Sequenom v. Ariosa: Invalidating the patent on Non-Invasive Pre-Natal Genetic Testing

Sequenom’s Patent No. 6,258,540 is really fascinating. The inventors (Oxford Professors Lo and Wainscoat) had previously discovered that human fetal DNA existed in small quantities within the pregnant mother’s blood plasma.  That discovery was important because it would allow for non-invasive prenatal genetic testing without risking the health and safety of the unborn child.  However, a sticking point was the difficulty in separating-out the very small number of fetal-DNA from the large quantity of mother-DNA.  That problem was solved by recognizing the fundamental genetic difference between mother and child DNA is the addition of DNA from the biological father.  With that insight the inventors were able to use 1997 PCR technology to particularly amplify DNA that included elements inherited from the father.  Those amplified nucleic acid molecules can then be tested for various potential genetic anomalies. The test (commercialized by Sequenom) is hugely popular because it does not involve sticking a needle through the placenta and the resulting significant likelihood of miscarriage.

The patent here does not actually cover the diagnostic tests done on the fetal DNA but instead covers simply the method of finding the fetal DNA in the first place.  Thus claim 1 includes two steps: (1) “amplifying” the paternal-inherited DNA from the maternal plasma then (2) “detecting” the presence of the paternally-inherited DNA.  Independent claims 24 and 25 provide some further limitations such as fractioning the maternal blood sample to isolate only the plasma.

Despite the patent, Ariosa launched its competing fetal sampling services and in 2011 filed for declaratory judgment of invalidity of the patent. On Summary Judgment, the district court agreed with the DJ plaintiff – finding the claimed invention ineligible under 35 U.S.C. 101.  That case is now on appeal before the Federal Circuit. (Docket 14-1139).

In invalidating the patent, the district court followed the two-step method of Mayo:  First finding that the presence of fetal-DNA within the maternal plasma is an unpatentable natural phenomena; and Second finding that the PCR methods used to take advantage of the phenomena used lacked sufficient inventiveness. In the patent document, the patentee had identified these methods as conventional. The court also considered preemption – and determined that the patents carry “substantial risk” of preemption because there was no evidence any of the alternative methods of finding fetal-DNA (proposed to the court by the patentee) were both available at the time of the application filing and also currently commercially practical.

In the appeal, the patentee makes several arguments:

1. Sure, it is a natural phenomena that fetal-DNA is present in maternal blood plasma DNA. However, the core invention here is the process of detecting the fetal-DNA from the blood plasma that had previously been discarded as waste and uses technology to solve the medical dilemmas created by amniocentesis.

2. The practical limits found in the the claim are themselves inventive because no-one had ever accomplished the combinations of claimed steps.

3. The PCR process actually creates new DNA molecules – this case should be analyzed under Myriad not Mayo.

4. There are several scientifically validated methods of accomplishing the goals of the invention that do not infringe the patent — thus, the claims are not preemptive.

MBHB attorney Kevin Noonan has filed an Amicus brief on behalf of BIO supporting the patentee’s position. The primary thrust of Noonan’s argument is to show a strong policy argument that this type of innovation is important and that the research should be supported by patent protection. Noonan also highlights the district court’s commercially viable” requirement as problematic and not historically required in the law. (but query the “substantial practical application” language of Benson). A responsive amicus brief filed by the genetic testing company Invitae pushes back against Dr. Noonan’s arguments and argues that allowing this type of patent will “bury” the genomics industry and that (if they were ever useful) patents are no longer needed to research in this area because of the fallen price of genetic lab work and data anlaysis. SDIPLA also filed a brief making an interesting point: Here, the diagnostic process was only found ineligible because the subject matter being detected was a natural phenomena. If instead, the same process was being used to detect the presence of a man-made compound then the test would not be challenged on 101 grounds.  SDIPLA then argues that distinction does not make sense.

In its responsive brief, the patent challenger pushes in several ways. Most squarely, the brief recognizes that the discovery of a natural phenomena may be very important, but even when a critical breakthrough, that discovery is not patent eligible. Rather, to make something patent eligible, the inventors must then take the discovery and apply it in a way that adds substantial and inventive limitations. The argument here is that the patentee’s addition (the process of detection) was well known at the time of the patent filing and offered no inventiveness.  Ariosa seemingly does not defend the “commercially viable” requirement for preemption, but does indicate that the time-focus of preemption should be at the time the patent application was filed.

The outcome of this case will be fascinating.

= = = =

  • This same case was previously before the Federal Circuit with regard to a preliminary injunction (Federal Circuit vacated lower court’s denial of preliminary relief to the patentee). That decision was written by Judge Rader and joined by Judges Dyk and Reyna. On appeal, I believe that the case will go back to Judges Dyk and Reyna with a third judge added based upon the Federal Circuit’s internal operating procedure.
  • I apologize, but I accidentally deleted the briefs (can someone email them to me?).

134 thoughts on “Sequenom v. Ariosa: Invalidating the patent on Non-Invasive Pre-Natal Genetic Testing

  1. 20

    Unfortunately, this decision can only go one way, in view of Mayo: where it was detecting a metabolized man-made product and then determining dosing based on its detection, was also unpatentable subject matter. The US Biotech industry needs to turn to Congress for help

  2. 19

    The problem I have with the two step analysis of Mayo is the dissecting of the claim into separate elements. Whatever happened to the requirement of construing the claim as a whole? It is certainly required in a section 103 inquiry, though does not necessarily apply to a section 101 inquiry. In this case, the discovery of fetal DNA in maternal blood, which one must admit is an important technical discovery and the core feature of the claim, becomes diluted in the two step approach.

    Nevertheless, I do recognize that the discovery of fetal DNA in maternal blood is a “natural occurrence”. Are isolated compounds useful in the treatment of a disease and derived from a natural source still patentable under 101?

    1. 19.1

      J.,

      I think they are construing the claim as a whole. Have you been reading any of my posts on this topic? If a claim has mixed statutory and non statutory subject matter, and the statutory is old, the claim as a whole is unpatentable…. (With the exception where the nonstatutory is integrated with the statutory in a functional manner to improve the statutory as in Diehr.)

    2. 19.2

      Good questions, J. A few thoughts in response:

      Whatever happened to the requirement of construing the claim as a whole? It is certainly required in a section 103 inquiry, though does not necessarily apply to a section 101 inquiry.

      The requirement of “construing the claim as a whole” is indeed found in 103. In part, the language prevents Examiners and judges from deciding that some aspect of a claim is obvious, therefore all the rest of the claim is obvious without any discussion of the remaining elements. It also forces judges to consider the effects of combined elements, rather than simply arguing that each separate element is old, therefore the claim is unpatentable (unexpected results and unexpected synergy must be taken into account).

      It does not, however, mean that every element recited in a claim must be given patentable weight for obviousness considerations. A few easy examples will make this clear:

      a) A recitation of “intended use” may have no patentable weight (“a statement of intended use cannot distinguish over a prior art apparatus that discloses all the recited limitations and is capable of performing the recited function,” Ex Parte Taeyong Yoon citing In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) and Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003);

      b) Precatory language such as “wherein said improvement is a non-obvious improvement” are not given patentable weight (for obvious reasons!) ;) ;

      c) Claim preambles are given no patentable weight if they fail to “breathe life and meaning” into the claim; and

      d) elements directed to subject matter that would be ineligible on their own terms can be ignored (In re Ngai, 367 F.3d 1336, 1338 (Fed. Cir. 2004 (allowing claims where the printed matter was the only novel contribution would allow “anyone [to] continue patenting a product indefinitely provided that they add a new instruction sheet to the product”, cited approvingly by the Fed Cir as recently as 2011 in In re Kao link to patentlyo.com).

      Note that (d) quite plainly imports eligibility considerations into 103 (some might call it “conflation”). Whether that’s the appropriate or not is an open question (Prometheus seems to strongly indicate that it’s a 101 question, not a 103 question) but the result (invalid claim) doesn’t change if the analysis is performed correctly.

      All that said, the eligibility concerns presented by claims like the ones at issue in this case are somewhat different from those presented by claims such as the “determine and infer” claims in Prometheus and the typical printed matter claims. I’ve already posted some analysis in the thread trying to understand/explain the 101 “problem” that was identified by the district court.

      1. 19.2.1

        MM,

        Just want to thank you for the thoughtful responses, and I agree with your analysis. A practitioner must be careful when drafting claims on the cusp of 101 and think hard on how to back up those “cusp” claims with dependent claims with some meat on the bones as you suggest. What we tend to see in the Courts, and discuss extensively in this forum are the invalidity of claims that are beyond the cusp, and really should not have been granted. It will be interesting going forward with the more stringent PTO 101 examination to see how the growing 101 jurisprudence will challenge claims that are more that an “abstract idea”. Something more than “You have to be kidding” claims.

