Patents Encompassing a Human Organism

by Dennis Crouch

Ex Parte Kamrava (PTAB 2012), APN 10/080,177  Download 10080177

Most Section 101 subject matter eligibility problems can be cured by integrating the ineligible subject matter with subject matter that is patent eligible. This works because the fact that an invention encompassing some ineligible material does not preclude patentability – as long as the invention also includes sufficient eligible subject matter. Following this theory, the Supreme Court in Diamond v. Diehr, 450 U.S. 175 (1981), agreed that a practical use of a mathematical formula was patentable even though the formula on its own would not have been subject matter eligible. 

120112_1347_PatentsEnco1One exception to the cured-by-integration rule involves the patenting of human organisms.  Generally speaking, a patent clam cannot encompasses a human organism and likewise, a claim encompassing an otherwise unpatentable human organism will not become patentable by integrating elements that are subject matter eligible. Following this rule, applicants typically carve-out offending portions of their claims. Thus, recently issued U.S. Patent No. 8,283,517 claims a "transgenic non-human animal" with certain genetic properties that result in alzheimer's-like brain plaques. Likewise, U.S. Patent No. 8,247,644 claims a "method for manufacturing a non-human animal" that is likely to develop a pulmonary tumor. The PTO sees these as subject matter eligible because they have disclaimed any coverage for human animals.

In Kamrava, the patent is generally directed toward a uterine catheter that can be used to deposit a fertilized embryo. Some of the claims also include the embryo as an element of the claim itself with "the catheter … further comprising an embryo in the distal portion." In its November 26, 2012 decision, the Patent Trials and Appeals Board (PTAB) concluded that those claims could not be patentable.

Focusing first on Section 101, the board noted that an embryo is subject matter ineligible because it is a part of the human body. Further, the combination of the ineligible subject matter with the eligible subject matter catheter offers no cure. "To allow one to sidestep 35 U.S.C. §101 by simply pairing in combination patent-ineligible subject matter with patent-eligible subject matter would impermissibly exalt claim strategy (form) over claimed subject matter (substance)." As a second ground of rejection, the Board raised the new Section 33(a) of the Leahy-Smith America Invents Act. That section prohibits the patenting of "a claim directed to or encompassing a human organism."

The PTAB's form-over-substance statement loses significant weight because, in the same paragraph, the Board note that the claims may become eligible by a simple amendment. As the Board notes, on remand to the examiner, applicant can rather easily cure the defect by claiming a catheter "adapted to hold the embryo" rather than claiming a catheter that includes the embryo. The U.S. does grant patents on non-human organisms, such as a genetically modified mouse, soybean, or bacterium. Canada denies patentability on multi-cellular organisms.

The issues presented here have obvious potential ties to the Myriad gene patent case. However, while most practitioners would agree with the idea that human organisms should not be patentable, the bar is much more divided on the question of the patentability of chemical compounds isolated from a human body, and almost all practitioners agree that methods of treating diseases in humans should be patentable. This case is likely most helpful for those supporting Myriad because it indicates that congress and the PTO have both considered the issue and have drawn a line that prohibits certain patents too closely tied to the core of humanity but allows for the patenting of genes.

The language of Section 33(a) was initially pushed by Representative Dave Weldon as a measure to support the sanctity of life. Although Weldon was out of Congress by the time the AIA passed, he spoke on the issue several times. Most poignantly, Weldon spoke on the issues in 2003 after receiving some initial criticism for his proposal.

[S]ome have continued to misrepresent my amendment by claiming it would also prohibit patent claims directed to methods to produce human organisms. Moreover, some incorrectly claim that my amendment would prohibit patents on claims directed to subject matter other than human organisms. This is simply untrue.

What I want to point out is that the U.S. Patent Office has already issued patents on genes, stem cells, animals with human genes, and a host of non-biologic products used by humans, but it has not issued patents on claims directed to human organisms, including human embryos and fetuses. My amendment would not affect the former, but would simply affirm the latter.

