Chao & Mapes: An Early Look at Mayo’s Impact on Personalized Medicine Patenting

Many predicted that the Supreme Court’s 2012 decision in Mayo v. Prometheus would have a major impact on the patenting of personalized medicine inventions, such as those at issue in Sequenom. In their Patently-O Patent Law Journal essay, Professor Bernard Chao and Amy Mapes (Denver ’17) take a look at the data:

The percentage of office actions that contain § 101 subject matter eligibility rejections abruptly increased after Mayo [for Personalized Medicine patent applications]. . . . The percentage of such rejections then continued to gradually increase every year until last year. . . . Mayo has significantly increased patent eligibility rejection rates at the patent office for at least one class of patents.

Chao & Mapes present this early look as a mechanism for providing some context for the Sequenom v. Ariosa case whose petition for writ of certiorari is pending before the United States Supreme Court.

Read the Article: Bernard Chao and Amy Mapes, An Early Look at Mayo’s Impact on Personalized Medicine, 2016 Patently-O Patent Law Journal 10.

56 thoughts on “Chao & Mapes: An Early Look at Mayo’s Impact on Personalized Medicine Patenting

  1. According to Hal Wegner, link to laipla.net

    “The Patent Office should revise its procedures to mandatorily examine any case with a patent-eligibility issue under 35 USC § 101 by, first, requiring the Examiner to make a complete action on the merits as to patentability (§§ 102, 103, 112) and then, if and only if, there is clearly patentable subject matter, a second examination at the level of the PTAB should be conducted for patent-eligibility.” [Makes sense to me]

    1. Hal “tour de farce” Wegner and his acolytes at his old firm have been notoriously (and presumably willfully) behind the learning curve on subject matter eligibility for many years now. Is the Florida water likely to change that? I doubt it.

      Mandating that “Examiners make a complete action on the merit as to patentability first” is an absurd requirement. If it takes two seconds to look at a claim and determine that it’s protecting an ineligible correlation, why on earth should the Office waste its time with 102, 103 and 112? If applicants can’t be bothered with the basics, why should the PTO have to waste its resources?

      Maybe Hal should exercise his dwindling muscle trying to force the Federal Circuit into “mandatorily” discussing every validity issue raised by the parties, even when most of them are mooted by the fact that invalidity under one of the statutes (or ineligibility) is a slam dunk.

      What should be mandatory is a first check for blatant subject matter eligiblity transgressions followed by a re-check each and every time the applicant amends his/her claim in response to art-based or other statute-based rejections. Why is that? Because subject matter eligibility is important and because desperate applicants are prone to wade into the swamp when they’ve got nowhere else to do.

      Makes sense to me

      Why does Hal’s proposition makes sense to you? Share your reasoning.

      1. Why don’t you post here more often and with longer posts? I mean, as of 4/4 at 2:47pm, you’re unfairly under represented and only have about 80-90% of the text in the comments.

        1. He’s only posting here 2 hours a week. On average. This is one of those 27 hour weeks. But on average, he’s only posting here 2 hours a week.

          1. It is not inte11ectually honest to average in time before this blog existed.

            This past February marked his Decade of Decadence. There is NO possible way that he has a “two hour a week” average.

            1. At some point Dennis will have to take responsibility for allowing this blog to be run by K Street bloggers. They have pushed the propaganda over and over again. Such nonsense from MM. Dennis is responsible for this. He should ban paid bloggers.

    2. Fish, Consider printed matter. That is excluded from novelty and obviousness, given no weight, because printed matter is not statutory.

      So, if there is ineligible subject matter in a claim, how in the world is one going to properly examine it for novelty and obviousness unless such is identified and given the weight or lack of weight it deserves?

        1. Consider the exceptions to the judicial doctrine of printed matter…

          Consider the instances where it takes two seconds to figure out that there are no “exceptions” that are going to save the claim.

          Or just bow down and kiss Hal Wegner’s feet because … Hal Wegner! He’s super serious and never, ever puts those feet in his own mouth.

  2. From the article:

    Any decision the Supreme Court makes on patent eligibility should be made with an understanding of how its decisions have impacted actual patent applications on new medical technologies, particularly in the emerging field of personalized medicine.

