Are Drill Bits Now Summary Concepts Too?

The next is a very fantastic Visitor Publish from UC San Francisco Legislation College Professor Jeffrey Lefstin specializing in a latest ITC choice discovering a claimed drill bit summary due to its purposeful limitations. 

by Jeffrey Lefstin

Not too lengthy after the Supreme Court docket determined Mayo v. Prometheus, I wrote an article suggesting, based mostly on a number of the historical past that adopted Funk Brothers, that patents on peculiar industrial processes and compositions might turn into ineligible in Mayo’s wake. Because the Federal Circuit has interpreted Mayo and Alice, a few of that has come to cross. Within the controversial case of American Axle v. Neapco, the Federal Circuit held claims to a course of of producing car driveshafts ineligible underneath § 101, as a result of the claims have been directed to ‘legal guidelines of nature’ and nothing extra. And in Yu v. Apple, the Federal Circuit held claims directed to a digital digicam ineligible as “summary concepts.”

The newest improvement in that development is the Worldwide Commerce Fee’s choice in a piece 337 investigation, In The Matter of Sure Polycrystalline Diamond Compacts and Articles Containing Identical. [2022-10-26 [DI 783166].Fee Opinion] Affirming the Preliminary Dedication, the ITC discovered that the entire asserted claims, directed to diamond composites that can be utilized in drill bits, have been ineligible ‘summary concepts’ underneath § 101.

The claims within the case have been directed to polycrystalline diamond compacts (PDCs), which can be utilized because the chopping components in instruments such rotary drill bits. A PDC consists of a diamond-containing layer (a “desk”) bonded to a substrate. The diamond desk is fabricated by mixing diamond grains with a metal-solvent catalyst, normally together with cobalt. When the substrate and the diamond-catalyst combination is subjected to warmth and strain, the diamond grains turn into bonded to one another and to the substrate.

The patents are based mostly on the strategy of fabricating the PDC at elevated pressures, at the least 7.5 GPa. In line with the patent specs, PDCs fabricated underneath these situations present improved diamond bonding and density, leading to larger thermal stability and resistance to put on.

The asserted claims outline the diamond desk by way of three sorts of properties: (i) structural properties, comparable to the dimensions of the diamond grains; (ii) efficiency measures, such because the diploma of thermal stability or put on resistance achieved in a compact; and (iii) different parameters, comparable to electrical conductivity or magnetic coercivity of the desk, which can be mentioned to replicate the quantity of remaining metal-solvent catalyst or the gap between the diamond grains within the desk.[1]  A consultant declare is from patent US10507565, with the declare limitations at situation within the case highlighted:

18. A polycrystalline diamond compact, comprising:

a polycrystalline diamond desk, at the least an unleached portion of the polycrystalline diamond desk together with:

a plurality of diamond grains instantly bonded collectively through diamond-to-diamond bonding to outline interstitial areas, the plurality of diamond grains exhibiting a mean grain dimension of about 30 μm or much less;

a catalyst occupying at the least a portion of the interstitial areas;

whereby the unleached portion of the polycrystalline diamond desk reveals a coercivity of about 115 Oe to about 175 Oe;

whereby the unleached portion of the polycrystalline diamond desk reveals a mean electrical conductivity of lower than about 1200 S/m; and

whereby the unleached portion of the polycrystalline diamond desk reveals a thermal stability, as decided by distance lower, previous to failure in a vertical lathe take a look at, of at the least about 1300 m.

All of the asserted claims have been upheld towards enablement challenges underneath § 112. Nonetheless, the Preliminary Dedication discovered, and the Fee affirmed, that every one the asserted claims have been directed to “summary concepts” and thus not patent-eligible material underneath § 101.

How might the ITC attain such a end result? Whereas the reasoning will not be all the time straightforward to comply with (the Preliminary Dedication dismissed {the electrical} and magnetic properties recited by the declare as “gratuitous relatively than creative”), the crux of the Fee’s choice is its discovering that the claims recite desired properties however not the best way to obtain these properties:

The claims right here cowl a set of targets for the PDCs that the specs posit could also be derived from enhanced diamond-to-diamond bonding. The claims don’t recite a approach of attaining the claimed traits; they merely recite the specified vary of values for every attribute.

The Fee acknowledged that the specification might have taught the situations and enter supplies wanted to make PDCs with the recited properties – in step with its discovering that lack of enablement had not been proven. However these situations weren’t recited by the claims. In line with the Fee, underneath the Federal Circuit’s choice in American Axle v. Neapco, “unclaimed options of the manufacturing course of ‘can not operate to take away [the claims] from the realm of ineligible material.’” (quoting American Axle). The claims have been due to this fact directed solely to the end result or objective of a diamond desk with the specified properties – an summary thought underneath § 101.

The Fee thus held {that a} composition of matter or manufacture declare, which defines material partly by impact or end result, is patent-eligible underneath § 101 provided that it moreover recites the method by which the claimed materials is made. In any other case, the declare is just directed to the summary thought of attaining that end result.