    3. 19.3

      J: the discovery of fetal DNA in maternal blood, which one must admit is an important technical discovery

      I think your choice of words here highlights the issue, J (not sure if you intended this or not). A “natural fact” (e.g., fetal DNA exists in maternal plasma) is not itself protectable and it doesn’t matter how “technical” that fact is. The fact could be a fact about some aspect of rocket science, or a fact about your fingernail — the fact can’t be patented either way, regardless of how many children are saved by the “discovery” of the fact and regardless of how much money someone would be willing to pay to “own” the fact.

      The eligibility question(s) then becomes: does the claim add sufficient limitations to avoid the eligibility problem? Do these limitations leave enough of the “fundamental building blocks” in the public domain where they belong?

      As I discussed below, there is a genuine concern presented by claims like the claims here which broadly recite the use of old conventional technology (like PCR) to detect newly discovered “stuff” that was previously not believed to exist (e.g., fetal DNA in maternal plasma).

      Some of those concerns were already taken care of by the application of 102, along with an inherency argument. But those aren’t the only concerns. In particular, courts are beginning to recognize that if a lid isn’t put on these types of claims, then the old technology (e.g., PCR or a telescope or a microscope or an X-ray machine) becomes useless to the public as a tool for obtaining information (the whole point of PCR) because of the thousands of patents that might be infringed.

      The correct answer, I think, is to require more limitations in such claims than the recitation of the old technology and a description of what’s being “detected.” In this case, specifically, I think that the claims should be more specific about the steps used to prepare the maternal plasma for the PCR reaction and/or the concentrations of the reagents (e.g., primers) that make it work.

      It’s worth remembering again that the existence of fetal DNA in maternal sera was not a “new” concept as of the filing date of this invention. That certainly was not the “technical” advance in this case (as always I’m happy to be correct if I’ve got the facts wrong).

  3. 18

    Another interesting tidbit on this case, Dennis: in an inter partes review decision last week, the PTAB canceled a number of the ‘540 patent’s claims as anticipated. (IPR2012-00022)

    1. 18.1

      Thanks for that, boo far. It’s a very interesting read.

      From the decision, an extremely important point of claim construction: when the “detecting” step is construed in conjunction with the use of “comprising” as the transitional phrase, there is nothing in the language of claim 1 that limits the detecting step to also determining or identifying the detected nucleic acid as being of fetal origin and not being possessed by the pregnant female.

      In other words, the claimed method (in the broadest claims) is construed to cover a method of amplifying maternal that contains both paternal and maternal sequences (such DNA will be present where ordinary recombination between maternal and paternal sequences has occurred between the region targeted by the amplication primers). Thus, the method as construed by the Board is not limited to a method that amplifies and detects only sequences of paternal origin, nor is it limited to methods that

      From the decision:

      The Kazakov reference teaches that it is known that extracellular
      DNA is contained in the blood of humans and animals. Ex. 1014, 232.
      According to Kazakov, the “level of extracellular DNA increases in the
      blood of women during pregnancy.” Kazakov studied
      the sera from blood of women in both the first and third trimesters of
      pregnancy, as well as women with late toxicosis of pregnancy. Kazakov … performed PCR …. Kazakov then detected the DNA … Kazakov notes that both the cells of the fetus (trophoblasts) and the mother (cells of the endometrium and lymphocytes) may excrete DNA.

      The discussion of the obviousness of Isis’s narrower claims is also very interesting. The Board sided with Isis on those and it does a decent job, I think, of explaining why.

      Interestingly, Isis attempted to amend its claims after the district court declared them ineligible. The Board denied entry of the amendment with the following argument:

      Although we agree with Isis that an inter partes review cannot be
      instituted using 35 U.S.C. § 101 as the basis for a challenge brought by a
      petitioner…, in a motion to amend, the patent owner has the burden of demonstrating the patentability of the claims (see 37 C.F.R. § 42.20(c) . . . . in a case such as this, where the claims have been determined to be invalid
      by a district court, we decline to enter an amendment to claims where the
      patent owner did not explain how the proposed amendments addressed the
      district court’s concerns regarding the validity of the claims

  4. 17

    How about this hypothetical claim:

    A method of amplifying fetal DNA from maternal blood comprising subjecting the maternal blood to PCR using primers specific to paternal nucleic sequences.

    This claim may be obvious, but I do not think it should be patent ineligible. As argued in one of the amicus briefs, if a non-naturally occurring nucleic acid was in maternal blood and you were amplifying that, it should be patent eligible.

    1. 17.2

      That claim looks very similar to the amended claims that Isis/Sequenom tried to enter (unsuccessfully) during the course of the IPR proceedings in response to the district’s invalidation of the original claims under 101.

      The argument against eligibility would be that the prior art taught the use of paternal-specific primers for detecting the presence of paternal DNA, generally. The fact that paternal DNA exists in maternal plasma in amounts that are detectable by PCR is ineligible for patenting. The mere recitation of conventional, generic detection methods — the same methods used to make the discovery — are insufficient to confer eligibility. Why are they insufficient? Because allowing ineligible facts to be transformed into patents in this manner will tie up the basic building blocks.

      It seems to me the better solution for the applicant would be to more specifically recite limitations about the volume of maternal blood plasma needed for the invention to work. I haven’t pored through the Examples but I suspect it was more than a drop (a drop would be ideal, of course). That sort of limitation (perhaps in addition to the use of specific primers) would seem to more accurately capture the technological advance than the broader claims that have been asserted (and found anticipated in some cases). In particular, it leaves room for those wishing to design around the patent to improve the detection technology.

  5. 16

    Just curious, where in U.S. Patent Law (statute, case law, etc.) does the “principle” of pre-emption as a reason *as such* to weigh against patentability, first appear?

        1. 16.1.1.1

          And, anon2, the only thing new in the patent is the new information about father-DNA being the clue.

          Everything else is old.

          This is Funk Bros. and Mayo redux.

          Once the “information” is published, everyone and anyone, using common ordinary techniques can use that information to obtain the improved result.

          To allow patents on new information would essentially allow patents on the results of scientific investigations into the universe and how it works. If we were to allow patents of new discoveries without more, arguably we would radically retard the progress of science.

        2. 16.1.1.2

          But the only thing new here is the discovery of that father DNA is the clue.

          That is information.

          Once published, it is in the public domain. I do not believe anyone can effectively patent information even if one tried.

        3. 16.1.1.3

          But the only thing new here is the discovery of that fa ther DNA is the clue.

          That is information.

          Once published, it is in the public domain. I do not believe anyone can effectively patent information even if one tried.

    1. 15.1

      The problem Dennis is that the discovery is of a relationship between one thing and another thing a physical phenomena. That simply is information. There is no new technology involved in this discovery.

      One of the reasons I believe the founding fathers recognized that we could not patent natural phenomena is that the essence of discovery is simply information. The patent laws exists under the Constitution to incentivize the development of useful machines, manufactures, or compositions of matter. They do not exist to prohibit scientific inquiry into the universe to discover how it works. The patents would then not only not promote the development of useful inventions, but would arguably retard the progress of science.

      However, that being said, if discoveries of new laws of physics or of natural phenomena required the incentive of a patent, I believe we would have to have a constitutional amendment. I daresay, the scientific community would be opposed.

      1. 15.1.1

        Note that the US Constitution explicitly refers to discoveries. Now, one must still have a practical application of the discovery. But, that application does not need to be inventive, just the whole process. This was the bedrock of English law back in the 1800s with the bast furnace cases of Neilson. Prof. Leftsin at Hastings has written a great law review article on this. The UK Courts explicitly said that the application of a new law can involve routine steps and be straightforward once the new principle is known. This was followed by Morse and other cases, until Funk brothers hwere Justice Douglas just made up new rules, presumably following the flash of genius rule, which is no longer good law, not for a long time.

        1. 15.1.1.1

          one must still have a practical application of the discovery

          I agree that a practical application of a discovery is a foundational requirement (it’s necessary) but I’m not convinced that it’s sufficient to keep the system from being inundated with claims that fail to promote progress or worse.

          The utility prong of 101 has been used in the past to render certain types of claims ineligible (e.g., expressed sequence tags — note again how DNA keeps coming up in these 101 cases) but typically the emphasis in those cases is not on the “practicality” of the discovery (expressed sequence tags are/were certainly “practical”, as were the methods of using them) but on the substantiality and specificity of that practicality.

          The thorniness seems to arise from the fact that all information (at least all factual information) has a “practical” use to somebody, in some context. If a certain bit of extremely useful information, e.g., a correlation, is ineligible (something I think just about everyone agrees on), should more be required in a claim than the recitation of old technology for obtaining/storing/sharing that information?

