Zircore, LLC v. Straumann Manufacturing, Inc. (E.D. Tex. 2017)

Method for Manufacturing Product (Dental Crown) Found to be Patent Eligible

By Joseph Herndon --

Zircore sued Straumann Manufacturing for patent infringement in the U.S. District Court for the Eastern District of Texas (Marshall Division) of three patents including U.S. Patent No. 7,967,606.  Straumann moved to dismiss Zircore's allegations with respect to the '606 patent for failure to state a claim, contending that the '606 patent claims are not patent eligible under 35 U.S.C. § 101.  The Court denied the motion and found that the '606 patent was not directed to an abstract idea, but alternatively, was directed to a method of manufacturing physical crown copings for prosthodontics.  This was found to be necessarily rooted in the physical world.

The '606 Patent

When a patient requires a tooth replacement, a three-dimensional model of the patient's mouth is prepared.  Using the model of the patient's mouth, a lab technician will fit a metal portion of an abutment into an appropriate location in the model.  The model will then be scanned.  The scan provides data about an orientation of a metal insert within the model of the mouth and also data about the existing teeth surrounding the position of the abutment.  The data from the scan, along with stored data about the standard shape of the metal insert to which the ceramic portion is to be mounted, is used to determine and design the appropriate shape for the ceramic portion of the abutment.  At the same time, the shape of the coping is internally designed, using the data so that the coping will fit over the designed ceramic portion of the abutment.

The invention includes designing the coping and infrastructure by first determining the shape and orientation of the final crown, subtracting a thickness for the crown from the shape to determine the shape and orientation of a coping, and subtracting a thickness for the coping to form the shape and orientation of an abutment.

The invention allows both the coping at the ceramic portion of the abutment to be manufactured from a single block, significantly reducing the amount of material required.  In addition, the inventive system significantly reduces the amount of labor necessary to manufacture the coping and the abutment.  Because the abutment is custom manufactured, a superior mounting surface is achieved, regardless of the orientation of the metal insert with the mouth.

Figure 2 of the '606 patent is reproduced below, and diagrammatically illustrates the manufacturing process.

Claim 1 is representative and reproduced below:

1.  A method of manufacturing custom crown copings and infrastructures comprising the steps of:
    preparing a three-dimensional model of a patient's mouth;
    fitting an implant abutment insert into the model;
    storing data about the implant abutment insert standard size and shape in a file;
    scanning the model while the implant abutment insert is in the model;
    utilizing the implant abutment insert size data and data from said scanning step to determine and design a core to fit over the insert and at the same time determine and design a coping to fit over the core; and
    manufacturing said core and said coping.

Patent Eligibility

In assessing subject matter eligibility, a court must first determine whether the claims at issue are directed to a patent ineligible concept.  If the claims are directed to an ineligible concept, the court must then consider the elements of each claim both individually and as an ordered combination to determine whether the additional elements transform the nature of the claim into a patent eligible application.

Straumann alleged that the claims are directed to the abstract idea of designing two components at the same time.  This highly generic view of the claims was rejected by the Court.

The Court found that Straumann isolated two steps from the '606 patent claims, the combination of which is allegedly the point of novelty, and ignored the remainder of the claims.  Contrary to Straumann's (Defendants) assertion, the '606 patent claims are directed to a method of manufacturing physical crown copings for prosthodontics.

The '606 patent describes a physical process for collecting information about a patient's mouth, preparing a three-dimensional model of the mouth, scanning the model, and on the basis of data collected from this process, manufacturing the custom crown coping.  The Court found that the context of the patent as a whole suggests that the invention is rooted in the physical world.

The Defendants suggested that the claims, at least on their face, appear to include certain steps that could be construed as computerized steps, and thus steps that could arguably be carried out mentally.  But the Defendants cited no authority for the proposition that a claim reciting a method of manufacturing becomes abstract simply because it includes modeling or involves the use of computerized data.

The Court found that the '606 patent claims look nothing like the claims found to be abstract in previous cases, including claims within the two major abstract categories -- those directed solely to collecting and analyzing information, and those involving fundamental economic and conventional business practices.

The Court appeared to take a realistic and pragmatic view of the claim, namely, that it is directed to manufacturing custom crown copings and infrastructures, which is necessarily rooted in in the physical world.

Accordingly, because the Court found that the '606 patent claims are not directed to an abstract idea, the Court found that Zircore had plausibly stated a claim for patent infringement and the motion was denied.

