September 30, 2023

The next is a very great Visitor Publish from UC San Francisco Legislation Faculty Professor Jeffrey Lefstin specializing in a latest ITC resolution discovering a claimed drill bit summary due to its useful limitations. 

by Jeffrey Lefstin

Not too lengthy after the Supreme Courtroom determined Mayo v. Prometheus, I wrote an article suggesting, based mostly on a few of the historical past that adopted Funk Brothers, that patents on strange industrial processes and compositions may change 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 beneath § 101, as a result of the claims had been directed to ‘legal guidelines of nature’ and nothing extra. And in Yu v. Apple, the Federal Circuit held claims directed to a digital digital camera ineligible as “summary concepts.”

The most recent growth in that development is the Worldwide Commerce Fee’s resolution in a bit 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, had been ineligible ‘summary concepts’ beneath § 101.

The claims within the case had been directed to polycrystalline diamond compacts (PDCs), which can be utilized because the slicing parts 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, often together with cobalt. When the substrate and the diamond-catalyst combination is subjected to warmth and stress, the diamond grains change into bonded to one another and to the substrate.

The patents are based mostly on the strategy of fabricating the PDC at elevated pressures, a minimum of 7.5 GPa. In accordance with the patent specs, PDCs fabricated beneath these circumstances present improved diamond bonding and density, leading to increased thermal stability and resistance to put on.

The asserted claims outline the diamond desk by way of three sorts of properties: (i) structural properties, corresponding 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, corresponding to electrical conductivity or magnetic coercivity of the desk, which might be stated to mirror 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 concern within the case highlighted:

18. A polycrystalline diamond compact, comprising:

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

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

a catalyst occupying a minimum of a portion of the interstitial areas;

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

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

whereby the unleached portion of the polycrystalline diamond desk displays a thermal stability, as decided by distance minimize, previous to failure in a vertical lathe check, of a minimum of about 1300 m.

All of the asserted claims had been upheld in opposition to enablement challenges beneath § 112. Nonetheless, the Preliminary Dedication discovered, and the Fee affirmed, that each one the asserted claims had been directed to “summary concepts” and thus not patent-eligible subject material beneath § 101.

How may the ITC attain such a consequence? Whereas the reasoning isn’t at all times straightforward to comply with (the Preliminary Dedication dismissed {the electrical} and magnetic properties recited by the declare as “gratuitous somewhat than ingenious”), the crux of the Fee’s resolution 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 objectives for the PDCs that the specs posit could also be derived from enhanced diamond-to-diamond bonding. The claims don’t recite a method of reaching the claimed traits; they merely recite the specified vary of values for every attribute.

The Fee acknowledged that the specification might have taught the circumstances and enter supplies wanted to make PDCs with the recited properties – per its discovering that lack of enablement had not been proven. However these circumstances weren’t recited by the claims. In accordance with the Fee, beneath the Federal Circuit’s resolution in American Axle v. Neapco, “unclaimed options of the manufacturing course of ‘can not perform to take away [the claims] from the realm of ineligible subject material.’” (quoting American Axle). The claims had been subsequently directed solely to the consequence or purpose of a diamond desk with the specified properties – an summary thought beneath § 101.

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

That could be a outstanding proposition, and would signify a drastic change within the legislation. For it has lengthy been settled that composition or manufacture claims could also be outlined partly by perform or consequence, 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 Courtroom’s condemnation of “conveniently useful language on the actual level of novelty” in Basic Electrical v. Wabash Equipment, 304 U.S. 364 (1938), the Patent Workplace and the courts had been hostile to the usage of ‘useful’ limitations to outline compositions. In In re Fullam, 161 F2d. 247 (CCPA 1947), the Courtroom of Customs and Patent Appeals thought of a declare to a technique for sharpening a baked resin end, which recited the usage of 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 cloth “not by way of what it’s, however of what it does,” the declare was ‘useful’ and subsequently unpatentable beneath Basic Electrical. This principle survived via In re Fisher, 307 F.2nd 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 beneath of § 112 beneath the 1952 Act, (now § 112(b)), the court docket discovered the declare invalid as a result of it outlined “what that focus will do somewhat than what it’s.” The courts didn’t invalidate these claims as a result of the boundaries of the declare had been unclear, or as a result of the claims had been broader than the disclosure. Slightly, any use of useful language to outline a composition was enough to invalidate a declare.

