Promega v. Life Tech: Enablement and Open Claim Elements

By Jason Rantanen

Promega Corp. v. Life Tech. Corp. (Fed. Cir. 2014) Download Promega v Life Tech
Panel: Prost (dissenting-in-part), Mayer, Chen (author)

This decision is interesting for its enablement analysis, which revolves around the term “comprising,” and for its holding on 271(f) liability for international inducement (the portion of the opinion as to which Chief Judge Prost dissented).  I’ll write more about the 271(f) issue in a subsequent post.

A few core technical details are useful for understanding this opinion.  The patents at issue relate to DNA, and specifically to the amplification of particular “short tandem repeats” (STR) loci.  These loci are important because they can be used to create a DNA “fingerprint” unique to each individual.  These fingerprints are valuable in both criminal forensics and health sciences research.

To create these DNA fingerprints, the STR loci must first be “amplified,” which essentially means copying the DNA many times over.  While the technology for DNA amplification described in the patent (polymerase chain reaction) was well known at the time of the patent application (1994), amplifying multiple STR loci at the same time (called “multiplexing”) remained challenging.  A central problem with multiplexing was the extreme difficulty in predicting what would happen when a new locus was added to the multiplex.  The multiplex might work or it might not, depending on the interactions between the new locus, the existing loci, and primers used in the reaction.   The patents-in-suit do not purport to solve this problem generally; rather, they identify specific combinations of loci that will successfully co-amplify.

Enablement and The Use of “Comprising”: The set of claims for which enablement was an issue all contained the term “comprising” before the set of loci (not just after the preamble).  Claim 23 of one of the patents-in-suit  is representative:

23. A kit for simultaneously analyzing short tandem repeat sequences in a set of short tandem repeat loci from one or more DNA samples, comprising:

A single container containing oligonucleotide primers for each locus in a set of short tandem repeat loci which can be co-amplified, comprising HUMCSF1PO, HUMTPOX, and HUMTH01.

(The “HUM” terms refer to specific loci.)  It’s black letter patent law that “comprising” is an “open” term; in other words, the claims encompass both products that are limited to the specific elements recited in the claims as well as those that contain those elements.  Here, that meant that the claims encompassed both “products that use no loci other than those listed in the claims” as well as “any other loci combination containing those three recited loci–whether that combination includes 13, 1,1300 or 13,000 STR loci.”  Slip Op. at 7.  Life Tech moved for summary judgment, which the district court denied because “the asserted claims need not enable ‘unrecited elements.'”  Id. at 14.

Applying the concept of commensurability, the Federal Circuit reversed.  “The enablement requirement ensures that ‘the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims.'”   Slip Op. at 14 (quoting Nat’l Recovery Techs v. Magnetic Separation Sys., 166 F.3d 1190 (Fed. Cir. 1999)).

Here, the scope of the claims was not “less than or equal to the scope of enablement.”  Id.  First, the unstated STR loci combinations are not merely “unrecited elements;” “they are part of the claim scope.”  And not only are they are part of the claim scope, they are an important part.  Promega itself repeatedly argued the unpredictability point to the patent office during prosecution of the claims-in-suit to support their patentability over the prior art and during the litigation itself in defense of their nonobviousness.  “Promega explained that without a preexisting publication or teaching, a skilled artisan ‘could not predict with any certainty whether a given set of loci would co-amplify successfully together.'”  Slip Op. at 17.

These arguments proved fatal given the broad scope of Promega’s claims.  This case was similar to MagSil v. Hitachi, and Wyeth v. Abbott,  and the Federal Circuit concluded that “the teachings of Promega’s patents would not have enabled a skilled artisan at the time of filing to identify significantly more complicated sets of STR loci combinations that would successfully co-amplify–such as those found in LifeTech’s STR kits–without undue experimentation.”  Slip Op. at 18.  Ultimately, “Promega’s ‘difficulty in enabling the asserted claims is a problem of its own making.'”  Id. at 18, quoting MagSil.