At the time, PTO Director James Rogan also submitted a letter to Congress indicating that the language was already "fully consistent with [current PTO] policy." (Note, parallel language has been regularly included in PTO appropriations bills that prohibit the PTO from spending money on issuing patents directed-to or encompassing human organisms.)

These issues will be interesting as we move forward with the gene patent debate. However, the history of patentability limitations suggest that, unless the Supreme Court takes a radical step in its decision, skilled patent attorneys will continue to be able to protect innovations through the patent system.

There is unlikely to be any successful appeal of this case to the Federal Circuit. Importantly, the applicant had not challenged the notion that an embryo is a human organism. Rather, the applicant argued that the examiner had erred in the claim construction and that the proper claim scope did not include the embryo.  In addition, the applicant's patent attorneys at Blakeley Sokolof have withrdawn from the representation and Dr. Kamrava's medical license has been revoked

50 thoughts on “Patents Encompassing a Human Organism

  1. Where is MM and the promised substantive discussion that was to be had while anon was taking his nap?

    Interesting. Do you often feel that others are letting you down by failing to live up to their promises,anon? Or is it just this “MM” character?

  2. But this isn’t about me, is it?

    Your butting in on the wrong side of who needs to deliver answers does appear to make it about you. The better question, and one you should have asked, is: Where is MM and the promised substantive discussion that was to be had while anon was taking his nap?

    And I venture to say it’s not really about MM, either.

    I’d venture to day that you would be dead wrong on this. You should have MM on the couch, explaining why he cannot seem to be bothered to actually have adult conversations (for all the QQ’ing that he does, very little of anything of value seems to be forthcoming). Now, doesn’t that bother you?

  3. Curious too, that you don’t seem too concerned with getting answers from MM, especially when he says he will give them (and of course, never seems to get around to it).

    But this isn’t about me, is it? And I venture to say it’s not really about MM, either.

    Go ahead, make yourself comfortable. Now, tell me about your childhood, anon.

  4. And by the way, I notice that you don’t address the fact that your post at 7:16 is shown to be in error, but only delve to throw insults my way.

    Seems to be quite a pattern…

  5. Fascinating, what you call pathology.

    Curious too, that you don’t seem too concerned with getting answers from MM, especially when he says he will give them (and of course, never seems to get around to it).

  6. Even more impressive Oliver is the fact that you miss MM’s comment on December 4th at 11:20 – clearly he was NOT ignoring all my comments and clearly he was suggesting that he would talk substantively on the topic (and clearly, my post is in reference to the timing of his post – no fooling).

    But that’s all I ever seem to see from MM – the talk about later talking. Ask him a question and you never seem to get an answer with any substance. He seems to always have a weasel out or a “clarifying” question, or he loses his understanding on what “effectively” means or some other B$ excuse – but never a substantive answer.

    Hey, I was looking forward to MM talking substantively about anything. Whenever he tries that, he sticks his foot in his mouth and we get to add to things that he self-defeats on.

  7. Impressive, anon. MM announces on Dec. 2 that he’s going to ignore all of your comments, so you spend the next nine days crowing about the fact that MM hasn’t said anything on this thread. Are you even fooling yourself with this one?

  8. My apologies to the good Professor Crouch for misspelling his name in my post. None the less my appreciation for seeing an esteemed member of the Patent Community acknowledge the existence of the Court’s use of “Integration” for determining 101 statutory subject matter still stands.

  9. Almost two more days and still nothing of consequence from MM. Surely in the past two days, I must have had some afternoon nap time for him to discuss these things in a substantive manner, and yet, nothing from MM.

    Maybe he has run away and forgot his way back.

  10. LOL right back at you.

    See my Dec. 2, 11:30 pm comment, anon.” the one you finally admit to reading the case but don’t change any of your posted absurdity made before you bothered reading the case?

    See my comment at 8:32 PM Dec 3rd for a fitting response.