        2. 15.1.1.2

          David, Under the English view, then, the claims here would be eligible as the discovery of the new law of nature would support patentability of an otherwise routine method.

          I’m not so sure the rule can be so broadly stated.

          I think there has to be a functional application of the discovery to produce a new result. That was the actual holding of Neilson.

          Thus viewed, Funk Bros. was a faithful application of the principles of Nielson.

          And, without a functional application to produce a new result, then Benson, Flook, Bilksi, Mayo, and Alice are all wrongly decided.

          But the claims in this case might pass muster.

          1. 15.1.1.2.1

            Ned, please read the law review article by Prof. Lefstin, and I don’t think you will continue to beleive that Funk Bros was a faithful application of Nielson. Prof. Lefstin did a great job of actually finding deposition and briefs from the actual case. Nielson was actually a 112 case, where the patent had no claims (claims did not exist back then) and simply mentioned that a heater could be used between a blower and the bast furnace. The patent was about 3 paragraphs. The Court ruled that the patent was enabled since a heater was conventional. As to covering the law of nature (hot air ingites better), the court looked at the disclsoure and concluded that heating air along with element of a blower and the furnace provided a paractical application. In Funck, the court considered the law of nature to be prior art, and then determined whether the implementation was inventive. That is expressly counter to the holding in Nielson.

            1. 15.1.1.2.1.1

              But David, all Funk Bros. held was that the discovery of the law of nature itself could not provide patentable weight.

              This is consistent with Rubber-Tip Pencil that involved an idea instead of a law of nature. The idea of attaching the rubber-tip to a pencil was given no weight, and the claimed rubber tip was found to be old.

              Regardless of what happened in England, the Morse court found the heated box to be an application of the principle, not the principle in the abstract. But it is also clear that the heated box actually worked according to the principle to produce an improved furnace. Rubber Tip provided nothing in the claim as to how to attach the tip to the pencil. And, in Funk, there was no modification of the bacteria or anything else to produce an improved result. What was claim was not truly an application, but little more than the idea.

              Benson’s math did not improve the computer. Flook’s math was not applied. Neither was Mayo’s correlation, nor Alice’s method. There was no application in any of these cases to modify or improve otherwise statutory subject matter.

              But, I agree that the present case might be a sufficient application.

              1. 15.1.1.2.1.1.1

                As to rubber-tip, the attachment to the pencil was given no weight because the claim was to the eraser and not to the pencil. It has nothing to do with it being an idea, but simply a claim drafting issue.

                As to Funk, your statement proves my point. The Court held that a simple, practical application of a new discovery was not patentable. To somehow rationalize this goal that Douglas was after, he effectively stated that the new dsicovery must be considered prior art. Thus, the actual application of the new dsicovery must be new and inventive, and not just the the total produce be new and inventive. Douglas said that once the property of certain bacteria being non-inhibitive to each other, it was siply packaging to put them together. The analysis focused on the packaging, and thus the analysis presumed that the non-inhibitive property was known. This was the first time that such a rule was presented. After Funk, many patents were invalidated for manufacturing processes because once the natural principle was assumed to be known, the application of it would be obvious. Presumably Douglas felt that a discovery did not show genius Accordingly, Funk is a very insidious rationale that does not hold water after the flash of genius test was done away with.

                As to Benson, a careful review the application and claims show that the shift register and algorithm actually did change the operation of the computer. Old systems were slow as they retrieved tables from memory. The new technique used more steps, but did not have to retrieve a table. The Court did not mention this fact, nor did they even mention the exitence of a shift register. As is common, the Court ignored claim language that did not suit their desired result. Or, more likely, the litigators just failed in their job, and the Court just did not pick up on these important facts. Instead, the Court just looked at claim 13 (which did not include the shift register), and it was not directed to any hardware. It rightfully was held to be nonstatutory, as it is a pure math algorithm, separated from any particular phsyical data and any practical result. Thus, there was no particular use, and the claim was not a useful method.

                1. David, As to rubber-tip, the attachment to the pencil was given no weight because the claim was to the eraser and not to the pencil. It has nothing to do with it being an idea, but simply a claim drafting issue.

                  According to the Supreme Court, the claim was for “a new and useful rubber head for lead-pencils.”

                  It is clear that the “for lead-pencils” was given no weight.

                2. David, As to Funk, your statement proves my point. The Court held that a simple, practical application of a new discovery was not patentable.

                  David, consider what the court said in Funk Bros. about what it was looking for and compare and contrast this with Flook, and for that matter Benson and Mayo and Alice, and in further consideration of Diehr. In considering this, observe that an addition of the routine and conventional to the claim is not sufficient, but the application of the nonstatutory subject matter to the statutory such as to transform it into a new state or thing is what the court time and time again has said is what transforms the claim into a patentable application.

                  From Funk Brothers,

                  The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning.

                  Funk Bros. is entirely consistent with Flook/Diehr/Mayo/Alice, and is a very good example to review to see exactly what kind of “transformation” the Court is looking for. The court is clearly looking for a functional relationship between the non statutory subject matter and the statutory such as to transform the latter into a new state or thing.

                  Circling back to Le Roy v. Tatham and Morse. The heated box of Nielson clearly was functional with respect to the furnace. It was not simply a routine appendage.

                3. David, As to Benson, a careful review the application and claims show that the shift register and algorithm actually did change the operation of the computer. Old systems were slow as they retrieved tables from memory.

                  Had the applicants focused on claim 13 and the shift register ONLY, the case may have come out differently. But they did not do that, did they?

      1. 15.2.1

        Ned,

        You state “In considering this, observe that an addition of the routine and conventional to the claim is not sufficient, but the application of the nonstatutory subject matter to the statutory such as to transform it into a new state or thing.” You suggest that these two propoisitons are mutually exculsive, but they are not. And, thus the logic fails.

        What if the application of the nonstatutory is routine, but it still provides a new thing. As in Neison, it was routine to heat air, but just not in the context of air being blown into a furnace. I agree there needs to be an application of the nonstatutory so that the end claim does not pre-empt the nonstatutory. But, it is misplaced to refer to the routine in a 102/103 sense. The Court has used routine to be mean “must” or “necessary.” It was a poor choice of words, as the use of routine is misleading and suggests 102/103 analysis. But, the COurt has said repeatedly that 102/103 is no relevance. If they had just used “necessary,” as the Federal Circuit unanimously interepreted in Alice, then it would been more clear. The level of writing at the Court has been abismal, and really has disallusioned me in the quality of the justices.

        1. 15.2.1.1

          David, Consider printed matter. It has a functional relationship to the book. But if the meaning of the words change, does it have a new functional relationship?

          There has to be a functional relationship and it must be new so as to improve the underlying statutory subject matter. Otherwise, we are patenting the unpatentable.

          Regarding 102/103, the Circuit courts have for 100 years given no weight to nonstatutory subject matter in a 102/103 analysis. Are these cases overruled?

          In 101, the statutory subject matter must be old, admittedly so or notoriously so. Otherwise the inquiry must move on to 102/103.

          I think we need to stop playing games with words and look to the substance of things. We can all dress up a claim to nonstatutory subject matter by sprinkling the claim with the routine, but statutory. It is done all the time, and examiners are routinely fooled. But, not the courts — at least not the Supreme Court. There were, and notoriously so, some on the CCPA and Federal Circuit who were in fact nominalists. Sprinkling was all that was required for 101 purposes because they had an agenda — force everything into 102/103/112.

  6. 14

    I scroll through this thread quickly, and can’t believe how refreshingly free it is from insults (despite the trenchant opposite views continuing to be expressed provocatively, as before).

    Something has changed for the better.

    I don’t know whether I should thank Dennis for that, or somebody else. But if anybody reading this was responsible for bringing about the change, I say Thank You. Without the insults, the threads will be more concentratedly interesting, and so much less infected with tedium.

  7. 13

    NWPA: Isn’t the test just like the alloy or the fiber cable? It is the end product of the work and when the science of how and why is known then there is nothing else to it.

    Very interesting formulation. I don’t think the claimed test at issue in this case is like a new alloy or a new fiber cable (where those compositions are properly claimed, in objective structural terms). Intuitively I don’t think that’s correct. And the second sentence in this quote helped me formulate an explanation.

    The ineligibility argument in this case would be that the discovery made by the scientists here is not a discovery of “the science of how” or “the science of why” but only the discovery that “this stuff is detectable in small amounts in a certain place when it is present in small amounts”. And then they want exclusive rights to use that well-known method to detect that stuff in that place.

