinite if the PON is claimed in terms of function, results or properties.

              If the novelty is in the combination, the patent is not invalid even where the claim elements are functionally claimed. Faulkner v. Gibbs.

              Thus a claim to an old combination A, B, C and D cannot be distinguished from the prior art (showing A, B, C and D in combination) by its function, etc., in a wherein clause reciting results or properties or the like

              The Halliburton claim was of the form A, B, C, where the combination was old. All elements were MPF as was the apparent style of the age.

              C was the only element that was new, and it simply claimed a result. In effect, this was a single means claim as the other elements were old in combination.

              Held: violated the RS statute that is analogous to 112(a) and (b).

              In the case at bar, apparently all the salts were known laxatives, and a claim to specific combinations and solutions defined over the art — see the European claims for example. However, the applicant in the US distinguished the prior art because of the functional limitation. Thus it qualifies as the point of novelty, and, as such, the claim is indefinite.

            27. ” what if I write the claims so that element B (the rectifier) and/or element E (the inverter) are recited as mpf terms (e.g. means for converting AC to DC and/or means for converting DC to AC)? Is the claim indefinite under 112, 6th (or f or whatever subsection it is now)? If so, why?”

              That’s going to depend on what you have in your specification. But presuming you did your spec up just fine I don’t see the problem. Though Ned I’m sure will he has quite the thoughts on 112 6th.

              Throughout this thread my focus is not so much on 112 6th as it was on anon’s usage of the term PON and how it differed from the ordinary usage.

            28. they flushed your beloved “printed matter doctrine” down the toilet

              LOL – not even close Malcolm. Besides, as we both know, the critical part is the exceptions to the judicial doctrine of printed matter – not the judicial doctrine of printed matter itself – we’ve gone over this before.

              <–note: "may be patentable", not "is patentable" or "is eligible." Again, trivial stuff.

              The funny thing continues to be how you simply don’t grasp what you are calling “trivial.” Funny thing is how it is you that slips back into conflating patent eligibility and patentability so often. Funny thing how you continue to ignore that all three branches of the government have recognized business method and software patents. Funny how even “your side” and Perry put on the record that certain such patents are without a doubt both patent eligible and patentable.

              And lastly they rejected the government’s position that claim limitations can be ignored in an 102/103 analysis.

              I think you are confused about the government’s position in the Prometheus case – in fact you were aligned with that “whatever approach that the Court rejected. Funny how you conveniently forget that little detail.

              They quoted Diehr, but Diehr was simply quoting from 35 USC 103.

              Wrong – but try again.

              Did the Federal Circuit and the PTO get the memo?

              LOL – you tell me as you were the VERY FIRST ONE jumping up and down and dancing a jig with the link to the PTO take on the Prometheus case, or don’t you remember that supreme embarrassment when you posted that link without bothering to read what that takeaway was, and how that takeaway gave ZERO credit to your little pet theory, and instead relied on integration as the keystone?

              How could you not remember these things?

            29. 6’s myopia continues with “ my focus ” and not realizing that I am criticizing Ned’s (mis)use of that term as he uses it in his 101 canard style.

              Wake up 6 – you need to recognize just who is misusing the term, and why.

          2. anon, since the “functional at the point of novelty” aspect of the Halliburton did not originate Halliburton, but is the rule developed in cases such as Perkins Glue, Wabash Appliance, could you tell me and everyone else here what it is about Halliburton that was abrogated.

            Just want to note for the record that the Supreme Court did not disagree with the lower courts that the claims to find a new combination. The first two elements of the claim defined the existing Lehr and Wyatt apparatus. That apparatus provided the means for inducing, and measuring, sound waves in an oil well. Tuning apparatus, namely a tuned acoustical resonator, in a sound detecting device which measured distances, had been invented by Tucker. Thus without the details of the Walker tuning apparatus, the combination claimed was a combination, each element of which was old. The only novelty disclosed, the particular tuning structure invented by Walker, was not claimed. The Supreme Court held the claims indefinite. Was this clearly wrong?

            Again, what about Halliburton was abrogated? The requirement that claims particular point out and distinctly claim the invention? The requirement the claims not be functional at the point of novelty? What?