    Looks like at least one of the authors is fully bloated on the k00l-aid.

    The term “personalized medicine” is simply a buzzword used by industry to move product and attract those oh-so-important investors who are prone to d ump their golden eggs into the hottest trend du jour.

    Not only scientists and doctors but their patients have been practicing “personalized medicine” for literally thousands of years. It’s just another term for “use information about a person when considering what kind of medicine and how much medicine to administer”. There’s nothing “emerging” about that.

    But we all know that when those super shiny comp00ters get into the game, everybody in the patent system has to pretend they were born yesterday. Because … shiny! And $$$. Ka-ching! Giant piles of glorious green money. Yum!

    The reality is that computers have made the storage and processing of information easier. That’s why computers were created. That was a long time ago. The reality is that collecting ge netic information is easier because of techn0l0gy such as DNA sequencing and PCR — techn0logies that were created for that purpose a long time ago. The reality is that searching a collection of data for matches and identifying correlations is also an ancient concept.

    The reality is that you can’t own or monopolize a correlation with a patent. That was well understood before Prometheus by most people who spent a minute or two thinking about it.

    Chao writes: Up until 2012, the idea of patenting medical breakthroughs was not particularly controversial. Laws of nature, natural phenomena, and abstract ideas were not eligible for patent protection under 35 U.S.C. § 101. However, the vast majority of medical inventions were not classified as mere laws of nature, but instead as patentable applications of those laws.

    There are two major problems with that last sentence. First, as the author admits in the preceding sentence, it’s not just the ineligible “laws of nature” that are implicated but also “natural phenomena” and “abstract ideas”. Second, the author glosses over the critical point that the incorrect “classification” of cleverly scrivened claims as eligible was (and is) the exact issue addressed by the Supreme Court. The whole point of Prometheus v. Mayo is that subject matter eligibility is not a mere formatting requirement where some magic word (e.g., “process” or “manufacture”) gets you over the hurdle.

    Do the authors really think that everyone else is as naive as they are? It gets worse. I’m still trying to wrap my brain around this one:

    We suspect that while there is some hostility to protecting software, most judges and legislators believe that patents on medicines and personalized medicine technology provide important incentives.

    In fact, as every reasonable person understands, what “judges and legislators” “believe” about a topic depends very much on the specifics of what is being discussed.

    For instance, I would be shocked to learn that “most judges and legislators” believe that it is “important” for corporations to own, for 17 years, the exclusive right to interpret the result of an old data-gathering method. What do you think, Chao and Mapes? What does your “research” tell you about that question? That question, of course, gets right to the heart of what was going on before Prometheus and what is going on at the PTO now, whereas your statement about “patents on medicines” goes to something completely different.

    Here’s a question for the authors: What percentage of claims describing novel, non-obvious structurally distinguished therapeutic compositions of matter are being rejected by the PTO under 101 these days? It must be some huuuuuuge scary number! Tell everyone! “Legislators and judges” want to know so they can make an informed decision.

    1. novel, non-obvious structurally distinguished

      …and yet again Malcolm seeks to make an issue one optional claim format…

      Y
      A
      W
      N

      1. Remember when “anon” used to drive-by and recite his vapid scripts 20 times a day using different pseudonyms so he could pretend that he was part of a super serious crowd of fellow True Believers?

        I do.

        And then he was outed by Dennis. Ah, the good ol’ days.

        Go ahead and tell everyone about your alternative “option” for claiming a new drug composition, “anon.” It must be very special indeed. So go ahead. Share it with everyone, in plain English.

        1. Your reply is a non-sequitur to what I point out Malcolm.

          Of course, you already knew that, right?

          How about you first drop your C R P posts and their vapid and faulty rhetoric, and try to stay on point and within a proper legal argument?

          (I won’t hold my breath – happy Decade of Decadence)

          1. Almost forgot — we’re still waiting for you to explain the other “option” for claiming a new drug composition.

            You were talking like a real big boy and then suddenly you went all quiet (except for the mewling and whining). Where’s the substance, “anon”? Is there some problem with your keyboard today? Just answer the straightforward question you were asked in direct response to your own self-worshipping comment. Go ahead. Make everybody’s day.