So does the court’s treatment of “comprising” mean that every claim using this transitional phrase is invalid.  In a word, No.  In more words:

It is true that when used in the preamble of a claim, the term “comprising” permits the inclusion of other steps, elements, or materials in addition to the elements or components specified in the claims. [] As we stated in Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367, 1371 (Fed. Cir. 2005), open claims “embrace technology that may add features to devices otherwise within the claim definition” (emphasis added). But the relevant usage of “comprising” here is not the one recited in the preamble. Rather, it is within the specific claim limitation that lists combinations of successfully co-amplifying STR loci, combinations whose identification and discovery Promega itself asserts is a complex and unpredictable endeavor. While the term “comprising” in a claim preamble may create a presumption that a list of claim elements is nonexclusive, it “does not reach into each [limitation] to render every word and phrase therein open-ended.” [] Promega’s claims differ from customary “open-ended” claims in that Promega’s usage of “comprising” in its “open loci set” limitation, as construed, expands the claims at a key limitation in order to cover what are indisputably advances in this unpredictable art. Under the circumstances here, the numerous embodiments covered by Promega’s claims cannot be merely regarded as “unrecited elements” in a standard “open-ended” claim.

Slip Op. at 20-21.

80 thoughts on “Promega v. Life Tech: Enablement and Open Claim Elements

  1. I know this is a legally savvy group; but as a practitioner for a university tech transfer office, I’m pulling my hair out. As if the 101 patentable subject matter wasn’t enough.

    Maybe someone can clarify.
    Current judicial policy – don’t we want investments in the biotech industry because patents are making medicine too expensive?

    How do we patent unpredictable technologies – life science technologies? Use transitions with “having” or “consisting of?” How is the Patent office going to implement this? Comprising means not patentable, outside/inside the preamble?

    For example, it was almost enviable that there were more STI loci that could be found in the future, say STI loci FUTURE1.

    Primers amplifying HUMCSF1PO, HUMTPOX, HUMTH01, and the FUTURE1 would not infringe such an improvement.

    It was just a matter of finding FUTURE1 – as non-obvious as it is to find it. Isn’t the question – to what extent are we willing to allow a patent claim overlap with future specific non-obvious discoveries that contain the same concept? What if it takes 2 years to identify FUTURE1, 10 years? I thought the term of a patent was 20 years plus or minus all the exceptions.

    If this opinion is the legal standard for unpredictable innovations, there is a huge disincentive to invest in patenting prototypes. There is just enormous risk that your patent claim is too narrow or someone will come up with an improvement that will make your prototype patent useless. Isn’t the point of a patent system to set up a monopoly to spur investments in innovation? If old broad patents are causing to many problems, shorten patent term. Don’t make all the patents invalid.

  2. What is the ‘objective physical‘ structure of a claim (any claim) with even just a single ‘appropriate’ usage of the term “comprising”…?

    1. I’m not sure I fully understand the question…but, I’ll provide an example for discussion.

      I’d argue the following claim has ‘objective physical structure’:

      A compound comprising:

      h-C-C-C-h

      I’d just insert a chemical formula if I could but I don’t know how to do that in a comment. Preferably, I’d show that the C’s had two other carbons attached, but I assume one skilled in the art would know that.

      Alternatively, I could write the claim as R1-C-C-C-R2, wherein R1 is selected from the group consisting of “X, Y, Z” and R2 is selected from the group consisting of “A, B, C.”

      I assume you don’t think this has ‘objective physical structure.’

      Why?

      1. Is it that you think ‘comprising’ is sort of contradictory? I could see how in the first example ‘comprising’ is sort of meaningless because the structure is defined such that you really can’t add anything.

            1. The part where you post conclusions without analysis, I guess.

              If you want people to follow your thought process, you have to type it out. We can’t read your mind, anon.

        1. “anon”: It does not have a complete objective physical structure, now does it?