            1. Again, what about Halliburton was abrogated?

              When you are able to understand that it is you that needs to answer that question, you will be on the road to understanding many other cases; such as Nazomi.

            2. The requirement the claims not be functional at the point of novelty?

              LOL – what was the point of novelty in Diehr?

              (and please, do try to be consistent in how you treat the claims)

  8. Prof. Crouch, can you clarify this statement: “Now, although patent law does not require that the accused have intented to infringe the patent, the acts that eventually resulted in infringement must have been intentional.

    As far as I know, there is no concept of ‘intentional’ in any shape in direct infringement. There is no ‘oops, I did not intend to do that act/element’ get out of infringement card.

    1. Here’s a tip for future defendants and Federal Judges who are apparently easily blinded by excessive dust being kicked into their faces: composition claims must be construed (and should be written) in objective structural, physical terms.

      You can’t define a composition or an apparatus by what it does to a person. Such limitations are meaningless unless there is an art-recognized or otherwise defined relationship between the effect and some objective physical descriptor corresponding to the stated effect.

      When courts are confronted with terms like “in an amount effective to” the first step must be to determine exactly what that amount (or range of amounts) is. They can look first to the claims themselves for guidance, then to the specification, then to extrinsic evidence and expert testimony. But the goal has to be a determination of the objective physical identity of the composition. How else can scope and validity of a composition claim be established without doing this? When courts don’t do this, we end up with ridiculous metaphysical arguments like those in this garbage case.

      Just learn how to construe claims, litigants and judges. Better yet: USPTO please learn how to force applicants to write composition claims that aren’t hand-waving crap. Thanks.

      1. unless there is an art-recognized or otherwise defined relationship between the effect and some objective physical descriptor corresponding to the stated effect.

        LOL

        LOL LOL LOL ,

        no wait,

        LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL LOL

      2. “How else can scope and validity of a composition claim be established without doing this?

        Easy. Was the accused amount effective? If so, then it was withing the claimed scope.

        Was there prior art indicating any amount of X was effective? If not, then the claim to an effective amount is valid.

        1. Easy. Was the accused amount effective?

          Whether it’s “easy” or not would seem to depend on how “easy” it is to (1) make a composition with the recited structural characteristics and (2) determine whether the recited “effect” is achieved (or not) by that particular composition.

          Let’s say the recited “effect” is that the “composition maintains electrolyte balance in a human for 24 hours in zero gravity.” You think that’s “easy”? You think that’s fair to the public to describe a composition in that manner?

          I think mine is the better rule. I’m not surprised that you’d favor a rule that promotes bottom-feeding and the expenditure of potentially hundreds of thousands of dollars in research and/or legal fees to determine what is actually covered by a claim.

          1. “Let’s say the recited “effect” is that the “composition maintains electrolyte balance in a human for 24 hours in zero gravity.” You think that’s “easy”? You think that’s fair to the public to describe a composition in that manner?

            I think mine is the better rule. I’m not surprised that you’d favor a rule that promotes bottom-feeding and the expenditure of potentially hundreds of thousands of dollars in research and/or legal fees to determine what is actually covered by a claim.”

            I think if you are in the zero G colon purgation business, then yes, it is easy for you to mix a solution of the three salts and test it for electrolyte balance for 24 hours at zero G, because you already have zero G monkeys or rabbits and a zero-G-matron in the lab ready to go.

            Also, the claims give you fair notice to stay out of the particular salt cocktail business. Any mix of those chemicals in water that is worth making (because it is effective and maintains balance without the other nasty chemical) has been claimed. Accordingly, there is no point in experimenting to poke at the boundaries because if you are on the safe side of the boundary, the solution you have will not be effective or wont provide balance to the force. I’m sure that t is the case whether you are looking at claim 16 or 15, so there is no point in whining about claim 15.

            1. Les, the better rule is to leave the effect entirely out of the claim. It should be ignored for patentability purposes. Its presence in the claim that otherwise describes the steps or compositions complicates proving infringement because one must conduct the fricken test on each subject, or get some concession that the result happens in every case.

            2. .Les, the better rule is to leave the effect entirely out of the claim. It should be ignored for patentability purposes

              Ned – you realize that you are contradicting yourself given what you said above as to what doctor’s (or to broaden the concept, what any person having ordinary skill in the art to which the invention pertains ) can figure out, right?