    As to substantive comments, and even alienating “regulars,” to the first the record does in fact show just how much more substantive points I bring to the table, and to the second, your warm and (overtly hostile – rampant insulting) mature style gives you such a great low road to look up at comment at my postings.

  11. you’ve already had more than two full days

    See my Dec. 2, 11:30 pm comment, anon. Everyone can scan the threads from the last few days and see for themselves how much “substance” you contribute. Too bad about your sockpuppets, huh? It’s impressive how quickly you managed to insult and alienate most of the regular commenters here. Todd Aiken called and he wants his reputation for subtle, thoughtful comments back. LOL.

  12. I look forward to your substantive comments at that time MM (but you will excuse me as I do not hold my breath and wait for any such things to appear – you’ve already had more than two full days and ‘pfffft’ nothing of any consequence from you).

  13. The silence is curious.

    People are more willing to discuss these things when folks like you are taking their afternoon naps, anon.

  14. Anon,

    Most of the cases at the PTO in this area were not drawn to embryos, but rather either to “crazies” trying to claim human beings themselves, or to chimeric humans. There have been rejections on these cases on all grounds, from 101 to 13th amendment, depending upon the Examiner. The new legal exclusion simply gives real authority to the USPTO to reject these without having to stretch other statutes. There was the famous human/ape chimeric case which might be published, but most of these were never appealed and will not show up in any database.

  15. …until one realizes that MM has never played the deal with topics in a professional and substantive manner game.

  16. Aside from MM’s obvious trainwreck diversion, does no one want to touch the delicate balance evident in the sanctifying exclusion from patent coverage of things human that flows from this decision’s AIA Section 33(a) basis?

    Would I digress if I were to point out that the facts of this case deal explicitly with a human embryo (rightfully calling into the policy picture the pro-choice/pro-life divide), rather than isolated human DNA or even of isolated human antibodies? If you lean towards the pro-choice side of the fence, then even a human embryo should be every bit as patent eligible as the human DNA or human anti-bodies that the good professor indicates as acceptable. Pray tell, what is the policy difference that would apply in the patent world to the exclusion of the rest of the legal world (a la eBay)?

    The silence is curious.

  17. Just one more point 6, software is not a Court created Judicial Exception. Software is just one of the many methods such as business methods, medical methods, etc. that falls under the broad category of process, and thus deserves the same integration analysis for statutory subject matter.

  18. “I’ll waste my time addressing your drivel in another month or two,”

    Drivel?

    Integration, is not drivel.

    Integration is a Court sanctioned analysis for what “is” statutory subject matter.

    Established in Diehr.

    Relied on in Prometheus.

    Incorporated in the Office Guidelines.

    And recognized by our host and owner of the blog, Dennis Couch.

    As a self proclaimed Patent Attorney one would think you could deal with the topic in a more professional and substantive manner.

  19. Explain please

    LOL – he is far too busy telling other people that they are not cogent in insulting manners to be bothered with actually adding anything substantive to the conversation.

    BTW, did you ever read the Office Guidance on Integration?

    Not likely, but he does have a pretty link to them that he does not mind sharing.

  20. Written description rears its head.

    …checks into the actual specification and realizes that 6 is only emulating MM by not checking into the actual case prior to making comments, and lays its head back down.

  21. further comments by you in this thread pre-ignored

    LOL – you wish you could stay away from my comments, my personal little troll.

    But you might want to try to actually add to the discussion rather than standing by comments that only earn you laughter (“at” not “with”).

  22. The revocation of the inventor’s medical license is relevant to the discussion at hand. I’m surprised you stooped to the level of mentioning it.

  23. software, integrated into a process

    Assuming the answer.

    Explain please,

    Oh, and do try and be cogent.

    ::Silence::

  24. software, integrated into a process

    Assuming the answer.

    Thanks for playing. I’ll waste my time addressing your drivel in another month or two, maybe.

  25. There is no assumption in the question. The Court in Prometheus did tell you
    9-0, a judicial exception, ( in that case a LoN) integrated into a process transforms the process into an inventive application of the Judicial Exception.

