Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011)

By Kevin E. Noonan --

Today, the Federal Circuit revisited the patent-eligibility of claims directed to methods for optimizing childhood immunization, in Classen Immunotherapies, Inc. v. Biogen IDEC.  The Federal Circuit's original opinion, handed down in December 2008, was vacated by the Supreme Court in view of that Court's decision in Bilski v. Kappos, and remanded to the Federal Circuit for reconsideration in view of the Supreme Court's instructions on the proper standard to be applied to determine patent-eligibility for method claims.

Today's decision could not be more different from the Federal Circuit's earlier decision.  That decision, in its entirety, was as follows:

In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court's grant of summary judgment that these claims are invalid under 35 U.S.C. § 101.  Dr. Classen's claims are neither "tied to a particular machine or apparatus" nor do they "transform[] a particular article into a different state or thing."  Bilski, 545 F.3d at 954.  Therefore we affirm.

That decision was written by Judge Moore, joined by Judge Newman (who dissented in the Court's en banc In re Bilski decision) and District Court Judge Joseph Farnan, sitting by designation.  Today's opinion was written by Judge Newman, joined by Chief Judge Rader, and Judge Moore penned a furious dissent.  In addition, Judge Rader wrote an opinion containing "additional views" regarding challenges to patent validity sounding in § 101.  The Court in its opinion also addressed not only the § 101 issues raised by the parties but also the denial of summary judgment of invalidity for anticipation and the District Court's determination that the activities of several co-defendants were within the "safe harbor" provisions of 35 U.S.C. § 271(e)(1).  In view of the complexities of these opinions, this post is limited to the majority opinion; future posts will consider Judge Moore's dissent and Chief Judge Rader's "additional views," which are directed to policy implications of § 101 challenges to patent eligibility.

There are three patents in suit:  U.S. Patent Nos. 5,723,283, 6,420,139, and 6,638,739; these patents contain a total of 230 claims asserted in the lawsuit.  Plaintiff designated certain claims as "representative claims," and the panel opinion made its determination on these claims.  The majority opinion draws a distinction between the claims of the '283 patent (which it found were not patent-eligible under § 101) and the claims of the '139 and '739 patents (which the majority found to be patent-eligible).  Claim 1 of the '283 patent can be compared to claim 1 of the '739 patent to illustrate the differences in the claims:

The '283 patent claim:

A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

The '739 patent claim:

1.  A method of immunizing a mammalian subject which comprises:
    (I)  screening a plurality of immunization schedules, by
        (a)  identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and
        (b)  comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s),
    (II)  immunizing said subject according to a subject immunization schedule, according to which at least one of said infectious disease-causing organism-associated immunogens of said lower risk schedule is administered in accordance with said lower risk screened immunization schedule, which administration is associated with a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule.

Plaintiff espoused a broad scope for these claims.  According to the majority opinion, plaintiff argued that the claims of the '739 patent were infringed "when a health care provider reads the relevant literature and selects and uses an immunization schedule that is of lower risk for development of a chronic immune-mediated disorder:" specifically:

[T]he '139 and '739 patents in suit are directly infringed when a physician, hospital or other health care provider reads the relevant literature and selects an immunization schedule and immunizes a patient in accordance with the schedule which appears to have minimal risk.

On the other hand, plaintiffs contended that the claims of the '238 patent were infringed "when a person reviews relevant information, whether the person is a producer of vaccines, a health care provider, or a concerned parent," specifically, "the infringer need only assess risk, it is not necessary for the infringer to conduct its own clinical trials or prove the cause of any adverse effects."

Although the majority opinion suggests that there was sufficient knowledge in the prior art that the patentability of these claims is in question, the opinion draws a strict line between such concerns and the question of patent-eligibility.  And the opinion expressly relies on the intervening precedent of Research Corp. Technologies, Inc. v. Microsoft Corp., 627 F.3d 859 (Fed. Cir. 2010); Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010), cert. granted, _ S. Ct. _ , 2011 WL 973139 (June 20, 2011); and Association for Molecular Pathology v. U.S. Patent & Trademark Office, _ F.3d _, 2011 WL 3211513 (Fed. Cir. July 29, 2011), in reaching its determination on patent-eligiblity.  In reciting the conflicting positions of the parties, the majority opinion appears to be setting forth the basis for its decision:  whether the claims recite merely a mental step or a fundamental scientific principle, or an application of a principle that properly falls within the scope of § 101.