          The point is that the inventor has described his contribution to the art in objective physical terms that distinguish his/her invention from the objective physical structures described in the prior art.

          The rest of the universe in which the object resides does not need to be described.

          There can be no greater contrast between Go Arthur’s claim and a claim reciting “machine that performs new function X”.

          You seem to be trying to “argue”, in your usual oblique fashion that allows you to run away when challenged, that this latter sort of claim is somehow “equivalent” to “Go Arthur’s” claim because neither claim tells you the precise location of the electrons in their orbitals or some such nonsense. That’s a ridiculous argument. If that’s not your argument, then use the English language to tell everyone what your argument is.

          1. MM,

            Of course it is making an oblique equivalency argument. Anon will do so until the courts limit functional language… Which they will do. Then Anon will yell and cry about how the courts lack authority or some such, and that anyone who disagrees isnt entitled to be an attorney because of their oath or some such similar line of non-reasoning.

            Why feed anon’s pathology? This is anon’s game and no input by you will make anon change course… Why? Because its incredibly rewarding to anon to continue. It gets tons of little self-induced ego boosts from this blog, and your small negative input has no chance of outweighing that.

            Why bother engaging?

            1. Lovely ‘analysis’ and if course, completely wrong, as you fail to notice that I am the one asking people to join the dialogues here.

              Perhaps Dr. Freud has a phrase to capture your relentless characterizations that you employ instead of actually tackling the substantive points of law?

              (you do know how to do that, do you not?)

    1. Yeah, that claim would have problems even without the comprising issue. Assuming the preamble isn’t considered, it’s trying to claim a kit containing some stuff. Without the preamble, there’s really nothing to lend patentability to the claim.

      Does the preamble “breathe life into the claim”? It seems not, but the caselaw for preambles is incredibly confusing. One never knows when a preamble will be limiting or not. To me, the preamble does not seem limiting.

    2. Moocow: Patent-ineligible under last week’s Myriad II decision.

      Really?

      I’d like to hear your argument, with the cites to the Myriad II case that you are relying on for support. The facts here are not the same as the facts the court was dealing with in Myriad II.

      1. Per Myriad II, an oligonucleotide primer per se is not patent-eligible because its nucleotide sequence is necessarily naturally-occurring. Dyk also extended patent-ineligibility to combination claims of more than 1 such primer (the Myriad II claims were to primer “pairs” specifically claimed for use in PCR amplification). The intended use/function of Myriad’s primer pairs as PCR reagents was irrelevant.

        The Promega claim likewise is to a combination of oligonucleotide primers, each of which necessarily has a naturally-occurring sequence. Like in Myriad II, Promega’s primers are claimed for use in PCR to amplify naturally-occurring DNA sequences. Like in Myriad II, Promega claims any combination of such primers that work to accomplish the intended amplification reaction. The only difference to Myriad’s claim is that Promega’s claim combines more ‘naturally-occurring’ primers (shouldn’t make a difference – if 2 ‘naturally occurring’ primers in combination are ineligible, so should 6) and recites a generic “container.”

        Read p. 7-8 of Dyk’s opinion in Myriad II; you could substitute Promega’s claim for Myriad’s and it would track Dyk’s analysis handsomely. I really don’t see how these two cases can be distinguished but would be interested in you see a way.

        1. Moocow: The intended use/function of Myriad’s primer pairs as PCR reagents was irrelevant.

          Is there a statement to this effect in Myriad II?

          The only difference to Myriad’s claim is that Promega’s claim combines more ‘naturally-occurring’ primers

          That “only difference” is a pretty huge difference because of the logarithmic complexities that arise when primers are combined in a multiplex PCR reaction. The argument would be that Promega’s combination is key because of the unpredictablity of multiplex sequencing — a hurdle that Promega had to overcome with testing and which severely limited the scope of its claims (or should have if the PTO had been doing its job).