    So the question stands as valid..why then can’t technology, such as software, integrated into a process transform the process into an inventive application of the software?

    Now if you are assuming software is not technology then you need to prove that assumption.

    Otherwise you have no credibility on this issue.

    BTW, did you ever read the Office Guidance on Integration?

  26. Everybody has an opinion:

    link to rightwingwatch.org

    You know the scripture said it is the glory of God to conceal a matter and it is the glory of kings to search it out. […]You know, God’s buried those treasures there because he loves to see us find them and put them to use.

    Spread the word!

  27. have you bothered to read the case yet?

    Yes.

    And I stand behind my comments, especially my 10:22 pm comment. Maybe someone else can make sense of your blathering. I won’t hold my breath and you can consider all further comments by you in this thread pre-ignored by me. Have fun, kid, and keep your hand out of the foetus jar.

  28. accusing others of what he does

    *yawn*

    It’s ridiculous to link the USPTO’s longstanding prohibition against claims that cover non-embryonic human cells in vivo (which are typically self-replicating, by the way) with a “pro-choice” or “pro-life” position. If that’s not what you were doing in your 11:26 comment then your comment is even more incoherent than it seemed at first glance (which was merely “nearly completely incoherent”).

  29. why then can’t technology, such as software, integrated into a process transform the process into an inventive application of the software?

    If assuming the answer to my question allows me to integrate the question with the answer, when then can’t the answer be integrated with the question in a manner which allows the question to answer itself?

  30. ” “To allow one to sidestep 35 U.S.C. §101 by simply pairing in combination patent-ineligible subject matter with patent-eligible subject matter would impermissibly exalt claim strategy (form) over claimed subject matter (substance).”

    If the PTAB follows the Office Guidance on “Integration” this need not be a problem at all. Using the Courts line of 101 cases as the lens thru which to determine when claims are “integrated” it is apparent that a new and useful process claim in general has a clear presumption of “Integration” and the presumption remains valid, and requires no further analysis under 101 unless the claims as a whole recite;

    1. A bare Court created Judicial Exception, (derived implicitly from the Congressional Statute of 101) or

    2. The first element of the claim is a bare Court created Judicial Exception, (derived implicitly from the Congressional Statute of 101) followed by additional steps that apply the Judicial Exception. In the case of the latter, extra-solution analysis, (pre or post ) occurs to determine if the claims are integrated. What follows is a brief synopsis of how the Court has applied “Integration Analysis” in each of the 101 cases, which the PTAB and every Examiner can used as a guide post.

    The Supreme Courts Integration Analysis

    Synopsis
    Benson = (Non Integrated)

    Reason/Analysis: Begins with a bare Court Created Judicial Exception of an algorithm followed by additional steps that apply the the Judicial Exception.

    Flook = (Non Integrated)

    Reason/Analysis: Begins with a Bare Court Created Judicial Exception of math followed by additional steps that apply the the Judicial Exception. Extra solution ( pre or post ) analysis required.

    Diehr = (Integrated)

    Reason/Analysis: Claims as a whole are not a bare Court created judicial exception, nor does the first element of the claims begin with a bare Court created judicial exception followed by additional steps that apply it. The claims maintains their presumption of “Integration” and are therefore integrated and statutory subject matter.

    Bilski = (Non Integrated)

    Reason/Analysis: Claims as a whole are a Bare Court Created Judicial Exception of a math formula. No extra solution (pre or post ) analysis required.

    Prometheus = (Non Integrated)

    Reason/Analysis: Claims begins with a Bare Court Created Judicial Exception of a Law of Nature followed by additional steps that apply the the Judicial Exception. Extra solution ( pre or post ) analysis required.

  31. 6 Wrote: “Obviously, and yet we give computerlol claims a pass on this like all the time due to people’s misunderstanding of the “theory” you referred to before.”

    Again, if the claims achieve integration you are required to pass them at least at 101, irregardless of the subject matter. As I have asked on this board before. Since the Court told you 9-0, a concept integrated into a process transforms the process into an inventive application of the concept, why then can’t technology, such as software, integrated into a process transform the process into an inventive application of the software?