            LOL

            1. And if you aren’t too busy after revealing the other optional claim formats anon, please cite some authority that says “software is a machine component”. I’ve been searching but I can’t seem to find it.

                1. The standard anon non-answer whenever asked to back up his claims. Typical. I’ll throw you a bone this time, anon.

                  Mr. Snyder: an early (possibly the first) software patentee wrote an article for Patently O about 7 years ago. The author, Martin A. Goetz, wrote “It also explains why software should be viewed [as] a machine component of a general purpose computer (a machine).“.

                  In anon’s black-and-white, no-compromise world view, that “should” becomes an irrefutable, immutable “FACT“, which must be repeated at every opportunity, to drown out anyone who might question the origin.

                  I’ll attempt a link, for them’s what cares:
                  Patently O

                2. Thanks Dobu. His arguments have not aged well.

                  “Definition, Design, Implementation, Delivery, Maintenance, and Enhancements” could describe encyclopedia publishing just as easily as manufacturing.

                  And of course “software transforms a general purpose computer into a special purpose computer (or machine)” has been completely dismissed by the CAFC and USSC.

                  “Asked and answered’ is a lazy response, particularity when never answered.

            2. I said optional claim format – I did not specify for drug compositions.

              Maybe you should pay better attention….

              Or maybe you want to show that your optional choice is somehow NOT an option….?

              (I won’t hold my breath)

              1. “anon” I said optional claim format – I did not specify for drug compositions.

                You are aware, “anon,” that we can all read the thread for ourselves.

                Right?

                Better tr0lls please.

    1. What’s the data on (1) the percentage of applications in that art unit resulting in granted claims over that same time period and (2) the total number of grants in that art unit over the same time period?

      Seems like that info would be far easier to obtain, relatively speaking, then the info obtained and shared by the authors. I wonder why they left it out?

  3. Mayo has significantly increased patent eligibility rejection rates at the patent office for at least one class of patents.

    Of course it did.

    And we should all be incredibly grateful for that. Can you imagine what the system would look like now if the Supreme’s had decided in favor of Prometheus and allowed people to protect correlations with patents? Good grief.

    Note that it’s not only “determine and infer” type patents that are susceptible in 1634 but also claims that protect “naturally occurring” sequences of polymeric nucleic acid and amino acids.

    I’ll also add that misunderstanding of how to apply 101 is largely the fault of the PTO itself and the terrible advice it receives from its “customers”. Examination being a human endeavor, mistakes will always be made. But the mistakes being made now are nothing compared to the mistakes being made before the perfectly predictable and correct decision in Prometheus.

    Question for the insiders: why is Wanda Walker, a person with zero professional training in molecular biology, the Director of the 1630 art unit and for how long has she been in that role?

    1. “Examination being a human endeavor, mistakes will always be made. But the mistakes being made now are nothing compared to the mistakes being made before the perfectly predictable and correct decision in Prometheus.”

      Why is that? It is simply an abstract idea or can be done in the human mind or with pencil and paper and it would be trivial to get a generic computer to do it, and the generic computer would only be doing generic computer functions… receiving information, processing information, outputting information… whats the big deal?

      1. I wrote: “Examination being a human endeavor, mistakes will always be made. But the mistakes being made now are nothing compared to the mistakes being made before the perfectly predictable and correct decision in Prometheus.”

        And Les asked: Why is that?

        The answer is that (1) fewer mistakes are being made now and (2) the mistakes that are being made affect a microscopic number of people whereas the mistakes being made before were affecting the public as a whole.

        Prior to being schooled by the Supremes, the PTO had unofficially adopted the ridiculous position that you could scriven past 101 using magic words or by salting the claim with some old techn0l0gy (e.g., data gathering technology) that might have been eligible when it was new. That practice opened the door to untold thousands of “determine and infer” type claims that protected “inferences” that could be made by practitioners of prior art data-gathering methods. You’ll recall — assuming that you have a brain — that the making of such an inference was the critical final step according to Prometheus’s theory of infringement.

        Any other questions, Les? You’re a very serious person with lots of deep insights. It’s important to make sure you have a say in all this.

        1. My question was a bit more extensive. The GIST of my question is, why haven’t you programmed a computer to do the examination. That would be error free.