        2. “Easy. Was the accused amount effective? If so, then it was withing the claimed scope.”

          That doesn’t determine what the scope is, that simply determines if Y suspected thing (“it”) is “within” the scope.

          That also doesn’t determine if X (Or X1, X2, X3 etc.) in the prior art that has no indication of whether X was effective or not actually is effective. And if old X is effective in reality then you’re granting a patent on that which is old because someone told you something new about it. Of course the only way to investigate this situation is to go and make X (along with potentially X1, X2, X3 etc. for all suspected compositions in all potentially relevant refs) potentially costing a gazillion dollars.

          Yeah. Not a good rule of thumb. And not one liable to be adopted in bio anytime soon. Just because you guys get away with it currently in the softiewaftie arts doesn’t make it good for other arts.

          1. “That also doesn’t determine if X (Or X1, X2, X3 etc.) in the prior art that has no indication of whether X was effective or not actually is effective. And if old X is effective in reality then you’re granting a patent on that which is old because someone told you something new about it. Of course the only way to investigate this situation is to go and make X (along with potentially X1, X2, X3 etc. for all suspected compositions in all potentially relevant refs) potentially costing a gazillion dollars.

            Yeah. Not a good rule of thumb. And not one liable to be adopted in bio anytime soon. Just because you guys get away with it currently in the softiewaftie arts doesn’t make it good for other arts.”

            What are you talking about? The “effective amount” language is as standard a phrase in drug claims as “comprising” is in other claims.

            Also, any examiner that finds any flavor of X, even if it is used as a shoe polish, would reject claim 15 under 103, if not 102, on the theory that one of ordinary skill in the art of colon purgation clearly wears shoes and would have been motivated to try to use shoe polish as a purgation catalyst because its handy (he keeps in it the bottom draw of his desk, just in case he ever gets a data) and it smells bad enough to make one gag, so, why wouldn’t it work at the other end of the digestive system too, therefore there are no unexpected results.

            Of course the Office Action wouldn’t be so detailed or articulate, it would just say

            Obvious cause stuff works and its late, wants go home, so try…court said.

            1. What are you talking about?

              LOL, Les, 6 is clearly confused. He wanted to play a smart@$$ jibe at the “softy-wofty” arts, not realizing that his position there is trounced by the bio arts.

              The hypocrisy of those denigrating the software arts, yet wanting ‘nothing to be wrong in our backyard’ is in the spotlight here.

            2. What I’m talking about is exactly what I said. What you proposed does not determine the scope of the claim as you asserted. Instead what you propose simply determines if y is within the scope. Nothing more. Specifically one thing your proposal does not do is determine if old solution x does achieve purgation.

              The language may well be standard, and that may be how examiners treat such language. I express no opinion on that just yet. The issue before us is how your proposal leads to absurd results where some claims will eventually sqiggle around 103 where no proper vetting under 102 was even carried out since nobody knows whether old composition x does z. Whereas mm’s proposal, that just so happens to be in line with the law, avoids that absurdity.

            3. If that’s what you are talking about, then why did you say:

              “And not one liable to be adopted in bio anytime soon. Just because you guys get away with it currently in the softiewaftie arts doesn’t make it good for other arts.”

              effective amount HAS been adopted in “bio” and WAS so adopted way before the softiewaftie arts existed.

          2. “effective amount HAS been adopted in “bio” and WAS so adopted way before the softiewaftie arts existed.”

            Yeah I wasn’t talking about “effective amount” not having been adopted in bio.

            I was talking about your approach to determining the scope of claims and subsequently applying art. And, to the extent that approach has been adopted in bio, or anywhere outside of software, as it appears the judges decided to do here since nobody harped on it in the case (poor lawlyering), those wishing that approach to be adopted in their case will still need to deal with the copious amounts of caselaw to the contrary when some adversarial party takes the time to bring that caselaw up.

            That said, I’m not sure that approach was actually adopted in this case, I haven’t looked far enough into the case to see what the prior art disclosed etc. etc.

      3. “Better yet: USPTO please learn how to force applicants to write composition claims that aren’t hand-waving crap.”

