The next is a extremely great Visitor Put up from UC San Francisco Legislation Faculty Professor Jeffrey Lefstin specializing in a current ITC determination discovering a claimed drill bit summary due to its practical limitations.
Not too lengthy after the Supreme Courtroom determined Mayo v. Prometheus, I wrote an article suggesting, primarily based on a number of the historical past that adopted Funk Brothers, that patents on extraordinary industrial processes and compositions might turn out to be ineligible in Mayo’s wake. Because the Federal Circuit has interpreted Mayo and Alice, a few of that has come to move. Within the controversial case of American Axle v. Neapco, the Federal Circuit held claims to a course of of producing vehicle 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 digital camera ineligible as “summary concepts.”
The newest growth in that pattern is the Worldwide Commerce Fee’s determination in a piece 337 investigation, In The Matter of Sure Polycrystalline Diamond Compacts and Articles Containing Similar. [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 out to be bonded to one another and to the substrate.
The patents are primarily based on the strategy of fabricating the PDC at elevated pressures, a minimum of 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 when it comes to three sorts of properties: (i) structural properties, reminiscent of 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, reminiscent of electrical conductivity or magnetic coercivity of the desk, which are stated 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 difficulty 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 straight bonded collectively through diamond-to-diamond bonding to outline interstitial areas, the plurality of diamond grains exhibiting a median 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 reveals a coercivity of about 115 Oe to about 175 Oe;
whereby the unleached portion of the polycrystalline diamond desk reveals a median 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 minimize, previous to failure in a vertical lathe check, of a minimum of 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 each 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 consequence? Whereas the reasoning just isn’t at all times simple to observe (the Preliminary Dedication dismissed {the electrical} and magnetic properties recited by the declare as “gratuitous fairly than ingenious”), the crux of the Fee’s determination is its discovering that the claims recite desired properties however not the way in which 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 manner 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 – per 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 determination in American Axle v. Neapco, “unclaimed options of the manufacturing course of ‘can’t 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 consequence 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 partially by impact or consequence, 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 simply directed to the summary thought of attaining that consequence.
That may be a exceptional proposition, and would symbolize a drastic change within the regulation. For it has lengthy been settled that composition or manufacture claims could also be outlined partially by operate 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 practical 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 ‘practical’ 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 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 cloth “not when it comes to what it’s, however of what it does,” the declare was ‘practical’ and due to this fact unpatentable underneath Basic Electrical. This idea 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 fairly 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. Relatively, any use of practical language to outline a composition was ample 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 proof against thermal shock, the identical being a solidified soften of two elements current in proportion roughly eutectic, considered one of stated elements being BaF2 and the opposite being CaF2.
Notably, eutectic compositions of barium fluoride and calcium fluoride have been identified 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 said: “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 “practical,” 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 mistaken in defining a composition “by what it does fairly than by what it is.” The courtroom defined that the one points from utilizing such a mode of definition have been (1) potential lack of novelty, the place the practical traits have been inherent within the prior artwork; (2) potential indefiniteness underneath § 112, the place the language was not sufficiently exact to delineate the subject material embraced by the declare, and (3) potential inadequate disclosure underneath § 112, the place the breadth of the declare raised questions reminiscent of 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 fairly 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 difficulty recited a powdered PFTE composition outlined partially by desired outcomes (reminiscent of tensile energy when sintered), and partially by ‘gratuitous’ properties (reminiscent of 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 increase any difficulty 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 permitted 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 line 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 bounds 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 not too long ago 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 practical language. Very very similar to 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, fairly than its precise composition.” The Federal Circuit reversed, holding that practical language was permissible as long as the declare glad the Nautilus customary of cheap certainty.
However all that was earlier than at the moment’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 the best 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 method to attain a specific 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 might justify the end result in American Axle as an I-know-it-when-I-see-it check for lack patentability underneath § 112, a lot as Alice has turn out to be 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 have been nonetheless invalid underneath § 101 as directed to outcomes fairly than options.
Whereas maybe shocking, the Fee’s determination 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 reality of patent regulation in Roberts – that the claims outline the bounds of the invention, and the specification particulars how the invention is to be practiced – is arguably now not good regulation following American Axle.
Relatively mockingly, 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 right in its utility of American Axle, the Supreme Courtroom and the Federal Circuit have swept away many years of patent jurisprudence. Little question the judges of the CCPA would have been stunned to study that the claims in Fuetterer, Swinehart, Miller, Roberts, and comparable circumstances I’ve not talked about right here, have 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.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 averted painstaking inquiry into the details of enablement, as a result of the claims did not recite the best way to obtain the specified actions. And at the moment the Supreme Courtroom can save itself quite a lot 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 determination is at the moment on enchantment. 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 should not directed to summary concepts – a lot as Vanda imposed an advert hoc rule that strategies of therapy should not 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 the moment’s patent-eligibility regime. Sooner or later we would possibly come to suppose that the entire edifice is constructed upon a rotten basis, and maybe can be higher swept away.
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[1] Much less remaining catalyst and shorter grain-grain distances are each advantageous.
[2] Fuetterer cited the 1952 Act’s new provision on practical 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 primarily based on this provision, however the courtroom took it as proof that its method was per Congress’s intent. The CCPA prolonged using practical 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 strategies have been described within the disclosure as “typical crystal-growing strategies.”
[4] It may very well be so outlined, based on the CCPA.
[5] In American Axle the district courtroom denied the defendants’ indefiniteness problem, and the defendants didn’t increase lack of enablement or written disclosure.
[6] 659 F.3d 1057, 1063 (Fed. Cir. 2011).
[7] However ominously, the Federal Circuit’s current determination in Chromadex applies the Mayo/Alice two-step inquiry to a composition declare in its place evaluation.