          Contrast with Myriad’s far broader claims which are the sort of claims that any high school kid would have drafted once he/she knew the patent-ineligible sequence “of interest” in the genome. Those claims represent the “building blocks” for sequencing methods, including multiplex sequencing (not the other way around).

          if 2 ‘naturally occurring’ primers in combination are ineligible, so should 6

          The key here is that “2 primers in combination” is the minimum number for PCR (one primer being the minimum number for initiation of polymerization by the typical DNA polymerase). A solution consisting of six primers doesn’t tie up these two “building blocks” in the same way.

          One counter-argument would be to argue that “multiplex sequencing” is itself another “building block” for learning about the genome in the same manner that PCR or primer-inititiated sequencing per se is a “building block”. But because of the factual differences and the more unpredictable nature of multiplex PCR relative to the other two methods (not to mention the more limited scope and the fact that the more basic building blocks are completely unfettered), that argument seems much less likely to succeed.

          Note that the key here is for the USPTO (especially the USPTO!) to recognize that claims to multiplex PCR combinations can’t be granted without experimental data showing that the multiplex primer combinations have the ascribed utility, i.e., they provide the desired information reliably under typical “field” conditions. In addition, both the composition claims and the method claims (almost certainly the method claims) may need to be limited to reflect the concentrations of reagents (e.g., buffers, salts) and other necessary parameters (temperature, time) required to achieve the stated utility.

          1. Perhaps the key is to realize that only a full scale working model is actually required to be submitted with a patent application…

            Oh wait, that’s not the law, is it?

  3. Max, I was struck by the other post talking about trying to attribute the right to own intellectual property as a basic human right. Apparently, a copyright infringer in Sweden, or some other misbegotten European locale, is claiming the basic human right to infringe copyrights as an attribute of the basic human right of free speech. In order to counter this argument, the copyright owners are arguing that intellectual property is a basic human right as well because statutory rights are not given very much weight when balanced against human rights.

    Originally copyrights in England were common law rights based upon the basic human right that one should own the sweat of one’s brow. I think patents would’ve developed in the same way had not the Statute of Monopolies intervened.

    1. ???

      Ned, “sweat of brow” has no place in US jurisprudence for patent or copyright.

      Not sure how you want to use a “would have” supposition in order to re-write actual history and somehow come to a current legal basis for supporting whatever it is that you are trying to put forth.

      1. Not sure how you want to use a “would have” supposition in order to re-write actual history and somehow come to a current legal basis for supporting whatever it is that you are trying to put forth.

        Was that gibberish actually produced by a human?

        1. I seriously don’t understand why you judicial activist even read. According to MM all information and information processing is the same, so what’s the point? Why don’t you just random type in letters and randomly read pages on the Internet?

          What anon said was easily understandable.

          1. What anon said was easily understandable.

            To you, maybe. But then again you two were separated at birth, weren’t you? Maybe “fish sticks” will jump in with his usual high-five (“good comment”), too. Truly informative and enlightening!

            Go ahead and explain to us what “anon”‘s gibberish “means”, NWPA. Should be easy for you.

            1. My comment to Ned about his misapplication of history to US jurisprudence now rolls three deep into the weeds…?

              Hey, I “get” RH being snippy because below I corrected his “improved” hypothetical; I even “get” NWPA smacking RH for the attempted putdown, but Malcolm, don’t you have anything better to do? I mean, you are tr011ing a tr011 attempt (and not even a very good one at that).

              P@thetic.

        2. >>Was that gibberish actually produced by a human?

          How can you tell gibberish from non-gibberish? I thought you judicial activists have taken the stand that all information is the same?

          The fact is that you guys are an incredible joke to anyone that has science education and isn’t a judicial activist. Shameful obfuscation of American patent law.

          1. I thought you judicial activists have taken the stand that all information is the same?

            Meet NWPA: the best and the brightest that Team Patent Everything has to offer.

            1. So, two insults do not a substantive response make. But then we know that to you all words are the same–just information with no meaning.

              And that machines that will replace 10’s of millions of information workers are the “lowest” form of innovation. ’cause you said so.

