Patent Law Exam: Questions 2-4

This year I gave a very straightforward patent law exam that was worth 30% of the student grade. The remaining 70% was based upon a series of graded projects during the semester that included drafting claims, drafting office action rejections; drafting responses to rejections; problem sets; case summaries; briefing a mock-appeal; and holding oral arguments in our 3rd Annual Patent Law Moot Court at the University of Missouri. – Dennis

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2. Bob’s patent application is directed to a replicating in vitro cell culture of human embryonic stem cells capable of living without differentiation on a fibroblast feeder layer. Is the application subject-matter eligible? (100 words)

3. Referring back to Bob’s application, it turns out that Bob came up with a working model of the invention and then waited 11-months to file his patent application. Meanwhile, about six-months before Bob filed his application Cindy independently created a replicating in vitro cell culture of pig embryonic stem cells capable of living without differentiation on a fibroblast feeder layer.  Cindy immediately published her work in Science magazine.  Identify three additional facts that would help you know whether Cindy’s publication counts as prior art against Bob's pending patent application and indicate the relevance of those facts. (100 words). 

4. Referring back to Bob’s application and Assuming that Cindy’s publication counts as prior art under 35 U.S.C. 102(a), what is the most likely reason why the Bob’s application would be rejected as unpatentable? (20 words). 

34 thoughts on “Patent Law Exam: Questions 2-4

  1. 2. Bob’s patent application is directed to a replicating in vitro cell culture of human embryonic stem cells capable of living without differentiation on a fibroblast feeder layer. Is the application subject-matter eligible? (100 words)No, because while the claim states that the cells are “capable of” liviing without differentiation on a fibroblast feeder layer, there are no limitations in the claim that exclude isolated human embryonic stem cells per se. By analogy to the Supreme Court’s decision in Myriad, mere isolation of such cells is not enough to confer eligibility to otherwise ineligible subject matter.The claim might also be found ineligible as an attempt to claim a “new property” of an old composition (i.e., isolated embyronic stem cells) without any description of a novel structure which confers that newly discovered property to the cells. In that sense, the claim is ineligible for attempting to claim a new scientific principle itself (as in Prometheus) or an abstraction.

    1. MM: “There are no limitations in the claim that exclude isolated human embryonic stem cells per se.”"…without differentiation…”Is this a property of wild embryonic stem cells, or must they by changed in some fashion?

      1. Is this a property of wild embryonic stem cells, or must they by changed in some fashion?Ask the inventor of the claim. The claim recites a culture with embryonic stem cells, wherein the cells are “capable” of something that apparently is “new” (or believed to be, by whoever filed the claim). Whether the cells are modified in some manner to permit this “new” functionality or whether there is something magical about the culture conditions is left for everyone else to figure out apparently.Oh wait — perhaps all those pesky details are in the specification, you say? That’s unfortunate because the claim only recites the desired function, which could be achieved in a gazillion different ways as far as anyone knows. Is this what we grant patents on now? New “functions” for old compositions of matter? You disclose one solution in your specification (or not even one solution, if you’re claiming, e.g., a new function that’s “enabled” by software that nobody’s written yet but is apparently “enabled” for every operating system on earth immediately upon description of the desired debugged functionality) and then you get all the rest of the solutions for the next twenty years?The patent system is broken.

        1. “The patent system is broken”Um, Malcolm, you do realize that this was a test question made up by Prof. Crouch, right?You can rest your Crusade a bit now.

          1. you do realize that this was a test question made up by Prof. CrouchHe didn’t make the question up out of thin air. There’s a pretty big case pending with claims not dissimilar from the claims in the question. Dennis has written about that case, too.link to patentlyo.com

            1. LOLYou link a thread on standing with no discussion of the claims to the claims here. I notice that you did not join into the conversation on that thread either, that you recently posted in ignorance of what Ned had discussed on that thread, and that you still play your games including your favorite of Accuse-Others-Of-That-Which-You-Do.Try something different Malcolm, your current rhetorical practices are not working.

            2. “You link a thread on standing with no discussion of the claims to the claims here. I notice that you did not join into the conversation on that thread either, that you recently posted in ignorance of what Ned had discussed on that thread, and that you still play your games including your favorite of Accuse-Others-Of-That-Which-You-Do.”W t f are you babbling about? He’s critiquing the claims in that case. He never said there has been previous critique or accused any others of anything he himself is doing you ta rd.

    2. In other words, you agree with me.Why didn’t you just say so? (well I got a little ahead of myself – Malcolm now thinks an actual product is ‘an abstraction’….).6,That has never ever ever stopped you before. Are you feeling ok?

      1. you agree with meReally? I agree with you? Or do I agree with your “devil”? Either way, it’s impossible for anyone to determine what you are saying. I suggest next time you try writing statements which express your views and arguments directly instead of just spouting your usual incomprehensible innuendo in response to what others have written.

        1. LOL – the “What are you saying?” gambit.How banal.Check out Chisum – he (amongst quite a few) appears to understand exactly what I have postedSort of like Myriad – remember that? 30,000 plus mewling words of QQ from you and still not those little three words…

          1. the “What are you saying?” gambit.Not a “gambit.” Just a question. I’m sure you get asked that question a lot. And I’m sure you always answer it with an insult.

      2. “That has never ever ever stopped you before. Are you feeling ok?”Actually that happens all the time. You just don’t see the posts because they never happen.