        Would be loads easier if we simply had a statute setting all that forth instead of the old school sht we have to use from the stone ages of the 1950’s and beyond.

        1. 6, do not you find it surprising that we have to resort to pre- ’52 case law that claiming a result is inherently indefinite?

          Recall the Arbeit case that was overruled by Donaldson? That case prevented anyone from distinguishing the prior art based upon results, properties, or functions. Had that case, Arbeit, been applied in the present case, the specific compositions that were known to be effective would have had to have been claimed rather than all combinations that produced a specified result.

          1. “the specific compositions that were known to be effective would have had to have been claimed rather than all combinations that produced a specified result.”

            Which would also just so happen to be proper for promoting the useful arts so that others could still come in and make their own distinct compositions/solutions that did the same thing.

    2. Excellent point, anon.

      The problem with this case is that the prior art was distinguished on the basis that it caused electrolyte shifts. Thus, if the claimed composition is administered within the parameters of the claim, it must not cause electrolyte shifts — otherwise the claim simply is invalid.

      How the invention can be distinguished over the prior art on a basis which is demonstrated to be in fact not enabled is where we are at. But this might be as must a problem of bad representation as anything, as it does not appear that the defendant raised the issue below.

    3. Strict liability is a qualification of the mens reus. The actus reus must always be met. The alleged infringer has no more control over the effect that the compound will produce in any given individual than a person who hits someone by an involuntary spasm, or who fails to reduce his car speed because the car brakes fail. If one were to write a patent that turned on someone tripping and falling down, there’s an argument that the patent would be unenforceable.

      In this case, I believe Prof. Couch is pointing to the fact that the same actions may be deemed infringing or uninfringing based upon the effect/result, which by definition cannot be known until the other acts are committed, and then only by happenstance.

      Giving patentable weight to the effect/result is problematic because though it may limit the people who the patentee can recover from, it in fact chills the public as if the effect limitation was not present (since they have no control over if the effect will occur, the real scope is just the steps, not the effect).

      1. I believe Prof. Couch is pointing to the fact that the same actions may be deemed infringing or uninfringing based upon the effect/result, which by definition cannot be known until the other acts are committed, and then only by happenstance. Giving patentable weight to the effect/result is problematic because though it may limit the people who the patentee can recover from, it in fact chills the public as if the effect limitation was not present (since they have no control over if the effect will occur, the real scope is just the steps, not the effect).

        Just a friendly reminder folks: this is a composition claim, not a method claim.

      2. pointing to the fact that the same actions may be deemed infringing or uninfringing based upon the effect/result

        No. Action either infringes or not. Period.

        1. For any given composition, it will be effective for some patients and for others it wont. This kind of composition exists in a schrodinger’s cat-like situation where it is both infringing and non-infringing until it is tested on patients, which by definition can’t occur until it is made. Further, the testing doesn’t even really solve the problem, since it’s more a statement of the random grouping of the patients than the result.

          Let’s say you and I make the same compound, the same one. I test it on 30 people and it’s effective. You test on 30 and it isn’t. Have we both infringed ON THE COMPOUND (at the time of making)? Has one of us? Have neither? The state of the compound is both infringing and non-infringing, and our possible infringement occurred before anyone could prove it was infringing. The actual result of this case is that the claim is invalid, but I doubt you’ll see it that way.

          The court granted summary judgment of infringement on a clearly invalid claim.

          1. Don’t quit your day job Random Examiner, um, wait – maybe you should quit that job if you are bringing this type of analysis to it.

    4. There is no ‘oops, I did not intend to do that act/element’ get out of infringement card.

      Equity would seem to provide such a card for liability purposes anyway.

      If someone attaches or spills something to/on my shirt without my knowledge, I might infringe some claim as a result of that act. But nobody is going to get any money out of me for my “infringement”, even if I unknowingly obtained some benefit from that “infringement.” I mean, you can certainly try to get damages, if you want to be a pr*ck. But you won’t win.

      1. would seem to

        LOL – because equity is a consideration in a validity determination…
        No wait – it is not.

        D’Oh ! (said in the best Homer Simpson tones)

      2. if you want to be a pr*ck.