          I’m sure for you it would be trivial to get a generic computer to do it, and the generic computer would only be doing generic computer functions… receiving information, processing information, outputting information… whats the big deal?

          1. Les: the GIST of my question is, why haven’t you programmed a computer to do the examination.

            I haven’t programmed a computer to “do the examination” because (1) nobody’s offered me the money to do it and (2) I don’t see any demand for it.

            With respect to (1), I think if “slide to unlock” was worth a few hundred million then “accurately examine all kinds of patent claims for validity” would be worth at least $750 billion. Are you going to pay by check or credit card?

            With respect to (2), I think that people are happy to tolerate a few mistakes in exchange for the benefits brought to the table thanks to the astounding flexibility of the human brain.

            Seriously, though, the fact that you’d find that kind of question remotely relevant to this discussion says a lot about you and your computer-lovin’ cohorts, Les.

            How’s our awesome robot car future doing, by the way?

            link to reuters.com

            Volvo’s North American CEO, Lex Kerssemakers, lost his cool as the automaker’s semi-autonomous prototype sporadically refused to drive itself during a press event at the Los Angeles Auto Show.

            “It can’t find the lane markings!” Kerssemakers griped to Mayor Eric Garcetti, who was at the wheel. “You need to paint the bloody roads here!”

            LOL

            Clearly more patents are needed.

            LOLOLOLOLOLOLOL

            1. “With respect to (1), I think if “slide to unlock” was worth a few hundred million then “accurately examine all kinds of patent claims for validity” would be worth at least $750 billion. Are you going to pay by check or credit card?”

              Well, The Examining corp is a few thousand strong (sorry I dont remember the exact number (2000 – 4000?)). Each of them must earn at least 50,000 a year. So, conservatively, one would assume you could lease your software to the USPTO for $100,000,000 per year. Probably more, because if you get rid of the corp. you don’t need as many managers. And, that just the U.S. . The EPO and the Australian and Canadian offices would probably jump on leases right away. And once you perfect the translations you could go world wide.

              So….hop to it.

              Or are you concerned that once the idea becomes public, someone will copy your invention and undercut you?

              1. are you concerned that once the idea becomes public

                The idea of using a computer to automate data processing tasks performed by humans is already public, Les, and has been public for many years.

                But go ahead and pretend that you were born yesterday! It’s how you guys roll — as I’ve been pointing out to everyone for many years.

                1. Lol – there is Malcolm once again with the “logic” of the Big Box of protons, neutrons, and electrons.

                  Clench tight those eyes even more, pumpkin.

                2. the “logic” of the Big Box of protons

                  Now your magical box includes logic as well as sub-atomic particles?

                  Wow. It really is special.

                  And very serious! Let’s all pay attention to “anon” and his magical box.

                3. “The idea of using a computer to automate data processing tasks performed by humans is already public, Les, and has been public for many years.”

                  Yes, but the particular way YOU come up with for GETTING A MACHINE TO DO PATENT EXAMINATION, is not.

                  The riches are there for the taking MM. Whip up some code this weekend and demonstrate it to the Commissioner next week.

                  Just think of all the good you can do with the windfall as you distribute it to all the patent victims around the world.

                  Or do you think someone would reverse engineer your code and sell copies at a lower price?

                  Too band you can’t patent it and protect all those redistribution funds for the victims.

                4. Les: the particular way YOU come up with for GETTING A MACHINE TO DO PATENT EXAMINATION, is not [public].

                  That depends. There’s been quite a bit of discussion in “the art” about how to logically examine a patent application. Oh but wait! This is “on a computer”. That’s totally different! Sure it is.

                  The riches are there for the taking

                  You always gotta love it when the truth leaks out of the patent maximalists. Yes, there’s been quite a bit of “taking” over the past decade by super “innovative” patent attorneys trying “make it rich off the Internets”, hasn’t there? Surely there’s nothing wrong with that!

                  After all, who doesn’t l0ve to watch attorneys manipulate a system for their own benefit? It’s a favorite pasttime of Americans. Then everyone prays to Saint Ronnie and waits for that money to “trickle down”, which it always does.