  32. 6 wrote: “The only “theory” relied on in Diehr was that the applicant was not attempting to claim the Arrhenius equation.”

    What you fail to understand is that the reason why the Court did not hold the “Arrhenius equation” was the claimed invention is that the Arrhenius equation was “integrated” with all the other steps in the invention.

    Thus, a Court created Judicial Exception integrated into process as a whole, transforms the process into an inventive application of the Judicial Exception ( Concept, Equation, Formula, LoN/Physical Phenomenon) and is statutory subject matter by law.

  33. Dennis Couch wrote: “Most Section 101 subject matter eligibility problems can be cured by integrating the ineligible subject matter with subject matter that is patent eligible.

    101 Integration Expert wrote: First I want to thank Professor Couch for his leadership in broaching the subject of the Court’s “Integration”. Let’s hope this is the beginning of other patent professionals following suit and engaging in substantive discussion of the use of “Integration Analysis” to establishing a claim is patent eligible under 35 U.S.C. § 101

    Dennis Couch wrote: “This works because the fact that an invention encompassing some ineligible material does not preclude patentability – as long as the invention also includes sufficient eligible subject matter. ”

    101 Integration Expert wrote: This is also correct and what I would add is that the analysis for whether an invention encompasses sufficient eligible subject matter.” is an extra ( pre or post ) solution analysis that properly occurs only when a claim begins with a bare Court created Judicial Exception, (derived implicitly from the Congressional Statute of 101) followed by additional steps applying the Judicial Exception. Then of course the Court proceeds by looking at each individual element to determine if the steps as an ordered combination adds something more to the judicial exception that is not already present when the steps are considered separately.

    “Finally, considering the three steps as an ordered combination adds nothing to the laws of nature that is not already present when the steps are considered separately.” ( Opinion of the Court 11, Prometheus V Mayo 566 U. S. ____ (2012) )

  34. “As the Board notes, on remand to the examiner, applicant can rather easily cure the defect by claiming a catheter “adapted to hold the embryo” rather than claiming a catheter that includes the embryo.”

    Written description rears its head.

  35. ” “To allow one to sidestep 35 U.S.C. §101 by simply pairing in combination patent-ineligible subject matter with patent-eligible subject matter would impermissibly exalt claim strategy (form) over claimed subject matter (substance).” ”

    Obviously, and yet we give computerlol claims a pass on this like all the time due to people’s misunderstanding of the “theory” you referred to before.

  36. “This works because the fact that an invention encompassing some ineligible material does not preclude patentability – as long as the invention also includes sufficient eligible subject matter. ”

    That isn’t really the “theory” relied on in Diehr…

    The only “theory” relied on in Diehr was that the applicant was not attempting to claim the Arrhenius equation.

  37. MM: “I haven’t read the case…

    Read the case first, then attempt irony, less it is your expense the laughter comes at.

    Irony that MM self-defeats accusing others of what he does and gets laughed at himself.

  38. “Generally speaking, a patent clam cannot encompasses a human organism…”

    I’m curious under what conditions a clam COULD encompass a human organism.

  39. Why not check into Weldon’s past?

    As anyone whose been prosecuting biotech patents for years will tell you, the prohibition against claims which cover human beings or human cells in vivo predates Mr. Weldon’s involvement with the issue. That’s why the existence of 33(a) was not a necessary part of the USPTO’s rejection of these claims.

    mindless snap retorts

    *yawn* I’ll just let your jerky comment speak for itself, anon. Even if you can’t appreciate irony, everyone else can have a little laugh at your expense.

  40. Dennis: Some of the claims also include the embryo as an element of the claim itself with “the catheter … further comprising an embryo in the distal portion.” … Focusing first on Section 101, the board noted that an embryo is subject matter ineligible because it is a part of the human body. Further, the combination of the ineligible subject matter with the eligible subject matter catheter offers no cure. “To allow one to sidestep 35 U.S.C. §101 by simply pairing in combination patent-ineligible subject matter with patent-eligible subject matter would impermissibly exalt claim strategy (form) over claimed subject matter (substance).”