        LOL – because enforcing patent rights is like the second worst thing ever (right behind having patent rights…)

        /eye roll

  9. There is a potential procedural problem with this case.

    1. The term “patient” was construed adversely to the defendant on appeal.
    2. The court confirmed a finding that the patent was not invalid as indefinite based on “purgation.” The issue of definiteness based on “patient” has not been litigated.

    Has the defendant waived a defense of indefiniteness based on “patient?” What about enablement and written description — as it seems that there is no guidance on how one can administer the composition to a patient and avoid electrolyte shift. The composition does not do what is claimed, and the novelty appears to be in the “without electrolyte shift.”

      1. anon, the convention wisdom is that the Federal Circuit was formed precisely to overrule Supreme Court cases such as Sakraida — by way of ignoring the precedents of other circuits which were the source of the problem and inferentially ignoring Sakraida.

        It is amusing to note that the District Court that held the claims at issue in Sakraida to be “obvious” was the Western District of Texas.

        But back to Stratoflex: “Judge Boyle said “synergism” is “a symbolic reminder of what constitutes nonobviousness when a combination patent is at issue,” and that under “either standard (Graham analysis or synergism) the combination … simply lacks the unique essence of authentic contribution to the Teflon art which is the heart of invention.”

        A requirement for “synergism” or a “synergistic effect” is nowhere found in the statute, 35 U.S.C. When present, for example in a chemical case, synergism may point toward nonobviousness, but its absence has no place in evaluating the evidence on obviousness. The more objective findings suggested in Graham, supra, are drawn from the language of the statute and are fully adequate guides for evaluating the evidence relating to compliance with 35 U.S.C. § 103. Bowser Inc. v. United States, 388 F.2d 346, 181 Ct.Cl. 834, 156 USPQ 406 (Ct.Cl.1967). Judge Boyle treated synergism as an alternative consideration. Hence the error of its analytical inclusion is harmless in view of Judge Boyle’s employment of the Graham aids.

        The reference to a “combination patent” is equally without support in the statute. There is no warrant for judicial classification of patents, whether into “combination” patents and some other unnamed and undefined class or otherwise. Nor is there warrant for differing treatment or consideration of patents based on a judicially devised label. Reference to “combination” patents is, moreover, meaningless. Virtually all patents are “combination patents,” if by that label one intends to describe patents having claims to inventions formed of a combination of elements. It is difficult to visualize, at least in the mechanical-structural arts, a “non-combination” invention, i.e., an invention consisting of a single element. Such inventions, if they exist, are rare indeed. Again, however, Judge Boyle’s inclusion in her analysis of a reference to the ‘087 patent as a “combination” patent was harmless in view of her application of Graham guidelines.”

        The court never mentioned Sakraida. Nor is its discussion of “synergism” and combination patents at all consistent with the Supreme Court analysis. The discussion of the Federal Circuit here essentially is a strawman argument, ignoring the thrust of the Supreme Court opinion in order to ridicule it.

        Moreover in the final analysis, the Supreme Court in Sakraida held that the claims were obvious to one of ordinary skill in the art.

        1. Single means claims are distinctly different than combination patents Ned.

          Do you really want to eliminate this distinction – and throw out even your over-reading version of Frederico?

          Let me know.

          Just like (exactly like) your attempted PON in 101 contexts, you cannot have this both ways and use it only when it is convenient for you and ignore it when it is not convenient for you.

          1. Anon, again you elevate the formal from the substance.

            The point of the court in Halliburton was that the only novel element in the claims was claimed functionally. This WAS a single means claim.

            One can mask any single means claim by adding conventional elements around it. THAT is Frederico’s point.

            It is fricken amazing, anon, that you refuse to get this simple concept.

            1. elevate the formal from the substance.

              No Ned – it is you – as you are the one that wants to hold conflicting views based on your convenience of the moment.

              Single means different than combination claims – yes or no. Frederico in or out.

              Choose one stand and stick with it.

              (and please do not try to quote abrogated cases – that is not an ethical legal move)

  10. Someone please draft and share with us a claim for this invention which solves all of the noted problems.

    1. If by the “noted problems” you mean the construction of “effective”, “patient” and the functional feature, what about this:

      A composition for use in inducing purgation of the colon of a patient, consisting of a volume of between 100 ml and 500 ml of an aqueous solution wherein the solution comprises between 2 grams and 40 grams of Na2SO4, between 2 grams and 20 grams of MgSO4, between 1 gram and 10 grams of K2SO4, and between 0.1 gram and 50 grams of PEG.