The majority opinion begins its analysis of the patent-eligibility question by reciting the broad scope of the statutory language, citing ancient precedent as well as Diamond v. Chakrabarty for the principle.  According to Judge Newman and Chief Judge Rader, the Supreme Court's decision in Chakrabarty arose at a time when the courts were also considering the patent-eligibility of inventions in "the evolving fields of computer science and technology," including especially Diamond v. Diehr.  In making determinations on patent-eligibility, the majority states that the Supreme Court has directed that "the boundary between abstract principle and practical application may vary with the subject matter."  These principles remain the standard as evidenced by the Supreme Court's decision in Bilski v. Kappos, which the majority opinion cites for the proposition that:

The §101 patent-eligibility inquiry is only a threshold test.  Even if an invention qualifies as a process, machine, manufacture, or composition of matter, in order to receive the Patent Act's protection the claimed invention must also satisfy "the conditions and requirements of this title."  §101.  Those requirements include that the invention be novel, see §102, nonobvious, see §103, and fully and particularly described, see §112.

The majority "appli[ed] this distinction [between patent-eligibility and the substantive requirements of patentability] to the Classen patents" in arriving at its decision that the claims of the '139 and '739 patents satisfy the test and the claims of the '238 patent do not.

Turning to the District Court's decision on summary judgment that the claims of all the patents-in-suit did not recite patent-eligible subject matter, the majority states that the lower court's reasoning was based on its determination that "the method claimed in all three patents includes the mental step of reviewing the relevant literature to determine the lower-risk immunization schedule" and that the lower court did not consider whether the claims satisfied the other provisions of the Patent Act.  Citing Application of Prater, 415 F.2d 1393, 1402 n. 22 (CCPA 1969), the opinion states that "the presence of a mental step is not of itself fatal to §101 eligibility" and that there was no "universal rule" governing "all situations that include mental activity."

Classen argued, and the majority appear to agree, that an important distinction between the claims here and the claims in Bilski is that the presence of "immunization" steps in Classen's claims distinguish them from the commodity hedging method claimed by Bilski.  Recognizing the deficiencies in the Supreme Court's Bilski opinion (through the voice of former Justice Stevens, who "observed" that the majority "never provide[d] a satisfying account of what constitutes an unpatentable abstract idea"), the majority turn to the Federal Circuit's own Research Corp. precedent, for the principle that a claim should be disqualified from patent-eligibility only if the characteristic of "abstractness" "should exhibit itself so manifestly as to override the broad statutory categories of eligibile subject matter."  Although this "standard" appears subjective at best, the majority illustrates its application in Research Corp., where the claimed method was "functional and palpable" and thus patent-eligible.

Again turning to its Research Corp. precedent, the majority recites the statements in that case that subject matter eligibility is a "course eligibility filter" that is not the "final arbiter" of patentability (rather, the substantive provisions of §§ 102, 103 and 112 fulfill that role).  "The preferable procedure" is to "apply the substantive conditions and requirements of patentability" if the claims recite one of the statutory classes of invention and are not "manifestly abstract."  Also relevant to the question is whether there is a "commercial application of the technology," which the opinion contends is an indication that the subject matter is not "so abstract as to negate" patent eligibility under § 101.

Using these guidelines, the majority states that the '139 and '739 patent claims are patent-eligible, inter alia, because they recite methods that include "the physical step of immunization on [a] determined schedule" and thus are "directed to a specific, tangible application."  Although again raising the possibility that the claims do not satisfy the substantive provisions of the Patent Act, the majority concludes that finding these claims to be patent-eligible is consistent with Supreme Court precedent that subject matter eligibility should be construed broadly, and that "categorical rules" should not be adopted due to the possibility that such rules might have "wide-ranging and unforeseen impacts" on innovation.

The claims of the '238 patent, on the other hand, are not patent-eligible according to the majority, because they do not recite affirmative immunization steps.  The distinction appears to be that the patent-eligible claims of the '139 and '739 patents recite immunization steps after the appropriate schedule has been arrived at by operation of the other steps of the claim, whereas the claims of the '238 patent do not require any immunization step (except the steps that produce the pattern of immunization-related diseases and disorders recited in the claim).  This distinction is supported by arguments plaintiff made regarding acts constituting infringement, such as alleging that defendant Merck "induced direct infringement by parents when Merck provides and physicians distribute . . . [a] book that advises parents to understand vaccines and vaccination schedules."  Citing AMP v. USPTO, the majority states that "methods that simply collect and compare data, without applying the data in a step of the overall method, may fail to traverse the §101 filter."  That is the case here for the '238 patent claims.