              1. NWPA what is your proposal for an economy with that many workers being displaced? Are we just going to go to the “minimum living expenses being paid by the gov” model advocated in some areas?

                1. Actually 6, there are a lot of people worried about what is going to happen. It doesn’t look good right now to a lot of forecasters, but you never know.

                2. Well it surely isn’t something I’d lose sleep over just now as it seems like the econ always replaces jobs lost to these sorts of things and the promised “computer revolution” always seems to be somewhat less AWESOMZSAUCE than what was promised and some people figure would happen.

                  But if such a thing does happen before I die I’d be interested in where we go from here.

                  And anon, you can feel free to repost brosef, I’ll even be interested to hear what you have to say on that issue. I don’t know why your post disappeared but perhaps you included two+ links in it and the site kicks those comments out. One link per post at a time usually.

                3. No links at all 6.

                  It was as if an invisible hand swept away the words of an American President and a phrase that captures a certain left-of-center ideology…

                4. It is nice to see that invisible hand starting to pull back on your chain anon. Refreshing actually.

                  You have gotten better from the off the walls behavior of the past, but its still pretty bad.

        3. RH: The tone could be better RH, if you wanted clarification, just ask.

          NWPA: Didn’t contribute anything to the conversation and made the tone worse.

          MM: Didn’t contribute anything to the conversation and made the tone worse.

          Anon: Didn’t actually clarify his stance, but did take the opportunity to get snippy back at RH. For the record, I knew what you meant.

          Fishsticks: I get that MM made a swipe at you, but you admit your post wasn’t informative, either?

          Happy Holidays everyone!

          Anyways… I don’t see the “Max” post you were replying to. Can you restate your point again?

          1. J, there is a blog post on the topic of corporate human rights. If you read the linked article, it is about the primacy courts give human rights in Europe — at actually appears to be a defense to any statutory right violation.

            See here: link to patentlyo.com

  4. A simple scope of enablement problem. Disclosure conveyed X, but not Y, claim directed to both X and Y, full scope is unenabled.

    I’m going to take one paragraph and use our good friend legal substitution for software context again:

    Despite the overwhelming evidence that [a different method of infringement] can fundamentally transform the [computer algorithm], Promega argues that LifeTech’s STR kits infringe its claims because any and all [algorithm] combinations that [perform the function] recited in the claims are encompassed by the claims. Promega has chosen broad claim language “at the peril of losing any claim that cannot be enabled across its full scope of coverage.”

    The VAST majority of software examiners do not understand this concept – that a single point, or even multiple points, within the scope being enabled does not end the enablement inquiry. In other words, in most examiner’s minds, the disclosure of (to use another example in the opinion) an 11% change resistor, over the industry standard <10% resistor, would singlehandedly support a claim to "a change in resistance by at least 10%." Or in Ariad's language (though Ariad dealt with WD) – there is a belief that a single species supports the entire genus.

    This is in contravention of a particular AIA form paragraph (correctly titled Scope of Enablement) and the language in the MPEP around both enablement and WD.

    There is a distinction between the two arts – namely the predictability difference. But that would only go to the nature of the further inquiry, not whether it should occur.

    Software applicants would do well to self-censor or layer their dependent claims in such a manner as to protect against scope of enablement issues such as those in MagSil.

    1. Random, is there a difference from an enablement point of view, of the following two steps?

      1. Determine price from equation X according to variable Y and Z determined in previous steps.

      2. Using a programmed process, driving a car between point A and point B, determined, where point A and point B were determined in previous steps.

      I have my views. I just want to know yours.

      1. They’re likely not the same at all. In 1, the relationship between output X and inputs Y and Z is likely known and unchanging, and you’re not interested in anything more than the result X. In 2, you are interested in more than the end because you’re interested in the process (which roads get you there faster) and the relationship (i.e. the algorithm) is likely different for different people – there is no generally accepted “best” means of determining the most efficient route.