      (taken from one of the granted claims of the European family member, which means this is a formulation which was good enough for the patentee as well)

  11. Dennis I see this case as highlighting the most critical and problematic problem with our patent system – that patent claim scope is intentionally ambiguous and malleable. Consistent with the subject matter of the invention, this case may potentially serve as a trigger for cleaning-out the patent system.

    Funny stuff, D.

    I read this case yesterday … or tried to slog through it. What an incredible mess. Is the Federal Circuit simply incapable of rising above the situation when garbage like this presents itself? Are they to blame or is the seemingly awful work of the defense team to blame (they may still escape liability on remand but it doesn’t appear that any of the results to date were due to any clever or coherent strategery)?

    Here’s the “representative” claim:

    A composition for inducing purgation of the colon of a patient, the composition comprising from

    about 100 mL to about 500 mL of an aqueous hypertonic solution comprising an effective amount of Na2SO4, an effective amount of MgSO4, and an effective amount of K2SO4, wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.

    Note that this is a composition claim. Removing all the garbage about intended use and the desired result, we’re left with the following limitations:

    100 mL to about 500 mL of an aqueous hypertonic phosphate-free solution comprising Na2SO4, MgSO4, and K2SO4

    This reads (or comes close to reading) on a tall glass of phosphate-free seawater. It’s very difficult to believe that in the massive literature concerning sulfate salt solutions that there isn’t art teaching such a composition (or a similar composition), for some purpose. Why the excessive focus during examination and, apparently, in litigation, on colon-cleansing art alone?

    The excessive reliance on the term “effective” in the context of a composition claim like this is also absurd, as it is surely the concentrations of the salts that are responsible for the composition’s stated utility. How can it be left to the public to determine what those concentrations are?

    Here’s claim 16 (not asserted, presumably because it’s not infringed…?), which gives us some idea of the breadth of claim 15:

    16. A composition according to claim 15, wherein the solution comprises between about 2 grams and about 40 grams of Na2SO4, between about 2 grams and about 20 grams of MgSO4, and between about 1 gram and about 10 grams of K2SO4.”

    When we consider the limitations regarding volume in claim 15, we discover that each of the named salts can vary in concentration by several orders of magnitude (e.g., the magnesium sulfate concentration in claim 16 can vary between roughly 30 mM and 3M)! It’s absurd. And this is the narrower dependent claim. To make matters worse, both claim 15 and 16 are open-ended, such that any number of other solutes can be present (except phosphate) and you still infringe.

    Given that the claims require the solution to be “phosphate free”, I wonder why the defendant simply didn’t add some very small amount of phosphate to its solution. Then we’re even closer to seawater territory. Let the patentee try to argue “equivalents” and open the art up even further.

    In case anyone is wondering, these salts are all readily available for purchase anywhere and have all kinds of uses. Does anyone really believe that the patentees possess the exclusive right to make any of a zillion different solutions comprising these three common salts for any of zillion different purposes? Because they allegedly discovered that that a few very specific solutions purge one’s bowels? Give us a break.

    1. MM, I agree.

      Also consider that the claims require, but specification does not teach, how one can have an effective amount without any electrolyte shift.

      I would think the patent is invalid under both 112(a) and (b). This would be a nice candidate for a motion for summary judgment along these lines on remand.

    2. or tried to slog through it

      You had to try to slog through a mere 24 page opinion….

      Isn’t this stuff in your backyard?

    3. “Does anyone really believe that the patentees possess the exclusive right to make any of a zillion different solutions comprising these three common salts for any of zillion different purposes?”

      No. There is only one covered purpose: for inducing purgation of the colon of a patient.

      I believe: effective amount language is allowed in the chemical (and especially medical arts) because the effective dose varies from patient to patient.

      Nevertheless, the correct amount of Crestor does indeed get ones cholesterol in the target zone.

      Accordingly, the variability in biologic response should not bar one from patenting newly invented miracle drugs.