The opinion also makes a distinction, termed "special consideration," when courts make patent-eligibility determinations for "evolving technologies" in order to provide the "liberal encouragement" for innovation resulting from the "permissive approach" to patent-eligibility taken by Congress in implementing the Patent Act and recognized by courts since (including the recent Bilski opinion by the Supreme Court).  Even under this expansive approach, however, the majority found that the '238 patent claim "is directed to the single step of reviewing the effects of known immunization schedules, as shown in the relevant literature" which, while a "first step in the scientific method" is not sufficient to recite patent-eligible subject matter.  The majority found that the method claimed in the '238 patent "do[es] not include putting this knowledge to practical use" and is merely "directed to the abstract principle that variation in immunization schedules may have consequences for certain diseases."  This "abstraction" is not patent-eligible because it "is unrelieved by any movement from principle to application."

In making this distinction between the '238 patent claims and the '139 and '739 patent claims, the majority states that "[p]ragmatic thoroughness is thereby achieved, for extensive precedent guides the continuum from abstractness to specificity, in the context of a vast breadth of subject matter.  Aided by this experience, courts may more readily resolve close questions such as are here presented."

With regard to the other questions presented for review the majority declined to consider whether the claims were invalid for anticipation, on the grounds that denial of summary judgment was not generally appealable, citing Kendall v. City of Chesapeake, Va., 174 F.3d 437, 443-44 (4th Cir. 1999), as well as the pragmatic consideration that "there is no record, no factual findings or representations on which such findings might be made, indeed no basis for factual inferences, even on the premises of summary adjudication."  The Court did consider the question of infringement and whether certain of the defendants' (Biogen and GlaxoSmithKline) accused activities fell within the "safe harbor" provisions of 35 U.S.C. § 271(e)(1).  These activities constituted post-approval studies to determine whether immunizations with hepatitis B and Haemophilus influenza vaccines increase the incidence of type 1 diabetes, as well as an allegation that Biogen induced infringement by GSK by "providing instructions and/or recommendations on a proper immunization schedule for vaccines."  Classen argued that the § 271(e)(1) safe harbor is limited to pre-approval activities, and the majority agreed.  Assaying the legislative history and the purported purposes of the Hatch-Waxman Act, the opinion states that the safe harbor only applies to pre-approval activities (which the Biogen and GSK actions clearly were not):

§271(e)(1) provides an exception to the law of infringement in order to expedite development of information for regulatory approval of generic counterparts of patented products.  The statute does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.

The majority opinion also finds no change in this analysis based on the Supreme Court's decision in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 207 (2005), which was directed towards "preclinical research" that was, by definition, "pre-approval."  The Supreme Court's Merck decision was directed towards (and limited to) "preclinical research, whether or not ultimately included in a submission to the Food and Drug Administration, [that] is exempted from infringement by §271(e)(1) 'as long as there is a reasonable basis for believing that the experiments will produce "the types of information that are relevant to an IND [investigational new drug application] or NDA [new drug application].'"  Since the accused actions by Biogen and GSK were "not related to producing information for an IND or NDA," the majority concludes that § 271(e)(1) does not provide a safe harbor under the Merck precedent.

Finally, the majority directed that, on remand, the District Court should determine whether allegations of infringement for performing "studies 'to evaluate suggested associations between childhood vaccinations, particularly against hepatitis B and Haemophilus influenza . . . and risk of developing type 1 diabetes; and to determine whether timing of vaccination influences risk'" is properly within the bounds of the right to exclude granted to Classen or whether it is "impermissible under patent principles," i.e., as "preempting the field of study and prevent[ing] any investigation into any immunogen, known or unknown, and to any disease."

Classen Immunotherapies, Inc. v. Biogen IDEC (Fed. Cir. 2011)
Panel:  Chief Judge Rader and Circuit Judges Newman and Moore
Opinion for the court by Circuit Judge Newman; additional views by Chief Judge Rader; dissenting opinion by Circuit Judge Moore

Comments

[6]

Righteous decision wasn't it man?

Did you catch the part where, iirc, the majority was talking about research (pure) never infringing?

[Dan Feigelson]

As usual, Judge Newman gets it right - and shows her integrity to boot: First, yesterday's opinion shows what she wanted to say but didn't the first time Classen came up before the CAFC, because at the time she correctly viewed herself as being bound by the then-in-force en banc decision in Bilksi. Would that all of her colleagues exhibited similar restraint under analogous circumstances. Second, she made it clear that there may be substantive 102/103 patentability issues as well as 112 issues for at least some of the claims, but she wisely threw the case back to the district court to decide on those issues.

Given the current jurisprudence under which there's only joint infringement if the two parties act together or under the control of a third party, what are your thoughts about Classen's chances of proving infringement? The final immunization step is obviously carried out by a physician who is not under the direction of the vaccine manufacturer; if the manufacturer publishes the results of the first two steps separately, but doesn't include include in the package labeling those results and the immunization schedule they suggest, it seems to me there's no infringement and no inducement to infringe under current law.