That may be a outstanding proposition, and would signify a drastic change within the regulation. For it has lengthy been settled that composition or manufacture claims could also be outlined partly by operate or end result, as long as the claims meet the definiteness and disclosure necessities now embodied in § 112.

It’s true that for a time after the Supreme Court docket’s condemnation of “conveniently purposeful language on the actual level of novelty” in Basic Electrical v. Wabash Equipment, 304 U.S. 364 (1938), the Patent Workplace and the courts have been hostile to using ‘purposeful’ limitations to outline compositions. In In re Fullam, 161 F2d. 247 (CCPA 1947), the Court docket of Customs and Patent Appeals thought of a declare to a way for sharpening a baked resin end, which recited using a novel abrasive powder – the powder being characterised within the declare solely by the property of forming flocculates with the abraded materials. The CCPA held that when a declare defines a fabric “not by way of what it’s, however of what it does,” the declare was ‘purposeful’ and due to this fact unpatentable underneath Basic Electrical. This principle survived via In re Fisher, 307 F.second 948 (CCPA 1962), the place the CCPA affirmed the rejection of a declare to a hormone focus outlined by its efficiency. Now framed as a query of indefiniteness underneath of § 112 underneath the 1952 Act, (now § 112(b)), the courtroom discovered the declare invalid as a result of it outlined “what that focus will do relatively than what it’s.” The courts didn’t invalidate these claims as a result of the boundaries of the declare have been unclear, or as a result of the claims have been broader than the disclosure. Somewhat, any use of purposeful language to outline a composition was adequate to invalidate a declare.

However after casting doubt on the Fullam doctrine in In re Fuetterer, 319 F.second 259 (CCPA 1963)[2], the CCPA settled the difficulty conclusively in favor of such claims in In re Swinehart, 439 F.second 210 (CCPA 1971). Swinehart thought of the next declare to an infrared-transparent crystal (helpful, amongst different issues, for the entrance window of heat-seeking missiles):

24. A brand new composition of matter, clear to infra-red rays and immune to thermal shock, the identical being a solidified soften of two elements current in proportion roughly eutectic, certainly one of mentioned elements being BaF2 and the opposite being CaF2.

Notably, eutectic compositions of barium fluoride and calcium fluoride have been recognized within the prior artwork. The fascinating properties of infrared transparency and thermal resistance arose from the situations for preparation described within the disclosure. The disclosure even acknowledged: “The important characteristic of the current invention is the rising of the moment our bodies underneath managed situations.”[3] Thus precisely just like the claims in Polycrystalline Diamond Compacts, the declare recited desired traits of the crystal, however didn’t state how these traits have been achieved.

The Patent Workplace rejected the declare as “purposeful,” as a result of not all eutectic mixtures of BaF2 and CaF2 would have the properties of infrared transparency and thermal resistance recited by the declare. Reversing the rejection (and explicitly overruling Fisher), the CCPA held that there was nothing intrinsically incorrect in defining a composition “by what it does relatively than by what it is.” The courtroom defined that the one points from utilizing such a mode of definition have been (1) attainable lack of novelty, the place the purposeful traits have been inherent within the prior artwork; (2) attainable indefiniteness underneath § 112, the place the language was not sufficiently exact to delineate the subject material embraced by the declare, and (3) attainable inadequate disclosure underneath § 112, the place the breadth of the declare raised questions comparable to scope of enablement.

Subsequent circumstances confirmed that claims might outline compositions by outcomes or results, the place the outcomes relied on the unclaimed manufacturing course of relatively than being derived solely from the chemical or structural properties recited by the declare. For instance, in In re Miller, 441 F.second 689 (CCPA 1971), the declare at situation recited a powdered PFTE composition outlined partly by desired outcomes (comparable to tensile power when sintered), and partly by ‘gratuitous’ properties (comparable to dielectric power), the place the recited properties arose from the method of grinding the powder. The inclusion of properties that derived from the preparation didn’t even elevate any situation on the Patent Workplace, the difficulty within the case being whether or not the powder may very well be outlined by properties manifested solely when the powder was sintered in a mould[4]. Likewise, in In re Roberts, 470 F.second 1399 (CCPA 1973) the courtroom accepted of a declare to “Corrugated polyethylene terephthalate movie having a floor coefficient of friction of lower than about 0.40 as decided by the Bell take a look at,” the place the claimed discount in friction arose from manufacturing steps disclosed within the specification however absent from the declare.  In line with the CCPA, “the absence within the declare of particular steps which might carry concerning the desired friction property is not any defect. The claims outline the boundaries of the claimed invention, and it’s the operate of the specification to element how this invention is to be practiced.”