      1. There is only one covered purpose

        Composition, apparatus and article claims are not limited to any one “purpose.” Composition X “for the purpose of cleaning fingernails” is anticipated by composition X in the prior art, regardless of why composition X is used. Likewise, if the art teaches similar composition Y and suggests modifying Y to achieve X, then X is prima facie obvious, regardless of its allegedly new “purpose.”

        1. Likewise, if the art teaches similar composition Y and suggests modifying Y to achieve X, then X is prima facie obvious, regardless of its allegedly new “purpose.”

          Are you sure of that “prima facie” thinking there?

          I think otherwise.

          You need several other factors (think Graham) to reach the obviousness case – especially in other art fields than which the person having ordinary skill in the art to which the invention pertains would be placed.

          1. It doesn’t matter what the applicant’s “stated purpose” for the composition is. All that matters for the prima facie case of obviousness is the identity of the claimed composition and its relationship to the prior art.

            Here’s a simple example to help you understand. I claim “A composition for teeth cleaning, wherein said composition comprises MgSO4 and peanuts.”

            The prior art teaches peanut butter. Another piece of art teaches that very small amounts of any sulfate salt will improve the taste of peanut butter. Because a person of ordinary skill in the art of food preparation would be motivated to make the claimed invention, a composition comprising peanuts and MgSO4 salts is prima facie obvious.

            I think In re Dillon (Lourie writing for the en banc court, with Newman (LOL!), Cowen and Mayer dissenting) is the classic case on point: “[I]t is not necessary in order to establish a prima facie case of obviousness . . . that there be a suggestion or expectation from the prior art that the claimed [invention] will have the same or a similar utility as one newly discovered by applicant.” Same case: “This court, in reconsidering this case in banc, reaffirms that structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, creates a prima facie case of obviousness . . .”

            People do forget this quite often. Unfortunately, those people often include Examiners, crappy defense lawyers, and Federal Circuit judges.

            1. It doesn’t matter what the applicant’s “stated purpose” for the composition is. All that matters for the prima facie case of obviousness is the identity of the claimed composition and its relationship to the prior art.

              LOL – wrong.

              The stated purpose matters for the identification of the art to which the invention pertains.

              This very much matters when it comes to the world of prior art that obviousness deals with.

              The classic case (as mentioned) is Graham.

            2. If you think In re Dillon was wrongly decided or has been overturned, you’re free to believe that. The cited passages from the case seem pretty clear and straightforward.

              If I was your client and came to you with the claim I described, and you found the prior art I described, would you ignore In re Dillon and encourage me to spend thousands of dollars prosecuting the claim?

              The stated purpose matters for the identification of the art to which the invention pertains

              The applicants newly discovered “purpose” (usually deriving from a newly discovered “property”) may affect the obviousness anlaysis in some instances, depending on the composition and the prior art elements to be combined.

              But the blanket proposition that prior art must be directed to the problem of concern to the applicant was addressed and wisely rejected by the en banc Federal Circuit in In re Dillon. Newman acknowledges as much in her dissent when she describes the majority’s holding: “[P]rima facie obviousness of new chemical compounds and compositions is determined based only on structural similarity to prior art compounds and compositions having a known use.”

              Like I said, it’s a classic case and one that every defendant in every chem/bio case (and other art units as well) should be very, very familiar with.

            3. LOL – from the guy who proudly boasted that he started a business (knowing patents in the art field) and chose not to bother to check out any patent coverage,, his ‘concern’ for clients is, um, touching…

              (also the guy that advised not to pay loss in a court decision…)

            4. Shorter Tr0llb0y: “You’re right about In re Dillon, MM. I wish I could apologize but that’s inconsistent with my abnormal psychiatric profile.”

            5. That’s pretty psycho to have me talking about In re Dillon when I did not do so.

              You also misapply the case – and leave out the Graham factor that I shared (and that wrecks your blind attempt to use “In re Dillon: you have to first get into the art filed that applies to the person having ordinary skill in the art to which the invention pertains – (that’s kind of important).

              Like I said, the classic case (as mentioned) is Graham.

        2. Anticipation is not an issue. You were addressing what is covered by the claim. What is covered by the claim is the range of mixtures used for colon cleaning.

          You are free to use the mixture as a brush cleaning solution when art time is over in the rest home.