[Kevin E. Noonan]

Dear Dan: I think we won't know the answer to your question until we get the court's decision in McKesson and Akamai.

Thanks for the comment.

[EG]

Kevin,

As usual, a nice summary of a very complex ruling. I've written an article on this case as well with more editorializing as there are many "subtle" issues in this case that require some explanation. Also, Judge Moore's statement that “I see no distinction between the ’283 claims and ‘139 and ‘739 claims which warrants differing treatment” gets, at most, no more than a D- in my book. I had high hopes for Moore after AMP, but her dissent in the Classen remand dashed them. She's frankly clueless about "claim construction" in the Classen remand.

[Patrick]

EG,

Re: Judge Moore's comment, the contrast between the eligible and ineligible claim is even more pronounced than the contrast between Graham Bell's claim and Morse's.

After a departure in Cybersource, I was thrilled to see the "coarse filter" and "manifestly abstract" language return to a decision. Rader's "additional comments" (joined by Newman, by the way) are a good read and foreshadow the Chief Judge's tendencies regarding a possible en banc rehearing of Cybersource.

[Tim G.]

"[T]he '139 and '739 patents in suit are directly infringed when a physician, hospital or other health care provider reads the relevant literature and selects an immunization schedule and immunizes a patient in accordance with the schedule which appears to have minimal risk."

In fact, according to Classen, the claims are infringed by a "reader" of the "relevant literature" even if the "reader" has been practicing the same immunizing schedule with "minimal risk" for decades and doesn't change the schedule.

Have you thought about this much, Kevin? Does anything about that result strike you as problematic? Does that result appear to raise any issues related to the eligibility of claims under 101? It certainly raises some flags for me, and I believe Judge Moore was also troubled.

What do you think? Do you think that one should be liable for patent infringement merely because one has *considered* an unpatentable fact but is otherwise not engaging in any novel or non-obvious acts?

I suppose one could shrug this "hypothetical" off and say that nobody would ever sue you if you were practicing the prior art while "considering" some new discovery. Except that Classen did exactly that, and he's still doing it.

What do you think, Kevin?

[Tim G.]

EG: "Judge Moore's statement that “I see no distinction between the ’283 claims and ‘139 and ‘739 claims which warrants differing treatment” gets, at most, no more than a D- in my book."

What is the distinction, EG?

[Kevin E. Noonan]

Dear Tim:

I thought it best to set out the three opinions (since Judge Moore does a nice job of presenting the "counter" arguments) and then posting on what I think the decision means (on its own and with regard to Prometheus and Myriad). I do think that the plaintiff was his own worst enemy - it is easy to reach the conclusion that all these claims should be patent-ineligible if they were construed as broadly as he would like them to be. And I think that may be the petard that the majority is strongly suggesting the district court use to hoist the plaintiff on remand - as with many of the statutory subject matter cases, the problem is easily solved by overbreadth and failure to satisfy 112 (for enablement if nothing else) or novelty (since the claims encompass the prior art). That's what I think some of the dicta that appear to be "tangents" in the majority opinion are - a roadmap (or at least a hint) to the defendants and the district court about the way to eliminate this troublesome plaintiff.

More to come. Thanks for the comment.

[EG]

"What is the distinction, EG?"

Tim G.

Here's how I described that distinction in the article I wrote posted today on IPWatchdog:

Briefly, Classen involved three related patents (the ‘739 patent, the ‘139 patent, and the ‘283 patent) directed generally to a method for essentially evaluating an immunization schedule for a treatment group, relative to a control group. But where the ‘739 and ‘139 patents differ from the ‘283 patent is in how this immunization schedule calibration method is claimed (and which became a contentious issue between Judge Newman and Chief Judge Rader in the majority, and Judge Moore in the dissent). In the ‘283 patent, this immunization schedule method is claimed simply as “immunizing” the mammals in the control group according to the immunization schedule and then “comparing” the “incidence, prevalence, frequency or severity of [the] chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.” (As my patent attorney brother Mark has astutely observed, how the method is claimed in the ‘283 patent leaves much to be desired because it never says what “end result” is caused by this claimed method). By contrast, the ‘739 and ‘139 patents start out similarly to the ‘283 patent in defining the claimed method initially as “screening a plurality of immunization schedules” by “identifying” first and second groups of mammals, “immunizing” the first and second groups by different immunization schedules, and then “comparing” the effectiveness of the different immunization schedules. (A side note: the “comparing” step also recites that the “screened immunization schedules may be identified as a lower risk and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing [the] chronic immune mediated disorder(s),” which raises another “can of worms” with regard to the underlined word, also noted by my brother Mark, as to whether the 739 and ‘139 patent claims would even pass muster under 35 U.S.C. §112, second paragraph.) But where the claimed methods of the ‘739 and ‘139 patents part company with the ‘283 patent is in an additional “immunization” step which is carried out on a “subject” by using the “lower risk” immunization schedule (characterized by the majority opinion as the “optimum schedule”) that resulted from the initial “screening” step. (Or to use my brother Mark’s words, we now have an “end result” caused by the “immunization” step of the method claimed in the ‘739 and ‘139 patents.)