This line of authority is hardly out of date. As just lately as 2017, in BASF v. Johnson Matthey, 875 F.3d 1360 (Fed. Cir. 2017) the Federal Circuit relied on Swinehart to reverse a district courtroom which had invalidated claims that outlined a composition with purposeful language. Very very like the Fee on this case, the district courtroom invalidated the claims for indefiniteness as a result of they “recite a efficiency property the composition should show, relatively than its precise composition.” The Federal Circuit reversed, holding that purposeful language was permissible as long as the declare glad the Nautilus normal of affordable certainty.

However all that was earlier than at this time’s regime of patent-eligibility, and earlier than the Federal Circuit determined American Axle. When Professor Peter Menell and I filed our amicus brief urging the Supreme Court docket to grant certiorari in American Axle, one of many factors we made was that, by making a declare’s alleged failure to explain the right way to perform an invention a query of § 101, the Federal Circuit had successfully supplanted § 112. Whereas § 112 requires factual inquiries about what the disclosure teaches, American Axle teaches that underneath § 101 the one query is whether or not the “declare on its face” describes a option to attain a specific end result.

At the very least in American Axle there might need been questions whether or not the claims met the necessities of § 112.[5]  So maybe we might justify the result in American Axle as an I-know-it-when-I-see-it take a look at for lack patentability underneath § 112, a lot as Alice has turn into an I-know-it-when-I-see-it take a look at for lack of patentability § 103. But in Polycrystalline Diamond Compacts the Fee particularly discovered that lack of enablement had not been confirmed. The claims have been nonetheless invalid underneath § 101 as directed to outcomes relatively than options.

Whereas maybe shocking, the Fee’s choice is a logical improvement of American Axle’s strategy. To cite American Axle, “options not claimed are irrelevant to step 1 or step 2 of the Mayo/Alice evaluation.” The CCPA’s articulation of the fundamental reality of patent regulation in Roberts – that the claims outline the boundaries of the invention, and the specification particulars how the invention is to be practiced – is arguably now not good regulation following American Axle.

Somewhat sarcastically, the Fee’s patent-eligibility evaluation begins with this quote from Classen Immunotherapies:[6] “The assertion of patent-eligible material has been considerably unchanged for the reason that first Patent Act in 1790.” But when the Fee is appropriate in its utility of American Axle, the Supreme Court docket and the Federal Circuit have swept away many years of patent jurisprudence. Little question the judges of the CCPA would have been stunned to be taught that the claims in Fuetterer, Swinehart, Miller, Roberts, and related circumstances I’ve not talked about right here, have been all “summary concepts,” as a result of the claims recited capabilities relying on “options not claimed.”

And when courts wrestled with the enablement of biotechnology claims in circumstances like In re Fisher, 427 F.second 833 (CCPA 1970), or Amgen v. Chugai, 927 F.second 1200 (Fed. Cir. 1991), the place the claims recited molecules outlined by their organic exercise, the judges might have prevented painstaking inquiry into the information of enablement, as a result of the claims did not recite the right way to obtain the specified actions. And at this time the Supreme Court docket can save itself a substantial amount of time in within the pending enablement case of Amgen v. Sanofi, as a result of the claims are clearly directed to the ‘summary thought’ of antibodies that block the interplay of the PSCK9 and LDLR proteins, with out figuring out how these antibodies are achieved.

The Fee’s choice is at present on attraction. Little question the Federal Circuit might resolve the case, if it’s so inclined, with an advert hoc rule that claims to compositions of matter will not be directed to summary concepts – a lot as Vanda imposed an advert hoc rule that strategies of therapy will not be directed to legal guidelines of nature.[7] However with out addressing the deeper doctrinal and historic errors of American Axle (and in the end Mayo), the courts might discover themselves endlessly plugging their fingers within the leaking holes of at this time’s patent-eligibility regime. Sooner or later we  may come to suppose that the entire edifice is constructed upon a rotten basis, and maybe can be higher swept away.

= = = = =

[1] Much less remaining catalyst and shorter grain-grain distances are each advantageous.

[2] Fuetterer cited the 1952 Act’s new provision on purposeful claiming that now seems as § 112(f). Some, however not all, of the CCPA’s subsequent case regulation on compositions relied on this provision as properly. Swinehart was not based mostly on this provision, however the courtroom took it as proof that its strategy was in step with Congress’s intent. The CCPA prolonged using purposeful claiming to the novel group of a compound (as in comparison with an ingredient in a composition) in In re Barr, 444 F.second 588 (CCPA 1971).

[3] U.S. Patent 3,766,080. These methods have been described within the disclosure as “standard crystal-growing methods.”

[4] It may very well be so outlined, in accordance with the CCPA.

[5] In American Axle the district courtroom denied the defendants’ indefiniteness problem, and the defendants didn’t elevate lack of enablement or written disclosure.

[6] 659 F.3d 1057, 1063 (Fed. Cir. 2011).

[7] However ominously, the Federal Circuit’s latest choice in Chromadex applies the Mayo/Alice two-step inquiry to a composition declare in its place evaluation.