Report and Recommendation by Magistrate Judge Roy S. Payne

Comments

[EG]

Hey Joseph,

A "slam dunk" for being patent-eligible. How in the world can a "method of manufacturing physical crown copings for prosthodontics" be deemed abstract? But then again, the Alice in Patentland world that our Judicial Mount Olympus has foisted on us with its nonsensical Mayo/Alice framework has created such silliness. As Skeptical has correctly stated, time to strip SCOTUS of any jurisdiction to hear/review appeals relating to patent law

[Paul Cole]

What is the likely reaction to denial of cert in Sequenom?

One possible answer is a regression to the mean in the decisions of the lower courts. This decision is perhaps a welcome instance of that phenomenon.

[GrzeszDeL]

As ever, Paul Cole is a font of useful insight. I never thought of it that way, but now that you mention it, I expect that you are probably right.

If ever there was a case the cried out for cert, it was Sequenom. By not taking Sequenom, the SCotUS has rather convincingly shown that they are bored of subject matter eligibility and disinclined to take any more such cases. That in turn signals to those down that ladder that it is safe to nudge the system back into its previous equilibrium.

I was ardently hoping for the Court to take Sequenom. I see, now, that their passing on Sequenom might well have been a blessing in disguise. Thanks for the happy thought.

[Paul Cole]

With the utmost respect to EG, who is personally known to me and is a friend, the time has come to stop referring to "Alice in Patentland", "our Judicial Mount Olympus" and the "nonsensical Mayo/Alice framework". There can be no substitute for careful and detailed factual and legal analysis, which will both identify the correct rules of law flowing from the decisions of the Supreme Court and the Federal Circuit and any flaws in the legal and factual findings in any given decision.

Notwithstanding denial of cert in Sequenom, the underlying reasoning in the CIPA brief remains highly pertinent. The panel opinion erred in not determining whether the claimed subject-matter fell as a matter of substance within the “process” category of §101, see Diamond v. Chakrabarty, 447 U.S. 303, 307 (1980). Instead, it focused unduly on the eligibility of cffDNA as isolated or amplified materials when these were only recited as elements of the claimed process. It gave insufficient weight to the series of acts recited in the claims and to the transformations that they produce: Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, 676, (1972), quoting Cochrane v. Deener, 94 U.S. 780, 788, 24 L. Ed. 139, (1877). It insufficiently considered the recited acts as an ordered combination and the benefits flowing from that combination. In applying the Mayo/Alice framework, the panel opinion applied the words “directed to” over-expansively, thereby bringing an unintendedly broad range of inventions within the scope of the exclusion framework. In the second step of analysis, the panel opinion applied the word “art” with undue generality and treated activity as “well known, routine and conventional” whereas in reality the steps were novel when applied to serum or plasma from a maternal blood sample, that provenance setting the claimed process apart from all other processes, see United States v. Adams, 383 U.S. 39 (1966).

In relation to the amplification step, the naturally occurring phenomenon properly defined is the existence of cffDNA in maternal blood. The resulting synthetic oligonucleotides differ from that phenomenon in that (a) they are of defined length and defined starting and end positions differing from the naturally-occurring nucleotides in cffDNA, (b) they are the result of enzymatic chemical synthesis and not a natural occurrence in their defined form, and (c) they occur in a concentration 1000-1,000,000 times that of the original cffDNA as acknowledged in the panel opinion. They are therefore a newly created article in a new form (higher oligonucleotide concentration), with new provenance and with new utility (detectability), all of which are attributes of eligibility as a “manufacture” under the criteria in Hartranft v. Wiegmann, 121 U. S. 609, 121 U. S. 615 (1887), quoted with approval in American Fruit Growers, Inc. v. Brogdex Co., 283 U. S. 1, 283 U. S. 11 (1931), Diamond v. Chakrabarty, 308 and Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ___, 133 S.Ct. 2107 (2013). The real and tangible oligomer sequences in their amplified form have also become for every practical purpose a new thing commercially and analytically: Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.S.D.N.Y. 1911) (adrenalin), Kuehmsted v. Farbenfabriken of Elberfeld Co., 179 F. 701 (7th Cir. 1910) (aspirin), Merck & Co. v. Olin Mathieson Chem. Corp., 253 F.2d 156 (4th Cir. 1958) (vitamin B12).