        Things that would make it the same: If there was disagreement as to how the price should be determined in 1, or uniformity in paths in 2.

    2. RG: There is a distinction between the two arts – namely the predictability difference.

      This distinction is arguably thinner that it might appear at first glance.

      Note that in the instant case there wasn’t much doubt that someone could identify some additional primer(s) that worked in conjunction with the patentee’s listed primers, using the conventional approaches (after all, that’s exactly what the accused infringer did). What was unpredictable was the structure of that particular primer(s) — the same unpredictability that the patentee relied heavily on to obtain its patent.

      In the digital information-processing context, the relationship between the desired function recited in the claim and the actual physical structure of the “improved” device is equally unpredictable. That fact is glossed over in the software context because, at present, the recited functionality in “software” claims is blessed with a remarkable legal fiction, i.e., the recited functionality “is the essence” of the physical structure. As a result, the scope of a functionally-claimed information-processing device or “readable media” has all the “commensurality” it needs built into it.

      That’s why (until recently) obtaining a patent in the art of information information was a magical cakewalk compared to pretty much any other art on earth. You didn’t know to anything except “computers can do this if they are programmed to do it.” Has recent 101 jurisprudence changed this in any significant way? One would hope so. Regardless, the other shoe is bound to drop shortly.

        1. Anon, do you agree or disagree with the way the PTO is determining “directed to,” essentially by determining whether there is anywhere in the claim that IS nonstatutory subject matter? They are not looking for inventive concept or gist of what the invention is. They are simply looking for the presence of ineligible subject matter.

          1. Ned,

            Your ruminations carry ZERO weight until you can come to grips with what the Supreme Court actually did in Alice, wherein it was stipulated that the statutory category portion of 101 had been met.

            I have pointed out previously to you that you just engage in obvious pedantic semantics in your attempts to NOT accept what the Court has done.

      1. magical cakewalk

        Just like your ‘magic’ lack of inherency and how ‘old box’ somehow obtains a new functionality that it did not have prior to any change…?

        Like that?

        (Further, please tell me that you remember what the “ITA” in PHOSITA stands for.

        Do you need a reminder?

    3. Your post Random is not bad advice in and of itself. One should always draft carefully and make sure the legal requirements are met.

      Your (implicit) error remains your lack of appreciation for what the ladders of abstraction mean, and your odd over-reliance on some chem-style specious-genus for software code, when a higher rung simply encapsulates all of the lower level rung code because (in part) the Supreme Court themselves super-empowered PHOSITAs.

      1. and your odd over-reliance on some chem-style specious-genus for software code

        I do nothing more than quote MPEP 2161.01, titled “Computer Programming and 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph”

        I suspect that applies to software.

    4. “The VAST majority of software examiners do not understand this concept – that a single point, or even multiple points, within the scope being enabled does not end the enablement inquiry. In other words, in most examiner’s minds, the disclosure of (to use another example in the opinion) an 11% change resistor, over the industry standard <10% resistor, would singlehandedly support a claim to "a change in resistance by at least 10%." Or in Ariad's language (though Ariad dealt with WD) – there is a belief that a single species supports the entire genus."

      I'm glad to see you got around to reading about that.

      But I have to tell you that enablement is so easy in in the softiewaftie arts that such won't often concern them.

  5. Hoisted on your own canard. The canard of unpredictability. I love it. Maybe this will be useful against all the synergistic effect patents supported by hokey declarations.

  6. So what’s the alternative? If they said “consisting of” instead, couldn’t an infringer simply add something insignificant to get around it? Do we need to start playing around with “consisting essentially of” now?

    1. Ken, there are two comprising’s in the claim, one of which would cover the addition of something insignificant.

      1. I guess I can see how “consisting essentially of” in this context may protect against adding a trivial amount of some other “primer” in the “container.”

        It does seem like changing the rules, though…this kind of stuff is the reason I hope to God they never take away our ability to maintain perpetual continuation applications in every patent family.