If that's not clear enough for you, then I suggest you read my article posted on IPWatchdog to understand what that "distinction" is (and why Judge Moore's failure to understand that "distinction is so mind-boggling to folks like me): http://ipwatchdog.com/2011/09/01/cafc-patent-eligibility-firestorm-of-opinions-in-classen/id=18927/

[Tim G.]

EG, thanks for the laugh.

You forgot to mention that the claims in the '739 and '139 patents have, on average, more words.

Judge Moore is wondering, as I am wondering: what is the distinction between the claims for the purposes of determining their eligibility under 101? Both claims recite a patent ineligible mental step followed by a "transforming step" that may or may not be old in the art (but is certainly drafted broadly enough to inherently cover prior art methods). Is it a data-gathering issue? If so, why does the broadest claim in Prometheus (which recites only a data-gathering "transformative" step) survive but Classen's '283 claim fails (in which when an animal is actually immunized)?

What's the *legal* distinction?

[Tim G.]

"More to come. Thanks for the comment."

You're welcome, Kevin. I will ask the questions again if you don't answer them directly in your post, which you seem loathe to do for whatever reason (while remaining voal and opinionated about a great many other areas of patent law).

[EG]

Tim G.

You may be laughing, but I'm deadly serious about the distinction between the claims in the '739/'139 patents versus those in the '283 patent. If you don't understand the distinction between those two sets of claims, then you didn't read/understand what I wrote in my article, or you share the same "claim construction" myopia that Judge Moore does. That's the best I can do for you, so you can choose to take it or leave it.

[Kevin E. Noonan]

If you don't want to be vocal and opinionated, why have a blog in the first place?

I have no intentions of not setting out my position. Never fear.

[DA]

Like Judge Moore and Tim G and I suspect many others, I do not see how the claims in the '739/'139 patents differ from those in the '283 patent FOR PATENT ELIGIBILITY PURPOSES. (I admit that reading Tim G's explanation above of the alleged difference did not incentivize me to read his article posted on IPWatchdog.) In the '739/'139 claims, a screening step to identify a desirable immunization schedule is followed by an immunization step, whereas in the '283 claims, a step involving the immunization of a group of mammals according to an immunization schedule precedes a comparison step to determine whether this immunization schedule affects the incidence or severity of disease. (To EG's astute brother Mark: note that this determination would clearly seem to be the “end result” caused by the claimed method.) The majority simply pretends that the active step of immunization in the '283 claims does not exist. Judge Moore fully addresses this serious defect in the majority's analysis in n. 1 of the dissent. Incidentally, Judge Moore also ignores this immunization step when it's convenient for her argument (see p. 7, 2nd paragraph - "These claims do nothing more ...")

[6]

EG I has a question, and not to be a total arse about it, but why on earth are you concerned that "he ll on earth" or "chaos" or whatever is going to happen to you patent attorneys?

I mean, it's child's play to avoid 101 issues, even as Moore and I see them, what is all the fuss about? Is all the fuss about your inability to understand how to avoid them? Or are you simply poed that you'll get a tiny fraction less claim scope? Or are you worried about all 50 or so of your prior cases going down the toilet because you didn't understand the lawl properly back when you drafted them?

I'm legitimately curious. Is all of that a concern to you? And if so, why would you not trade it for the stability that the preemption test delivers?

[Kevin E. Noonan]

Dear 6:

Could you please draft a claim that would satisfy 101 for this technology? Since you believe it to be easy I am curious as to how you would do it. And to sweeten the pot, if you post your claim I'll post mine.

[EG]

6,

The reason I'm concerned is because I have clients who are frankly (and rightly) befuddled and alarmed by all the judicial malarkey (that's my late uncle's expression for nonsense) they see in all these court decisions on patent-eligibility (that's not to say that many of us patent attorneys are also not alarmed at trying render sense out of nonsense). Also, "preemption" in my opinion is not primarily a 35 USC 101 issue but instead a 35 USC 112, 1st paragraph issue, per O'Reilly v. Morse (a case that in my opinion is also miscited as a patent-eligibility case).