  12. Here is the claim in questions:

    15. A composition for inducing purgation of the colon of a patient, the composition comprising a small volume of an aqueous hypertonic solution comprising an effective amount of Na2SO4, an effective amount of MgSO4, and an effective amount of K2SO4, wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.

    If the accuse infringers solution included those three chemicals and does not include phosphate and it did not produce any clinically significant electrolyte shifts in one patent, then clearly there is one count of infringement.

    If the argument is that the same solution does not usually work so well and in the face of one example of where it did, they can show that it usually does not work so well, then award damages based on the one instance.

    Otherwise, at a minimum, the infringer is dancing very close to the magic ratios and volume and is infringing at least under the doctrine of equivalents. :-p

  13. I see this case as highlighting the most critical and problematic problem with our patent system – that patent claim scope is intentionally ambiguous and malleable. Consistent with the subject matter of the invention, this case may potentially serve as a trigger for cleaning-out the patent system.

    Bravo to Tourbillion for introducing this, and to me for seconding it – the usual to Malcolm for trying to denigrate our posts and poo-poo the item.

  14. Judge Moore’s “one or more patients” interpretation could also raise a potential question of whether the claim as interpreted even meets the admittedly very low threshold requirement of patentable utility, or alternatively is being given such a large scope as to exceed the scope of enablement. Since the record indicates that the problem the invention addresses is electrolyte shifts, if 99 out of 100 patients were to experience such shifts with some purging composition within the scope of the claim, I’d doubt the problem would be considered solved by that composition.

    1. Mark, I agree. The main argument for patentability was the claimed ability to avoid electrolyte shifts — a capability not demonstrated by the prior art.

      Thus, if in practice, one giving patients the composition in the claimed ranges induces both purgation and electrolyte shifts, the claim is not enabled and/or indefinite.

      I am surprised by the very low quality of the defense here if you and I are right on this.

  15. Correction: “a patent” in ¶4 should be “a patient”

    Comment: What’s the effect of “desired result” language in the chemical arts? It looks like the claim just recites a number of possible structures with the instruction to select the composition as appropriate to achieve the result. Is there any requirement that the specification direct the public as to how the result is to be achieved? If so, should that metric be used to test whether the accused product infringes? I believe these questions touch on similar issues raised by Dennis above.

    1. Assuming the specification provides no instructions on how to induce purgation without electrolyte shifts in every patient as substantially required by the claims, do we not have an insufficient disclosure problem?

    2. Bryan: What’s the effect of “desired result” language in the chemical arts?

      Same as in all the arts: a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’ See, e.g., Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)

      Given that the “desired result” language in this composition claim is achieved only when the composition is used for its stated purpose (administration to a patient), the language should be interpreted as if it appeared in a process claim (i.e., the desired result should not be “given weight”).

      1. Given that the “desired result” language in this composition claim is achieved only when the composition is used for its stated purpose (administration to a patient), the language should be interpreted as if it appeared in a process claim (i.e., the desired result should not be “given weight”).

        Got a cite for that?

        Or are you assuming that you can lump both whereby clauses and other clauses together at a whim? Keep in mind that preamble language can be given weight if such breathes life into the claim.

        1. Dear Shirtforbrains,

          You don’t need a “cite” for every logical proposition based on existing case law.

          You’re welcome.

      2. Thanks for the reply – I was thinking along the same lines. Despite the fact that your citation is with respect to methods, I do find it persuasive (though perhaps not dispositive) for composition claims as well. I think the reason the case law doesn’t directly address compositions is likely that a claim for a composition, theoretically, should describe what something is, not what something does.

  16. Here’s a third way to interpret the claims. The limitation says, “wherein the composition does not produce any clinically significant electrolyte shifts”. The court could have emphasized does not produce any, interpreting it to mean that a composition that produces a significant electrolyte shift in even a single patient does not meet the claim limitation.

    1. The counterargument would be that “clinically significant” means “having a practically important effect when considering the patient population as a whole.” That’s as opposed to “having a practically important effect on the particular patient to which the solution was administered.”

      There’s some merit to that argument. Doctors often speak of the distinction between statistical significant and clinical significance, and that’s almost always in the context of a population, not repeated trials on a single patient.

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