        1. That’s down right scary given all the threads that you do not stop and desist from posting when you clearly do not hesitate to post with no understanding of the facts (or law).

    3. “limitations in the claim that exclude isolated human embryonic stem cells per se”I was hesitant to answer the question since I did not understand the facts well enough to know this.

  2. 2. While a claim to the human embryonic stem cell per se is ineligible as claiming a product of nature, a claim directed to a culture on a man-made fibroblast feeder layer is a man-made article of manufacture and is therefore eligible regardless that one element might be a product of nature.3. Fact one: was the description of the process in the science magazine enabling? Fact two: did the article describe that Cindy’s invention was reduced to practice? Fact three: was Bob’s application filed prior to March 16, 2013?4. Obviousness based upon section 103: one of ordinary skill in the art would obviously try to use the Cindy “process” with human embryonic stem cells.

    1. 2a. To play the devil’s advocate, please elucidate the structural difference of the stem cell on the fibroblast layer (noting that what is claimed is only the fact that the stem cell is capable of living without differentiation on that layer and that the layer itself is NOT a claim element.)2b. Isn’t the point here the law regarding ‘related to’ human claiming…?4. Is the difference between human and pig cell use/viability sufficient to differentiate? After all, any chemical, biochemical, even manufacture claim is “merely” the obvious use of well-known items old in the universe (electrons, protons and neutrons) using laws of nature also old and well known…. (OK, that last bit doesn’t fit well, but you can figure out the gist)

      1. Re: 2a. If the culture includes various non-naturally occurring substances or is made up of genetically engineered cells, that might be enough to evade the product of nature exception. I would think such a culture would have “markedly different characteristics” from naturally occurring stem cells. On the other hand, if the culture is merely made up of isolated, purified stem cells, then that’s probably not going to work, per Assoc. for Molecular Pathology.Re: 2b. If the culture is capable of living without differentiation, then that would seem not to be “directed to or encompassing a human being”, as a human being is necessarily made up of differentiated cells. On the other hand, if the stem cells could be coaxed into forming a viable embryo, then I think that could be problematic. Perhaps Bob could get around that with a disclaimer, which would still allow the claim to cover using the stem cells to, e.g., grow individual organs.

        1. Why is something that could be coaxed, with additional steps or processes, to become a human being a human being in fact? I would think that to be a human being, the object must become a such on its own without being further prodded or coaxed.

            1. The abortion “debate” hah. Calling it a debate gives it too much credit. It looks to me to be naught but a bunch of people with “beliefs” politically fighting people who have knowledge.

      2. 2a. Claim as a whole. You are ignoring a claim element.2b. Could be that human was intended to invoke the statute that humans could not be claimed. I was thinking of that. But the stem cells are not humans — or are they?4. Regardless that they are different, I still think one would try the technique with human stem cells.

        1. More devil’s advocacy for your amusement Ned…:2a. Yes, claim as a whole. re-read the claim. Note that you are reading into a claim a limitation not actually there (the layer itself is not a claim element).2b. Note the distinction between “related to” and a human itself per se. The AIA’s version is NOT a human itself per se, and the (in)famous prior congressional record dialogue (and negotiated terms) is different for the AIA than the previous versions in which the “related to a human” provision was offered. You need to actually dig down into the details here to get the rest of the story.(note too that that rest of the story is not dependent on actual ‘human’ standing [re: human as a (legal) person], and thus the abortion debate is nothing but a red herring)

          1. 2a. You need to prove the layer to prove infringement. I don’t understand how you can think the layer is not part of the claim.2b. What distinction are you making?

            1. Ned,2a. Read the claim again – the layer is not an element in the claim. I don’t understand how you think the layer is an element in the claim.2b. What part of the difference between “related to” and a human itself per se are you having trouble understanding?

            2. 2a. Sorry, but not good enough to say “we disagree.” The claim does not include the layer. All the claim includes is “human embryonic stem cells capable of something. You need to accept what is presented.Add (and reordered for clarity): I see now the disagreement:You: a replicating in vitro cell culture of human embryonic stem cells on a fibroblast feeder layer. removing the “capable of living without differentiation” only.Me: a replicating in vitro cell culture of human embryonic stem cells capable of living without differentiation on a fibroblast feeder layer. – the layer being where the cells (alone claimed) are capable of living without differentiation. 2b. Again, what do you not understand in the fact that there is a difference between “related to” and a human itself per se? Do you need me to provide a definition of the phrase “related to?”Try: related: being connected either logically or causally or by shared characteristics;

            3. 2a. I see your point and agree.2b. I would like you to tells us what you are talking about. You assume that we (or at least me) know the basics. I do not. I never followed the debate about “humans” and do not understand the distinctions you are making.

            4. concerning the agenda pushed heavily by the ‘distinguished’ congressional leader from Florida that found its way into the AIA (sans the background earlier pushed, including key trade-offs) in earlier sessions of Congress. Since those earlier sessions of Congress are NOT a part of the AIA, the plain reading of the AIA is much broader than many suspect when it comes to the language of “related to.”

            5. Anon, are we talking about this? AIA 33(a) LIMITATION.—Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. If we are, I think you are saying that it was intended to forbid patents on human embryonic stem cells. Right?

            6. Yes.Check out the congressional history of this section – and the ‘related’ congressional history of past attempts to write this section into law.The rest of the story makes for an interesting read.

            7. Not yet Ned – dig into the congressional record first. Note the tradeoffs in the prior ‘negotiations’ and how explicit items were not offered in the last congressional go around.

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