I'm also not saying the claims in the '739/'139 patent are "picture perfect" or even close (the "may" term in the "comparing" sub-step raises a serious question as to whether the 739 and ‘139 patent claims would even pass muster under 35 U.S.C. §112, second paragraph). But we would all be better of if the courts (and especially SCOTUS) would simply dump all the rhetorical nonsense in Gottshalk v. Benson, Parker v. Flook and especially Bilski v. Kappos, and adopt the objective “tangible, concrete, and useful result” test that was unfortunately dumped by the Federal Circuit in their en banc Bilski deciions. All other tests/standards pale to subjectiveness compared to the TCU test for judging what is and what is not “abstract,” and thus patent-eligible/ineligible under 35 USC 101.

[EG]

6,

One other thing about your reply to my concern about "chaos" and "hell on earth." It reminds me of what the Joker (played by the late Heath Ledger) in Dark Knight said to Two-Face/Harvey Dent (while he’s in the hospital) before the Joker blows up the hospital: “Upset the established order, and everything becomes chaos. I'm an agent of chaos. Oh, and you know the thing about chaos? It's fair!

Enjoy the quote.

[Tim G.]

DA: "I admit that reading Tim G's explanation above of the alleged difference did not incentivize me to read his article posted on IPWatchdog."

That would be *EG's explanation* and *EG's article*, not mine.

[Tim G.]

Kevin "Could you please draft a claim that would satisfy 101 for this technology? Since you believe it to be easy I am curious as to how you would do it. And to sweeten the pot, if you post your claim I'll post mine."

It's a good question, Kevin. For the reasons I alluded to in my earlier comment, a statutory claim would need to describe at least one non-mental step, where that step was not in the prior art, or at least two non-mental steps, where the combination of those two steps is not in the prior art (in this latter instance, each of the two steps need not be new).

Why is this the case? The answer is that facts such as "correlations" are not "technology". They are, well, facts. If your patent directly ("I claim a method of thinking about a fact") or indirectly ("I claim a method a method of thinking about a fact and doing [old transforming step]") turns a person thinking about a fact into an infringer, the patent must be ineligible, invalid or otherwise unenforceable.

Is this a problem for companies who in the business of discovering useful facts? Yes, it certainly is. Those companies need to consider alternatives to patents for protecting the information they are obtaining, or lobby Congress for new patent laws that allow information itself (and the use thereof, in mental processes) to be monopolized. There may be Constitutional issues with the latter approach.

In any event, it must be remembered: everything useful and valuable is not patentable. It's not a bug in the patent system. It's a feature.

[Kevin E. Noonan]

OK, for your consideration:

The ‘283 patent claim:

A method for immunizing a mammal with a vaccine effective in provoking a desired immune response in the mammal, according to an immunization schedule that minimizes chronic immune-mediated disorder or the incidence, severity, prevalence or frequency thereof, wherein said immunization schedule is produced by a) immunizing a treatment group of mammals with one or more doses of one or more immunogens according to a first immunization schedule, and b) determining whether the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, is higher or lower than the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder that occurs when a control group of mammals is immunized with said one or more doses of one or more antigens according to a second, control immunization schedule, and

Immunizing said mammal according to said first immunization schedule when the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder is lower in said first immunization schedule than in said control immunization schedule.

The ‘739 patent claim:

1. A method of immunizing a mammalian subject with a vaccine specific for an infectious disease-causing organism, the method comprising:

(I) immunizing each of a plurality of treatment groups of mammals with an vaccine effective in provoking a desired immune response specific for said infectious disease-causing organism according to a plurality of immunization schedules; and

(II) immunizing said mammalian subject according to the immunization schedule in step (i) that produces the lowest incidence, prevalence, frequency or severity of a chronic immune-mediated disorder in said treatment groups.

I welcome your comments., particularly with regard to enforcement.

[6]

"Also, "preemption" in my opinion is not primarily a 35 USC 101 issue but instead a 35 USC 112, 1st paragraph issue, per O'Reilly v. Morse (a case that in my opinion is also miscited as a patent-eligibility case)."

Well EG, I don't think your opinion matters all that much because the USSC says differently.

"I'm also not saying the claims in the '739/'139 patent are "picture perfect" or even close (the "may" term in the "comparing" sub-step raises a serious question as to whether the 739 and ‘139 patent claims would even pass muster under 35 U.S.C. §112, second paragraph)."

Yeah I busted someone on "may" the other day.

" All other tests/standards pale to subjectiveness compared to the TCU test for judging what is and what is not “abstract,” and thus patent-eligible/ineligible under 35 USC 101."

The preemption doctrine, when properly applied, is 100% objective sir. If it is subjective then you did something wrong in your analysis.

I appreciate your attempt at an answer but it appears, through all your blustering, that your only real issue is that you have clients who are confuzzled. And apparently they're confuzzled about why courts excepted some subject matter back in the day and/or that they're trying to patent some of it now.