    Imagine I go to your planetarium and look through your incredible telescope at a certain area of the sky and lo and behold I see a comet that nobody’s seen before! Obviously everybody is going to want to study this new comet because it’s going to provide a lot of information and possibly answers that might otherwise never be answerable given the rarity of this kind of comet. Thankfully I know the most important thing to do is to immediately file a patent application claiming a method of observing this new comet and detecting certain things about it and, of course, using a computer to make all sorts of determinations about it. I’ll inevitably leave some really expensive and not totally tested cutting edge comet detecting and analysis technology out so I won’t be totally pre-empting anybody!

    As for the rest of the astrophysicists: time to pony up. Sure, some of them were probably planning on looking at that section of the sky next week and no doubt they wish they had discovered the comet first. Never fear: my license terms will be very reasonable!

    Anybody have a problem with this scenario?

    I do. I think a lot of scientists and researchers would. Here’s an idea: go ahead and ask a bunch of scientists and researchers what they think about this sort of scenario. Because it’s exactly the sort of scenario they can be guaranteed to find themselves in more often than not if we let discoveries be converted into patent claims in this manner. Go ahead and try to convince those scientists that they just have to get used to this sort of thing (i.e., being sued for using existing or licensed technology to detect or determine the presence of “new” stuff) because … “it promotes progress”? I can tell you that I’ve talked to quite a few scientists and researchers already and they are skeptical, to say the very least.

    One difference between this scenario and the instant case is that the number of astrophysicists in the US is smaller than the number of pediatricians and far smaller than the number of women. Does that weigh for or against finding eligibility in either case?

    1. 13.1

      But the alternative might be “I see a new comet, but I must not tell anybody. I will instead exploit this secret knowledge to my advantage and not share it with a single soul.” Perhaps granting patent protection of the type at issue in Sequnom is just a lesser of two evils. After all, the patentee could have kept his method secret and we would not have known about it. Is it really wise to adopt a policy that encourages secrecy? What good does that do for all the children who may have benefited from more widespread testing but must suffer because we as a nation are so besotted with the sanctity of the abstract idea?

      1. 13.1.1

        It has been known for a very very long time that material from the fetus leaks across the placenta.

        It makes some women very sick and has been known to kill both fetus and woman at the same time.

        The only thing missing was the idea of identifying the fetal cells… Even now, it can only identify less than half.

        1. 13.1.1.1

          The ONLY thing?

          It had been known for a long time that the Energy equivalent of a mass was proportional to that mass.

          The “only thing” missing was that the proportional constant was the speed of light…. squared.

          pffft easy pezzy

      2. 13.1.2

        the alternative might be “I see a new comet, but I must not tell anybody. I will instead exploit this secret knowledge to my advantage and not share it with a single soul.”

        Another alternative is “I’m going to freely share this fact with as many people as possible so the maximum number of people — especially children — can benefit from the knowledge.” That’s what most researchers and scientists do now, and what most researchers and scientists have always done. There’s no evidence whatsoever that slowing down disclosure by injecting patent considerations into the acquisition of knowledge using old research tools leads to more knowledge. None.

        Is it really wise to adopt a policy that encourages secrecy?

        It’s extremely wise if (1) the effect of the secrecy is short-lived because the information is going to be obtained in due course regardless (such as the comet hypothetical and this maternal fetal DNA thing); and (2) the alternative is the increased likelihood that you’ll need to hire a patent lawyer before you use a public, purchased or licensed technology for its intended purpose.

        Everyone has useful knowledge that they don’t share, for a variety of reasons. Enouraging more patents that protect scientific facts without adding any technological advances has got to be the single most inefficient way of promoting the advancement of science or bona fide patent-worthy methods of using those facts.

        People are going to try to keep certain advantageous knowledge or harmful facts “secret” no matter how many patents are granted. They always have and they always will. There’s absolutely nothing wrong per se with keeping information secret, particularly secrets that can be freely unearthed by anyone willing to unearth them and which will inevitably be discovered in short order anyway.

        Lastly, I’ll note that this an odd case in which to rely heavily on “benefits to children” given that it’s not a new therapeutic method for treating children but a very broadly claimed method for gathering information for prospective parents that will be used, in part, to assist them in deciding whether to continue with the pregnancy.

        1. 13.1.2.1

          Yes, it’s a funny case for playing the benefit to children card, since the whole point is to let the parent decide whether to abort. I just couldn’t resist though, as it’s such a good card to play for rhetorical flourish, and sometimes nobody notices.

          Anyway, you’re right that many people like to share knowledge just for fun. Nobody really knows if the whole patent system promotes innovation or not. The only way to tell is a massive global experiment that nobody wants to volunteer for. But anecdotally, the patent system seems to have gotten its start around the early renaissance, and there has been more inventing since then than in the centuries before. But that doesn’t prove anything either.

          My theory is that the patent system plays more of a role in commercializing innovations. As you point out, people like to share knowledge and invent things, whether or not patents exist. It’s just that investors get skittish when you tell them anybody can copy your product.

    2. 13.2

      MM – I think that the discovery of the new star is a fine example.

      You know, we’ve been looking up at the stars for all of human existence – tens of thousands of years. There is lots of curiosity associated with space, but as far as I know, there are no businesses that are funding star-gazing research. Rather, that research is all funded through government and philanthropy. I truthfully don’t see the problem with awarding a 20-year limited exclusive right to someone who discovers something new about the night sky if that is offered as an incentive to do more and better research. The 20-year term will be a small blip in history but the discovery will last and the new technique may be the building block for future innovation.

      1. 13.2.1

        Dennis, you are clearly arguing that new discoveries of natural phenomena be protected with patents for 20 years in order to incentivize pure research. Given the pace a scientific advance, such a long-term monopoly on information would obviously cripple the pace of scientific advance.

        You might also consider that companies willingly invest in pure research today in order to spawn new products and services for tomorrow. This has been going on for some time in the United States at least. In my former company, for example, we allocated a good percentage of our R&D budget for long-term scientific research that had no immediate payoff in terms of products. But we thought it necessary.

  8. 12

    One really must wonder how this is any different than any other invention. Isn’t every new alloy really just a scientific truth with nothing added on? Once you know the science then all you are doing is added whatever the carbon to make steel for the alloy.

    Fiber optic cable is the same thing. Once you know the science of Hook’s Law than you are merely choose glass with different indexes to get internal reflection.

    In fact, I think everything is like this. Isn’t the test just like the alloy or the fiber cable? It is the end product of the work and when the science of how and why is known then there is nothing else to it.

    (Remember the following: that information processing takes time, space, and energy. That conservation of information is the most important law of physics. That software plus a general purpose machine is a new machine. That software/firmware/hardware are equivalent. That the Church-Turing Thesis tells us that arguments that the distinctions trying to made between information processing methods are meaningless. That the SCOTUS is afraid of the software that is going to replace them.)

    1. 12.1

      Also remember that Ned is an anti. He is their secret leader and the keeper of their standard. He organizes the meetings with Lemley and Lee. In fact, Ned is considering changing his name to Led so it looks more like an anti name.

    2. 12.2

      A “test” is nothing like fiber optic cable.
      A “test” is nothing like steel either.

      I see you still have no concept of math either.

      1. 12.2.1

        Jesse: why do you always say “you have no concept of math”? I was trained in theoretical computer science at one of the best universities in the country. So, please be more specific.

        1. 12.2.1.1

          Because your belief that a program loaded into a computer makes a different computer.

          To a computer, everything is data, even programs.
          A computer is a symbolic processor – Nothing it processes exists. Information has no mass.

          Assuming that reality is the same as information is called magic. And it isn’t real.

          Steel is a composition of matter. A test is to identify information – and that information has no intrinsic mass or reality.

          Your belief that similarities is the same thing as reality is usually called magic.

          Not science.

          1. 12.2.1.1.1

            NWPA is correct. WMS Gaming held that a computer+new program=new_machine. And it is common sense to anyone who has been trained in computer science. The boundary that defines where a computing machine ends can be somewhat arbitrary.

            I do not see why having mass is a prerequisite for existence. Photons do not seem to have mass and they seem to exist. And how do you know for a fact that information has no mass? It’s difficult to prove a negative. Maybe we just haven’t learned the particular law of nature that lets us measure it.

            Anyway, leaving that aside, we certainly have an objective way to measure how much information there is in a particular signal. It seems a bit hard to measure something that allegedly has no existence.

            1. 12.2.1.1.1.1

              Tino, you cannot possibly believe that a computer plus a new program is a “new” machine and therefor statutory without more? That is what Rich said in Benson and the basis for its holding there that the claimed BCD binary algorithm was eligible because it was limited to a computer.

              This notion of the Federal Circuit is not good law and has never been good law. It was overruled implicitly long ago in Benson.

              1. 12.2.1.1.1.1.1

                WMS Gaming and Alappat are from the 1990s and Benson is from the 1970’s. How could Benson overrule WMS Gaming?