However after casting doubt on the Fullam doctrine in In re Fuetterer, 319 F.2nd 259 (CCPA 1963)[2], the CCPA settled the difficulty conclusively in favor of such claims in In re Swinehart, 439 F.2nd 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 stated elements being BaF2 and the opposite being CaF2.

Notably, eutectic compositions of barium fluoride and calcium fluoride had been recognized within the prior artwork. The fascinating properties of infrared transparency and thermal resistance arose from the circumstances for preparation described within the disclosure. The disclosure even said: “The important characteristic of the current invention is the rising of the moment our bodies beneath managed circumstances.”[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 had been achieved.

The Patent Workplace rejected the declare as “useful,” 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 fallacious in defining a composition “by what it does somewhat than by what it is.” The court docket defined that the one points from utilizing such a mode of definition had been (1) doable lack of novelty, the place the useful traits had been inherent within the prior artwork; (2) doable indefiniteness beneath § 112, the place the language was not sufficiently exact to delineate the subject material embraced by the declare, and (3) doable inadequate disclosure beneath § 112, the place the breadth of the declare raised questions corresponding to scope of enablement.

Subsequent circumstances confirmed that claims may outline compositions by outcomes or results, the place the outcomes trusted the unclaimed manufacturing course of somewhat than being derived solely from the chemical or structural properties recited by the declare. For instance, in In re Miller, 441 F.2nd 689 (CCPA 1971), the declare at concern recited a powdered PFTE composition outlined partly by desired outcomes (corresponding to tensile energy when sintered), and partly by ‘gratuitous’ properties (corresponding to dielectric energy), 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 concern on the Patent Workplace, the difficulty within the case being whether or not the powder could possibly be outlined by properties manifested solely when the powder was sintered in a mildew[4]. Likewise, in In re Roberts, 470 F.2nd 1399 (CCPA 1973) the court docket authorized 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 check,” the place the claimed discount in friction arose from manufacturing steps disclosed within the specification however absent from the declare.  In accordance with the CCPA, “the absence within the declare of particular steps which might carry in regards to the desired friction property isn’t any defect. The claims outline the boundaries of the claimed invention, and it’s the perform 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 court docket which had invalidated claims that outlined a composition with useful language. Very very similar to the Fee on this case, the district court docket invalidated the claims for indefiniteness as a result of they “recite a efficiency property the composition should show, somewhat than its precise composition.” The Federal Circuit reversed, holding that useful language was permissible as long as the declare glad the Nautilus customary of affordable certainty.

However all that was earlier than right now’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 Courtroom to grant certiorari in American Axle, one of many factors we made was that, by making a declare’s alleged failure to explain easy methods 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 beneath § 101 the one query is whether or not the “declare on its face” describes a option to attain a selected consequence.

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

Whereas maybe shocking, the Fee’s resolution is a logical growth of American Axle’s method. 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 fact of patent legislation 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 legislation following American Axle.

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

And when courts wrestled with the enablement of biotechnology claims in circumstances like In re Fisher, 427 F.2nd 833 (CCPA 1970), or Amgen v. Chugai, 927 F.2nd 1200 (Fed. Cir. 1991), the place the claims recited molecules outlined by their organic exercise, the judges may have averted painstaking inquiry into the information of enablement, as a result of the claims didn’t recite easy methods to obtain the specified actions. And right now the Supreme Courtroom 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 resolution is at the moment on attraction. Little doubt the Federal Circuit may 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 remedy will not be directed to legal guidelines of nature.[7] However with out addressing the deeper doctrinal and historic errors of American Axle (and finally Mayo), the courts might discover themselves endlessly plugging their fingers within the leaking holes of right now’s patent-eligibility regime. In some unspecified time in the future we  would possibly come to assume 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 useful claiming that now seems as § 112(f). Some, however not all, of the CCPA’s subsequent case legislation on compositions relied on this provision as nicely. Swinehart was not based mostly on this provision, however the court docket took it as proof that its method was per Congress’s intent. The CCPA prolonged the usage of useful claiming to the novel group of a compound (as in comparison with an ingredient in a composition) in In re Barr, 444 F.2nd 588 (CCPA 1971).

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

[4] It could possibly be so outlined, in line with the CCPA.

[5] In American Axle the district court docket 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 resolution in Chromadex applies the Mayo/Alice two-step inquiry to a composition declare in its place evaluation.