                  LOL

                5. MM:”Then everyone prays to Saint Ronnie and waits for that money to “trickle down”, which it always does.”

                  Who said anything about trickle down. Aren’t you going to give all your riches to the poor unfortunate downtrodden copyists that are otherwise harmed by the patent system? There should be no trickle. There should be a deluge as you redistribute your otherwise ill gotten gains.

          2. Here’s the problem. The claim would end up something like this:

            1. A computer/method (all the magic words here) configured to perform patent examination, comprising the steps of:
            -receiving a patent application;
            -parsing the patent application into at least a claim and a specification;
            -analyzing the claim with reference to the specification to confirm conformity with (s)112 requirements;
            -determining a set of search key words based on the claim and the specification;
            -performing a prior art search using the set of search key words to receive prior art search results;
            -selecting a set of art to be applied from the prior art search results;
            -applying prior art from the set of art to be applied using element matching techniques with at least 80% confidence rating;
            -populating an Office Action; and
            -mailing the Office Action; wherein
            -if no art can be applied, the Office Action is an Allowance; and
            -if (s)112 requirements are not met, the Office Action includes a (s)112 rejection.

            There. There’s your “invention.” It’s not that I’m opposed to software patents, per se, but the level of difficulty and complexity of invention in the software arts NEVER appears in the applications and claims as filed.

            1. You don’t have to worry about how to claim it. MM would never attempt to patent the abstract idea of patent Examination.

              MM recognizes that this is merely mental steps that could be done with a pencil and a paper.

              Furthermore, the act of doing a patent search is just a correlation of one set of information with another. When the correlation is high, you have a match, issue a 102 rejection. When the correlation is lower, but you have plural such documents, issue a 103 rejection. Simple logic added to simple correlation and correlations are not patentable. Junk. MM would never attempt to patent that.

              1. MM recognizes that this is merely mental steps that could be done with a pencil and a paper.

                More accurately, it requires a pencil, paper and a brain capable of performing logical operations on data. And some existing technology, like a postal system or the Internet.

                I’m not the only person who “recognizes” this, by the way. There’s a lot of reasonable people out there whose brains don’t liquefy every time a shiny computer is mentioned in a patent claim.

                I know that it’s a popular myth among the crowd Les hangs with that in five years everyone in the country is going to be sitting at home with our “virtual” headgear building virtual highways and driving virtual cars while we farm our virtual food in virtual soil watered with virtual water from the virtual atmosphere.

                But here on planet earth there’s real work to be done, by real people. This can be a very difficult concept for certain types of lawyers to grasp. Go figure.

  4. Its always nice to see actual data studies on controversial law. This study notes that it is based on 774 applications [1 out of every 10] of the published applications examined only in Art Unit 1634 in the time period shortly before and after Mayo v. Prometheus. The result found was 101 application rejections from that data sample rose from 15.9% before Mayo to 86.4% after Mayo.
    Note that may or may not correspond directly to actual final decisions, including Board appeal decisions, because it has been widely reported that some examiners have gone way overboard on applying 101 rejections after Alice in some other art units?

    1. From what has come across my desk, I would say that 86.4 % of all Office Actions (from “other art units”) issued in the past 2 months have included words that give the appearance, at first glance, of being rejections under 35 USC 101. That is to say, they are usually incomplete or incoherent when one looks a bit closer. However, they are there and have to be dealt with.

        1. Here is a quote from one: “All the steps can be performed by human-being using a computer/processor, therefore it is an abstract idea…”

          That’s using a computer/processor, not pencil and paper mind you, a computer/processor… aaaaargh.

      1. For electrical engineering cases, the PTO/Examiners have also seemed to drop the term “Alice” from these rejections. I’m not sure why that is. That is, they don’t use the term “Alice” but use the abstract idea language.

        1. Do they at least use “101”? This information will help as we move to an automated system for coding. I am not sure if we will move on to software because that seems fairly well understood. But just in case . . .
          thanks Bernard

          1. Unless the rejection is really, really poor, they do use 101. Here’s an example (paraphrased): “Claims X to Y are rejected under 35 USC 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.” So, 101 is mentioned, but there’s no mention of “Alice” anywhere I can find.

            I’ve had other rejections where I had to read between the lines to determine it was a 101/Alice rejection, but those are relatively rare.

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