                1. Actually, those later case rely on Application of Bernhart, 417 F.2d 1395, 163 U.S.P.Q. 611 (C.C.P.A. 1969) that was before Benson. Rich in Benson relied on it for his holding there. Benson was overruled, implicitly overruling the per se nature of the involvement of a programmed computer being eligible.

                2. NWPA,

                  I would also point out Alappat was not unanimous, it has not been visited by the USSC, and most computer professionals consider it a legal fiction that does not comport with reality.

                  But, yes, it is still the law. You’re correct there.

                  For now.

                3. Well, Dobu I would like to know why you think it is a legal fiction. I am one skilled in the art of computer and a patent attorney. I have a MS in computer science and worked in the field for a number of years.

                  For example, do you contest that hardware/software/firmware are equivalent. Certainly the most used book on computer architecture Mano says so.

                4. NWPA,

                  I would like to know why you think it is a legal fiction.

                  I expressed some views to Tino in post 12.2.1.1.1.2, below, that I think are applicable to your query.

                  I am one skilled in the art of computer and a patent attorney.

                  Ditto on the former, layperson on the latter.

                  I have a MS in computer science and worked in the field for a number of years.

                  MS in Computer Engineering (tips more towards the hardware design side than C.S. studies tend to), 20+ years experience in the field.

                  For example, do you contest that hardware/software/firmware are equivalent.

                  They can be logically interchangeable, which is the angle I suspect you’re aiming along. Some applications have requirements that would eliminate one or more of the triad as reasonable solutions.

              2. 12.2.1.1.1.1.2

                Tino, you cannot possibly believe that a computer plus a new program is a “new” machine and therefor statutory without more?
                Ned — that is your opinion — not a statement of the law (which states the opposite).

                It was overruled implicitly long ago in Benson
                Explain.

                1. I have posted twice a reply and it has not show up here. I don’t know why.

                  But you might start with the newly recognized doctrine of implicity overruling: Troy v. SAMSON MANUFACTURING CORPORATION, No. 2013-1565 (Fed. Cir. July 11, 2014).

                2. Oh No, my explanation would not post no many how many times I tried and no many how many edits I made. I simply gave up.

            2. 12.2.1.1.1.2

              Tino,

              WMS Gaming actually relied on in re Alappat for that “new machine” silliness. It was not an independent holding.

              “Anyone who has been trained in computer science” should be aware that the entire reason for the existence of general-purpose programmable computers is so that a new machine doesn’t need to be created for processing every different algorithm.

              I will also add that as a modern computer executes an algorithm, it’s memory contents and data pathways are changing BILLIONS of times per second. If changing the data contents or pathways creates a new machine, then each of these billions of changes would necessarily be creating new machines. That is just ridiculous on its face.

              If photons have no mass, how are they being affected by gravitational fields (e.g., black holes)?

              You and NWPA are both conflating “information” as used in discussions of thermodynamics (concrete) with “information” as used in discussions of knowledge (abstract). They are not the same thing.

              1. 12.2.1.1.1.2.1

                “If photons have no mass, how are they being affected by gravitational fields (e.g., black holes)?”

                They aren’t – they ARE affected by the space distorted by the gravitational field… they don’t slow down or speed up due to gravity. They are still moving at the speed of light.

              2. 12.2.1.1.1.2.2

                The interaction of a black hole with photons arises from a distortion in space caused by presence of mass. It does not take a black hole to do this. The sun bends light. So do very fat people, just not enough to make it practical to sit behind them in the movies.

                Actually, the purpose of a general purpose computer is not so you don’t have to create a new machine, it’s to make it really easy to do so.

                As for the transitions between states defining new machines, you can call those new machines if you wish. I don’t see what’s ridiculous about that. Or you could call it one new machine that changes states many times. It is statutory either way.

                1. As for the transitions between states defining new machines, you can call those new machines if you wish. I don’t see what’s ridiculous about that.

                  The “ridiculousness” comes in when you open the gates to the claiming of old machines in “new states” and the patent office is flooded with massive piles of unexaminable claims that turn people using those old machines into infringers when they use the old machines for their intended purposes.

                  That’s how we got to this point. That’s why we’re pulling back. I’m not suggesting that you are guilty of this, but hat’s “ridiculous” is to pretend that these changes we’re seeing now are just “pendulum swings.”

                2. It is quite ridiculous.

                  Is it a different water pump if there is different water in it? After all it has changed state….

                  The computer was DESIGNED to support every possible state the memory or CPU could be in.

                  It it can’t, then the hardware is faulty….
                  Which is exactly the failures that memory and CPU diagnostics are looking for.

                3. The computer was DESIGNED to support every possible state the memory or CPU could be in.
                  OK … so what? A piece of wood can be carved (i.e., placed into a different state) into a million different objects. Put a piece of metal onto a lathe it can be machined into a million different objects.

                  The existence of the piece of wood or the piece of metal does not preclude patents from objects created therefrom. It takes human ingenuity combined with human intervention to create these objects.

                  Like the piece of wood or piece of metal, a computer is little more than a glorified paperweight without human ingenuity and intervention.

                  ‘could be configured to be put into a different state’ is not relevant. If it was, nothing would be patentable.

                4. Did you create the Wood?
                  Or the bar of metal? (though there you could have refined it…)

                  Wood was not designed to hold every possible shape…

                  Neither was metal.

                  Just changing configurations should not make something patentable.

                  Can you patent a water pump if you configure it upside down? Nope.

                  Something that was designed to be reconfigured should not be patentable just because somebody DID reconfigure it.

              3. 12.2.1.1.1.2.3

                ” If changing the data contents or pathways creates a new machine, then each of these billions of changes would necessarily be creating new machines. That is just ridiculous on its face.”

                Are you the same person as you were the day you were born?
                Are you the same size?
                Are you the same weight?
                Are you made of any of the same carbon atoms or water molecules now as you were on that day?

                You must have changed into a different person billions of times over the course of your life. You are what you eat, after all. Ridiculous on its face. But, its true.

                1. Take a bar of iron. Melt it. Cast it into a new form (of a patentable machine). Melt it. Cast it into a different new form (of a second patentable machine). Repeat.

                  Its OK if we change the state of the bar of iron but not OK if we change the state of the computer?

                2. Les,

                  I don’t believe the I.R.S. would buy that argument, seeing as how they expect me to keep paying taxes for all those other me’s that came before me.

                  Aren’t you arguing on the wrong side here?

                  You usually come down on the side of patenting anything and everything. Here, you’re helping me show that minor changes don’t make a new “machine”.

                3. Yes, and even though the atoms that physically make up a body are always in flux, we don’t usually think of the person as changing. This suggests that a “person” is something different from the constituent atoms of the person’s body. In fact, the use of the possessive form “my body, my blood” etc suggests a separation between the person and the corporeal embodiment of that person at any instant. This is not unlike the distinction between “invention” and “embodiment of invention.” In fact, just the word “embodiment” suggests you are taking something without a “body” and somehow giving it one.

                  The central question is “is a thing that changes among N states really N different things or one thing that has multiple states?”

                4. Oh no,

                  Your (general-purpose?) iron bar is hardly a “machine”.

                  If you’re considering a moldable material that can be instantly hardened into useful shapes, you’re venturing into 3D printer territory, which I think our current patent system is woefully ill-equipped to handle. (And for which I have no solutions to offer.)

                  A running computer is, by design, continually changing states. Your molded iron bar isn’t. (Not in any useful regard, anyway.)

                5. It looks like you are directing those comments to me. In case you were, I will point out that you are preaching to the choir.

                6. “Aren’t you arguing on the wrong side here?

                  You usually come down on the side of patenting anything and everything. Here, you’re helping me show that minor changes don’t make a new “machine”.”

                  No. You are a different person than you were the day you were born. You are arguably a different machine. The fact that you and the IRS do not recognize that is beside the point.

                  Moreover, the information that has been loaded into you (the sum of your education and experiences) is a significant part of what makes you the person/machine that you are today.

                  Even if software is “just information” or “just data” it is a component of the machine and changing or adding components is what makes a new machine.

                  Wood, cloth and rope are old. But they can be configured to make a new kind of sailing ship or they can be configured to make a new kind of wind mill or a new kind of flying machine.

                  Similarly processors, memories and touch screens are old, but they can be configured, via software to make many new and wonderful machines.

                  Sorry GTG. I’m in line to get a new watch and fablet. I hope they have rounded corners…

                7. Your (general-purpose?) iron bar is hardly a “machine”.
                  It is a manufacture. How about if I build a machine out of an erector set. There is your machine. Then I reconfigure the erector set to create a new machine.

                  A running computer is, by design, continually changing states.
                  Not relevant.