    I haven’t read the case but the analysis above misses the point and confuses some key issues.

    Catheter’s are eligible subject matter. If I invent a novel, non-obvious catheter, there is no 101 issue presented by claims to methods of using that catheter to deliver human embryos into or out of a human being. Likewise, there is no 101 issue presented by dependent claims that recite “wherein the catheter comprises an animal cell” or “wherein the animal cell is a human cell.” It’s still a catheter and there is no “part of a human being” that is encompassed by the claim unless it is understood that catheters are “parts of human beings.” That seems more than a bit silly.

    Are stents “parts of human beings” as well? What about gloves? If I claim a novel glove do I need to include a literal disclaimer indicating that the claim doesn’t cover the same glove with a human hand inside?

    What about a novel space-ship? Does it become ineligible subject matter if I include a dependent claim that recites “wherein said space ship comprises a human being”? Seriously?

    The PTAB’s form-over-substance statement loses significant weight because, in the same paragraph, the Board note that the claims may become eligible by a simple amendment. As the Board notes, on remand to the examiner, applicant can rather easily cure the defect by claiming a catheter “adapted to hold the embryo” rather than claiming a catheter that includes the embryo.

    On the contrary, if the term “adapted to” is construed here to exclude coverage of the novel catheters when they comprise human embryos (which is how the term should be consrued in light of the prosecution history”) then this is the furthest thing from “form” over “substance.” The amendment literally removes the (alleged) issue presented by the original claim. How can such an amendment be deemed anything but substantive?

  41. I’m pretty sure the prohibition against claims…

    I’m pretty sure that you are wrong (again).

    Why not check into Weldon’s past?

    And then, (gasp) contemplate the content provided before making one of your mindless snap retorts. Try applying your own position on the AIA amendment to the actual case reasoning here under the AIA prong.

    Let me know how that goes for you.

  42. tones of a “part of a human” (pro-choice) versus a “human with all its genetic potential, just not capable of supporting itself yet” (pro-life).

    I’m pretty sure the prohibition against claims that would read on parts of human beings (e.g., human cells in vivo) has nothing at all to do with abortion rights and everything to do with a desire to avoid patents that would turn people into infringers merely because they were treated at some point (e.g., because patented cells or patented nucleic acids were inserted into their bodies as part of a therapy).

    The form-over substance should lose out, given Diehr,

    Huh?

  43. Now here is a policy debate that sparks some non-patent law (i.e. eBay) battle zones with tones of a “part of a human” (pro-choice) versus a “human with all its genetic potential, just not capable of supporting itself yet” (pro-life).

    A Hobson’s choice (in some philosophical bents): wide or narrow construction: NARROW: If the decision stands as stated (in pro-choice terms), then ANY parts of a human becomes off-limits, interestingly enough, even the case at the Supreme Court (Myriad). WIDE: If the decision stands as stated (in pro-life terms), the rejection under the AIA indicates that the fetus (or fertilized embryo) is being recognized as ‘human’ and sanctified enough to escape patent eligibility.

    The form-over substance should lose out, given Diehr, and the speaking to the AIA provision of “directed to” differentiating from “encompassing” should also spark some ‘legal’ interest.

    What is (critically) missing from the good professor’s historical treatment above of the originating Weldon amendment is extremely important fact: The Weldon comments listed here are not applicable to the AIA versioneven as congressional record support, for two reasons. One (as noted), Weldon was not even in Congress at the time of the AIA, and Two, his comments (and importantly the congressional record during his actual time in office) included a specific amendment during the attempt by him to pass his language and that amendment was not included in the AIA process, thus rebroadening the actual language used by the AIA to go beyond Weldon’s explanation and attempted narrowing.

    skilled patent attorneys will continue to be able to protect innovations through the patent system

    Gotta love those scriveners

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