  7. What’s the current thinking on claims that recite an open ended property or element. E. G. Original claim: Tensile strength greater than 100 MPa. Spec supports 100 200 300 with examples. Clearly 100 is enabled but is 1000, 10,000, 500billion?

    1. The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). MPEP 2164.08. Also, one of the Wands factors to consider is the breadth of the claims. MPEP 2164.01(a).

      If the claims recite an open-ended property, and the spec. and the art don’t teach one how to make and use the full scope of the materials having the recited property, then it seems that an examiner would have a good case for a scope of enablement rejection.

      Hopefully the drafter had the foresight to include some narrower ranges of values for the tensile strength in the spec. so that the applicant can retreat to one of those islands of patentability.

      That’s my two cents.

      1. That is my understanding as well but there are so many claims out there which are open ended with respect to material properties. I try to put other limitations in my specs 1-1000, 10-100, etc etc. But I see a lot which don’t do this and I worry it’s really doing the client a disservice to the client eventually the examiner or the courts going to pick up on a wildly over broad range.

  8. The CAFC picked up an important and subtle detail here, particularly in that last quoted paragraph. Another way of putting it, though:

    In this case, the presence of other loci makes the behavior of the recited loci unpredictable, so that the claim as a whole is not fully enabled for those embodiments that include loci that interfere with the recited loci in unpredictable ways.

    On the other hand, in the case where “comprising” is used more conventionally (i.e., to avoid limiting the claim so that irrelevant tacked-on items can’t differentiate over the claim), you could claim “a car comprising a stainless steel body”, and the claim scope will still be considered fully enabled, even though the claim also encompasses a stainless steel car with a flux capacitor and a Mr. Fusion.

    1. APoTU, In this case, the presence of other loci makes the behavior of the recited loci unpredictable …

      APoTU, I don’t know whether this is a scientific fact or not, but certainly was the argument made by the applicant to the PTO dozens of times in order to get the claims allowed. Therefore I don’t know whether this is properly a case of enablement or case of prosecution history estoppel. The word comprising in the claim is clearly inconsistent with the argument made to the PTO to gain allowance of the claims.

    2. Perhaps a more analogous hypothetical would be:

      X gets a patent on “a car comprising a stainless steel body.”

      Then competitor Y comes along and invents “a car comprising a stainless steel body, a flux capacitors, and a Mr. Fusion.”

      X sues Y for infringement and loses because of scope of enablement.

      1. ??

        X would not lose, as Y infringes (regardless of having ‘more,’ – you need to brush up on your improvement patent understanding)

        Further note: this is also a supporting reason why having a “working” requirement does not fit into US law – an improvement patent does not give the improver a right to the underlying improved-upon patent)

        1. you need to brush up

          How puerile. Read the case law yourself. No wonder you have so much free time to troll this board – you probably can’t get any clients.

        2. I’m with anon on this one.

          As a less ridiculous example, Pharma Company 1 develops Drug A and gets a patent on a mixture comprising Drug A and a few inactive ingredients.

          Pharma Company 2 develops a previously unknown stabilizer chemical that prevents Drug A from breaking down in the presence of ultraviolet light (e.g., sunlight). They get a patent as well, but for whatever reason, they start producing and selling a drug that combines Drug A with the stabilizer, thus clearly infringing Pharma Company 1’s patent.

          In the inevitable litigation, would the term “scope of enablement” ever come up? Doubtful. But that situation differs from the case recently decided, because additional DNA loci are expected to be added to the mix, and getting all of the loci to play along nicely is apparently considered an unpredictable challenge in the art.

  9. I would quibble with the statement:

    “It’s black letter patent law that “comprising” is an “open” term; in other words, the claims encompass both products that are limited to the specific elements recited in the claims as well as those that contain those elements.”

    Based on prior CAFC decisions, I think it is only “Black Letter Law” when comprising is used immediately after the preamble as the transition.