Over-expansive interpretation of the words "directed to" is considered in the EPI brief, commenting on the panel's holding that the claimed method begins
and ends with a naturally occurring phenomenon and is therefore directed to naturally occurring phenomena. That this is a non-sequitur is apparent by applying the same analysis to a method of making an omelette. On the panel’s reasoning the method begins with eggs, ends with an egg product and is therefore directed to eggs. The transformative intermediate stages of the cooking process are overlooked. In the panel opinion in Sequenom the transformative nature of the amplification step, the resulting multitude of amplified sequences produced by nucleotide polymerization, and the utility of the amplification product for subsequent analysis are also overlooked

As lead author of both briefs, I can give personal testimony of the toil and sweat involved, not to mention that of my UK colleagues who reviewed the initial drafts and provided comments. I greatly hope that the effort that we all put into creating these documents will not go to waste, but will encourage our colleagues in the US to take up these ideas and develop skilful and persuasive patentability arguments in future cases.

Where a decision is based on gross error it should not be followed but should be distinguished on its facts, as is part of the tools of the trade of any skilled lawyer. For example In re BRCA1- & BRCA2-Based Hereditary Cancer Test, 774 F.3d 755 (Fed. Cir. 2014) which followed on from Myriad concerned a pair of single-stranded DNA primers for determination of a nucleotide sequence of a BRCA1 gene by a polymerase chain reaction. The primers were held to be not distinguishable from the isolated DNA found patent ineligible in Myriad and were held to be not similar to the cDNA found to be patent-eligible. Practitioners inclined to blindly follow the factual outcome rather than seeking the underlying rules of law should reflect that no such prohibition is derivable from the
opinion in Myriad, which as explained in the EPI brief left open the eligibility of claims to isolated DNA elements of new utility. It should be added that the Federal Circuit failed to realize that even if, contrary to the belief of the EPI as amicus, the individual primers were patent-ineligible natural materials, the claim was to a pair of them, being a combination or mixture selected and made by human intervention and therefore plainly qualified under the “composition of matter” category of §101. Failure of the Federal Circuit to recognise this fact was a student-level error which should be pointed out with clarity and determination in argument in subsequent cases.

The only way to bring about change given the difficulty in getting legislation through Congress is to work with the decisions that we have, work out what the rules of law truly are and to find ways of using or working around them. As Margaret Thatcher famously said: "There is no alternative".

[GrzeszDeL]

"The resulting synthetic oligonucleotides differ from that phenomenon in that (a) they are of defined length and defined starting and end positions differing from the naturally-occurring nucleotides in cffDNA, (b) they are the result of enzymatic chemical synthesis and not a natural occurrence in their defined form, and (c) they occur in a concentration 1000-1,000,000 times that of the original cffDNA..."

I feel fairly certain (although I welcome thoughtful correction) that of these three distinctions, only (c) can really matter under U.S. law. Myriad made consideration (a) irrelevant, and (b) is irrelevant on account of Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293, 309 (1884).

Distinction (c) still holds good, in my opinion.

[skeptical]

Mr. Cole,

Sadly, as I have been correct so many times already now, (the "I told you so" thrill is long gone), your crusade is simply misplaced.

The path you want to take (being "all nice" with the Court), is simply not the correct path to take.

You do not get rid of the wolf at the back door by throwing him a nice juicy steak.

[Paul Cole]

@GrzeszDei

Many thanks for your comment.

As to feature (a), a synthetic nucleotide probably qualifies as a composition of matter by virtue of synthesis by the hand of man. If it were to be considered as a new manufacture, then there would be a requirement for Hartranft utility. Example A (Rapamycin) and Example B1 (plasmid pAC1 useful for inserting a gene for promoting the synthesis of β-lactam antibiotics)from my comments submitted to the USPTO in June 2014, see https://www.uspto.gov/sites/default/files/patents/law/comments/mm-f-cole20140615.pdf show natural products not eligible as compositions of matter but arguably eligible as manufactures by virtue of Hartranft utility (see the detailed discussion in those comments).

As regards (b) if the relevant material is synthesized from smaller molecules by the hand of man, it falls within the "composition of matter" category, and the available objection is lack of novelty, not eligibility.

(c) is, I agree, the most persuasive.

However when preparing arguments firstly ALL the differences need to be pointed out because you never can tell how the judges will react (you can predict how they SHOULD react, if you want to know how they WILL react, consult a fortune-teller), and secondly because the differences need to be considered both individually and as an ordered combination

[Paul Cole]

@ Skeptical

I am not advocating appeasement and being nice to the US courts.