          2. 12.2.1.1.2

            >>and that information has no intrinsic mass or reality.

            Of course it does. Information takes time, space, and energy to represent. A test is represented in your brain with neurons that take space, energy, and time to store and access. The test has structure.

            1. 12.2.1.1.2.1

              Key word there: “REPRESENT”.

              A representation is not the same thing as the information represented….

              A representation is composed of matter…

              A “test” takes time to PROCESS, but that is strictly a physical limitation of chemicals in a mind.

              The information is abstract… In fact, they still don’t know how memory works. Some certainly seems to be in chemicals… but they still can’t identify the chemical that is a memory…

              1. 12.2.1.1.2.1.1

                Jesse: what is the difference between humans and squirrels? Certainly our brains are the biggest difference and our brains are all there to represent and process information.

                The brain takes space, energy, and time to access etc.

                Big picture: representing information and processing information is tangible. It is a physical process. The machines and algorithms to process the information make huge differences. As evidenced by humans where our methods and machines are the reason we survived and we have those methods and machines due to evolution.

                Our thoughts do not exist in the ether as Justice Stevens believes.

                1. The difference between humans and squirrels?
                  Not much.

                  The squirrels I have met all process information, they have the same sensors we do. They are just smaller.

                  “representing” is a physical process. Processing (as in manipulating chemicals) is a physical process.

                  Information though? Information can exist by ABSENCE of anything physical. Information can be represented by two frequencies of light… It can even represented by the absence of light…

                  Thus “information”, in the math sense, has no real physical embodiment.

                  As philosophers debated many times… What is a “1”?

                2. Light is physical, as is the absence of light. Furthermore, the presence or absence of light requires further physicality to represent information. Something has to sense or measure the presence of the light or lack thereof.

                  As philosophers debated many times… If a tree false in the woods and there is no one there to here it, did it make a sound?

                3. Nice one.

                  “if a tree falls…”

                  To the physicists, the answer is yes there is sound.

                  To the squirrel in the tree, the answer is yes.

                  To the tree next to the one that fell, the answer is yes.

                  To the philosopher, the answer is “I didn’t hear it”.

              2. 12.2.1.1.2.1.2

                And jesse review equivalence of hardware/software/firmware to understand why software + GPS = new machine.

                (And Ned the software is permanent to the solution of the problem. Never is the machine used to solve the problem without the software.)

                1. Um… they aren’t equivalent.

                  Hardware ALWAYS has more than boolean algebra; things like temperature, clock frequencies, power supplies,…. Software never does.

                2. Jesse, please read Mano’s computer architecture book. We have posted quotes from it in the past that expressly say that software/hardware/firmware are equivalent.

                  Equivalent doesn’t mean exactly the same.

                3. You seem to be missing the context.

                  Within computer science there is no difference between hardware that emulates a math function and the math function.

                  To the math they are the same.

                  Once you get into engineering they are not the same. They aren’t even equivalent.

                4. Jesse: please respond to the Mano reference. Mano is highly regarded in computer architecture.

          3. 12.2.1.1.3

            A plank combined with a rock makes a new machine, a lever.

            A door stop (computer without software) combined with particular software (e.g., excel) makes a new machine, a spread sheeting tool.

            A generic computer is a component. Software is a component.

            The combination of two old components can make a new machine.

            1 + 1 = 2 or 10.

            capice?

            1. 12.2.1.1.3.1

              software + hardware => hardware.

              Now subtract hardware.

              software => null.

              Old presentation in design.

              You are confusing the recursive mathematics of computation with reality. Yes, any Turing complete machine can be programmed to emulate any other Turing machine (complete or not).

              But the software still isn’t the hardware.

              1. 12.2.1.1.3.1.1

                I said software is a component.

                Whether or not it is combined with the generic processor et al. in the form of firmware or not is irrelevant.

                A claim to computer and particular software or instructions for carrying out a particular method is not anticipated by a generic computer alone and is not infringed by a generic computer alone.

      2. 12.2.2

        And Jesse really ? Why isn’t a test like steel? In the information age we should all be able to understand that there are a lot of similarities.

      1. 12.3.1

        I am not sure Dennis. One thing though is that it goes to whether or not the science or abstraction is known.

      2. 12.3.2

        I will say though that the test is not nothing like so many suggest. The test has structure. It does not exist in the ether. It is human made structure that is useful. It is –to some extent—like software. The test plus a human to carry it out or implement it with a machine is useful.

        I think that framework is the proper framework for the information age.

    3. 12.4

      Does anyone here truly believe that information processing in the sense that Night uses it has anything to do with the conservation of information in the sense of the physical law that the universe has states which are reversible because information is retained as the universe moves one state to the next? One is talking about the abstract. The other is talking about the real physical universe.

      1. 12.4.1

        I am not aware of any such physical law. There are certainly many irreversible processes in nature, mostly arising from the fact that entropy tends to increase, thus often making it impossible to revert to a previous state. To the extent information is that which reduces entropy, it seems like it cannot be conserved for that reason, since in the long run, the universe will end up in a state of maximum entropy with no information.

        And who is to say information is not real? It certainly has many of the attributes of real things: we can measure it, create and destroy it, and process it. It seems to have real physical effects on people and thus interacts with the “real” world. Just because we haven’t seen it leave tracks in a cloud chamber doesn’t mean it’s not real. What exactly does it take to be what you call “real” anyway?

        1. 12.4.1.1

          Actually, Tino, I have seen demonstrations of the phenomena where one can reconstruction from evidence of where particles made traces or the like of what impacted what at what location.

          Regardless, when a system includes measurement, processing, and some recording or further transmission, information processing can be affect the real world in the sense of the physical law.

          But simply calculating the amount of grace one receives from 5 Hail Mary’s is not the kind of calculation that anything to do with this universe, although it operates on information.

          But Night states his proposition as a universal truth, like the law of physics.

          1. 12.4.1.1.1

            It is possible sometimes to figure out what a past state must have been based on observation of a present state. But going back to the past state is a different matter. I don’t think anyone knows how to do that. It sounds like time travel.

            I suspect you could calculate the grace value per Hail Mary by going into a confessional multiple times with different sin sets and counting how many HMs the priest gives you. Then you could develop a sin/HM exchange table for a given confessional and choose the confessional that offers the most bang for the buck per Hail Mary. This would not be a law of nature I think, so maybe a method of choosing a confessional based on this table would be patentable.

        2. 12.4.1.2

          Your last paragraph is also a use of “magic”.

          And a belief in magic does have physical effects – but not from the magic, the belief in magic that can cause people to do silly things.

      2. 12.4.2

        Also he seems to be mixing two different definitions of “information”.

        To a physicist, “information” is the properties of matter and energy.

        To a mathematician, “information” is the properties of “information” and how that information relates to other information.

        An engineer tries to map one to the other – sometimes successfully, sometimes not. But it is a mapping, not an identity.

  9. 11

    Dennis: Most squarely, the brief recognizes that the discovery of a natural phenomena may be very important, but even when a critical breakthrough, that discovery is not patent eligible. Rather, the a patentee must then take the discovery and apply it in a way that adds substantial and inventive limitations. The argument here is that the patentee’s addition (the process of detection) was well known at the time of the patent filing and offered no inventiveness.

    That’s a good argument.

    I’m curious about the diagnostic service/products that these companies offer based on this discovery and whether one service/product is deemed significantly better than the other.

    1. 11.2

      I believe this statement of the law to be incorrect, as it follows the specific rationale of Parker V. Flook, where that specific rationale was overruled by Diamond V. Diehr. One cannot assume that a new discovery is prior art and then apply 102/103 to it. The US Supreme Court has forbade this in multiple decisions that follow Diehr. The test is whether the claim pre-empts the natural principle (abstract idea, law of nature, etc). The specific steps that make the claim different than the natural principle just don’t have to be necessary (as stated by Mayo and the unanimous Federal Circuit in Alice), and thus make the claim to be something else than the natural principle.

      1. 11.2.1

        David, when the subject matter is non statutory, as with laws of nature and products of nature, and, for that matter, math or fundamental economic principles, simply adding the routine to it may make it a specific application and not preempted (Flook), such is still not sufficient.

        In dealing with claims that include mixed subject matter, the nonstatutory and the statutory, the proper procedure has always been that the nonstatutory is ignored (unless it effects an improvement in the statutory (Diehr)), not that the nonstatutory is prior art. Check, for example, the Rubber-Tip Pencil case where the statutory part of the claim was found to be old, and the nonstatutory idea part was given no weight.

        I think Flook was misinterpreted. Flook was trying to apply Funk Bros. and Rubber-Tip Pencil that gave he nonstatutory subject matter no weight.