    1. Maybe “dark grey letter law” is more accurate.

      I do seem to recall the term being construed opposite the usual sense some time recently, although I don’t recall a very good reason for doing that. For example, the applicant didn’t expressly define the term as indicating a closed group. Maybe it was somehow “clear” that the applicant simply had no clue that the term was a term of “the patent arts,” with a recognized legal meaning, so they gave him a freebie.

      It’s an incredibly great and important idea, I think, to provide patent applicants with some formal terms (and necessarily formal rules) for writing claims, particularly for basic concepts that are necessary for the description of frequently claimed inventions (e.g., the group of possibilities which follow are the only members of the group, versus the group of possibilities which follow are the minimum necessary but others are permitted). But the rules about interpreting formal terms so they have “one meaning only” need to be followed pretty strictly or the formal terms will lose their utility. The safest bet is just to define the “formal terms” that you use in your claims, otherwise there’s a fair chance that the term will be construed differently than you wish.

    2. I think you are right, but the patentee insisted comprising was open ended here also, i.e., not meaning consisting of, because this was needed to show infringement. Somehow, they seem to think that enabling three recited loci (whatever those are) entitled them to more as needed for infringement.

      Plurality distinguishes the case where an additional element is harmless.

  10. “repeat loci which can be co-amplified”

    CAN BE. Red flag right off the bat. Permissive language. Claims are supposed to be what the invention is, not what it “can/may be”.

    “one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention”

    What the inventor regards as the invention, not what “can be” the invention and not what “may be” the invention.

    But even so the actual decision on enablement is good too.

    “Applying the concept of commensurability, the Federal Circuit reversed. “The enablement requirement ensures that ‘the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims.’” ”

    ^There’s at least one reader that will like that tidbit.

    1. At least one reader, 6? Well, me for starters.

      From when the EPC started, nearly 40 years ago, in the established caselaw of the EPO (its “White Book”) it has been an undisputed, indisputable “given”, banal, trite, that the scope of the claim must be “commensurate” (that is to say, proportionate) with the contribution to the art that is delivered by the enabling disclosure in the specification. I presume it was always the case too, in the USA, long before the EPO opened its doors for the first time.

      This “Principle of Commensurability” thing sounds very fancy though.

      Indeed it is:

      link to en.wikipedia.org

      Can two ethical values be compared, or are they incomparable, that is to say, incommensurable? Why must it be cited here? What has it got to do with asking the banal age-old question whether the Applicant is fairly claiming no more than he has enabled or is unfairly claiming more than he has enabled? Will I find my questions answered if I read the Decision?

    2. CAN BE. Red flag right off the bat. Permissive language. Claims are supposed to be what the invention is, not what it “can/may be”.

      This is the kind of short-cut analysis that is pervasive in the examining corps. “Can be” is not always a synonym of “may be” or “might be” – the meaning depends on the context. The “can be” phrase here is providing a characteristic of the short tandem repeat loci in the recited set. By the plain language of the claim, it is perfectly clear that this is a mandatory characteristic of those loci. The phrase does not recite an optional feature of the invention, and is not directed to some latent, unrealized, purpose or functionality of the invention.

      It drives me up the wall when examiner jump on “magic words” in claims instead of actually attempting to read them for what they actually say.

      1. “By the plain language of the claim, it is perfectly clear that this is a mandatory characteristic of those loci.”

        If that be so, why even bother with “can be”?

        Essentially you want it to read “which is capable of being amplified”. And that of course may lead to other issues.

        “It drives me up the wall when examiner jump on “magic words” in claims”

        You have to brosef otherwise sht falls through the cracks.

        “instead of actually attempting to read them for what they actually say.”

        I actually did attempt to read it for what it actually “says” aka “means”. And what it “means” is something that raises yet another red flag.

        1. A double “treat” from 6:

          Not only exemplifies the worst of blogging, but here the worst of examing.

          “B-b-b-but I don’t care about context, the key word I focused on means what I think it means no matter what”

          This is why First and often Second Office Actions are worthless.

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