Where past opinions are blatantly wrong and demonstrate mistakes unworthy of a law student (as with the University of Utah case and the pair of primers) the mistake should be clearly identified to the court and the criticism of the degree of error should be included in articles and blogs (which often get read by the law clerks). We should not blindly accept a result of a past decision simply because it is in an opinion handed down by the Federal Circuit or even by the Supreme Court. As Oliver Cromwell wrote to the Synod of the Church of Scotland on 5 August 1650 shortly before the Battle of Dunbar: "I beseech you, in the bowels of Christ, think it possible that you may be mistaken."

However, we need skill in analysing past decisions, identifying the relevant rules of law handed down in those cases and applying reasoned argument in the hope of achieving the results we need for our clients.

Legislative clarification would be good if it could be achieved, and if the resulting legislation was in itself clear. But the argument that we need legislative action because we cannot be bothered or lack the legal analytical skills to properly interpret the case law that has already been handed down does not carry much weight. It may be the latter considerations that discouraged the Supreme Court from granting cert in the Sequenom case.

[skeptical]

As an example, Mr. Cole, you blame (again) the lower court for something the Supreme Court itself set as the example with your statement of:

"In applying the Mayo/Alice framework, the panel opinion applied the words “directed to” over-expansively, thereby bringing an unintendedly broad range of inventions within the scope of the exclusion framework."

A single word covers your entire sentence: "Gist"

The Supreme Court in Alice used that very same "Gist" to make claims that had been stipulated by both sides to pass the "machine" statutory category element of 101 into something called (but chosen not to be defined) as "abstract."

This is not the first time this fact has been presented to you.

Sadly, this is also not the first time that you are choosing to ignore the facts and continue to advocate for some (rather undeserved) "respect" of the High Court.

You can - as you so choose - continue to do so and continue to admire the Emperor's clothes, but please desist from hushing the child (here EG, your known friend) when EG is merely reiterating the fact the Emperor is not actually wearing any clothes.

[Paul Cole]

@ Skeptical

A computer check of the Alice opinion reveals a number of occurrences of the words "directed to" but none of the word "gist". On the whole I prefer to use the actual words of the statute and the opinions because that minimizes the risk of inadvertent error. But I agree with you that the word "gist" summarizes what was intended, the alternative word "substance" which has similar meaning being used in the CIPA brief.

It is regrettable in Alice that the Supreme Court did not first consider positive patent eligibility before considering the judicial exclusions. The MPEP cites in relation to "machine" Burr v. Duryee, 68 U.S. (1 Wall.) 531, 570, 17 L. Ed. 650 (1863)and Corning v. Burden, 56 U.S. 252, 267, 14 L. Ed. 683 (1854). If you look at those decisions, the case for positive eligibility in Alice looked very weak since what was claimed was essentially the result achieved by the computer without anything new and innovative in the way in which the computer worked to achieve those results.

Far be it from me to hush EG. But reasoned and detailed criticism is more positive than name-calling.

[skeptical]

Mr. Cole,

You seek "positive" and cringe from name-calling, all the while missing he point that the Emperor is, in fact, not wearing clothes.

This is not about name-calling.

This is about the judicial activism that STARTS at the top of the judicial food chain and is being MERELY reflected in the lower courts.

As much as it pains me - I told you so.

[Paul Cole]

@ Skeptical

You favour abuse and name calling: "Got no clothes, you asshole!" I favour pointing out in detail where habitual clothes are missing, where this offends against public codes of decency and what those codes are. We differ in style, but are essentially on the same side.

[GrzeszDeL]

ALL the differences need to be pointed out because you never can tell how the judges will react (you can predict how they SHOULD react, if you want to know how they WILL react, consult a fortune-teller)...

Too true, and well said (as usual).

[skeptical]

Mr. Cole,

My posts have been absent of abuse and name-calling.

And while you may view us "on the same side," I will agree only to the point that I do point out: you seem stuck on wanting to NOT see the fault that starts with the Supreme Court themselves.

It is not abusive to make this distinction, and (yet again), I have been proven correct in the effects that ripple through the court system (even as you want something else).

Your issue then - in truth - is not with me, but in the real world cause and effects that simply do not take your ever so careful view of the law.

(mind you, I am not denigrating your careful view of the law per se - such care and meticulousness is certainly a virtue - but the lack of being in touch with the reality of US jurisprudence on the topic is an observation that you should, but insist on not, take to heart.