Other than that it appears that you simply disagree with the USSC.

Other than the above I simply don't understand what you're upset about. You have some ignorant clients and you have a difference of opinion from the USSC. Big surprise and big whop. We all get it. I have a suggestion though, why not simply write as a prelude to your posts "I'm against the USSC! And my clients are confused! This cannot be tolerated!" Just so that we know what your issues are and if we don't particularly care that you disagree with the USSC or if your clients are confused then we can just read the rest of your post for chuckles.

And I'm not saying that to be mean, it just seems like there's a lot of people arguing against preemption, as a 101 doctrine, that really have no reason at all to be against it. They just think they're against it... SOOOOOOOO BADDDDDDDD that it hurts.

[6]

Oh and how about a magic trick?

http://www.youtube.com/watch?v=QehZjjwb7-I&feature=related

Tada! It's, it's gone!

Also, get with the times. Quotes are so yesteryear. Provide links.

http://www.youtube.com/watch?v=ZRG1tWQN6e8&feature=related

My fav part is where he keeps clicking the remote.

[6]

"Could you please draft a claim that would satisfy 101 for this technology? "

For which "technology" Kev? You mean the abstraction of selecting and using an immunization schedule that is of lower risk for development of a chronic immune-mediated disorder?

Because if so, that's not technology. And so no I will not draft a claim for it.

If they have some specific "technology" in these apps which you'd like me to draft a claim for to compare with your own I don't mind doing it, but you'll have to be more specific because it appears you want me to draft a claim to an abstraction.

[Kevin E. Noonan]

Kinda weak response, 6. Since you said in you earlier comment "I mean, it's child's play to avoid 101 issues, even as Moore and I see them, what is all the fuss about? Is all the fuss about your inability to understand how to avoid them?", I thought you had something to say. My mistake.

[EG]

"The preemption doctrine, when properly applied, is 100% objective sir. If it is subjective then you did something wrong in your analysis."

6,

OK, since you believe the "preemption doctrine" is "100% objective," please explain: (1) your definition of what doctrine means; (2) why your definition is "100% objective"; and (3) how you would analyze a claim under your definition. If you would like, you can analyze the claims in the Classen case based on (1) and (3).

Also, my opinion does matter (just like you're entitled to your opinion): it's called free speech. Whether you like it or not, SCOTUS' technological-ignorance (and arrogance) really shows in the three cases I noted above. Again, like I told Tim G. above, you can take (or leave) my opinion, that's your choice.

And Kevin is correct: your response to his question is "kinda weak." I do hope you do better with questions (1)-(3) I posed to you.

[patent litigation]

Decisions like this one may render it all too easy for clever patent claim drafting to compensate for weaknesses in a supposed "invention."
http://www.generalpatent.com/press/your-opinion-matters-participate-first-ever-pulse-ip-industry-survey

[6]

"I thought you had something to say. My mistake. "

I did say that its child's play to AVOID them Kev. And I did avoid them. In this case I avoided it by not drafting you a claim to an unpatentable abstract idea. You could do the same in your practice if you wanted to.

Again, I don't see what all the fuss is about. Either you guys don't understand that you need to avoid making these kinds of claims in the first place, or you simply don't like that you can't claim these things. Well, it's the USSC v you on the later, and on the former, well, I suppose you may very well know how to avoid them, you're just playing coy because you really really don't like the USSC holding that you can't claim them.

[6]

1. There is no "definition" of what "doctrine" means other than the dictionary one. But I presume you want to know what the instant doctrine is. "the" preemption doctrine is simple, abstract ideas, natural phenom, and laws of nature cannot be patented. And likewise, no drafting tricks can make them patentable.

Some specific examples of drafting tricks that will not make them patentable are: limiting them to a specific technologic environ and post solution activity does not make abstract ideas patentable.

That is from the USSC's words.

And the lower courts recently added tossing in a CRM onto a method to the list of drafting tricks that will not save a claim to an abstract idea.

It should be noted that if the claim does not preempt an abstract idea, natural phenom, or law o nature and if it otherwise appears to fall into a statutory category then the claim passes 101 as of today under this doctrine.

2. Well, the definition of the word doctrine is 100% objective because it is in the dictionary. But the preemption doctrine is objective because it utilizes only objective criteria in the analysis.