        1. 11.2.1.1

          Ned, Please point to the legal basis that adding limitations that overcome pre-emption is not enough. It seems that you are saying that Benson is not good law, and that whether a claim pre-empts a natural principle is irrelevant. Maybe I am missing something here.

          As to your comment about “prior art,” the statement about statutory and nonstatutory is confusing. Are you talking about a 101 analysis or a 102/103 analysis. Your comments blur the two, and thus are not clear. One should not mix the analysis of the two. A claim is statutory or not. There is no part statutory (i..e, partly satisfies 101), and then only that statutory part of the claim is analyzed with respect to 102/103. Please provide a cite to authority for such a rule. I know that is the rule used in EP, but I have not seen any case that uses it in the US.

          In Rubber-Tip Pencil, the claim was an omnibus claim, and this a bit unusual. Although the case is a little difficult to read, given the awkward language used at the time, the holding seems to simply be a 102/103. The claim was for the eraser, and erasers were known. The claim was not directed to a combination with the pencil part, but just the eraser. And, the eraser head was found to not be novel. There is not separation of statutory and nonstatory. If the claim had included the apparatus that included the pencil and the socket, it might have been different. Note that the disctrict court used a novelty/obvious standard of what someon could do, which is anachronostic today.

          And, by ignoring claim language, that effectively assumes it is prior art, if it is done at the 102/103 anlaysis, as there has to be something that differentiates it from the prior art. For 101 analysis, one can look at whether additional limitations are enought not to pre-empt, but this is a separate analysis from 102/103.

          1. 11.2.1.1.1

            David, Ned, Please point to the legal basis that adding limitations that overcome pre-emption is not enough. It seems that you are saying that Benson is not good law, and that whether a claim pre-empts a natural principle is irrelevant. Maybe I am missing something here.

            Simply adding limitations is not enough. I think this is been well-established since Flook –

            “The notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance. A competent draftsman could attach some form of post-solution activity to almost any mathematical formula; the Pythagorean theorem would not have been patentable, or partially patentable, because a patent application contained a final step indicating that the formula, when solved, could be usefully applied to existing surveying techniques.[11] The concept of patentable subject matter under § 101 is not “like a nose of wax which may be turned and twisted in any direction.”

            Thus sprinkling a claim with conventional elements by itself is not enough. The proposition that was reiterated in Bilski, and certainly was the basis for the holding in Mayo.

            What makes a difference is using the ineligible subject matter such as math, or printed matter, in a functional way with respect to the otherwise statutory subject matter, i.e., a conventional process as in Diehr, conventional because it passed the MOT, is what is important.

            Thus, it is not adding otherwise patentable subject matter to claim that transforms the claim into something less preemptive if that subject matter is conventional and completely obvious.

            Of course, if there is invention in that otherwise statutory subject matter, we have a completely different case.

          2. 11.2.1.1.2

            David, As to your comment about “prior art,” the statement about statutory and nonstatutory is confusing. Are you talking about a 101 analysis or a 102/103 analysis. Your comments blur the two, and thus are not clear. One should not mix the analysis of the two. A claim is statutory or not. There is no part statutory (i..e, partly satisfies 101), and then only that statutory part of the claim is analyzed with respect to 102/103. Please provide a cite to authority for such a rule. I know that is the rule used in EP, but I have not seen any case that uses it in the US.

            David, I would like to refer you to Hotel Security, a case that followed it, Guthrie v. Curlett, and CCPA cases that follow that In re Russell, and In re Patton. (Hotel Security Checking Co. v. Lorraine Co., 160 F. 467 (2d Cir. 1908). The uniform approach these cases is to first declare that a method of doing business or printed matter or the like is not statutory. They then say that invention must be in the statutory part, the means. In modern usage, the nonstatutory part, the business method or the printed matter for example, is given no weight.

            But if you reflect for a moment, Funk Brothers openly declared that invention must be in the otherwise statutory part less the claim be directed to the otherwise unpatentable law of nature.

            But of course there is an exception, and that is when the nonstatutory part is applied to the statutory to transform it. See, e.g., Diehr. These cases speak to a functional relationship between printed matter and the underlying subject matter which is otherwise patentable. That functional relationship actually improves the underlying subject matter which is otherwise statutory.

            Also consider the cases such as Benson which included both a mathematical formula that was nonstatutory, and a computer, a machine, which is certainly statutory. Judge Rich in his CCPA case, In re Benson, relied upon the presence of the computer in the claim to declare that the claim as a whole was directed to eligible subject matter. Of course that thinking did not prevail on appeal. The only way to view Benson is that it included both statutory subject matter and nonstatutory subject matter, and the nonstatutory subject matter, the math, was given no weight in determining the patentability of the claim. Thus the claim was unpatentable because the statutory part was old and conventional.

            The case would an entirely different if the nonstatutory subject matter was used to transform the statutory to improve it. Clearly that is the test everyone is looking for in trying to figure out what to do here. Is always been there in the cases involving printed matter doctrine, and it is also present in Diehr.

            1. 11.2.1.1.2.1

              David, In Rubber-Tip Pencil, the claim was an omnibus claim, and this a bit unusual. Although the case is a little difficult to read, given the awkward language used at the time, the holding seems to simply be a 102/103. The claim was for the eraser, and erasers were known. The claim was not directed to a combination with the pencil part, but just the eraser. And, the eraser head was found to not be novel. There is not separation of statutory and nonstatory. If the claim had included the apparatus that included the pencil and the socket, it might have been different. Note that the disctrict court used a novelty/obvious standard of what someon could do, which is anachronostic today.

              You have to also understand that the claim did include the suggestion that the piece of rubber be for attachment to the tip of a pencil or the like. The court determined that this “purpose” simply an idea, and gave it no weight.

              The statutory part of claim, the rubber tip, was old and conventional.

              But you still have to consider that the Supreme Court gave no weight to the idea.

              Perhaps today the claim would be structured more like the purpose would be in the preamble and the rubber tip in the body of the claim. The preamble would be given no weight.

              The same result should be achieved if the claim was to a rubber tip, and a purpose was then added to the claim element in some form. That purpose should be given no weight. Unfortunately, in many cases today, that purpose is given weight and is the point of novelty in the claim.

          3. 11.2.1.1.3

            David, And, by ignoring claim language, that effectively assumes it is prior art, if it is done at the 102/103 anlaysis, as there has to be something that differentiates it from the prior art. For 101 analysis, one can look at whether additional limitations are enought not to pre-empt, but this is a separate analysis from 102/103.

            The law has developed over time that nonstatutory subject matter must be ignored in a 102/103 analysis. This is almost hornbook law today. See, e.g., all the cases involving printed matter. It is also consistent with Funk Brothers.

            Of course, there is an exception, and that is when the nonstatutory subject matter such as printed matter, math or the like, is integrated with the statutory subject matter per Diehr such as to transform it into a new state or thing.

  10. 10

    Dennis: The inventors (Oxford Professors Lo and Wainscoat) had previously discovered that human fetal DNA existed in small quantities within the pregnant mother’s blood plasma.

    That’s a very helpful discovery. We can query whether they were the first to recognize that it was likely that fetal DNA existed in small quantities within the mother’s blood plasma, or whether they were the first to “show” it. That’s likely more relevant to the question of the obviousness of these claims.

    1. 10.1

      Dennis: a sticking point was the difficulty in separating-out the very small number of fetal-DNA from the large quantity of mother-DNA. That problem was solved by recognizing the fundamental … difference between mother and child DNA is the addition of DNA from the biological father.

      Just so nobody is confused, the listed inventors were not the first people to “recognize” this rather mundane fact, nor were they the first people to exploit this fact to achieve the same objective that their claimed method achieves (i.e., DNA testing of the fetus in utero).

      1. 10.1.1

        Sure, folks did previously obtain and test fetal DNA. The problem was that you had to stick a needle through the mother into the amniotic fluid and that testing procedure had a pretty high risk — apparently killing ~5% of tested fetus’s.

        It seems to me that these facts push toward the notion that the invention is related to a practical advance rather than merely a law of nature.

        1. 10.1.1.1

          folks did previously obtain and test fetal DNA. The problem was that you had to stick a needle through the mother into the amniotic fluid and that testing procedure had a pretty high risk — apparently killing ~5% of tested fetus’s.

          I don’t think that’s correct. Very very very few women would go through the trouble if that was the case (I’m sure many if not most of us were born to parents who remained mostly clueless about what they were getting until we popped out). I’m sure there’s plenty of women who opt out of these prenatal ge netic tests anyway because the data doesn’t interest them.

          According to Wikipedi link to en.wikipedia.org, even back in the 70s the number was 1 in 200 (0.5%) and [a] more recent study (2006) has indicated this may actually be much lower, perhaps as low as 1 in 1,600 (0.06%). Unlike the previous studies, the number in this study only reflects the loss that resulted from amniocentesis complications and excluded the cases when parents decided for an abortion following the test results.[11]

          But my point was just that, other than the ineligible discovery of this fact of nature (fetal DNA is present in small amounts in human maternal blood), there is nothing inventive in the claim.

          I’m happy to be mistaken about these facts but I’m pretty sure that PCR (polymerase chain reaction link to en.wikipedia.org) and its power was very well understood as of the filing date of this patent. PCR is what makes the method work, along with the fact of the presence of the fetal DNA. Then they ran to the patent office and filed a claim that says, in essence, “we used this method that was known to be useful for detecting small amounts of DNA to detect small amounts of DNA in this particular place so now you can’t use that well-known method in this place without paying us a license.”

          It seems to me that these facts push toward the notion that the invention is related to a practical advance rather than merely a law of nature.

          Every discovery is a practical advance on some level because all information is useful to somebody in some context. Scientifically established facts are especially useful because they allow us to control our experiences in relatively predictable ways (unless we prefer unpredictable experiences, in which cases scientifically established facts are also useful).

          PCR was a practical advance that, in some form, was deemed worthy of a patent, as I recall (now expired and in the public doman — yay!). It’s technology like that where the patent system’s focus should be in our “information age”: technology for acquiring information. Endlessly hamstringing extremely effective and, in some cases, relatively inexpensive data-collecting technology with a patent on every new discovery made using that technology seems to me like a guaranteed way to effectively take a non-patented “public” technology out of the public’s hands.

          This is how it plays out: “You can practice that old DNA detection technology, unless you’re detecting this, this, this, this, this, this, this, this, this, this, this, this, this, this, this, this, this, this, this, [repeat 10,000,000 times for every discovery] … or this.”

          Note that in every case, PCR will make that test less invasive than it otherwise would be because less material is needed.

          Myriad, by the way, is eventually going to run into a similar wall, or run through it, if it keeps up its present litigation strategy.

    2. 10.2

      The bottom line is that we have an incredible breakthrough here in an important area of medicine. This was done at a time (late 1990s) where patent rights in biotechnology advances such as this were held in high regard. And I think that it would be a useful case study to consider what role patents played in the overall incentive structure. And – what particularly were the breakthroughs and bottlenecks in the pathway toward getting this product into the hands of those who need it. The advances by these professors appear to be an important step, but certainly there were major contributions by others along the way.

      A recent comprehensive review of studies in this area appear to credit Lo (the inventor here) as the originator of this idea of finding fetal DNA in maternal blood plasma and also the first to create a process that makes that DNA accessible for testing. link to humupd.oxfordjournals.org

      1. 10.2.1

        Dennis: I think that it would be a useful case study to consider what role patents played in the overall incentive structure. And – what particularly were the breakthroughs and bottlenecks in the pathway toward getting this product into the hands of those who need it. The advances by these professors appear to be an important step, but certainly there were major contributions by others along the way.

        I agree. Were government grants used to fund this research? My understanding is that it’s relatively difficult for researchers to get a decent wad of cash from the government now compared to the early 90s.

  11. 9

    Here’s representative claim 1:

    A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises

    amplifying a paternally inherited nucleic acid from the serum or plasma sample and

    detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

  12. 8

    Depending on the ineligibility argument, one key factual question for the ineligibility determination is whether the existence of fetal DNA or even nucleus-containing fetal cells were present in maternal blood plasma. If that’s the case, then the detection of the fetal DNA using PCR (a well-known Nobel-prize winning method for detecting and amplifying vanishingly small amounts of specific DNA molecules from complex mixtures) is either obvious or ineligible.

    The eligibility question arises (according to this argument) because a claim as broad as this prevents people from using old observation tools to observe a new phenomenon. An analogy could be made to someone who discovers that a certain microscopic fingerprint pattern correlates with cancer and tries to prevent people from using a microscope to look at the fingerprint and “determine” the meaning of what they are seeing (a clearly ineligible claim).

    A major problem I have with Kev’s policy argument is the idea that this sort of basic research discovery — because it made something easier and it’s popular, I guess — demands patent protection (and hefty financial rewards) as an incentive or else researchers will stop discovering stuff. These guys were risking their lives diving underneath the Antarctic collecting jellyfish stingers. I’m certain there were lots of other people out there using PCR and other methods to study the molecules floating around in maternal blood plasma.

    1. 8.2

      Another eligibility argument requires answering the question as to whether people had been using PCR to detect DNA molecules in maternal plasma generally.

      If so, then it seems likely (or certain) that paternal DNA was amplified right along with maternal DNA. Now, the researchers who performed that investigation might not have known what they were looking at (they might just have seen some bands on a gel). But they did amplify the paternal DNA from a maternal plasmid, as required by step 1 of the method.

      Let’s say that there was one mysterious “band” on the gel or column used to analyze the amplified DNA (or many such bands). The correct application of Prometheus would, I believe, block an effort to use a patent to prevent someone from “knowing” what that band corresponds to. The applicant for such a claim can’t prevent me from running my same experiment again just because I have learned something, nor does it seem reasonable for them to prevent me from using standard techniques to determine the meaning of what I did based on the disclosure of an ineligible fact (“fetal DNA is present in maternal blood plasma”).

  13. 7

    Dennis: SDIPLA also filed a brief making an interesting point: Here, the diagnostic process was only found ineligible because the subject matter being detected was a natural phenomena. If instead, the same process was being used to detect the presence of a man-made compound then the test would not be challenged on 101 grounds.

    I’m pretty sure that human fetal DNA is just as “man-made” as every other part of a human fetus.

    Thanks, folks. I’ll be here all night.

  14. 6

    “The PCR process actually creates new DNA molecules”

    Then maybe they should have patented “a process to make new DNA molecules comprising xyz steps. You know, instead of trying to patent on the correlation.

  15. 5

    The case seems a lot like Funk Bros. and Mayo where a basic discovery is made concerning a natural phenomena. Conventional methods are used to develop data, etc. The comparison step may also be conventional. What beyond the unpatentable natural phenomena is in the claim?

    1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises
    amplifying a paternally inherited nucleic acid from the serum or plasma sample and
    detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

  16. 3

    So far the Supreme Court has not been presented with explanations of the line-drawing problems that exist between where the discovery ends and the invention begins. Once one finds that there is fetal DNA in a mother’s blood, is testing that DNA for genetic abnormalities inventive? After all, the fact that it is there does not mandate that such testing be done, or that it be done in a particular way. This line-drawing problem will come up time and again. The basic discovered fact is rarely what is being patented. That line-drawing problem is ordinarily in the realm of obviousness, subject to a particular type of analysis under statutory terms as interpreted by certain case law.

    This is complicated by the fact that “laws” of nature are so subject to revision. Is the latest study on whether statins are good for you under these conditions or those conditions “laws” of nature or just the way the wind is blowing today? I ask because I do not know, and I bet you don’t either. And how would a judge know?

    I’m dying to find out.

    1. 3.1

      Erik, the solution to this line drawing problem would be to use the printed matter doctrine under 103 to give no patentable weight to ineligible subject matter in a claim. This has been suggested by a number of others, but I am not aware of any litigant or amicus offering the idea to the Federal Circuit or SCOTUS.

  17. 2

    Some non-101 questions of general interest as this develops, not just as to this case: Was a preliminary injunction granted after the remand on that issue, was a substantial and sufficient bond posted for that given the indicated high commercial importance, and if so, now what will happen, especially IF the D.C. decision is sustained?

    1. 2.1

      Although there is a right to appeal decisions on preliminary injunctive relief, district courts generally continue pushing the case forward during that inerlocutory appeal period. Thus, the case continued to move forward while the Federal Circuit was deciding the preliminary injunction issue. A couple of months after that decision, the district court found the patent claims invalid on summary judgment.

  18. 1

    This is why the Supreme Court should not get involved with section 35 USC 101 issues. The Supreme Court is stacked with eggheaded liberal arts instead of practical science/engineering majors, and 35 USC 101 is too blunt of a litigation tool. Instead, the case should have been decided 102, 103 (validity), and 283 and 284 (remedy) grounds, e.g., whether Ariosa should be enjoined and/or pay royalties for what seems to be a novel and nonobvious patent.

    1. 1.1

      Agreed. That are confusing things and gutting way too many patents regardless of whether the claims were novel, non-obvious and extraordinarily useful.

      Just look at this invention. Provides a much better alternative compared to what used to be done.

      Why not reward these innovators?

        1. 1.1.1.1

          I’m not sure that lobbyists are at fault. It’s the fault of judges and/or claim drafters. I wonder what would happen if every independent claim began with:

          A new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, comprising …

          This preamble would determine whether judge are solely at fault.

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