3. It's rather simple, you construe the claim, then you think of any possible abstract ideas, laws of nature, or natural phenom that might be an issue for the claim. When you think you've thought of one, you write it down. You then compare the scope of the instant claim to all embodiments which would be covered under a claim just to the abstract idea etc. you wrote down already. If your comparison yeilds a determination that all embodiments which would be covered by a claim to the abstract idea etc. are covered by the instant claims then you have an issue. If your comparison does not, you then consider the reason why it does not. If it appears that the only thing keeping the claim from covering all embodiments which would be covered by a claim to the abstract idea etc. is a "field of use" or "post-solution activity" then you have an issue. If there appears to be a different kind of claim drafting trick then you probably have an issue and need to address it.

It's as simple as that guys. Seriously, it is not rocket science. It can get complex in given situations, but it will rarely take you more than an hour or two of hard work to figure out the answer to that. And all parts of the analysis can be made explicit and subject to any reasonable argument, but if you did it right then there is never really any room for argument. The only questions are, is what was written down one of the exceptions? It's a simple yes or no. The benson algorithm, the arrhenius equation, selecting for use an immunization schedule that is of lower risk for development of a chronic immune-mediated disorder, all of those are great examples of easy to identify judicially excepted subject matter. Then you ask what the claims cover and would the claims cover every embodiment of a claim to just those things. If the answer is yes, which it was in two of these cases, then there is an issue. If the answer is no, as with the arrhenius equation case, then no issue.

"Also, my opinion does matter "

Meh, not really. But, wishful thinking. Carry on with your wishful thinking.

How you guys think my response was weak I cannot fathom. I said it was easy as pie to avoid these issues, and I meant it. Indeed, I showed that I would have avoided the current classen case. The fact that they're going to have to go all the way to the en banc court or the USSC to have their claims properly invalidated (note: not that I think they've invalid as that is a question for a court lol) shows off the wisdom of such avoidance. At least in so far as their independents were concerned. Surely somewhere buried in their applications is some actual technology to which I would be glad to draft you a claim if you be specific.

[6]

"Then you ask what the claims cover and would the claims cover every embodiment of a claim to just those things. "

* Sorry I didn't specify that the "things" were all the embodiments covered by a claim to just the abstract idea etc.

[EG]

Come on 6, you can do better than that. For all that verbiage, that was still a pretty feeble response to my questions. Saying "there is no definition [for the preemption doctrine] other than in the dictionary" was pretty telling. Do you ever bother to consider what's said by the courts as to what the "preemption doctrine" is as being relevant? Or hadn't you heard in AHW v. Phillips that dictionaries are considered "extrinsic evidence" (meaning they have far less weight/value)?

[Skeptical]

EG,

It appears that you assume 6 has a foundation in legal knowledge when such an assumption does not appear warranted.

[EG]

Skeptical,

I made no such assumption (for good reason as you obviously understand); that's why I asked whether he had bothered to consult and cite legal authority, which he obviously did not.

[6]

EG, I personally made up the term "preemption doctrine" to describe the application of judicial exceptions to situations where judicial exceptions are relevant to the instant claims. Got that? I coined it. So far as I know. The term "preemption doctrine" is not in the dictionary. Only the word "doctrine" is. And I'm only telling you that to be snarky. Which apparently you don't understand because you're going down some irrelevant rabbit trail about dictionaries.

Note also that I said "doctrine" is in the dictionary, not "preemption doctrine". Look to your own weak wording of the question for why I put in the bit about it being in the dictionary.

"Do you ever bother to consider what's said by the courts as to what the "preemption doctrine" is as being relevant? "

Considering I made up the term, not really. But I do consider what they have to say relevant to the underlying legal principle. Obviously I'm well versed in the BFDB.

Also, I note that all that I told you above was to tell you what it was, in easy to understand terms rather than the court's confusing "verbiage" AND to show you how it is an objective determination.

Which, I note you really have nothing to say about it not being objective now. So, I guess maybe you got helped out a bit.

[6]

Oh, and I guess I should note for the [Redacted] out there that probably don't understand, I'm using the term in a different context than the constitutional preemption doctrine. Kind of like a man called an NPE a troll in a different context from the three billy goats gruff.

I know, you [Redacted] have a hard time with language.

[EG]

"EG, I personally made up the term "preemption doctrine" to describe the application of judicial exceptions to situations where judicial exceptions are relevant to the instant claims."

Your lack of understanding of legal doctrine continues to show 6. Preemption is an existing doctrine in the patent-eligibility area (and it means basically the claim scope covers too broad a range of technology to be permitted, somwewhat a flavor of 35 USC 112, first paragraph). See headnote to the slip opinion for Bilski v. Kappos (citing O'Reilly v. Morse for the preemption doctrine in the patent-eligibility area). The fact that you say you "made it up" speaks volumes. And the fact that you must resort to profanity (see your redacted comment above) doesn't speak well of your ability to debate. You sometimes have cogent views, but what you say on this thread isn't cogent in my opinion.